The Global Clinical Supplies Group 2017 US Conference: Program

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:

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:

Jan Pieter (JP) Kappelle, Owner of STAR CSM Consultancy and Strategy Consultant to 4G Clinical, is a Supply Chain Executive with 30 years of industry experience, of which 15 years were spent leading clinical trial supplies departments in global pharmaceutical and biotech companies. Trained as an Electronic and Quality Engineer, JP has a strong financial background and brings a methodical, analytical and process-oriented approach to his work. Coupled with his MBA and MSc in Supply Chain Management, JP has the unique ability to switch between strategic and operational discussions.
An energetic team player and trusted business partner, JP focuses on driving strategy and delivering results. JP also serves as the Global Clinical Supplies Group (GCSG) Master of Ceremony where he connects clinical supply professionals for the purposes of education, knowledge sharing and the development of industry best practices.

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:

Performing Artist and Performance Advisor Victoria Labalme helps you express your most authentic self and transform even the simplest daily communication into a work of art.

Her courses and Keynote Performances™ have influenced hundreds of thousands of people across the globe to take creative risks and deliver their unique message with the unexpected twist that distinguishes their brand and leaves a lasting impression.

A graduate of Stanford University and founder of Rock The Room®, Victoria has been the private advisor to New York Times best-selling authors, professional speakers and leading entrepreneurs.

Victoria Labalme has worked with the top executives and teams at dozens of the world’s most recognized brands including Starbucks, PayPal, IBM, Oracle and Microsoft.

Victoria has helped her clients win contracts worth $400 million, craft landmark keynotes and TEDx talks, rock it on stage for Oprah’s Super Soul Sessions, and wow audiences ranging from 1 to 17,000.

A member of the Speaker Hall of Fame, Victoria offers organizations and teams unexpected communication insights developed from two decades of professional show business: her one-woman shows across the United States, appearances on HBO and Caroline’s on Broadway, comedy clubs, scores of television commercials, advanced training with legendary mime Marcel Marceau, and documentary films with Academy Award winners.

Her recent TEDx talk—Risk Forward –went viral and has been seen by tens of thousands of people in a few short months.

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:

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:

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:

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:

Sharon McCarthy is a Director in Clinical Supply Logistics at Pfizer where she leads the US Import/Export team.  Although this is a recent assignment, Sharon was previously the Director of the Global IRT Oversight Team at Pfizer.  With 25 years of Pharmaceutical Sciences experience, the majority of Sharon’s career has been devoted to the implementation, support and continuous improvement of Interactive Response Technology (IRT) services and Supply Chain Logistics

Biography:

Barbara Campbell is currently a Senior Clinical Supply Chain Manger for Fisher Clinical Services.  She has more than 20 years’ experience  with clinical trials and is responsible for demand planning of investigational product needed to support clinical trials from first patient visit to last patient visit.  This is inclusive of RACI development, label management as well as packaging and distribution management.  Her previous roles throughout her career include, Clinical Supply Chain Manager,  Study Drug Coordinator and Research Study Coordinator.    Her expertise with clinical trials and that of managing communication with CRO’s and Sponsors have provided her with the tools needed to develop robust relationships with clients.  In 2012, she spoke at an ISPE Conference discussing the topic of Building a Supply Chain around a Protocol.

Biography:

Lisamarie Georgen is currently the Director of Clinical Supplies at MacroGenics. She has had over 20 years of experience within the Pharmaceutical Industry. Lisamarie leads a team of Clinical Supplies Managers at MacoGenics and has been with the company for a year. Previous to MacroGenics, Lisamarie worked at Fisher Clinical Services for 12 years in various positions of increasing responsibility.

Biography:

Greg Hottell is a Director in the Clinical Interface team 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, helped redesign GSK’s approach to clinical supply blinding and unblinding risk management, was a core team member for the Investigational Material Supply strategic planning initiative, all while consistently delivering top-tier performance with on-time supply 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, presenting, and authoring white papers.
Greg has been a Supply Chain professional since 1999, most recently holding positions of increasing responsibility at Eli Lilly & Company and Fisher Clinical Services prior to joining GSK. Greg has a diverse background in the Pharmaceutical Industry spanning roles that include clinical trial materials management, demand planning, site inventory management, IRT utilization, drug product supply planning, temperature excursion management, study drug expiry dating extensions, customer service, operations planning & scheduling, and procurement.
Greg holds a bachelor’s degree in Operations Management, an MBA, and is a Certified Fellow in Production and Inventory Management (CFPIM) through APICS.

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:

Steven Barry is currently an Associate Director in the Research and Development Quality-Clinical Trials & Safety group, located in Wallingford, CT. Since joining the company in 2001 in the clinical operations group, Steven held various positions in Global Clinical Operations directly operationalizing studies as well as managing clinical teams, both in the US and in Brazil. He joined the R&D quality and compliance group in 2011 and has responsibility to perform GCP audits to assess regulatory compliance in phase 1 to 4 clinical trials. This includes study specific external site audits, internal system audits of all processes related to clinical research, vendors audits, and pharmacovigilance audits. Additionally, he is responsible to provide quality and compliance consultation to multi-disciplinary clinical teams across all therapeutic areas, inspection readiness support, and supporting and leading regulatory agency inspections.

Steven is a Registered Nurse and received a BS in Psychology from Charter Oak College.

Biography:

Kristen Fahmy is currently an Associate Director in the Global Quality and Regulatory Compliance-GMP group, located in New Brunswick, NJ. Since joining the company in 2002, Kristen has held various positions within quality. In her current position, she is responsible for managing a quality assurance team which provides oversight for packaging and labeling, warehousing, and regional logistics activities. She also has responsibilities for investigations and field complaints, Quality Agreements, GMP training, inspection readiness, and providing support for regulatory agency inspections. Kristen is a trained Lean Sigma Kaizen Leader and has experience conducting internal and external audits.

Kristen received a BS in Public Health from Rutgers University, a MS in Quality Assurance from California State University, and is a Certified Quality Auditor with the American Society for Quality (ASQ).

Biography:

With 15 years of direct Life Sciences globalization experience, Eric Jacobs has assisted many leading companies in the Pharmaceutical and Biotechnology sectors in successfully creating and implementing strategic initiatives across a wide spectrum of their ecosystem globally, from IMP labeling to regulatory filings. In his current role, Eric is responsible for outlining and managing the execution of SDL’s Life Sciences strategy globally and for driving vertical innovations across the entire portfolio of products and services.

Biography:

Brian is currently a Clinical Research Pharmacist (CRP) at Pfizer (2 years) supporting programs in hematology, oncology, and rare disease.  At Pfizer He has co-lead efforts focused on improving consistency of blister card design and sits on the clinical supplies Label Review Board. Previously Brian was employed at Genzyme where he held various positions over his 7 year tenure including Clinical Supplies Research Pharmacist, Rare Disease Medical Science Liaison, and Post-PharmD MCPHS University/Genzyme Fellowship Director.
Before joining the biopharmaceutical industry, Brian worked as an Investigational Drug Services Pharmacist and a Clinical Oncology Pharmacist at Methodist Hospital in San Antonio, TX.  Brian earned his Bachelor of Science degree in Pharmacy and his PharmD from University of Toledo.

