The 2018 Global Clinical Supplies Group US Conference: Program

Biography:

Steve is a successful consultant, trainer, business leader, executive coach, mentor and speaker. For the past 25 years he’s been heavily involved in clinical supply chain operations, IMPs, cGMPs, cGCPs, cGDPs, clinical development and quality (ICH Q8, Q9 & Q10) for pharmaceuticals, and biotech products.

He sits on the Board of Directors of the largest professional clinical supply organization in the world, the Global Clinical Supplies Group. His expertise also includes success in leadership, innovation, global cultural dynamics, organizational development, and high performing teams.

In the past he has been a CEO and COO, as well as the president and Global Chief Operating Officer, of a multinational clinical supply chain contract organization that served companies like Novartis, Eisai, Lilly and others in the pharmaceutical and biotech sector. Before that he was head of US clinical supply operations for Johnson & Johnson.

Steve was also a logistics and aviation officer, in the U.S. Army, where he rose to the rank of Major and was a maintenance test pilot, and pilot in command, for both helicopters and fixed wing aircraft.

His undergraduate degree is in Pharmacy from the University of the Sciences in Philadelphia and his MBA is from the University of Phoenix with a specialization in global management.

Steve has traveled all over the world (4 Continents, 25 Countries, 42 States) and enjoys spending time with his Fiancé, son, and good friends, whenever he gets the chance.

Biography:

Mr. Dallmann is currently the Principal of CMD Clinical Supply, a consulting group focused on pharma Supply Chain management.  He was previously the Director, Clinical Packaging and Labeling for Gilead Sciences and has more than 20 years’ experience in product and process development.  Prior to joining Gilead Sciences, Mike served as Director, Global Clinical Trial Supply for Cubist Pharmaceuticals and at Forest Laboratories subsidiary Cerexa as Associate Director – Global Pharmacy and Logistics Management. He has held similar roles at Peninsula Pharmaceuticals, Inc., a Johnson & Johnson company and at Elan Pharmaceuticals.  Early in his career he was a Research & Development Scientist for Oral-B Laboratories. He received a bachelor’s degree in biochemistry from the University of Guelph in Ontario, Canada. Mike is also on the board of directors for the Global Clinical Supply Group.

Biography:

Roopal Patel is as global head and Sr. Director of Global Trade Compliance at PAREXEL International with accountability for the company’s policies and procedures related to import and export activities.
Roopal has over 14 years of experience in life sciences that comprise of developing and managing international trade compliance strategies and policies in areas such as duties/VAT, licensing, Free Trade Zone, product classifications and customs regulations.
Additionally, she participates in national and international import/export committee sponsored by regulatory authorities and trade associations by authoring comments on proposed trade regulations by government authorities.

Roopal has an MJ in Health Law, an MBA and an MS in Organic Chemistry.

Biography:

Rich Nelson is the Senior Manager of Global Logistics for PCI Clinical Services.  He has been with PCI in various capacities since 2012.  Prior to joining the company, Rich was a member of the Distribution Project Management team at Fisher Clinical Services, Allentown, and a PM at Cenduit IRT Solutions, for a total of almost 15 years of experience in the clinical industry.  Rich holds a Bachelor of Arts from Monmouth University in New Jersey, USA. 

Biography:

Steve is a successful consultant, trainer, business leader, executive coach, mentor and speaker. For the past 25 years he’s been heavily involved in clinical supply chain operations, IMPs, cGMPs, cGCPs, cGDPs, clinical development and quality (ICH Q8, Q9 & Q10) for pharmaceuticals, and biotech products.

He sits on the Board of Directors of the largest professional clinical supply organization in the world, the Global Clinical Supplies Group. His expertise also includes success in leadership, innovation, global cultural dynamics, organizational development, and high performing teams.

In the past he has been a CEO and COO, as well as the president and Global Chief Operating Officer, of a multinational clinical supply chain contract organization that served companies like Novartis, Eisai, Lilly and others in the pharmaceutical and biotech sector. Before that he was head of US clinical supply operations for Johnson & Johnson.

Steve was also a logistics and aviation officer, in the U.S. Army, where he rose to the rank of Major and was a maintenance test pilot, and pilot in command, for both helicopters and fixed wing aircraft.

His undergraduate degree is in Pharmacy from the University of the Sciences in Philadelphia and his MBA is from the University of Phoenix with a specialization in global management.

Steve has traveled all over the world (4 Continents, 25 Countries, 42 States) and enjoys spending time with his Fiancé, son, and good friends, whenever he gets the chance.

Biography:

Paul O’Connor is Global Vice President of Quality at Almac Clinical Services and a member of the Executive leadership team which supports the full range of client engagement and excellence in service delivery. He is responsible for leading the Quality function on all sites encompassing over 220 professional staff in areas of Quality Assurance and Control, Regulatory Support, Quality Systems, and Validation. Prior to that, Paul held other Quality Assurance and laboratory roles in relation to investigational and licensed medicinal products in Almac and Galen Holdings in a pharmaceutical career of over 25 years.
He is eligible to act as a European Union Qualified Person (QP) since 2001 and also holds a BSc First in Biochemical Sciences from the Ulster University.
Paul has written multiple industry articles and presents regularly at Investigational Medicinal Product conferences on Quality Assurance and Qualified Person matters

Biography:

Adrian Peskett has just moved to the new role, Head of Operational Strategy within Pfizer’s Global Clinical Supply Chain. He has worked with Pfizer for over 15 years supporting various aspects of the supply chain. Adrian’s responsibilities have included master planning, inventory management, commercial sourcing, packaging, labeling, process improvement, external vendor management, business development, licensing management and distribution. Today he is responsible for a team that is developing clinical supply operation strategy for the entire Pfizer portfolio. He is currently located in the US but spent many years in the UK and has considerable experience in optimizing international clinical supply chain activities. Adrian obtained his first degree from University of Wales, College of Cardiff and his MBA from the University of Kent.

Biography:

Ms. Borgeson is a Director in the Quality Assurance Operations Support Group based at Pfizer Inc. in Groton, Connecticut responsible for supporting global operational groups involved in clinical supply packaging, labeling, distribution and IRT system use. She has over 15 years of experience in the pharmaceutical industry in both the Commercial and Clinical GMP manufacturing operational areas as well as Clinical Supply Quality Assurance. Her experience spans roles that include vaccines, parenteral manufacturing, packaging, lyophilization, inventory management, distribution, validation and quality assurance. Prior to her roles in the pharmaceutical industry she held roles in patient care both in the private Physician and Hospital settings. She holds a Bachelor degree in Biology and Business from Oakland University in Rochester Hills, Michigan.

Biography:

Greg Brazier is Director, Clinical Operations for PCI’s North American Clinical Services business. Greg has held various roles within the company since joining PCI in 2000 and has overseen many large global clinical and commercial packaging operations, and offers extensive experience and expertise in operations.

In his current role he has overall responsibility and leadership for production, engineering, order processing, warehouse operations and logistics. Greg also oversees the compliance of all plant operations with company policy, federal, state and local regulations including OSHA, FDA and employment law.

Prior to joining PCI Greg held a number of roles within the pharmaceutical industry and is a United States Navy Veteran.

Biography:

Stephen Flaherty is the Global Director for Demand Led Services (DLS) – FastChainTM within Catalent Pharma Solutions.
He has worked in various clinical supplies roles of increasing responsibility for 28 years, mainly focussed in the Project Management area, previously having had responsibility for PM teams in UK and Germany. He has (IMP) QP eligibility status within Europe (for the time being.)
His latest role has been to lead the: creation, development and deployment of the DLS – FastChainTM model within the Catalent network.
He has overseen the set up and delivery of global and regional teams, systems and procedures which have enabled 5 local and regional DLS – FastChainTM hubs, in Americas, EU, and Asia, to become operational, in the last 3 years, with plans for more to follow in the future.
Currently the network supports both regional and global studies and processes several thousand individual orders p.a. with significant expansion forecasted and planned.
Stephen also acts as the main point of contact with key clients, at a senior level, during the inception, development, execution, maintenance, refinement and scale-up of the FastChainTM model, to meet each client’s: portfolio, programme and study requirements

Biography:

Mike is responsible for the development, implementation, product management and ownership of World Courier’s patient centric services across 140+ company-owned offices in 50+ countries, with focus on direct-to-patient services. Since joining World Courier in 1992, Mike assumed a number of positions within US operations, customer service, training, compliance, marketing, sales and clinical trials management. He progressed to senior roles, including director of US customer service / operations, director of new service development and director of regional accounts, before transitioning into a global IT leadership position and prior to his current cross-functional role within the global services team. Based in Philadelphia, Pennsylvania (USA), Mike works extensively across World Courier’s global network.

Biography:

David began his pharmaceutical career in 2007 with Hospira, in Lake Forest, IL, performing BET and potency testing in the global stabilities lab. From there, he began managing packaging and labeling activities at Fisher Clinical Services for five years.  In 2015, David moved to Takeda where he was a Senior Program Manager, focusing on delivery of clinical supplies for Takeda’s vaccines division.  David is  now a Clinical Supplies Lead at Shire, at their Lexington, MA, location.  He is responsible for packaging, labeling, distribution, returns, reconciliation, and destruction activities for both large and small molecule drug products for global studies, which involve direct-to-patient services in North America and the EU.  Through these efforts, David has focused on developing Shire’s management of direct-to-patient services which include improving logistics, chain of custody, communication, understanding regulatory impact, issue tracking, and lessons learned.

Biography:

Cyrille Lefevre has a background of engineer in applied mathematics. He has been working on the development of CT-FAST optimization software at N-SIDE in the last 6 years. He has experience advising both large and small pharma for the forecasting and optimization of their clinical trials for all phases and through multiple therapeutic areas. Cyrille also has a large experience training teams from multiple large organisations focusing on improving IRT resupply algorithms and the way they are used

Biography:

Innovative and effective biotech/pharma development operations leader with 20+ years of industry experience. Successful build out and leadership of clinical supply organizations in small and mid-sized companies to deploy industry best practices to ensure successful end-to-end supply process to support program and study level support for phase I-IV global clinical studies. Expertise in business operations and biological sample management. Successful in implementing process, technologies, and teams to enable optimally functioning organizations.

Biography:

James Oberhauser is currently Associate Director, Device Development and Clinical Packaging Engineering at Gilead Sciences in Foster City, CA. His responsibilities include growing a device development team to meet the needs of the parenteral and biologics pipeline and establishing the quality system infrastructure essential to a successful device development enterprise. Previously, Dr. Oberhauser led product development of Abbott Vascular’s Absorb™ Bioresorbable Vascular Scaffold (BVS), authoring the seminal article on the therapy in EuroIntervention and receiving the Innovation Team Award from the Abbott Laboratories Volwiler Society. Dr. Oberhauser holds 47 issued patents and has authored 22 peer-reviewed journal publications.
Dr. Oberhauser received his Ph.D. in chemical engineering from the University of California, Santa Barbara, where he studied structure-property relationships in polymeric materials. He also spent over 6 years on the faculty of the Department of Chemical Engineering at the University of Virginia.

Biography:

Yvonne Stephens has worked in Clinical Trial Supply Chain Planning at Eli Lilly and Company for the past 14 years. In this role, she supports the Diabetes business unit in clinical trial supply planning.  Her responsibilities encompass development of molecule/trial demand forecasts in partnership with a clinical team, strategic development of packaging, labeling and sourcing of investigational product as well as devices, supporting innovation and process optimization to speed drug development, as well as applying knowledge on GMP/GCP compliance in a clinical trial environment.

Biography:

Mark Mancuso is National Sales Manager at Faubel Pharma Services.  Mark was educated at Boston University with a degree in Biology. He has  worked in  research laboratories, and also provided solutions to labs,  looking to discover the next life changing drug.  Mark  has always had a strong passion towards science and its ability to improvepatient’s lives so the move to clinical trial supplies, specifically labels & blinding solutions, was a natural fit.

Biography:

Beth Young is currently a Manager within Global Clinical Supply Solutions at PRA Health Sciences. Prior to this, she worked for Takeda Pharmaceuticals and Almac Clinical Services. Beth has 11 years of pharmaceutical supply chain experience, which includes DP manufacturing, FG packaging and labeling, Global distribution, IRT development, and portfolio management of large global phase 3 trials in Oncology and GI. Beth holds a Bachelors of Arts in Psychology from Emory University.

Biography:

Andrea is an Enterprise SaaS executive and investor focused on delivering the highest possible quality in Enterprise System strategy and implementations to the Pharmaceutical, Biotech, Medical Device and Clinical Supplies industries. Starting from a strategic assessment of a company’s business needs and opportunities, he advises on optimizing processes and implementing existing technology like ERP, LIMS Weighing & Dispensing, Business Intelligence for the Pharma and Biotech industries, and how to select and deploy emerging technology like AI, ML, RPA, etc.

Biography:

Massimo Crudeli has joined the ARconsulting Group in 2002. His work experience mainly focuses in the implementation of the Microsoft Dynamics ERP solutions (AX and NAV) for Life Sciences and regulated industries (Pharmaceutical, Chemical, Cosmetics, Medical Devices and Food) and Industrial Equipment Manufacturing industries.
He has 15+ years of expertise in international ERP Implementation projects (USA, Brazil, Ecuador, UK, Germany, Finland, France, Italy, Romania and Bulgaria) as Solution Architect and Senior Consultant for Manufacturing, Trade & Logistics and Quality Management.
He also has 12+ years of expertise as Pre-Sales Manager in ERP systems (Microsoft Dynamics AX, NAV and others).

Biography:

Having worked in the pharmaceutical industry for almost 20 years within various quality positions, in his position as Global Clinical Quality Director, Tristram is responsible for quality within PCIs clinical trial supply services division; In this role Tristram engages with PCI clinical teams in the USA, UK and Ireland, also liaising with global customers on various clinical supply chains generally advising on quality matters.  Tristram is an EU Qualified Person (QP), qualifying under the permanent provisions in 2011, Tristram is responsible for the QP certification of both commercial and investigational medicinal products on various PCI UK MHRA site licences across a range of dosages forms.  Tristram joined PCI back in in 2007 within one of PCIs acquired companies, Biotec Services International where Tristram held various Quality Management and Director positions.

Biography:

Steve is a successful consultant, trainer, business leader, executive coach, mentor and speaker. For the past 25 years he’s been heavily involved in clinical supply chain operations, IMPs, cGMPs, cGCPs, cGDPs, clinical development and quality (ICH Q8, Q9 & Q10) for pharmaceuticals, and biotech products.

He sits on the Board of Directors of the largest professional clinical supply organization in the world, the Global Clinical Supplies Group. His expertise also includes success in leadership, innovation, global cultural dynamics, organizational development, and high performing teams.

In the past he has been a CEO and COO, as well as the president and Global Chief Operating Officer, of a multinational clinical supply chain contract organization that served companies like Novartis, Eisai, Lilly and others in the pharmaceutical and biotech sector. Before that he was head of US clinical supply operations for Johnson & Johnson.

