Panel: Staying Ahead of the Curve in the Increasingly Complex Regulatory World of Cell and Gene Therapy

  • Discussing the growing regulatory complexity in the world of pharmaceutical manufacturing. How are new guidelines and regulators’ expectations during inspections changing?
  • Taking a process-based approach to impact assessment, and customizing a setup that identifies and acts on signals proactively
  • Bringing a structured approach to your advocacy within your network of industry and trade organization connections
  • Embracing the idea that keeping things simple even in a complex environment generates the best outcomes

Pat Yang
Former EVP at Juno Therapeutics, Roche and Genentech

Dr. Patrick Y. Yang has over 35 years leadership experience in technology, manufacturing, supply chain, and operational management functions in General Electric, Merck, Genentech, Roche, and Juno Therapeutics.

He was Executive Vice President and Global Head of Roche Pharmaceuticals Technical Operations based in Basel, Switzerland from January 2010 to March 2013. In this role, he was accountable for Roche’s pharmaceutical and biotech manufacturing operations, and process development. He and as previously Executive Vice President of Product Operations of Genentech, based in South San Francisco. Dr. Yang worked for Genentech for 10 years, from 2003 until his retirement in October 2013.

Prior to joining Genentech, Dr. Yang spent 11 years at Merck & Co. in various leadership positions including Vice President, Supply Chain Management, and Vice President, Asia/Pacific Operations.

Before joining Merck in 1992, Dr. Yang spent 12 years at General Electric (1980-1992), serving in research, engineering, technology, and manufacturing leadership roles with increasing scope of responsibilities.

Dr. Yang holds a Ph.D. degree in engineering from Ohio State University, Columbus, Ohio.

He a member of Board of Directors of Tesoro Corporation, Codexis, Celladon, Amyris, and PharmaEssentia.

Murali Bilikallahalli
VP & Head Technical Operations
Acceleron Pharma

Murali, currently at Acceleron Pharma overseeing the Technical Operations division that develops, manufactures and supplies finished products to clinical and commercial. Murali is an accomplished Senior Executive with more than 20 years of success across the higher education, pharmaceutical, and biotechnology industries. Leveraging extensive experience in biologics & vaccines development, manufacturing operations and acquisition/merger deals. He serves on the editorial boards of reputed journals Drug Discovery Today and mAbs. He served on the advisory boards of USP and various international conference

His broad areas of expertise include all aspects of Biologics Discovery, Development and Commercialization; Operational excellence, competitive landscape, portfolio prioritization, and logistics of business acquisitions and mergers. He and his team successfully developed, manufactured, and launched six commercial protein & vaccine products (Flumist®, Elelyso®, Xiapex®, Trumenba®, Imfinzi®, and Crysvita®).

Throughout his executive career, Murali has held leadership positions with Acceleron Pharma, Ultragenyx Pharmaceutical Inc., AstraZeneca Biologics, Pfizer Biotherapeutics and Univ of Texas Medical Branch.

José Eduardo Vidal
SVP, Quality Assurance and Process Sciences
Atara Biotherapeutics

Dr. José Eduardo Vidal joined Atara Biotherapeutics in August 2018 and as SVP, Quality Assurance and Process Sciences. Prior to Atara, Dr. Vidal served as Vice President, Drug Substance Operations at Amgen where he oversaw 1,200 employees and managed a $500 million budget across their global drug substance manufacturing network. Previously at Amgen he was Executive Director, Process Development, where he collaborated closely with manufacturing and quality to accelerate the delivery of a product portfolio comprised of over ten Phase 3 products.

José also held several senior roles at Pfizer, where he was responsible for leading Quality Operations across multiple sterile manufacturing plants, as well as at Wyeth and Biovail in local and global technology, manufacturing and quality operations.

José received his bachelor’s degree in molecular biology, master’s degree in molecular endocrinology and biochemistry and his doctorate in biochemistry and cellular molecular biology all from the University of Puerto Rico, Rio Piedras.

Snehal Patel
VP and JuMP Site Head
Juno Therapeutics

Snehal has been at Juno Therapeutics a Company of Celgene since 2018. Snehal is the Site Head for Juno’s Cell Therapy Manufacturing Plant in Bothell, Washington. Prior to joining Juno, Snehal spent 18 years at Genentech/Roche in roles of Internal and External Manufacturing, and Quality.

Prentice Curry
SVP, Quality and Compliance
Kite, A Gilead Company

Prentice Curry has been a biotechnology and pharmaceutical professional for more than 30 years. He started his career at Cetus Corporation, one of the first biotechnology start-up companies in quality laboratory and manufacturing roles. He has expertise in the management of quality assurance and quality control laboratories, corporate quality functions, validation, construction, and manufacturing along with international assignments in Europe and Asia. He has spent the last five years at Kite Pharma building out the technical operations functions in manufacturing, supply chain, and quality.