Menu Back toSpeakers

Advertising and Promotion Regulatory Affairs Conference

This event is now offered in a new entirely virtual format.


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 18 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 4 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.

  • Kimberly  Belsky, MS

    Kimberly Belsky, MS

    • Executive Director Reg Policy & Intelligence and AdPromo
    • Mallinckrodt Pharmaceuticals, United States

    Kimberly (Kim) Belsky is the Executive Director of Regulatory Policy & Intelligence and Labeling Operations at Mallinckrodt Pharmaceuticals (MNK) assessing key changes in the global regulatory environment and providing strategic insights to the company regarding impact on the portfolio and activities. With over 30 years of global experience in the medical product industry, including 20 years in regulatory affairs, Kim's diverse experience including scale up and tech transfer, quality/compliance, advertising & promotion, labeling, and regulatory policy intelligence. Her background includes Rx drug/biologics, OTCs/Nutritionals/Cosmetics, and medical devices.

  • Carla  Brooks, MSc, RAC

    Carla Brooks, MSc, RAC

    • Senior Director, Regulatory Affairs, Advertising and Promotion
    • Blueprint Medicines Corporation, United States

    Carla is the Head of Promotional Regulatory Affairs responsible for overseeing the review and submission of prescription drug marketing communications and materials at Blueprint Medicines Corporation (BPMC) to the health authorities serving as an expert on international and other regional regulations and guidance governing the promotion of prescription drug products and disease activities. Carla joined BPMC with 19 years of biopharma experience ranging from pre-clinical and clinical research to prescription drug launch and marketing. Prior to joining BPMC, she was a leader at United Therapeutics Corporation, Astra Zeneca and Medimmune in Global Regulatory Affairs, Research and Development, and Quality Assurance.

  • 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.

  • Virginia  Foley

    Virginia Foley

    • Principal Consultant
    • Opus Regulatory Inc, United States

    Virginia Foley joined Opus Regulatory as a Principal Consultant in June 2017, focused on Advertising and Promotion review and in January 2020 she transitioned to a full time role in Business Development. Before joining Opus, her 20-year tenure in Regulatory Affairs spanned positions of increasing 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, leading the strategy and execution for the consecutive waves of Hepatitis C product launches. She lives in beautiful Traverse City, Michigan with her husband, son and lab retriever where they enjoy spending time outside in all seasons.

  • Catherine  Gray, PharmD

    Catherine Gray, PharmD

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

    Catherine Gray leads the Office of Prescription Drug Promotion (OPDP) at the FDA. Her diverse team of professionals focuses on the challenging and evolving policy and operational issues pertaining to the promotion of prescription drugs. She oversees policy development, social science research, regulatory counseling, compliance activities, stakeholder engagement, and operational support to the 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. Dr. Gray received her B.S. from the University of Notre Dame and her Doctor of Pharmacy from Campbell University.

  • Joanne  Hawana, JD, MS

    Joanne Hawana, JD, MS

    • Member
    • Mintz, Levin, Cohn, Ferris, Glovsky & Popeo P.C., 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 20007.

  • Mary L Raber  Johnson, PhD, RAC

    Mary L Raber Johnson, PhD, RAC

    • Assistant Professor - Clinical
    • The Ohio State University, College of Pharmacy, United States

    Mary is an Assistant Professor-Clinical at The Ohio State University, College of Pharmacy, including a role as lead faculty in the regulatory affairs specialization of the Masters in Clinical Research (MCR) program; additionally, she develops and teaches courses related to pathophysiology and drug development in the MS Translational Pharmacology. Mary also continues to consult based on over 10 years of experience supporting commercial and/or medical affairs teams as a medical strategist / scientific director, including close collaborations with regulatory affairs teams. She earned her PhD in Chemistry from Johns Hopkins University (2009) and BS in Pharmaceutical Sciences from The Ohio State University (2004).

  • Kevin  Madagan, JD

    Kevin Madagan, JD

    • 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. Among other things, Kevin has spent the last 15+ years advising compliance teams and serving as legal counsel to startup and global drug and medical device clients.

