Speakers
See the whole list of speakers!
Steven Jacobs
Global BioPharm Solutions
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.
Rob Pizzie
Brizzey
Rob has over 39 years 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 subsequently held roles of increasing responsibility with Pharmacia & Upjohn, Pharmacia, Pfizer, Schering Plough and Merck.
During his career Rob led large clinical supply chain organizations through six mergers while maintaining business continuity.
In 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, Quality Assurance, R&D change management & process optimization.
Jp Kappelle
4G Clinical
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.
Naomi Wilmer
Thermo Fisher Scientific
Naomi currently holds the position of QA Manager & QP supervising the Client liaison and Auditing functions at Thermo Fisher Scientific Horsham.
She has in depth experience of Clinical Packaging and Distribution of Investigational Medicinal Products (IMPs).
Naomi qualified as a Qualified Person (QP) in September 2019 and has been supporting the site in various roles including clinical project management for over 13 years.
She holds a Bachelor’s degree in Medical Biochemistry and a post graduate diploma in Pharmaceutical studies. She is a full charted member of the Royal Society of Biology.
Rima Darwiche
CPL Australia
Registered Pharmacist who has worked across all phases of Clinical Research in sponsor and industry driven trials. Rima has extensive experience in the Pharmaceutical Industry since 2005 in clinical trials, and marketing within regulatory and ethical guidelines. Rima has implemented clinical studies requirements in collaboration with Pharmaceutical companies according to GCP, ICH guidelines and TGA/FDA requirements. Prior to working in the Pharmaceutical industry, Rima was in medical research for approximately 8 years, with over 20 journal publications in high impact journals. Currently, Rima is the CEO and founder of Central Pharmacy Logistics Australia which is a licensed 'Direct to Patient' Clinical Trials solutions service, supporting the decentralised model of Clinical Trials. Rima also sits on a number of clinical trial advisory committees and Strategy steering committees globally & locally.
Casey Ferrier
4G Clinical
Casey comes to 4G with 14+ years of experience in the Clinical Trial supply industry. Casey has implemented and led supply chain strategies to deliver solutions which support both packaging, distribution and logistics requirements for clinical trials for Pharma, Biotech and CRO organizations.
Beth Gardner
Beam Therapeutics
Beth Gardner is Senior Director, Patient Supply at Beam Therapeutics (apheresis operations, autologous patient operations, and allogeneic clinical supplies). I bring over 25 years of global pharma/biotech experience. My passion for helping people with unmet medical needs began when I was diagnosed with a chronic disease as a child. Now a bionic woman with technology to dose medication, I bring my passion and compassion for patients to Beam.
Prior to Beam, I pivoted from large and small molecule clinical supplies at Pfizer and Takeda to joining bluebird bio. There, I supported the development and commercialization of SkysonaTM and ZyntegloTM cell and gene therapies.
Beyond Beam, I am energized to create new industry standards: Apheresis Label for Further Manufacturing standards (ISBT-128 ST-018), Chain of Identity standards (ISBT-128 ST-028) and is a standing member of ICCBBA’s Cellular Therapy Coding and Labeling Advisory Group (CTCLAG).
Outside the office, you will find me with my husband raising three sons (who like to reminder me that even at 6’2”, I will soon be the shortest in her family), maintaining my sanity with Peloton rides, and despite now residing in Boston – remaining a lifelong Chicago Cubs fan!
My educational background includes: EMBA from Quantic School of Business and Technology; Executive Education certification from Massachusetts Institute of Technology (MIT), Sloan School of Management; Bachelor of Science from the University of Illinois.
Trish Demko
Catalent
Over 15 years of experience in Case Management facilitating bone marrow and stem cell transplant coordination across a global network, overseeing team productivity, quality, and maintaining excellence in customer service. Throughout the course of my career I have acquired much leadership experience, relationship management, program and project management experience including Lean Six Sigma Green Belt certification. Currently working at Catalent, I am working to build and launch a patient first focused supply chain offering to support cell and gene therapy customers.
Scott Ohanesian
QuickSTAT
Scott Ohanesian has held executive roles over the past 19 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 the 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.
Scott co-leads the Cell and Gene Therapy Education Team for the Global Clinical Supplies Group.
Eric Deschamps
Thermo Fisher Scientific
Eric is the Sr. Director of Pharma Services Integration for PSG / Thermo Fisher Scientific. He has 20+ years of clinical supply chain experience and is currently managing an end-to-end drug development solution offering to new & emerging, mid-tier, large pharma, and biotech drug development companies. Over the years Eric has led business teams at Clintrak Clinical Labeling, Acculogix and Clintrak Pharmaceutical Services. He is an 83’ graduate of St. John’s University’s School of Business where he captained the schools NCAA Ice Hockey team his Jr. and Sr. year. A former GCSG Executive Member and Board Member, Eric has facilitated several GCSG US and European based workshops over the past several years.
