Faculty – Innovative Regulatory Pathways Summit


Christopher Adams
CEO, ANDARIX PHARMACEUTICALS


Ron Bartek, President, FRIEDREICH’S ATAXIA RESEARCH ALLIANCE

Ron Bartek
President and Co-Founder, FRIEDREICH’S ATAXIA RESEARCH ALLIANCE (FARA)

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Co-founder/President, Friedreich’s Ataxia Research Alliance (FARA); Board of Directors, National Organization for Rare Disorders (NORD); 4-year member, NIH/NINDS National Advisory Council; former partner and president, government affairs firm; 20 years federal executive and legislative branches service in defense, foreign policy and intelligence: six years on Policy Staff of House Armed Services Committee; four years at the State Department, including one year on U.S. Delegation to the Intermediate-Range Nuclear Forces (INF) Treaty talks in Geneva; six years as CIA analyst of East-West balance, following graduation from the U.S. Military Academy at West Point, four years as Army officer, as company commander in Korea & Infantry and Military Intelligence officer in Vietnam; Master’s Degree in Russian Area Studies, Georgetown U.


John Billington
Director, U.S. Public Policy, Vaccines, GLAXOSMITHKLINE


Jennifer Dudinak, Pharm.D.
Vice President Global Regulatory Affairs Oncology and Head, Pharma Regulatory Therapeutic Teams, GLAXOSMITHKLINE

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Jennifer Dudinak, Pharm.D. is Vice President Global Regulatory Affairs Oncology and Head, Pharma Regulatory Therapeutic Teams at GlaxoSmithKline. Her primary strategic focus is to lead global regulatory therapeutic teams across the R&D portfolio and Franchises to deliver innovative global regulatory strategies and drive development and implementation of policies and strategies for optimization of drug development. Jennifer has worked across all phases of drug development, including small molecules and biologics, for over 20 years. She has held multiple senior leadership roles in regulatory across a variety of disease areas (e.g., oncology, virology, immuno-inflammation, Ophthalmology) with an emphasis on precision medicine and development of novel approaches to advance regulatory pathways. Jennifer has overseen numerous global regulatory filings and approvals in her career, including NCEs, combination therapies and medicines with a companion diagnostics. Jennifer received a Bachelor of Pharmacy and Doctorate of Pharmacy from Rutgers University. Jennifer joined GSK from Roche/Genentech where she served for over 15 years. Prior to that, Jennifer practiced in community, retail and hospital pharmacy as well as a founding member of Heart to Hearts, a non-profit women’s wellness organization with the aim to empower women through education.


Chitra Edwin, Director of Regulatory and Quality Affairs, CLEVELAND HEARTLAB

Chitra Edwin
RAC Senior Vice President of Regulatory Affairs and Compliance, SPOTLIGHT INNOVATION

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Chitra Edwin, Ph.D., RAC, is the Director of Regulatory and Quality Affairs at the Cleveland HeartLab in Cleveland, OH. She has been a key member in the development of infectious diseases, oncology and cardiovascular products.

Dr. Edwin is an adjunct associate professor of pharmaceutical sciences at the University of Cincinnati.

Dr. Edwin founded Biotechnology Consulting Solutions, Ltd. in 2006. Dr. Edwin obtained her Ph.D. from the University of Minnesota, and received post-doctoral training at the Harvard Medical School and the Dana Farber Cancer Institute. She is Regulatory Affairs board certified (RAC). She was a Review Board member of Opus Institutional Review Board (IRB).


Jayne C. Gershkowitz
Senior Vice President and Chief Patient Advocate, AMICUS THERAPEUTICS

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Jayne is a long-time patient advocacy professional with expertise on issues affecting individuals with rare diseases and the partnership between the patient community and industry in orphan drug development.

She joined Amicus in 2006, with increasing operational and leadership responsibilities for the company’s highly regarded Patient Advocacy function. Jayne currently leads relationship management strategy and execution with patient and healthcare professional key opinion leaders. Founder of the Patient Advisory Boards program, she guides Amicus’ patient focus and gives voice to patient concerns regarding disease management, unmet medical need, the communication of clinical trial results and access. Through Public Policy activities, she helps Amicus as an agent for safe, expedited change of public policies to satisfy unmet need among those living with rare diseases. She also directs Amicus’ Grants & Charitable Contributions Program.

Jayne serves on industry and association boards and committees and is co-founding board member of the newly established Professional Patient Advocates in Life Sciences, a nonprofit organization.


