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Advertising and Promotion Regulatory Affairs Conference


Speakers

  • Micheline  Awad, MBA

    Micheline Awad, MBA

    • Director Regulatory Affairs, Advertising and Promotion
    • Neurocrine Biosciences, Inc., United States

    Micheline Awad leads the Neurocrine Biosciences Promotional Review Committee (PRC) as well as represents Regulatory on the Medical Review Committee (MRC). She has over 17 years of Biotechnology/Pharmaceutical industry experience including 3 years in Regulatory Affairs (RA) and 12 years in RA - Advertising & Promotion. She has been at Neurocrine Biosciences for 3 years. Micheline’s Regulatory experience includes Biologic, Drug, and Device, and multiple product/indication launches. She received her M.B.A. from University of Southern California with a focus on Strategy and Marketing, and her B.S. in Biology specializing Biotechnology from George Mason University.

  • Madhavi  Bellamkonda, MSc

    Madhavi Bellamkonda, MSc

    • Director Regulatory Affairs, Advertising & Promotion
    • Abbott, United States

    Madhavi is a seasoned medical device regulatory affairs professional with extensive, specialized experience in advertising and promotion. She has been employed with the cardiovascular medical devices division of Abbott since 2007 and worked on high-tech based medical devices with Cisco Systems Inc. She has extensive experience in leadership, management and execution of digital and social media programs in addition to authoring and implementing regulatory policies globally, to address evolving regulations. Madhavi is an expert trainer and has led several training workshops worldwide. She is currently Global Director for Regulatory Affairs for Abbott’s Vascular business.

  • Kimberly  Belsky, MS

    Kimberly Belsky, MS

    • Head of Regulatory Policy & Intelligence, Regulatory Affairs
    • Mallinckrodt Pharmaceuticals, United States

    Kimberly (Kim) Belsky is the Head of Regulatory Policy & Intelligence at Mallinckrodt Pharmaceuticals (MNK) assessing changes in the regulatory environment and applicability to the MNK portfolio and activities. Prior to Mallinckrodt, Kim was an Executive director at OneSource Regulatory responsible for AdPromo regulatory review and an Executive Director of AdPromo, Labeling, and Policy in Regulatory Affairs at Valeant Pharmaceuticals (formally Bausch + Lomb). Kim has diverse experience in medical products including Rx drug/biologics, OTCs/Nutritionals/Cosmetics, and medical devices. Kim has more than 28 years of pharmaceutical experience, including 18 years in regulatory.

  • Jason  Cober

    Jason Cober

    • Lead Project Manager, OPDP, CDER
    • FDA, United States

    Jason Cober is the Lead Project Manager in the FDA's Office of Prescription Drug Promotion. He leads OPDP's eCTD outreach efforts and has 10 years experience with the Agency's eCTD specification and guidance development process.

  • Ratinder  Dhami, MS, RAC

    Ratinder Dhami, MS, RAC

    • Director, Regulatory Affairs
    • Network Partners, United States

    As Director of Regulatory Affairs, Ratinder has a broad knowledge in Regulatory Affairs covering the medical device, pharmaceutical and combination product industries. She has served in several medical device and pharmaceutical regulatory affairs roles with Abbott Neuromodulation (formerly St. Jude Medical), Cantox Health Sciences (now Intertek), Sanofi Pasteur, Dalton Pharma Services and Novopharm. During her time at Abbott Neuromodulation, Ratinder served as the lead regulatory representative for new product development teams and CAPA teams. Her role included the development and implementation of regulatory strategies for Class III Premarket Approval (PMA) products, Class II 510k devices and EU Active Implantable Medical Devices.

  • Mark  Gaydos

    Mark Gaydos

    • VP, NA Marketed Product Strategy & Maintenance/US Advertising & Promotion
    • Sanofi, United States

    Mark is VP, US Marketed Product Strategy & Maintenance/Advertising & Promotion within Sanofi's Global Regulatory Affairs organization. In his role, Mark is accountable for regulatory leadership and strategy for marketed products, including lifecycle management. He also oversees the review of promotional, medical and other company communications across US business units to ensure regulatory compliance. Prior to joining Sanofi, Mark held positions of increasing responsibility with Pfizer, Amgen, Block Drug Co., Whitehall-Robins Healthcare and Biocraft Labs. Mark has 25 years of pharmaceutical industry experience, which includes development of regulatory strategies in the areas of advertising & promotion, labeling and product development.

