IPEC-Americas and the Parenteral Drug Association (PDA) West Coast Chapter to Offer Joint Workshop: Changes in the Global Excipient Quality and Regulatory Landscape

Wednesday, March 4, 2020 (All day)
Location: 

IPEC-Americas and the West Coast Chapter of the Parenteral Drug Association (PDA) will be offering a 1-day Excipient workshop that will be held at the Genentech facility located in South San Francisco.

The workshop will be Wednesday, March 4th, 2020, 8:00 am – 6:00 pm and representatives from both IPEC-Americas and PDA will be in attendance. The final program is now available!

The workshop is intended to provide education specifically related to current excipient issues for the respective memberships and regulators, however, non-members are encouraged to attend as well. There will be no charge for the workshop for IPEC-Americas and PDA members and government attendees, and a nominal fee for non-members. Workshop space is limited, and registration is required - so be sure to register early! If you have an interest in excipients, you will not want to miss this workshop! CLICK HERE TO VIEW THE PROGRAM!

Training Objectives

The program will highlight the following topics: 

  • The Impact of Composition and Excipient Variability on QbD and Drug Performance
  • Chinese Pharmacopeia – Changes and Impact on Excipients
  • China Excipient Regulation Changes Since 2015 – Path Forward
  • Excipients and Biologics
  • PDA-IPEC Technical Report on Risk Assessment and the Developing Nitrosamines Issue
  • Excipient Supplier Approaches to Providing TUPP (Technically Unavoidable Particle Profile) Information
  • Emerging Excipient Topics such as FDA’s Draft Novel Excipient Qualification Pilot Program and Excipient Contamination

It is hoped that this inaugural workshop will become an annual event, providing outreach to the important biopharma industry. Please join us for what will be a great workshop!

Overview

Many thanks to our generous sponsors, Genentech, for providing the facilities and luncheon, and Millipore Sigma for sponsoring the breaks and networking reception.

Luncheon, coffee breaks and networking reception will be provided.

WORKSHOP LOCATION

Genentech
305 DNA Way
South San Francisco, CA 94080
Building 24, Room: 1N

Attendees are responsible for their travel arrangements. A list of nearby hotels is available on the registration webpage.

Presenter(s)

Dave R. Schoneker

Consultant

David R. Schoneker is currently an independent consultant, specializing in developing regulatory strategies related to excipients, food additives, color additives used in drug and dietary supplement development.  With over 42 years of experience working in these areas, he has developed strong networks with regulatory agencies and pharmacopeias around the world.

David R. Schoneker is currently the President/Owner of Black Diamond Regulatory Consulting, LLC, a consulting firm specializing in providing regulatory and quality consulting for the pharmaceutical, dietary supplement, food and related industries. The firm provides expert advice for difficult problems and training on excipient and food additive regulatory, quality and supply chain concerns.

Prior to August 2019, David R. Schoneker was the Global Regulatory Director – Strategic Relationships at Colorcon, Inc. His responsibilities included global coordination of Colorcon’s worldwide regulatory activities. His expertise has been invaluable in developing market expansion projects to gain regulatory acceptance of Colorcon’s products and components for various target markets. Mr. Schoneker also worked closely with Colorcon’s customers and suppliers to provide regulatory training and advice. From 1995 to 2018 he was Director of Global Regulatory Affairs.  Prior to 1995 he was Director of Quality Assurance and Quality Control.  He was employed at Colorcon from 1977 until 2019.  

Mr. Schoneker has been active in many professional organizations such as AAPS, PQRI, RAPS, ASQ, ACS, AOAC and the Delaware Valley Chromatography Forum.  He also is involved with a number of trade organizations such as the International Pharmaceutical Excipients Council (IPEC), the International Association of Color Manufacturers (IACM), the Consumer Health Products Association (CHPA), the International Food Additives Council (IFAC), the Council for Responsible Nutrition (CRN) and the Institute of Food Technologists (IFT).  

Mr. Schoneker was the President of IACM in 2019 and has been on the IACM Board for many years.  In these roles he coordinated IACM’s international regulatory activities related to Synthetic and Natural colorants for use in foods and drugs and participated as one of IACM’s NGO representatives at the Codex Committee on Food Additives (CCFA) for several years.

