GCSG – Global Clinical Supplies Group

Jan Pieter (JP) Kappelle, 4G Clinical Vice President of Strategy, 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) European Membership Officer and Master of Ceremony where he connects clinical supply professionals for the purposes of education, knowledge sharing and the development of industry best practices

Terry studied applied biology as an honours degree and completed a master’s degree in pharmaceutical science. 

He has worked in the field of clinical trials for almost 19 years, 17 of which were within IVRS/IWR groups. 

Terry has supported IWR studies from both vendor and sponsor roles which have provided him a clear understanding of how IWR developments works from both perspectives. 

He worked at J&J for over 7 years, 4 years of which was as a full time employee. Prior to J&J Terry gained IWR and IVRS experience working at ICON Clinical Research and GSK. 

On a personal level, Terry is married and has 2 children (boys 9 and 12) which keep him busy outside of work. He enjoys travelling and has been lucky enough to visits numerous locations around the world (including pyramids of Egypt, Everest Base Camp and more) 

Karen McNamara is the lead of Product Development at Infinity Pharmaceuticals, Inc. which includes clinical supplies responsibilities.  Karen has worked in the biotech/pharma industry for 13 years.  Before joining Infinity eight years ago, Karen was with Biogen Idec in the Global Operations team focused on clinical and commercial logistics.  Over the past three 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 a global phase 2 study earlier this earlier.  As you can imagine, Karen has found herself in a unique situation with a new perspective on influencing and collaborating with other key functions including taking on product development at Infinity.   

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. 

Gavin has worked within the clinical trial industry for 19 years, with a focus on the distribution of clinical materials globally. 

 He is currently working as the Senior Manager, Global Logistics at PCI Pharma Services, located at our Bridgend facility in South Wales. 

 He has been overseeing clinical distribution at PCI since 2009 with him previously working as the Logistics Manager at Bilcare Global Clinical Services between 2000 – 2009. 

 Gavin’s main responsibilities at PCI  include the overseeing of all activities associated with UK imports along with supporting the full supply chain of clinical trial supplies, including the selection and management of 3rd party depots. 

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

Camila Drigo has over 10 years of experience in Clinical Trials with emphasis in clinical supply logistics, 6 of them at Pfizer within their Global Clinical Supply Chain supporting various aspects of the clinical supply chain in Latin America and globally. Camila’s responsibilities have included drug supply forecast and inventory management, regulatory affairs, labeling, process improvement, documentation, Expanded Access (Compassionate and Post-Trial Access), external vendor management and distribution & logistics. Today Camila is a Coordinator in Digital Business Operations group responsible for deploying Latin America regional strategic plan to deliver the Pfizer Research, Development & Medical clinical portfolio in alignment with Pfizer’s corporate plans, to enable Global Clinical Supply team to meet the patients’ needs in the region. She has worked from Brazil supporting Latin America countries and US/UK colleagues, and has considerable experience in optimizing regional clinical supply chain distribution lanes. Camila has a Master of Business Administration in Business Management and Strategy and she has a bachelor’s degree in Pharmacy from the University of São Paulo. Camila is an active member of the Global Clinical Supplies Group.

Billie Key has over 25 years of experience in the pharmaceutical and academic research
areas. He spent over 14 years working in research laboratories, ultimately managing
target discovery and pharmaceutical development groups for both small and large
molecules. In 2009, he moved to Lexicon’s clinical operations group as a Pharmacy
Liaison managing IP logistics and secondary packaging vendors as well as trial master
file and interactive response technology platform support. In 2011 he lead the creation of
a clinical supplies department responsible for development of the procedures and
processes required to conduct all aspects of the clinical supply chain from packaging
through reconciliation.
In 2013 Billie assumed additional roles by joining the small, highly integrated
Commercial Supply team responsible for developing the procedures and processes
required to oversee and control global production, packaging, and distribution for the
consecutive marketing approvals of Lexicon’s drugs for carcinoid syndrome and
diabetes.
In 2019, he joined the Supply Management And Readiness (SMART) team at PCI
Pharma Services where he partners with clinical trial sponsors to optimize supply
strategies and assess risk across the supply chain. Billie has a bachelor of microbiology
from Texas Agricultural and Mechanical (Texas A & M).

