GCSG 2021 US Virtual Conference: Program

Biography:

Meagan Johnson speaks to audiences all over the world on how they can manage and motivate different generations in the workforce.  After graduating from Arizona State University School of Business in 1993, Meagan spent several years working in sales for three Fortune 500 companies. Although very successful, she became discouraged to hear all the negative comments about Generation X. Being a Gen Xer herself, she felt these comments were unfounded.

Meagan began researching small and large corporations to find successful ways to work with the younger generation. From that search, the seeds for Generation Inc. were planted. Since 1997, she has entertained and educated thousands of audience members from all over the globe. She has written a variety of articles about multiple generations in the workplace, and has been interviewed for many publications and audio programs. In 2003, she received the designation of CSP, Certified Speaking Professional.

Meagan lives in Phoenix, Arizona with four dogs that have a total a total of 15 legs. You do the math!

Biography:

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.

Biography:

Summer Doty is currently Director, Clinical Supply Chain at Gossamer Bio, responsible for end-to-end clinical supply management and oversight for the IBD and Oncology programs with additional CMC project management responsibilities. Summer joined Gossamer Bio in September 2018 with 19 years of global supply chain management experience in commercial and clinical supplies at Becton Dickinson Biosciences and Fisher Clinical Services. She has a BA in Chemistry from University of San Diego and is Certified in Production and Inventory Management (CPIM) through APICS.

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:

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:

Lisette Wijnen is the Sr. Director Clinical Supply Chain at Erasca. She is setting up the Erasca supply chain for phase I, II, and III clinical studies, from drug substance to finished clinical product. Lisette received her M.A. in history at Radboud University and her M.M.O at TIAS Business School (Tilburg University), both in the Netherlands. She has worked in the bio-pharmaceutical industry over the last 20 plus years. She started her career at Amgen’s European Logistics Center (later Amgen Europe) in the Netherlands and worked in the packaging and labeling group, creating clinical and commercial labels for Europe, before becoming an international operations leader responsible for all operational activities leading to launch various commercial products in Europe. In 2006 she moved to Southern California to work at Amgen’s corporate headquarters. She held various management positions in project management, clinical planning, inventory management, warehousing and distribution. She continued her tenure in clinical planning at Gilead Sciences in the Bay Area, leading a team of clinical supply planners to support studies in the HIV therapeutic area. In 2018, Lisette got the opportunity to join Myovant Sciences where she set up their supply chain management department to support CMC and Clinical Operations in furthering the clinical programs in woman’s health and prostate cancer. Most recently, she took on a position as the head of clinical supply chain at the start-up biotech company Erasca in San Diego to build up the supply chain process and team, as well as to support their clinical studies.

Biography:

Amy Thompson is currently Sr. Director Supply Chain Management at Eidos Therapeutics, Inc. She has set up and maintains the Eidos supply chain for phase I, II, and III clinical studies, from drug substance to finished clinical product. Amy received her B.S. in biology and chemistry at Western Washington University. After working in the Bering Sea for the National Oceanic and Atmospheric Administration, has worked in the bio-pharmaceutical industry over the last 20 plus years. She has had a myriad of positions from chemical operator making pharmaceutical intermediates, to working in R&D labs, setting up GLP laboratories and GMP clinical biological manufacturing plants as Manager of Support Operations and Materials Management. Amy made her transition from biologic manufacturing into clinical supply management when joining Gilead Sciences, where she led a team of Clinical Supply Planners to support up to 7 programs over five therapeutic areas, including solid dose, inhalation and biologic products. During that time at Gilead Sciences, she was involved with clinical supplies management, collaborating with internal and external partners to ensure IMP is delivered to patients without delay, as well as involved in supporting and participating in multiple Regulatory agency inspections, both GMP and GCP. In 2018 Amy joined Eidos Therapeutics, Inc. where she has set up their supply chain management department to support CMC and Clinical Operations in furthering the clinical programs. Amy previously lived and worked in the Seattle area and has been in the San Francisco Bay Area for the last 7 years. Since moving to the Bay Area, in her limited spare time, she has been enjoying exploring the local area craft small scale wineries and distilleries. Ask her about her favorites.

Biography:

With over 30 years’ experience in Operational Excellence Phil has delivered diverse and varied projects across a vast array of organisation types around the globe including Pharma, healthcare, chemicals and power generation. As a certified management consultant Phil partners with clients to deliver “real life” strategic and operational solutions to develop their employees, improve efficiency and manage profits. A graduate of the university of Manchester and a Fellow of the Institute of Consulting Phil has acted as an assessor for the Institutes CMC scheme and is a former member of the examinations committee of the Institute of Asset Management whilst also holding a PG Certificate in Executive Coaching and Mentoring.

