Early decisions can either accelerate or undermine the success of advanced therapy programs. From product conception through clinical and commercial scale, proactive planning is essential, especially for programs reliant on cryopreservation and complex manufacturing workflows. This webinar explores how early supply chain strategy decisions can help advanced therapy companies reduce regulatory risk, improve scalability and prepare for key development milestones.
This one-hour roundtable discussion will focus on how early-stage companies can build regulatory readiness from day one by aligning development strategy and supply chain considerations well before pivotal milestones. The featured speakers will explore key challenges and best practices to support success as programs evolve from preclinical development to clinical trials and beyond.
The webinar brings together regulatory and operational perspectives on the decisions that shape long-term program success, including shipping lanes, cryopreservation planning and manufacturing workflow considerations. Attendees will gain practical insights into common regulatory pitfalls and how early decisions around shipping lanes and cryopreservation can impact scalability.
Register for this webinar to learn how supply chain strategy can help advanced therapy programs build regulatory readiness, improve scalability and reduce downstream risk.
Speakers
Lorraine Hicks, Supply Chain & Clinical Logistics Expert / Cell & Gene Therapy Specialist
Lorraine Hicks is a Supply Chain and Clinical Logistics professional with more than 15 years of experience in the pharmaceutical and life sciences industries, specializing in the clinical logistics challenges of cell and gene therapy programs. Her experience spans early-stage clinical development through commercial-scale planning, with hands-on roles at both sponsor companies and CDMOs.
Most recently, Lorraine led Supply Chain and Clinical Logistics Operations at Triumvira Immunologics, where she was responsible for the end-to-end movement of time- and temperature-sensitive biological materials supporting active clinical trials. Previously, she directed Supply Chain and Cold Chain Operations at KBI Biopharma, overseeing logistics strategy, procurement and vendor management across a multi-client development and manufacturing environment. Earlier in her career, she managed Clinical Trial Logistics at Opexa Therapeutics, supporting more than 30 trial sites across the US and Canada.
Lorraine holds Dangerous Goods certifications (49 CFR, IATA and ICAO) and has deep expertise across DOT, FDA, ISO and IATA regulatory frameworks governing the transport of biologics, with particular emphasis on chain-of-custody and cold-chain requirements for cell-based therapies.
Now an Independent Consultant, Lorraine partners with cell and gene therapy sponsors, academic medical centers and CDMOs to design clinical logistics programs that are regulatory-ready, operationally sound and scalable from first-in-human studies through commercialization.
Message Presenter
Dominic Clarke, PhD, Associate Chief Scientific Officer, Cryoport, Inc. / Vice President - Technical Operations, Integricell®, Cryoport Systems
Dominic Clarke is a recognized authority in the Cell and Gene Therapy (CGT) industry, bringing over 20 years of leadership and innovation to the field. As Vice President of Technical Operations at IntegriCell, Cryoport, he oversees technical development, MSAT and operational services, driving forward the company’s mission to advance cell therapy manufacturing and delivery.
Throughout his career, Dominic has held key executive roles at leading biotech organizations including HemaCare (Charles River Laboratories), the Charter Medical and BioLife Solutions. His deep technical knowledge and strategic insight have consistently delivered operational excellence, enhanced visibility and commercial growth. Dominic earned his PhD in Cell and Molecular Biology from the State University of New York, specializing in Cryopreservation and Low-Temperature Biology, followed by postdoctoral research in Developmental Biology at Syracuse Upstate Medical University.
A long-standing contributor to the CGT community, Dominic has served for over 15 years on the International Society for Cell & Gene Therapy (ISCT) Process Development and Manufacturing Committee, where he currently leads as Chair, helping shape global standards and best practices in advanced therapy manufacturing.
Message Presenter
Gwendolyn Erskine, Senior Director – Consulting Services, Cryoport Systems
Gwendolyn Erskine is a senior industry leader with more than 20 years of experience in the life sciences and supply chain logistics space, bringing extensive experience from her work at Cryoport Systems, a global leader in temperature-controlled supply chain solutions supporting advanced therapies. Based in College Grove, Tennessee, she is known for connecting scientific innovation with operational excellence across complex, highly regulated environments.
Gwendolyn holds a Bachelor of Science from Penn State University, reflecting an early foundation in applied sciences. Her career spans pharmaceutical research, clinical operations, consulting services and global cold-chain logistics, giving her a unique ability to bridge scientific rigor with real-world execution.
Recognized for her collaborative leadership style and deep industry knowledge, Gwendolyn frequently works at the intersection of science and business, helping teams and partners navigate the evolving demands of advanced therapies and global distribution networks. She is particularly passionate about building strong cross-functional partnerships, driving process improvements and delivering client-focused solutions that support the future of advanced therapies.
Message PresenterWho Should Attend?
This session is particularly valuable for early‑stage and growth‑stage cell and gene therapy teams making decisions that will impact regulatory success, including those in roles such as:
- Supply Chain, Logistics or Operations
- Quality Assurance, Compliance or Regulatory Affairs
- MSAT, CMC, PD or R&D
- Preclinical Discovery
- Clinical Trial Management
- Clinical to Commercial Scale-Up
- Consulting, Contract Research or Manufacturing
- Vendor Supply Chain Management
What You Will Learn
Attendees will gain insight into:
- How early regulatory and technical decisions shape long term success and why readiness must begin well before clinical milestones
- Why cryopreservation should be treated as a strategic regulatory decision, not simply a logistics or operational consideration
- How to stage development intentionally to balance phase appropriate rigor with future regulatory and commercial expectations
- The importance of cross‑functional alignment and experience in making defensible early decisions across regulatory and supply chain operations
Xtalks Partner
Cryoport Systems
Cryoport Systems is a market leader in globally integrated temperature-controlled supply chain support for critical, irreplaceable products and materials in the Life Sciences industry. We are already trusted to support over 650 active clinical trials and leading commercial products worldwide, delivering unparalleled, integrated supply chain services for products, therapies and treatments requiring unique, specialized temperature-controlled management. And, as the Life Sciences constantly evolve and advance, so do we.
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