GCSG – Global Clinical Supplies Group

Azra Beganovic is the study manager at the hospital pharmacy Amsterdam UMC, location AMC. The Academic Medical Center (AMC) is one of the biggest university hospitals in the Netherlands.  

She has kicked off her career 3 years ago at the same academic hospital. Azra is the main contact person within the trial pharmacy for the setup of new clinical trials. Her experience in this field has made her knowledgeable in the field of clinical supply management. She is also a member of the Clinical Supplies Forum Group in the Netherlands, which is held twice a year.  

Azra received a BS degree in Pharmaceutical Sciences from the Free University of Amsterdam. 

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.

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.

Colin is a Partner and leader in our UK / Swiss Life Science practice. He has been with Deloitte since 2011 working in the US firm until 2014 when he moved to the UK. ​

Colin’s client advisory work in the Life Sciences sector ranges from strategy into operations focused on the R&D function including operating model development and implementation as well as post-merger integration (PMI). These engagements have been serving client Boards and their senior leadership teams in R&D, Commercial and Private Equity. ​

Colin is the co-author of our annual R&D productivity and IRR analysis study which reviews productivity of the worlds largest pharmaceutical businesses. ​

His recent engagements include developing a vision of the future R&D model including internal and external attributes; creating a digital R&D strategy and business cases of new technologies and pilot programs; design and implementation of a world first GXP validated Robotic Process Automation; and design of a new Pharma vaccine R&D model post integration​

Colin has a B.Sc (Hons). in Microbiology from the University of London, Queen Mary & Westfield and a Marketing Diploma from the Chartered Institute of Marketing.

Gail Adinamis is founder and CEO of GlobalCare Clinical Trials, a global patient-centric service organization that conducts study visits at patients’ homes or alternate settings via a global network of ambulant healthcare providers to support traditional, virtual or hybrid studies. 

Adinamis has 40 years of comprehensive global clinical trials experience including over 12 years of global trials management at Abbott Laboratories and Astellas Pharma US.  She established the clinical trials divisions for three national home infusion companies and served as president of those wholly-owned subsidiaries. In 2004, she founded and was President and CEO of an independent ambulant care service company for clinical trials prior to establishing GlobalCare Clinical Trials, LLC in 2010. 

Adinamis is active in many industry associations and has been an invited speaker at several industry conferences and recipient of numerous awards and recognitions including twice being among INC 5000’s fastest growing private companies, CEO and International Game Changer of the Year, and among the top 50 fastest growing Woman-owned companies in 2018 and 2019. 

David is a pharmaceutical services professional with over 15 years’ experience in the provision of GXP compliant services. He is a Clinical Supplies Specialist and one of the few GMP/GDP professionals whose experience includes the administration of investigational products in a clinical setting, gained whilst working as a Research Physiologist with a Phase 1 Clinical Research Unit. David holds a post-graduate diploma in clinical research and is currently Global Account Director at World Courier where he is often called upon to assist in solving the supply chain challenges associated with novel therapies. He has previously worked as a Clinical Supplies Lead for Penn Pharma where he managed pharmaceutical development and supply chain projects for a variety of small, medium, and large pharmaceutical companies.

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

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

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.

Caitriona Lenagh joined Almac in 2009 and has first-hand experience in all QP requirements in the world of Global Clinical Trials. She has worked with global teams, educating and mentoring them in the requirements of EU legislation, particularly the roles and responsibilities of the Qualified Person. She has extensive experience in a number of dosage forms and has performed audits of manufacturing, testing and packaging sites throughout the world, imparting knowledge on the regulatory requirements and industry expectations. 

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

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Paula Pulsoni leads World Courier’s global depot network. She is responsible for ensuring value is delivered to clients through innovative logistics solutions that drive efficiency and agility into their pharmaceutical supply chains.​

Paula is based in Madrid and earned her pharmacy degree from the University of Buenos Aires. She started her career in World Courier 13 years ago as a depot pharmacist, later on moving into a regional and then global role.

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

Dr Nicolas Sireau is the CEO and Chair of Trustees at the AKU Society, a patient group that helps people with AKU (short for alkaptonuria), a rare genetic disease affecting both his children. He is also co-founder and Chair of Findacure, an organisation that helps rare disease patient groups, and of Orchard, a charity that seeks to develop new and better treatments for obsessive-compulsive disorder (OCD). Previously, Nick was the CEO of SolarAid, an NGO working in Africa. He is a fellow of the Ashoka Fellowship of Social Entrepreneurs and has a PhD in the social psychology of social movements. He is the editor of ‘Rare Diseases: Challenges and Opportunities for Social Entrepreneurs’ (Greenleaf 2013) and of the ‘Patient Group Handbook: A Practical Guide for Research and Drug Development’ (Findacure 2016).  

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.

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.

Working for 10+ years on the pharmaceutical industry, currently acts as Head of E2E CTS Planning, Felipe has been working on leading positions on clinical trial supplies (CTS) planning since September 2017. He holds a degree on Business Administration from State University of Londrina and is CPIM APICS certified. Very result oriented, he acted on different leading roles of growing responsibility improving efficiency and processes through the course of his career. On CTS, contributed to the implementation of processes, practices and KPIs for a newly created planning team focused on demand and distribution planning. 
Before relocating to Belgium, he led the UCB Brazil SC planning team for 3 years as one of the leaders responsible for transforming the company portfolio from legacy portfolio to the introduction of the UCB global portfolio. Additionally, supported various key projects like SAP implementation and change of 3PL partner. Prior to UCB, Felipe worked for almost 4 years at Sandoz and EMS (Brazilian Generics market leader) as supply chain analyst, launch team lead and project manager.  

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.

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.

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 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.

Tom Gray is an innovation and strategy consultant with over 20 years experience of bringing applied creativity to blue chip businesses and global brands – helping them to build innovation capability and develop new products, services, propositions and business models. 
 
Formerly Director and Head of Idea Development at innovation and growth consultancy Fahrenheit 212, and Strategy Director at creative agency Imagination, Tom has worked with clients including Diageo, IKEA, Land Rover, Shell, HSBC and Samsung. 

The European Knowledge Forum references architecture for Clinical trial supplies; the greatest architecture (the ones that redefine the very definition of the word) are the sort that think outside the box, inspire, and bring an emotional response; yet are built on a foundation of stability and robustness. The GCSG committee would like to take this Knowledge forum as a charge to do the same; think outside the box to create the next era of our sector; or in other words; drive innovation by take learnings wherever they can be found.

With that in mind, Nick Jankel is a thought leader and author; whose life’s work is to understand how people and organizations can lead transformations that forge the future so everyone thrives. Nick therefore is a perfect fit for helping us shape our thinking an challenge our own internal ‘mind architecture’.

We welcome Nick Jankel as our keynote speaker this year.

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. 

Sarah is a very experienced chemical scientist with many years background covering Process Development, Speciality Chemical R&D, and Cosmetics.  Sarah joined Vectura 11 years ago and has held various positions in the Pharmaceutical Development teams working on Vectura’s pipeline products. After many years in the lab and plant Sarah is now managing Clinical Trial Supplies spanning all clinical phases in Vectura.