The Global Clinical Supplies Group 2016 US Conference: Speakers

Biography:

Kristen DeVito is Global Director, Clinical Supply Services at Catalent Pharma Solutions. In this role, she is global lead for Customer Service Excellence, Project Management, Clinical Supplies Management and Strategic Supply Solution functions of the business. With over 20 years of industry experience, she previously held the positions of General Manager of the CSS site in Mt. Laurel, NJ and Director, Project Management with Aptuit and Quintiles Clinical Supplies. Kristen is a committee member and former Chair of the ISPE Investigational Products COP Steering Committee and former instructor for the Center for Professional Advancement Course, Clinical Trial Materials.

Biography:

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

Biography:

Esther is currently Global Director, Strategic Alliance Development and Innovation for Catalent Pharma Solutions Catalent acquired Aptuit CTS in February 2012, a company which had previously acquired Almedica where Esther was Director of Client Development having been a founder member of the then 10 year old European facility. So Esther has worked for 3 different companies for over 20 years without moving offices! As a pharmacist, Esther has had over 30 years experience in various pharmaceutical fields including 5 years with Sanofi Winthrop where she was Head of Research Services during which time she managed groups of CRA.’s, medical writers and information/adverse event surveillance specialists. Previous roles include Principal Pharmacist with the Regional Drug Information Service at St Mary’s Hospital in Manchester, and Pharmacy Manager with Boots the Chemist. Esther is also a past Chair of ISPE’s EU Investigational Products COP and has been a lead author for the ISPE guidance document on NIMPs and Delivery of IMP’s Direct to Patients’ Homes.

Biography:

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

Biography:

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

Biography:

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:

Catherine Hall has over 15 years of Clinical Supply Chain experience and currently holds the position of Director of Clinical Supply Chain with Alnylam Pharmaceuticals. She has been an active member of the Investigational Products communities and is a member of both the New England Clinical Supply Organization and the North America ISPE Investigational Products Community of Practice Steering Committees. Catherine started her career as an academic scientist in the area of Molecular and Cellular Biology before finishing her MBA and transitioning into Supply Chain with Pfizer. She has also worked for Millennium/Takeda and more recently Biogen. During her career she has developed training programs, led process improvement initiatives, and helped build partnerships and solidify alliances. Catherine is probably the most well known for her efforts at Biogen where she led a team that focused on bridging the GMP/GCP gap to bring supply chain customer service through the last mile to patients.

Biography:

Mark Woolf – Global Manager, Depot Network, Catalent

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

Biography:

Vildan Kortan is currently the Group Director of R&D Supply Chain Organization within Bristol-Myers Squibb based in New Brunswick, NJ. In this role she is responsible with global planning, procurement, materials operations, and logistics in support of internal and external production of investigational medicines.She has over 25+ years of experience in pharmaceutical industry holding various leadership positions including Director of Worldwide Clinical Supplies Logistics, Clinical Supply Chain Manager, Production Planner, Quality Specialist, Chemical Process Engineer, and Analytical Scientist. She was also the team lead for global SAP implementation for R&D at Bristol Myers Squibb.Vildan holds an M.S. degree in Ceramic Engineering from Rutgers University and a B.S. degree in Chemical Engineering from Istanbul Technical University.

Biography:

Sue Lee is a healthcare supply chain professional with over 30 years of GxP process development and application, utilising risk management and logistics planning. with extensive experience shipping clinical and specialty commercial drug, and clinical samples, and evolving patient centric options to ensure continuity of care. She is passionate about empowering patients, their families and carers.

Biography:

In 2013, Nurdan Citamak joined Faubel Pharma Services as Director of Business Development and Sales for North America. In this role, her primary focus is to build awareness of Faubel’s unique capabilities in clinical trial labelling among prospective and existing clients. She is committed to maintaining Faubel’s position as the clients’ most trusted business partner and providing a variety of technically advanced labelling solutions with a constant eye on innovation.

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:

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:

Sashin has 16 years of clinical supply experience supporting packaging and labeling operations, global scheduling, forecasting, planning, IVRS, randomization and drug supply management. Sash currently holds the title of Associate Director, Drug Supply Manager in the Clinical Supply Operations group at Bristol-Myers Squibb. In this role, he provides drug supply support for Investigator Sponsored Trials (IST/ISRs), Early Patient Access (EPA), and Phase IV or Late Phase Post Marketing Clinical Research. Sash obtained his Bachelors of Science from Philadelphia College of Pharmacy and his MBA from Drexel University. At home, Sash loves to spend time with his wife and two kids. He has coaches his daughter in softball. He is an avid New York Mets and New York Giants fan.