  • Sheetal  Patel, PharmD

    Sheetal Patel, PharmD

    • Head, Regulatory Advertising and Promotion
    • Johnson & Johnson International, United States

    Sheetal Patel is the Head, Regulatory Advertising and Promotion, within Pharmaceutical Group Health Care Compliance organization at Johnson & Johnson. Previously, she held the position of Lieutenant Commander, Senior Regulatory Review Officer, at the Food and Drug Administration, Office of Prescription Drug Promotion.

  • Victoria  Tamarkin, MS

    Victoria Tamarkin, MS

    • Founding Partner & President, Global Regulatory Affairs, Promotional Compliance
    • Victoria Tamarkin Consulting LLC, United States

    Victoria Tamarkin is an FDA and healthcare regulatory compliance consultant with more than 20 years’ experience at large, multinational companies and virtual, venture-backed start-ups. Founder of Victoria Tamarkin Consulting, LLC group, Victoria advises pharmaceutical and medical device companies on pre- and post-market FDA regulatory compliance and enforcement matters ranging from regulatory strategies to advertising and promotion and labeling of FDA-regulated products. Victoria has been the lead FDA regulatory advisor to her clients on 100+ transactional matters. Victoria counsels pharma and device companies on promotional compliance, advertisement, social media platforms, and digital marketing.

  • Mark  Gaydos

    Mark Gaydos

    • Vice President, US Advertising & Promotion, Global Regulatory Affairs
    • United States

    Mark is VP, US Advertising & Promotion within Sanofi's Global Regulatory Affairs organization. In his role, Mark is accountable for the regulatory review of product advertising, promotion and other company communications across US business units to ensure regulatory compliance. He has also led teams responsible for overall regulatory product strategy and support. Prior to joining Sanofi, Mark held positions of increasing responsibility with Pfizer, Amgen, Block Drug Co., Whitehall-Robins Healthcare and Biocraft Labs. Mark has more than 25 years of pharmaceutical industry experience, which includes development of regulatory strategies in the areas of advertising & promotion, labeling and product development.

  • Wayne  Pines

    Wayne Pines

    • President, Health Care
    • 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.

  • Lucy  Rose, MBA

    Lucy Rose, MBA

    • President
    • Lucy Rose and Associates, LLC, United States

    Lucy graduated as a physician assistant, earned an MBA, and worked for seven years in sales and sales training with Bristol-Myers Squibb prior to serving as the Director of the Division of Drug Marketing, Advertising, and Communications and the Office of Training and Communications at FDA. For the last 18 years she has consulted with numerous pharmaceutical companies on promotional regulations/strategy, drug development and regulatory strategy, health policy, and has enjoyed training many professionals on advertising/promotional regulations.

  • Renee  Ambrosio

    Renee Ambrosio

    • Department Head, Advertising & Promotion, Regulatory Affairs
    • Merck & Co., Inc., United States

    Renee Ambrosio is Head, Advertising and Promotion Regulatory Affairs at Merck & Co., Inc. Renee oversees the regulatory review, approval, submission, and promotional regulatory strategy for all U.S. pharmaceuticals and biologic products. Renee has over twenty-nine years of experience across the healthcare spectrum; including 22 years in the pharmaceutical industry, with an emphasis in regulatory requirements and strategies, overlapping product launches for indications under accelerated approval, as well as sales and marketing. Renee is also the current DIA Ad/Promo Working Group Co-Chairperson.

  • Heather  Banuelos, JD

    Heather Banuelos, JD

    • Counsel, FDA and Life Sciences
    • King & Spalding, United States

    Heather Bañuelos is Counsel in King & Spalding’s FDA & Life Sciences practice group. She advises clients on regulatory strategies and initiatives for the labeling, promotion and advertising of FDA-regulated products, with particular focus on prescription drugs and medical devices. She routinely serves on promotional review committees and medical/scientific review committees, with a knack for practical advice and recommendations to help clients find a successful path forward. Heather is a former Associate Chief Counsel in the FDA’s Office of the Chief Counsel, and has also served as senior in-house regulatory counsel for multiple clients. Her experience in government and in-house give her a unique and valuable perspective as outside counsel.