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:

Lorna Briddick is an accomplished team leader with 19 years of experience in the leadership of business process management and large scale process improvement initiatives with the last 15 years focused on the clinical supply chain. She has successfully led numerous initiatives to re-engineer and optimize clinical supply chain end to end processes from design to implementation. Lorna joined the pharmaceutical industry as a consultant to Pfizer, where she led a corporate wide initiative to optimize 2000+ clinical supply chain procedures across 6 countries to 200+ global procedures. Lorna then joined Schering Plough to lead the optimization of the clinical supply chain, supporting 3 large workstreams that integrated processes across multiple business units. She also held the position of Global Clinical Supply Regional Lead for Latin America, serving as the key interface between the clinical supply team and the clinical operations teams in 9 countries, with responsibility for audit and qualification of depot partners.

Biography:

Mrs. Buchanan is currently the Associate Director of MRL Global Development Quality supporting Global Clinical Supplies at Merck & Co. Over the past twenty-five years, she has held commercial Quality and commercial packaging operational experience. While supporting Global Clinical Supply, she has worked in Global Clinical Supply as a program manager, Global Clinical Supply as Logistics Support and in Global Development Quality supporting release of Clinical Supplies and now supporting operations and technology.

Biography:

Eric enters his twentieth year in our industry as Head of Commercial Operations, Americas for Thermo Fisher Scientific in the Clinical Trial Division (CTD). He oversees supply chain services with both strategic and key accounts in delivering packaging, labeling, distribution, comparator drug and clinical supply chain management solutions.

He is responsible for driving commercial growth within three different customer segments across ten different territories. Guiding his company’s commercial team with a Differentiated Value Proposition strategy that utilizes consultative selling approaches while leveraging the strengths of Thermo Fisher Scientifics global network.

Eric has served as both an executive and board level member with the Global Clinical Supply Group, and has been a conference attendee for all twenty years of his career.

Biography:

Sandra Cook, Ph.D., is a project management, strategy and training consultant with thirty years experience in the pharmaceutical industry. The past twenty have been focused on Investigational Products where she has held both line management and senior level project management roles facilitating high performing teams in the delivery of worldwide clinical supplies, including materials supporting key priority blockbuster products for large pharma.  Additionally, she has been instrumental in the design, development and implementation of several global process improvement projects for R&D Supply Chain.  An active contributor to the IP Metrics Task Team of the International Society of Pharmaceutical Engineering, Cook also manages the bi-annual Equal Partners in Clinical Supplies industry forum

Biography:

Oliver Cunningham is the Vice President of Supplies Management at Signant Health, accountable for managing and growing Signant’s portfolio of randomization, trial supply management, forecasting, clinical supply chain and supply accountability solutions. Oliver leads a global team of product managers in designing and building industry leading clinical supply chain software.

Prior to joining Signant Health in 2017, Oliver spent 14 years at AstraZeneca, holding scientific and supply chain management positions. He is an expert in supply chain management and has held various roles in global planning, clinical supplies and leading early development technical teams. As the Clinical Supply Chain Optimization lead at AstraZeneca, Oliver was responsible for delivering clinical supply chains across all phases of development, including the Fulvestrant and Lynparza programs.

Oliver has a Masters in Chemistry with Industrial Chemistry from the University of Liverpool.

Biography:

Kate Carey is currently Director of Strategic Supply Solutions for Catalent Clinical Supply Services. She has been in Pharmaceutical industry for 15+ years. She has held multiple roles in clinical supplies project management and operations. Kate has responsibility to support Catalent’s innovative demand led supplies model (Pull model). She has worked with cross functional teams to evaluate how the late stage Pull model can transform the management of drug product to increase flexibility of supplies when sponsors are facing the complex and ever-changing environment of clinical supplies. Kate Carey will highlight the topics of how demand led/late stage packaging can • Add flexibility to clinical supply chains • Support patient specific requirements (such as weight-based dosing)

Biography:

Patrick Newingham is a Senior Clinical Trial Supply Manager at Novavax. In his current role, he manages and oversees the clinical supplies function for all products, including the COVID-19 and variant strain vaccines. Prior to joining Novavax, Patrick worked on vaccine clinical product development at Astrazeneca (MedImmune) and at Chrion for over 10 years. He has worked in clinical supplies management at numerous other sponsor and vendor companies for over 19 years. Patrick received his Bachelor of Arts degree in Environmental Sciences at The Evergreen State College in Olympia, WA.

