GCSG 2021 Spring Boot Camps: Program

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:

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.

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:

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

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:

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:

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:

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 services. 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, before transitioning into a global IT leadership position and prior to his current cross-functional role within the global services team. Based in Philadelphia, Pennsylvania (USA), Mike works extensively across World Courier’s global network.

Biography:

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.

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:

Since 2009, Gavin has been leading the clinical distribution team based at PCI’s Bridgend facility in the UK. In his role as Associate Director, European Clinical Services he provides full oversight of the distribution activities performed across the European region including the clinical services at PCI Bridgend, Dublin, and Berlin. Gavin also has the responsibility for clinical imports into Europe including supporting sponsors with Importer of Record, import VAT and various customs procedures. Having worked within Storage and Distribution of clinical trials since 2001, Gavin has over 23 years of experience within the industry.

Biography:

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.

Biography:

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.

Biography:

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 led 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).

Biography:

With more than 13 years of experience in the Clinical Trial Supply Chain, Lina has been able to work with the main countries in the LATAM region including México, Colombia, Perú, Chile, Argentina, Brazil and Uruguay, enabling clinical trials to be developed in the region and looking for solutions for the challenges that such a diverse region may bring. Based in Bogotá Colombia, Lina currently holds the position of Regional Operations Manager for Clinical Supply Solutions for World Courier in Latin America, is a registered Pharmacist and MBA, fluent in English, Portuguese and Spanish.