Steve was also a logistics and aviation officer, in the U.S. Army, where he rose to the rank of Major and was a maintenance test pilot, and pilot in command, for both helicopters and fixed wing aircraft.

His undergraduate degree is in Pharmacy from the University of the Sciences in Philadelphia and his MBA is from the University of Phoenix with a specialization in global management.

Steve has traveled all over the world (4 Continents, 25 Countries, 42 States) and enjoys spending time with his Fiancé, son, and good friends, whenever he gets the chance.

Biography:

Gretchen Randlett is a consultant for Clinical Trial Commercial Products, part of Eli Lilly’s Clinical Trial Material Management (CTMMS) department. Her responsibility is to be the primary interface between clinical and CTMMS to support Expand Access programs and requests. As part of her role, she is responsible for designing CTMMS’s infrastructure by leading cross-functional teams to develop packaging, labeling, distribution and regulatory strategies, to support these unique programs. She also consults across organizations in Lilly to deliver the appropriate supply solution to patients requesting Lilly products under the Expand Access umbrella.Gretchen has over 10 years of clinical trial experience supporting phase I-IV global trial in multiple therapeutic areas including neuroscience, men’s health, women’s health, cardiovascular, oncology, autoimmune and endocrine. In addition to her clinical knowledge, she has 6 years bioanalytical laboratory experience in developing bio assays for phase I-IV clinical trials. Her leadership experience includes supervisory roles, Six Sigma Black Belt, alliance and partner management, in addition to leading multiple cross-functional transformation projects and initiatives. Gretchen holds a Bachelor’s degree in Biology from the University of West Alabama and executive MBA from Indiana University.

Biography:

Doug Meyer is Associate Director, Operations and Capabilities Management for Biogen’s Clinical Drug Supply department.  In this role, he oversees all critical business systems, including IRT, as well as operational support for the department, including Clinical Site Support, Label Development and Vendor Management.  Doug has over 23 years in the industry with a focus on investigational product planning and logistics, development and implementation of clinical supply chain systems and leading continuous process improvement projects.  He also participates with other clinical supply leaders in the Clinical Supplies Working Group.  Doug holds a BS in pharmacy and an MBA both from the University of Connecticut.  He is a certified Project Management Professional (PMP), APICS Certified in Production and Inventory Management (CPIM) as well as a Certified Supply Chain Professional (CSCP).

Biography:

Jackie Amico is a Lead Supply Planner within Clinical Drug Supply for Biogen.  She has been with Biogen in this role for 3.5 years, but has over 14 years of global supply chain experience in various roles.  Jackie manages multiple drug supply chain issues including delivering supply plans for clinical trial material, developing risk mitigated supply scenarios and ensuring continuous supplies to patients for all phases of drug supply  to ensure that it reaches patient being treated for rare and debilitating diseases such as MS, Alzheimer’s and rare diseases.  Luckily Jackie thrives on the fast paced and very demanding environment of clinical supplies.  Prior to joining Biogen, Jackie was a Senior Manager within Global Supply Planning for the adidas Group.

Biography:

Scott Ohanesian has held executive roles over the past 16 years for Clinical Logistics Organizations and Contract Manufacturing Organizations (CMOs), managing global logistics for Phase I through IV clinical trials.

He currently leads the QuickSTAT U.S. commercial operations team to build strategic relationships with pharmaceutical and biotech companies in order to provide comprehensive solutions for their global supply chain, ensuring product integrity and patient safety.

Prior to joining QuickSTAT, Scott managed the Asia Pacific commercial operations for Marken Limited, where he implemented the commercial strategy for his company in key markets, such as Australia, China, India, Japan, Singapore, South Korea, and Taiwan.  Prior to that position, he was in a global strategic management role at a CMO, creating mutually beneficial partnership models.

He is trained and well versed in Good Manufacturing Practices, (GMP) and has helped create innovative logistics solutions for numerous new drug products–from formulation development through to commercialization, including cutting edge cell, gene, and CAR-T therapies.

Scott is a graduate of Boston College with a Bachelor of Science in Finance and a Masters of International Law in Diplomacy from The Fletcher School at Tufts University, with affiliated course work at Harvard Law School and Harvard Business School.

Biography:

Patrick is currently a director of Clinical Supply Strategy & Management and leads a team of talented senior strategic project managers across multiple therapeutic areas at Pfizer. Patrick has 15 years of pharmaceutical supply chain experience – including analytical chemistry and quality control, clinical packaging operations, and developing sound clinical supply strategies for large and complex programs. Patrick has also focused over the past 2 years to collaborate across Pfizer to develop and implement innovative end-to-end supply chain strategies addressing the unique requirements for their growing cell and gene therapy portfolio. Patrick holds a Bachelors of Science in Chemistry from Stonehill College and a Masters of Business Administration from the University of New Haven.

Biography:

Lee Sutton has over 10 years of supply chain experience within the clinical and commercial pharmaceutical sector. For the majority of his career, Lee has worked for large global logistics companies and has specific expertise in the areas of specialty logistics management, cold chain, and supply chain optimization.
Over time Lee has worked with several clinical-stage pharmaceutical companies to help streamline their supply chain efforts resulting in positive trial outcomes. Some of these efforts included supply chain optimization through consolidation, as well as coaching clients to effectively communicate customs requirements for importing Investigative Medicinal Products and Clinical Trail Application materials ahead of shipping schedules.
At Priority Solutions, in addition to his responsibilities for global transportation sales, Lee serves as a client advocate and is responsible for establishing solutions that improve the overall client experience. He is detailed in his approach to solving complex logistical challenges and solves these problems through a logical & data driven approach.
Lee received his BS in Industrial Distribution and Logistics Management from East Carolina University; he is also active with local trade organizations such as the North Carolina Biotech Center.

Biography:

Marc has spent his entire career in the eClinical technologies space, with most of that time focused in the area of IRT. Having spent years on the client services side, Marc has worked with 7 of the top 10 pharmaceutical companies and 6 of the top 7 CROs to design, implement, and maintain IRT solutions across a variety of therapeutic areas. As a Co-founder and Director of Business Development at Suvoda, Marc uses his IRT subject matter expertise to provide creative solutions to customers’ problems, all while growing Suvoda’s business globally. Marc enjoys creating long-lasting relationships with customers and colleagues and loves brokering introductions within his network. Marc is a graduate of Lafayette College with a degree in biochemistry and minor in music.

Biography:

Dan Bell joined Marken in 2003 and is their Vice President, Regulatory Compliance and Technical Affairs.
Dan is a licensed US Customs Broker and Certified Customs Specialist, with more than twenty five years of combined education and practical logistics experience, with a focus on trade compliance and time and temperature critical areas within the global life science supply chain. He regularly serves as a liaison between pharma, CMO, CRO, lab clients, customs, and the alphabet soup of regulatory agencies, to ensure the maximum level of compliance with US & international trade laws and regulations.

Early in his career, Dan was headquartered in Europe and was responsible for establishing the US entity of a company that developed temperature monitors and data loggers. His expertise in temperature logging, thermal packaging solutions and regulatory compliance, has helped Marken and its customers with the challenges of finding solutions for complex shipping routes, correct storage and transport of temperature-sensitive lifesaving drugs.

Biography:

Mr. Valentine is the Vice President, Clinical Supply Services with responsibilities for Client Services, Clinical Storage and Transportation Services, Comparator Services and Strategic Projects. In his previous role as Global Director of Distribution Services for Catalent Pharma Solutions, he was responsible for developing the global facility and depot network and logistics strategies in support of Catalent’s Clinical Supply Services business.  He has a background of over 20 years’ experience serving in leadership positions in the CRO and drug development services industries.  Mr. Valentine holds an MBA in Finance from Seton Hall University and a B.A. in Business Administration from the University of Vermont.

Biography:

Terry Iacobucci has worked in Clinical Supplies for over 15 years for vendors, pharmaceutical and biotech companies.  She continued her career at TESARO, initially managing the large portfolio of Investigator Sponsored Studies, partnerships with other pharmaceutical sponsors, development of the Global Compassionate Use Program and development of sustainable processes for all of these programs.    Terry is currently an Associate Director at TESARO where she oversees the management of  the sponsored studies, CMOs and external contractors.  

 Prior to joining TESARO, Terry worked in clinical supplies with the Phase I team at Bayer, and the Medical Affairs team at Sanofi.   She has facilitated GCSG workshops on Investigator Sponsored Trials and is a member of the GCSG EAP E-team.  Terry is a licensed professional BioChemical Engineer. 

Biography:

Kazuaki joined Pfizer Japan Inc. in 2013 as a Japan Import/Export specialist. In 2014 he became a Packaging Coordinator to support clinical supply packaging in Asia as an additional role. He has worked on various process changes as well as continuous improvement projects and managed local vendors in Asia.
Kazuaki transferred to Pfizer Inc. and relocated to Groton, CT in 2017. In his Planning Lead role, he is supporting vendor and internal scheduling activities, coordinate demand forecasting and planning across internal packaging sites and the external vendor network. He is also responsible for resource allocation of Quality assurance, and He is continuing to manage packaging and labeling activities in Asia.

Biography:

Andrew has 15 years leadership experience in IMP Storage and Distribution, Biological Specimen Logistics & Kit Manufacturing and Ancillary Clinical Trial Supplies. He has successfully delivered on strategy and growth for global regions whilst based in Europe and of late, the United States, for the world’s largest specialty clinical supply chain organizations . Andrew is focused on developing multi-national key global relationships by providing leadership to dedicated commercial development teams.

Biography:

Jason Nolte has 17 years of industry experience with 15 of those years working in clinical supply chain.  He has planned many different trial designs and complexities; from open label studies to double blind double dummy pediatric titration studies; from taste studies to devices studies.  Jason enjoys working in global cross functional teams that drive results and who drive for right first time through operational excellence.  Jason Nolte currently works for Fisher Clinical Services as a Comparator Key Account Manager, in this role he applies his clinical supply chain knowledge to help clients expedite their commercialization strategies through flawless comparator drug purchasing and clinical trial execution.

Biography:

TJ has 13+ years’ experience in all aspects of the global life-science supply chain with extensive understanding of temperature sensitive packaging, logistics, regulations and best-practices. At CCT, TJ is responsible for providing leadership, coordination, and oversight of all business development activities in addition to the operational and financial aspects of strategic initiatives including reusable solutions and global expansion. TJ also serves as CCT’s Advisory Board Chair and is extensively involved in the industry at large as a member of various groups including the PDA PCCIG, ISTA Thermal Council and new industry guidance initiatives. He was a key member and co-author of PDA Technical Reports 46 and 52. TJ graduated from Pennsylvania State University with a bachelor’s degree in Mechanical Engineering and has a M.B.A. from the University of Massachusetts.

Biography:

Eric enters his twentieth year in our industry as Head of Commercial Operations, Americas for Thermo Fisher Scientific in the Clinical Trial Division (CTD). He oversees supply chain services with both strategic and key accounts in delivering packaging, labeling, distribution, comparator drug and clinical supply chain management solutions.

He is responsible for driving commercial growth within three different customer segments across ten different territories. Guiding his company’s commercial team with a Differentiated Value Proposition strategy that utilizes consultative selling approaches while leveraging the strengths of Thermo Fisher Scientifics global network.

Eric has served as both an executive and board level member with the Global Clinical Supply Group, and has been a conference attendee for all twenty years of his career.

Biography:

Adrian Peskett has just moved to the new role, Head of Operational Strategy within Pfizer’s Global Clinical Supply Chain. He has worked with Pfizer for over 15 years supporting various aspects of the supply chain. Adrian’s responsibilities have included master planning, inventory management, commercial sourcing, packaging, labeling, process improvement, external vendor management, business development, licensing management and distribution. Today he is responsible for a team that is developing clinical supply operation strategy for the entire Pfizer portfolio. He is currently located in the US but spent many years in the UK and has considerable experience in optimizing international clinical supply chain activities. Adrian obtained his first degree from University of Wales, College of Cardiff and his MBA from the University of Kent.

Biography:

Rob Montague is currently the Head of Global Supply Chain Logistics for GSK’s R&D unit, where he is responsible for the Global Distribution and Cross Border Compliance of investigational product for GSK’s Pharmaceutical development portfolio.In the four years since moving to R&D, Rob led a global harmonization initiative, implemented a global in transit temperature monitoring process and improved the organization’s on-time performance. Equally he has improved R&D Cross Border compliance and implemented a number of duty deferral/duty reclaim programs.Rob is an experienced Supply Chain professional with the majority of his career in the Pharmaceutical environment. Prior to moving to R&D, Rob held various senior positions, including leading Production Planning and Warehousing Operations for Commercial Production and leading the US Finished Goods Distribution Group. Rob has worked globally in the Import/Export Cross Border Compliance area leading the US and UK Import/Export teams. Additionally, Rob led the Global Distribution and Warehousing Shared Service which initiated a redesign of the European physical supply chain and reduced 27 distribution facilities down to 4. Rob holds a Bachelor’s of Science degree in Transportation and Logistics.

Biography:

Paul O’Connor is Global Vice President of Quality at Almac Clinical Services and a member of the Executive leadership team which supports the full range of client engagement and excellence in service delivery. He is responsible for leading the Quality function on all sites encompassing over 220 professional staff in areas of Quality Assurance and Control, Regulatory Support, Quality Systems, and Validation. Prior to that, Paul held other Quality Assurance and laboratory roles in relation to investigational and licensed medicinal products in Almac and Galen Holdings in a pharmaceutical career of over 25 years.
He is eligible to act as a European Union Qualified Person (QP) since 2001 and also holds a BSc First in Biochemical Sciences from the Ulster University.
Paul has written multiple industry articles and presents regularly at Investigational Medicinal Product conferences on Quality Assurance and Qualified Person matters

Biography:

A Chartered biologist, with a Masters in Pharmaceutical Sciences, Harry has over 20 years’ industry experience in Steriles, Biologics & Solid Dose in both Commercial and Clinical Manufacturing and Packaging. Harry currently holds the position of Senior Director, Quality, EMEA, leading the EMEA Quality function across the Clinical Trials Division at Thermo Fisher Scientific. Based in Horsham, UK, Harry oversees 6 sites specializing in the Manufacture, Packaging and Distribution of Investigational Medicinal Products (IMPs). Harry previously led Quality at the Thermo Fisher Scientific Horsham site for several years. Harry is an experienced Qualified Person (QP) for clinical and commercial products.

Biography:

Ed Groleau has over 30 years of experience in the Pharmaceutical industry. The first 15 years were spent in a variety of laboratories for small molecule drug development.  He started out developing and validating analytical testing methods at Merrell Dow Pharmaceuticals and Eli Lilly.  He became Lilly’s primary X-ray powder diffraction expert and was a founding member of the company’s Physical Characterization group that established the optimal salt form for compounds in development.  Being responsible for all XRD, XRF, and thermometric techniques, Ed was also part of Lilly’s internal forensics team conducting investigations for internal manufacturing issues and external litigations.  After 7 years of physical characterization Ed moved to the chemical characterization group where he helped determine the structures of degradation products using NMR.

