Hillel Cohen, PhD
- Executive Director, Scientific Affairs
- Sandoz Inc., United States
Hillel Cohen is Executive Director at Sandoz, helping explain policies to the healthcare community, patient advocacy groups, & health authorities. Current areas of focus include switching, substitution, interchangeability & safety. He led Sandoz efforts for the first biosimilar presentation (Zarxio®) to an FDA advisory committee and participated in BsUFA2 negotiations. Dr. Cohen is active in biosimilar trade associations, focusing on education. He received a BA from NYU and a PhD from Dartmouth.
Thomas Felix, MD
- Medical Director, R&D Policy, Global Regulatory Affairs and Safety
- Amgen Inc., United States
As Amgen develops its biosimilars, Dr. Thomas Felix works to advance science and policy for a successful, patient-focused implementation. Dr. Felix partners with drug safety experts to characterize the ability to track and trace multisource therapeutic outcomes in various treatment settings and regions. He is committed to advancing pharmacovigilance systems to quickly and accurately identify adverse events and facilitate manufacturer accountability.
Suzette Kox, MPharm
- Senior Director International-Biosimilars Medicines Group
- Medicines for Europe, Belgium
Suzette Kox is Senior Director International of the Biosimilar Medicines Group, a sector group of Medicines for Europe and the first Chairperson of the Biosimilars Committee of the International Generic and Biosimilar Medicines Association (IGBA). Suzette has been involved with biosimilar medicines since 2001 and is passionate about access to medicines around the world. Previously, she worked in regulatory affairs and management for ratiopharm (now Teva). She was also a visiting faculty member of the School for International Training in Geneva. Before joining the generic and biosimilar medicines industries in 1991, she followed a hospital and retail pharmacy career.
Laura McKinley, PhD
- Director, US Regulatory Policy Lead, Pfizer Essential Health
- Pfizer, Inc., United States
Laura McKinley is Director of US Regulatory Policy and Intelligence for Pfizer Essential Health. Laura has been with Pfizer for nearly 10 years and has extensive experience working on biosimilars. Laura represents Pfizer on industry trade association biosimilar committees and was an industry representative during the initial BsUFA negotiations. Prior to joining the Regulatory Policy team at Pfizer, Laura was a Global Regulatory Lead on biosimilar development teams working to advance the development of Pfizer's portfolio of monoclonal antibody biosimilars.
Cecil J. Nick, MS
- FTOPRA, Vice President (Technical)
- PAREXEL Consulting, United Kingdom
BSc (Hons) in Biochemistry from University of Cape Town. Working in regulatory affairs and clinical development for over 30 years with focus on biological medicines and particular expertise in biosimilars. Joined PAREXEL in 2001 prior to which was with Novo Nordisk Ltd.
Juliana Marguerite Reed, MS
- Vice President, Government Affairs
- Coherus BioSciences, United States
Extensive experience in the development of biosimilars policy around the globe. Prior to joining Coherus Biosciences, Juliana was at Hospira Inc, for over 10 years working to advance biosimilars in multiple global regions. Juliana is one of the founders of the Biosimilars Forum, the industry trade association in the US and holds the current position of "Immediate Past President" of the Biosimilars Forum. Juliana was an industry participant in the BSUFA II negotiations.
Emily Shacter, PhD
- Independent Consultant
- ThinkFDA, LLC, United States
Dr. Shacter regulated therapeutic proteins at the FDA for 18 years, serving as Chief of the Lab of Biochemistry in CDER’s Office of Biotechnology Products until leaving FDA in 2012. She supervised the regulatory review of a wide range of protein products & contributed to FDA policies & expectations for the manufacture, control, & analytical characterization of therapeutic proteins & biosimilars. She now consults on the science & regulation of protein products through her business ThinkFDA LLC.
Charles E Barr, MD, MPH
- Chief Science Officer, BBCIC
- AMCP BBCIC, LLC, United States
Dr. Charles Barr is Chief Science Officer at AMCP Biologics and Biosimilars Collective Intelligence Consortium. He worked in academic medicine, industry and research (clinical trials, registries & RWD). He was Group Medical Director and Head, Strategy & External Relationships in US Medical Affairs, Evidence for Access at Genentech. His MD and MPH is from Loma Linda University and post-doctoral studies in biomedical computing, biostatistics, and health policy at Harvard School of Public Health.
