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Tuesday, October 19
 

9:30am EDT

Panel | Future proofing production for the looming gene therapy wave
In the quest to bring cell and gene therapies to the fore, players of all sizes are clamoring for capacity, innovation and standardization. Making advanced therapies at scale is one of the biggest hurdles, with a shortage of viral vectors—the engineered viruses used to deliver gene therapies and CAR-Ts—already upon us. Now, as a wave of potential approvals threaten to crowd the bottleneck even more, the industry will need to pull out all the production stops to meet demand. Join us as we discuss the latest tactics to avoid process pitfalls in the field, from the upsized role of contract manufacturing to automation, flexible production and more.

Moderator
avatar for Kevin Dunleavy

Kevin Dunleavy

Staff Writer, Fierce Pharma
Kevin Dunleavy is a staff writer for Fierce Pharma. He joined the Fierce team after working 26 years as a newspaper sportswriter. He compiles Fierce Pharma’s COVID Tracker and writes about manufacturing and other topics. Kevin is a longtime resident of Northern Virginia and a graduate... Read More →

Speakers
avatar for Curran Simpson

Curran Simpson

Chief Operations and Technology Officer, Regenxbio
Curran M. Simpson is the Chief Operations and Technology Officer at REGENXBIO. Prior to joining REGENXBIO, Mr. Simpson was the Head of North American Supply Chain and Interim Chief Operating Officer and Integration Lead at GlaxoSmithKline and the Human Genome Sciences division... Read More →
avatar for Jerry Keybl, Ph.D.

Jerry Keybl, Ph.D.

Head of Cell and Gene Therapy Manufacturing, MilliporeSigma
Jerry Keybl heads the Cell & Gene Therapy Manufacturing business for MilliporeSigma. As part of a diverse science and technology company, Jerry is focused on products and services for cell therapy and viral vector manufacturing, with the potential to transform therapies to cures. Jerry joined MilliporeSigma... Read More →
avatar for Kim Raineri

Kim Raineri

Chief Manufacturing and Technology Officer, Avrobio
Kim has deep global experience in the cell and gene therapy industry, biologics and medical device spaces, with a distinguished track record of innovation and implementation of Good Manufacturing Practices (GMP). Prior to joining AVROBIO, he served as the vice president of operations... Read More →


Tuesday October 19, 2021 9:30am - 10:30am EDT

10:30am EDT

Partner Keynote
Speakers
avatar for Maya Fuerstenau-Sharp

Maya Fuerstenau-Sharp

Head of Marketing Advanced Therapies, Sartorius
avatar for Qasim Rafiq, Ph.D.

Qasim Rafiq, Ph.D.

Associate Professor in Cell and Gene Therapy Bioprocess Engineering Department of Biochemical Engineering, University College London


Tuesday October 19, 2021 10:30am - 10:50am EDT

10:55am EDT

Executive Interview : John Leonard, M.D. President and CEO, Intellia Therapeutics
Speakers
avatar for Annalee Armstrong

Annalee Armstrong

Senior Editor, Fierce Biotech
Annalee Armstrong is a senior editor for Fierce Biotech. Prior to joining Fierce in April 2021, Annalee was an associate editor for S&P Global Market Intelligence’s healthcare news team. Before that, she was the EPA reporter covering climate and energy policy on the Hill in Washington... Read More →
avatar for John Leonard, M.D.

John Leonard, M.D.

President and Chief Executive Officer, Intellia Therapeutics
After a 30-year career in pharmaceutical R&D, John Leonard retired from his position as Chief Scientific Officer and Senior Vice President of Research and Development at AbbVie in 2013. Inspired by the opportunity to work with a new therapeutic modality and form a new company, he... Read More →


Tuesday October 19, 2021 10:55am - 11:15am EDT

11:15am EDT

Executive Interview: Thomas VanCott, Global Head of Product Development, Cell & Gene Therapy
Moderator
avatar for Rebecca Willumson

Rebecca Willumson

Publisher, Fierce Biotech, Fierce Pharma and Fierce Healthcare, Questex

Speakers
avatar for Thomas VanCott, Ph.D.

Thomas VanCott, Ph.D.

VP and Global Head of Product Development, Catalent Cell and Gene Therapy
Dr. VanCott joined Catalent through its acquisition of Paragon Gene Therapy in 2019. Prior to Paragon he spent 14 years as the President and CEO of Advanced Bioscience Laboratories Inc. (ABL), and previously held several positions at the Henry M. Jackson Foundation for the Advancement... Read More →


Tuesday October 19, 2021 11:15am - 11:35am EDT

11:40am EDT

Executive Interview: Mike Fraser, General Manager of Europe, Middle East and Africa, Novartis Gene Therapies
Speakers
avatar for Eric Sagonowsky

Eric Sagonowsky

Senior Editor, Fierce Pharma
Eric Sagonowsky is a senior editor with Fierce Pharma. He joined the Fierce staff in November 2014 and covers topics such as drug pricing, biosimilars and product liability litigation. Before joining Fierce, Eric worked as a news reporter for the Manistee News Advocate in Manistee... Read More →
avatar for Mike Fraser

Mike Fraser

General Manager of Europe, Middle East and Africa, Novartis Gene Therapies
Mike Fraser is General Manager of Europe, Middle East and Africa for Novartis Gene Therapies. In this role, Mike is leading a team that will introduce innovative Gene Therapies to the market to help babies and their families who suffer from rare neuromuscular diseases. Previously... Read More →


Tuesday October 19, 2021 11:40am - 12:00pm EDT

12:00pm EDT

Lunch Break
Tuesday October 19, 2021 12:00pm - 1:30pm EDT

1:30pm EDT

Panel | Promising therapies, real risk: Overcoming regulatory hurdles in gene therapy
Gene therapies have great promise for human medicine, but lately have made headlines for all the wrong reasons. SOME therapies have slammed to a halt after serious adverse events arose in patients, while others encountered unexpected delays because of FDA concerns. How can gene therapy makers work with the FDA and other regulators to manage these risks?