Ed moved to Lilly’s Clinical Trial Supplies group in 2003 starting in the group responsible for packaging and labeling of IP.  His responsibilities increased as the department changed over the years to include all aspects of CT supplies from planning to distribution. In 2011 he became part of a small, highly integrated CM&C team responsible for overseeing the development of compounds from discovery through proof-of-concept stage.  On this team Ed developed the procedures and processes required to conduct all aspects of the supplies for clinical trials from manufacturing through reconciliation.

In 2016 Ed moved to Elanco, Lilly’s animal health division, where he established a global clinical trial supplies group for developing companion and food animal projects.  Ed’s career at Lilly/Elanco ended in 2017 when he took advantage of an early retirement program the company offered.  Not ready to actually retire, Ed has joined a growing supply chain group at PCI where he continues to provide his experience and expertise to other companies in need of the service.

Biography:

Brian Keesee, Senior Vice President of PCI’s Clinical Trial Services Segment, has spent his entire career in the Pharmaceutical industry.

In his current role, Brian is responsible for Global Clinical Operations, Logistics, and Project Management for PCI’s Clinical Trial Services sites globally.

Prior to his role at PCI, he held leadership positions in Compliance, Operations Management, and Project Management within the pharma industry.

Brian has managed large global clinical studies and offers extensive experience and expertise in Supply Chain Management, Logistics, Clinical Package and Label design, Project Management, Cold Chain Technologies and IRT.

Brian brings a unique perspective based on his global project management knowledge from his prior positions within the Clinical Supplies Industry, his Compliance and Operations roles at AmerisourceBergen Drug Corporation, and his involvement in a Lean Six Sigma Black Belt Program.

He holds a Bachelor of Science in Business Administration from Missouri Western State University.

Biography:

Steve is a successful consultant, trainer, business leader, executive coach, mentor and speaker. For the past 25 years he’s been heavily involved in clinical supply chain operations, IMPs, cGMPs, cGCPs, cGDPs, clinical development and quality (ICH Q8, Q9 & Q10) for pharmaceuticals, and biotech products.

He sits on the Board of Directors of the largest professional clinical supply organization in the world, the Global Clinical Supplies Group. His expertise also includes success in leadership, innovation, global cultural dynamics, organizational development, and high performing teams.

In the past he has been a CEO and COO, as well as the president and Global Chief Operating Officer, of a multinational clinical supply chain contract organization that served companies like Novartis, Eisai, Lilly and others in the pharmaceutical and biotech sector. Before that he was head of US clinical supply operations for Johnson & Johnson.

Steve was also a logistics and aviation officer, in the U.S. Army, where he rose to the rank of Major and was a maintenance test pilot, and pilot in command, for both helicopters and fixed wing aircraft.

His undergraduate degree is in Pharmacy from the University of the Sciences in Philadelphia and his MBA is from the University of Phoenix with a specialization in global management.

Steve has traveled all over the world (4 Continents, 25 Countries, 42 States) and enjoys spending time with his Fiancé, son, and good friends, whenever he gets the chance.

Biography:

Steve is a successful consultant, trainer, business leader, executive coach, mentor and speaker. For the past 25 years he’s been heavily involved in clinical supply chain operations, IMPs, cGMPs, cGCPs, cGDPs, clinical development and quality (ICH Q8, Q9 & Q10) for pharmaceuticals, and biotech products.

He sits on the Board of Directors of the largest professional clinical supply organization in the world, the Global Clinical Supplies Group. His expertise also includes success in leadership, innovation, global cultural dynamics, organizational development, and high performing teams.

In the past he has been a CEO and COO, as well as the president and Global Chief Operating Officer, of a multinational clinical supply chain contract organization that served companies like Novartis, Eisai, Lilly and others in the pharmaceutical and biotech sector. Before that he was head of US clinical supply operations for Johnson & Johnson.

Steve was also a logistics and aviation officer, in the U.S. Army, where he rose to the rank of Major and was a maintenance test pilot, and pilot in command, for both helicopters and fixed wing aircraft.

His undergraduate degree is in Pharmacy from the University of the Sciences in Philadelphia and his MBA is from the University of Phoenix with a specialization in global management.

Steve has traveled all over the world (4 Continents, 25 Countries, 42 States) and enjoys spending time with his Fiancé, son, and good friends, whenever he gets the chance.

Biography:

Provide leadership, direction and oversight to team responsible for setting Sourcing Strategies and Classification for clinical trials.  Develop team to proactively manage issues, propose mitigation/response plans to resolve issues and effectively implement action plan that translates across the portfolio for the management of Commercial Product.  Understand global regulations and the external environment which impacts commercial product sourcing and enable strategic plan to meet these influences.  Accountable for classification of commercial products as investigational or non-investigational.  Responsible for complex technical decisions regarding Commercial Product regulations, cGMPs, and cGCPs.  Accountable to create unique solutions to complex commercial product sourcing problems that ultimately supports innovation and patient needs.  Previously was responsible for overall ownership of master label orders, utilizing the input provided by the supply planning organization, to ensure on-time delivery of master labels.  In addition, served as a key contact and liaison for FIPNET-related service providers related to labels and was responsible for the label library.  Lead CTMMS Labeling department including establishment of strategy and associated yearly objectives, metrics to measure success and leading staff to achieve strategy and goals.  Prior to joining Product Delivery, was in Project Management where she led multiple late phase assets from Phase II development through submission.

Biography:

Michael is currently the CEO of Myoderm, where he has worked the past 18 years.  Michael’s passion, leadership, and commitment to meeting each client’s unique needs have been a driving force in making us a global leader in clinical trial supply. Before Myoderm, Michael served in positions in the publishing, advertising, financial, and utility industries. He holds a B.S. in Statistics from the University of Pittsburgh, and an M.B.A. from the university’s Katz Graduate School of Business. 

Biography:

Stephen Flaherty is the Global Director for Demand Led Services (DLS) – FastChainTM within Catalent Pharma Solutions.
He has worked in various clinical supplies roles of increasing responsibility for 28 years, mainly focussed in the Project Management area, previously having had responsibility for PM teams in UK and Germany. He has (IMP) QP eligibility status within Europe (for the time being.)
His latest role has been to lead the: creation, development and deployment of the DLS – FastChainTM model within the Catalent network.
He has overseen the set up and delivery of global and regional teams, systems and procedures which have enabled 5 local and regional DLS – FastChainTM hubs, in Americas, EU, and Asia, to become operational, in the last 3 years, with plans for more to follow in the future.
Currently the network supports both regional and global studies and processes several thousand individual orders p.a. with significant expansion forecasted and planned.
Stephen also acts as the main point of contact with key clients, at a senior level, during the inception, development, execution, maintenance, refinement and scale-up of the FastChainTM model, to meet each client’s: portfolio, programme and study requirements

Biography:

Jennifer Snyder is the US Team Head of External Operations Management for Novartis Pharmaceuticals in the Global Clinical Supplies group.  She has been in the pharmaceutical industry for over twenty years and has worked in all areas of pharmaceutical development including formulation, analytical, quality, and global clinical supplies.  For the past three years Jennifer has been a member of the Novartis team building and implementing a decentralized model for clinical supply.  Her focus has been on working within Region America’s to establish this more responsive model and building vendor relationships for optimal support.

Biography:

Nadia Laouar is the Global Head of External Operations Management for Novartis Pharmaceuticals.  She has been in the pharmaceutical industry for over fifteen years and has worked in discovery chemistry as a research scientist prior moving to Global Clinical Supply Organization. Nadia has led various roles with increasing responsibilities including Compliance lead and Portfolio management.  For the past three years Nadia has been a member of the Novartis team building and implementing a decentralized supply model for clinical supply.  Her focus has been on working to establish, at a global scale, this flexible, more responsive model and building vendor relationships for optimal support.

Biography:

John has spent 22 years at Catalent Pharma Solutions beginning in Deeside (UK) as a Distribution Technician and advancing through to Distribution & Logistics Manager in 2009 making considerable changes in developing and improving processes.
Joined the Global CI & Technology group in 2015 in the role of Global Clinical Supply Shipping Solutions Specialist responsible to identify new and innovative temperature controlled packaging to minimize risk of temperature excursions and improve Cold Chain shipping performance.
Moved to the role of Global Clinical Supply Process Leader for Distribution in 2016 retaining responsibility for shipping solutions whilst expanding the role to lead standardisation and harmonisation of distribution processes across the global Clinical Supply business.

Biography:

Adam Tetz brings more than 20 years of marketing experience to the role.  He is responsible for worldwide branding, product launch and communications strategy.  Prior to Pelican BioThermal, Tetz held positions in product management, marketing communications and account management across a variety of industries, including medical software, financial software and professional services.  He holds an MBA in Marketing from the University of Saint Thomas and a BA in Advertising from the University of Minnesota.

Biography:

Mark Woolf – Global Manager, Depot Network, Catalent

• Over 35 years logistics and operational experience
• Extensive background in global storage and distribution including residency for over 15 years in many European, Middle East and APAC countries.
• Zuellig Pharma Asia Pacific (4 years) where he was resident, working in the Philippines
• Almac Clinical Services (6 years) both in the UK and USA.
• Freight Forwarder and Distributor within Free Trade Zones in Turkey & Africa.
• 12 years of Clinical Trial Logistic, Operations and Vendor management

Biography:

Erin is a Project Manager at Catalent Pharma Solutions with over 22 yrs. experience in the Japanese Market with more than 10 yrs. working both in Japan and the US, with Japanese clients and Global clinical trials going into Japan.    She has extensive design and strategy expertise for Japanese clinical supplies and advising foreign companies wishing to do business in Japan.   Erin previously managing the North Carolina Japan center and was responsible for consultancy on technology transfer and bridging cultural gaps with Japanese and US entities doing business in the US or bridging into Japan.

Biography:

Yuki Hayashi has 5 years experience as QC/QA specific for clinical supplies and more then 10 years experience as clinical supplies management in Yamanouchi/Astellas Pharma Inc., the 2nd largest pharmaceutical company in Japan. In addition to his role in Japan, Yuki has also worked for 3 years at Astellas US (Chicago, IL, USA) during 2012-2015 ) in Clinical Supply Management.

Biography:

Natalie Balanovsky is the Supply Chain Solutions Manager at Almac Clinical Services in Souderton, PA, managing the Strategic Product and Business Development, implementation, education and training of Almac’s JIT service suite.

Natalie has previously held other roles at Almac including Global Project Leader and Project Manager of Distribution, managing Phase 1 through 4 clinical trials of various size, and complexity. She has over 15 years of professional experience within Project Management, Business Development, GMP Operations, and Quality Compliance for various industries including pharmaceutical, financial and b2b.

She holds a Bachelor of Science degree in Business from Delaware Valley University and earned her Master of Business Administration with concentration in Finance from LaSalle University. She is a certified Project Management Professional and is a Member of the Delaware Valley Chapter of Project Management Institute.

Biography:

Mark Rohlfing is Vice President Operations at Almac Clinical Services in Souderton, PA, leading day-to-day site operations in clinical supply chain management, project services, manufacturing, packaging, and global logistics. As a member of the executive team, he works closely with Almac’s entire global service organization to ensure superlative collaboration and optimal process development and control to meet and exceed customer standards.

Mark was previously Director of Quality at Almac and has 25 years of professional experience within GMP/GCP Operations, QA/QC, and Regulatory Compliance including positions at Almac, Cell Pathways Inc., and Teva Pharmaceuticals USA.

He holds a Bachelor of Science degree in Biology from Millersville University of Pennsylvania and earned his Master of Science degree in Biology from Villanova University. He is an ASQ Certified Manager of Quality/Organizational Excellence, ASQ Certified Quality Auditor, and ASQ Certified Six Sigma Green Belt. He is also a Senior Member of the American Society for Quality and a member of the Parenteral Drug Association.

Biography:

Nicohle J. McGeorge is Senior Lead Project Manager in Clinical Supply Operations Packaging and Labeling for Bristol-Myers Squibb Company in New Jersey. With over 14 years in the industry, Nicohle has gained expertise in area of clinical labeling regulatory requirements and label vendor management.

Biography:

Kevin began his career at Clintrak (later purchased by ThermoFisher Scientific) in May 2004 in the Manufacturing Division and was directly involved with label production. He joined the Client Services Department where he worked closely with clients in order to insure the successful completion of their jobs from protocol interpretation to label production. Throughout his tenure, Kevin has gained broad knowledge of the clinical label production process and the clinical supply chain as a whole while developing innovative solutions for clinical labeling challenges. Over the past few years, Kevin has spearheaded the development of translation and regulatory review solutions for clinical trial labels as a Label Program Director. Kevin provides customer service support including client and site visits, quarterly meetings, trade meetings, exhibitions, seminars, whitepapers and leads industry discussion groups. He works closely with ThermoFisher Scientific specialists to develop customized solutions to meet client’s unique needs. Kevin received his Bachelor of Arts degree from Hobart College in the year 2000. He currently resides in Patchogue, NY with his wife and two children.

Biography:

My passion for the practice of pharmacy began immediately after I graduated from pharmacy school and learned all of the ways a pharmacist can positively influence a patient’s life. For over 33 years, this passion and drive has motivated me to bring the practice of pharmacy into the clinical research sector. I have always challenged traditional clinical trial models and through new processes, innovative study designs, and patient counseling services, I have been able to revolutionize the way patients receive and take their medications in clinical trials.

With the mission of making a difference in the clinical supplies sector, I founded CSM in 1997 and grew the company from a one-person consulting operation, to a multi-million dollar organization with multiple locations and 100+ employees. In 2001, I created and launched the On-Demand packaging and labeling platform, an industry breakthrough enabling a flexible clinical supply chain to keep pace with breakthrough therapies, diagnostics, and technology by delivering patient-centric medication.

While working with sponsor companies and seeing first-hand the struggle of getting FDA approval, I launched CTRP® (Clinical Trials Research Pharmacist) services as a division of CSM. By piloting this services through CSM, we were able to prove that pharmacists counseling patients in clinical trials can improve compliance, adherence, retention, and more importantly, the overall quality of the studies. In 2014, I rebranded and re-launched the CTRP® service through Center Point Clinical Services, LLC.

Both Center Point and CSM are re-defining the way our industry conducts clinical trials with the overall strategy of finding innovative solutions to help companies decrease timelines, improve study outcomes, and reduce costs while improving the strategic quality in all aspects of patient-centric medication and care.

Biography:

Rüdiger Weber is based in Germany leading the German CSM – Clinical Supplies Management site as General Manager. He joined CSM in 2016 via the acquisition of Theorem Clinical Research where he headed the Clinical Supplies department since 1997. Prior to that Rüdiger held a similar appointment for another CRO. He looks back on more than 24 years of experience in contract packaging and distribution of investigational medicinal products. Rüdiger is a pharmacist by training and since 1995 registered as Qualified Person (QP) at the German Health Authority. He is member of the European Qualified Person Association.