Biography:

20 years experience within high volume manufacturing, last 10 within Pharma Clinical Supplies industry.
At Almac Clinical Services 3 years experience within Clinical Supplies Project Management function working with range of large & small Pharma & Biotech companies to deliver range of contracted services.
Spent 3 years as full time Business Representative for development of Supply Chain Planning Function as part of Almac’s ERP implementation.
Subsequently, for the past 4 years lead team of 12 Business Analysis & Support staff responsible for support and development of Almac’s ERP and intergrated business systems, including responsibility for delivery of Almac’s external systems integrations strategy.

Biography:

Jill Hagan has been working in Clinical Trial Supply Chain Management at Eli Lilly and Company for 10 years.  She has experience forecasting and planning for all phases of clinical trials and multiple therapeutic areas.  She has also supported implementation of integrated supply chain systems for both commercial and clinical trial supply chains.

Biography:

Melissa Gallardo is an Associate Manager of Clinical Supplies where she is responsible for leading CTM coordination for various Phase I – IV clinical studies. Currently an SME for forecasting utilizing SmartSupplies ClinApps. She authored a Global IP Forecast and Ordering procedure at Astellas.  She established a formal new employee onboarding program for clinical supplies, developed a CTM education center SharePoint and does new employee training.  Prior to that she was a member of the Global Quality Assurance team for seven years.  She was involved in the development and managed several programs, amongst which were:  Product Complaints, Q10 Management Review, Internal Audit and Regulatory Inspection Readiness and Change Controls.

Biography:

Michael Sparozic is the Lead Trial Supply Operations Manager at Sanofi in Bridgewater, NJ. He has worked in the Clinical Supplies field for close to 20 years. He has experience managing a global supply chain including planning, manufacturing, packaging and distribution of the CTM. He is now leading the US efforts for Direct to Patient trails for Sanofi. Michael attended Massachusetts College of Pharmacy and Health and has a B.S. in Pharmacy.

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:

Senior QA Project Manager at AbbVie

Biography:

Dr. Janelle A. Sabo is a recognized leader in product delivery and drug development.  Her unique background has driven a strong patient focus and desire to find innovative ways to deliver faster new therapies to patients and the global medical community.

Janelle leads product delivery at Eli Lilly and Company enabling product development while delivering the right drug to the right patient at the right time, every time.  Her organization encompasses CMC (chemistry, manufacturing, controls) Project Management, CMC Quality System, Drug Product Manufacturing (large and small molecules), CMC Supply Planning (raw materials, drug substance, drug product and clinical trial material), Clinical Trial Material Production and Management, Commercial Comparators, Supply Chain Collaborations/Partnership Management and CMC Portfolio Management and Analytics.  The organization is accountable for supporting the portfolio globally from bench to end of life cycle for development and research.  Over the last 5 years, this organization has doubled the portfolio supported, improved cycle times by 15% YOY, created operational efficiency exceeding $45M while dramatically improving customer satisfaction.

Janelle has extensive drug development experience including development and implementation of innovative development designs, portfolio management and project management organizations. She also has played a key leadership role in CMC, clinical research and global research and development for multiple medicines, including CIALIS and ADCIRCA®.   She is the recipient of multiple awards at Eli Lilly and in the industry.  She has been named to the Global Product Development President’s Council, twice honored with the Lilly Research Laboratories President’s award, selected as the University of Missouri Pharmaceutical Industry Alumni of the Year.  She has served on dean’s advisory boards, including Butler University and UMKC Dean’s Advisory Board.  Janelle holds a Doctorate of Pharmacy from the University of Missouri, Global Executive MBA from Georgetown University and a Global Executive MBA from ESADE- Barcelona, Spain.

Dr. Sabo is a guest lecturer at several universities and colleges of pharmacy on drug development and has spoken at conferences within the pharmaceutical industry and was the keynote graduation speaker for the UMKC School of Pharmacy.

Biography:

David Volk is responsible globally for Genentech’s & Roche’s clinical supply strategy, resource and portfolio management.  He is active in the clinical supply industry through multiple benchmarking forums and as a Steering Committee member of the ISPE Investigational Products North America community of practice.  Prior to his current role, David was responsible for Clinical Demand & Supply Planning for Roche in Basel, Switzerland.  He has held positions of increasing responsibility in process development, manufacturing, and supply chain at Merck and Genentech.  David received his degree in Chemical Engineering from Princeton, his MBA from Stanford, and is APICS CPIM and CSCP certified.

Biography:

Michael Ku is Vice President of Global Clinical Supply (GCS) within the Medicinal Sciences organization of Pfizer’s Worldwide Research and Development.  Dr. Ku has over 20 years of biopharmaceutical experience and currently provides strategic leadership for multiple global functions supporting Pfizer’s clinical trials.  Dr. Ku is very committed with supporting the clinical development of new investigational products for patients as well as the advancement of technology and innovation.
Prior to joining Pfizer, Dr. Ku was the Global Head and Vice President of Clinical Pharmacy Research Services (CPRS) at Genzyme Corporation.  He also held several roles of increasing responsibility at Astra Pharmaceuticals (currently AstraZeneca) and Novopharm Limited (currently Teva Canada Limited) in the areas of Clinical Research, Pharmacovigilance, Regulatory Affairs and Quality Assurance.
Dr. Ku’s educational background includes a Doctor of Pharmacy and Bachelor’s Degree in Pharmacy from MCPHS University as well as a Master’s Degree in Business Administration from Anna Maria College.  He also holds a Bachelor of Science Degree in Toxicology from the University of Toronto and is a graduate of the General Management Program from Harvard Business School.

Biography:

Dr. Alexander Debets is heading the Global Clinical Supply organization within the Merck Research Laboratories at Merck & Co. Inc. He has and more than 20 years of experience in analytical and pharmaceutical R&D, and currently chairs the Clinical Supply Chain Council, a cross-functional and cross-divisional decision-making body for the integrated clinical supply chain.

He previously worked for Organon and Schering-Plough. He held several roles of increasing responsibility in Analytical Development, Pharmaceutical Development and Clinical Supply Operations in the Netherlands. He was site head of development manufacturing sites in Germany and in Switzerland, which involved the transition of a site from research and development into commercial.

His educational background includes a Doctor in Chemistry, and a Master’s Degree in Analytical Chemistry and Toxicology from the Free University of Amsterdam, the Netherlands.
He was chairman of several committees and councils, including global harmonization steering committees for Analytical Chemistry, Manufacturing and Control (CMC) processes, Quality and international Procurement Improvements. He was board-member of the Analytical Section of the Royal Dutch Chemical Society and president of the Analytical Lab Managers Association.

Biography:

Michael has been with Myoderm since 2001. Through his passion, leadership, and commitment to meeting each client’s unique needs, he has enabled the company to grow into a global leader in comparator and commercial drug sourcing for clinical trials. Prior to working for Myoderm, Michael held positions in the publishing, advertising, financial, and utility industries. He holds a B.S. degree in statistics from the University of Pittsburgh, and an M.B.A. degree from the university’s Katz Graduate School of Business.

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:

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:

Katy Ostertag is Senior Manager, Clinical Supply Chain at PCI Pharma Services. Katy joined PCI in October 2016 with over 10 years of clinical supply experience in the pharmaceutical industry at Vertex, Sunovion, and Takeda. She earned her Bachelor of Science in Kinesiology in 2001, and Master of Science in Kinesiology in 2004; both degrees coming from Indiana University. In January 2016, Katy earned her Project Management Professional certification, and is a member of the Project Management Institute.