Sashin Bhuta
Bristol-Myers Squibb
Sash has 22 years of clinical supply experience supporting packaging and labeling operations, global scheduling, forecasting, planning, IVRS, randomization and drug supply management. He also has 10 years of experience in developing drug supply processes to support Early Access Programs (EAP) and Investigator Sponsored Trials (IST/IIT). Sash currently holds the title of Director, Clinical Supply Program Lead in the Clinical Supply Chain group at Bristol-Myers Squibb.
Sash obtained his Bachelors of Science from Philadelphia College of Pharmacy and his MBA from Drexel University.
R Lonie Scott
PCI Pharma Services
Executive leader with 20+ years success developing strategic partnerships and growing organizations through creation of innovative & scaleable business solutions that can be easily monetized. I am passionate about examining and discussing behaviors and actions that improve DE&I as a catalyst to organizational growth.
Rizwana Seeham
Blueprint Medicines
Rizwana is a female, Muslim, bi-racial immigrant who strongly believes equity, diversity, and inclusion are critical elements of personal lives and work environments. With this passion, Rizwana brings perspective to Blueprint Medicines’ highly engaged and rapidly evolving culture and business model, ensuring Black, Indigenous, and People of Color (BIPOC) and other historically marginalized voices are consistently elevated. Rizwana earned her Bachelors in Neuroscience from Boston University and her Masters in Pharmaceutical Sciences with a specialization in Regulatory Affairs from George Washington University. Diverging from her educational background and flexing her lived experiences, Rizwana now sits as the Associate Director of ED&I at Blueprint Medicines where she manages the organization’s global ED&I strategy, tactics, and programs, chairs the ED&I Committee, and serves as an advisor to leaders and employees.
Barbara Campbell
PPD, a division of Thermo Fisher Scientific
Sue Lee
Hexagon Supply Chain
Healthcare Supply Chain professional with extensive experience shipping clinical and specialty commercial drug, and clinical samples with particular interests in patient centric healthcare. With over 25 years of GxP process development and application, utilising risk management and logistics planning with business experience. Member of the GCSG Cell and Gene Therapy E Team.
Paul Ingram
Tata Consultancy Services
During my 25-year career, my work has focused on pharmaceutical research and development and medical devices. With over 15 years of experience in clinical supplies, working in both Phase 1 unit manufacturing suites and trial supplies service companies, including Quintiles (later Aptuit), Fisher Clinical and Catalent. In 2021 I joined TCS as an Industry Leader and support the digitalization of clinical supply chains to drive and improve patient centric and decentralised trials focused on dose adherence with smart packaging, digital labels on smart devices and end to end kit tracking all the way to patient using apps and web portal based access via the TSC-ADD Platform. I obtained my doctorate in pharmaceutical development from Strathclyde University in Glasgow, U.K.
Kevin Shea
ThermoFisher Scientific
Kevin began his career at Fisher Clinical Services in May 2004 in the Manufacturing Division and was directly involved with label production. He transitioned to the Project Management Department where he worked closely with clients to offer a consultative approach to completion of jobs from protocol interpretation to label production. Throughout his tenure, Kevin has developed a broad knowledge of clinical supplies while enhancing clinical label production from just label printing to overall clinical label services. Over the past few years, Kevin has been an integral part in the development of translation and regulatory solutions for clinical trial labels with Clintrak’s industry leading ATLAS Translation Management System.
Kevin provides customer support including client and site visits, quarterly meetings, trade meetings, demonstrations, seminars and industry lead discussion groups. He works closely with Clintrak specialists to develop customized solutions to meet client’s unique needs while also being on the forefront of new services for Clintrak and the industry as a whole.
Kevin received his Bachelor of Arts degree from Hobart College in the year 2000. Kevin currently resides in Medford, NY with his wife and two children.
Caitlin Bowne
Alkermes
Caitlin Bowne is Director of Clinical Supply Chain, Oncology and Biologics at Alkermes Inc.
Caitlin has over 15 years of industry experience spanning across Rare Disease, Oncology and Central Nervous System disorders. She has held roles in Quality, Technical Operations, Manufacturing, Clinical and Commercial Supply Chain including Packaging and Label Development, Comparator Sourcing, Distribution and Logistics (including Import/Export requirements).