Biography:

Brianna Brooks is a Senior Project Manager at PCI Pharma Services. She has been with PCI as a project manager for 4 years. Brianna holds a Bachelor of Arts from Eastern Illinois University.

Biography:

Adam Duran is the Head of Consulting – US at N-SIDE, currently overseeing a fast-growing team of consultants responsible for delivering optimization, implementation, and training services. He also consults with pharma and biotech organizations on change management, supply and production planning, and clinical supply chain optimization.Before moving to the US, Adam was responsible for the N-SIDE Suite for Clinical Trials – an advanced analytics platform for end-to-end, risk-based clinical supply chain optimization – and leading a cross-functional product management team. He’s a firm believer in continuous experimentation, rapid prototyping, and the growing role of advanced analytics in life sciences. Prior to concentrating on product development, Adam optimized the packaging, labelling, and distribution of therapeutic products, performed strategic analysis of drug product and drug substance ordering and manufacturing for top pharma clients, and co-developed N-SIDE’s business intelligence dashboards for monitoring patient recruitment and dispensing.In a life before N-SIDE, Adam built a clinical trial supply simulator and worked on the design and validation of RTSM systems.When he’s not working, Adam’s favourite pastime is exploring NY parks with his dog Misio.

Biography:

Jill Hagan is a Clinical Trial Supply Planning Advisor at Eli Lilly and Company.  She received B.S. and M.S. degrees in Industrial Engineering from Purdue University before joining Eli Lilly in 2002.  For the last 14 years she has held a number of roles in the Clinical Trial Supply Planning function with responsibility for planning and managing clinical supply chains across multiple therapeutic areas and all phases of development.  For much of that time she has also been a power user and subject matter expert for simulation-based forecasting tools including CT-FAST and N-SIDE Suite for Clinical Trials.  In her current role she leads a team of Clinical Trial Supply Managers, primarily supporting diabetes programs.  Jill loves working with a passionate team of supply planning professionals to plan, optimize and execute clinical trial supply chains and deliver the right product at the right time.

Biography:

Mitch Horoho is currently a Clinical Supply Planning Consultant with Eli Lilly and Company.  Before joining Lilly, Mitch received a BA from Wabash College in Mathematics.  During the last 20 years at Lilly, Mitch has worked in IVR/IWRS and clinical supply planning supporting therapeutic areas spanning oncology, biomedicines, diabetes, and pediatric trial research.  Mitch has enjoyed a long partnership with N-SIDE dating back to 2004 and has contributed to the development and implementation of stochastic based simulation forecasting technology at Lilly.  Mitch enjoys solving problems creatively and collaborating with clinical supply planning colleagues to leverage data to optimize clinical trial supplies.

Biography:

Sateria Venable is a patient advocate who was diagnosed with fibroids at the age of 26.  After receiving the recommendation of a hysterectomy in her 20s, she was prompted to explore other options to manage her fibroid diagnosis.  She began a quest for information, which led her to found The Fibroid Foundation. Preserving her fertility has always been her primary concern.  Unfortunately, she soon discovered that there were limited resources and information available to women, who, like her, had severely symptomatic fibroids.  Sateria researched and interviewed physicians to find trusted, patient-focused medical professionals.  Holistic professionals provided a vast storehouse of information.  Frustrated by the return of fibroids after four surgeries, she was determined to find answers. Sateria learned to listen to her body, and allowed it to guide her.  This awareness led to major nutrition and lifestyle changes.  Along the way, Sateria patented a design for an undergarment for women with heavy flow issues and those in need of incontinence protection.

The Fibroid Foundation has developed a substantial network within the medical community.  Sateria Venable is a sought after speaker.  She has been featured online, in the Washington Post and Huffington Post, and is published in the American Journal of Obstetrics & Gynecology. Sateria holds a bachelor’s degree in architecture from Carnegie Mellon University.

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:

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:

Mr. Valery Ochollah is a Quality Assurance Manager based at Pfizer Inc. in Groton, Connecticut responsible for supporting Inspection Readiness activities within the Global Clinical Supplies group involved in clinical supply packaging, labeling, distribution and IRT system use. He has over 10 years of experience in the pharmaceutical industry in both the clinical GMP manufacturing operational areas as well as Clinical Supply Quality Assurance. His experience spans roles that include biologic manufacturing, packaging, inventory management, distribution and quality assurance. Prior to his roles in the pharmaceutical industry he held a role in a Hospital setting. He holds a bachelor’s degree in Business Administration from Southern New Hampshire University.

Biography:

Brian Keesee, Senior Vice President of PCI’s Clinical Trial Services Segment, has spent his entire career in the Pharmaceutical industry.