Sudip Parikh, PhD
- Senior Vice President and Managing Director, DIA Americas
- DIA, United States
Daniel F Alvarez, MD
- Senior Director
- Pfizer, United States
Daniel Alvarez M.D. is a Senior Director at Pfizer. He works in the development of monoclonal antibody biosimilars. Dr. Alvarez interacts with regulatory agencies, clinicians and scientist to advance the knowledge of biosimilars development.
Leah Christl, PhD
- Associate Director for Therapeutic Biologics, TBBT, OND, CDER
- U.S. Food and Drug Administration (FDA), United States
Dr. Christl is the Director of the Therapeutic Biologics and Biosimilars Staff (TBBS) in the Office of New Drugs in the FDA's CDER. TBBS is responsible for ensuring consistency in the scientific and regulatory approach and advice to sponsors regarding development programs for biosimilar biological products and related issues regarding therapeutic biologics. TBBS is also responsible for developing scientific and regulatory policy as it relates to the review and approval of biosimilar products.
- Scientist, Technologies, Standards and Norms Team, Group Lead
- World Health Organization, Switzerland
Patrick J. Lynch
- Biologist, Product Quality Reviewer
- U.S. Food and Drug Administration, United States
Patrick Lynch is a product quality reviewer in the Office of Biotechnology Products at CDER. He has served in this position since 2014 where he reviews product quality information for therapeutic proteins, including analytical similarity information in biosimilar applications. Dr. Lynch first joined FDA in 2009 as a post-doctoral fellow and has worked for five years as a product quality reviewer in both CBER and CDER. Dr. Lynch received a Bachelor of Science in Biochemistry and Molecular Biology from the University of Georgia in Athens, Georgia. He received his Ph.D. in Biochemistry from Duke University in Durham, North Carolina.
Carlos Sattler, MD
- VP, US Clinical Development and Medical Affairs
- Sandoz Inc. (a Novartis Company), United States
- Associate Director, OMEPRM, OSE, CDER, FDA
- FDA, United States
KellieTaylor is currently the Associate Director of the Office of Medication Error Prevention and Analysis in the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research’s (CDER) where she is responsible for the Center’s programs in risk management and medication error prevention. She provides oversight, coordination, and technical expertise for the pre- and post-marketing activities involving medication error prevention and analysis regulated drug and drug/device products, human factors studies, proprietary names, and the nonproprietary naming convention for biological products.
Cindy (Yang) Cao, PhD
- Head, US Regulatory Affairs, Biopharmaceutical
- Sandoz, Inc. A Novartos Division, United States
Dr. Cindy Cao oversees the Sandoz US regulatory affair biopharmaceutical department for all US regulatory activities to support the Sandoz Biosimilar development and commercialization. Her team is responsible for all filings of Sandoz biosimilar products to FDA. With 17 years of pharmaceutical R & D experience, Dr. Cao has played a number of leadership roles and accumulated extensive experience with clinical, nonclinical, CMC and device aspects of development projects as well as marketed products. Prior to joining the pharmaceutical industry, Dr. Cao was an Assistant Professor in University of Utah, conducting basic biological research in inflammation and cancer biology.
Mark J Cziraky, PharmD
- Vice President of Research
- Anthem HealthCore, United States
Mark Cziraky, PharmD, CLS is a healthcare executive with over 25 years of experience in leading, designing and conducting research studies to improve quality, safety and affordability in healthcare, including randomized clinical trials, retrospective and prospective observational research designs. Dr. Cziraky is the co-founder and Vice President of Research at HealthCore and serves as key architect in creating unique, multi-stakeholder research collaborations within the healthcare industry.
