Speakers: Prabu Nambiar, Edward Ciolkowski, James Bush (Syner-G Pharma Consulting)
Organizers: Jim Zhang, Dave Toman and SynerG
Date: 3/30/2017
Time: 12:30-17:00
Registration fee (USD): Regular: $125; Academic: $75; For unemployed & students: $25; For vendor-show reps: $25; For major-sponsor rep (incl lunch): $0;
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor: (1)Catalent Pharma Solutions
Vendor show vendors registered to date: (9)Almac; Cardinal Health; CoreRx, Inc.; DiscoveRx; Intertek Pharmaceutical Services; Pacific BioLabs; Patheon; Quotient Clinical Ltd; Solid Form Solutions Ltd
Registration: https://www.PBSS.org
Registration deadline:3/28/2017  (it will close sooner if the seating cap is reached)

About the Topic

This workshop provides an overview of the Chemistry, Manufacturing, and Controls (CMC) development activities throughout the entire pharmaceutical product development lifecycle.  In particular, it will cover the fundamentals of Quality by Design (QbD) and the use of risk-based scientific approaches to identify areas of both low- and high-risk during each phase of product development.  These concepts also help ensure that the technical, regulatory, and quality resources are efficiently utilized during each phase of drug development.  Case studies will be presented to illustrate how risk-assessment can be used to focus CMC activities and investment on those areas that will have the greatest impact on achieving the key milestones for each development phase.

This workshop will benefit scientists, analysts, research associates, managers, directors, regulatory affairs professionals, quality professionals, and process engineers currently working in the pharmaceutical and biopharmaceutical industry seeking to improve their understanding of current best practices in CMC drug development. This workshop is also useful for non-development scientists who seek a better understanding of CMC activities that need to occur following the discovery stage.

Specific topics that will be covered include:

• ICH Q8, Q9, Q10, and Q11 Guidelines as a basis for CMC development
• The concepts of Quality Target Product Profile, Critical Process Parameters, and Critical Quality Attributes
• The application of these concepts during each of the major stages of pharmaceutical product development
  • Discovery to IND
  • Phase 1 to Phase 2a
  • Phase 2b to Phase 3
  • Product approval, launch readiness and post-approval changes

About the Speakers

Prabu Nambiar, PhD MBA RAC (Syner-G Pharma Consulting, LLC)

Prabu acquired his Ph.D. in Organic Chemistry from Oregon State, completed his post-doctoral training at Brown University and got his Executive MBA from Boston University.  He has over 25 years of industry experience including last 20 years in CMC Regulatory Sciences.  His extensive CMC experience includes resolution of complex CMC/Quality and Compliance issues (regulatory starting materials, Genotox impurities, specifications, QbD implementation, PAI responses) using science and risk-based approaches and leading NDA/Regulatory Teams.  He has worked in various therapeutic areas and on a broad range of dosage forms including immediate and modified release oral products, inhalation products, sterile injectables and drug-device combination products.  He has led the filing and approval of 11 NDAs, numerous sNDAs, INDs and international filings.  He is a member of RAPS, ACS and AAPS and was the chair of Regulatory Science section at AAPS.

Edward Ciolkowski, PhD (Syner-G Pharma Consulting, LLC)

Ed received his Ph.D. in Analytical Chemistry from University of North Carolina, Chapel Hill and has over 20 years of industry experience in pharmaceutical development and management at Upjohn, Pharmacia, Pfizer and Bausch and Lomb.  Ed’s responsibilities have included analytical method development for solid-oral, sterile, and topical dosage forms, developing biopharmaceutics strategies to bridge dosage form changes during product development, CMC technical team leadership, clinical supply-chain management, and leading drug product manufacturing technical transfer and post-approval change activities.  At Syner-G, Ed heads up the CMC Development and Outsourcing function and his team is responsible for providing both strategic stewardship and tactical solutions for the scientific and technical aspects of drug development programs.

James Bush, MBA (Syner-G Pharma Consulting, LLC)

James holds a B.S. in Biochemistry from Union College and recently completed his M.B.A. from Babson College. He has over 12 years of pharma industry experience with a successful track record as an Analytical Chemist and as a CMC Regulatory Affairs professional.  He takes a strategic approach to decision making and emphasizes sound scientific principles.  James played an integral part in the successful commercialization of four products and has introduced and managed multiple compounds in various phases of global development.   James began his career in Pharmaceuticals as an Analytical Chemist and subsequently transitioned in to a CMC Regulatory Affairs professional.