Biography:

Dave Lecher is currently working as Business Development Executive within the Global PCI Clinical Services Sales team and is based in Philadelphia, PA.Prior to joining PCI Pharma Services as Manager of Global Logistics in November 2010, Dave worked for over 7 years for Fisher Clinical Services in a number of increasingly critical quality, project management, and distribution roles. Dave is a graduate of Ursinus College where he studied Biology and Biostatistics and holds a graduate certificate in project management from Lehigh University. Whilst working for PCI, Dave helped to establish the processes, systems, and foundations of our clinical organization. These efforts led him to his most recently held position, as Director of Clinical Operations & Supply Chain. In this role, Dave was responsible for the management of Global Logistics including distribution order entry, IVRS setup, global depot network setup and auditing, and product import/export; as well as, Warehousing operations including receiving, inventory management, production order staging, distribution order fulfilment, shipping, returns, and destruction. In this role Dave was also responsible for all clinical packaging operations at the Rockford, IL site including everything from manufacturing to primary fill and secondary packaging.In 2014-2015, Dave also lead the design, development, and build out of PCI’s Logistics Parkway facility, a 93,000 square foot purpose built site in Rockford, IL, which was constructed to support the growth PCI has experienced in its Clinical Trial Services business.

Biography:

Karen McNamara is the Product Development lead at Infinity Pharmaceuticals, Inc. which includes clinical supplies responsibilities. Karen has worked in the biotech/pharma industry for 15 years. Before joining Infinity 10 years ago, Karen was with Biogen Idec in the Global Operations team focused on clinical and commercial logistics. Over the past 5 years, Infinity has been through a roller coaster of events slimming down from a 300+ person, phase 3 registrational, NDA writing company down to a 25 person, phase 1, US only company and most recently beginning to grow again starting two global phase 2 studies in 2019. As you can imagine, Karen has found herself in a unique situation with a new perspective on influencing and collaborating with other key functions (both internally and externally) including taking on product development and alliance management at Infinity.

Biography:

After graduating from Penn State University, Keith started his clinical supply career at National Packaging Systems, a venture funded startup for clinical supplies, in Quality Assurance. During his 12 years working on the vendor side of the industry he took on roles in Quality Assurance and Logistics Management. He then transitioned to the sponsor side of the supply chain by joining Schering-Plough in their Resource Management group. In 2005 Keith joined a newly formed clinical supply group at Celgene Corporation managing clinical packaging and logistics vendors. During his time at Celgene he’s had roles within clinical supply Operations Management as well as Strategic Program Management. He currently is the Sr. Director, Operations, in Celgene’s Investigational Material Supply Chain department.&.

Biography:

Bob Albanese brings over 30 years of experience in diversified industries to the CSM team. As Vice President of Operations, Albanese implements processes and tools that allow continual growth while reducing costs through streamlined operations. As leader of the business development, operations, and marketing teams, Albanese is the catalyst of innovation and growth by expanding CSM’s global footprint and implementing cutting-edge technologies throughout the entire company. Last year Albanese introduced a Direct-to-Patient shipping strategy for a pediatric clinical trial, which recently won the Clinical Informatics News’ Best Practices Award in the category of Study Startup and Design. Currently, he is leading a multi-million dollar expansion effort that includes opening an second CSM facility on the East Coast early this year. Prior to joining CSM, Albanese spent 20 years in cold chain logistics, managing the daily operations for a nationwide refrigerated trucking company. He also spent 12 years with a large-scale construction company, managing software design solutions including cost control, budget management and real-time data from field operations. Albanese joined CSM in 2011 as the Director of Operations.

Biography:

Expertise in clinical supplies management and vendor management gained during 12 years working at several pharmaceutical/biopharmaceutical companies including J&J, Bristol-Myers Squibb, and Cardinal Health/Catalent.

Biography:

Mike Yoon – ThermoFisher ScientificMike Yoon is an Account Executive for Thermo Fisher Scientific, the world leader in serving science. He has spent the past five years in multiple roles within the company, focusing on the provision of ancillary materials used in clinical trials. Currently Mike works in the Clinical Ancillary Management group of Fisher Clinical Services, helping pharmaceutical companies and CROs establish global supply chain solutions for the management of ancillaries.

Biography:

Michael Faughey is a Strategic Accounts Manager for Ancillare, Inc – a global company specializing in the proactive management of ancillary supplies for clinical trials. As a pharmaceutical supply chain professional for 28 years, Mike has significant experience encompassing multiple levels within both the operational and R&D disciplines of several pharmaceutical industry leaders. Recently Mike has had the opportunity to focus on stream-lining and simplifying the complexities of global ancillary supply management within Johnson & Johnson and Ancillare.

Biography:

Philippe Van der Hofstadt is CEO of B&C Group (www.bnc-group.com), a European packaging & logistics companydedicated to clinical research and active on a worldwide basis.After the degree of Pharmacist at Université Catholique de Louvain (UCL), Philippe worked at SGS Laboratoires Simonand Biopharma to become Industrial Pharmacist and did a third cycle in Pharmaceutical Engineering. He has workedas Junior Consultant in Regulatory Affairs and Clinical Research with Cogepharm in France and Belgium, SalesManager with SmithKline Beecham Clinical Laboratories’ Central Laboratory (now QUEST) in Europe, and GeneralManager of CRL-Medinet (now Eurofins Medinet Central Laboratory) in the Netherlands.In 1999, he founded B&C Group as a niche service provider in clinical research offering innovative & flexible drugpackaging & warehousing, transport, biobanking and drug archiving solutions to Pharma & Biotech companies, CROs,Central Labs and Academic or Research Institutions. Since 2014, B&C Group has a worldwide depot networkin 18 countries covering all continents.