Bruce Leicher, JD
- Senior Vice President and General Counsel
- Momenta Pharmaceuticals, Inc., United States
Mr. Leicher is Senior Vice President and General Counsel at Momenta Pharmaceuticals, Inc. Mr. Leicher has advised biotechnology companies for over 25 years. Mr. Leicher is a frequent lecturer on biotechnology law and is Chair of the Board of the Biosimilars Council, a Division of the Association for Accessible Medicines (AAM). In private practice, he served as the Co-Chair of the Life Sciences Practice Group at Hill and Barlow, was an attorney at Hale & Dorr and Butler & Binion, and served as a law clerk to the Honorable Thomas F. Hogan in the US District Court in DC after receiving his J.D. from Georgetown University Law Center and his B.A. from the University of Rochester.
Cathy A. Parker
- Director General, Biologics & Genetic Therapies Directorate HPFB
- Health Canada, Canada
Catherine Parker Director of the Office of Policy and International Collaboration within the Biologics and Genetic Therapies Directorate of Health CanadaHer Office has overall responsibility for all policy and regulatory development respecting biologic drugs. She played a key role in the regulatory activities around the licensure of the H1N1 pandemic vaccine for Canada in 2009. Her Office is also responsible for coordinating international collaboration activities for the Directorate.
Julie Ann Rosenberg, MD
- Development Asset Lead, Oncology Biosimilars, Pfizer Essential Health
- Pfizer, Inc., United States
Julie Rosenberg, MD is a Senior Director and Global Asset Leader at Pfizer, Inc. Julie is a pediatric oncologist who has worked in a variety of leadership roles in both academic medicine and the pharmaceutical industry. In her current role, she oversees the development of key oncology biosimilar programs from proof-of-concept through successful completion and product launch. Dr. Rosenberg is also a writer and the author of: Beyond the Mat: Achieve Focus, Presence, and Enlightened Leadership Through Principles and Practice of Yoga (Da Capo Press; Hachette Book Group; Dec. 2017).
Martin Schiestl, PhD
- Chief Science Officer, Sandoz Biopharmaceuticals
- Sandoz GmbH, Austria
Martin Schiestl received his PhD in chemistry with a specialization in bioanalysis from the University of Innsbruck. He started his work on Biosimilar medicines at Sandoz in 1996, where he built up the analytical and pharmaceutical development departments in charge of the biosimilar pipeline and other biological medicines of Sandoz. In 2009, he moved into the regulatory and policy field, and since 2015 he is working as Chief Science Officer for Sandoz Biopharmaceuticals. In addition, Martin has been serving as a member in the expert groups for biological products at the European and US Pharmacopoeia. He also represented the generic and biosimilar industry in the expert working groups for the ICH Q11 guideline and the ICH Q7 Q&A document.
Angus Worthing, MD
- Chair, Government Affairs Committee
- American College of Rheumatology, United States
Dr. Worthing is a practicing rheumatologist at Arthritis & Rheumatism Associates in Washington DC, clinical assistant professor of medicine at Georgetown University Medical Center, and chair of the Government Affairs Committee of the American College of Rheumatology (ACR). He speaks regularly on behalf of the ACR regarding biosimilars policy and other issues of access to rheumatology care and treatment.
- Vice President, Government Affairs
- Express Scripts, Inc., United States
Leah Howard, JD
- Vice President, Government Relations and Advocacy
- National Psoriasis Foundation, United States
Richard Markus, MD, PhD
- Vice President, Global Development
- Amgen Inc., United States
Richard Markus is Vice President, Global Development at Amgen, where he leads development activities for the Biosimilar Business Unit. He received his BS degree from the University of California, Los Angeles (UCLA) and his MD/PhD at the University of Southern California, where he stayed for medical training before going into industry to lead clinical research. He now oversees non-clinical and clinical activities across a portfolio of ten biosimilar products in multiple therapeutic areas.
Elizabeth Clare Pollitt, PhD
- BioPharma CMC Regulatory Consultancy Services, Ltd., United Kingdom
Liz Pollitt is an independent consultant at BPCRCS, providing strategic and technical advice to clients on regulatory aspects of CMC for biological and biosimilar products. Formerly a senior pharmaceutical assessor in the Biologicals Unit at the MHRA involved in the assessment of all types of biological products, her focus on biosimilar products began as VP of CMC for Regulatory Affairs at CELLTRION, and she subsequently worked in the Biosimilars unit at Merck KGaA. Liz holds a PhD in Viral Immunology from the University of Leicester and completed postdoctoral studies at the Institute of Virology, University of Glasgow.