In her role as Senior Manager, Clinical Supply Chain, Katy is growing a team of clinical supply professionals who can bring PCI’s experience to the clinical trial, providing expertise throughout the clinical study supply lifecycle. She is responsible for acting as the single point of contact in coordinating the necessary information between clinical functions, ensuring the clinical supplies are available in appropriate quantities where and when they are needed to support a global clinical study.

Biography:

Janelle Livermore is a Sr. Supply Chain Manager at Vertex Pharmaceuticals, Inc.   Janelle has 6 years of experience in pharmaceutical Supply Chain; all occupied within the Supply Chain team at Vertex Pharmaceuticals.  Prior to Vertex, Janelle spent 7 years at eClinical Solutions and Perceptive Informatics working in EDC and IXRS. In her current role, Janelle is responsible for managing forecasting, packaging, and distribution of Investigational Medicinal Product for global clinical studies.  Janelle received her B.S. in Biology from Salve Regina University in Newport, Rhode Island.

Biography:

Nimer Yusef leads the IVRS consultancy and software development company Trial Brain, which was founded in 2010 and has since evolved into one of the largest IVRS consultancy providers worldwide. The objective of Trial Brain is to support clients in implementing IVRS-Systems, to optimize Clinical Trial Logistics strategies, to provide efficient trouble shooting support as well as to offer a portfolio of trainings in IVRS and logistics.

Nimer has a strong IT background and more than 10 years experience as expert for IVRS and Clinical Trial Supply with a Focus on Inventory Management. After completing his diploma in mathematics at the Berlin University of Applied Sciences in 2004, he joined Perceptive Informatics as Software Developer and Validation Engineer for IVRS projects. In 2008, he moved on to join the Clinical Logistics Group at PAREXEL as Project Manager, IVRS Consultant and Trainer. There, he developed a deep insight into the interdependencies of IVRS and Clinical Logistics. From 2009, he implemented the use of Clinical Supply Chain Simulation Tools within the Clinical Logistics Group at PAREXEL.

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:

Kunal Jaiswal is Vice President, Global Strategic Development Solutions at Catalent Pharma Solutions

Biography:

Global Marketing Director at Catalent, and President-Elect at American Marketing Association

Biography:

Vice President of Operations at Clinical Supply Management, Inc.

Biography:

Volker Niermann is an Associate Director of Product Development Manager, Device Operations at Bristol-Myers Squibb.

Biography:

Nicola Barnes is Senior Director of Clinical Supply Packaging, Pfizer, UK.  Residing within Medicinal Sciences, Nicola has over 20+ years of experience in the industry and leads the Global Clinical Supply Packaging group.  Responsible for the packaging and labelling of clinical supplies with oversight of internal operations packaging facilities and external vendor partnerships.

Nicola is the global business process owner for IMP labelling: she has developed processes and published guidance documents for Pfizer to define the requisition, design and production of labels for clinical supplies.  She is also a subject matter expert in clinical supply packaging design and supply strategies and has implemented new capability including the utility of 3D printing and CAD technology to advance packaging design.

Nicola holds a Bachelor of Science degree in Pharmaceutical Science and a Masters degree in Industrial Pharmaceutical Science

Biography:

Loretta Cipkus Dubray has 35 years’ experience in the pharmaceutical arena. Loretta began her career in research, at Case Western Reserve University Medical School, Department of Pharmacology. The past 22 years have been spent working in the area of Clinical Supplies. Starting out as a Clinical Supplies coordinator, she gained much experience with international studies, expertise with collaborative in-licensing ventures, was Group Lead for the Materials Management Group; overseeing the functions of procurement, receiving, dispensing, warehousing, distribution, and destruction of drugs. Additionally, Outsourcing Liaison and Global Lead for Michigan at Pfizer. Here she participated in outsourcing many programs to US/EU vendors. She participated in global SOP harmonization initiatives and training and also participated in the Global Quarterly Vendor Reviews. As Program Director for the Lilly Grant Office at Alta Resources, under her leadership, the Lilly Grant Office was awarded Global Vendor of the Year, August 2006. Currently, as President and CEO of Global Clinical Connections, a consulting and clinical supplies coordination firm for small, medium, and large biotech and pharma companies, the group oversees drug product mfg->packaging->labeling->distribution of Phase I-IV clinical supplies and brings her experience into the forefront. She recently was the SME for Section 6 (IMP) of the TMF Reference Model team for DIA.

Loretta has a BS, and MS from John Carroll University, Cleveland, Ohio. She has a Certification in Executive Leadership and Management through the University of Notre Dame Mendoza School of Business. She is currently affiliated with PEAK (Professional Executive Association of Kalamazoo), Global Clinical Supplies Group, Aquatic Exercise Association, Hospitality House, YMCA/YWCA. She was awarded the YWCA Woman of Achievement Award in 2009, Makers in 2013, and the Goldman Sachs 10000 Small Business Designation in 2015.

Biography:

Shawn Murtough is an EU and UK Qualified Person. Having graduated with a doctorate in pharmaceutical microbiology, he has worked in various roles within the pharmaceutical industry for the last twenty years. He has over ten years’ experience working as a qualified person with both traditional small molecule drug products and novel therapies. In recent years he has specialised in cold chain logistics for clinical trials. This has entailed handling a wide range of product types including, cell therapies, viral vectors, monoclonal antibodies and vaccines. In his current role as Director of Quality and Regulatory Services he assists Sponsors with all their Quality requirements from QP audits to advice on difficult deviations and he is growing a new Regulatory service offering to support Sponsors with Regulatory writing and submissions.

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:

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:

Kevin O’Donnell, Vice President, Cold Chain Standards, Practices & Compliance, BioLife Solutions, Inc.
As an innovative engineer, author and educator, Kevin’s 37-years of experience has centered on continuously improving transport packaging, logistics and distribution beginning with the biopharmaceutical industry and currently in cell therapy and regenerative medicine. He is recognized internationally as a key opinion leader devoting much of his time to co-authoring, promoting and implementing good cold-chain distribution practices throughout the supply chain.
Kevin retired from a 26-year carrier at Abbott Laboratories in 2005 as a principle packaging engineer specializing in insulated transport packaging. He is a former elected member to the United States Pharmacopeia Convention Expert Committee for Packaging, Storage and Distribution (2010-2015) and a recipient of the 2013 USP Award for Innovative Response to Public Health Challenges for outstanding work and leadership. He a Temporary Advisor to the World Health Organization, a Certified Facilitator for the WHO/PDA Pharmaceutical Cold Chain Management on Wheels Course, and their ePELA Authentic e-Learning Course on Pharmaceutical Cold Chain Management.
A prolific writer, Kevin has published dozens of papers and articles in numerous publications on the topic of cold-chain management for healthcare products.  He is the recipient of the Parenteral Drug Association 2015 Distinguished Author Award for his groundbreaking book Cold Chain Chronicles: A practitioners outside the box perspectives on the importance of temperature-sensitive drug stewardship.

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:

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:

Scott is approaching 30 years at World Courier, a highly specialized global transportation company in the pharmaceutical and biotech industry. As Director of Business Development, Scott’s emphasis is working closely with those companies and government medical research institutions in handling all aspects of time and temperature sensitive materials. Scott is responsible for sales, marketing and account management.

Scott is a graduate of University of Maryland.

