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The Great Debate: Internal vs. external manufacturing for advanced therapies

Determining the right approach to manufacturing is crucial when bringing advanced therapies from clinical to commercialization. The focus of this webinar is to address the growing industry concerns regarding manufacturing hurdles unique to cell and gene therapy. Our panel of experts will help set the landscape for the current state of the advanced therapy sector and share key considerations that go into deciding whether to scale-up manufacturing internally or look to an external supplier like a CDMO.

Watch this webinar to:

  • 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 that sometimes a hybrid solution may be the best approach.
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Brian Riley

Brian Riley

SVP | Technical Operations, Beam Therapeutics

Brian Riley, an experienced leader in operations, quality and manufacturing, is Senior Vice President of Technical Operations at Beam. Prior to Beam, Mr. Riley spent five years at Catalent Pharma Solutions, initially as General Manager, Biologics and most recently as the Vice President of Operations. There, he helped to cultivate the Company’s biologics business, managing five biologics plants supporting the Company’s drug substance and products across North America and Europe. Prior to Catalent, Mr. Riley served as the site director of Durham, NC operations at bioMerieux, where he led both the company’s compliance remediation effort and global growth platform. Before bioMerieux, Mr. Riley held progressive roles through quality and operations at Biogen Idec, Amgen and Diosynth Biotechnology.

Mr. Riley holds an MBA from Campbell University and a B.S. from North Carolina State University.

John Khoury

John Khoury

EVP | Project Farma

John Khoury is a 20+ year veteran and leader in the biotech / pharmaceutical industry. As a member of the Project Farma Leadership Committee, John has spearheaded Project Farma’s growth in the gene and cell therapy space. He has led and provided strategy on key partner initiatives including make vs. buy analysis, site and vendor selection, tech transfer execution strategies, and facility start-ups.

In addition to his experience in advanced therapies, John has extensive experience with small and large molecules including biologics and biosimilars. Over the past four years, he has led facility builds totaling over $500MM. During this time, he has worked with small and large biotech and pharmaceutical companies including gene and cell therapy startups and CMOs/CROs.

Bruce Goldsmith

Bruce Goldsmith

President & CEO | Passage Bio, Inc.

Bruce A. Goldsmith, PhD, MBA, has served as president and chief executive officer of Passage Bio and as a member of the company’s board of directors since January 2020. Before Passage Bio, Dr. Goldsmith served as an advisor and venture partner at Deerfield Ventures from January 2019 to January 2020. From April 2019 to January 2020, Dr. Goldsmith also served as interim CEO of Civetta Therapeutics. Prior to that, Dr. Goldsmith served initially as chief business officer and then as chief operating officer at Lycera Corp. from April 2013 to January 2019. From 2008 to 2012, Dr. Goldsmith served as vice president and then senior vice president of Corporate Development at Allos Therapeutics. Prior to Allos, Dr. Goldsmith served in various leadership roles at GPC Biotech in 2007 and Tibotec Therapeutics, a subsidiary of Johnson & Johnson, from 2005 to 2007. Dr. Goldsmith also previously held various positions at Johnson & Johnson in oncology global strategic marketing, business development and licensing and acquisition finance. Prior to joining Johnson & Johnson, Dr. Goldsmith was a research fellow at Novartis Pharma, K.K., where he conducted scientific research in a neurodegeneration drug discovery group. Dr. Goldsmith received a B.A. in biology from Colgate University, a Ph.D. in biology with a research thesis in neuroscience from the University of Pennsylvania, and an MBA from Columbia University.

Audrey Greenberg

Audrey Greenberg

Co-founder | Discovery Labs

Audrey Greenberg is Co-founder of Discovery Labs (DL), a global platform company streamlining the path to commercialization for cell and gene therapies. The Discovery Labs Center for Breakthrough Medicines (CBM) is a fully integrated cell and gene therapy contract development and manufacturing organization that enables rapid development and commercialization of advanced therapies. DL CBM’s comprehensive service offering accelerates speed to market and mitigates risk through robust platform technologies, advanced analytics, and integrated program and supply chain management. Our vision and execution are supported by a first-class team of seasoned scientists and biopharmaceutical leaders with a unique approach to CDMO relationships which put the client and patient first.

Audrey has a track record and passion in guiding companies through their lifecycle using capital attraction and optimization strategies, key strategic relationships, novel technologies, and the finest management teams. Prior to launching Discovery Labs, Audrey spent two decades working in private equity (CBRE, ING Clarion), investment banking (Merrill Lynch and Morgan Stanley) and public accounting (Deloitte).

Faraz Ali

Faraz Ali

CEO | Tenaya Therapeutics

Faraz Ali has served as Chief Executive Officer at Tenaya Therapeutics since 2018. Mr. Ali was previously Chief Business Officer at REGENXBIO, a leading AAV gene therapy company. Prior to that, he was a Vice President at bluebird bio, a leading LVV gene therapy company. Mr. Ali also had roles of increasing global commercial leadership at Genzyme Corporation, where he helped launch multiple first-in-class therapies for orphan diseases. He started his career at General Electric, including technical roles at GE Healthcare and business assignments at GE Corporate. Mr. Ali received his M.B.A. from Harvard Business School and his B.S. from Stanford University.

Arsalan Arif
moderator

arsalan arif

Founder & Publisher, Endpoints News

Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.