Caitlin graduated with a Bachelor of Science in Meteorology with a minor in Mathematics from Plymouth State University. While her career path has not involved forecasting the weather, it has led to forecasting vital medications for patients around the world and she wouldn’t have it any other way.
Sylvain Berthelot
Calyx
Sylvain has acquired extensive experience in IRT and Clinical Supplies through various roles within Calyx over his 12+ years in the company. It allows him to grasp where IRT can make a difference based on the protocol design, and accordingly advise clinical trial teams what solution is the most suitable for each trial. Sylvain is a key member of the Calyx IRT product core team, acting as an advocate for end-users, as well as sharing his vision with the team to push the boundaries of IRT.
Tris Evans
PCI Clinical Services
Experienced pharmaceutical professional with 20 years experience within quality roles for both commercial and investigational medicinal product manufacturers and service providers.
Vice President, Global Quality - Clinical Services for PCI Clinical Services with responsibility for clinical quality activities across PCIs global operational facilities; EU Qualified Person (QP) qualifying under the permanent provisions in 2011, named on both investigational and commercial manufacturing import licences at PCIs UK and Ireland facilities.
Michelle Friedman
Beacon BioPharm Associates LLC
Lyn Mcneill
Almac Group
Lyn McNeill is the Just-In-Time Manufacturing Solutions Manager at Almac Clinical Services. Based in Northern Ireland, Lyn is responsible for service implementation, stakeholder engagement and strategic development of Almac's Just-In-Time service suite which includes; Just-in-Time Manufacturing (Almac Adapt ™), Just-in-Time Labelling and Lean Manufacturing. As Business Process Owner, Lyn works across Departments to ensure Almac have a commercially compelling offering, are sustainable and fit coherently within Almac’s overall supply chain solutions portfolio.
Lyn joined Almac in 2016 as an IRT Project Manager. She then transitioned to Clinical Services to the role of Business Projects Manager where she headed complex strategic projects before commencing her current role as Just-In-Time Manufacturing Solutions Manager during 2021.
Lyn graduated from Queen’s University Belfast, Northern Ireland with a Bachelor of Sciences degree in Business Administration and Management and is a PRINCE 2 Project Management Practitioner.
Frances Smith
Almac Clinical Services
Frances Smith is a Regulatory Compliance Manager at Almac Clinical Services in Souderton, Pennsylvania. She has 20 years of experience in clinical supplies packaging and distribution through various roles in Project Management, Operations and Quality Assurance. In her current role with Almac, Frances is responsible for monitoring global pharmaceutical regulations and facilitating the assessment and application of those regulations at Almac. Frances holds a Master's degree in Regulatory Affairs and Quality Assurance from Temple University in Philadelphia, PA.
Lizbeth Sherman
Loxo Oncology @ Lilly
Liz Sherman is currently Associate Director of Clinical Supply Management at Loxo Oncology at Lilly. In her current role, Liz provides management oversight and technical leadership to a group of professionals accountable for supply chain forecasting, planning, and clinical trial material packaging, labeling, and distribution for the oncology portfolio. She has over 20 years of pharmaceutical industry experience spanning many functions in development operations, including formulation development, clinical manufacturing, packaging and labeling quality assurance, and procurement.
Henk Dieteren
Suvoda / The Clinical Supply Chain Management B.V.
As Clinical Supply Chain Solutions Consultant, Henk has been assisting Suvoda with his knowledge in various areas of clinical trial supply management since October 2020. Prior to joining Suvoda, Henk co-founded the clinical supply chain department at Grünenthal GmbH (Aachen - Germany) and served as Associate Director of this department for 10 years. At Grünenthal, Henk developed operational processes and promoted risk management procedures to establish the company as a clear market leader in the area of the clinical trial supply chain.
Following his time at Grünenthal, Henk moved to BioNTech S.E. (Mainz - Germany) where he assumed the role of Senior Investigational Medicinal Product Manager. At BioNTech, he streamlined data processing in the clinical supply chain for personalized oncology therapies.
Henk is an innovative expert in IRT, temperature excursion management and direct-to-patient logistics and a member of the DtP sub-team of the GCSG Regulatory e-Team.
Lisa Palla Tavolaro
Thermo Fisher Scientific
I have more than 21 years of experience in multinational companies working on commercial leadership and business development for clinical research and development of new drugs and treatments. Proud to be leader of different committees in order to develop logistics for pharmaceutical products, clinical trials and women development in Latin America.
I am passionate for Clinical Trials, including Protocol Development, Regulatory Affairs, Quality, Imports & Exports, Clinical Site Monitoring, Supply Chain management, Procurement and Commercial fields.