In his current role, Brian is responsible for Global Clinical Operations, Logistics, and Project Management for PCI’s Clinical Trial Services sites globally.

Prior to his role at PCI, he held leadership positions in Compliance, Operations Management, and Project Management within the pharma industry.

Brian has managed large global clinical studies and offers extensive experience and expertise in Supply Chain Management, Logistics, Clinical Package and Label design, Project Management, Cold Chain Technologies and IRT.

Brian brings a unique perspective based on his global project management knowledge from his prior positions within the Clinical Supplies Industry, his Compliance and Operations roles at AmerisourceBergen Drug Corporation, and his involvement in a Lean Six Sigma Black Belt Program.

He holds a Bachelor of Science in Business Administration from Missouri Western State University.

Biography:

Digital transformation global leader, strategizing and operationalizing digital value at scale.

Currently PCI Pharma Services Global Digital, Technology and Marketing Officer across North America, Europe, and Asia Pacific.

+20 years industry operating experience in global Managing Director and C-Level Executive positions across: Bio/Pharmaceuticals, Telecommunications, Contract Development & Manufacturing, Digital Product Design & Engineering, Enterprise Software and Management Consulting.

Also, Board Director of Christel House South Africa, and member of the Young Presidents Organization. Live in the US and previously have lived in South Africa, Switzerland, and UAE.

Harvard University and IMD Business School executive programmes. Honors Degree, Bachelor of Social Science, Industrial Sociology from the University of Cape Town, South Africa.

Biography:

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.

Biography:

Holly Bagley is committed to fostering the achievement of better patient outcomes with global clinical trials as a Global Account Manager at Ancillare headquartered in Horsham, PA. Her relentless focus on flexibility and scalability has benefited clinical trial teams to accelerate an effective and efficient modeling for Clinical Trial Ancillary Supply Chain (CTASC).

Proficient within strategic business development, she holds twenty years’ experience within supply chain, customized program implementation and LEAN initiatives to reduce delays with effective process improvement. Her ability to access and understand current to ideal landscape modeling provides her Sponsors with unique advantages.

She is a proud member of the Global Clinical Supplies Group and the Diversity Alliance for Science (DA4S), serving on their membership committee sharing her expertise to promote business and procurement practices within small/diverse business. While grateful for achieving various individual contributor and team recognition awards, her proudest accomplishment is being “Mom” to her ten-year old daughter.

Biography:

Aaron Steinbrecher is a Clinical Supply Project Manager at AbbVie based in Lake County, IL. He has been with the Clinical Drug Supply Management group for 4 years. He previously worked in public heath, as a program coordinator for an HIV and Hepatitis C program at a federally-qualified community health center in Chicago. He graduated with a Bachelor’s Degree in Psychology and a double-minor in Spanish and Anthropology from the University of Illinois at Urbana-Champaign. He lives in Chicago with his fiancée, cat and dog. In his free time, he enjoys swimming, cycling and running (sometimes all together), and playing and recording music. He is excited to attend his first GCSG conference this year!

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:

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:

Levi Goner joined VAT IT ‘s North American Business Development team in early 2018. VAT IT is the global leader and service provider in tax reclaim and compliance. Levi’s initial focus was working with new VAT IT clients helping to solve and consult on their VAT recovery and compliance needs across a variety of industries. As Levi transitioned into a leadership role heading up the business development efforts in 2019, he leaned heavily on his entrepreneurial background to match the vast industry knowledge, expertise and experience within the group to help solve some of the critical problems and challenges clients were facing. With a strong passion for the pharmaceutical industry much of his efforts were poured into catering for the unique needs and requirements for VAT IT’s clients conducting global clinical trials. As a Senior Director in the USA Levi is the in-house specialist on all VAT matters that are pervasive with in the clinical supply chain.

Levi currently lives in Brooklyn with his wife and approximately 2.6 million other people.

Biography:

Sophia Sophos was appointed Managing Director of VAT IT North America in 2017; VAT IT is the global leader and service provider in tax reclaim and compliance. Sophia’s VAT IT career began in Australia overseeing the Australian/New Zealand markets but after a short time, she was transferred to New York following a key acquisition by the business. She now leads a dynamic team servicing the region, with special focus on delivering value to and maintaining executive relationships with VAT IT’s key global enterprise clients. Sophia forms part of a core specialist unit, focused on VAT reclamation and compliance for the pharmaceutical industry at VAT IT. Prior to VAT IT, Sophia spent her earlier career in the consulting space with notable time spent on developing and implementing strategy and governance initiatives. Sophia is a qualified actuary, having completed her studies in South Africa and Australia. She lives in New Jersey with her husband and very new baby boy.