Biography:

Sharon McCarthy is a Director in Clinical Supply Logistics at Pfizer where she leads the US Import/Export team.  Although this is a recent assignment, Sharon was previously the Director of the Global IRT Oversight Team at Pfizer.  With 25 years of Pharmaceutical Sciences experience, the majority of Sharon’s career has been devoted to the implementation, support and continuous improvement of Interactive Response Technology (IRT) services and Supply Chain Logistics

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:

Barbara Campbell is currently a Senior Clinical Supply Chain Manger for Fisher Clinical Services.  She has more than 20 years’ experience  with clinical trials and is responsible for demand planning of investigational product needed to support clinical trials from first patient visit to last patient visit.  This is inclusive of RACI development, label management as well as packaging and distribution management.  Her previous roles throughout her career include, Clinical Supply Chain Manager,  Study Drug Coordinator and Research Study Coordinator.    Her expertise with clinical trials and that of managing communication with CRO’s and Sponsors have provided her with the tools needed to develop robust relationships with clients.  In 2012, she spoke at an ISPE Conference discussing the topic of Building a Supply Chain around a Protocol.

Biography:

Lisamarie Georgen is currently the Director of Clinical Supplies at MacroGenics. She has had over 20 years of experience within the Pharmaceutical Industry. Lisamarie leads a team of Clinical Supplies Managers at MacoGenics and has been with the company for a year. Previous to MacroGenics, Lisamarie worked at Fisher Clinical Services for 12 years in various positions of increasing responsibility.

Biography:

Paula Teixeira is a Quality Manager in the External Party Quality Assurance (EPQA) organization within Pharmaceutical Sciences Division within Pfizer.  She has been with Pfizer since 1985 and has held numerous roles in various division over her tenure.  Starting in production, with many years spent in analytical laboratories (In-Process and Stability), she moved to the quality approximately 3 years ago.  In her current role she manages Quality Investigations and Complaints for clinical supplies.

Biography:

Greg Hottell is a Director in the Clinical Interface team 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, helped redesign GSK’s approach to clinical supply blinding and unblinding risk management, was a core team member for the Investigational Material Supply strategic planning initiative, all while consistently delivering top-tier performance with on-time supply 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, presenting, and authoring white papers.
Greg has been a Supply Chain professional since 1999, most recently holding positions of increasing responsibility at Eli Lilly & Company and Fisher Clinical Services prior to joining GSK. Greg has a diverse background in the Pharmaceutical Industry spanning roles that include clinical trial materials management, demand planning, site inventory management, IRT utilization, drug product supply planning, temperature excursion management, study drug expiry dating extensions, customer service, operations planning & scheduling, and procurement.
Greg holds a bachelor’s degree in Operations Management, an MBA, and is a Certified Fellow in Production and Inventory Management (CFPIM) through APICS.

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:

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:

Kunal Jaiswal is Vice President, Global Strategic Development Solutions at Catalent Pharma Solutions

Biography:

Global Marketing Director at Catalent, and President-Elect at American Marketing Association

Biography:

Vice President of Operations at Clinical Supply Management, Inc.

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:

Regulatory Scientist at Eli Lilly and Company.

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:

Director, Takeda Development Center, Deerfield, Illinois USA
Beth is currently the Director, Clinical Supply Strategy and leads a talented team of strategic clinical supply program managers at Takeda.  Prior to this, she worked for Pfizer / Pharmacia / Monsanto.  Beth 17+ years of pharmaceutical supply chain experience, which includes – aseptic GMP drug product manufacturing, microbiological QC testing, computer validation, design of robust, uninterrupted global clinical supply chain strategies within budget, and a global assignment in Europe.   Beth holds a Bachelors of Science in Microbiology from the University of Illinois, has her Project Management Professional (PMP) certification, and was part of the team to develop the ISPE Good Practice Guide: Harmonizing the Definition and Use of Non IMPs.  She is currently the ISPE North American Investigational Product Community of Practice Co-Chair.

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:

Greg Hottell is a Director in the Clinical Interface team 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, helped redesign GSK’s approach to clinical supply blinding and unblinding risk management, was a core team member for the Investigational Material Supply strategic planning initiative, all while consistently delivering top-tier performance with on-time supply 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, presenting, and authoring white papers.
Greg has been a Supply Chain professional since 1999, most recently holding positions of increasing responsibility at Eli Lilly & Company and Fisher Clinical Services prior to joining GSK. Greg has a diverse background in the Pharmaceutical Industry spanning roles that include clinical trial materials management, demand planning, site inventory management, IRT utilization, drug product supply planning, temperature excursion management, study drug expiry dating extensions, customer service, operations planning & scheduling, and procurement.
Greg holds a bachelor’s degree in Operations Management, an MBA, and is a Certified Fellow in Production and Inventory Management (CFPIM) through APICS.

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:

T.J. Sharpe writes the Patient #1 blog on Philly.com about his ongoing battle with stage IV melanoma. In August of 2012, he walked into the ER with a spiking fever—and didn’t leave for over two weeks. Melanoma tumors were in both lungs, his liver, spleen and abdomen. His oncologist told T.J. and his wife that he would be surprised if he survived for two years. Thirty months later, after six surgeries and two clinical trials, his tumors continue to shrink.

His blog began from a chain of emails that took a positive, slightly humorous view on a very dire situation. He was lucky enough for Philly.com to pick it up, and the website has been publishing insight on his journey since the end of 2012. T.J. expands to touch on the human side of cancer and how it affects more than just the patient. He also explores general cancer-related topics, and he hopes the blog and his outlook will set the bar high for those who are or will face their own cancer challenges. T.J’s message: “Stay Strong—nobody fights alone.”

Biography:

Scott is approaching 30 years at World Courier, a highly specialized global transportation company in the pharmaceutical and biotech industry. As Director of Business Development, Scott’s emphasis is working closely with those companies and government medical research institutions in handling all aspects of time and temperature sensitive materials. Scott is responsible for sales, marketing and account management.

Scott is a graduate of University of Maryland.

Biography:

Paula Teixeira is a Quality Manager in the External Party Quality Assurance (EPQA) organization within Pharmaceutical Sciences Division within Pfizer.  She has been with Pfizer since 1985 and has held numerous roles in various division over her tenure.  Starting in production, with many years spent in analytical laboratories (In-Process and Stability), she moved to the quality approximately 3 years ago.  In her current role she manages Quality Investigations and Complaints for clinical supplies.

Biography:

Steven Barry is currently an Associate Director in the Research and Development Quality-Clinical Trials & Safety group, located in Wallingford, CT. Since joining the company in 2001 in the clinical operations group, Steven held various positions in Global Clinical Operations directly operationalizing studies as well as managing clinical teams, both in the US and in Brazil. He joined the R&D quality and compliance group in 2011 and has responsibility to perform GCP audits to assess regulatory compliance in phase 1 to 4 clinical trials. This includes study specific external site audits, internal system audits of all processes related to clinical research, vendors audits, and pharmacovigilance audits. Additionally, he is responsible to provide quality and compliance consultation to multi-disciplinary clinical teams across all therapeutic areas, inspection readiness support, and supporting and leading regulatory agency inspections.

Steven is a Registered Nurse and received a BS in Psychology from Charter Oak College.

Biography:

Kristen Fahmy is currently an Associate Director in the Global Quality and Regulatory Compliance-GMP group, located in New Brunswick, NJ. Since joining the company in 2002, Kristen has held various positions within quality. In her current position, she is responsible for managing a quality assurance team which provides oversight for packaging and labeling, warehousing, and regional logistics activities. She also has responsibilities for investigations and field complaints, Quality Agreements, GMP training, inspection readiness, and providing support for regulatory agency inspections. Kristen is a trained Lean Sigma Kaizen Leader and has experience conducting internal and external audits.

