Speakers Title & Biography

Size: px

Start display at page:

Download "Speakers Title & Biography"

Hubert Francis
5 years ago
Views:

1 Speakers Title & Biography Dr. Janice M. Soreth Deputy Director, FDA Europe Office/CDER, Liaison to EMA Dr. Soreth 20-year agency veteran with unparalleled experience, including serving as CDER's director of the division of Anti-Infectives and Ophthalmology as well as working in CBER and the Office of Combination Products/Office of the Commissioner. Dr. Soreth is FDA CDER liaison based with EMEA. Having an FDA presence in Europe greatly facilitates and enhances the large body of work on which FDA currently collaborates with its European counterpart agencies. The EMEA is one of FDA s closest regulatory partners in the area Dr. Theresa M. Finn Assoc. Director for Regulatory Policy, Office of Vaccines Research and Review, CBER, FDA Dr. Theresa Finn is the Associate Director for Regulatory Policy in the Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER), FDA. Theresa received her B.A and Ph.D from Trinity College Dublin, Ireland. After postdoctoral positions in Bern, Switzerland and Boston, Massachusetts she joined CBER in 1990 as a Visiting Scientist in the Laboratory of Pertussis, OVRR. In 1999, she took a full time regulatory position in the Division of Vaccine and Related Product Applications, OVRR. She has over 20 years of vaccine regulatory experience. This experience includes serving as reviewer on numerous INDs, and as chair and reviewer on a number of vaccine license applications and supplements. She has represented FDA and OVRR on several working groups and committees. 1 P a g e

2 Dr. Anthony Newcombe Dr. Anthony Newcombe, Principal Consultant, at PAREXEL Consulting, is a PhD Biochemist who draws on 15 years of experience providing operational & manufacturing support for late stage development activities, including process transfer, scale up and validation of biopharmaceutical production processes. Dr. Newcombe has expertise supporting the development and validation of a broad range of biologics including vaccines, antibodies and recombinant proteins and has managed pre-qualification (design space) studies in accordance with the FDA's QbD pilot regulatory submission program. Dr. Newcombe utilizes his industrial experience to provide process validation strategies and policies to support enhanced or traditional approaches to biopharmaceutical development and process validation. Prior to joining PAREXEL, Dr. Newcombe held senior leadership positions within industry as Head of Process & Product Validation, Global Industrial Operations, GlaxoSmithKline Biologicals and as a member of the Technical Leadership Team at Pfizer Biotechnology Ireland. He was responsible for developing global validation strategies for biopharmaceutical development through global implementation with a strategy of challenging industry standard practices to improve speed and efficiency of process validation. Dr. Newcombe holds a PhD in Biochemistry from the MRC National Institute for Medical Research, London and undertook postdoctoral studies to evaluate anticancer therapeutics at the Marie Curie research Institute, Surrey UK. Dr. Newcombe is a frequent speaker at industry forums, is a Fellow of the Royal Society of Chemistry (FRSC) and certified Chartered Chemist (CChem), has been a member of the PDA CMC Vaccines and ISPE working groups and is a member of the Editorial Board, Journal of Protein Expression and Purification. 2 P a g e

3 Dr. Vann Parker Vann Parker, Principal Consultant, at PAREXEL Consulting, during 25 years in the industry has been a team leader for products in all stages of development from discovery research and pre-ind stages, through market applications and post-approval support. Dr. Parker has worked in a broad range of therapeutic areas including Oncology, Neurology, Metabolism, Infectious Diseases, Inflammation and Cardiovascular, primarily focused on clinical and program management aspects. Dr. Parker provides strategic support for clients in the generation of product development plans and in preparation for Regulatory Agency review meetings. He has represented clients as their US Agent for interactions with the FDA, providing guidance and advice for timing and content of submissions. Dr. Parker has helped clients with other important aspects of development such as Orphan Drug Designation, Pediatric Investigational Plans, REMS submissions, and product labeling. At PAREXEL he has coordinated project teams to facilitate the integration of PAREXEL and client expertise. Prior to joining PAREXEL, Dr. Parker worked at Ribozyme Pharmaceuticals where he helped the company file its first IND and build a Development group. He was team leader for the program, coordinating efforts with corporate development partners. Dr. Parker began his career at Amgen, where he held various positions in Research and Development over fifteen years, including Clinical Research Project Team Leader. Dr. Parker has a PhD in Molecular Biology from Caltech and a BS in Chemistry and Biology from Duke University. His publications include papers on receptor-ligand interactions and clinical research. 3 P a g e

4 Dr. Partha Roy Dr. Partha Roy, Principal Consultant, at PAREXEL Consulting, has over 13 years of pharmaceutical R&D experience both in industry and US FDA with proven expertise in Clinical Pharmacology and Regulatory Sciences across multiple therapeutic areas (pulmonary, cough/cold/allergy, rheumatology and GI) encompassing both small molecules and biologics. Dr. Roy recently joined PAREXEL Consulting as a Principal Consultant providing strategic guidance on various clinical and regulatory aspects of drug development. His primary areas of expertise include Biosimilars and Biologics, Inhalation and Nasal drug products, Pediatric and Formulation development and OTC medications. As a FDA reviewer/team leader, Dr. Roy had extensive review experience dealing with issues around 505(b)(2) pathway, BA/BE, dose selection, PK and PK/PD, biomarkers, clinical trial design, drug-drug interactions, special populations, pediatric plan and labeling. Dr. Roy utilizes his experience to negotiate drug development plans with review divisions at FDA and develop regulatory strategies with clients for a favorable outcome. He is currently helping multiple clients mapping out regulatory strategies for drug candidates ranging from pre-ind to NDA stages, each one facing significant development challenges. Dr. Roy also frequently leads and coordinates FDA submissions (PIND, IND, NDA, postmarketing) for clients. Dr. Roy holds a PhD in Biochemical Toxicology from the College of Public Health, University of South Florida, a B.S. in Pharmacy from Jadavpur University, India, and has completed a postdoctoral training in Drug Metabolism and Pharmacokinetics at Boston University. Dr. Roy is a frequent speaker at national and international meetings and has authored several peer-reviewed articles including invited reviews. 4 P a g e

5 Mr. Joakim Steen Mikkelsen, M.Sc. Health Care & Lifesciences Attaché, Royal Danish Embassy, Washington D.C. Mr. Mikkelsen leads the Danish Foreign Ministry and Trade Councils Medical and Lifesciences efforts in the United States, providing regulatory, policy and market access guidance for the medical and pharmaceutical industry. Prior to joining the Embassy, Mr. Mikkelsen was part of the management team at CMC Biopharmaceuticals, a CMO for protein-based biopharmaceuticals. At CMC, he served as Business Development and Sales Director and assisted with obtaining and expanding its European Manufacturing Authorization. Further, Mr. Mikkelsen has obtained several certificates at the Medical Faculty of Copenhagen University within Human Care and Medicine, as well as followed executive pharmaceutical and biotech programs at the Wharton School, PA and at Rutgers Business School, NJ. Finally, Mr. Mikkelsen has completed Certificate Programs for International Regulatory Authorities, with the FDA CDRH and FDA CDER. Mr. Mikkelsen holds an international M.Sc. degree in Management of Technology from Copenhagen Business School and Rouen Graduate School of Management in France. 5 P a g e

CONTRACT RESEARCH SERVICES

CONTRACT RESEARCH SERVICES 1537 NW 65th Avenue Plantation, FL 33313 USA Phone: (954) 321-8988 Fax: (954) 321-9778 info@receptopharm.com www.receptopharm.com ReceptoPharm has installed the pathways to develop, produce and supply