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  • Speakers

  • Barbara Adams

    Barbara Adams

    Dr. Adams is the Founder of GAR (Gender, Age and Race) Diversity Consulting, based in the San Francisco Bay Area, and author of the bestselling book Women, Minorities, and Other Extraordinary People: The New Path to Workforce Diversity (Greenleaf Press, Sept. 2018). She holds a Doctorate of Psychology in Organizational Development. Dr. Adams is a former director in the National Diversity & Inclusion Office at Kaiser Permanente (KP), consistently ranked among the top performers in the DiversityInc Top 50 annual survey. Before KP, Dr. Adams worked for 10 years as a global management and technology consultant for American Management Systems (now CGI).

    Jennifer Ahearn

    Jennifer D. Ahearn

    Mrs. 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.

    Donald Ashley

    Donald Ashley, J.D.

    As Director of CDER’s Office of Compliance, Donald D. 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.

    Mr. 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.

    Before joining DOJ, Mr. Ashley served as senior litigation associate with a major D.C. law firm, representing clients under investigation for FD&C Act violations. He also served on active duty as an Army captain assigned to the Office of General Counsel, Department of the Army. Mr. Ashley was an adjunct professor of law at Georgetown, George Washington, American and Catholic Universities.

    Mr. Ashley earned his law degree from Harvard Law School.

    Eric Brass

    Eric Brass

    Dr. Eric Brass received his M.D. and Ph.D. (Pharmacology) degrees from Case Western Reserve University. He completed an internal medicine residency and clinical pharmacology fellowship at the University of Washington. After holding faculty positions at the University of Colorado and Case Western Reserve University, Dr. Brass moved to the UCLA School of Medicine where he was Chair of the Department of Medicine at the Harbor-UCLA Medical Center from 1994-2000. He is currently Director of the Harbor-UCLA Center for Clinical Pharmacology and Professor Emeritus, David Geffen School of Medicine at UCLA. Dr. Brass has long standing interests in drug discovery, development and regulation, with a particular focus on the challenges of prescription to OTC switches. He served as a member, and then as Chair, of the FDA’s Nonprescription Drugs Advisory Committee. Dr. Brass has authored over 160 scientific papers.

    Anita Brikman

    Anita Brikman

    Anita Brikman joined CHPA in 2016 and is responsible for leading the association’s communications and public affairs functions, as well as leading the CHPA Educational Foundation. She is a member of the senior management team and responsible for establishing and directing the organization’s communications strategies and goals. Anita leads all external and internal association communications and public affairs campaigns. In addition, she directs the CHPA Educational Foundation, including working with its board of directors to establish priorities, achieve financial independence and growth, and ensure successful execution of the foundation’s consumer education campaigns.

    Prior to joining CHPA, Anita served as Senior Vice President, Communications and Outreach, at the National Hospice and Palliative Care Organization (NHPCO) where she led communications and marketing for the association and its affiliates, including the National Hospice Foundation. For more than two decades prior to her association work, Brikman worked as a news anchor and health reporter in the major television markets of Philadelphia, Pa., (WPVI 6ABC) and Washington, D.C., (WUSA 9), where she served as chief medical correspondent directing coverage on a wide range of healthcare issues.

    David Campbell

    David Campbell, M.S., M.B.A.

    David Campbell holds the position of vice president of regulatory affairs and policy, NA with RB, a consumer healthcare products company with U.S. headquarters in Parsippany, N.J. He has held this position since 2013.

    Prior to joining RB, Campbell was the NA regional regulatory lead for Pfizer Consumer Healthcare preceded by a similar role within RB. Before entering the consumer healthcare space in 2009, Campbell held various roles in R&D and regulatory for multiple prescription drug companies, most recently Sanofi.

    In addition to CHPA, Campbell currently serves as the chair of the board of directors for the Household and Consumer Products Association (a one-year term for 2018) and is chair-elect of the board of directors of the Council for Responsible Nutrition (a two-year term ending in 2020).

    Jesse Catlin

    Jesse Catlin, Ph.D.