  • Catherine B. Gray, PharmD

    Catherine B. Gray, PharmD

    • Staff Supervisor, Office of Prescription Drug Promotion, OMP, CDER
    • FDA, United States

    Catherine Gray leads the Advertising and Promotion Policy Staff in OPDP at the FDA. Her diverse team of professionals focuses on the challenging and evolving policy issues pertaining to the promotion of prescription drugs. She oversees policy development, social science research and operational support to the full office as it realizes its mission to protect the public health. Her over twenty years of experience include roles in clinical pharmacy and the pharmaceutical industry.

  • Joanne S Hawana, JD, MS

    Joanne S Hawana, JD, MS

    • Member
    • Mintz Levin, United States

    Joanne Hawana is a Member at the law firm of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, practicing in the Health Law/FDA Group and based in the firm’s Washington D.C. office. She counsels global clients on the business impact of new U.S. federal and state actions related to drugs, biologics, cellular therapies, foods, and medical devices. Her counseling and compliance support work reaches into all aspects of FDA-regulated companies’ operations, both pre-market and post-market, and including enforcement matters. Joanne has a masters degree in molecular genetics from UMDNJ and a bachelors degree in biology from the College of William & Mary. She received her JD from the University of Maryland Francis King Cary School of Law in 2007.

  • Mary L Raber  Johnson, PhD, RAC

    Mary L Raber Johnson, PhD, RAC

    • Assistant Professor, Clinical
    • The Ohio State UniversityCollege of Pharmacy, United States

    Since 2009, I have worked at pharmaceutical agencies to support marketing and/or medical affairs teams. I served as lead medical/scientific director for products in various stages of their lifecycles - all while intersecting with regulatory affairs in various capacities. In 2012, I earned a US Regulatory Affairs Certification from RAPS, which covers regulatory functions throughout product lifecycles. Recently I became regular faculty at The Ohio State University, College of Pharmacy where I develop and teach in the online MS Pharmacology program and within the Regulatory Affairs specialization of the Masters of Applied Clinical and Preclinical Research (MACPR) program.

  • Barbara  Lopez Kunz, MSc

    Barbara Lopez Kunz, MSc

    • Global Chief Executive
    • DIA, United States

    Barbara Lopez Kunz, MS, is responsible for the leadership and oversight of DIA global operations, implementing strategies that focus on driving thought leadership and innovation in therapeutic development to improve the health of people worldwide. Ms. Lopez Kunz previously served as President of Health and Life Sciences at Battelle, one of the world’s largest, most respected research and development organizations. She has also served as Senior Vice President/General Manager for Thermo Fisher Scientific’s Biosciences Business and on the inaugural board of the Childhood League School. She holds 14 patents, earned her Masters Degree in Polymer Science from the University of Akron, and is certified in INSEAD’s International Executive program.

  • Kevin M Madagan

    Kevin M Madagan

    • Partner
    • Reed Smith, LLP, United States

    Kevin is a health care attorney and member of Reed Smith’s Life Sciences Health Industry Group. He advises clients across the life sciences and health care spectrum about FDA regulatory issues related to the manufacturing, distribution, and sale of drugs (Rx, OTC, homeopathic), biologics, devices (Rx and OTC), and dietary supplements. Kevin specializes in providing legal and strategic advice regarding advertising and promotion, FDA enforcement, and supply chain logistics.

  • Wayne L. Pines

    Wayne L. Pines

    • President, Regulatory Services and Healthcare
    • APCO Worldwide Inc., United States

    Wayne Pines is a consultant on FDA-related issues. He specializes in ad promo regulation, serving as the regulatory expert on promotional review committees for several pharma companies. He also assists pharma and device companies with product approvals and regulatory and media strategy. Mr. Pines has authored or edited a dozen books on FDA including the FDA Advertising and Promotion Manual and A Practical Guide to FDA's Laws and Regulations.

