A joint CSPS/Health Canada/IPEC-Americas Workshop
Information: Canadian Society for Pharmaceutical Sciences
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 – IPEC-Americas Immediate Past-Chair; 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 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 is Head of Pharma Registrations within the Regulatory organization of the Life Science division of MilliporeSigma. She manages a global team of regulatory experts, focused on regulatory registration of products such as excipients, active pharmaceutical ingredients (APIs), highly potent APIs, linkers, antibodies & antibody-drug conjugates, and pharmaceutical materials for the (bio-) pharmaceutical industry. She is currently Chair-Elect of IPEC-America’s and has previously held roles within the association such as Vice Chair of Administrative affairs and chair of the Excipient Qualification Committee. Bretta has also been actively involved in the planning of ExcipientFest Americas (now Excipient World), for the last several years. She has over 20 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 9 years in various roles from R&D Product Development, Product Management, Regulatory Affairs and Business Development. Bretta has a bachelor’s degree in Biology from the University of New Hampshire and Master of Biotechnology Engineering from Tufts University.
Ms. Skutnik-Wilkinson is currently with BIOGEN where she is responsible for Regulatory Intelligence and Pharmacopoeial Affairs. Previously she was the Vice President of NSF Health Sciences Pharma-Biotech. Before that, she was the Director of Quality Strategy at Pfizer, and was responsible for working with various trade associations and also developing Pfizer Positions on Quality and CMC issues on a global scale. Janeen has over 22 years of experience and expertise in compendial activities, quality and regulatory policy. She also has held a variety of positions spanning from responsibilities in documentation, change control, analytical method validation and product launch. Ms. Skutnik-Wilkinson earned a Bachelors of Science from the University of Connecticut in 1994. Ms. Skutnik-Wilkinson is Past-Chair of the International Pharmaceutical Excipients Federation (IPEC Fed). She is also past-Chair of IPEC-Americas and served as Chair of IPEC Compendial Review/Harmonization Workgroup (1999 – 2007). She sits on the ICH Assembly (formerly known as the steering committee) as a representative for IPEC Federation, and is also actively involved in PDA, PhRMA and BPOG.
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.