Mr. Schoneker was the Chairman of IPEC-Americas during the period 2007-2009 and is currently a member of the Executive Committee.  He is now serving as the Vice Chair for Science and Regulatory Policy, where he is actively involved with the development of Regulatory, Safety, Excipient GMP and Supplier Qualification related guidelines to improve Excipient Acceptability, Safety and Global Supply Chain Security.  Mr. Schoneker also Co-Chairs IPEC’s QbD/Product Development Committee, Composition Committee and IID Working Group.  He also is a member of the Board of Directors of the IPEC Foundation.  He is the Global Expansion Coordinator for the IPEC Federation, and has been critically involved in the development of many of the IPEC groups and partnerships around the world.

He has acted as an interface with many international regulatory agencies and pharmacopeias for IPEC-Americas.  He previously was the USP Liaison for IPEC-Americas and, for many years, represented them as a member of the United States Pharmacopeial Convention.  Mr. Schoneker previously coordinated International Harmonization efforts for IPEC-Americas and participated in the development of IPEC’s Good Manufacturing Practices Guide and Auditing Guide for Bulk Pharmaceutical Excipients.  

He has also led IPEC’s efforts in developing guidelines for excipient qualification, significant change notification, and the appropriate use of certificates of analysis.  He was involved in the development of several third-party auditing and certification programs and standards, such as EXCiPACT, NSF/ANSI IPEC 363 and the International Pharmaceutical Excipients Auditing, Inc. (IPEA).  Additionally, Mr. Schoneker chairs a number of harmonization working groups on various excipients and since 2010, has chaired the Coalition for Rational Implementation of the Elemental Impurity Requirements 

Mr. Schoneker has participated in the area of Color Science for many years and is author of the chapter “Coloring Agents for Use in Pharmaceuticals” in the 4th edition of the Enclyclopedia of Pharmaceutical Technologywhich was published in 2013.  He has also authored many other excipient regulatory, quality, supplier qualification and safety related papers in various journals and trade magazines.

Priscilla Zawislak

Global Regulatory Affairs Advocacy Manager
Dupont Nutrition and Biosciences

Priscilla Zawislak – IPEC-Americas Immediate Past-Chair; Vice President, IPEC Federation; Global Regulatory Affairs Advocacy Manager for Dupont Nutrition and Biosciences.

Ms. Zawislak Priscilla has over 35 years’ experience in regulatory affairs and quality for excipients, food additives and ingredients for personal care products.  She is IPEC-Americas Immediate Past-Chair and is the current Vice President of the IPEC Federation.  Priscilla is the Global Regulatory Affairs Advocacy Manager for Dupont’s pharmaceutical and nutrition business.  Her responsibilities include regulatory advocacy for excipients, APIs and food additives. Prior positions include Global Regulatory Affairs Manager for Ashland Inc.’s Pharmaceutical and Nutrition business where she was responsible for regulatory compliance for food additive and excipient products and Quality Manager at FMC BioPolymer (now DuPont Health & Nutrition).

Ms. Zawislak is the Immediate Past Chair of IPEC-Americas, has been a member of IPEC-Americas committees since 2001 and is a member of the Executive Committee.  She is also President of the IPEC Federation, a global organization consisting of regional IPECs in the US, Europe, Japan, China and India. She is an IPEC-Americas representative on several USP related committees including the Excipients Project Team, Compendial Process Improvement Team, General Notices Project Team, has served as Chair for several Stakeholder Forums, and is a Delegate to the USP Convention. Priscilla has also participated for over 10 years in the International Food Additives Council and OFCA, a trade association for cellulose derivatives. Priscilla earned her Bachelor degrees in Biological Sciences and Chemistry from the University of Delaware.