    Jesse Catlin is an Associate Professor of Marketing at California State University, Sacramento. His research focuses on consumer behavior, with an emphasis on pharmaceutical marketing and health decision-making, including how consumers process and interpret over-the-counter drug information. He holds a Ph.D. in Management with an emphasis in Marketing from the University of California, Irvine in addition to M.A. and B.A. degrees in Economics from California State University, Sacramento.

    Aditya Dinge

    Aditya Dinge

    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.

    Rose Mary Dollard

    Rose Mary Dollard

    Rose Mary Dollard is currently a Senior Director of Regulatory Compliance in Johnson & Johnson’s enterprise compliance organization. She has over 30 years of driving lean solutions in quality, compliance and manufacturing spanning across consumer, pharmaceutical and medical device industries. Her broad range of experience includes leadership roles in quality, compliance and supply chain functions that support fast-paced manufacturing environments, with strengths in business acquisitions, efficient quality & compliance program development as well as strong knowledge of solid oral dose, solution, suspension, and packaging manufacturing technologies. She was responsible for the design and deployment of several novel compliance solutions across global J&J businesses, including establishing robust compliance assessment and remediation programs and a progressive, science and risk commissioning & qualification methodology. Rose Mary is an active member CHPA’s Dietary Supplement and Product Quality Manufacturing Committees. She has authored chapters in several publications including, Good Design Practices for GMP Pharmaceutical Facilities (Drugs and the Pharmaceutical Sciences), 2nd Edition and the ISPE Good Practice Guide on Applied Risk Management for Commissioning and Qualification.

    Brandon Essink

    Brandon Essink

    Brandon Essink is a board certified Family Medicine physician who currently serves as a principal investigator for Meridian Clinical Research in Omaha, NE. He also serves as Medical Director of US sites for Meridian. He has 16+ years of research experience in all Family Medicine therapeutic areas with an emphasis on vaccine research. He also has experience serving as a medical monitor for multiple trials and has authored multiple journal articles while serving as coordinating investigator. In addition to his research practice, he also practices as an emergency room and hospitalist physician, primarily utilizing telemedicine modalities, serving rural communities in Nebraska, South Dakota and Kansas. He received his MD from the University of Nebraska Medical Center and completed his residency and rural fellowship at the University of Nebraska Medical Center.

    Guliz Guler

    Guliz Guler

    Guliz Guler has more than 15 years of work experience where she experienced different aspects of healthcare environment including clinical pharmacy, retail pharmacy and pharma industry. She has a strong regulatory expertise in different areas including Consumer Healthcare Products, Pharmaceutical Products, Medical Devices, Food Supplements and Digital Products. She led local regulatory activities in different countries where she played a very strategic role for enabling new product innovations.

    She has a strong management and technical skills where she can manage complex issues and lead cross functional teams effectively. She has a strong understanding of global regulatory environment and ability to influence internal and external stakeholders. She is a strategic thinker and can manage challenging regulatory environment.

    Guliz received a Bachelor of Pharmacy Degree from Gazi University in Turkey and completed The Industrial Pharmacy Residency Program from University of Toronto.

    She is currently working at GSK Consumer Healthcare at Warren NJ, US as ‘” Associate Director Regulatory Affairs Digital and Respiratory.”

    Carlos Gutierrez

    Carlos Gutierrez, M.A.

    Carlos Gutiérrez is responsible for the development and implementation of state governmental affairs strategies for the association. He advocates on behalf of CHPA and advises member companies on legislation and regulations affecting their interests. Prior to joining CHPA, Gutiérrez was assistant vice president of State & Local Government Affairs for the National Association of Home Builders (NAHB). Operating within NAHB's Government Affairs Division, he managed state and local legislative and regulatory issues in the 50 states cooperatively with NAHB's 850 state and local affiliates nationwide.

    Before locating to Washington, D.C., Gutiérrez was on the governmental affairs staff for both the Texas Association of Builders and the Home Builders Association of Greater Austin. He also served as a neighborhood housing consultant for the NBA's San Antonio Spurs during the construction of the AT&T Center in San Antonio, and also had stints with the City of Austin and the Congressional Research Service.