From the past 8 years I am dedicated to sales inside Thermo Fisher Scientific, enabling customers to develop their clinical trials around the world and inside Latin America and faster and with quality. I am brazilian, Portuguese is my mother tongue and also I am able to communicate in Spanish and English. Looking forward to meet GCSG colleagues in May!
Sajaylis Curry
MacroGenics
Sajaylis has been in the pharmaceutical industry for 10 years. From IRT Support and Project Management to further developing in Clinical Supplies Management. She is now an Associate Director of Clinical Supplies at MacroGenics, a Biopharmaceutical focused on Oncology.
Rhys Evans
RxSource
Rhys Evans is Senior Director - CTS & Global Supply at RxSource, responsible for commercial strategy and growth across the business. Rhys, and his team, are accountable for delivering excellence when it comes to RxSource's core services: sourcing, packaging and depot services. Rhys has previously worked for a global comparator sourcing organisation and a major CDMO. He has a background in Physiology and Pharmacology and completed his PhD in Respiratory Pharmacology at Cardiff University.
Craig Duffy
Moderna
I’m currently a Director on the Clinical Supplies team at Moderna, with primary responsibilities overseeing our Covid program. I have been in supply chain for the past 16 years, 12 of which have been within the pharma industry. I have a particular interest in all-things-inspection-readiness and enjoy sharing my knowledge on the topic with others. Outside of work I live in the greater Boston area with my wife, two young boys and Golden Retriever.
Tanya Momtahen
Thermo Fisher Scientific
Tanya Momtahen is vice president of integrated product
solutions at Thermo Fisher Scientific. She is accountable to lead
a service-oriented group and bring customers the benefit from a
broader Thermo Fisher partnership. Tanya and her team drive the
Thermo Fisher product development partnership model and oversee
and meaningfully address key challenges in product development,
from discovery to clinical and commercialization. Tanya joined
PPD, a part of Thermo Fisher in the beginning of 2019 and has held
several roles including vice president, global partnership solutions.
Previously Tanya was vice president, global scientific and clinical
procurement, at Sanofi since 2014, where she was responsible for
outsourcing across pharmacovigilance, regulatory, medical, clinical
and research in R&D, the chief medical office and those markets for
Sanofi Group worldwide. She led an international procurement team
focused on improving strategic partnerships and new approaches
in outsourcing and contracting.
For 15 years, Tanya lead the strategy and execution of R&D products
at Sanofi, She was vice president, anti-IL-6R global project head in
the immunology and inflammation area and led that project – which was
co-developed with Regeneron. Over her time in Sanofi R&D, she held
several leadership positions, including vice president, development
and realization for the previous fibrosis and wound repair therapeutic
strategic unit, where she led a team of development product leaders
focused on bring research projects to proof of concept; and vice
president of metabolism project direction, where she focused on
driving products through development in areas of obesity, T2D,
NASH and CV programs. Tanya joined Sanofi as a project director in
oncology and lead two phase three programs in NSCLC and head
and neck cancer.
Prior to Sanofi, Tanya was a project leader at Glaxo Wellcome,
now GSK, working in oncology and respiratory therapy areas.
She has experience from research to marketed products and has lead
several product successfully to commercialization. She started her
career in medicinal chemistry in research at both Glaxo and Rhone
Poulenc Rorer. She holds a master’s degree in organic chemistry from
Villanova University.
Terry Iacobucci
Morphic Therapeutics
Ms. Iacobucci has worked in the pharmaceutical industry in Clinical Supplies for the past 10 years. In her current position at GSK, she manages clinical supplies for the TESARO legacy portfolio including global oncology expanded access program and multiple Investigator Sponsored Trials. At Bayer and Sanofi, she managed clinical supplies for Phase I studies and Investigator Sponsored Trials in oncology, endocrinology and cardiovascular.. Prior to her career in the pharmaceutical industry, Terry was a Professional Chemical Engineer with the Philadelphia Water Department.
Gretchen Randlett
Eli Lilly and Company
Gretchen Randlett is Eli Lilly’s Expanded Access and Contiued Access Supply Stategy Senior Director. Her responsibility is to be the primary interface between clinical, medical, clinical trials organization and commercial, to support Expand Access programs and requests. As part of her role, she is responsible for designing Lilly’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 20 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 She is the Chair of the Global Clinical Supplies Group Expanded Access Resource Committee and a member of the Managed Access Industry Forum. In her spare time she enjoys gardening, hiking, kayaking, riding horses and volunteering in her community.
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