Collection to commercialization: is standardization the bottleneck or breakthrough for cell and gene therapy

Dr. Don Fink is a Master Practice Expert-Regulatory with Dark Horse Consulting (DHC) Group providing support across multiple service areas including strategic regulatory that pertain to cell and gene therapies (CGT) and tissue engineering products. Since joining DHC in 2021, Don has worked with over 100 clients engaged in developing CGT products from initial FDA interactions (INTERACT and pre-IND meetings) through IND, biologics license application (BLA) and post-approval activities. Prior to DHC, Don was an expert Chemistry, Manufacturing and Control (CMC) reviewer in the current FDA Office of Therapeutic Products accumulating over 20-years of experience principally in the cell therapy space.

Kurtis Carlisle is a biotech supply chain leader with nearly two decades of experience guiding teams and building global networks to bring therapies to patients. He currently serves as Vice President of Supply Chain at Cabaletta Bio, where he oversees end-to-end supply chain strategy, vendor partnerships, and patient operations to support autologous cell therapy programs in clinical development. Since 2021, Kurtis has been deeply engaged in the cell therapy industry, leading supply chain and external manufacturing functions that enable patient-specific therapies to advance through clinical trials and toward commercialization. Throughout his career, Kurtis has held senior leadership roles at companies including TCR² Therapeutics, Viela Bio and AstraZeneca, where he built and led supply chain organizations that supported everything from first-in-human trials to global commercial launches. His expertise spans demand and supply planning, global distribution, cGMP operations, and organizational development, with a consistent focus on creating scalable systems and teams that enable innovation.

𝗠𝗮𝘆𝗼 𝗩𝗲𝗻𝘁𝘂𝗿𝗲 𝗣𝗮𝗿𝘁𝗻𝗲𝗿 | 𝗕𝗶𝗼𝘁𝗲𝗰𝗵 𝗕𝘂𝗶𝗹𝗱𝗲𝗿 | 𝗖𝗮𝗽𝗶𝘁𝗮𝗹 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝘀𝘁 | 𝗦𝗰𝗮𝗹𝗶𝗻𝗴 𝗜𝗱𝗲𝗮𝘀 𝗧𝗵𝗮𝘁 𝗜𝗺𝗽𝗿𝗼𝘃𝗲 𝗢𝘂𝘁𝗰𝗼𝗺𝗲𝘀
Audrey Greenberg turns moonshot ideas into market-shaping companies, and builds the teams, capital, and strategy to scale them. She is an award-winning biotech executive and company builder with a proven track record of scaling businesses at the intersection of science, capital, and impact. Audrey specializes in launching high-growth startups through capital formation, strategic partnerships, differentiated positioning, and top-tier team development. Her portfolio includes several multi-billion-dollar companies, and her experience spans C-suite roles across strategy, finance, operations, and commercialization. Audrey currently serves as a Mayo Venture Partner where she leads enterprise-wide efforts in venture creation, strategic capital markets, institutional spinouts, and the commercialization of transformative science and care delivery models. She works across the Mayo ecosystem to build and scale the next generation of healthcare companies - from therapeutics and diagnostics to enabling platforms and digital health. She serves on multiple boards and is active in industry organizations focused on women’s leadership, healthcare innovation, and public-private collaboration. Previously, Audrey was Global Head of SK pharmteco and Co-Founder and Chief Business Officer of the Center for Breakthrough Medicines (CBM), where she raised over $500 million and led the company through its acquisition by SK Group. Prior to CBM, she spent two decades as a private equity executive, investment banker, and CPA, with deep domain expertise in M&A, corporate finance, and life sciences investing. She holds an MBA from the Wharton School and is a registered CPA in Illinois. Audrey has been recognized with honors including the Medicine Maker Power List (2x), Titan 100 (3x), Titan Hall of Fame, Philly Power 100, Most Influential Philadelphian, Women of Influence, Leader of the Year, and Healthcare Power Player. Under her leadership, her companies received accolades including Startup of the Year, DEI Initiative of the Year, Tech Translator of the Year, Deal of the Year (2x), and Employer of the Year.

𝘼𝙪𝙙𝙧𝙚𝙮’𝙨 𝙣𝙤𝙧𝙩𝙝 𝙨𝙩𝙖𝙧: 𝙗𝙪𝙞𝙡𝙙𝙞𝙣𝙜 𝙫𝙚𝙣𝙩𝙪𝙧𝙚𝙨 𝙩𝙝𝙖𝙩 𝙩𝙧𝙖𝙣𝙨𝙛𝙤𝙧𝙢 𝙘𝙖𝙧𝙚, 𝙚𝙡𝙚𝙫𝙖𝙩𝙚 𝙚𝙭𝙥𝙚𝙧𝙞𝙚𝙣𝙘𝙚, 𝙖𝙣𝙙 𝙨𝙘𝙖𝙡𝙚 𝙬𝙝𝙖𝙩 𝙢𝙖𝙩𝙩𝙚𝙧𝙨.

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), 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, with a specialization 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.