  • Mark  Bard, MBA, MHA

    Mark Bard, MBA, MHA

    • Founder
    • Digital Health Coalition, United States

    Mark Bard is a new media, marketing, and technology entrepreneur. In addition to personal ventures, he invests in technology and health startups taking an active advisory role with founders. Mark’s focus and passion includes digital, data analytics, and customer service in a connected world. Mark co-founded the Digital Health Coalition, a non-profit think tank based in New York, in 2011. Mark previously sold Manhattan Research, a company he co-founded, to Providence Equity Partners.

  • Trish  Dring, JD, MS

    Trish Dring, JD, MS

    • Vice President, Associate General Counsel
    • Aurinia Pharmaceuticals Inc., United States

    Trish Dring is the Vice President, Associate General Counsel of Aurinia Pharmaceuticals Inc., a biopharmaceutical company launching its first product. Previously she has worked in a variety of legal roles at both small and large biopharma companies, including MedImmune, AstraZeneca, United Therapeutics, and MacroGenics. Trish has her J.D. and Masters in analytical chemistry from the University of Maryland, and her BS from SUNY Binghamton.

  • Kevin  Gomba

    Kevin Gomba

    • Associate Director, Global Regulatory Affairs, Promotion Compliance
    • Otsuka Pharmaceutical Development & Commercialization, Inc, United States

    Kevin Gomba is a Associate Director, Promotion Compliance in Global Regulatory Affairs at Otsuka Pharmaceutical Development & Commercialization, Inc. with more than 10 years of pharmaceutical industry experience. He has held various marketing and patient support roles and provides guidance and review of commercial and developmental products. Kevin has a Bachelor of Science degree in Business Administration, with a focus on Management/Organizational Leadership.

  • Laura M Sullivan, JD

    Laura M Sullivan, JD

    • Senior Attorney, Division of Advertising Practices
    • Federal Trade Commission, United States

    Laura Sullivan is a senior attorney in the Federal Trade Commission’s Division of Advertising Practices. She works on consumer protection issues related to digital advertising, technology, and health products, and led the development of the Commission’s Enforcement Policy Statement on Deceptively Formatted Advertisements and business guidance document on native advertising. At the Commission, Ms. Sullivan has served in a variety of positions, including attorney advisor to a Chairman of the Commission and Counsel to the Director of the Bureau of Consumer Protection. She has litigated cases in federal court against affiliate advertising networks, malware distributors, and marketers of health and financial products.

  • Kathryn  Aikin, PhD, MS

    Kathryn Aikin, PhD, MS

    • 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 healthcare provider prescription drug promotional pieces.

  • Elaine  Böing, MPH

    Elaine Böing, MPH

    • Director, Health Economics and Outcomes Research (HEOR), Rare Disease
    • Ipsen Biopharmaceuticals, Inc., United States

    Elaine Boing is Director HEOR, Rare Diseases, at Ipsen Biopharmaceuticals. She received her Pharmacy degree from Universidade Federal de Santa Catarina in Brazil and her MPH degree with a concentration in Epidemiology from Emory University. Her educational foundation in science drives her passion to collaborate at the intersection of medical and commercial efforts to strategize on optimal ways to undertake rigorous research that informs healthcare decisions. In her recent roles, Elaine has been responsible for generating HEOR evidence from concept to publication as well as communicating value information to population decision-makers.

  • Glenn N. Byrd, MBA

    Glenn N. Byrd, MBA

    • President
    • GByrd Ad-Promo Solutions, LLC, United States

    Glenn is a part-time faculty member at UNCW’s College of Health and Human Services teaching Regulatory Affairs (BS and MS). He also runs his own consulting company focused on providing expert advertising and promotion regulatory support to the biopharmaceutical industry. Glenn previously served over 11 years at AstraZeneca/MedImmune and has held numerous regulatory and leadership roles across pharma, biotech, and device organizations over his 30-year career in regulatory affairs. Glenn has served on the RAPS Board of Directors for the last 10 years and became Chairman of the Board in January 2021. He spent 10 years at the US FDA (CDRH&CBER), including 4 years as head of the Advertising and Promotional Labeling Branch, CBER.