Moderator
avatar for Annalee Armstrong

Annalee Armstrong

Senior Editor, Fierce Biotech
Annalee Armstrong is a senior editor for Fierce Biotech. Prior to joining Fierce in April 2021, Annalee was an associate editor for S&P Global Market Intelligence’s healthcare news team. Before that, she was the EPA reporter covering climate and energy policy on the Hill in Washington... Read More →

Speakers
avatar for Eric Crombez

Eric Crombez

Chief Medical Officer, Ultragenyx Gene Therapy
Dr. Crombez has extensive experience and expertise in the development and execution of clinical development programs for rare genetic disorders. He currently serves as chief medical officer, Ultragenyx Gene Therapy and Inborn Errors of Metabolism. He has held this position since Ultragenyx... Read More →
avatar for Janet Lynch Lambert

Janet Lynch Lambert

CEO, Alliance for Regenerative Medicine
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... Read More →
avatar for Robert Pietrusko, PharmD

Robert Pietrusko, PharmD

Chief Regulatory and Quality Officer, Vor Biopharma
Dr. Pietrusko has directed the worldwide approval of more than 30 new products. He also led the submission and approval strategies for more than 30 new drug applications (NDAs), supplemental NDAs, biologics license applications and marketing authorization applications in multiple... Read More →


Tuesday October 19, 2021 1:30pm - 2:30pm EDT

2:30pm EDT

Executive Interview: Ying Huang, Ph.D. , Chief Executive Officer, & Chief Financial Officer, Legend Biotech
Moderator
avatar for Ben Adams

Ben Adams

Senior Editor, Fierce Biotech
Ben Adams is a business, science and healthcare journalist who has worked as an editor for the UK publication Pharmafocus, as a group editor for Pharmaceutical Marketing Europe, as well as a features and news writer for the BMJ and the Pharmaceutical Journal. He has an especial interest... Read More →

Speakers
avatar for Ying Huang, PhD

Ying Huang, PhD

CEO & CFO, Legend Biotech
Dr. Ying Huang was named Chief Executive Officer of Legend Biotech on November 6, 2020. He also has served as Chief Financial Officer since July 2019. He has over 9 years of experience in research and development at major multi-national pharmaceutical companies and 12 years of experience... Read More →


Tuesday October 19, 2021 2:30pm - 2:45pm EDT

2:45pm EDT

Executive Interview: Sheila Mikhail, CEO, AskBio
Moderator
avatar for Kyle LaHucik

Kyle LaHucik

Staff Writer, Fierce Biotech
Kyle LaHucik is a staff writer for Fierce Biotech, where he covers drug development, biotech startup funding, chutes and ladders and other topics. Kyle previously reported on venture capital, private equity and M&A of software and tech companies for Mergermarket. After graduating... Read More →

Speakers
avatar for Sheila A. Mikhail, JD, MBA

Sheila A. Mikhail, JD, MBA

Chief Executive Officer & Co-Founder, Asklepios BioPharmaceutical, Inc.
Sheila Mikhail has over 20 years of biopharmaceutical leadership experience and is Chief Executive Officer and co-founder of Asklepios BioPharmaceutical, Inc. (AskBio), a company she started in 2001. With $235 million in Series A funding, she built the company to more than 450 employees... Read More →


Tuesday October 19, 2021 2:45pm - 3:05pm EDT

3:05pm EDT

Executive Interview: Bobby Gaspar, CEO, Orchard Therapeutics
Moderator
avatar for Kyle LaHucik

Kyle LaHucik

Staff Writer, Fierce Biotech
Kyle LaHucik is a staff writer for Fierce Biotech, where he covers drug development, biotech startup funding, chutes and ladders and other topics. Kyle previously reported on venture capital, private equity and M&A of software and tech companies for Mergermarket. After graduating... Read More →

Speakers
avatar for Bobby Gaspar

Bobby Gaspar

CEO and Co-Founder, Orchard Therapeutics
Dr. Gaspar is a world-renowned scientist and physician and accomplished strategic and organizational leader with more than 25 years of experience in medicine and biotechnology. As one of Orchard’s principal scientific co-founders, Dr. Gaspar serves as chief executive officer of... Read More →


Tuesday October 19, 2021 3:05pm - 3:20pm EDT

3:30pm EDT

Virtual Happy Hour
Join us for a Virtual Happy Hour at the conclusion of the Fierce Biotech Cell & Gene Therapy Virtual Event. First, hear from Dr. Anthony Ting, Chief Scientific Officer from Bone Therapeutics. Then watch our professional mixologist Sam show you how to make a Magic Hour Mule. Be sure to stick around for a unique networking opportunity and converse with fellow cell & gene therapy colleagues in a virtual setting.

If you haven't already, please RSVP here: https://pages.questexnetwork.com/Sartorius-Happy-Hour-10921-Registration.html
Feel free to go ahead and set up your profile to join the Happy Hour here: https://live.remo.co/e/virtual-happy-hour-55/register

Speakers
avatar for Anthony Ting

Anthony Ting

Chief Scientific Officer, Bone Therapeutics
Dr. Ting brings to Bone Therapeutics over 30 years of academic and industry experience in translational science and global regulatory filing, and 20 years specifically in stromal cell-based therapeutics. He is currently the Chief Commercialization Officer on the board of directors... Read More →


Tuesday October 19, 2021 3:30pm - 5:00pm EDT
 
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