Kristen received a BS in Public Health from Rutgers University, a MS in Quality Assurance from California State University, and is a Certified Quality Auditor with the American Society for Quality (ASQ).

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:

Kunal Jaiswal is Vice President, Global Strategic Development Solutions at Catalent Pharma Solutions

Biography:

Global Marketing Director at Catalent, and President-Elect at American Marketing Association

Biography:

Vice President of Operations at Clinical Supply Management, Inc.

Biography:

Nicola Barnes is Senior Director of Clinical Supply Packaging, Pfizer, UK.  Residing within Medicinal Sciences, Nicola has over 20+ years of experience in the industry and leads the Global Clinical Supply Packaging group.  Responsible for the packaging and labelling of clinical supplies with oversight of internal operations packaging facilities and external vendor partnerships.

Nicola is the global business process owner for IMP labelling: she has developed processes and published guidance documents for Pfizer to define the requisition, design and production of labels for clinical supplies.  She is also a subject matter expert in clinical supply packaging design and supply strategies and has implemented new capability including the utility of 3D printing and CAD technology to advance packaging design.

Nicola holds a Bachelor of Science degree in Pharmaceutical Science and a Masters degree in Industrial Pharmaceutical Science

Biography:

Loretta Cipkus Dubray has 35 years’ experience in the pharmaceutical arena. Loretta began her career in research, at Case Western Reserve University Medical School, Department of Pharmacology. The past 22 years have been spent working in the area of Clinical Supplies. Starting out as a Clinical Supplies coordinator, she gained much experience with international studies, expertise with collaborative in-licensing ventures, was Group Lead for the Materials Management Group; overseeing the functions of procurement, receiving, dispensing, warehousing, distribution, and destruction of drugs. Additionally, Outsourcing Liaison and Global Lead for Michigan at Pfizer. Here she participated in outsourcing many programs to US/EU vendors. She participated in global SOP harmonization initiatives and training and also participated in the Global Quarterly Vendor Reviews. As Program Director for the Lilly Grant Office at Alta Resources, under her leadership, the Lilly Grant Office was awarded Global Vendor of the Year, August 2006. Currently, as President and CEO of Global Clinical Connections, a consulting and clinical supplies coordination firm for small, medium, and large biotech and pharma companies, the group oversees drug product mfg->packaging->labeling->distribution of Phase I-IV clinical supplies and brings her experience into the forefront. She recently was the SME for Section 6 (IMP) of the TMF Reference Model team for DIA.

Loretta has a BS, and MS from John Carroll University, Cleveland, Ohio. She has a Certification in Executive Leadership and Management through the University of Notre Dame Mendoza School of Business. She is currently affiliated with PEAK (Professional Executive Association of Kalamazoo), Global Clinical Supplies Group, Aquatic Exercise Association, Hospitality House, YMCA/YWCA. She was awarded the YWCA Woman of Achievement Award in 2009, Makers in 2013, and the Goldman Sachs 10000 Small Business Designation in 2015.

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:

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:

Shawn Murtough is an EU and UK Qualified Person. Having graduated with a doctorate in pharmaceutical microbiology, he has worked in various roles within the pharmaceutical industry for the last twenty years. He has over ten years’ experience working as a qualified person with both traditional small molecule drug products and novel therapies. In recent years he has specialised in cold chain logistics for clinical trials. This has entailed handling a wide range of product types including, cell therapies, viral vectors, monoclonal antibodies and vaccines. In his current role as Director of Quality and Regulatory Services he assists Sponsors with all their Quality requirements from QP audits to advice on difficult deviations and he is growing a new Regulatory service offering to support Sponsors with Regulatory writing and submissions.

Biography:

Regulatory Scientist at Eli Lilly and Company.

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:

Kevin O’Donnell, Vice President, Cold Chain Standards, Practices & Compliance, BioLife Solutions, Inc.
As an innovative engineer, author and educator, Kevin’s 37-years of experience has centered on continuously improving transport packaging, logistics and distribution beginning with the biopharmaceutical industry and currently in cell therapy and regenerative medicine. He is recognized internationally as a key opinion leader devoting much of his time to co-authoring, promoting and implementing good cold-chain distribution practices throughout the supply chain.
Kevin retired from a 26-year carrier at Abbott Laboratories in 2005 as a principle packaging engineer specializing in insulated transport packaging. He is a former elected member to the United States Pharmacopeia Convention Expert Committee for Packaging, Storage and Distribution (2010-2015) and a recipient of the 2013 USP Award for Innovative Response to Public Health Challenges for outstanding work and leadership. He a Temporary Advisor to the World Health Organization, a Certified Facilitator for the WHO/PDA Pharmaceutical Cold Chain Management on Wheels Course, and their ePELA Authentic e-Learning Course on Pharmaceutical Cold Chain Management.
A prolific writer, Kevin has published dozens of papers and articles in numerous publications on the topic of cold-chain management for healthcare products.  He is the recipient of the Parenteral Drug Association 2015 Distinguished Author Award for his groundbreaking book Cold Chain Chronicles: A practitioners outside the box perspectives on the importance of temperature-sensitive drug stewardship.

Biography:

20 years experience within high volume manufacturing, last 10 within Pharma Clinical Supplies industry.
At Almac Clinical Services 3 years experience within Clinical Supplies Project Management function working with range of large & small Pharma & Biotech companies to deliver range of contracted services.
Spent 3 years as full time Business Representative for development of Supply Chain Planning Function as part of Almac’s ERP implementation.
Subsequently, for the past 4 years lead team of 12 Business Analysis & Support staff responsible for support and development of Almac’s ERP and intergrated business systems, including responsibility for delivery of Almac’s external systems integrations strategy.

Biography:

Jill Hagan has been working in Clinical Trial Supply Chain Management at Eli Lilly and Company for 10 years.  She has experience forecasting and planning for all phases of clinical trials and multiple therapeutic areas.  She has also supported implementation of integrated supply chain systems for both commercial and clinical trial supply chains.

Biography:

Senior QA Project Manager at AbbVie

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:

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:

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:

Sharon McCarthy is a Director in Clinical Supply Logistics at Pfizer where she leads the US Import/Export team.  Although this is a recent assignment, Sharon was previously the Director of the Global IRT Oversight Team at Pfizer.  With 25 years of Pharmaceutical Sciences experience, the majority of Sharon’s career has been devoted to the implementation, support and continuous improvement of Interactive Response Technology (IRT) services and Supply Chain Logistics

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:

Michael has been with Myoderm since 2001. Through his passion, leadership, and commitment to meeting each client’s unique needs, he has enabled the company to grow into a global leader in comparator and commercial drug sourcing for clinical trials. Prior to working for Myoderm, Michael held positions in the publishing, advertising, financial, and utility industries. He holds a B.S. degree in statistics from the University of Pittsburgh, and an M.B.A. degree from the university’s Katz Graduate School of Business.