Mike is responsible for the development, implementation, product management and ownership of World Courier’s patient centric services across 140 company-owned offices in 50+ countries, with focus on direct-to-patient and supporting cell and gene therapy. Since joining World Courier in 1992, Mike assumed a number of positions within US operations, customer service, training, compliance, marketing, sales and clinical trials management. He progressed to senior roles, including director of US customer service/operations, director of new service development and director of regional accounts, prior to transitioning into a global IT leadership position and more recently into his current cross-functional role within the global services team. Based in the Northeast US, Mike travels extensively throughout World Courier’s global network. Effective in 2018, Mike has began volunteering for GCSG as Global Communications Coordinator.

Nicole Gray is currently Director, Strategic Supply Solutions for Catalent Clinical Supply Services, responsible for developing the Direct to Patient business and other new strategic service offerings.  She has been in the Pharmaceutical industry for 15 years and has held multiple roles in clinical supplies project management.  Prior to moving to her new role in August 2018, Nicole spent 6 years as the Director of Project Management for the Catalent Philadelphia site, responsible for a team of 45 Project Coordinators, Project Managers, and Sr. Project Managers.  Prior to moving to Catalent Philadelphia, Nicole was responsible for the Mt. Laurel and Allendale Project Management teams (previously Aptuit).

Prior to joining Catalent, Nicole held various project management, communications and marketing coordination roles at Omnicare Clinical Research, GE Financial Assurance, and the United States House of Representatives.

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.

Paul Ingram, Ph.D. was appointed Global Director, Strategic Development and Innovation for Clinical Supply Services in November 2018
Joined Catalent in 2011 and has 25+ years of experience in clinical supplies, medical device, and research & development
Paul was previously Global Director, Strategic Business Development for CSS
Paul is responsible for developing an Innovations Road Map for the CSS Global Network. This will include enhancement and additions to our offerings and services provided to customers to meet future regulatory and supply chain challenges

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.

Matthew is one of the founders of TrakCel, using his knowledge in handling and distribution of ATMPs he has assisted with the development of TrakCel’s technology platform, writing user-stories for GMP critical functions. Following completion of initial development work Matthew has moved into Project Delivery at TrakCel, assisting with the configuration of the product and undertaking detailed FMEA analysis of existing and proposed supply chain models. Matthew provides a technical bridge between the software development side of the technology platform and the GxP application of the system. He is also a member of the company’s Quality Unit to ensure that development and configuration of TrakCel’s technology platform adheres to a GAMP-5 framework. Prior to TrakCel, Matthew worked as Head of Technical Support for a specialist clinical supplier company where he was responsible for identifying, assessing and validation new equipment for use in GMP Pharmaceutical manufacturing including temperature controlled shipping, storage, and labelling systems for cell therapy products

Healthcare Supply Chain professional with over 25 years of experience shipping clinical and specialty commercial drug, and clinical samples. Quality management embracing GxP process development and application, utilising risk management and logistics planning, including packaging, temperature control and emerging markets expertise, combining business experience and practical solutions to deliver results.

Mr. Jacobs is a successful trainer, business leader, consultant, executive coach and speaker. He’s been heavily involved in clinical supply chain operations, IMP cGMPs, cGCPs, clinical development and quality for pharmaceuticals, and biotech products. His expertise also includes success in innovation, global cultural dynamics, organizational development, and high performing teams. He has presented globally on leadership, management, forecasting, planning, creativity, making global teams successful, emotional intelligence, generational differences, human error prevention, clinical supplies logistics, project management, problem solving and contract negotiations.

In the past he has been the CEO and COO of a start up company as well as the president and Global Chief Operating Officer of a multinational contract organization that served companies like Novartis, Eisai, Lilly and others in the pharmaceutical and biotech sector.

His ability to lead, drive outcomes, and bring teams together to deliver products and services on time and on budget was honed and developed as the head of US clinical supply operations for Johnson & Johnson. This was part of his 20 years of experience in clinical supplies, clinical development and global team leadership.

Mr. Jacobs 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 Army 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

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 organizationsIn 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.