  • Cheryl Y Roberts, JD, MS

    Cheryl Y Roberts, JD, MS

    • Sr. Director Regulatory Affairs Lead
    • Mylan, United States

    Cheryl Roberts is a Senior Director in Regulatory Advertising and Promotion at Mylan Pharmaceuticals. Her 20 years of experience in the Advertising and Promotion space began at FDA in DDMAC (currently OPDP) and included positions at AstraZeneca and Genzyme/Sanofi. Prior to becoming an Advertising and Promotion regulatory professional, Cheryl was an attorney in the Baltimore/DC area. She holds a JD from the University of Maryland School of Law and a MS from the Arnold & Marie Schwartz School of Pharmacy at LIU. She did her undergraduate studies in Biology at Cornell University and SUNY Albany.

  • Victoria  Tamarkin, MS

    Victoria Tamarkin, MS

    • Founder and Principal, Regulatory Compliance, Advertising and Promotion
    • Victoria Tamarkin Consulting LLC, United States

  • Benjamin  Zegarelli, JD, MS

    Benjamin Zegarelli, JD, MS

    • Associate
    • Mintz, Levin, Cohn, Ferris, Glovsky & Popeo P.C., United States

    Benjamin provides counsel on compliance and regulatory issues to clients in the pharmaceutical, medical device, and biotech industries. With a clear focus on FDA regulatory counseling, Benjamin advises a breadth of life science industry clients on compliance with federal and state laws relating to pre- and post-marketing operations, including clinical development, quality systems, and advertising and promotion. He guides companies through developing corrective action plans and communicating with regulatory authorities following inspections or enforcement actions. He also provides counsel on clinical trial contract negotiations, regulatory strategy for obtaining marketing authorization, and compliance with government grant requirements.

  • Dolores Marie Shank-Samiec, MS

    Dolores Marie Shank-Samiec, MS

    • Executive Director, Office of Promotion and Advertising Review
    • Merck, United States

    Dolores Shank-Samiec, M.S., is Executive Director of the Office of Promotion and Advertising Review at Merck & Co., Inc., with responsibility for Merck’s regulatory review of US promotional materials in support of the pharmaceutical and vaccine businesses, as well as oversight for Merck’s global review process. Dolores earned her Master’s of Science degree in Cognitive Psychology from the University of Massachusetts, and has held positions of increasing responsibility in promotional regulatory review, marketing compliance, oversight of external consulting arrangements, marketing communications, and brand marketing. She is married with two children.

  • Dale  Cooke, JD, MA

    Dale Cooke, JD, MA

    • President
    • PhillyCooke Consulting , United States

    Dale Cooke is president of PhillyCooke Consulting, which helps prescription product marketers use 21st century technology to provide healthcare information while ensuring compliance with FDA regulations written in the 1960s. Dale is the author of Effective Review & Approval of Digital Promotional Tactics, now in its second edition, which was published by the Food & Drug Law Institute.

  • Danielle Asuncion Carreon, MPH

    Danielle Asuncion Carreon, MPH

    • Director, Regulatory Affairs
    • Bristol-Myers Squibb, United States

  • Theresa  Mullin, PhD

    Theresa Mullin, PhD

    • Associate Director for Strategic Initiatives, OCD, CDER
    • FDA, United States

    Theresa Mullin, Ph.D., serves as CDER’s Associate Director for Strategic Initiatives. She leads the Patient-Focused Drug Development initiative, which includes work related to the FDA Reauthorization Act and implementation of the 21st Century Cures Act. Leads FDA Patient Focused Drug Development and heads the FDA delegation to ICH. She previously served as director of CDER’s Office of Strategic Program (OSP) for almost a decade. Under her leadership, the office became a critical part of CDER’s sustained effort to modernize drug regulatory operations. Dr. Mullin received her bachelor’s degree in economics from Boston College and a Ph.D. in public policy analysis from Carnegie-Mellon University.

