RAPS Workshop: Science and Risk-based Strategies to Manage CMC Complexities

Registration Fees & Deadlines

Learning Objectives

• Understand the complexities and challenges of CMC development of ADC drugs
• Identify science and risk-based approaches to manage complex regulatory challenges during development, regulatory filing, approval and commercialization of ADC drugs
• Learn the basics of science and risk-based approaches to manage complex GMP compliance challenges associated with development, regulatory filing, approval and commercialization of ADC drugs

Who Should Attend?

• Pharma/Biotech development professionals
• CMC Development scientists/engineers (drug substance and drug product)
• CMC Analytical development scientists
• Tech-Ops and process validation experts
• QA/QC professionals
• CMC Regulatory professionals
• CMC writers
• CMC Project managers

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Agenda

Speakers

Prabu Nambiar, PhD MBA, FRAPS
Founder and Principal, Syner-G Biopharma Group 

Prabhu Nambiar has worked as a regulatory CMC professional for more than 30 years.  He received his PhD in organic chemistry from Oregon State University and post-doctoral training at Brown University.  After starting his pharmaceutical career at Bristol-Myers Squibb as a process development scientist, he transitioned to CMC regulatory sciences and subsequently held CMC regulatory leadership roles of increasing responsibilities at Sepracor, Wyeth, Cubist and finally at Vertex Pharmaceuticals as Vice President and Head of CMC Regulatory Affairs. Currently, he is the principal at Syner-G Biopharma Group, a regulatory consulting firm he founded in 2007. Nambiar has provided CMC regulatory leadership for the development, filing and approval of more than 10 new drug applications including several breakthrough products, numerous post approval supplements, and investigational new drug applications. 

T.G. Venkateshwaran, PhD
Vice President, Global Head, GRA CMC and Devices, Takeda Pharmaceuticals

TG Venkateshwaran joined Takeda in September 2021 as vice president and global head, GRA CMC and devices.  Prior to Takeda, TG was at Merck & Co., where he served as Vice President, CMC Biologics, Devices and Drug-Device Combinations and CMC Policy, Global Regulatory Affairs & Clinical Safety. TG has 22 years of pharmaceutical industry experience in R&D, quality, regulatory and manufacturing.  During his tenure at Merck, TG and his team were accountable for the approval and rapid expansion of Keytruda™ globally, creating, optimizing and streamlining the device, combination product filings (pre and post approval) for products in all platforms/modalities, and enabling CMC policy through active engagement with health authorities, academicians and industry peers through various forums.  Key accomplishments include the rapid expansion of Keytruda™ manufacturing footprint through novel approaches, post approval life cycle management plans to register multiple API sites expeditiously, thereby enabling supply and access to the medicine.

Robert Herbst, PhD
Vice President, AbbVie (formerly ImmunoGen, Inc.)

Bob has been with AbbVie for 15 years and joined via the acquisition of ImmunoGen. While at AbbVie, Bob has served in different roles with increasing responsibility, including conjugation development, manufacturing sciences, process development, and CMC leadership. Currently, he is a Vice President leading a team responsible for the development and on-market support for ADC modalities. He received his B.S. from Union College and Ph.D. in Chemistry from the University of Massachusetts, Amherst, after which he completed post-doctoral training at Boston University.

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions