Pharma Intelligence is part of the Business Intelligence Division of Informa PLC
This is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.
Keynote & Panel Discussion
Watch Now
Biotechnology companies are investing significantly in gene therapy, resulting in a dramatic increase in approved therapies for patients. However, manufacturing capabilities must keep up as these therapies evolve. This session will begin with an overarching view of the market, followed by a panel discussion on the trends in gene therapy manufacturing that can help bring therapies to the clinic and market effectively.
You will learn:
Moderated By:
Ly Nguyen-Jatkoe
Executive Director, Custom Intelligence & Analytics, Americas
Informa Pharma Intelligence
As head of the Custom Intelligence team for the Americas and lead for cell and gene therapy thought leadership at Informa, Ly partners with clients to develop personalized solutions using Informa’s suite of pharma data and insights. She has 20+ years of experience in the healthcare and pharmaceutical industry and extensive experience in market research and analysis.
Jan ter Meulen
Chief Scientific Officer
Obsidian Therapeutics
Dr. ter Meulen is Obsidian's Chief Scientific Officer. A veteran researcher in pharmaceutical, biotechnology and academic settings, Dr. ter Meulen brings more than 25 years of operational and strategic research experience to Obsidian. Previously, as Chief Scientific Officer of Immune Design, Seattle, he was responsible for devising and communicating the immuno-oncology research strategy of the company, building its pipeline, and participating in the IPO and later sale of Immune Design to Merck & Co. in 2019. Before Immune Design, Dr. ter Meulen was Head of Vaccine Basic Research at Merck Research Laboratories, where he had operational responsibility for the entire vaccine discovery pipeline, and before, Head of Antibody discovery at Crucell N.V., Leiden, The Netherlands. He has held appointments at the German Cancer Research Center, Heidelberg, the Bernhard Nocht Institute of Tropical Medicine, Hamburg, and the Institute of Virology at the Philipps-University, Marburg, Germany. Dr. ter Meulen was an International Scholar of the Howard Hughes Medical Research Institute, and a consultant for scientific agencies in the US, UK, Germany, France, South Africa and for the European Commission.
Tim Kelly
Chief Operating Officer
Homology Medicines
Tim Kelly brings more than 20 years of global product development and manufacturing experience to Homology encompassing preclinical to commercialization with a focus on rare disease therapies and biologics. He joined Homology from Sarepta Therapeutics, where he served as Head of Technical Operations and was responsible for the process development and manufacturing strategy for Sarepta’s gene therapy programs, and the development, commercialization and scale-up of novel RNA-based chemical therapies. Prior, Mr. Kelly spent eight years at Shire, most recently as Senior Vice President and Head of Biologics Operating Unit, where he was responsible for technical operations for all clinical and commercial biologics and gene therapy products, including internal and external manufacturing. At Shire, Mr. Kelly also served as Interim Head of Technical Operations, Head of Product Strategy & Planning, Head of Global External Operations and Head of Global Supply Chain. He was previously the Head of Technical Operations at UCB in Belgium, with direct management of operations in Belgium, Switzerland, the United Kingdom, Germany, Ireland, Japan and India. Mr. Kelly also held roles of increasing responsibility at Biogen Idec, including Senior Director of International Operations. Mr. Kelly holds a B.S. with emphasis in Engineering Mechanics from the United States Air Force Academy and an M.B.A. from Troy University.
Dennis Huang
Chief Technical Operations Officer
Ultragenyx
Mr. Huang joined Ultragenyx in May 2015 and is responsible for leading the technical and pharmaceutical development, manufacturing and supply chain functions. Prior to joining Ultragenyx, Mr. Huang was Senior Vice President of Manufacturing and Supply Chain for InterMune Inc., where he led the global manufacturing organization and supply chain activities for the company. Prior to InterMune, he served as Vice President of Biologics Manufacturing and Development for Allergan, Inc. Earlier in his career, Mr. Huang held positions at Novartis AG (formerly Chiron, Inc), Genentech, Inc., and Synergen, where he worked in manufacturing, quality and process development. Mr. Huang serves on the Board of Directors of CytoDel and the Technical Advisory Board of Solid Biosciences. Mr. Huang earned a B.A. in chemistry from Knox College.
Keynote
Watch Now
As gene therapy clinical trials progress to later phases and approach regulatory approval, developers must demonstrate sufficient capabilities, both in their facilities and partnerships, to scale their manufacturing operations appropriately. In this session, the challenges of scalability to meet increased demand will be discussed.