    Gutiérrez is a member of the Washington Area State Relations Group, the State Government Affairs Council, the LBJ School D.C. Alumni Group, and serves on the Professional Advisory Board for Texas Tech University's College of Mass Communications.

    Lawrence Halprin

    Lawrence Halprin

    Lawrence Halprin is nationally recognized for his work in the areas of occupational safety and health, and chemical regulation. He represents clients in Federal and state enforcement actions, incident investigations and audits, compliance counseling, agency rulemakings, development of formal agency guidance documents and pre-enforcement challenges to final agency rules before OSHA, EPA and NIOSH. His practice includes: chemical hazard communication (US, Canada and the EU), Prop 65, EPA’s Risk Management Program Rule, CERCLA and EPCRA chemical release and right-to-know reporting, ethanol regulations enforced by the U.S. Treasury and investigations conducted by the Chemical Safety Board. Mr. Halprin represents clients in the development of national consensus standards and appeals of actions taken by consensus bodies. He has extensive experience with risk assessment, compliance management, strategic planning and product stewardship programs.

    Carolyn Herrmann

    Carolyn Herrmann, Esq.

    Carolyn Herrmann is responsible for providing legal advice and recommendations to Association staff and members on key issues affecting the OTC and dietary supplement industry, representing industry interests on a range of food and drug law regulatory matters, assisting with Association policy development, and managing various industry projects through direct engagement with member company representatives. Prior to joining CHPA in June 2012, Herrmann was an attorney at Shook, Hardy & Bacon LLP, practicing in the Pharmaceutical and Medical Device Litigation Division, where she focused primarily on counseling and defending product-liability actions against pharmaceutical and medical device manufacturers.

    Herrmann is a member of the American Bar Association and D.C. Bar Association.

    Denise Hinton

    Denise Hinton

    Rear Admiral Denise Hinton is FDA’s Chief Scientist. In this capacity, she is responsible for leading and coordinating FDA's cross-cutting scientific and public health efforts. The Office of the Chief Scientist works closely with FDA’s product centers, providing strategic leadership and support for FDA’s regulatory science and innovation initiatives, including the Advancing Regulatory Science Initiative, the Critical Path Initiative, health informatics, scientific professional development, scientific integrity, and the Medical Countermeasures Initiative (MCMi).

    RADM Hinton previously served as Deputy Director of the Office of Medical Policy (OMP) in FDA’s Center for Drug Evaluation and Research (CDER), where she concurrently served as Acting OMP Director from 2014 to 2016. There, she led the development, coordination, and implementation of medical policy programs and strategic initiatives, including the efficient integration of rapidly evolving science and new technologies into the drug development and regulatory review processes. RADM Hinton’s work involved close collaboration with other CDER program areas, FDA product centers, and a broad variety of stakeholders.

    Desmond Hunt

    Desmond Hunt

    Dr. Desmond G. Hunt has been with USP since 2005 and holds the position of Principle Scientific Liaison in the Compendial Science Group-General Chapters. He is the scientific liaison to the Packaging and Distribution and Dosage Forms Expert Committees, where he works to develop and revise USP Standards. He has authored many publications and peer-reviewed articles and is a frequent speaker and instructor on topics related to pharmaceutical packaging, particulate matter in parenteral and ophthalmic dosage forms and good storage and transportation practices. He participates on several industry Working Groups and Technical Committees related to his areas of expertise. Dr. Hunt obtained his M.S. and Ph.D. from the University of Texas at Austin and prior to joining USP, was a Research Fellow at the National Institutes of Health, Bethesda, MD, USA.

    Paul Kim

    Paul Kim, Esq.

    Regarded as one of the top food and drug lawyers in Washington, Paul Kim draws on his extensive governmental experience to advise clients on legal, legislative and regulatory issues in food, drug and device law, Medicare and Medicaid coverage and reimbursement, and the conduct of clinical research. He represents leading biotechnology, pharmaceutical and medical device companies before the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and Congress.