Bretta Lichtenhan

Head of Pharma Registrations - Pharma and Food Materials Life Science
MilliporeSigma

Bretta Lichtenhan is Head of Pharma Registrations within Pharma Food Materials organization of the Life Science division of MilliporeSigma. She manages a global team of regulatory experts, focused on regulatory registration of products such as active pharmaceutical ingredients (APIs), highly potent APIs, linkers, antibody-drug conjugates, excipients, and pharmaceutical materials for the (bio-) pharmaceutical industry. Bretta also currently serves as Chair-Elect of IPEC-Americas, an industry association focused on advocating, educating, innovating and developing best practices for excipients, with a focus on patient safety. She has over 22 years of experience in the industry with previous experience at Biopharma companies Genzyme (a Sanofi Company) and Percivia LLC. Bretta has worked for MilliporeSigma for over 10 years in various roles from R&D Product Development, Product Management, Business Development and Regulatory Affairs. Bretta has a bachelor’s degree in Biology from the University of New Hampshire and Master’s of Biotechnology Engineering from Tufts University in the United States.

Janeen Skutnik-Wilkinson

Associate Director, Quality Intelligence
Biogen

Ms. Skutnik is the Associate Director for Quality Intelligence at Biogen; the Chair of PDA's Pharmacopoeial Interest Group and the current Chair of IPEC-Americas.  Her former positions include: Vice President at NSF DBA; and Director /Team Leader of Quality & Regulatory Policy at Pfizer, responsible for working with various trade associations and also developing Pfizer Positions on Quality and CMC issues. She has over 25 years experience and expertise in compendial activities, quality and regulatory policy, and has held a variety of positions with responsibilities in documentation, change control, analytical method validation and product launch. Ms. Skutnik earned a Bachelors of Science from the University of Connecticut in 1994. She is a member of the ICH IWG for ICH Q3D Elemental Impurities, and was also on the EWG for Q3D. She was the Chair of PhRMA's Compendial Liaison Team (2000-2012); and the PhRMA Topic Leader for the ICH Topic - Q4B Regulatory Acceptance of Pharmacopoeial Interchangeability. She is the IPEC Delegate to the ICH Assembly and ICH Informal Quality Discussion Group

Nigel Langley

Director Technical Service and Scientific Affairs
BASF Pharma Solutions

Nigel Langley

 

Nigel Langley–Director Technical Service and Scientific Affairs, BASF Pharma Solutions, provides technical support to the pharmaceutical industry and helps solve drug development challenges with BASF's platform solutions. Prior to joining BASF Nigel worked for Croda Inc. as Technical Director Health Care, responsible for product and application development for both dietary supplements and Pharmaceutical excipients (liquid dosage). He has also worked in Japan and England with Croda. He gained his Chemistry (Hons) degree and PhD (Liquid Crystals) from the University of Hull, (UK) and an MBA from Leeds University (UK). Nigel has been a member of the Executive Committee at IPEC Americas since 2010 and is currently VC Membership. He is also helping to lead the Novel Excipients initiative for IPEC Americas in collaboration with the IQ Pharma Consortium.

Fabio De Martino

Associate Director of Finance and Information Management Process Improvement
BioMarin Pharmaceutical

Fabio De Martino is currently Associate Director of Finance and Information Management Process Improvement at BioMarin Pharmaceutical. In this role, his main responsibilities are identifying, leading and delivering continuous improvement projects with significant tangible monetary impact, which supports continuous reinvestment in the Company.

Prior to this role he was a Senior Manager in the Global Quality function at Genentech, where he managed continuous improvements global projects and programs, and a Manufacturing Engineer at Novartis Vaccines and Diagnostics where he led critical projects and investigations in compliance with FDA regulations and international quality standards, managing continuous improvement initiatives across Europe, Asia and the US.

Fabio holds a Bachelor's degree in Chemical Engineering from the University of Salerno and a Master's degree in Chemical Engineering from Pisa University, Italy. He is a licensed/registered engineer (Italy), a certified Lean Manufacturing Six-Sigma Black Belt and a Project Management Professional (PMP).

Fabio is the President of the local Parenteral Drug Association (PDA), a PMP Instructor for the San Francisco Bay Area PMI chapters, adjunct professor of MBA and Project Management programs at San Francisco State University and UC Berkeley Extensions.

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