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:

Greg Hottell is a Director in the Clinical Interface team 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, helped redesign GSK’s approach to clinical supply blinding and unblinding risk management, was a core team member for the Investigational Material Supply strategic planning initiative, all while consistently delivering top-tier performance with on-time supply 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, presenting, and authoring white papers.
Greg has been a Supply Chain professional since 1999, most recently holding positions of increasing responsibility at Eli Lilly & Company and Fisher Clinical Services prior to joining GSK. Greg has a diverse background in the Pharmaceutical Industry spanning roles that include clinical trial materials management, demand planning, site inventory management, IRT utilization, drug product supply planning, temperature excursion management, study drug expiry dating extensions, customer service, operations planning & scheduling, and procurement.
Greg holds a bachelor’s degree in Operations Management, an MBA, and is a Certified Fellow in Production and Inventory Management (CFPIM) through APICS.

Biography:

Katy Ostertag is Senior Manager, Clinical Supply Chain at PCI Pharma Services. Katy joined PCI in October 2016 with over 10 years of clinical supply experience in the pharmaceutical industry at Vertex, Sunovion, and Takeda. She earned her Bachelor of Science in Kinesiology in 2001, and Master of Science in Kinesiology in 2004; both degrees coming from Indiana University. In January 2016, Katy earned her Project Management Professional certification, and is a member of the Project Management Institute.

In her role as Senior Manager, Clinical Supply Chain, Katy is growing a team of clinical supply professionals who can bring PCI’s experience to the clinical trial, providing expertise throughout the clinical study supply lifecycle. She is responsible for acting as the single point of contact in coordinating the necessary information between clinical functions, ensuring the clinical supplies are available in appropriate quantities where and when they are needed to support a global clinical study.

Biography:

Janelle Livermore is a Sr. Supply Chain Manager at Vertex Pharmaceuticals, Inc.   Janelle has 6 years of experience in pharmaceutical Supply Chain; all occupied within the Supply Chain team at Vertex Pharmaceuticals.  Prior to Vertex, Janelle spent 7 years at eClinical Solutions and Perceptive Informatics working in EDC and IXRS. In her current role, Janelle is responsible for managing forecasting, packaging, and distribution of Investigational Medicinal Product for global clinical studies.  Janelle received her B.S. in Biology from Salve Regina University in Newport, Rhode Island.

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:

Nimer Yusef leads the IVRS consultancy and software development company Trial Brain, which was founded in 2010 and has since evolved into one of the largest IVRS consultancy providers worldwide. The objective of Trial Brain is to support clients in implementing IVRS-Systems, to optimize Clinical Trial Logistics strategies, to provide efficient trouble shooting support as well as to offer a portfolio of trainings in IVRS and logistics.

Nimer has a strong IT background and more than 10 years experience as expert for IVRS and Clinical Trial Supply with a Focus on Inventory Management. After completing his diploma in mathematics at the Berlin University of Applied Sciences in 2004, he joined Perceptive Informatics as Software Developer and Validation Engineer for IVRS projects. In 2008, he moved on to join the Clinical Logistics Group at PAREXEL as Project Manager, IVRS Consultant and Trainer. There, he developed a deep insight into the interdependencies of IVRS and Clinical Logistics. From 2009, he implemented the use of Clinical Supply Chain Simulation Tools within the Clinical Logistics Group at PAREXEL.

Biography:

Volker Niermann is an Associate Director of Product Development Manager, Device Operations at Bristol-Myers Squibb.

Biography:

With 15 years of direct Life Sciences globalization experience, Eric Jacobs has assisted many leading companies in the Pharmaceutical and Biotechnology sectors in successfully creating and implementing strategic initiatives across a wide spectrum of their ecosystem globally, from IMP labeling to regulatory filings. In his current role, Eric is responsible for outlining and managing the execution of SDL’s Life Sciences strategy globally and for driving vertical innovations across the entire portfolio of products and services.

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:

Kunal Jaiswal is Vice President, Global Strategic Development Solutions at Catalent Pharma Solutions

Biography:

Global Marketing Director at Catalent, and President-Elect at American Marketing Association

Biography:

Vice President of Operations at Clinical Supply Management, Inc.

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:

Brian is currently a Clinical Research Pharmacist (CRP) at Pfizer (2 years) supporting programs in hematology, oncology, and rare disease.  At Pfizer He has co-lead efforts focused on improving consistency of blister card design and sits on the clinical supplies Label Review Board. Previously Brian was employed at Genzyme where he held various positions over his 7 year tenure including Clinical Supplies Research Pharmacist, Rare Disease Medical Science Liaison, and Post-PharmD MCPHS University/Genzyme Fellowship Director.
Before joining the biopharmaceutical industry, Brian worked as an Investigational Drug Services Pharmacist and a Clinical Oncology Pharmacist at Methodist Hospital in San Antonio, TX.  Brian earned his Bachelor of Science degree in Pharmacy and his PharmD from University of Toledo.

Biography:

Scott is approaching 30 years at World Courier, a highly specialized global transportation company in the pharmaceutical and biotech industry. As Director of Business Development, Scott’s emphasis is working closely with those companies and government medical research institutions in handling all aspects of time and temperature sensitive materials. Scott is responsible for sales, marketing and account management.

Scott is a graduate of University of Maryland.

Biography:

Barbara Campbell is currently a Senior Clinical Supply Chain Manger for Fisher Clinical Services.  She has more than 20 years’ experience  with clinical trials and is responsible for demand planning of investigational product needed to support clinical trials from first patient visit to last patient visit.  This is inclusive of RACI development, label management as well as packaging and distribution management.  Her previous roles throughout her career include, Clinical Supply Chain Manager,  Study Drug Coordinator and Research Study Coordinator.    Her expertise with clinical trials and that of managing communication with CRO’s and Sponsors have provided her with the tools needed to develop robust relationships with clients.  In 2012, she spoke at an ISPE Conference discussing the topic of Building a Supply Chain around a Protocol.

Biography:

Lisamarie Georgen is currently the Director of Clinical Supplies at MacroGenics. She has had over 20 years of experience within the Pharmaceutical Industry. Lisamarie leads a team of Clinical Supplies Managers at MacoGenics and has been with the company for a year. Previous to MacroGenics, Lisamarie worked at Fisher Clinical Services for 12 years in various positions of increasing responsibility.

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:

Paula Teixeira is a Quality Manager in the External Party Quality Assurance (EPQA) organization within Pharmaceutical Sciences Division within Pfizer.  She has been with Pfizer since 1985 and has held numerous roles in various division over her tenure.  Starting in production, with many years spent in analytical laboratories (In-Process and Stability), she moved to the quality approximately 3 years ago.  In her current role she manages Quality Investigations and Complaints for clinical supplies.

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:

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:

Kunal Jaiswal is Vice President, Global Strategic Development Solutions at Catalent Pharma Solutions

Biography:

Global Marketing Director at Catalent, and President-Elect at American Marketing Association

Biography:

Vice President of Operations at Clinical Supply Management, Inc.

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:

Shawn Murtough is an EU and UK Qualified Person. Having graduated with a doctorate in pharmaceutical microbiology, he has worked in various roles within the pharmaceutical industry for the last twenty years. He has over ten years’ experience working as a qualified person with both traditional small molecule drug products and novel therapies. In recent years he has specialised in cold chain logistics for clinical trials. This has entailed handling a wide range of product types including, cell therapies, viral vectors, monoclonal antibodies and vaccines. In his current role as Director of Quality and Regulatory Services he assists Sponsors with all their Quality requirements from QP audits to advice on difficult deviations and he is growing a new Regulatory service offering to support Sponsors with Regulatory writing and submissions.

