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  • Speakers

  • Jennifer Ahearn

    Jennifer D. Ahearn

    Jennifer Ahearn specializes in pharmaceutical and medical device regulatory compliance. She has served numerous roles within the FDA including bench chemist, domestic and international investigator, technical liaison for FDA’s Office of Criminal Investigations, and member of FDA’s National Training Cadre making her an expert in the interpretation and application of cGMP regulations in 21 CFR 210/211 relating to pharmaceutical manufacturing, and 21 CFR 820 relating to medical devices. Mrs. Ahearn has assisted pharmaceutical and medical device companies preparing for FDA inspections, as well as responding to FDA 483 observations after an inspection. She has worked to resolve technical and FDA compliance issues for virtually all pharmaceutical dosage forms and medical device classes. Mrs. Ahearn has worked with manufacturers with such aspects as sterility, material supply chain, vendor auditing, validation programs, laboratory and manufacturing investigations, laboratory and manufacturing audits, and CAPA implementation.

    Julie Aker

    Julie L. Aker, BS, MT (ASCP)

    Julie Aker, MT(ASCP) is the President and CEO at Concentrics Research and provides consultation in the areas of regulatory and program strategy for new OTC and RX development programs for drugs and devices. Aker has been involved in over 600 consumer behavior studies and is often a key speaker at industry trade meetings, with regulatory authorities in the US and ROW, sponsors and industry meetings and key agencies such as FDA, CDC, NIH, Health Canada, Consumer Health Products Canada, and MHRA. She has been involved in creating novel methods, presenting webinars and contributing to manuscripts, and has over 30 years of healthcare experience working with patient outcomes in large healthcare systems and over 20 years’ experience in clinical research, including consumer behavior research. Aker has been invited to speak at Brookings Institution, NIH, CDC, and has participated in key FDA meetings such as a Part 15 Hearing for NSURE and various Advisory Committees including those for Consumer Behavior Methods (which included input about label comprehension, self-selection and actual use studies that led to Guidances for Label Comprehension and Self-Selection), Risk Communications, Approaches Using Antivirals for Pandemics and various Advisory Committees for new drugs and devices.

    Donald Ashley

    Donald Ashley, J.D.

    As Director of CDER’s Office of Compliance, Donald Ashley, J.D., leads efforts to shield the American public from unsafe, ineffective, and low-quality drug products through measures designed to assist industry-wide compliance with federal standards for quality and safety, as well as regulatory and enforcement measures to address violations of those standards.

    Ashley joined FDA after more than 18 years of criminal enforcement and investigation experience with the Department of Justice. His positions included serving as a Trial Attorney in the Office of Consumer Litigation (now the Consumer Protection Branch), prosecuting consumer fraud offenses and violations of the Food Drug and Cosmetic Act, as Associate Director of the Office of International Affairs, and as the DOJ Attaché stationed at the U.S. Embassy in Rome and at the U.S. Embassy in Manila, Philippines.

    He also served on active duty as an Army captain assigned to the Office of General Counsel, Department of the Army. Ashley was an adjunct professor of law at Georgetown, George Washington, American, and Catholic Universities. He earned his law degree from Harvard Law School.

    Laura Bix

    Laura Bix, Ph.D.

    Laura Bix, Ph.D., is the Assistant Dean for Teaching, Learning and Academic Analytics for the College of Agriculture and Natural Resources and a Professor at the School of Packaging at Michigan State University. She specializes in healthcare packaging at MSU, where she has been recognized with an Excellence in Teaching Award (2007). She has served as an expert to international and national panels convened by ISO, the US Food and Drug Administration (FDA), the US Centers for Disease Control and Prevention (CDC), the Consumer Healthcare Products Association (CHPA) and the Gerontological Society of America (GSA). In 2008 when she was named one of the 100 most notable people in the medical device industry by Medical Device and Diagnostics Magazine and her multidisciplinary efforts regarding healthcare packaging and ease of use were honored again in 2014 when she was awarded the Phi Kappa Phi Excellence in Interdisciplinary Scholarship Award. More recently, her leadership skills were recognized when she was appointed as an academic fellow of the CIC’s Academic Leadership Program. Work from her group has been published or highlighted in numerous outlets, including: PLoS One, The Proceedings of the National Academy of Sciences of the US, Consumer Reports and Men’s Health.