Biography:

Barbara Berman is the Senior Vice President and Regional Director of Professional Services at Lee Hecht Harrison, the global talent mobility leader in connecting people to jobs and helping individuals improve performance. In her role, Barbara manages the delivery of career transition services in Georgia, Florida, Alabama and Tennessee. Barbara has over 20 years experience in management and consulting across several industries. She has been recognized for her focus on quality, team development and customer service.
Prior to joining LHH, Barbara worked internationally with extensive background in training, management, and delivery of consulting services. Her experience is in both training organizations and universities. She has a proven track record of building strong client relationships, facilitating high quality presentations and successfully managing global projects to achieve business goals. She has been recognized as an outstanding communicator with success in creating new initiatives to serve national and international audiences.
Barbara holds a Master of Science in Education and has completed post-graduate work in Higher Education Administration. She is also a certified corporate coach and works closely with SHRM Atlanta, Girls Inc and Partners Against Domestic Violence (PADV). Barbara grew up in New York and has been in Atlanta for the last 25 years.

Biography:

Rob is a seasoned executive with 30 years combined global experience in Pharmaceutical R&D with a focus on clinical supply chain leadership, quality assurance, process re-engineering and leadership of change initiatives.

After obtaining a PhD in Analytical Chemistry from Southampton University UK Rob joined The Upjohn Company as a scientist and has subsequently held roles of increasing responsibility with Pharmacia & Upjohn, Pharmacia, Pfizer, Schering Plough and Merck.

Rob has had extensive experience in clinical supply quality assurance and laboratory operations including proposing regulatory specifications and reviewing CMC regulatory submissions for drug candidates. He has a strong track record of optimizing international Clinical Supply Chain operations and a proven ability to forge global relationships across lines and disciplines. A valued and effective change leader with extensive experience in helping organizations navigate organizational change without compromising business performance.

During his career Rob led large clinical supply chain organizations through six mergers while maintaining business continuity. He also has had the opportunity to lead a number of high profile process improvement initiatives:
• Co-led a corporate wide initiative to globalize, and optimize clinical supply chain across multiple country sites
• Collaborated on a cross functional initiative with clinical partners to optimize planning and delivery of clinical supplies
• Negotiated and successfully managed the integration of commercial and R&D logistics business units
• Established cross functional governance between clinical and clinical supply organizations

In February 2014 Rob co-founded and is now a Managing Partner at Brizzey LLC, a small firm of professionals with a track record of success in the areas of clinical supplies, R&D change management & process optimization.

Biography:

Lorna is an Electrical Engineer with experience across the following industries:  Heavy equipment design & manufacturing, financial, and information technology.  She joined the Pharmaceutical Industry as a consultant to Pfizer, where she was involved in a corporate wide initiative to globalize, and optimize 2000+ clinical supply chain procedures across 6 countries to 200+ global procedures.

Lorna was then retained as a consultant by Schering Plough to lead the optimization of the clinical supply chain. Following that assignment, she was hired by Schering Plough as the Global Clinical Supply Regional Lead for Latin America, serving as the key interface between the clinical supply team and the clinical operations team. In this role, she continued her leadership of process integration and optimization in support of the mergers with Organon and Merck.

She is now a Managing Partner at Brizzey, a small firm dedicated to helping companies navigate the complexities of bringing new medicines to the market through the reliable, optimized and cost effective delivery of clinical supplies.

Biography:

Henryk Junker has worked in the Pharmaceutical Industry for over thirty years. Whilst being based in the UK he has worked for a number of US companies.

He is a Fellow of the Royal Society of Chemistry and in 1984 became a Qualified Person. His career has been in Quality Assurance and Operations working in Commercial and Clinical Supplies.

In particular Henryk has been involved in setting up multiple clinical supplies units.

Today Henryk is the Head of Quality and Qualified Person for the Xerimis UK.

Biography:

Pfizer’s Global Clinical Supply Chain.  She has worked at Pfizer for 17+ years in finance and clinical supply chain.  Her responsibilities have included project management, providing uninterrupted global clinical supply chain strategies within budget, ensuring patient continuity.  In addition to managing the forecasting, planning, scheduling and coordination of key activities to ensure the timely provision of clinical supplies, Lauralyn has recently focused on creative solutions for clinical trials with multiple comparator and/or co-med options, better known as ‘Basket Studies’.  Lauralyn received her degree from Western Carolina University.

Biography:

Ed Groleau has over 30 years of experience in the Pharmaceutical industry. The first 15 years were spent in a variety of laboratories for small molecule drug development.  He started out developing and validating analytical testing methods at Merrell Dow Pharmaceuticals and Eli Lilly.  He became Lilly’s primary X-ray powder diffraction expert and was a founding member of the company’s Physical Characterization group that established the optimal salt form for compounds in development.  Being responsible for all XRD, XRF, and thermometric techniques, Ed was also part of Lilly’s internal forensics team conducting investigations for internal manufacturing issues and external litigations.  After 7 years of physical characterization Ed moved to the chemical characterization group where he helped determine the structures of degradation products using NMR.

Ed moved to Lilly’s Clinical Trial Supplies group in 2003 starting in the group responsible for packaging and labeling of IP.  His responsibilities increased as the department changed over the years to include all aspects of CT supplies from planning to distribution. In 2011 he became part of a small, highly integrated CM&C team responsible for overseeing the development of compounds from discovery through proof-of-concept stage.  On this team Ed developed the procedures and processes required to conduct all aspects of the supplies for clinical trials from manufacturing through reconciliation.

In 2016 Ed moved to Elanco, Lilly’s animal health division, where he established a global clinical trial supplies group for developing companion and food animal projects.  Ed’s career at Lilly/Elanco ended in 2017 when he took advantage of an early retirement program the company offered.  Not ready to actually retire, Ed has joined a growing supply chain group at PCI where he continues to provide his experience and expertise to other companies in need of the service.

Biography:

Laurie is currently a Director of Solutions Consulting- Clinical Trial Supplies and Logistics at PAREXEL. She is responsible for managing a team of solutions consultants who provide subject matter expertise in order to develop supply strategies to meet each client’s unique need. She has been with PAREXEL since 2012, and held positions in clinical supply project management and account management. Prior to joining PAREXEL Laurie’s primary focus was project management of the full drug supply lifecycle from forecasting and planning through returns and destruction. Since joining PAREXEL she has expanded her area of focus to include ancillary supplies management and laboratory logistics.  Laurie has worked in the clinical trial industry for 20 years. She is an experienced clinical supply professional with 10+ years of global clinical supply chain project management experience. She has a B.S in Biochemistry and an MA in Kinesiology from the University of Texas.

Biography:

Justin Schroeder is the Vice President for Global Program Management at PCI Pharma Services. Mr.Schroeder is responsible for PCI’s customer facing staff, ensuring seamless delivery of PCI’s #1 Commitment in providing the leading customer experience and ensuring successful development and commercialization of new medicines for its clients. Mr. Schroeder has over 20 years of experience in outsourced pharmaceutical services in various roles including Package Engineering and Development, Project Management, Marketing and Business Development. He holds a Bachelor of Science from the School of Packaging at Michigan State University and an MBA in Marketing from Northern Illinois University. Mr. Schroeder is a Certified Packaging Professional from the Institute of Packaging Professionals (IoPP) and is the Vice Chairman of the US Healthcare Compliance Packaging Council (HCPC).

Biography:

Mike is responsible for the development, implementation, product management and ownership of World Courier’s patient centric services across 140+ company-owned offices in 50+ countries, with focus on direct-to-patient services. Since joining World Courier in 1992, Mike assumed a number of positions within US operations, customer service, training, compliance, marketing, sales and clinical trials management. He progressed to senior roles, including director of US customer service / operations, director of new service development and director of regional accounts, before transitioning into a global IT leadership position and prior to his current cross-functional role within the global services team. Based in Philadelphia, Pennsylvania (USA), Mike works extensively across World Courier’s global network.

Biography:

David began his pharmaceutical career in 2007 with Hospira, in Lake Forest, IL, performing BET and potency testing in the global stabilities lab. From there, he began managing packaging and labeling activities at Fisher Clinical Services for five years.  In 2015, David moved to Takeda where he was a Senior Program Manager, focusing on delivery of clinical supplies for Takeda’s vaccines division.  David is  now a Clinical Supplies Lead at Shire, at their Lexington, MA, location.  He is responsible for packaging, labeling, distribution, returns, reconciliation, and destruction activities for both large and small molecule drug products for global studies, which involve direct-to-patient services in North America and the EU.  Through these efforts, David has focused on developing Shire’s management of direct-to-patient services which include improving logistics, chain of custody, communication, understanding regulatory impact, issue tracking, and lessons learned.

Biography:

Buz has been working in supply chain management in the healthcare sector for 40 years.  Currently he is the system owner for the Optimizer clinical supplies forecasting system and the clinical supplies dashboard.  Over the recent years, he has developed innovative approaches to clinical supply forecasting, IWR supply management and waste reduction.  These efforts have literally changed the J&J clinical supply operations landscape.

Biography:

Greg Hottell holds the role of Director, Clinical Supply Chain at GSK, where he is responsible for the cost-effective, patient-focused supply of investigational product for GSK’s pharmaceutical development portfolio. Since joining GSK in 2011, Greg implemented an end-to-end planning platform for clinical supplies (D&OP), helped redesign GSK’s approach to clinical supply blinding and unblinding risk management, implemented and operates a monthly clinical demand governance process (Demand Review), implemented the Smart Supplies Forecasting tool, and has overseen GSK’s performance with on-time delivery of IP to patients. Greg is a member of the ISPE North American Investigational Product community of practice steering committee. Additionally, he has been active with the Global Clinical Supplies Group since 2016 by facilitating workshops and presenting at annual meetings. Greg has been a Supply Chain professional since 1999, most recently holding positions of increasing responsibility at Eli Lilly & Company and Fisher Clinical Services, and GSK. He holds a bachelor’s degree in Operations Management, an MBA, and is a Certified Fellow in Production and Inventory Management (CPIM-F) through APICS.

Biography:

Lee Sutton has over 10 years of supply chain experience within the clinical and commercial pharmaceutical sector. For the majority of his career, Lee has worked for large global logistics companies and has specific expertise in the areas of specialty logistics management, cold chain, and supply chain optimization.
Over time Lee has worked with several clinical-stage pharmaceutical companies to help streamline their supply chain efforts resulting in positive trial outcomes. Some of these efforts included supply chain optimization through consolidation, as well as coaching clients to effectively communicate customs requirements for importing Investigative Medicinal Products and Clinical Trail Application materials ahead of shipping schedules.
At Priority Solutions, in addition to his responsibilities for global transportation sales, Lee serves as a client advocate and is responsible for establishing solutions that improve the overall client experience. He is detailed in his approach to solving complex logistical challenges and solves these problems through a logical & data driven approach.
Lee received his BS in Industrial Distribution and Logistics Management from East Carolina University; he is also active with local trade organizations such as the North Carolina Biotech Center.

Biography:

Dan Bell joined Marken in 2003 and is their Vice President, Regulatory Compliance and Technical Affairs.
Dan is a licensed US Customs Broker and Certified Customs Specialist, with more than twenty five years of combined education and practical logistics experience, with a focus on trade compliance and time and temperature critical areas within the global life science supply chain. He regularly serves as a liaison between pharma, CMO, CRO, lab clients, customs, and the alphabet soup of regulatory agencies, to ensure the maximum level of compliance with US & international trade laws and regulations.

Early in his career, Dan was headquartered in Europe and was responsible for establishing the US entity of a company that developed temperature monitors and data loggers. His expertise in temperature logging, thermal packaging solutions and regulatory compliance, has helped Marken and its customers with the challenges of finding solutions for complex shipping routes, correct storage and transport of temperature-sensitive lifesaving drugs.

Biography:

Mr. Valentine is the Vice President, Clinical Supply Services with responsibilities for Client Services, Clinical Storage and Transportation Services, Comparator Services and Strategic Projects. In his previous role as Global Director of Distribution Services for Catalent Pharma Solutions, he was responsible for developing the global facility and depot network and logistics strategies in support of Catalent’s Clinical Supply Services business.  He has a background of over 20 years’ experience serving in leadership positions in the CRO and drug development services industries.  Mr. Valentine holds an MBA in Finance from Seton Hall University and a B.A. in Business Administration from the University of Vermont.

Biography:

Cyrille Lefevre has a background of engineer in applied mathematics. He has been working on the development of CT-FAST optimization software at N-SIDE in the last 6 years. He has experience advising both large and small pharma for the forecasting and optimization of their clinical trials for all phases and through multiple therapeutic areas. Cyrille also has a large experience training teams from multiple large organisations focusing on improving IRT resupply algorithms and the way they are used

Biography:

Innovative and effective biotech/pharma development operations leader with 20+ years of industry experience. Successful build out and leadership of clinical supply organizations in small and mid-sized companies to deploy industry best practices to ensure successful end-to-end supply process to support program and study level support for phase I-IV global clinical studies. Expertise in business operations and biological sample management. Successful in implementing process, technologies, and teams to enable optimally functioning organizations.

Biography:

Sandra Cook, Ph.D., is a project management, strategy and training consultant with thirty years experience in the pharmaceutical industry. The past twenty have been focused on Investigational Products where she has held both line management and senior level project management roles facilitating high performing teams in the delivery of worldwide clinical supplies, including materials supporting key priority blockbuster products for large pharma.  Additionally, she has been instrumental in the design, development and implementation of several global process improvement projects for R&D Supply Chain.  An active contributor to the IP Metrics Task Team of the International Society of Pharmaceutical Engineering, Cook also manages the bi-annual Equal Partners in Clinical Supplies industry forum

Biography:

Steven Yoder is the Global Director of Clinical Supply Optimization at Fisher Clinical Services.

Steve has over 25 years of supply chain experience and leadership in the pharmaceutical industry, with the last 12 years focused specifically on Investigational Products. His career spans experiences in Finance and Leadership in Manufacturing, Distribution, Outsourcing, and Global Logistics.

He earned a Bachelor’s degree in Management and Finance from Purdue University and a Masters Degree in Business Administration (MBA) with an Operations focus from Indiana University. He is APICS certified in Production and Inventory Management (CPIM), and served as a member (and Past Chair) of the ISPE Investigational Products North America Steering Committee.

He may be reached via email at: Steven.yoder@thermofisher.com

Biography:

James Oberhauser is currently Associate Director, Device Development and Clinical Packaging Engineering at Gilead Sciences in Foster City, CA. His responsibilities include growing a device development team to meet the needs of the parenteral and biologics pipeline and establishing the quality system infrastructure essential to a successful device development enterprise. Previously, Dr. Oberhauser led product development of Abbott Vascular’s Absorb™ Bioresorbable Vascular Scaffold (BVS), authoring the seminal article on the therapy in EuroIntervention and receiving the Innovation Team Award from the Abbott Laboratories Volwiler Society. Dr. Oberhauser holds 47 issued patents and has authored 22 peer-reviewed journal publications.
Dr. Oberhauser received his Ph.D. in chemical engineering from the University of California, Santa Barbara, where he studied structure-property relationships in polymeric materials. He also spent over 6 years on the faculty of the Department of Chemical Engineering at the University of Virginia.