You will learn:
Ingrid Markovic, PhD
Senior Science Advisor, Office of the Center Director
FDA
Ingrid Markovic, Ph.D. is Senior Science Advisor in the CBER/FDA Immediate Office of the Center Director. She leads CMC Policy efforts partnering with internal and external stakeholders to ensure consistent interpretation and application of CMC policies and programs. In the international arena, Ingrid is/was ICH Quality Lead for CBER, and additionally, FDA topic co-lead for QDG, Q12 and M4Q. She had an opportunity to briefly serve as Q3E Rapporteur. Ingrid previously worked in the industry sector as Senior Director leading US & EU CMC Regulatory Policy efforts focusing on Technological Innovation and Cell & Gene Therapies. She collaborated with Trade Associations (PhRMA & BIO) supporting continual improvement and innovation in the Biopharmaceutical sector.
Panel Discussion
Watch Now
In this roundtable, we will explore the significant challenges and opportunities posed by gene therapy production and how a CDMO partner may be uniquely positioned to assist innovators in navigating this landscape. We will explore the path to robust industrialization of viral vector manufacturing and the key considerations for scaling up to meet patient populations.
Panel Discussion Participants
Moderated By:
Lucie Ellis
Managing Editor, In Vivo
Informa Pharma Intelligence
Lucie Ellis has been covering the ups and downs of the pharmaceutical industry since joining the Informa Pharma Intelligence team in 2012. Prior to being Managing Editor of In Vivo, Lucie was a Senior Editor at Scrip and Pink Sheet. She is responsible for the production of In Vivo’s print and online editions and also contributes feature-length articles to the publication on the topics of leadership, R&D, innovation and more.
Henry George
Head of R&D - Viral Vector Producer Cell Lines
MilliporeSigma
Henry (Hank) George is the Head of R&D for Viral Vector Producer Cell Lines at MilliporeSigma. His team has recently developed a novel suspension cell-based platform for scale up r-lentiviral vector manufacturing. For over four decades, Henry has developed recombinant protein expression systems in bacterial, insect, and mammalian hosts within the biotech & pharma sectors. Henry received his B.A. in Biology from Southern Illinois University at Edwardsville, and performed graduate work in Genetics and Biochemistry at Florida State University and St. Louis University respectively.
Dr. Lisa Freeman-Cook
Head of Technical Operations for Viral and Gene Therapy Manufacturing
MilliporeSigma
Dr. Lisa Freeman-Cook is Interim Site Head as well as the Head of Technical Operations for Viral and Gene Therapy Manufacturing at MilliporeSigma’s Carlsbad, CA site, where she leads process development, tech transfer, failure investigation, and validation. Previously, she worked in biotech and medical device industries leading R&D, contract services, assay development, and technical operations. Lisa received her BA in Biology from Carleton College, her PhD in Molecular Biology from the University of Colorado Boulder, and she completed a Postdoctoral Fellowship in Virology at Yale University.
Kevin Lynch
Head of Manufacturing
MilliporeSigma
Kevin Lynch is currently the Head of Manufacturing for the MilliporeSigma Viral Vector contract manufacturing facility in Carlsbad CA, where he leads a manufacturing organization responsible for production of Viral and Gene therapies for some of the most innovative therapies in the clinic and on the market today. Kevin has over 30 years of experience in Biologic Life Sciences. He began his career working on Enzyme Replacement Therapies and Regenerative Medicines at Genzyme, TKT and Shire including Technical Transfer, Commercialization and Market approval for several Licensed Biological Products. Most recently, he served as Head of North America for Sartorius Integrated Solutions Division. He holds a BS in Biology from the University of Vermont, Burlington.
Natika Calhoun
Subject Matter Expert for Biological APIs, Virus and Gene Therapy Products
MilliporeSigma
Natika Calhoun is a regulatory Subject Matter Expert for biological APIs, virus and gene therapy products, antibodies, linkers, and antibody-drug conjugates, based in California, USA. In her current role, she consults on regulatory topics and works directly with customers as a Regulatory liaison to support technical writings, filings, and submission success for biological products. She previously served as the site Head of Quality for MilliporeSigma’s viral vector manufacturing site in Carlsbad, California, USA, where she was responsible for leadership of the Quality unit, and for preparing the facility for commercial and inspection readiness to support its first FDA and EU licensed products, which resulted in successful FDA and EMA inspections. With over 25 years of Quality and Regulatory experience, Natika brings a strong background in aseptic processing, GMP manufacturing, and leading regulatory inspections. Natika holds a B.S. in Biology from UC, San Diego, M.S. in Biology – Molecular Cell Science from U. of Memphis, and Certificate in Biotech Management from Vanderbilt Univ., Owen Graduate School of Business.