Brian E. Harvey, M.D., Ph.D.
Executive Vice President, Scientific and Regulatory Affairs, GLOBAL LIVER INSTITUTE

Former Vice President U.S. Regulatory Strategy, PFIZER

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Brian E. Harvey, M.D., Ph.D. is a physician and biochemist with academic research, clinical practice, U.S. FDA regulatory, bio-pharmaceutical industry and non-profit experience. He currently is Principal Consultant at Brian E Harvey LLC (https://www.facebook.com/brian.harvey.3348) providing regulatory advice for biologics, drugs and medical device development programs. In addition, he volunteers as the Executive Vice President, Science and Regulatory at the non-profit Global Liver Institute (www.globalliver.org) based in Washington, DC. Prior to his current activities, Dr. Harvey held positions as Vice President of U.S. Regulatory Strategy at Pfizer and Vice President of U.S. Regulatory Policy at Sanofi-Aventis, including during the period of the Genzyme merger (https://www.linkedin.com/in/brian-harvey-14788910/).

Dr. Harvey also held several senior roles at FDA, serving in the medical device (CDRH), biologic (CBER) and drug (CDER) Center from 1995 to 2007. As Director of CDER Division of Gastroenterology Products Office of New Drugs (OND), he headed the regulatory review teams for NDA and BLA submissions and chaired FDA meetings with regulated industry on a regular basis. As Director, he created the Inborn Errors of Metabolism Team within the GI division to focus on rare disease product approvals. Prior to this, he served as Deputy Director of the Office of Drug Evaluation 5 (CDER) and CBER Associate Director for Policy, Office of Therapeutics Research and Review (OTRR).

Brian graduated with honors from Middlebury College in Vermont. After college, he received his Ph.D. in biochemistry, followed by his MD at the University of Connecticut. In his last year of medical school, he began post-doctoral research on colorectal cancer and the role of sialic acid in site-specific metastasis at Harvard University. He completed his internship and residency in internal medicine at Harvard’s Beth Israel Hospital, which included clinical rotations at Dana-Farber Cancer Institute, West Roxbury Veterans Hospital, clinical research at Brigham and Women’s Hospital and the Harvard School of Public Health. His bench research activities resulted in several publications in peer reviewed journals. This was followed by a three-year gastroenterology fellowship at Johns Hopkins Hospital, Baltimore, MD, which included hepatology training and being a member of the Liver Transplant Service.


Stephen Hoffman
CEO, SANARIA INC


Sophia Kourliouros, Senior Manager, Regulatory Submissions, EISAI

Sophia A. Kourliouros
Senior Manager, Global Regulatory Operations, EISAI INC.

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Sophia Kourliouros is a Senior Manager in Regulatory Operations at Eisai Inc. Sophia has more than 13 years of experience in electronic submissions publishing (eCTD) and management. She serves as a Global Submission Manager and has successfully submitted and continues to lead Initial IND, Original (simultaneous) Global NDA/MAA/NDS and CTA/IMPD submissions in addition to Emerging Markets, specifically in Brazil, Mexico and the ASEAN market. Sophia is the lead contact for all CPP/Legalization/Apostille requests within Eisai. Sophia has greatly contributed toward business process improvements and is focusing on global standardization and harmonization activities within the company.


Lawrence Liberti, MSc
Executive Director, CENTER FOR INNOVATION IN REGULATORY SCIENCE (CIRS)


Tooba Murshedkar
Senior Director, Regulatory Affairs, SANARIA INC.


Lisa Parks, R.Ph.
Vice President, Sciences and Regulatory Affairs, ASSOCIATION FOR ACCESSIBLE MEDICINES

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Lisa holds a BS in Pharmacy from the Massachusetts College of Pharmacy in Boston, MA. In her current role, she assists with the development of AAM’s Scientific Affairs initiatives as well as member communications and training opportunities for these initiatives. She serves as the primary point of contact for relations with offices of the FDA and the USP. She is involved with facilitating discussions and efforts on bioequivalence; research and development of drug substance and drug product; IID; emerging technology; quality metrics; CMC; ICH initiatives; and FDA guidance and policy development. She also develops, plans, and coordinates AAM’s annual Fall Technical Conference, the annual CMC Workshop, and is involved in developing and planning the science and regulatory session at AAM’s Annual Meeting which targets key senior-level leaders across the generic drug industry. Lisa served as a key member of AAM’s team negotiating with the FDA on the reauthorization of both the Generic Drug User Fee Amendments (GDUFA II) program and the Biosimilar User Fee Act (BsUFA II).

