The Global Clinical Supplies Group 2016 European Conference: Speakers

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:

Graduated in 1995 with a BSc in Medical Biochemistry and shortly after joined DHL’s International management training scheme. Chris has worked in Operations, Strategic Marketing and Product Development roles. Chris completed his MBA in 2003 and currently has responsibility for the Global Clinical Trials Logistics business (Strategy, Operations, Project Management & Business Development). Chris has successfully overseen the development of the largest “single source provider” of end to end clinical supply chain solution; DHL.

Biography:

Nick believes passionately about the potential for success within us all. For many years, he was a Director in Barclays, leading the people workstream of large global change programmes before setting up his first training company which saw year on year growth consecutively for 10 years. As this company grew, it took Nick away from facilitating team workshops, so, in 2014, he set up Ngagementworks to enable him to focus once again on his passion for facilitating and conference speaking. Nick travels throughout the UK and abroad, working with household organisations as well as speaking at conferences and is highly-regarded as a facilitator and speaker, winning numerous awards. People say his style of presenting is ‘infotainment’, providing anecdotes and practical examples whilst also making the learning enjoyable. In his spare time, he is an acclaimed candid street photographer who goes under the pseudonym Few Peeps. If you would like to find out more about Nick and his company, he is on LinkedIn, has a website and also writes and shares articles and motivational quotes and images on his site Yours Behaviourally.

Biography:

Ignacio is currently the JIT Project Lead within the Tech. & Innovation department at Janssen. He recently completed the Global Operations Leadership Program at Johnson & Johnson where he worked as a Clinical Supply Chain Manager, Process Validation Engineer and SAP Master Data Team Lead. Prior to joining J&J he worked at one of the most promising Biotech startups in Switzerland. Ignacio holds a Master’s Degree in Industrial Engineering, speaks 5 languages and has lived in 4 countries in the last 5 years.

Biography:

Michal Gueron has worked at Teva Pharmaceutical Industries, Israel for 4 years. Michal has vast experience in supply chain activities from planning, set‐up till study closure. Michal has taken part in defining efficient clinical supply chain strategies, IRT set up and management, budget and resources management. Michal has recently been involved in re‐defining a master plan for clinical supply chain SOPs Before joining Teva Michal worked in a small Hi‐tech company as project manager and in a big Israeli retail company as an operation coordinator. Michal has a degree in B.Sc. Industrial management engineering from Tel Aviv University, Israel and MBA degree in Management from Tel Aviv University, Israel.

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:

Helen holds the position of Director, Strategic Client Relationships, at Fisher Clinical Services. With over 20 years experience in the clinical trials environment, her capabilities include demand planning, sourcing, production, project & relationship management for both IMP and ancillary supplies. Helen is responsible for all aspects of the client experience, relationship development and establishing solutions to meet Sponsors’ needs, primarily for large pharma and biotech companies. Helen is a registered Pharmacist, having received her BSc in Pharmacy from Heriot‐Watt University, UK and successfully qualified from the state hospital sector. Throughout her career, Helen has been recognised for consistently delivering results, dealing with difficult decisions, providing an analytical and logical approach to issues and actively participating in European clinical supplies conferences. In her free time Helen enjoys keeping active and walking in the outdoors.

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:

Roger started his career in 1976 in the Clinical Supply Unit of Janssen Pharmaceutica in Belgium. He has 40 years of experience in Clinical Supply Chain processes. For 25 years he was the head of the Clinical Supplies Packaging and Labeling department. He engineered highly automated primary and secondary packaging equipment and several in-house built Clinical Supply IT systems supporting on-demand labeling and electronic batch records. In his current role he is exploring new technologies to shape the future of the Clinical Supply Packaging and labeling department. Ongoing projects are : JIT (just in time) labeling, e-Labeling and Smart Packaging. These innovations will further drive down the scrap rate, shorten the lead times and provide patient centric solutions for Clinical Studies. Roger is also core team member of the ISPE & TransCelerate e-Label work stream.

Biography:

Mark leads Clinigen’s Clinical Trial Services team, providing strategic comparator sourcing solutions that are augmented by DDLD (Demand Driven Labelling and Distribution) and Direct to Site distribution.With over 18 years’ experience in the Pharma industry Mark’s prior roles included leading business development for a clinical trial cognition assessment firm, running the Medical Directors’ service for a Pharma benchmarking organization and helping organisations identify divestment and acquisition opportunities with a Pharmaceutical consultancy.