    Lucinda Buhse

    Lucinda F. Buhse, Ph.D.

    Lucinda (Cindy) Buhse is currently the Director for the Office of Quality Surveillance (OQS) in the Office of Pharmaceutical Quality (OPQ) in the Center of Drug Evaluation and Research in the US Food and Drug administration (FDA). Dr. Buhse joined FDA in 2001 in OPQ’s Office of Testing and Research. She was Director for Office of Testing and Research from 2013 to 2017. Before joining the FDA, Dr. Buhse worked in management positions in Production, Validation and Analytical Services at Sigma Aldrich Corporation and as a Senior Research Scientist for Rohm and Haas Company. Dr. Buhse received a B.A. in Chemistry from Grinnell College and a Ph.D. in Physical Chemistry from the University of California, Berkeley. OQS assures that quality medicines are available through signal detection, data analysis, review of the state of quality and proactive stakeholder engagement.

    Timothy Caulfield

    Timothy Caulfield

    Professor Timothy Caulfield is an unrivalled communicator who debunks myths and assumptions about innovation in the health sector — from research on stem cells to diets to alternative medicine — for the benefit of the public and decision-makers. He is a Canada Research Chair in health law and policy, a professor in the Faculty of Law and the School of Public Health, and a research director of the Health Law Institute at the University of Alberta.

    Over the past several years, Caulfield has been involved in a variety of interdisciplinary research endeavors that have allowed him to publish more than 350 articles and book chapters. His research focuses on topics like stem cells, genetics, research ethics, and the public representations of science and health policy issues. The recipient of numerous academic and writing awards, Caulfield is also a Fellow of the Royal Society of Canada and the Canadian Academy of Health Sciences.

    Caulfield also writes frequently for the popular press on a range of health and science policy issues and is the author of two national bestsellers: The Cure for Everything: Untangling the Twisted Messages about Health, Fitness and Happiness and Is Gwyneth Paltrow Wrong About Everything?: When Celebrity Culture and Science Clash. His most recent book is The Vaccination Picture. He is also the host and co-producer of the award-winning, hit documentary TV show, A User’s Guide to Cheating Death, which has been shown in over 60 countries and is currently streaming on Netflix.

    Aditya Dinge

    Aditya Dinge, Ph.D.

    Aditya Dinge is the Head of GMP Operations at Bayer Consumer Health, Morristown , NJ. He manages all aspects of the Global Research and Development Center’s GMP Pilot Plant including manufacture of new Consumer Health products for clinical trials/consumer testing, raw material management, equipment qualifications, cleaning validation master plan and special innovation projects. He has over 8 years of experience in various areas of the industry like formulation development, technology transfer, process development and supply chain project management. Aditya has held positions with increasing responsibilities at Bayer Consumer Health in the US and Europe. He has a PhD in Pharmaceutics from Temple University in Philadelphia.

    Valerie Gallagher

    Valerie Gallagher

    Valerie Gallagher has been employed by Perrigo Company for 22 years, serving in a variety of roles with increasing management responsibility within Regulatory Affairs. She is currently Vice President, Consumer Self-Care Americas Regulatory Affairs, the department responsible for cradle-to-grave management of activities for over-the-counter NDA/ANDA Drug products, Rx-to-OTC Switch products, Monograph Drug products, Medical Device products, Cosmetic products, and Personal Care products for US and Canadian markets. She has significant experience in setting and executing Regulatory strategies for these categories as well as DEA functions. She has been very active with pharmaceutical industry groups and is currently Chair, CHPA Regulatory & Scientific Affairs Committee (RSAC).