    Barb Kochanowski

    Barb Kochanowski

    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 recived 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.

    Peter Kratochvila

    Peter Kratochvila

    Peter has responsibility for the Regulatory Teams within GSKCH’s Americas and Global Switch & Innovation. In that capacity he is also the Head of the US Regulatory Affairs department. Ensuring Regulatory is a clear market and competitive advantage is Peter’s #1 priority. Peter started his Regulatory career straight from University at Bayer before joining Warner Lambert (WL) in its OTC Division. Peter then spend 15 years in WL/Pfizer/Pharmacia and then J&J/McNeil when it purchased Pfizer CH in 2006, having successfully negotiated several M&As. Upon joining GSK in March 2014, as VP RA Wellness and North America, Peter was instrumental with the successful registration and launch of several products including Rx to OTC switches. Peter holds a LLB in Law, a MSc in Biotechnology Law and an undergraduate degree in Microbiology and Business Studies, from various English Universities.

    Vonnie Lewis

    Vonnie D. Lewis, M.S.

    Vonnie Lewis has been with Pfizer Consumer Healthcare for over 21 years and holds as a Master’s Degree in Regulatory Affairs and Quality Assurance from Temple University. Vonnie has served in numerous roles over the past 21 years including Formulation Development and Regulatory Affairs. Vonnie currently has responsibility for the Product Lifecycle and Regulatory Conformance Team at Pfizer supporting lifecycle management for all OTC products globally.

    Douglas Duffy MacKay

    Douglas “Duffy” MacKay, N.D.

    Douglas ‘Duffy’ MacKay, N.D., is senior vice president, scientific and regulatory affairs for CV Sciences. CV Sciences is a market leader in consumer products that contain hemp extracts with cannabidiol (CBD). Dr. MacKay is responsible for CV Sciences scientific and regulatory affairs, functions that drive product quality, safety, and regulatory compliance. Dr. MacKay comes to CV Science after a ten-year career with the Council for Responsible Nutrition (CRN) where he served as the senior vice president, scientific and regulatory affairs. Dr. MacKay oversaw the scientific and regulatory affairs department, ensuring that the association’s scientific, policy and legislative positions were based on credible scientific rationale.

    Prior to joining CRN, Dr MacKay spent eight years working as a medical and nutrition expert for two companies in the dietary supplement industry, including four years as an executive with Nordic Naturals, where he was in charge of clinical research. He previously served as Technical Advisor for Thorne Research. Dr. MacKay has published articles in peer-reviewed journals and serves as an Associate Editor for the Journal of Dietary Supplements, as well as the Editorial Board for: the Journal of Alternative and Complementary Medicine, Integrative Medicine: A Clinician's Journal, Current Topics in Nutraceutical Research, and the official publication of the American Association of Naturopathic Physicians, Natural Medicine Journal. Dr. MacKay serves on the Advisory Board for the American Botanical Council. Dr. MacKay earned his degree in Marine Biology from the University of California, Santa Cruz and his naturopathic medical degree from the National University of Natural Medicine in Portland, Oregon.

    Scott Melville

    Scott Melville

    Scott Melville is the president and chief executive officer of CHPA and leads the organization’s efforts to empower consumer self-care by preserving and expanding choice and availability of consumer healthcare products, including OTC medicines, dietary supplements and consumer medical devices.

    Prior to joining CHPA, Melville served as senior vice president of government affairs and general counsel for the Healthcare Distribution Management Association (now the Healthcare Distribution Alliance), representing pharmaceutical wholesale distributors.

    Melville previously served in various public affairs and legal roles for the pharmaceutical and biotechnology companies Sterling-Winthrop, Hoffmann- LaRoche, and Cephalon. Melville began his professional career as a legislative assistant and appropriations committee associate on the staff of retired U.S. Congressman Jerry Lewis (R-Calif.).

    He earned his bachelor’s degree from Bucknell University, and his juris doctorate from George Mason University School of Law. He serves on the boards of the World Self-Medication Industry, the CHPA Educational Foundation, and the Food & Drug Law Institute.