Biography:

Yvonne Stephens has worked in Clinical Trial Supply Chain Planning at Eli Lilly and Company for the past 14 years. In this role, she supports the Diabetes business unit in clinical trial supply planning.  Her responsibilities encompass development of molecule/trial demand forecasts in partnership with a clinical team, strategic development of packaging, labeling and sourcing of investigational product as well as devices, supporting innovation and process optimization to speed drug development, as well as applying knowledge on GMP/GCP compliance in a clinical trial environment.

Biography:

Andrea is an Enterprise SaaS executive and investor focused on delivering the highest possible quality in Enterprise System strategy and implementations to the Pharmaceutical, Biotech, Medical Device and Clinical Supplies industries. Starting from a strategic assessment of a company’s business needs and opportunities, he advises on optimizing processes and implementing existing technology like ERP, LIMS Weighing & Dispensing, Business Intelligence for the Pharma and Biotech industries, and how to select and deploy emerging technology like AI, ML, RPA, etc.

Biography:

Massimo Crudeli has joined the ARconsulting Group in 2002. His work experience mainly focuses in the implementation of the Microsoft Dynamics ERP solutions (AX and NAV) for Life Sciences and regulated industries (Pharmaceutical, Chemical, Cosmetics, Medical Devices and Food) and Industrial Equipment Manufacturing industries.
He has 15+ years of expertise in international ERP Implementation projects (USA, Brazil, Ecuador, UK, Germany, Finland, France, Italy, Romania and Bulgaria) as Solution Architect and Senior Consultant for Manufacturing, Trade & Logistics and Quality Management.
He also has 12+ years of expertise as Pre-Sales Manager in ERP systems (Microsoft Dynamics AX, NAV and others).

Biography:

Andrew has 15 years leadership experience in IMP Storage and Distribution, Biological Specimen Logistics & Kit Manufacturing and Ancillary Clinical Trial Supplies. He has successfully delivered on strategy and growth for global regions whilst based in Europe and of late, the United States, for the world’s largest specialty clinical supply chain organizations . Andrew is focused on developing multi-national key global relationships by providing leadership to dedicated commercial development teams.

Biography:

Jason Nolte has 17 years of industry experience with 15 of those years working in clinical supply chain.  He has planned many different trial designs and complexities; from open label studies to double blind double dummy pediatric titration studies; from taste studies to devices studies.  Jason enjoys working in global cross functional teams that drive results and who drive for right first time through operational excellence.  Jason Nolte currently works for Fisher Clinical Services as a Comparator Key Account Manager, in this role he applies his clinical supply chain knowledge to help clients expedite their commercialization strategies through flawless comparator drug purchasing and clinical trial execution.

Biography:

Doug Meyer is Associate Director, Operations and Capabilities Management for Biogen’s Clinical Drug Supply department.  In this role, he oversees all critical business systems, including IRT, as well as operational support for the department, including Clinical Site Support, Label Development and Vendor Management.  Doug has over 23 years in the industry with a focus on investigational product planning and logistics, development and implementation of clinical supply chain systems and leading continuous process improvement projects.  He also participates with other clinical supply leaders in the Clinical Supplies Working Group.  Doug holds a BS in pharmacy and an MBA both from the University of Connecticut.  He is a certified Project Management Professional (PMP), APICS Certified in Production and Inventory Management (CPIM) as well as a Certified Supply Chain Professional (CSCP).

Biography:

Jackie Amico is a Lead Supply Planner within Clinical Drug Supply for Biogen.  She has been with Biogen in this role for 3.5 years, but has over 14 years of global supply chain experience in various roles.  Jackie manages multiple drug supply chain issues including delivering supply plans for clinical trial material, developing risk mitigated supply scenarios and ensuring continuous supplies to patients for all phases of drug supply  to ensure that it reaches patient being treated for rare and debilitating diseases such as MS, Alzheimer’s and rare diseases.  Luckily Jackie thrives on the fast paced and very demanding environment of clinical supplies.  Prior to joining Biogen, Jackie was a Senior Manager within Global Supply Planning for the adidas Group.

Biography:

Paul O’Connor is Global Vice President of Quality at Almac Clinical Services and a member of the Executive leadership team which supports the full range of client engagement and excellence in service delivery. He is responsible for leading the Quality function on all sites encompassing over 220 professional staff in areas of Quality Assurance and Control, Regulatory Support, Quality Systems, and Validation. Prior to that, Paul held other Quality Assurance and laboratory roles in relation to investigational and licensed medicinal products in Almac and Galen Holdings in a pharmaceutical career of over 25 years.
He is eligible to act as a European Union Qualified Person (QP) since 2001 and also holds a BSc First in Biochemical Sciences from the Ulster University.
Paul has written multiple industry articles and presents regularly at Investigational Medicinal Product conferences on Quality Assurance and Qualified Person matters

Biography:

Adrian Peskett has just moved to the new role, Head of Operational Strategy within Pfizer’s Global Clinical Supply Chain. He has worked with Pfizer for over 15 years supporting various aspects of the supply chain. Adrian’s responsibilities have included master planning, inventory management, commercial sourcing, packaging, labeling, process improvement, external vendor management, business development, licensing management and distribution. Today he is responsible for a team that is developing clinical supply operation strategy for the entire Pfizer portfolio. He is currently located in the US but spent many years in the UK and has considerable experience in optimizing international clinical supply chain activities. Adrian obtained his first degree from University of Wales, College of Cardiff and his MBA from the University of Kent.

Biography:

Ms. Borgeson is a Director in the Quality Assurance Operations Support Group based at Pfizer Inc. in Groton, Connecticut responsible for supporting global operational groups involved in clinical supply packaging, labeling, distribution and IRT system use. She has over 15 years of experience in the pharmaceutical industry in both the Commercial and Clinical GMP manufacturing operational areas as well as Clinical Supply Quality Assurance. Her experience spans roles that include vaccines, parenteral manufacturing, packaging, lyophilization, inventory management, distribution, validation and quality assurance. Prior to her roles in the pharmaceutical industry she held roles in patient care both in the private Physician and Hospital settings. She holds a Bachelor degree in Biology and Business from Oakland University in Rochester Hills, Michigan.

Biography:

Greg Brazier is Director, Clinical Operations for PCI’s North American Clinical Services business. Greg has held various roles within the company since joining PCI in 2000 and has overseen many large global clinical and commercial packaging operations, and offers extensive experience and expertise in operations.

In his current role he has overall responsibility and leadership for production, engineering, order processing, warehouse operations and logistics. Greg also oversees the compliance of all plant operations with company policy, federal, state and local regulations including OSHA, FDA and employment law.

Prior to joining PCI Greg held a number of roles within the pharmaceutical industry and is a United States Navy Veteran.

Biography:

Scott Ohanesian has held executive roles over the past 16 years for Clinical Logistics Organizations and Contract Manufacturing Organizations (CMOs), managing global logistics for Phase I through IV clinical trials.

He currently leads the QuickSTAT U.S. commercial operations team to build strategic relationships with pharmaceutical and biotech companies in order to provide comprehensive solutions for their global supply chain, ensuring product integrity and patient safety.

Prior to joining QuickSTAT, Scott managed the Asia Pacific commercial operations for Marken Limited, where he implemented the commercial strategy for his company in key markets, such as Australia, China, India, Japan, Singapore, South Korea, and Taiwan.  Prior to that position, he was in a global strategic management role at a CMO, creating mutually beneficial partnership models.

He is trained and well versed in Good Manufacturing Practices, (GMP) and has helped create innovative logistics solutions for numerous new drug products–from formulation development through to commercialization, including cutting edge cell, gene, and CAR-T therapies.

Scott is a graduate of Boston College with a Bachelor of Science in Finance and a Masters of International Law in Diplomacy from The Fletcher School at Tufts University, with affiliated course work at Harvard Law School and Harvard Business School.

Biography:

Patrick is currently a director of Clinical Supply Strategy & Management and leads a team of talented senior strategic project managers across multiple therapeutic areas at Pfizer. Patrick has 15 years of pharmaceutical supply chain experience – including analytical chemistry and quality control, clinical packaging operations, and developing sound clinical supply strategies for large and complex programs. Patrick has also focused over the past 2 years to collaborate across Pfizer to develop and implement innovative end-to-end supply chain strategies addressing the unique requirements for their growing cell and gene therapy portfolio. Patrick holds a Bachelors of Science in Chemistry from Stonehill College and a Masters of Business Administration from the University of New Haven.

Biography:

Gretchen Randlett is a consultant for Clinical Trial Commercial Products, part of Eli Lilly’s Clinical Trial Material Management (CTMMS) department. Her responsibility is to be the primary interface between clinical and CTMMS to support Expand Access programs and requests. As part of her role, she is responsible for designing CTMMS’s infrastructure by leading cross-functional teams to develop packaging, labeling, distribution and regulatory strategies, to support these unique programs. She also consults across organizations in Lilly to deliver the appropriate supply solution to patients requesting Lilly products under the Expand Access umbrella.Gretchen has over 10 years of clinical trial experience supporting phase I-IV global trial in multiple therapeutic areas including neuroscience, men’s health, women’s health, cardiovascular, oncology, autoimmune and endocrine. In addition to her clinical knowledge, she has 6 years bioanalytical laboratory experience in developing bio assays for phase I-IV clinical trials. Her leadership experience includes supervisory roles, Six Sigma Black Belt, alliance and partner management, in addition to leading multiple cross-functional transformation projects and initiatives. Gretchen holds a Bachelor’s degree in Biology from the University of West Alabama and executive MBA from Indiana University.

Biography:

Marc has spent his entire career in the eClinical technologies space, with most of that time focused in the area of IRT. Having spent years on the client services side, Marc has worked with 7 of the top 10 pharmaceutical companies and 6 of the top 7 CROs to design, implement, and maintain IRT solutions across a variety of therapeutic areas. As a Co-founder and Director of Business Development at Suvoda, Marc uses his IRT subject matter expertise to provide creative solutions to customers’ problems, all while growing Suvoda’s business globally. Marc enjoys creating long-lasting relationships with customers and colleagues and loves brokering introductions within his network. Marc is a graduate of Lafayette College with a degree in biochemistry and minor in music.

Biography:

Mark Mancuso is National Sales Manager at Faubel Pharma Services.  Mark was educated at Boston University with a degree in Biology. He has  worked in  research laboratories, and also provided solutions to labs,  looking to discover the next life changing drug.  Mark  has always had a strong passion towards science and its ability to improvepatient’s lives so the move to clinical trial supplies, specifically labels & blinding solutions, was a natural fit.

Biography:

Beth Young is currently a Manager within Global Clinical Supply Solutions at PRA Health Sciences. Prior to this, she worked for Takeda Pharmaceuticals and Almac Clinical Services. Beth has 11 years of pharmaceutical supply chain experience, which includes DP manufacturing, FG packaging and labeling, Global distribution, IRT development, and portfolio management of large global phase 3 trials in Oncology and GI. Beth holds a Bachelors of Arts in Psychology from Emory University.

Biography:

TJ has 13+ years’ experience in all aspects of the global life-science supply chain with extensive understanding of temperature sensitive packaging, logistics, regulations and best-practices. At CCT, TJ is responsible for providing leadership, coordination, and oversight of all business development activities in addition to the operational and financial aspects of strategic initiatives including reusable solutions and global expansion. TJ also serves as CCT’s Advisory Board Chair and is extensively involved in the industry at large as a member of various groups including the PDA PCCIG, ISTA Thermal Council and new industry guidance initiatives. He was a key member and co-author of PDA Technical Reports 46 and 52. TJ graduated from Pennsylvania State University with a bachelor’s degree in Mechanical Engineering and has a M.B.A. from the University of Massachusetts.

Biography:

Eric enters his twentieth year in our industry as Head of Commercial Operations, Americas for Thermo Fisher Scientific in the Clinical Trial Division (CTD). He oversees supply chain services with both strategic and key accounts in delivering packaging, labeling, distribution, comparator drug and clinical supply chain management solutions.

He is responsible for driving commercial growth within three different customer segments across ten different territories. Guiding his company’s commercial team with a Differentiated Value Proposition strategy that utilizes consultative selling approaches while leveraging the strengths of Thermo Fisher Scientifics global network.

Eric has served as both an executive and board level member with the Global Clinical Supply Group, and has been a conference attendee for all twenty years of his career.

Biography:

Pfizer’s Global Clinical Supply Chain.  She has worked at Pfizer for 17+ years in finance and clinical supply chain.  Her responsibilities have included project management, providing uninterrupted global clinical supply chain strategies within budget, ensuring patient continuity.  In addition to managing the forecasting, planning, scheduling and coordination of key activities to ensure the timely provision of clinical supplies, Lauralyn has recently focused on creative solutions for clinical trials with multiple comparator and/or co-med options, better known as ‘Basket Studies’.  Lauralyn received her degree from Western Carolina University.

Biography:

Ed Groleau has over 30 years of experience in the Pharmaceutical industry. The first 15 years were spent in a variety of laboratories for small molecule drug development.  He started out developing and validating analytical testing methods at Merrell Dow Pharmaceuticals and Eli Lilly.  He became Lilly’s primary X-ray powder diffraction expert and was a founding member of the company’s Physical Characterization group that established the optimal salt form for compounds in development.  Being responsible for all XRD, XRF, and thermometric techniques, Ed was also part of Lilly’s internal forensics team conducting investigations for internal manufacturing issues and external litigations.  After 7 years of physical characterization Ed moved to the chemical characterization group where he helped determine the structures of degradation products using NMR.

Ed moved to Lilly’s Clinical Trial Supplies group in 2003 starting in the group responsible for packaging and labeling of IP.  His responsibilities increased as the department changed over the years to include all aspects of CT supplies from planning to distribution. In 2011 he became part of a small, highly integrated CM&C team responsible for overseeing the development of compounds from discovery through proof-of-concept stage.  On this team Ed developed the procedures and processes required to conduct all aspects of the supplies for clinical trials from manufacturing through reconciliation.

In 2016 Ed moved to Elanco, Lilly’s animal health division, where he established a global clinical trial supplies group for developing companion and food animal projects.  Ed’s career at Lilly/Elanco ended in 2017 when he took advantage of an early retirement program the company offered.  Not ready to actually retire, Ed has joined a growing supply chain group at PCI where he continues to provide his experience and expertise to other companies in need of the service.

Biography:

Olive McCormick is the Head of Quality at Almac Clinical Services residing at the main headquarters in Craigavon, Northern Ireland. Olive is responsible for the QA, QC and the QP teams at this site. Olive has been with Almac for over 20 years where she has gained extensive experience in the practices employed in the manufacture, packaging and labeling of IMPs and has been acting as a QP for over 14 years. Her role involves management and oversight of the Pharmaceutical Quality System at the site and extends to include the routine duties of the QP. Olive has extensive experience in performing audits of sites involved in the supply chain globally. She routinely provides consultancy to clients on regulatory updates with particularly focus on the expectations of the regulators and how these impact you. More recently she has developed a strong interest in Data Integrity and is passionate with regards to how the requirements should be viewed as a positive impact on the industry.