Prior to joining AAM, Lisa held crucial positions in various Offices at the FDA’s Center for Drug Evaluation and Research (CDER). She began her FDA career at the Office of Generic Drugs (OGD) as a regulatory filing reviewer, where she enhanced the filing review checklist to better allow a regulated industry to submit substantially-complete applications and served as the FDA’s point of contact with industry for the IID improvement initiative and PIV website updates. Lisa’s ability to drive cross-functional teamwork led to her appointment as a key representative by the Director of OGD for the initial implementation of GDUFA I. She moved on to support the implementation of GDUFA I at the Center level and played a key role in the establishment of CDER’s Office of Pharmaceutical Quality (OPQ).


Usha Ramesh, Ph.D.
PMP Executive Director, Regulatory Affairs, CMC, PHARMACYCLICS, AN ABBVIE COMPANY


Alejandro D. Ricart, M.D.
Executive Medical Director, Oncology, Early Development Strategy and Innovation, NOVARTIS

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Alejandro D. Ricart is Executive Medical Director at Oncology Early Development Strategy & Innovation at Novartis Pharmaceuticals Corporation. In this position, he is part of the Oncology Senior Leadership Team and is responsible for the portfolio from first-in-human studies through proof of concept. Prior to this role, Alex was Senior Director Late Development for Merck Oncology. He played a key role in Pembrolizumab Breakthrough Therapy Designation and in the Supplemental Biologics License Application (sBLA) for Hodgkin lymphoma.

Alex was also a Director of Biotechnology and Oncology Clinical Research at Pfizer Inc. in San Diego, California. He participated in the clinical development of several investigational compounds, including Axitinib and Bosutinib. He was a Medical Oncologist in Urologic Oncology at Instituto Oncologico Henry Moore in Buenos Aires.

Alex has been an investigator on over 60 clinical trials in cancer, including several studies of immunotherapy, monoclonal antibodies, antibody-drug conjugates, signal transduction inhibitors and antiangiogenic agents, in all phases of clinical development. He completed an Advanced Oncology Drug Development / Medical Oncology Program at the Institute for Drug Development, Cancer Therapy, and Research Center and at the Division of Medical Oncology, University of Texas Health Science Center at San Antonio. He has published more than 80 journal articles, abstracts, reviews, and book chapters; including several first-authored articles in Clinical Cancer Research, Nature Reviews Clinical Oncology, Cancer Chemotherapy and Pharmacology, Clinical Pharmacology & Therapeutics and the Annals of Oncology. Dr. Ricart’s honors include receipt of the ASCO Foundation Merit Award in 2006.

Early in his career, Alex was a Consultant Oncologist at Cvitkovic & Associés Consultants SA (Paris, France). He also served as an Assistant Professor of Pharmacology at the Universidad de Buenos Aires, and as a Professor of Pharmacology at Universidad Hebrea Argentina Bar-Ilan until 1999. He was a fellow at the Department of Medical Oncology at the Instituto Alexander Fleming and holds an M.D. from the Universidad de Buenos Aires.


Joseph A. Sliman, M.D.
MPH Chief Medical Officer, SYNTHETIC BIOLOGICS


Mark Stewart, Ph.D.
Senior Science Policy Analyst, FRIENDS OF CANCER RESEARCH

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Mark Stewart is a senior science policy analyst at Friends of Cancer Research (Friends). Friends is an advocacy organization based in Washington, DC that drives collaboration among partners from every healthcare sector to power advances in science, policy, and regulation that speed life-saving treatments to patients. During the past 20 years, Friends has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible.

Prior to joining Friends, Mark worked at the National Academies of Sciences, Engineering, and Medicine. At the Academies, he assisted with a congressionally-mandated study that resulted in the report titled Ovarian Cancers: Evolving Paradigms in Research and Care. This report identified gaps in ovarian cancer knowledge and care and provided recommendations to overcome these gaps. Mark also helped workshops for the National Cancer Policy Forum.

At Friends, Mark leads the development of evidence-based policies that will improve care for cancer patients and survivors, facilitates dialogue between stakeholders through the organization of conferences and symposia, and advocates on behalf of cancer patients and survivors.

Mark has served on several committees, including the Associate Member Council of the American Association for Cancer Research (AACR) and the North Central Alabama Race for the Cure Committee. During his tenure on the Associate Member Council, Mark served as the 2015-2016 Chair and helped direct efforts to ensure the unique needs of early-career investigators were known and addressed through resources and programming at AACR. Mark continues to advocate for sustained biomedical research funding to maintain a predictable funding environment to allow for continued innovation and novel discoveries in cancer research.

Mark received his Ph.D. in cancer biology from the University of Alabama at Birmingham and was a recipient of NCI’s Ruth L. Kirschstein National Research Service Predoctoral Award.