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:

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:

Hi, I’m Sally Nardulli! I’m a Senior Clinical Supply Project Manager with AbbVie. I’ve been with AbbVie for 5 years and this is my second time attending the Global Clinical Supplies Group Conference. My past experience has been working in clinical settings as a Study Coordinator and as a Patient Care Technician. I hold a Bachelor’s Degree is Molecular and Cellular Biology from the University of Illinois at Urbana-Champaign and a Master’s Degree in Clinical Research Administration from Walden University. I’m a mom to 3 kids (ages 4, 6 and 8) and 2 fur babies (rescued 1 year old pit mix brothers). Outside of work, my hobbies include: traveling, scuba diving, and event planning. I look forward to connecting with you at this year’s GCSG conference!

Biography:

Lisette Wijnen is the Sr. Director Clinical Supply Chain at Erasca. She is setting up the Erasca supply chain for phase I, II, and III clinical studies, from drug substance to finished clinical product. Lisette received her M.A. in history at Radboud University and her M.M.O at TIAS Business School (Tilburg University), both in the Netherlands. She has worked in the bio-pharmaceutical industry over the last 20 plus years. She started her career at Amgen’s European Logistics Center (later Amgen Europe) in the Netherlands and worked in the packaging and labeling group, creating clinical and commercial labels for Europe, before becoming an international operations leader responsible for all operational activities leading to launch various commercial products in Europe. In 2006 she moved to Southern California to work at Amgen’s corporate headquarters. She held various management positions in project management, clinical planning, inventory management, warehousing and distribution. She continued her tenure in clinical planning at Gilead Sciences in the Bay Area, leading a team of clinical supply planners to support studies in the HIV therapeutic area. In 2018, Lisette got the opportunity to join Myovant Sciences where she set up their supply chain management department to support CMC and Clinical Operations in furthering the clinical programs in woman’s health and prostate cancer. Most recently, she took on a position as the head of clinical supply chain at the start-up biotech company Erasca in San Diego to build up the supply chain process and team, as well as to support their clinical studies.

Biography:

Amy Thompson is currently Sr. Director Supply Chain Management at Eidos Therapeutics, Inc. She has set up and maintains the Eidos supply chain for phase I, II, and III clinical studies, from drug substance to finished clinical product. Amy received her B.S. in biology and chemistry at Western Washington University. After working in the Bering Sea for the National Oceanic and Atmospheric Administration, has worked in the bio-pharmaceutical industry over the last 20 plus years. She has had a myriad of positions from chemical operator making pharmaceutical intermediates, to working in R&D labs, setting up GLP laboratories and GMP clinical biological manufacturing plants as Manager of Support Operations and Materials Management. Amy made her transition from biologic manufacturing into clinical supply management when joining Gilead Sciences, where she led a team of Clinical Supply Planners to support up to 7 programs over five therapeutic areas, including solid dose, inhalation and biologic products. During that time at Gilead Sciences, she was involved with clinical supplies management, collaborating with internal and external partners to ensure IMP is delivered to patients without delay, as well as involved in supporting and participating in multiple Regulatory agency inspections, both GMP and GCP. In 2018 Amy joined Eidos Therapeutics, Inc. where she has set up their supply chain management department to support CMC and Clinical Operations in furthering the clinical programs. Amy previously lived and worked in the Seattle area and has been in the San Francisco Bay Area for the last 7 years. Since moving to the Bay Area, in her limited spare time, she has been enjoying exploring the local area craft small scale wineries and distilleries. Ask her about her favorites.

Biography:

With over 30 years’ experience in Operational Excellence Phil has delivered diverse and varied projects across a vast array of organisation types around the globe including Pharma, healthcare, chemicals and power generation. As a certified management consultant Phil partners with clients to deliver “real life” strategic and operational solutions to develop their employees, improve efficiency and manage profits. A graduate of the university of Manchester and a Fellow of the Institute of Consulting Phil has acted as an assessor for the Institutes CMC scheme and is a former member of the examinations committee of the Institute of Asset Management whilst also holding a PG Certificate in Executive Coaching and Mentoring.

Biography:

Manav Gautam has a diverse background in the Pharmaceutical, Finance and Information Technology industries which fuels his passion for technology and leveraging it for clinical supply chain to enable the motto of delivering the Right Drug to the Right Patient at the Right Time. Manav is currently the Manager of Supply Chain Systems and Analytics for Eli Lilly and Company’s Clinical Systems and Supply Planning organization. Since joining Lilly in 2012, he has held various positions of increasing responsibilities spanning clinical trial supply management, demand planning, distribution, temperature excursion and IRT/RTSM supporting various technology solutions focused on improving patient/site experience and optimizing business operations. Prior to joining Lilly, Manav was an Information Technology consultant and has over a decade of experience in the clinical supply chain domain. Manav holds a B.E. in IT from Maharishi Dayanand University, India.