  • Gerrit  Nijveldt, MSc

    Gerrit Nijveldt, MSc

    • Labeling Consultant
    • EASi, United States

    Gerrit Nijveldt is currently Labeling consultant with EASi. Gerrit has more than 20 years of experience in Global labeling. He has a broad experience in developing and maintaining Company Core Data Sheets, US Prescribing Information and EU Summary of Product Characterisation, including the labeling for multiple development products (early phase to approval) and labeling for devices. Gerrit is also an associate adjunct professor for Temple University School of Pharmacy teaching Global Labeling in the RA/QA Master’s Program. Gerrit earned his MSc in Medical Biology from University of Utrecht in the Netherlands

  • Amie C O'Donoghue, PhD

    Amie C O'Donoghue, PhD

    • Social Science Analyst, OPDP, CDER
    • FDA, United States

    Amie C. O’Donoghue, Ph.D., is a Social Science Analyst in the Office of Prescription Drug Promotion (OPDP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration. She has published over 30 articles on professional and direct-to-consumer (DTC) advertising and the communication of information to physicians and consumers. She also provides technical assistance on research and communication issues to FDA staff and external organizations.

  • Bakul  Patel, MBA, MS

    Bakul Patel, MBA, MS

    • Director, Digital Health Division, CDRH
    • FDA, United States

    Mr. Patel leads regulatory policy and scientific efforts at the Center in areas related to emerging and converging areas of medical devices, wireless and information technology. This includes responsibilities for mobile health, Health IT, cyber security, interoperability, and medical device software. He is the FDA liaison between the FCC and the ONC and chairs the International Medical Device Regulators Forum (IMDRF) "software as a medical device" WG, a global harmonization effort.

  • Elizabeth  Pepinsky, JD

    Elizabeth Pepinsky, JD

    • Health Science Policy Analyst
    • FDA, United States

    Elizabeth Pepinsky is a Health Science Policy Analyst in FDA's Office of Prescription Drug Promotion, where she focuses on guidance and policy development. Prior to joining OPDP, she served as a Regulatory Counsel in FDA’s Center for Tobacco Products. Ms. Pepinsky received her B.S. from Wake Forest University and her J.D. from the University of Baltimore School of Law.

  • Lisa J. Pieretti, MBA

    Lisa J. Pieretti, MBA

    • Executive Director; Co-Founder
    • International Hyperhidrosis Society, United States

    Lisa J. Pieretti is Executive Director and co-founder of the global non-profit, International Hyperhidrosis Society (IHhS). With a master’s in marketing and international economics, and a passion for ethical, inclusive collaborations, Lisa’s life's work is leading programs for the greater good. Lisa oversees all IHhS activities including developing programs for sufferers, providers, industry, regulators, and the public. Lisa also leads research; advocates for access to treatments; educates; and fosters grassroots impact. Throughout, she believes that patients, the medical profession, and industry leaders can partner for positive change. Prior to becoming IHhS Executive Director in 2003, Lisa worked at Digitas Health, SCIREX Corp. and Merck.

  • Marci  Schentzel, PharmD

    Marci Schentzel, PharmD

    • Director, Regulatory Affairs
    • Mylan, United States

    Marci Schentzel serves as a Director of Regulatory Affairs at Mylan Pharmaceuticals in Advertising and Promotion. Her over 25 years of regulatory experience began at the FDA/CBER/OC and included positions at Aventis/Sanofi, King, Incyte and Mallinckrodt in Advertising and Promotion. Marci practiced as a pharmacist at the National Institutes of Health and received her PharmD from Temple University.

  • Mark  Stinson

    Mark Stinson

    • Founder & Principal Consultant
    • Bioscience Bridge, LLC, United States

    Mark Stinson is s founder and principal of Bioscience Bridge, LLC. He also serves as a brand strategy consultant for 83bar, a patient activation company. He is a medical industry veteran in brand innovation – an experienced marketer, venture catalyst, and group facilitator. His work has included market assessment, branding, and marketing strategy for health, science, and technology products in pharmaceuticals, diagnostics, medical devices, provider networks, and clinical research tools. He is the author of three books, Patient Activation, ForwardFast Branding, and N-of-8. Mark is a recipient of the Brand Leadership Award from Asia Brand Congress, and he has been included in the PharmaVoice 100 Most Inspiring People.