Andrew Storey
Vice President, Global Regulatory Strategy, ABBVIE

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Andrew Storey has over 30 years in the biopharmaceutical industry providing leadership for Regulatory Affairs. He is presently Vice President, Global Regulatory Strategy for AbbVie and was a VP with global responsibilities for the previous 14 years at Cangene (Toronto) and CBL (Baltimore). Prior to that, he held several regulatory positions in small biotech companies. He has also had VP responsibilities for Clinical Research, Medical Affairs, Quality Assurance and Quality Control in addition to his Regulatory Responsibilities. Post 9/11, he spent 11 years working on the development of Medical Countermeasures to Bioterrorism and worked with CDC, NIH and BARDA to install multiple biodefense products into the US Strategic National Stockpile (SNS) as well as in other global stockpiles. He is presently applying his expertise to exciting challenges at AbbVie including a comprehensive pipeline of Oncology products at.


Nicholas Tantillo
Head, Policy and Regulatory Strategy, SANDOZ INC


Dr. Henrietta Ukwu
Senior Vice President, Head of Global Regulatory Affairs, OTSUKA PHARMACEUTICAL COMPANIES

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Dr. Henrietta N. Ukwu, M.D., FACP, FRAPS, is a physician, infectious diseases expert, professor, pharmaceutical industry executive, thought leader, and author of the landmark textbook, Global Regulatory Systems – A Strategic Primer for Biopharmaceutical Product Development and Registration. Dr. Ukwu was named to the 2011 PharmaVoice 100 list of most inspiring industry leaders and the November 2012 TOPRA award for Most Inspiring Leaders. Dr. Ukwu is currently Senior Vice President Global Regulatory Affairs Otsuka Pharmaceutical (OPDC) Dr. Ukwu joined Otsuka in January 2013 from PPD Inc. where she was Senior Vice President and Head, Global Regulatory Affairs from 2010 to 2012. She has led numerous successful global regulatory product development activities across all regions and is directly responsible for over 25 original and key product approvals across multiple therapy areas and platforms. In addition, Dr. Ukwu serves on company executive and senior leadership committees, several scientific committees, and boards including NAPPSA Foundation that enhance public health policies. Dr. Ukwu has led major initiatives to drive regulatory excellence and redefined the role of regulatory affairs as an interactive, intellectual, strategic business partner and company resource to achieve significant public health goals. She has made significant contributions to medicine, science and pharmaceutical industry including developing and enriching the regulatory profession as well as producing many protégés in senior leadership positions in industry. She has received numerous awards and recognition for these contributions including Fellow of the Regulatory Affairs Professional Society and Fellow of the American College of Physicians and most recently the prestigious 2014 Otsuka President’s achieving excellence award. Dr. Ukwu is a pioneer professor of Temple University’s Quality Assurance / Regulatory Affairs graduate program.


Colin Vechery
Manager, U.S. Regulatory Affairs–Strategy, BIOGEN

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Dr. Colin Vechery received his Pharm.D. from Duquesne University located in Pittsburgh Pennsylvania. During his time at Duquesne, he partook in many internships including the FDA Division of Neurology and Psychiatry, Eli Lilly Department of Pharmacovigilance, and United States Pharmacopeia: Healthcare Quality Standards. After graduation, Dr. Vechery completed a Global Regulatory Strategy Post-Doctoral Fellowship with Allergan while working as an adjunct clinical professor at St. Johns University College of Pharmacy and Health Sciences. During his time at Allergan, Dr. Vechery worked on developing products in the Anti-Infective, CNS, and GI therapeutic areas. Throughout his years at Allergan, he developed skills in a multitude of areas across all stages of product development and regulatory engagement and led the planning and execution for pursuing a Sakigake designation for a key product. Currently, Dr. Vechery works at Biogen in Regulatory Affairs working on developing products for Alzheimer’s, Multiple Sclerosis, and Neuropathic Pain.


Stacy Woeppel
Advocate in Science, SUSAN G. KOMEN

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Stacy Woeppel is currently working as a Deputy Director in Regulatory Affairs at Sanofi Pasteur. During her 20 years of experience within the pharmaceutical industry, she has worked in various stages of the drug development process. She started her career as a preclinical pharmacologist in the area of immunology/allergy at Wyeth (now Pfizer) and moved into the clinical arena as both a CRA (CRO) and Clinical Trial Manager (Eisai) in the areas of HIV and oncology, before working as a regulatory/medical writer (Sanofi Pasteur & ISI).

Her regulatory affairs experience (CSC, B. Braun, Sanofi Pasteur) includes US pre- and post-marketing activities. Throughout her career, she has remained focused on making a difference in the lives of patients and is currently an Advocate in Science member for Susan G. Komen. As a patient advocate, she works with governmental organizations, such as the Reagan-Udall Foundation, on “big data projects” and expanded access.