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Manufacturing has been widely recognized as a bottleneck to bring advanced therapies to the patients and families in need. Cell and gene therapy organizations are faced with a difficult decision on whether to build internal capabilities to resolve this bottleneck or look externally for their manufacturing needs.

Co-hosted by Informa Pharma Intelligence, this panel discussion will provide key inputs to consider when choosing between a make vs. buy, to scale-up manufacturing internally or look to an external supplier like a CDMO. We will hear from industry experts on the state of the advanced therapy industry, the investment that is pouring into advanced therapies, why manufacturing is such a critical component, various approaches to the build or buy decision and advantages and challenges of the decision.

The panel discussion will be followed by an interactive Q&A session.

After participation, you will:

  • Understand the key factors that a cell and gene therapy should consider when deciding between scaling up manufacturing internally or using an external supplier
  • Appreciate the state of the advanced therapy industry and why we need to resolve the manufacturing bottleneck to bring advanced medicines to the patients and families who need them
  • Recognize that both solutions, build or buy, have their advantages and challenges and perhaps a hybrid solution may be the best approach.


Speakers:

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Janet Lynch Lambert

CEO

Alliance for Regenerative Medicine (ARM)


Janet Lynch Lambert joined ARM in 2017 as the organization’s first CEO. With more than 25 years in public and private sector management, Janet is an experienced government relations and business professional with an extensive record of accomplishment. Janet most recently served as the Acting Head of Engagement for the All of Us Research Program at the National Institutes of Health and as head of the Outreach Office in the Office of the NIH Director. Prior to joining NIH, she was Vice President of Government Relations and head of the Washington office of Life Technologies, aiding the company in its growth from $300 million in annual sales to more than $3 billion. Prior to Life Technologies, Janet held leadership positions in government relations, marketing and business development at large and small life science organizations, including GE and InforMax. Her experience also includes legislative and staff leadership positions in the U.S. Senate and House of Representatives. Janet received her MBA in International Business from Georgetown University and her B.A. in Political Science from Stanford University. She lives in the Washington, D.C. area with her husband and two daughters.

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Alexander Karnal

Partner and Managing Director

Deerfield Management


Alexander (Alex) Karnal is a Partner and Managing Director at Deerfield and joined the Firm in 2005. He is responsible for portfolio decisions across the Deerfield Funds. Beyond his direct investment activities at the firm, Mr. Karnal helped conceptualize and implement the Cure, Deerfield's healthcare innovation campus at 345 Park Avenue South. Furthermore, during the COVID-19 global health crisis, Mr. Karnal was appointed by Governor Ned Lamont to the Reopen Connecticut Advisory Group to provide counsel on the reopening of the state’s economy, community, and education systems. He is a co-founder, CEO and board chairman of The Institute for Life Changing Medicines, a nonprofit dedicated to saving one million people suffering from life-threatening and devastating diseases around the world with no barriers to access. . Prior to Deerfield, he was a member of Merrill Lynch’s Global Equity Linked Products Group and of its Capital Markets team. Mr. Karnal was featured in the April 2020 edition of “The 20 under 40: Inside the next generation of biopharma leaders – Endpoints News."

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Tony Khoury

EVP

Project Farma


Tony Khoury is a 17+ year veteran and leader in the biotech / pharmaceutical industry. As a member of the PF leadership committee, Tony has spearheaded Project Farma’s growth in the gene and cell therapy space. Tony has extensive experience with small and large molecules including biologics, biosimilars, and gene and cell therapies. He has worked with small and large biotech and pharmaceutical companies including gene and cell therapy startups and CMOs/CROs. He has led global programs greater than $350+ million in the following disciplines: project management, turnkey facility builds, automation, validation, engineering and serialization track and trace.

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David Carr

Director

PRECISIONadvisors


David Carr is a Director in the Global Pricing, Market Access & Analytics team at PRECISIONadvisors, and brings over 6 years’ experience executing and managing diverse pricing and access projects. David has broad knowledge across European geographies and multiple disease areas, and has specialist expertise in strategic consulting for orphan drugs and cell and gene therapies. He has also published analysis and commentary on trends within the pharma and biotech space, including insights on innovative contracting agreements for high cost therapeutics. Prior to joining Precision, David worked in the market access teams at Pope Woodhead, Market Access Solutions, and Evidera. David received a BSc in Biochemistry from the University of Bath, and an MRes and PhD in Neuroscience both from Imperial College London.

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Erin Harris

Editor In Chief

Cell & Gene

Moderator


Erin Harris is the Editor In Chief of Cell & Gene, the digital media resource that provides actionable information to professionals involved in the development and commercialization of cell and gene therapies. Cell & Gene’s editorial scope spans the entire product lifecycle from basic research to commercialization. For more than 10 years, Erin has covered and reported on the adoption of information technology from a B2B perspective. She's written on technology topics ranging from Big Data and analytics to security and e-commerce. In each case, her reporting centered on innovations that improved operational efficiencies, fostered interdepartmental collaboration, or enhanced supply chains. She has interviewed executives from Fortune 500 as well as startups.


Hosted by

Maire Gerrard

Custom Content Writer

Informa Pharma Intelligence

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