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:

Kevin O’Donnell, Vice President, Cold Chain Standards, Practices & Compliance, BioLife Solutions, Inc.
As an innovative engineer, author and educator, Kevin’s 37-years of experience has centered on continuously improving transport packaging, logistics and distribution beginning with the biopharmaceutical industry and currently in cell therapy and regenerative medicine. He is recognized internationally as a key opinion leader devoting much of his time to co-authoring, promoting and implementing good cold-chain distribution practices throughout the supply chain.
Kevin retired from a 26-year carrier at Abbott Laboratories in 2005 as a principle packaging engineer specializing in insulated transport packaging. He is a former elected member to the United States Pharmacopeia Convention Expert Committee for Packaging, Storage and Distribution (2010-2015) and a recipient of the 2013 USP Award for Innovative Response to Public Health Challenges for outstanding work and leadership. He a Temporary Advisor to the World Health Organization, a Certified Facilitator for the WHO/PDA Pharmaceutical Cold Chain Management on Wheels Course, and their ePELA Authentic e-Learning Course on Pharmaceutical Cold Chain Management.
A prolific writer, Kevin has published dozens of papers and articles in numerous publications on the topic of cold-chain management for healthcare products.  He is the recipient of the Parenteral Drug Association 2015 Distinguished Author Award for his groundbreaking book Cold Chain Chronicles: A practitioners outside the box perspectives on the importance of temperature-sensitive drug stewardship.

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:

Melissa Gallardo is an Associate Manager of Clinical Supplies where she is responsible for leading CTM coordination for various Phase I – IV clinical studies. Currently an SME for forecasting utilizing SmartSupplies ClinApps. She authored a Global IP Forecast and Ordering procedure at Astellas.  She established a formal new employee onboarding program for clinical supplies, developed a CTM education center SharePoint and does new employee training.  Prior to that she was a member of the Global Quality Assurance team for seven years.  She was involved in the development and managed several programs, amongst which were:  Product Complaints, Q10 Management Review, Internal Audit and Regulatory Inspection Readiness and Change Controls.

Biography:

Michael Sparozic is the Lead Trial Supply Operations Manager at Sanofi in Bridgewater, NJ. He has worked in the Clinical Supplies field for close to 20 years. He has experience managing a global supply chain including planning, manufacturing, packaging and distribution of the CTM. He is now leading the US efforts for Direct to Patient trails for Sanofi. Michael attended Massachusetts College of Pharmacy and Health and has a B.S. in Pharmacy.

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:

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:

Stacy Reisner is a Regulatory Program Manager at Genentech with more than 15 years of biopharmaceutical industry experience supporting drug development from research to impact on patients. In this role she is responsible for developing domestic and global clinical labels for clinical trial drug supply while ensuring its content meets all local regulatory requirements. Additionally, she provides strategic input on labeling solutions and serves as the Super User for SAP’s Global Label Management application. Her previous roles in Research and Clinical Regulatory have been instrumental in contributing towards innovative approaches to alternative solutions and processes in efficiency.

Intrigued with the demands of clinical labeling and her enthusiasm for continuous improvement, Stacy became a selected member of TransCelerate’s global cross-industry e-Label’s team where she is leading activities related to gathering patient feedback on e-Labels as a Patient Engagement Lead. Stacy is also an active collaborator on the e-Labels Technology team strategically evaluating solutions to improve delivery of drug information to patients while supporting operational efficiency including cost and time savings.

Stacy holds a Master’s Degree in Public Health from the University of Massachusetts Amherst and a Bachelor’s Degree in Biology from Indiana University Bloomington.

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:

Rachel Griffiths, Associate Director, Technical Services, PCI UK.  Rachel joined the company in 2004 and has held leadership roles in Operations and Technical Support. Her current role involves overseeing the installation and validation of new facilities at the company’s Bridgend site and the implementation of new technologies and innovations in controlled-temperature packaging, storage and distribution services. With a degree in Microbiology and Virology, Rachel is the Biological Safety Officer for the Bridgend site and also has previous experience as a development scientist, a technical support scientist and a product support specialist.

Biography:

Matthew is a co-founder of TrakCel. Using his knowledge advanced therapies, he helped with the development of the first iteration of TrakCel’s software, drafting user-stories for GMP critical functions.

Matthew is passionate about democratising advanced therapies, supporting several initiatives to introduce standardisation into the cell and gene therapy industry. He has over twenty years’ experience in the Pharmaceutical Industry and over ten years’ experience with advanced therapy products.

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:

Michael has been with Myoderm since 2001. Through his passion, leadership, and commitment to meeting each client’s unique needs, he has enabled the company to grow into a global leader in comparator and commercial drug sourcing for clinical trials. Prior to working for Myoderm, Michael held positions in the publishing, advertising, financial, and utility industries. He holds a B.S. degree in statistics from the University of Pittsburgh, and an M.B.A. degree from the university’s Katz Graduate School of Business.

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:

Katy Ostertag is Senior Manager, Clinical Supply Chain at PCI Pharma Services. Katy joined PCI in October 2016 with over 10 years of clinical supply experience in the pharmaceutical industry at Vertex, Sunovion, and Takeda. She earned her Bachelor of Science in Kinesiology in 2001, and Master of Science in Kinesiology in 2004; both degrees coming from Indiana University. In January 2016, Katy earned her Project Management Professional certification, and is a member of the Project Management Institute.

In her role as Senior Manager, Clinical Supply Chain, Katy is growing a team of clinical supply professionals who can bring PCI’s experience to the clinical trial, providing expertise throughout the clinical study supply lifecycle. She is responsible for acting as the single point of contact in coordinating the necessary information between clinical functions, ensuring the clinical supplies are available in appropriate quantities where and when they are needed to support a global clinical study.

Biography:

Janelle Livermore is a Sr. Supply Chain Manager at Vertex Pharmaceuticals, Inc.   Janelle has 6 years of experience in pharmaceutical Supply Chain; all occupied within the Supply Chain team at Vertex Pharmaceuticals.  Prior to Vertex, Janelle spent 7 years at eClinical Solutions and Perceptive Informatics working in EDC and IXRS. In her current role, Janelle is responsible for managing forecasting, packaging, and distribution of Investigational Medicinal Product for global clinical studies.  Janelle received her B.S. in Biology from Salve Regina University in Newport, Rhode Island.

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:

Kristen Fahmy is currently an Associate Director in the Global Quality and Regulatory Compliance-GMP group, located in New Brunswick, NJ. Since joining the company in 2002, Kristen has held various positions within quality. In her current position, she is responsible for managing a quality assurance team which provides oversight for packaging and labeling, warehousing, and regional logistics activities. She also has responsibilities for investigations and field complaints, Quality Agreements, GMP training, inspection readiness, and providing support for regulatory agency inspections. Kristen is a trained Lean Sigma Kaizen Leader and has experience conducting internal and external audits.

Kristen received a BS in Public Health from Rutgers University, a MS in Quality Assurance from California State University, and is a Certified Quality Auditor with the American Society for Quality (ASQ).

Biography:

Steven Barry is currently an Associate Director in the Research and Development Quality-Clinical Trials & Safety group, located in Wallingford, CT. Since joining the company in 2001 in the clinical operations group, Steven held various positions in Global Clinical Operations directly operationalizing studies as well as managing clinical teams, both in the US and in Brazil. He joined the R&D quality and compliance group in 2011 and has responsibility to perform GCP audits to assess regulatory compliance in phase 1 to 4 clinical trials. This includes study specific external site audits, internal system audits of all processes related to clinical research, vendors audits, and pharmacovigilance audits. Additionally, he is responsible to provide quality and compliance consultation to multi-disciplinary clinical teams across all therapeutic areas, inspection readiness support, and supporting and leading regulatory agency inspections.