Biography:

Steve is a successful consultant, trainer, business leader, executive coach, mentor and speaker. For the past 25 years he’s been heavily involved in clinical supply chain operations, IMPs, cGMPs, cGCPs, cGDPs, clinical development and quality (ICH Q8, Q9 & Q10) for pharmaceuticals, and biotech products.

He sits on the Board of Directors of the largest professional clinical supply organization in the world, the Global Clinical Supplies Group. His expertise also includes success in leadership, innovation, global cultural dynamics, organizational development, and high performing teams.

In the past he has been a CEO and COO, as well as the president and Global Chief Operating Officer, of a multinational clinical supply chain contract organization that served companies like Novartis, Eisai, Lilly and others in the pharmaceutical and biotech sector. Before that he was head of US clinical supply operations for Johnson & Johnson.

Steve was also a logistics and aviation officer, in the U.S. Army, where he rose to the rank of Major and was a maintenance test pilot, and pilot in command, for both helicopters and fixed wing aircraft.

His undergraduate degree is in Pharmacy from the University of the Sciences in Philadelphia and his MBA is from the University of Phoenix with a specialization in global management.

Steve has traveled all over the world (4 Continents, 25 Countries, 42 States) and enjoys spending time with his Fiancé, son, and good friends, whenever he gets the chance.

Biography:

Steve is a successful consultant, trainer, business leader, executive coach, mentor and speaker. For the past 25 years he’s been heavily involved in clinical supply chain operations, IMPs, cGMPs, cGCPs, cGDPs, clinical development and quality (ICH Q8, Q9 & Q10) for pharmaceuticals, and biotech products.

He sits on the Board of Directors of the largest professional clinical supply organization in the world, the Global Clinical Supplies Group. His expertise also includes success in leadership, innovation, global cultural dynamics, organizational development, and high performing teams.

In the past he has been a CEO and COO, as well as the president and Global Chief Operating Officer, of a multinational clinical supply chain contract organization that served companies like Novartis, Eisai, Lilly and others in the pharmaceutical and biotech sector. Before that he was head of US clinical supply operations for Johnson & Johnson.

Steve was also a logistics and aviation officer, in the U.S. Army, where he rose to the rank of Major and was a maintenance test pilot, and pilot in command, for both helicopters and fixed wing aircraft.

His undergraduate degree is in Pharmacy from the University of the Sciences in Philadelphia and his MBA is from the University of Phoenix with a specialization in global management.

Steve has traveled all over the world (4 Continents, 25 Countries, 42 States) and enjoys spending time with his Fiancé, son, and good friends, whenever he gets the chance.

Biography:

Provide leadership, direction and oversight to team responsible for setting Sourcing Strategies and Classification for clinical trials.  Develop team to proactively manage issues, propose mitigation/response plans to resolve issues and effectively implement action plan that translates across the portfolio for the management of Commercial Product.  Understand global regulations and the external environment which impacts commercial product sourcing and enable strategic plan to meet these influences.  Accountable for classification of commercial products as investigational or non-investigational.  Responsible for complex technical decisions regarding Commercial Product regulations, cGMPs, and cGCPs.  Accountable to create unique solutions to complex commercial product sourcing problems that ultimately supports innovation and patient needs.  Previously was responsible for overall ownership of master label orders, utilizing the input provided by the supply planning organization, to ensure on-time delivery of master labels.  In addition, served as a key contact and liaison for FIPNET-related service providers related to labels and was responsible for the label library.  Lead CTMMS Labeling department including establishment of strategy and associated yearly objectives, metrics to measure success and leading staff to achieve strategy and goals.  Prior to joining Product Delivery, was in Project Management where she led multiple late phase assets from Phase II development through submission.

Biography:

Michael is currently the CEO of Myoderm, where he has worked the past 18 years.  Michael’s passion, leadership, and commitment to meeting each client’s unique needs have been a driving force in making us a global leader in clinical trial supply. Before Myoderm, Michael served in positions in the publishing, advertising, financial, and utility industries. He holds a B.S. in Statistics from the University of Pittsburgh, and an M.B.A. from the university’s Katz Graduate School of Business. 

Biography:

Mike is responsible for the development, implementation, product management and ownership of World Courier’s patient centric services across 140+ company-owned offices in 50+ countries, with focus on direct-to-patient services. Since joining World Courier in 1992, Mike assumed a number of positions within US operations, customer service, training, compliance, marketing, sales and clinical trials management. He progressed to senior roles, including director of US customer service / operations, director of new service development and director of regional accounts, before transitioning into a global IT leadership position and prior to his current cross-functional role within the global services team. Based in Philadelphia, Pennsylvania (USA), Mike works extensively across World Courier’s global network.

Biography:

David began his pharmaceutical career in 2007 with Hospira, in Lake Forest, IL, performing BET and potency testing in the global stabilities lab. From there, he began managing packaging and labeling activities at Fisher Clinical Services for five years.  In 2015, David moved to Takeda where he was a Senior Program Manager, focusing on delivery of clinical supplies for Takeda’s vaccines division.  David is  now a Clinical Supplies Lead at Shire, at their Lexington, MA, location.  He is responsible for packaging, labeling, distribution, returns, reconciliation, and destruction activities for both large and small molecule drug products for global studies, which involve direct-to-patient services in North America and the EU.  Through these efforts, David has focused on developing Shire’s management of direct-to-patient services which include improving logistics, chain of custody, communication, understanding regulatory impact, issue tracking, and lessons learned.

Biography:

Buz has been working in supply chain management in the healthcare sector for 40 years.  Currently he is the system owner for the Optimizer clinical supplies forecasting system and the clinical supplies dashboard.  Over the recent years, he has developed innovative approaches to clinical supply forecasting, IWR supply management and waste reduction.  These efforts have literally changed the J&J clinical supply operations landscape.

Biography:

Greg Hottell holds the role of Director, Clinical Supply Chain at GSK, where he is responsible for the cost-effective, patient-focused supply of investigational product for GSK’s pharmaceutical development portfolio. Since joining GSK in 2011, Greg implemented an end-to-end planning platform for clinical supplies (D&OP), helped redesign GSK’s approach to clinical supply blinding and unblinding risk management, implemented and operates a monthly clinical demand governance process (Demand Review), implemented the Smart Supplies Forecasting tool, and has overseen GSK’s performance with on-time delivery of IP to patients. Greg is a member of the ISPE North American Investigational Product community of practice steering committee. Additionally, he has been active with the Global Clinical Supplies Group since 2016 by facilitating workshops and presenting at annual meetings. Greg has been a Supply Chain professional since 1999, most recently holding positions of increasing responsibility at Eli Lilly & Company and Fisher Clinical Services, and GSK. He holds a bachelor’s degree in Operations Management, an MBA, and is a Certified Fellow in Production and Inventory Management (CPIM-F) through APICS.

Biography:

Mr. Valentine is the Vice President, Clinical Supply Services with responsibilities for Client Services, Clinical Storage and Transportation Services, Comparator Services and Strategic Projects. In his previous role as Global Director of Distribution Services for Catalent Pharma Solutions, he was responsible for developing the global facility and depot network and logistics strategies in support of Catalent’s Clinical Supply Services business.  He has a background of over 20 years’ experience serving in leadership positions in the CRO and drug development services industries.  Mr. Valentine holds an MBA in Finance from Seton Hall University and a B.A. in Business Administration from the University of Vermont.

Biography:

Terry Iacobucci has worked in Clinical Supplies for over 15 years for vendors, pharmaceutical and biotech companies.  She continued her career at TESARO, initially managing the large portfolio of Investigator Sponsored Studies, partnerships with other pharmaceutical sponsors, development of the Global Compassionate Use Program and development of sustainable processes for all of these programs.    Terry is currently an Associate Director at TESARO where she oversees the management of  the sponsored studies, CMOs and external contractors.  

 Prior to joining TESARO, Terry worked in clinical supplies with the Phase I team at Bayer, and the Medical Affairs team at Sanofi.   She has facilitated GCSG workshops on Investigator Sponsored Trials and is a member of the GCSG EAP E-team.  Terry is a licensed professional BioChemical Engineer. 

Biography:

Greg is Executive Director at Jeiven Pharmaceutical Consulting, Inc. where he provides consulting services and training to pharmaceutical, biotech, and nutraceutical companies.

Prior to joining Jeiven, he founded Kushla Consulting, with the main focus of clinical trial material support, especially in developing appropriate cost-effective and timely solutions to clinical study challenges.

Greg established the clinical supply planning and operation function for Daiichi Sankyo (formerly Sankyo Pharma) in the US. His group’s responsibilities included import/export, development of study-specific packaging-labeling designs and IXRS specifications, vendor selection and contracting, execution of packaging, labeling, distribution, and returns/destruction activities for all phases of clinical trials. Studies ranged from single-country trials to global mega-trials.

A formulator by training, Greg has experience in developing a variety of dosage forms, several of which have been successfully commercialized. During his tenure at Abbott Laboratories (formerly Knoll Pharmaceutical Company), he led a team of scientists responsible for formulation development, scale-up, and transfer to manufacturing sites; led global technical development teams; and contributed to the CMC sections of numerous regulatory submissions. Greg was also responsible for the clinical supply function for studies conducted primarily in North America.

Greg received his degrees from Rutgers University.

Biography:

Kazuaki joined Pfizer Japan Inc. in 2013 as a Japan Import/Export specialist. In 2014 he became a Packaging Coordinator to support clinical supply packaging in Asia as an additional role. He has worked on various process changes as well as continuous improvement projects and managed local vendors in Asia.
Kazuaki transferred to Pfizer Inc. and relocated to Groton, CT in 2017. In his Planning Lead role, he is supporting vendor and internal scheduling activities, coordinate demand forecasting and planning across internal packaging sites and the external vendor network. He is also responsible for resource allocation of Quality assurance, and He is continuing to manage packaging and labeling activities in Asia.

Biography:

My passion for the practice of pharmacy began immediately after I graduated from pharmacy school and learned all of the ways a pharmacist can positively influence a patient’s life. For over 33 years, this passion and drive has motivated me to bring the practice of pharmacy into the clinical research sector. I have always challenged traditional clinical trial models and through new processes, innovative study designs, and patient counseling services, I have been able to revolutionize the way patients receive and take their medications in clinical trials.

With the mission of making a difference in the clinical supplies sector, I founded CSM in 1997 and grew the company from a one-person consulting operation, to a multi-million dollar organization with multiple locations and 100+ employees. In 2001, I created and launched the On-Demand packaging and labeling platform, an industry breakthrough enabling a flexible clinical supply chain to keep pace with breakthrough therapies, diagnostics, and technology by delivering patient-centric medication.

While working with sponsor companies and seeing first-hand the struggle of getting FDA approval, I launched CTRP® (Clinical Trials Research Pharmacist) services as a division of CSM. By piloting this services through CSM, we were able to prove that pharmacists counseling patients in clinical trials can improve compliance, adherence, retention, and more importantly, the overall quality of the studies. In 2014, I rebranded and re-launched the CTRP® service through Center Point Clinical Services, LLC.

Both Center Point and CSM are re-defining the way our industry conducts clinical trials with the overall strategy of finding innovative solutions to help companies decrease timelines, improve study outcomes, and reduce costs while improving the strategic quality in all aspects of patient-centric medication and care.

Biography:

Rüdiger Weber is based in Germany leading the German CSM – Clinical Supplies Management site as General Manager. He joined CSM in 2016 via the acquisition of Theorem Clinical Research where he headed the Clinical Supplies department since 1997. Prior to that Rüdiger held a similar appointment for another CRO. He looks back on more than 24 years of experience in contract packaging and distribution of investigational medicinal products. Rüdiger is a pharmacist by training and since 1995 registered as Qualified Person (QP) at the German Health Authority. He is member of the European Qualified Person Association.

Biography:

Barbara Berman is the Senior Vice President and Regional Director of Professional Services at Lee Hecht Harrison, the global talent mobility leader in connecting people to jobs and helping individuals improve performance. In her role, Barbara manages the delivery of career transition services in Georgia, Florida, Alabama and Tennessee. Barbara has over 20 years experience in management and consulting across several industries. She has been recognized for her focus on quality, team development and customer service.
Prior to joining LHH, Barbara worked internationally with extensive background in training, management, and delivery of consulting services. Her experience is in both training organizations and universities. She has a proven track record of building strong client relationships, facilitating high quality presentations and successfully managing global projects to achieve business goals. She has been recognized as an outstanding communicator with success in creating new initiatives to serve national and international audiences.
Barbara holds a Master of Science in Education and has completed post-graduate work in Higher Education Administration. She is also a certified corporate coach and works closely with SHRM Atlanta, Girls Inc and Partners Against Domestic Violence (PADV). Barbara grew up in New York and has been in Atlanta for the last 25 years.

Biography:

Henryk Junker has worked in the Pharmaceutical Industry for over thirty years. Whilst being based in the UK he has worked for a number of US companies.

He is a Fellow of the Royal Society of Chemistry and in 1984 became a Qualified Person. His career has been in Quality Assurance and Operations working in Commercial and Clinical Supplies.

In particular Henryk has been involved in setting up multiple clinical supplies units.

Today Henryk is the Head of Quality and Qualified Person for the Xerimis UK.

Biography:

Eric enters his twentieth year in our industry as Head of Commercial Operations, Americas for Thermo Fisher Scientific in the Clinical Trial Division (CTD). He oversees supply chain services with both strategic and key accounts in delivering packaging, labeling, distribution, comparator drug and clinical supply chain management solutions.

He is responsible for driving commercial growth within three different customer segments across ten different territories. Guiding his company’s commercial team with a Differentiated Value Proposition strategy that utilizes consultative selling approaches while leveraging the strengths of Thermo Fisher Scientifics global network.

Eric has served as both an executive and board level member with the Global Clinical Supply Group, and has been a conference attendee for all twenty years of his career.

Biography:

Laurie is currently a Director of Solutions Consulting- Clinical Trial Supplies and Logistics at PAREXEL. She is responsible for managing a team of solutions consultants who provide subject matter expertise in order to develop supply strategies to meet each client’s unique need. She has been with PAREXEL since 2012, and held positions in clinical supply project management and account management. Prior to joining PAREXEL Laurie’s primary focus was project management of the full drug supply lifecycle from forecasting and planning through returns and destruction. Since joining PAREXEL she has expanded her area of focus to include ancillary supplies management and laboratory logistics.  Laurie has worked in the clinical trial industry for 20 years. She is an experienced clinical supply professional with 10+ years of global clinical supply chain project management experience. She has a B.S in Biochemistry and an MA in Kinesiology from the University of Texas.