Biography:

Andrea is an Enterprise SaaS executive and investor focused on delivering the highest possible quality in Enterprise System strategy and implementations to the Pharmaceutical, Biotech, Medical Device and Clinical Supplies industries. Starting from a strategic assessment of a company’s business needs and opportunities, he advises on optimizing processes and implementing existing technology like ERP, LIMS Weighing & Dispensing, Business Intelligence for the Pharma and Biotech industries, and how to select and deploy emerging technology like AI, ML, RPA, etc.

Biography:

Ashish Honawar is an accomplished Business Intelligence, Data Strategy and Analytics Lead with extensive experience in identifying data analytics needs and helping clients gain insights into complex business problems. He has deep expertise in strategic planning, budget management and thought leadership while driving alignment across multiple cross functional stakeholders. He is a strategic business partner who has established strong working relationships with key stakeholders.

He has spearheaded several data visualization and data management projects to generate deep business insights and influence key business decisions. Adept at building and directing a team of technology experts and established cloud first architectures for analytical applications and data science teams. He has a strong history of sustaining and scaling business intelligence capabilities for an enterprise by aligning new technological capabilities and innovative concepts to answer relevant business questions.

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:

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:

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.

Biography:

Summer Doty is currently Director, Clinical Supply Chain at Gossamer Bio, responsible for end-to-end clinical supply management and oversight for the IBD and Oncology programs with additional CMC project management responsibilities. Summer joined Gossamer Bio in September 2018 with 19 years of global supply chain management experience in commercial and clinical supplies at Becton Dickinson Biosciences and Fisher Clinical Services. She has a BA in Chemistry from University of San Diego and is Certified in Production and Inventory Management (CPIM) through APICS.

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:

Lorna Briddick is an accomplished team leader with 19 years of experience in the leadership of business process management and large scale process improvement initiatives with the last 15 years focused on the clinical supply chain. She has successfully led numerous initiatives to re-engineer and optimize clinical supply chain end to end processes from design to implementation. Lorna joined the pharmaceutical industry as a consultant to Pfizer, where she led a corporate wide initiative to optimize 2000+ clinical supply chain procedures across 6 countries to 200+ global procedures. Lorna then joined Schering Plough to lead the optimization of the clinical supply chain, supporting 3 large workstreams that integrated processes across multiple business units. She also held the position of Global Clinical Supply Regional Lead for Latin America, serving as the key interface between the clinical supply team and the clinical operations teams in 9 countries, with responsibility for audit and qualification of depot partners.

Biography:

Mrs. Buchanan is currently the Associate Director of MRL Global Development Quality supporting Global Clinical Supplies at Merck & Co. Over the past twenty-five years, she has held commercial Quality and commercial packaging operational experience. While supporting Global Clinical Supply, she has worked in Global Clinical Supply as a program manager, Global Clinical Supply as Logistics Support and in Global Development Quality supporting release of Clinical Supplies and now supporting operations and technology.

Biography:

Sandra Cook, Ph.D., is a project management, strategy and training consultant with thirty years experience in the pharmaceutical industry. The past twenty have been focused on Investigational Products where she has held both line management and senior level project management roles facilitating high performing teams in the delivery of worldwide clinical supplies, including materials supporting key priority blockbuster products for large pharma.  Additionally, she has been instrumental in the design, development and implementation of several global process improvement projects for R&D Supply Chain.  An active contributor to the IP Metrics Task Team of the International Society of Pharmaceutical Engineering, Cook also manages the bi-annual Equal Partners in Clinical Supplies industry forum

Biography:

Eric enters his twentieth year in our industry as Head of Commercial Operations, Americas for Thermo Fisher Scientific in the Clinical Trial Division (CTD). He oversees supply chain services with both strategic and key accounts in delivering packaging, labeling, distribution, comparator drug and clinical supply chain management solutions.

He is responsible for driving commercial growth within three different customer segments across ten different territories. Guiding his company’s commercial team with a Differentiated Value Proposition strategy that utilizes consultative selling approaches while leveraging the strengths of Thermo Fisher Scientifics global network.

Eric has served as both an executive and board level member with the Global Clinical Supply Group, and has been a conference attendee for all twenty years of his career.