Biography:

Christine Fattore is the Executive Director of the Global Clinical Supplies Group. In this role she has overall strategic and operational responsibility for the organization’s programs and execution of its mission and strategic plan. She started in this role when it was created in January 2017 after having served on the GCSG Board of Directors since 2009 with the final year being in the role of Board Chair.

She has over 20 years of experience in the clinical trial/clinical supply arena at such companies as Aeras, MedImmune, Shire Pharmaceutical Development, Zeneca Pharmaceutical and Otsuka America Pharmaceutical where she established and developed the Clinical Supplies group.

Christine has also worked as a Clinical Research Associate and as a hospital pharmacist.

She received a BS degree in pharmacy from the University of Minnesota College of Pharmacy.

Biography:

Marianne Simone is currently the Shipment Execution Team Lead in Regional Logistics within Clinical Supply Operations (CSO) at Bristol-Myers Squibb, a role newly created in 2015. Previous to that, she was a Drug Supply Specialist within the Drug Supply Management group of CSO. Throughout her career at BMS (which began in 1997 on the Packaging and Labeling line in CSO), Marianne’s responsibilities have included packaging, labeling, line scheduling, label generation, process validation, inventory management, study planning, training, process improvement, interactive response technology development, and system interface support. She is also the Subject Matter Expert for the business users as it pertains to internal interfacing systems and applications. She is currently developing a new role to optimize distribution planning and improve efficiency across Drug Supply Management and Regional Logistics Operations Management. Marianne received her degree from Concordia University in Montreal.

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:

Patty Overley is a Sr. Consultant with Global BioPharm Solutions. She has worked in the BioPharm and Medical Device industries for 20+ years. Her experience spans clinical and commercial supply chain management, project management and systems implementations. Prior to joining Global BioPharm Solutions, Patty was a Sr. Manager of Clinical Supplies Planning & Systems at Allergan where she led a global team of Supply Chain professionals responsible for Allergan’s Pharma and Medical Device clinical supplies. Patty also worked at Advanced Medical Optics where she managed the US Commercial Eye Care Product inventory line. Patty holds a Bachelor’s degree in Industrial Technology from Cal State Long Beach and an MBA from Pepperdine University.

Biography:

Lynn Schumacher – SVP, Executive Coach Lee Hecht Harrison Tampa, FLLynn Schumacher is a highly experienced, certified LHH executive coach with an extensive background in career transition and leadership development across a variety of industry settings. She has deep expertise in assessment and talent development which is valuable in helping individuals identify strenghts and competencies that align with specific career goals and growth opportunities. Lynn is skilled in building collaborative business partnerships and has coached numerous executives in the healthcare, financial services, technology, manufacturing and retail industries. Lynn is certified on various 360 feedback and assessment instruments and holds a MS in Human Resource Management from Loyola University of Chicago.

Biography:

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

Biography:

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

Biography:

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:

Todd has been in the Pharmaceutical industry for over 20 years. He graduated from Michigan State University with a B.S. in Forensic Science in 1995, and following an internship with the R.I. State Crime Lab, began his career working as an Analytical Chemist at Hoechst Celanese. He joined Pfizer Inc. in 1997 in the Quality Control group responsible for commercial stability, technology transfers and reference standard testing. After earning his M.B.A from the University of New Haven in 2003, he left the Analytical R&D group joined the Pfizer Clinical Supply Chain organization as the Packaging Vendor Schedule, where he was accountable for project progression of all planned clinical packaging orders. Drawing on his previous experiences in commercial and R&D, Todd helped to create a ‘home grown’ supply planning tool which enabled forecasting to vendors and cross line communications easier, more efficient and more transparent. In his current role as Business & Regional Operations Master Planner, he is accountable for strategic program assignments, capacity/resource planning, budget adherence and pan-portfolio prioritization for the Clinical Supply Operations group. He has additional operational oversight of internal schedulers, conducts routine business and operation reviews, as well as contributing to the overall sourcing strategies within the Global Clinical Supply organization. Todd is also a Certified Six Sigma Greenbelt, and has been responsible for several continuous improvement efforts while at Pfizer.

Biography:

Joe Iacobucci is a Clinical Supplies Team Lead at Shire in Lexington, Massachusetts. He has been involved with clinical supplies for over thirty years.  Prior to joining Shire, Joe has held various positions in the industry including: Vice President of Clinical Supplies Services for Xcelience in Tampa; Vice President of Sales at Clinical Systems, Inc.; Manager of Clinical Supplies Operations at Rorer Central Research; Supervisor in Commercial Packaging Operations at Rorer Pharmaceuticals; and Manager of Investigational Materials at Berlex Laboratories.  Joe began his career as a Formulations Scientist at Berlex Laboratories.

His professional affiliations include GCSG (Global Clinical Supplies Group) where he is a current member of the Board of Directors, and ISPE (International Society of Pharmaceutical Engineers).
Joe received a BS in Pharmacy from Rutgers College of Pharmacy, a MBA in Global Marketing from Temple University and is a Registered Pharmacist in New Jersey and Pennsylvania.