Biography:

Justin Schroeder is the Vice President for Global Program Management at PCI Pharma Services. Mr.Schroeder is responsible for PCI’s customer facing staff, ensuring seamless delivery of PCI’s #1 Commitment in providing the leading customer experience and ensuring successful development and commercialization of new medicines for its clients. Mr. Schroeder has over 20 years of experience in outsourced pharmaceutical services in various roles including Package Engineering and Development, Project Management, Marketing and Business Development. He holds a Bachelor of Science from the School of Packaging at Michigan State University and an MBA in Marketing from Northern Illinois University. Mr. Schroeder is a Certified Packaging Professional from the Institute of Packaging Professionals (IoPP) and is the Vice Chairman of the US Healthcare Compliance Packaging Council (HCPC).

Biography:

Steve is a successful consultant, trainer, business leader, executive coach, mentor and speaker. For the past 25 years he’s been heavily involved in clinical supply chain operations, IMPs, cGMPs, cGCPs, cGDPs, clinical development and quality (ICH Q8, Q9 & Q10) for pharmaceuticals, and biotech products.

He sits on the Board of Directors of the largest professional clinical supply organization in the world, the Global Clinical Supplies Group. His expertise also includes success in leadership, innovation, global cultural dynamics, organizational development, and high performing teams.

In the past he has been a CEO and COO, as well as the president and Global Chief Operating Officer, of a multinational clinical supply chain contract organization that served companies like Novartis, Eisai, Lilly and others in the pharmaceutical and biotech sector. Before that he was head of US clinical supply operations for Johnson & Johnson.

Steve was also a logistics and aviation officer, in the U.S. Army, where he rose to the rank of Major and was a maintenance test pilot, and pilot in command, for both helicopters and fixed wing aircraft.

His undergraduate degree is in Pharmacy from the University of the Sciences in Philadelphia and his MBA is from the University of Phoenix with a specialization in global management.

Steve has traveled all over the world (4 Continents, 25 Countries, 42 States) and enjoys spending time with his Fiancé, son, and good friends, whenever he gets the chance.

Biography:

Scott Ohanesian has held executive roles over the past 16 years for Clinical Logistics Organizations and Contract Manufacturing Organizations (CMOs), managing global logistics for Phase I through IV clinical trials.

He currently leads the QuickSTAT U.S. commercial operations team to build strategic relationships with pharmaceutical and biotech companies in order to provide comprehensive solutions for their global supply chain, ensuring product integrity and patient safety.

Prior to joining QuickSTAT, Scott managed the Asia Pacific commercial operations for Marken Limited, where he implemented the commercial strategy for his company in key markets, such as Australia, China, India, Japan, Singapore, South Korea, and Taiwan.  Prior to that position, he was in a global strategic management role at a CMO, creating mutually beneficial partnership models.

He is trained and well versed in Good Manufacturing Practices, (GMP) and has helped create innovative logistics solutions for numerous new drug products–from formulation development through to commercialization, including cutting edge cell, gene, and CAR-T therapies.

Scott is a graduate of Boston College with a Bachelor of Science in Finance and a Masters of International Law in Diplomacy from The Fletcher School at Tufts University, with affiliated course work at Harvard Law School and Harvard Business School.

Biography:

Patrick is currently a director of Clinical Supply Strategy & Management and leads a team of talented senior strategic project managers across multiple therapeutic areas at Pfizer. Patrick has 15 years of pharmaceutical supply chain experience – including analytical chemistry and quality control, clinical packaging operations, and developing sound clinical supply strategies for large and complex programs. Patrick has also focused over the past 2 years to collaborate across Pfizer to develop and implement innovative end-to-end supply chain strategies addressing the unique requirements for their growing cell and gene therapy portfolio. Patrick holds a Bachelors of Science in Chemistry from Stonehill College and a Masters of Business Administration from the University of New Haven.

Biography:

Stephen Flaherty is the Global Director for Demand Led Services (DLS) – FastChainTM within Catalent Pharma Solutions.
He has worked in various clinical supplies roles of increasing responsibility for 28 years, mainly focussed in the Project Management area, previously having had responsibility for PM teams in UK and Germany. He has (IMP) QP eligibility status within Europe (for the time being.)
His latest role has been to lead the: creation, development and deployment of the DLS – FastChainTM model within the Catalent network.
He has overseen the set up and delivery of global and regional teams, systems and procedures which have enabled 5 local and regional DLS – FastChainTM hubs, in Americas, EU, and Asia, to become operational, in the last 3 years, with plans for more to follow in the future.
Currently the network supports both regional and global studies and processes several thousand individual orders p.a. with significant expansion forecasted and planned.
Stephen also acts as the main point of contact with key clients, at a senior level, during the inception, development, execution, maintenance, refinement and scale-up of the FastChainTM model, to meet each client’s: portfolio, programme and study requirements

Biography:

Jennifer Snyder is the US Team Head of External Operations Management for Novartis Pharmaceuticals in the Global Clinical Supplies group.  She has been in the pharmaceutical industry for over twenty years and has worked in all areas of pharmaceutical development including formulation, analytical, quality, and global clinical supplies.  For the past three years Jennifer has been a member of the Novartis team building and implementing a decentralized model for clinical supply.  Her focus has been on working within Region America’s to establish this more responsive model and building vendor relationships for optimal support.

Biography:

Nadia Laouar is the Global Head of External Operations Management for Novartis Pharmaceuticals.  She has been in the pharmaceutical industry for over fifteen years and has worked in discovery chemistry as a research scientist prior moving to Global Clinical Supply Organization. Nadia has led various roles with increasing responsibilities including Compliance lead and Portfolio management.  For the past three years Nadia has been a member of the Novartis team building and implementing a decentralized supply model for clinical supply.  Her focus has been on working to establish, at a global scale, this flexible, more responsive model and building vendor relationships for optimal support.

Biography:

Gretchen Randlett is a consultant for Clinical Trial Commercial Products, part of Eli Lilly’s Clinical Trial Material Management (CTMMS) department. Her responsibility is to be the primary interface between clinical and CTMMS to support Expand Access programs and requests. As part of her role, she is responsible for designing CTMMS’s infrastructure by leading cross-functional teams to develop packaging, labeling, distribution and regulatory strategies, to support these unique programs. She also consults across organizations in Lilly to deliver the appropriate supply solution to patients requesting Lilly products under the Expand Access umbrella.Gretchen has over 10 years of clinical trial experience supporting phase I-IV global trial in multiple therapeutic areas including neuroscience, men’s health, women’s health, cardiovascular, oncology, autoimmune and endocrine. In addition to her clinical knowledge, she has 6 years bioanalytical laboratory experience in developing bio assays for phase I-IV clinical trials. Her leadership experience includes supervisory roles, Six Sigma Black Belt, alliance and partner management, in addition to leading multiple cross-functional transformation projects and initiatives. Gretchen holds a Bachelor’s degree in Biology from the University of West Alabama and executive MBA from Indiana University.

Biography:

Dan Bell joined Marken in 2003 and is their Vice President, Regulatory Compliance and Technical Affairs.
Dan is a licensed US Customs Broker and Certified Customs Specialist, with more than twenty five years of combined education and practical logistics experience, with a focus on trade compliance and time and temperature critical areas within the global life science supply chain. He regularly serves as a liaison between pharma, CMO, CRO, lab clients, customs, and the alphabet soup of regulatory agencies, to ensure the maximum level of compliance with US & international trade laws and regulations.

Early in his career, Dan was headquartered in Europe and was responsible for establishing the US entity of a company that developed temperature monitors and data loggers. His expertise in temperature logging, thermal packaging solutions and regulatory compliance, has helped Marken and its customers with the challenges of finding solutions for complex shipping routes, correct storage and transport of temperature-sensitive lifesaving drugs.

Biography:

Erin is a Project Manager at Catalent Pharma Solutions with over 22 yrs. experience in the Japanese Market with more than 10 yrs. working both in Japan and the US, with Japanese clients and Global clinical trials going into Japan.    She has extensive design and strategy expertise for Japanese clinical supplies and advising foreign companies wishing to do business in Japan.   Erin previously managing the North Carolina Japan center and was responsible for consultancy on technology transfer and bridging cultural gaps with Japanese and US entities doing business in the US or bridging into Japan.

Biography:

Yuki Hayashi has 5 years experience as QC/QA specific for clinical supplies and more then 10 years experience as clinical supplies management in Yamanouchi/Astellas Pharma Inc., the 2nd largest pharmaceutical company in Japan. In addition to his role in Japan, Yuki has also worked for 3 years at Astellas US (Chicago, IL, USA) during 2012-2015 ) in Clinical Supply Management.

Biography:

Nicohle J. McGeorge is Senior Lead Project Manager in Clinical Supply Operations Packaging and Labeling for Bristol-Myers Squibb Company in New Jersey. With over 14 years in the industry, Nicohle has gained expertise in area of clinical labeling regulatory requirements and label vendor management.

Biography:

Kevin began his career at Clintrak (later purchased by ThermoFisher Scientific) in May 2004 in the Manufacturing Division and was directly involved with label production. He joined the Client Services Department where he worked closely with clients in order to insure the successful completion of their jobs from protocol interpretation to label production. Throughout his tenure, Kevin has gained broad knowledge of the clinical label production process and the clinical supply chain as a whole while developing innovative solutions for clinical labeling challenges. Over the past few years, Kevin has spearheaded the development of translation and regulatory review solutions for clinical trial labels as a Label Program Director. Kevin provides customer service support including client and site visits, quarterly meetings, trade meetings, exhibitions, seminars, whitepapers and leads industry discussion groups. He works closely with ThermoFisher Scientific specialists to develop customized solutions to meet client’s unique needs. Kevin received his Bachelor of Arts degree from Hobart College in the year 2000. He currently resides in Patchogue, NY with his wife and two children.

Biography:

James Oberhauser is currently Associate Director, Device Development and Clinical Packaging Engineering at Gilead Sciences in Foster City, CA. His responsibilities include growing a device development team to meet the needs of the parenteral and biologics pipeline and establishing the quality system infrastructure essential to a successful device development enterprise. Previously, Dr. Oberhauser led product development of Abbott Vascular’s Absorb™ Bioresorbable Vascular Scaffold (BVS), authoring the seminal article on the therapy in EuroIntervention and receiving the Innovation Team Award from the Abbott Laboratories Volwiler Society. Dr. Oberhauser holds 47 issued patents and has authored 22 peer-reviewed journal publications.
Dr. Oberhauser received his Ph.D. in chemical engineering from the University of California, Santa Barbara, where he studied structure-property relationships in polymeric materials. He also spent over 6 years on the faculty of the Department of Chemical Engineering at the University of Virginia.

Biography:

Yvonne Stephens has worked in Clinical Trial Supply Chain Planning at Eli Lilly and Company for the past 14 years. In this role, she supports the Diabetes business unit in clinical trial supply planning.  Her responsibilities encompass development of molecule/trial demand forecasts in partnership with a clinical team, strategic development of packaging, labeling and sourcing of investigational product as well as devices, supporting innovation and process optimization to speed drug development, as well as applying knowledge on GMP/GCP compliance in a clinical trial environment.

Biography:

Andrea is an Enterprise SaaS executive and investor focused on delivering the highest possible quality in Enterprise System strategy and implementations to the Pharmaceutical, Biotech, Medical Device and Clinical Supplies industries. Starting from a strategic assessment of a company’s business needs and opportunities, he advises on optimizing processes and implementing existing technology like ERP, LIMS Weighing & Dispensing, Business Intelligence for the Pharma and Biotech industries, and how to select and deploy emerging technology like AI, ML, RPA, etc.

Biography:

Massimo Crudeli has joined the ARconsulting Group in 2002. His work experience mainly focuses in the implementation of the Microsoft Dynamics ERP solutions (AX and NAV) for Life Sciences and regulated industries (Pharmaceutical, Chemical, Cosmetics, Medical Devices and Food) and Industrial Equipment Manufacturing industries.
He has 15+ years of expertise in international ERP Implementation projects (USA, Brazil, Ecuador, UK, Germany, Finland, France, Italy, Romania and Bulgaria) as Solution Architect and Senior Consultant for Manufacturing, Trade & Logistics and Quality Management.
He also has 12+ years of expertise as Pre-Sales Manager in ERP systems (Microsoft Dynamics AX, NAV and others).

Biography:

Rob is a seasoned executive with 30 years combined global experience in Pharmaceutical R&D with a focus on clinical supply chain leadership, quality assurance, process re-engineering and leadership of change initiatives.

After obtaining a PhD in Analytical Chemistry from Southampton University UK Rob joined The Upjohn Company as a scientist and has subsequently held roles of increasing responsibility with Pharmacia & Upjohn, Pharmacia, Pfizer, Schering Plough and Merck.

Rob has had extensive experience in clinical supply quality assurance and laboratory operations including proposing regulatory specifications and reviewing CMC regulatory submissions for drug candidates. He has a strong track record of optimizing international Clinical Supply Chain operations and a proven ability to forge global relationships across lines and disciplines. A valued and effective change leader with extensive experience in helping organizations navigate organizational change without compromising business performance.

During his career Rob led large clinical supply chain organizations through six mergers while maintaining business continuity. He also has had the opportunity to lead a number of high profile process improvement initiatives:
• Co-led a corporate wide initiative to globalize, and optimize clinical supply chain across multiple country sites
• Collaborated on a cross functional initiative with clinical partners to optimize planning and delivery of clinical supplies
• Negotiated and successfully managed the integration of commercial and R&D logistics business units
• Established cross functional governance between clinical and clinical supply organizations

In February 2014 Rob co-founded and is now a Managing Partner at Brizzey LLC, a small firm of professionals with a track record of success in the areas of clinical supplies, R&D change management & process optimization.

Biography:

Lorna is an Electrical Engineer with experience across the following industries:  Heavy equipment design & manufacturing, financial, and information technology.  She joined the Pharmaceutical Industry as a consultant to Pfizer, where she was involved in a corporate wide initiative to globalize, and optimize 2000+ clinical supply chain procedures across 6 countries to 200+ global procedures.

Lorna was then retained as a consultant by Schering Plough to lead the optimization of the clinical supply chain. Following that assignment, she was hired by Schering Plough as the Global Clinical Supply Regional Lead for Latin America, serving as the key interface between the clinical supply team and the clinical operations team. In this role, she continued her leadership of process integration and optimization in support of the mergers with Organon and Merck.

She is now a Managing Partner at Brizzey, a small firm dedicated to helping companies navigate the complexities of bringing new medicines to the market through the reliable, optimized and cost effective delivery of clinical supplies.

Biography:

Jason Nolte has 17 years of industry experience with 15 of those years working in clinical supply chain.  He has planned many different trial designs and complexities; from open label studies to double blind double dummy pediatric titration studies; from taste studies to devices studies.  Jason enjoys working in global cross functional teams that drive results and who drive for right first time through operational excellence.  Jason Nolte currently works for Fisher Clinical Services as a Comparator Key Account Manager, in this role he applies his clinical supply chain knowledge to help clients expedite their commercialization strategies through flawless comparator drug purchasing and clinical trial execution.