    Rosemary Gibson

    Rosemary Gibson

    Rosemary Gibson is Senior Advisor at the Hastings Center and award-winning author of China Rx: Exposing the Risks of America’s Dependence on China for Medicine which reveals the dramatic shift in where medicines are made and growing concerns about their quality. Ms. Gibson testified before the House Energy and Commerce Health Subcommittee in October 2019 and the U.S.-China Economic and Security Review Commission in July 2019. At the Robert Wood Johnson Foundation, Ms. Gibson was chief architect of its successful twelve-year $250 million national strategy to integrate palliative care in the nation’s acute care hospital.

    Barb Kochanowski

    Barb Kochanowski, M.S., Ph.D.

    Barbara Kochanowski is responsible for regulatory affairs activities, including cooperative programs with the U.S. Food and Drug Administration, ingredient safety, and dietary supplement programs at CHPA. Prior to joining CHPA in 2009, Kochanowski received her B.S. from Pennsylvania State University, her M.S. and Ph.D. in Nutritional Sciences from the University of Illinois. Kochanowski worked for more than 23 years in R&D at The Procter & Gamble Company (P&G), She is experienced in pharmaceutical, medical device, and dietary supplement regulatory affairs, Rx-to-OTC switch, product safety, clinical research, and pharmacovigilance. Kochanowski is a member of the American Society of Nutrition. She also serves on the board of directors of the American Foundation for Pharmaceutical Education.

    Theresa Michele

    Theresa M. Michele, M.D.

    Dr. Theresa Michele is the Director of the Division of Nonprescription Drug Products (DNDP) in the Office of New Drugs, Center of Drug Evaluation and Research (CDER), at the Food and Drug Administration (FDA). Previously the Director of the Division of Nonprescription Clinical Evaluation (OTC products regulated via the New Drug Application process), Dr. Michele oversaw the merger of that division with the Division of Nonprescription Regulation Development (OTC drugs regulated via the monograph process) to form DNDP. Prior to joining FDA, she spent 10 years in industry, with clinical research experience across a variety of therapeutic areas in both commercial and development stage companies. Dr. Michele left industry in 2007 to join the FDA in the Division of Pulmonary and Allergy Drug Products, where she served as both a clinical reviewer and team leader. She is board certified in internal medicine, pulmonary medicine, and critical care medicine, completing her training at Johns Hopkins University, where she currently serves on the faculty. She obtained her BS in Integrated Life Sciences from Kent State University and MD from Northeastern Ohio Universities College of Medicine as part of a 6-year combined program.

    Amanda Pike-McCudden

    Amanda Pike-McCrudden

    Amanda Pike-McCrudden is a social science analyst in the Division of Nonprescription Drug Products (DNDP), a division within the Office of Drug Evaluation IV (ODE IV) of FDA’s Center for Drug Evaluation and Research (CDER) charged with reviewing over the counter products. Pike-McCrudden was previously an ORISE Fellow within DNDP before joining the division in her current role in 2016. Trained as a Medical Anthropologist, she is interested in the intersections of culture and health, and has conducted extensive fieldwork in the areas of health education, maternal health, immigration and migration.

    Peter Stein

    Peter Stein, M.D.

    Peter Stein, M.D., is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products. OND provides guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters.

    A nationally-recognized leader in pharmaceutical research and development, Dr. Stein joined CDER in 2016 as the OND Deputy Director. Before coming to FDA, he served as Vice President for late stage development, diabetes, and endocrinology at Merck Research Laboratories. He also served as Vice President, head of metabolism development at Janssen. He has more than 30 years of academic, clinical, and industry experience.

    Dr. Stein holds a bachelor’s degree in history from the University of Rochester in New York and a medical degree from University of Pennsylvania. He trained at Yale University and Yale-New Haven Hospital in internal medicine and in endocrinology and metabolism.

    Catherine Vicente

    Catherine Vicente, M.S.

    Catherine Vicente has been with Johnson & Johnson for 12 years and has her Master’s Degree in Clinical Research & Organizational Management. Vicente began her career as an analytical chemist doing both stability testing and method development, and in later years became involved in Compendial Review activities for Johnson & Johnson’s OTC drug Consumer Sector. She is now the manager for Johnson & Johnson’s ERO (Enterprise Regulatory Outreach) group and is heavily involved in External Engagement.

     

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