  • John  Wong, MPharm

    John Wong, MPharm

    • Director, Regulatory Drug Advertising and Promotion
    • TPIreg/Innomar Strategies, Canada

    John Wong is a pharmacist graduate from Université Laval, Quebec, Canada. He started his career at the Toronto General as an Oncology Pharmacist. In 1998, he joined the Pharmaceutical Advertising Advisory Board (PAAB), a national regulatory body for the review of drug advertising, and later became the Deputy Commissioner. After 10 years at PAAB, John decided to cross over to the ‘other side' and landed at Ogilvy CommonHealth as an Account Director where he helped launch specialty products in Oncology, Hematology and HIV. John is currently the Director, Regulatory Drug Advertising & Promotion at TPIreg/ Innomar Strategies, and provides consultation and review services for drug and medical device advertising.

  • Darshan  Kulkarni, JD, PharmD, MS

    Darshan Kulkarni, JD, PharmD, MS

    • Principal Attorney
    • The Kulkarni Law Firm, United States

    Dr. Kulkarni is Principal Attorney for the Kulkarni Law Firm which focuses on providing legal and regulatory solutions to pharmaceutical companies and their providers. He is a pharmacist & lawyer and advises clients on bringing their product to market, focusing on post IND thru to commercialization.

  • Thomas W. Abrams, MBA, RPh

    Thomas W. Abrams, MBA, RPh

    • Director, Office of Prescription Drug Promotion, OMP, CDER
    • FDA, United States

    Thomas Abrams is the Director of the Office of Prescription Drug Promotion (formerly the Division of Drug Marketing, Advertising, and Communications (DDMAC)), Food and Drug Administration. Mr. Abrams has held the positions of Acting Director, Acting Deputy Director, and Branch Chief in DDMAC. He joined FDA as a reviewer in DDMAC where he was primarily responsible for reviewing promotional material for cardiovascular products. Prior to joining FDA, Mr. Abrams worked in pharmaceutical sales and marketing for Merck and Company. Mr. Abrams received his B.S. degree in pharmacy from the School of Pharmacy, Rutgers University and his M.B.A. degree from Rutgers School of Business.

  • William  Aprea, JD

    William Aprea, JD

    • Executive Director, Senior Franchise and Compliance Counsel
    • (former) Bristol-Myers Squibb, United States

    Bill Aprea is responsible for providing regulatory and compliance legal advice and strategic support to Bristol-Myers Squibb therapeutic franchises and its compliance function. Bill’s expertise includes FDA laws, regulations and guidance, anti-bribery and fraud and abuse and other laws, rules, regulations, policies, industry codes and guidelines applicable to the biopharmaceutical industry. Bill joined Celgene (now part of BMS) in 2016 and his experience as an in-house attorney in the biopharmaceutical industry spans almost 15 years with prior positions at multiple medium and large sized companies. He began his career as a corporate attorney in law firm practice. He is a 1999 graduate of Rutgers School of Law in Newark, NJ.

  • Kevin R. Betts, PhD

    Kevin R. Betts, PhD

    • Social Science Analyst
    • FDA, United States

    Kevin R. Betts, Ph.D., is a Social Science Analyst at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, where he plans and directs social science research studies, manages research contracts, and provides consultation pertaining to promotional prescription drug communications. His areas of expertise include individual and group perception, judgment, and decision-making. Dr. Betts received his Ph.D. in Health/Social Psychology from North Dakota State University.