Biography:

Having worked in the pharmaceutical industry for almost 20 years within various quality positions, in his position as Global Clinical Quality Director, Tristram is responsible for quality within PCIs clinical trial supply services division; In this role Tristram engages with PCI clinical teams in the USA, UK and Ireland, also liaising with global customers on various clinical supply chains generally advising on quality matters.  Tristram is an EU Qualified Person (QP), qualifying under the permanent provisions in 2011, Tristram is responsible for the QP certification of both commercial and investigational medicinal products on various PCI UK MHRA site licences across a range of dosages forms.  Tristram joined PCI back in in 2007 within one of PCIs acquired companies, Biotec Services International where Tristram held various Quality Management and Director positions.

Biography:

Paul O’Connor is Global Vice President of Quality at Almac Clinical Services and a member of the Executive leadership team which supports the full range of client engagement and excellence in service delivery. He is responsible for leading the Quality function on all sites encompassing over 220 professional staff in areas of Quality Assurance and Control, Regulatory Support, Quality Systems, and Validation. Prior to that, Paul held other Quality Assurance and laboratory roles in relation to investigational and licensed medicinal products in Almac and Galen Holdings in a pharmaceutical career of over 25 years.
He is eligible to act as a European Union Qualified Person (QP) since 2001 and also holds a BSc First in Biochemical Sciences from the Ulster University.
Paul has written multiple industry articles and presents regularly at Investigational Medicinal Product conferences on Quality Assurance and Qualified Person matters

Biography:

Adrian Peskett has just moved to the new role, Head of Operational Strategy within Pfizer’s Global Clinical Supply Chain. He has worked with Pfizer for over 15 years supporting various aspects of the supply chain. Adrian’s responsibilities have included master planning, inventory management, commercial sourcing, packaging, labeling, process improvement, external vendor management, business development, licensing management and distribution. Today he is responsible for a team that is developing clinical supply operation strategy for the entire Pfizer portfolio. He is currently located in the US but spent many years in the UK and has considerable experience in optimizing international clinical supply chain activities. Adrian obtained his first degree from University of Wales, College of Cardiff and his MBA from the University of Kent.

Biography:

Ms. Borgeson is a Director in the Quality Assurance Operations Support Group based at Pfizer Inc. in Groton, Connecticut responsible for supporting global operational groups involved in clinical supply packaging, labeling, distribution and IRT system use. She has over 15 years of experience in the pharmaceutical industry in both the Commercial and Clinical GMP manufacturing operational areas as well as Clinical Supply Quality Assurance. Her experience spans roles that include vaccines, parenteral manufacturing, packaging, lyophilization, inventory management, distribution, validation and quality assurance. Prior to her roles in the pharmaceutical industry she held roles in patient care both in the private Physician and Hospital settings. She holds a Bachelor degree in Biology and Business from Oakland University in Rochester Hills, Michigan.

Biography:

Greg Brazier is Director, Clinical Operations for PCI’s North American Clinical Services business. Greg has held various roles within the company since joining PCI in 2000 and has overseen many large global clinical and commercial packaging operations, and offers extensive experience and expertise in operations.

In his current role he has overall responsibility and leadership for production, engineering, order processing, warehouse operations and logistics. Greg also oversees the compliance of all plant operations with company policy, federal, state and local regulations including OSHA, FDA and employment law.

Prior to joining PCI Greg held a number of roles within the pharmaceutical industry and is a United States Navy Veteran.

Biography:

Buz has been working in supply chain management in the healthcare sector for 40 years.  Currently he is the system owner for the Optimizer clinical supplies forecasting system and the clinical supplies dashboard.  Over the recent years, he has developed innovative approaches to clinical supply forecasting, IWR supply management and waste reduction.  These efforts have literally changed the J&J clinical supply operations landscape.

Biography:

Greg Hottell holds the role of Director, Clinical Supply Chain at GSK, where he is responsible for the cost-effective, patient-focused supply of investigational product for GSK’s pharmaceutical development portfolio. Since joining GSK in 2011, Greg implemented an end-to-end planning platform for clinical supplies (D&OP), helped redesign GSK’s approach to clinical supply blinding and unblinding risk management, implemented and operates a monthly clinical demand governance process (Demand Review), implemented the Smart Supplies Forecasting tool, and has overseen GSK’s performance with on-time delivery of IP to patients. Greg is a member of the ISPE North American Investigational Product community of practice steering committee. Additionally, he has been active with the Global Clinical Supplies Group since 2016 by facilitating workshops and presenting at annual meetings. Greg has been a Supply Chain professional since 1999, most recently holding positions of increasing responsibility at Eli Lilly & Company and Fisher Clinical Services, and GSK. He holds a bachelor’s degree in Operations Management, an MBA, and is a Certified Fellow in Production and Inventory Management (CPIM-F) through APICS.

Biography:

John has spent 22 years at Catalent Pharma Solutions beginning in Deeside (UK) as a Distribution Technician and advancing through to Distribution & Logistics Manager in 2009 making considerable changes in developing and improving processes.
Joined the Global CI & Technology group in 2015 in the role of Global Clinical Supply Shipping Solutions Specialist responsible to identify new and innovative temperature controlled packaging to minimize risk of temperature excursions and improve Cold Chain shipping performance.
Moved to the role of Global Clinical Supply Process Leader for Distribution in 2016 retaining responsibility for shipping solutions whilst expanding the role to lead standardisation and harmonisation of distribution processes across the global Clinical Supply business.

Biography:

Adam Tetz brings more than 20 years of marketing experience to the role.  He is responsible for worldwide branding, product launch and communications strategy.  Prior to Pelican BioThermal, Tetz held positions in product management, marketing communications and account management across a variety of industries, including medical software, financial software and professional services.  He holds an MBA in Marketing from the University of Saint Thomas and a BA in Advertising from the University of Minnesota.

Biography:

Mark Woolf – Global Manager, Depot Network, Catalent

• Over 35 years logistics and operational experience
• Extensive background in global storage and distribution including residency for over 15 years in many European, Middle East and APAC countries.
• Zuellig Pharma Asia Pacific (4 years) where he was resident, working in the Philippines
• Almac Clinical Services (6 years) both in the UK and USA.
• Freight Forwarder and Distributor within Free Trade Zones in Turkey & Africa.
• 12 years of Clinical Trial Logistic, Operations and Vendor management

Biography:

Cyrille Lefevre has a background of engineer in applied mathematics. He has been working on the development of CT-FAST optimization software at N-SIDE in the last 6 years. He has experience advising both large and small pharma for the forecasting and optimization of their clinical trials for all phases and through multiple therapeutic areas. Cyrille also has a large experience training teams from multiple large organisations focusing on improving IRT resupply algorithms and the way they are used

Biography:

Sandra Cook, Ph.D., is a project management, strategy and training consultant with thirty years experience in the pharmaceutical industry. The past twenty have been focused on Investigational Products where she has held both line management and senior level project management roles facilitating high performing teams in the delivery of worldwide clinical supplies, including materials supporting key priority blockbuster products for large pharma.  Additionally, she has been instrumental in the design, development and implementation of several global process improvement projects for R&D Supply Chain.  An active contributor to the IP Metrics Task Team of the International Society of Pharmaceutical Engineering, Cook also manages the bi-annual Equal Partners in Clinical Supplies industry forum

Biography:

Steven Yoder is the Global Director of Clinical Supply Optimization at Fisher Clinical Services.

Steve has over 25 years of supply chain experience and leadership in the pharmaceutical industry, with the last 12 years focused specifically on Investigational Products. His career spans experiences in Finance and Leadership in Manufacturing, Distribution, Outsourcing, and Global Logistics.

He earned a Bachelor’s degree in Management and Finance from Purdue University and a Masters Degree in Business Administration (MBA) with an Operations focus from Indiana University. He is APICS certified in Production and Inventory Management (CPIM), and served as a member (and Past Chair) of the ISPE Investigational Products North America Steering Committee.

He may be reached via email at: Steven.yoder@thermofisher.com

Biography:

Natalie Balanovsky is the Supply Chain Solutions Manager at Almac Clinical Services in Souderton, PA, managing the Strategic Product and Business Development, implementation, education and training of Almac’s JIT service suite.

Natalie has previously held other roles at Almac including Global Project Leader and Project Manager of Distribution, managing Phase 1 through 4 clinical trials of various size, and complexity. She has over 15 years of professional experience within Project Management, Business Development, GMP Operations, and Quality Compliance for various industries including pharmaceutical, financial and b2b.

She holds a Bachelor of Science degree in Business from Delaware Valley University and earned her Master of Business Administration with concentration in Finance from LaSalle University. She is a certified Project Management Professional and is a Member of the Delaware Valley Chapter of Project Management Institute.

Biography:

Mark Rohlfing is Vice President Operations at Almac Clinical Services in Souderton, PA, leading day-to-day site operations in clinical supply chain management, project services, manufacturing, packaging, and global logistics. As a member of the executive team, he works closely with Almac’s entire global service organization to ensure superlative collaboration and optimal process development and control to meet and exceed customer standards.

Mark was previously Director of Quality at Almac and has 25 years of professional experience within GMP/GCP Operations, QA/QC, and Regulatory Compliance including positions at Almac, Cell Pathways Inc., and Teva Pharmaceuticals USA.

He holds a Bachelor of Science degree in Biology from Millersville University of Pennsylvania and earned his Master of Science degree in Biology from Villanova University. He is an ASQ Certified Manager of Quality/Organizational Excellence, ASQ Certified Quality Auditor, and ASQ Certified Six Sigma Green Belt. He is also a Senior Member of the American Society for Quality and a member of the Parenteral Drug Association.

Biography:

Andrew has 15 years leadership experience in IMP Storage and Distribution, Biological Specimen Logistics & Kit Manufacturing and Ancillary Clinical Trial Supplies. He has successfully delivered on strategy and growth for global regions whilst based in Europe and of late, the United States, for the world’s largest specialty clinical supply chain organizations . Andrew is focused on developing multi-national key global relationships by providing leadership to dedicated commercial development teams.

Biography:

TJ has 13+ years’ experience in all aspects of the global life-science supply chain with extensive understanding of temperature sensitive packaging, logistics, regulations and best-practices. At CCT, TJ is responsible for providing leadership, coordination, and oversight of all business development activities in addition to the operational and financial aspects of strategic initiatives including reusable solutions and global expansion. TJ also serves as CCT’s Advisory Board Chair and is extensively involved in the industry at large as a member of various groups including the PDA PCCIG, ISTA Thermal Council and new industry guidance initiatives. He was a key member and co-author of PDA Technical Reports 46 and 52. TJ graduated from Pennsylvania State University with a bachelor’s degree in Mechanical Engineering and has a M.B.A. from the University of Massachusetts.

Biography:

Pfizer’s Global Clinical Supply Chain.  She has worked at Pfizer for 17+ years in finance and clinical supply chain.  Her responsibilities have included project management, providing uninterrupted global clinical supply chain strategies within budget, ensuring patient continuity.  In addition to managing the forecasting, planning, scheduling and coordination of key activities to ensure the timely provision of clinical supplies, Lauralyn has recently focused on creative solutions for clinical trials with multiple comparator and/or co-med options, better known as ‘Basket Studies’.  Lauralyn received her degree from Western Carolina University.

Biography:

Ed Groleau has over 30 years of experience in the Pharmaceutical industry. The first 15 years were spent in a variety of laboratories for small molecule drug development.  He started out developing and validating analytical testing methods at Merrell Dow Pharmaceuticals and Eli Lilly.  He became Lilly’s primary X-ray powder diffraction expert and was a founding member of the company’s Physical Characterization group that established the optimal salt form for compounds in development.  Being responsible for all XRD, XRF, and thermometric techniques, Ed was also part of Lilly’s internal forensics team conducting investigations for internal manufacturing issues and external litigations.  After 7 years of physical characterization Ed moved to the chemical characterization group where he helped determine the structures of degradation products using NMR.

Ed moved to Lilly’s Clinical Trial Supplies group in 2003 starting in the group responsible for packaging and labeling of IP.  His responsibilities increased as the department changed over the years to include all aspects of CT supplies from planning to distribution. In 2011 he became part of a small, highly integrated CM&C team responsible for overseeing the development of compounds from discovery through proof-of-concept stage.  On this team Ed developed the procedures and processes required to conduct all aspects of the supplies for clinical trials from manufacturing through reconciliation.

In 2016 Ed moved to Elanco, Lilly’s animal health division, where he established a global clinical trial supplies group for developing companion and food animal projects.  Ed’s career at Lilly/Elanco ended in 2017 when he took advantage of an early retirement program the company offered.  Not ready to actually retire, Ed has joined a growing supply chain group at PCI where he continues to provide his experience and expertise to other companies in need of the service.

Biography:

Jodi is a registered pharmacist and received her pharmacy degree from Purdue University where she focused on Industrial pharmacy.  She has worked for Eli Lilly and company for 22 years and for Bristol-Myers Squibb for 4 years previously.  She is currently a Senior Advisor for the global Clinical Supply  organization at Lilly.  Previously she was the Global Director for Packaging, Labeling, North America Distribution and comparator sourcing for all of Lilly’s Clinical Trials.  Prior to joining the clinical supply organization she was the chief operating officer for drug development teams where she lead the Core Teams responsible for 11 new molecular entities while in development.   These assets included both small and large molecule compounds across numerous therapeutic areas.  Jodi also has lead CM&C teams, and was the Site Quality Leader, which includes QA, and QC for the US API biotechnology manufacturing locations.  Jodi started out in the industry in various technical service roles where she lead dry product scale-up projects, process validation, and coordinated the transfer of manufacturing from one site to another.

Biography:

Nicohle J. McGeorge is Senior Lead Project Manager in Clinical Supply Operations Packaging and Labeling for Bristol-Myers Squibb Company in New Jersey. With over 14 years in the industry, Nicohle has gained expertise in area of clinical labeling regulatory requirements and label vendor management.

Biography:

Steve is a successful consultant, trainer, business leader, executive coach, mentor and speaker. For the past 25 years he’s been heavily involved in clinical supply chain operations, IMPs, cGMPs, cGCPs, cGDPs, clinical development and quality (ICH Q8, Q9 & Q10) for pharmaceuticals, and biotech products.

He sits on the Board of Directors of the largest professional clinical supply organization in the world, the Global Clinical Supplies Group. His expertise also includes success in leadership, innovation, global cultural dynamics, organizational development, and high performing teams.

In the past he has been a CEO and COO, as well as the president and Global Chief Operating Officer, of a multinational clinical supply chain contract organization that served companies like Novartis, Eisai, Lilly and others in the pharmaceutical and biotech sector. Before that he was head of US clinical supply operations for Johnson & Johnson.

Steve was also a logistics and aviation officer, in the U.S. Army, where he rose to the rank of Major and was a maintenance test pilot, and pilot in command, for both helicopters and fixed wing aircraft.

His undergraduate degree is in Pharmacy from the University of the Sciences in Philadelphia and his MBA is from the University of Phoenix with a specialization in global management.

Steve has traveled all over the world (4 Continents, 25 Countries, 42 States) and enjoys spending time with his Fiancé, son, and good friends, whenever he gets the chance.