    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.

    Elizabeth Miller

    Elizabeth Miller, Pharm.D.

    Elizabeth Miller, Pharm.D., is Vice President, U.S. Regulatory Affairs, for USP. She leads USP’s strategic engagement and collaboration with the U.S. Food and Drug Administration (FDA) and other domestic regulatory agencies and stakeholders.

    Dr. Miller returned to USP in 2016, after nearly 10 years with the FDA Center for Drug Evaluation and Research (CDER)—where she most recently served as Director, Division of Nonprescription Drugs and Health Fraud, in the Office of Unapproved Drugs and Labeling Compliance. Prior to her FDA service, Dr. Miller spent nearly 10 years at USP, where her work focused on drug nomenclature, labeling, packaging, and patient safety standards to prevent medication errors and adverse events. Dr. Miller’s extensive experience in health care and medicines-related work also includes several years as a clinical pharmacist at the Washington Hospital Center in Washington DC.

    Dr. Miller earned her Bachelor of Arts in Biology from The Johns Hopkins University, and her Doctor of Pharmacy from the University of Maryland, School of Pharmacy.

    Ann Mond Johnson

    Ann Mond Johnson

    Ann Mond Johnson was named Chief Executive Officer of the American Telemedicine Association (ATA) in February 2018. With 25 years of healthcare leadership and entrepreneurial experience, Ann’s background includes launching, building and leading companies that have been innovators in using health care technology and data to improve consumer experience and maximize consumer benefit.

    Prior to her appointment as CEO of ATA, Ann served as CEO of Zest Health, a technology-enabled service that enables consumers to optimize their benefits by combining a mobile first solution with access to live support. Under her leadership, Zest solidified its value proposition and doubled its base business in one year. Prior to joining Zest, she served as Board Chair and Advisor to ConnectedHealth, a leading provider of private insurance exchanges. Working closely with the cofounders, she was responsible for strategy and business development as well as evangelizing consumerism and the benefits of exchanges in the media and through industry events.

    In 2000, Ann co-founded and served as CEO of Subimo, a pioneer in healthcare cost and quality transparency tools for consumers. Under her leadership, Subimo’s reach extended to major national and regional health plans (including a majority of the Blues plans) as well as Fortune 500 companies. Ann raised start-up funds, led the management team through significant growth and positioned the company as a market leader. Subimo was acquired by WebMD in 2006. Previously, Ann was Senior Vice President at Sachs Group (now part of IBM Watson/Truven Health), the leading provider of healthcare information for health organizations. She led the product development and operations for the company, providing data and applications for hospital systems, payers and medical device companies. Ann drove the expansion of the company into new markets (including carriers) and the transition from a desktop software company to a data information company.

    Ann graduated from Carleton College and received both her Master’s in Business Administration and Health Care Administration from the University of Minnesota.

    Jessica O'Connell

    Jessica O’Connell, Esq.

    Jessica O’Connell provides strategic advice to a broad range of companies and trade associations in engaging with food and drug regulatory bodies and Congress. She assists clients in complying with U.S. regulatory requirements for the manufacture and sale of foods, dietary supplements, cosmetics, OTC drugs, and animal products, and the import and export of FDA-regulated products. She also regularly counsels clients regarding potential crises, such as recalls and unanticipated regulatory attention.

    Ms. O’Connell works closely with food, cosmetic, and OTC clients to develop labeling and advertising options that are low-risk from both a regulatory and litigation perspective while also meeting marketing goals and objectives, and has specific expertise regarding organic labeling, “healthy” claims, and claim substantiation requirements. Ms. O’Connell has engaged with Congress on cosmetic legislative efforts and food labeling requirements and has prepared comments on behalf of individual companies and trade associations to FDA, USDA, and the NOSB. She also has significant expertise in issues relating the implementation of the FDA Food Safety Modernization Act (FSMA) and has advised clients both within the United States and abroad on compliance with the range of new requirements under that legislation.