  • Virginia  Foley

    Virginia Foley

    • Principal Consultant
    • Opus Regulatory Inc, United States

    Virginia Foley joined Opus Regulatory, Inc. as a Principal Consultant in June 2017, focused on Advertising and Promotion review. Before joining Opus, her career spanned positions of increasing Regulatory responsibility at a variety of pharmaceutical and biotechnology companies across the U.S. Immediately prior to Opus, she worked at Gilead Sciences as the Therapeutic Area head of Liver Diseases, responsible for the Hepatitis C franchise product launches. She now lives in beautiful Traverse City, Michigan with her husband, son and lab retriever where they enjoy spending time outside in all seasons.

  • Pamela  Goldberg, MBA

    Pamela Goldberg, MBA

    • President and CEO
    • Medical Device Innovation Consortium, United States

    Pamela Goldberg is an internationally recognized leader in medical technology innovation, leading strategy to affect change for industry and regulators. Her focus on collaboration and driving change have been instrumental in making progress with the medical device industry in partnership with the FDA, patient advocacy groups and clinical sites. Goldberg was previously CEO of the Massachusetts Technology Collaborative. Goldberg worked closely with industry, academic and government leaders to advance technology-based solutions that improved the health care system, expanded high-speed Internet access and strengthened the growth of the state’s technology sector. Goldberg received her BA from Tufts University and MBA from Stanford University.

  • Diane  Johnson, MS

    Diane Johnson, MS

    • Senior Director, North American Regulatory Affairs Policy and Digital Health
    • Johnson & Johnson, United States

    DIANE MACCULLOCH JOHNSON Diane Johnson is responsible for regulatory policy shaping for North America for the Johnson & Johnson Medical Device Companies, as well as serving as the regulatory Digital Health Policy Lead. She is responsible for identifying key emerging regulatory policy issues and shaping the outcomes through continued interactions with HAs. She also supports government affairs in shaping legislation. Activities are focused on laws, regulations, and guidance that will drive Business and Strategic Plans. She has over 30 years of experience in the device industry, specializing predominantly in Regulator Affairs. For five years, she was a senior scientific reviewer at FDA’s CDRH, with a focus on cardiovascular devices.

  • Francis  Nguyen, PharmD

    Francis Nguyen, PharmD

    • Assistant Director, Regulatory Advertising & Promotion
    • Bayer Healthcare Pharmaceuticals, United States

    Francis Nguyen is an Assistant Director at Bayer HealthCare Pharmaceuticals and represents Regulatory on the Promotional Review Team (PRT) to help ensure compliance with FDA regulations. Prior to Bayer, Francis was a post-doctoral fellow in Regulatory Affairs - Advertising and Labeling at Allergan. He received his Pharm.D. from the University of Maryland School of Pharmacy.

  • Josephine  Secnik, MBA, MS

    Josephine Secnik, MBA, MS

    • Director – Ad/Promo Regulatory Affairs
    • Eli Lilly and Company, United States

    Jo Secnik joined Lilly in 1990 where her career has included assignments in Biopharmaceutical Development, Quality Assurance and Regulatory Affairs. Her experience in Regulatory includes 10 years in global CMC and for the last 8 years supporting the US business on advertising and promotion for marketed products.

  • Arul  Sterlin

    Arul Sterlin

    • Director, Regulatory Affairs
    • Abbott Diabetes Care, United States

  • Julie  Tibbets, JD

    Julie Tibbets, JD

    • Partner
    • Goodwin Procter LLP, United States

    Julie Tibbets is a partner in Goodwin’s Technology and Life Sciences group and a member of its FDA practice. Ms. Tibbets focuses her practice on FDA-regulated product development, marketing and corporate communications as well as the intersection of each of those with corporate strategy and securities disclosure obligations. Her product areas of focus include biologics, drugs, medical devices, in vitro diagnostics, lab-developed tests, as well as digital health tools and apps. Ms. Tibbets advises clients on product development strategy, interactions with the FDA, clinical trial documentation, adverse event reporting, commercial strategy, product labeling and advertising.