Biography:

Mr. Valery Ochollah is a Quality Assurance Manager based at Pfizer Inc. in Groton, Connecticut responsible for supporting Inspection Readiness activities within the Global Clinical Supplies group involved in clinical supply packaging, labeling, distribution and IRT system use. He has over 10 years of experience in the pharmaceutical industry in both the clinical GMP manufacturing operational areas as well as Clinical Supply Quality Assurance. His experience spans roles that include biologic manufacturing, packaging, inventory management, distribution and quality assurance. Prior to his roles in the pharmaceutical industry he held a role in a Hospital setting. He holds a bachelor’s degree in Business Administration from Southern New Hampshire University.

Biography:

Kate Carey is currently Director of Strategic Supply Solutions for Catalent Clinical Supply Services. She has been in Pharmaceutical industry for 15+ years. She has held multiple roles in clinical supplies project management and operations. Kate has responsibility to support Catalent’s innovative demand led supplies model (Pull model). She has worked with cross functional teams to evaluate how the late stage Pull model can transform the management of drug product to increase flexibility of supplies when sponsors are facing the complex and ever-changing environment of clinical supplies. Kate Carey will highlight the topics of how demand led/late stage packaging can • Add flexibility to clinical supply chains • Support patient specific requirements (such as weight-based dosing)

Biography:

Oliver Cunningham is the Vice President of Supplies Management at Signant Health, accountable for managing and growing Signant’s portfolio of randomization, trial supply management, forecasting, clinical supply chain and supply accountability solutions. Oliver leads a global team of product managers in designing and building industry leading clinical supply chain software.

Prior to joining Signant Health in 2017, Oliver spent 14 years at AstraZeneca, holding scientific and supply chain management positions. He is an expert in supply chain management and has held various roles in global planning, clinical supplies and leading early development technical teams. As the Clinical Supply Chain Optimization lead at AstraZeneca, Oliver was responsible for delivering clinical supply chains across all phases of development, including the Fulvestrant and Lynparza programs.

Oliver has a Masters in Chemistry with Industrial Chemistry from the University of Liverpool.

Biography:

Brian Keesee, Senior Vice President of PCI’s Clinical Trial Services Segment, has spent his entire career in the Pharmaceutical industry.

In his current role, Brian is responsible for Global Clinical Operations, Logistics, and Project Management for PCI’s Clinical Trial Services sites globally.

Prior to his role at PCI, he held leadership positions in Compliance, Operations Management, and Project Management within the pharma industry.

Brian has managed large global clinical studies and offers extensive experience and expertise in Supply Chain Management, Logistics, Clinical Package and Label design, Project Management, Cold Chain Technologies and IRT.

Brian brings a unique perspective based on his global project management knowledge from his prior positions within the Clinical Supplies Industry, his Compliance and Operations roles at AmerisourceBergen Drug Corporation, and his involvement in a Lean Six Sigma Black Belt Program.

He holds a Bachelor of Science in Business Administration from Missouri Western State University.

Biography:

Digital transformation global leader, strategizing and operationalizing digital value at scale.

Currently PCI Pharma Services Global Digital, Technology and Marketing Officer across North America, Europe, and Asia Pacific.

+20 years industry operating experience in global Managing Director and C-Level Executive positions across: Bio/Pharmaceuticals, Telecommunications, Contract Development & Manufacturing, Digital Product Design & Engineering, Enterprise Software and Management Consulting.

Also, Board Director of Christel House South Africa, and member of the Young Presidents Organization. Live in the US and previously have lived in South Africa, Switzerland, and UAE.

Harvard University and IMD Business School executive programmes. Honors Degree, Bachelor of Social Science, Industrial Sociology from the University of Cape Town, South Africa.

Biography:

Aaron Steinbrecher is a Clinical Supply Project Manager at AbbVie based in Lake County, IL. He has been with the Clinical Drug Supply Management group for 4 years. He previously worked in public heath, as a program coordinator for an HIV and Hepatitis C program at a federally-qualified community health center in Chicago. He graduated with a Bachelor’s Degree in Psychology and a double-minor in Spanish and Anthropology from the University of Illinois at Urbana-Champaign. He lives in Chicago with his fiancée, cat and dog. In his free time, he enjoys swimming, cycling and running (sometimes all together), and playing and recording music. He is excited to attend his first GCSG conference this year!

Biography:

Holly Bagley is committed to fostering the achievement of better patient outcomes with global clinical trials as a Global Account Manager at Ancillare headquartered in Horsham, PA. Her relentless focus on flexibility and scalability has benefited clinical trial teams to accelerate an effective and efficient modeling for Clinical Trial Ancillary Supply Chain (CTASC).