    Raqiyyah Pippins

    Raqiyyah Pippins, Esq.

    Raqiyyah Pippins is a Partner in Arnold & Porter's Washington, D.C. office. She focuses her practice on food and drug law and consumer law matters, including advertising, FDA-regulated product labeling, Rx-to-OTC switches, and related regulatory and litigation considerations. Ms. Pippins counsels and defends companies that are engaged in the development, marketing, import and/or export of food, drugs, cosmetics, medical devices, biologics and veterinary products. Ms. Pippins has experience representing companies in advertising challenges and defending food and pharmaceutical companies in legal investigations conducted by the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), and state agencies concerning product marketing practices. She also advises companies on mechanisms for limiting the risk of marketing-related challenges by regulators or private litigants, with a primary focus on minimizing the risk associated with the development, labeling and marketing of FDA-regulated products.

    Jay Sirois

    Jay Sirois, Ph.D.

    Jay Sirois is responsible for regulatory and scientific 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 October 2011, Sirois was employed at Pharmaceutical Development Group as director, Scientific Research and Clinical Studies. He is experienced in pharmaceutical, medical device, and dietary supplement regulatory affairs, pharmacovigilance, Rx-to-OTC switch, product safety, and clinical research. Sirois is a member of the Regulatory Affairs Professionals Society and is an ad hoc reviewer for the Neurotoxicology journal.

    Bart Shrode

    Bart Shrode, M.B.A.

    Bart Shrode began his career with Perrigo Company as a quality control analyst in 1996. Since that time, Shrode’s background includes various management roles in quality control, quality assurance, operations, and technical operations across multiple Perrigo sites. Currently as vice president of quality operations, he has responsibility for all the Quality Control and Quality Assurance functions for the Michigan operational sites covering the entire lifecycle of products including Pre-Commercial Quality and Retailer/Contract Quality Programs. Shrode holds a B.S. in biology from Hope College and an M.B.A. from Grand Valley State University, both in Michigan.

    David Spangler

    David Spangler

    David Spangler directs CHPA's legal affairs and international affairs, and oversees association policy initiatives. He has particular expertise in regulatory matters. Spangler joined CHPA in 1984 as a legislative analyst. He subsequently served in a number of roles for the association in the president's office, project management, international affairs, and, after completing law school in 1995, the association's legal department. Spangler was named a vice president in 1997, and a senior vice president in 2006. His responsibilities were expanded to include the legal function in 2011.

    Spangler serves on the board of directors of the World Self-Medication Industry. He is a member of the District of Columbia Bar as well as the American Society of Association Executives. He authored the chapter on OTC medicines in "Modern Pharmaceutical Industry: A Primer" (Jacobsen and Wertheimer, eds., 2009) and is on the editorial board for the Food and Drug Law Institute's Policy Forum. Spangler earned his Certificate in Organizational Management in 1991 from the U.S. Chamber of Commerce's Institute for Organization Management.

    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.

    David Wiggins

    David E. Wiggins

    David E. Wiggins is an Analytical/Stability Consultant within the pharmaceutical industry with a focus on pre-market stability, analytical method validation and method transfer.

    Mr. Wiggins was previously Sr. Associate Director of Analytical Development for Bayer Consumer Care. Prior to joining Bayer, Mr. Wiggins worked for Schering-Plough and Merck with responsibility for Method Optimization, Method Validation, Method Transfer and Stability (both pre- and post-market). These responsibilities have additionally included involvement with multiple NDA submissions, ANDA submissions and FDA general and PAI inspections.

    Mr. Wiggins has over 35 years experience in the pharmaceutical industry in both a QC and an R&D setting. During this time, he has been instrumental in establishing and updating stability and method validation policy to be consistent with the changing regulatory requirements. Mr. Wiggins has frequently lectured on stability and analytical method validation in the US, Puerto Rico, and throughout Europe. He has been active in submitting comments and validated stability-indicating analytical methods to the U.S. Pharmacopeia and has been an invited speaker to FDA, university, and industry conferences.


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