  • Julia  Lake

    Julia Lake

    • Associate
    • Reed Smith, LLP, United States

    Julia is an associate in Reed Smith’s Life Sciences Health Industry Group in the firm’s Philadelphia office. Her practice is split between litigation and regulatory matters for life sciences clients, including a specialization in providing legal and strategic advice regarding advertising and promotion. Most recently, Julia was seconded to a life sciences client and provided full-time ad-hoc legal support to several commercial brands and sat on promotional and non-promotional review committees.

  • M. Jason  Brooke, JD, MS

    M. Jason Brooke, JD, MS

    • Attorney and Managing Member
    • Brooke Consulting, LLC, United States

    M. Jason Brooke, MSE, JD, CSQE is the Managing Member at Brooke Consulting, LLC—a digital health legal and regulatory advisory firm. Jason offers a unique, multi-disciplinary perspective on the digital health industry as a regulatory attorney, scientist, technologist, and quality consultant. Jason also serves as the General Counsel and VP of Regulatory & Quality for Amalgam Rx, Inc.—an early stage developer of software as a medical device (SaMD) focused on improving clinical and behavioral outcomes for chronic disease management and changing population health into personalized care by combining traditional therapies with best-in-class digital interventions.

  • Richard  Gersh, MD

    Richard Gersh, MD

    • Executive Director, Global Medical Affairs
    • Merck, United States

    Rick is an Executive Director in Global Medical Affairs supporting the General Medicine and Women’s Health physician team which includes responsibility for review of US and Global scientific and promotional materials in support of the pharmaceutical and vaccine businesses. After practicing general obstetrics and gynecology for 17 years he joined Merck and has held positions of increasing responsibility within medical affairs including medical information, US medical affairs strategy and supply-related issues.

  • Minerva  Hughes, JD, PhD

    Minerva Hughes, JD, PhD

    • Regulatory Counsel, Office of Clinical Evidence and Analysis
    • CDRH, FDA, United States

    Dr. Minerva Hughes serves as the Regulatory Counsel for the Office of Clinical Evidence and Analysis in the Food and Drug Administration’s Center for Devices and Radiological Health, which provides policy and program support regarding clinical trials, biostatistics, real-world evidence, epidemiological analysis and outreach and collaboration with hospitals and other external stakeholders. Dr. Hughes has over 15 years of experience in medical product development and FDA regulatory matters. She received her doctorate degree from the Department of Chemistry at the Johns Hopkins University and her law degree from the University of Maryland School of Law.

  • Dara S. Katcher Levy, JD

    Dara S. Katcher Levy, JD

    • Attorney
    • Hyman Phelps & McNamara P.C., United States

    Dara Levy helps pharmaceutical and medical device companies on a wide range of issues relating to product communications. Dara assists clients with products in all stages of development to design engaging communications compliant with FDA legal and regulatory requirements. In the pre-marketing stage, Dara works with companies to strategically communicate with investors, potential marketing partners, and the scientific community, as well as implement effective disease awareness initiatives. At launch and in the post-marketing stage, Dara works closely with corporate communications and marketing to help achieve their goals. Dara serves as the legal reviewer on promotional review committees and conducts company training programs.

  • Heather E Rennie, JD

    Heather E Rennie, JD

    • Executive Director, Managing Counsel
    • Merck Sharp & Dohme Corp., United States

    HEATHER RENNIE is currently Managing Counsel in the Commercial & Compliance Legal Group of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Previously, she was Managing Counsel in Merck's Regulatory Legal group, where she provided regulatory legal support for a variety of products, including pharmaceuticals and biologics. Prior to joining Merck, Ms. Rennie was a litigation partner at a large firm, where she handled a broad variety of litiation matters, including product liability and complex commercial litigation.

  • Lisa L. Stockbridge, PhD

    Lisa L. Stockbridge, PhD

    • Branch Chief, Advertising and Promotional Labeling Branch, OCBQ, CBER
    • FDA, United States

    Lisa Stockbridge, PhD is Chief of Advertising and Promotional Labeling (APLB) in FDA’s Center for Biologics Evaluation and Research (CBER). APLB reviews product labeling and promotional material for CBER. Dr. Stockbridge holds a BA in Biology and Psychology from Manhattanville College and an MS and PhD in Medical Physiology from New York Medical College. She joined FDA 25 years ago, following a Physiology Research Associateship at the University of Alberta-Edmonton and a Senior Staff Fellowship in Biophysics at NIH’s National Institute on Alcohol Abuse and Alcoholism.