Tammy P Powell, MLIS, MS
- Health Program Specialist
- National Library of Medicine, United States
Tammy Powell has over 25 years of vocabulary experience at the National Library of Medicine. She manages RxNorm and has been involved in the RxNorm project since inception. In addition, she managers UMLS editing and DailyMed.
Kyoko Sakurai, PharmD
- Reviewer, Office of Cellular and Tissue-Based Products
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Sakurai is a reviewer in the Office of Cellular and Tissue-based Products of the Japanese regulatory agency, Pharmaceuticals and Medical Devices Agency (PMDA) since 2011. She is responsible for the pharmaceutical quality review of biotechnological/biological products and performing review of biosimilars.
Jian Wang, MD, PhD
- Chief, Clinical Evaluation Division - Haematology/Oncology, HPFB
- Health Canada, Canada
Dr. Wang manages a team of clinical and medical reviewers. His division conducts non-clinical, PK/PD and clinical evaluations, and has regulatory responsibility over biological drugs. Radiopharmaceuticals, gene therapies and Subsequent Entry Biologics/biosimilars are also regulated by his division. He provides pre-submission consultations to drug manufacturers and makes pre-market regulatory recommendations to senior management. He participates in various Health Canada, ICH, WHO, PAHO, APEC and DIA working groups and expert committees. Dr. Wang received his MD from Harbin Medical University, China and his PhD in Physiology from the University of British Columbia, Canada.
Leon van Aerts, PhD
- Medicines Evaluation Board, The Netherlands, Netherlands
- Director, Government Affairs
- Express Scripts, United States
Chris Davis is Director of Government Affairs at Express Scripts, the nation’s largest independent pharmacy benefit manager and a strong advocate of biosimilars. He previously served as Senior Director of Federal Affairs at the Generic Pharmaceutical Association, where he advocated for the generic and biosimilars industries before Congress and worked on its Biosimilars Council. He was actively involved in Congressional passage of BSUFA I and educating Congress on the biosimilars approval pathway. Prior to joining GPhA, Chris was Legislative Director for former Congressman Rick Boucher, a member of the Energy and Commerce Committee, where he handled health care issues during the development of BPCIA.
Kyung-Ah Kim, PhD
- Vice President, Head of Bioanalysis
- Samsung Bioepis, Korea, Republic of
- Medical Officer, Therapeutic Biologics and Biosimilars Staff
- Food and Drug Administration, United States
Dr. Sue Lim is a Team Leader with the FDA, Office of New Drugs, Therapeutic Biologics and Biosimilars Staff. In this role, she provides review and oversight of therapeutic biologics and biosimilar products, as well as regulatory policy development for biosimilars. Dr. Lim was previously a Medical Officer with the FDA’s Division of Anti-Infective Products. Prior to the FDA, Dr. Lim served as an Infectious Diseases physician and Associate Hospital Epidemiologist at the University Health Network in Toronto, Canada. She received her MD from the University of Toronto where she also completed her residency in Internal Medicine and subspecialty training in Infectious Diseases. She has a MS in Health Policy from the University of Toronto.
Gerald McEvoy, PharmD
- Assistant Vice President of Drug Information
- American Society of Health-System Pharmacists, United States
- Executive Director of Federal Programs
- America's Health Insurance Plans, United States
- Health Communication Specialist/ Press Officer
- FDA, United States
- General Manager, US Biosimilars
- Pfizer, Inc., United States
Tânia Teixeira, PharmD
- EMA Liaison Official at FDA
- European Medicines Agency (EMA), United Kingdom
Tania Teixeira is the EMA Liaison Official to FDA. She started her career in the pharmaceutical industry and joined EMA in 2004. She held positions as a Head of service for Referrals, dealing with emerging concerns which require a harmonised position across the EU, and as Product Team Leader. Tania holds a PharmD, Pharmaceutical Sciences degree, and a post-graduate degree in Regulation and Evaluation of Medicines and Health Products from the Faculty of Pharmacy, University of Lisbon.