Steven is a Registered Nurse and received a BS in Psychology from Charter Oak College.

Biography:

Nicola Barnes is Senior Director of Clinical Supply Packaging, Pfizer, UK.  Residing within Medicinal Sciences, Nicola has over 20+ years of experience in the industry and leads the Global Clinical Supply Packaging group.  Responsible for the packaging and labelling of clinical supplies with oversight of internal operations packaging facilities and external vendor partnerships.

Nicola is the global business process owner for IMP labelling: she has developed processes and published guidance documents for Pfizer to define the requisition, design and production of labels for clinical supplies.  She is also a subject matter expert in clinical supply packaging design and supply strategies and has implemented new capability including the utility of 3D printing and CAD technology to advance packaging design.

Nicola holds a Bachelor of Science degree in Pharmaceutical Science and a Masters degree in Industrial Pharmaceutical Science

Biography:

Loretta Cipkus Dubray has 35 years’ experience in the pharmaceutical arena. Loretta began her career in research, at Case Western Reserve University Medical School, Department of Pharmacology. The past 22 years have been spent working in the area of Clinical Supplies. Starting out as a Clinical Supplies coordinator, she gained much experience with international studies, expertise with collaborative in-licensing ventures, was Group Lead for the Materials Management Group; overseeing the functions of procurement, receiving, dispensing, warehousing, distribution, and destruction of drugs. Additionally, Outsourcing Liaison and Global Lead for Michigan at Pfizer. Here she participated in outsourcing many programs to US/EU vendors. She participated in global SOP harmonization initiatives and training and also participated in the Global Quarterly Vendor Reviews. As Program Director for the Lilly Grant Office at Alta Resources, under her leadership, the Lilly Grant Office was awarded Global Vendor of the Year, August 2006. Currently, as President and CEO of Global Clinical Connections, a consulting and clinical supplies coordination firm for small, medium, and large biotech and pharma companies, the group oversees drug product mfg->packaging->labeling->distribution of Phase I-IV clinical supplies and brings her experience into the forefront. She recently was the SME for Section 6 (IMP) of the TMF Reference Model team for DIA.

Loretta has a BS, and MS from John Carroll University, Cleveland, Ohio. She has a Certification in Executive Leadership and Management through the University of Notre Dame Mendoza School of Business. She is currently affiliated with PEAK (Professional Executive Association of Kalamazoo), Global Clinical Supplies Group, Aquatic Exercise Association, Hospitality House, YMCA/YWCA. She was awarded the YWCA Woman of Achievement Award in 2009, Makers in 2013, and the Goldman Sachs 10000 Small Business Designation in 2015.

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:

Kunal Jaiswal is Vice President, Global Strategic Development Solutions at Catalent Pharma Solutions

Biography:

Global Marketing Director at Catalent, and President-Elect at American Marketing Association

Biography:

Vice President of Operations at Clinical Supply Management, Inc.

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:

Brian is currently a Clinical Research Pharmacist (CRP) at Pfizer (2 years) supporting programs in hematology, oncology, and rare disease.  At Pfizer He has co-lead efforts focused on improving consistency of blister card design and sits on the clinical supplies Label Review Board. Previously Brian was employed at Genzyme where he held various positions over his 7 year tenure including Clinical Supplies Research Pharmacist, Rare Disease Medical Science Liaison, and Post-PharmD MCPHS University/Genzyme Fellowship Director.
Before joining the biopharmaceutical industry, Brian worked as an Investigational Drug Services Pharmacist and a Clinical Oncology Pharmacist at Methodist Hospital in San Antonio, TX.  Brian earned his Bachelor of Science degree in Pharmacy and his PharmD from University of Toledo.

Biography:

20 years experience within high volume manufacturing, last 10 within Pharma Clinical Supplies industry.
At Almac Clinical Services 3 years experience within Clinical Supplies Project Management function working with range of large & small Pharma & Biotech companies to deliver range of contracted services.
Spent 3 years as full time Business Representative for development of Supply Chain Planning Function as part of Almac’s ERP implementation.
Subsequently, for the past 4 years lead team of 12 Business Analysis & Support staff responsible for support and development of Almac’s ERP and intergrated business systems, including responsibility for delivery of Almac’s external systems integrations strategy.

Biography:

Jill Hagan has been working in Clinical Trial Supply Chain Management at Eli Lilly and Company for 10 years.  She has experience forecasting and planning for all phases of clinical trials and multiple therapeutic areas.  She has also supported implementation of integrated supply chain systems for both commercial and clinical trial supply chains.

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:

Nimer Yusef leads the IVRS consultancy and software development company Trial Brain, which was founded in 2010 and has since evolved into one of the largest IVRS consultancy providers worldwide. The objective of Trial Brain is to support clients in implementing IVRS-Systems, to optimize Clinical Trial Logistics strategies, to provide efficient trouble shooting support as well as to offer a portfolio of trainings in IVRS and logistics.

Nimer has a strong IT background and more than 10 years experience as expert for IVRS and Clinical Trial Supply with a Focus on Inventory Management. After completing his diploma in mathematics at the Berlin University of Applied Sciences in 2004, he joined Perceptive Informatics as Software Developer and Validation Engineer for IVRS projects. In 2008, he moved on to join the Clinical Logistics Group at PAREXEL as Project Manager, IVRS Consultant and Trainer. There, he developed a deep insight into the interdependencies of IVRS and Clinical Logistics. From 2009, he implemented the use of Clinical Supply Chain Simulation Tools within the Clinical Logistics Group at PAREXEL.

Biography:

Volker Niermann is an Associate Director of Product Development Manager, Device Operations at Bristol-Myers Squibb.

Biography:

With 15 years of direct Life Sciences globalization experience, Eric Jacobs has assisted many leading companies in the Pharmaceutical and Biotechnology sectors in successfully creating and implementing strategic initiatives across a wide spectrum of their ecosystem globally, from IMP labeling to regulatory filings. In his current role, Eric is responsible for outlining and managing the execution of SDL’s Life Sciences strategy globally and for driving vertical innovations across the entire portfolio of products and services.

Biography:

Regulatory Scientist at Eli Lilly and Company.

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:

Melissa Gallardo is an Associate Manager of Clinical Supplies where she is responsible for leading CTM coordination for various Phase I – IV clinical studies. Currently an SME for forecasting utilizing SmartSupplies ClinApps. She authored a Global IP Forecast and Ordering procedure at Astellas.  She established a formal new employee onboarding program for clinical supplies, developed a CTM education center SharePoint and does new employee training.  Prior to that she was a member of the Global Quality Assurance team for seven years.  She was involved in the development and managed several programs, amongst which were:  Product Complaints, Q10 Management Review, Internal Audit and Regulatory Inspection Readiness and Change Controls.

Biography:

Michael Sparozic is the Lead Trial Supply Operations Manager at Sanofi in Bridgewater, NJ. He has worked in the Clinical Supplies field for close to 20 years. He has experience managing a global supply chain including planning, manufacturing, packaging and distribution of the CTM. He is now leading the US efforts for Direct to Patient trails for Sanofi. Michael attended Massachusetts College of Pharmacy and Health and has a B.S. in Pharmacy.

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:

Senior QA Project Manager at AbbVie

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.