  • Helen W. Sullivan, PhD, MPH

    Helen W. Sullivan, PhD, MPH

    • Social Science Analyst, OPDP, CDER
    • FDA, United States

    Helen Sullivan is a Social Science Analyst in the Office of Prescription Drug Promotion at the U.S. Food and Drug Administration (FDA). Prior to joining FDA, she was a Cancer Prevention Fellow at the National Cancer Institute. She received her BA from Yale University; her PhD in psychology from the University of Minnesota, Twin Cities; and her MPH from Johns Hopkins Bloomberg School of Public Health.

  • Kathryn J Aikin, PhD

    Kathryn J Aikin, PhD

    • Senior Social Science Analyst, Research Team Lead, OPDP, CDER
    • FDA, United States

    Kathryn (Kit) Aikin, Ph.D., is the Senior Social Science Analyst and Research Team Lead in the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP). Dr. Aikin conducts research and provides consultation on regulatory policy and enforcement review of consumer and professional prescription drug promotional pieces.

  • Jonathan  Bigelow

    Jonathan Bigelow

    • Executive Director
    • Coalition For Healthcare Communication, United States

    Jon Bigelow is Executive Director of the Coalition for Healthcare Communication, a non-profit health policy group. He previously was CEO and President of KnowledgePoint360 Group, a leading provider of multichannel medical communications, strategic consulting, benchmarking, and workflow solutions in the U.S., U.K., and Germany; president of Cliggott Publishing, provider of clinical journals and medical communications; president of the Association of Medical Media; and a consultant providing strategic support on health communications, pharma services, and health policy.

  • Melissa B. Burns, MS, MSc

    Melissa B. Burns, MS, MSc

    • Senior Program Manager, Office of Combination Products
    • FDA, United States

    Melissa Burns is a Senior Program Manager in FDA’s Office of Combination Products (OCP). In this role, she is responsible for coordinating activities related to combination product review and regulation including development and review of guidance documents, regulations, and procedures and policies. CDR Burns worked for several years in the private sector including positions with a medical device manufacturer, a large acute-care hospital, a healthcare architecture firm, and a consulting firm. CDR Burns received a Bachelor of Science degree in Mechanical Engineering from Virginia Tech and a Master of Science degree in Biomedical Engineering from The University of Connecticut.

  • Carlotta  Dillon, MA, MBA

    Carlotta Dillon, MA, MBA

    • Principal
    • Dillon Consulting, LLC, United States

    Carlotta DeMaio Dillon, MA, MBA Principal, Dillon Consulting LLC Carlotta provides patient-focused commercial development solutions to Pharma clients. She has extensive experience on Commercial and Clinical teams at companies including Adare, Endo, AstraZeneca, and DuPont Pharmaceuticals. Through her expertise in drug development and commercialization (including Medical Affairs, Commercial Development, and Brand Marketing) she has a unique perspective on the opportunities and challenges when striving for cross-functional alignment in the development of brand communications that address patient and other customer needs.

  • George  Wan, PhD, MPH

    George Wan, PhD, MPH

    • VP Health Economics & Outcomes Research
    • Mallinckrodt Pharmaceuticals, United States

    George Wan, Ph.D., is VP, Health Economics and Outcomes Research at Mallinckrodt Pharmaceuticals where he is responsible for leading the development and execution of the value evidence generation and dissemination strategy for the company. He has over 20 years of experience in this area. Prior to this, he lived in Belgium as Global Market Access Leader with Janssen, a division of Johnson & Johnson (J&J). Previously, he held roles of increasing responsibility at other J&J affiliates, Wyeth and Merck. George holds a B.A. in Economics/Political Science from the University of Richmond, a Master’s in Public Health from Virginia Commonwealth University and a Ph.D. in Health Services Research/Epidemiology from Saint Louis University.

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