Proficient within strategic business development, she holds twenty years’ experience within supply chain, customized program implementation and LEAN initiatives to reduce delays with effective process improvement. Her ability to access and understand current to ideal landscape modeling provides her Sponsors with unique advantages.

She is a proud member of the Global Clinical Supplies Group and the Diversity Alliance for Science (DA4S), serving on their membership committee sharing her expertise to promote business and procurement practices within small/diverse business. While grateful for achieving various individual contributor and team recognition awards, her proudest accomplishment is being “Mom” to her ten-year old daughter.

Biography:

Patrick Newingham is a Senior Clinical Trial Supply Manager at Novavax. In his current role, he manages and oversees the clinical supplies function for all products, including the COVID-19 and variant strain vaccines. Prior to joining Novavax, Patrick worked on vaccine clinical product development at Astrazeneca (MedImmune) and at Chrion for over 10 years. He has worked in clinical supplies management at numerous other sponsor and vendor companies for over 19 years. Patrick received his Bachelor of Arts degree in Environmental Sciences at The Evergreen State College in Olympia, WA.

Biography:

Brianna Brooks is a Senior Project Manager at PCI Pharma Services. She has been with PCI as a project manager for 4 years. Brianna holds a Bachelor of Arts from Eastern Illinois University.

Biography:

Former professor, researcher, clinician, and registered nurse, Dr. Janet Lapp was born and raised in Québec, Canada; her PhD is from McGill University in Montreal. Over the past 25 years, she has inspired over 2,500 audiences around the world to adopt a mindset skilled in leading others through disruptive change. A licensed clinical psychologist and author of five books, she is founder of ChangeFit™ Leadership Labs, has been admitted to the Speakers Hall of Fame, and one year was rated by Toastmasters as one of the top three speakers worldwide. She is the creator and host of the Emmy-nominated CBS series ‘Keep Well,’ and has appeared regularly on INN, ABC, CNN, and NBC affiliates.

A pilot and flight instructor, Janet has flown throughout South America and Africa on medical and rescue missions. She is a long time volunteer with the Flying Doctors of Mercy in central México and the founder of the award-winning ‘Agua Limpia’, giving clean water access to the Sinaloa indigenous. She is a 2019 National AG Triathlon champion, competes in 70.3 Ironmen races, and currently lives in southern California

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:

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:

Levi Goner joined VAT IT ‘s North American Business Development team in early 2018. VAT IT is the global leader and service provider in tax reclaim and compliance. Levi’s initial focus was working with new VAT IT clients helping to solve and consult on their VAT recovery and compliance needs across a variety of industries. As Levi transitioned into a leadership role heading up the business development efforts in 2019, he leaned heavily on his entrepreneurial background to match the vast industry knowledge, expertise and experience within the group to help solve some of the critical problems and challenges clients were facing. With a strong passion for the pharmaceutical industry much of his efforts were poured into catering for the unique needs and requirements for VAT IT’s clients conducting global clinical trials. As a Senior Director in the USA Levi is the in-house specialist on all VAT matters that are pervasive with in the clinical supply chain.

Levi currently lives in Brooklyn with his wife and approximately 2.6 million other people.

Biography:

Sophia Sophos was appointed Managing Director of VAT IT North America in 2017; VAT IT is the global leader and service provider in tax reclaim and compliance. Sophia’s VAT IT career began in Australia overseeing the Australian/New Zealand markets but after a short time, she was transferred to New York following a key acquisition by the business. She now leads a dynamic team servicing the region, with special focus on delivering value to and maintaining executive relationships with VAT IT’s key global enterprise clients. Sophia forms part of a core specialist unit, focused on VAT reclamation and compliance for the pharmaceutical industry at VAT IT. Prior to VAT IT, Sophia spent her earlier career in the consulting space with notable time spent on developing and implementing strategy and governance initiatives. Sophia is a qualified actuary, having completed her studies in South Africa and Australia. She lives in New Jersey with her husband and very new baby boy.

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:

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:

Hi, I’m Sally Nardulli! I’m a Senior Clinical Supply Project Manager with AbbVie. I’ve been with AbbVie for 5 years and this is my second time attending the Global Clinical Supplies Group Conference. My past experience has been working in clinical settings as a Study Coordinator and as a Patient Care Technician. I hold a Bachelor’s Degree is Molecular and Cellular Biology from the University of Illinois at Urbana-Champaign and a Master’s Degree in Clinical Research Administration from Walden University. I’m a mom to 3 kids (ages 4, 6 and 8) and 2 fur babies (rescued 1 year old pit mix brothers). Outside of work, my hobbies include: traveling, scuba diving, and event planning. I look forward to connecting with you at this year’s GCSG conference!

Biography:

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.