  • Nicole  Hoadley, MBA

    Nicole Hoadley, MBA

    • Vice President, Client Services
    • Snow Companies LLC, United States

    Nicole has over 15 years of marketing and business experience and began her career at the SNOW Companies in 2011. As a Vice President, Nicole has represented a broad spectrum of brands across a number of large companies. Nicole recently won a PM360 ELITE Leader of the Future Award in 2020. Nicole has deep expertise in rare, misunderstood and stigmatized diseases. She is a strategic marketer with strong project management expertise and the “can do; whatever it takes” attitude her clients love. Nicole holds a Bachelor of Science in Business Administration with a concentration in Marketing and Management and a Masters of Business Administration in Marketing. She and her husband, along with their 3 young children live in Williamsburg, Virginia.

  • Stefani  Klaskow

    Stefani Klaskow

    • Industry Lead
    • Google, United States

    Stefani leads Google’s healthcare advertising sales team to provide digital advertising solutions for the world’s largest pharmaceutical companies. Stefani came to Google from Crain Communications, where she was a Regional Sales Manager for the Modern Healthcare and Modern Physician properties responsible for creating large scale cross-platform advertising programs. Stefani is a graduate of Union College and holds a Master's Degree in Social Work from the University of Pennsylvania.

  • Anthony  Matyjaszewski, JD

    Anthony Matyjaszewski, JD

    • Vice President for Compliance & Member Development
    • Network Advertising Initiative , United States

    As Vice President, Compliance and Membership, Anthony Matyjaszewski leads the NAI team in conducting the NAI's annual compliance reviews of member companies. Anthony also oversees the drafting of updates to the NAI Code of Conduct and Guidance Documents, culminating most recently in the publication of the 2020 NAI Code of Conduct. Prior to joining the NAI, Anthony researched and wrote about the issues at the intersection of law and technology. He has clerked at both the NAI and the International Association of Privacy Professionals (IAPP). He received his B.A. cum laude in Psychology from the University of Maine at Farmington and his J.D. cum laude from the University of Maine School of Law.

  • Katherine  Norris, MPA

    Katherine Norris, MPA

    • Director, Life Sciences - Governance, Risk Management and Compliance
    • Guidehouse, United States

    Ms. Norris has 20 years of experience in corporate governance, risk and compliance focused predominantly in the life sciences and healthcare industries, including 12 years as an industry professional. Ms. Norris regularly supports counsel to assess the effectiveness of corporate compliance programs in privileged consulting matters coinciding with government investigations. Katie has supported clients in numerous high-profile matters, including the prosecution of individuals, involving the promotion of pharmaceutical and medical device products. She regularly works with industry clients to develop and implement effective promotional & medical review policies and supports internal review, distribution and monitoring of promotional materials.

  • Bakul  Patel, MBA, MS

    Bakul Patel, MBA, MS

    • Director, Digital Health Center of Excellence (DHCoE), CDRH
    • FDA, United States

    BAKUL PATEL is the Director for Digital Health Center of Excellence, at the Food and Drug Administration (FDA). Mr. Patel is responsible for providing leadership, development, implementing, execution, management and setting strategic direction and regulatory policy and coordinate scientific efforts for digital health, software and emerging technologies. Mr. Patel, in 2013, created the term “software as a medical device”(SaMD) and under his leadership the International Medical Device Regulators Forum (IMDRF) established the globally harmonized definition of SaMD. Mr. Patel subsequently led global regulators at IMDRF to create and author the globally harmonized regulatory framework for SaMD.

  • Lisa  Stockbridge, PhD

    Lisa Stockbridge, PhD

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

    Lisa Stockbridge, PhD is Chief of the Advertising and Promotional Labeling Branch (APLB) of the Office of Compliance and Biologics Quality in FDA’s Center for Biologics Evaluation and Research (CBER). With her background in Medical Physiology and Neuroscience, she has held positions in FDA's CDER, CBER, and CDRH. Prior to joining FDA 29 years ago, Dr. Stockbridge was a Research Associate in Physiology at the University of Alberta-Edmonton and a Senior Staff Fellow in Biophysics at NIH’s National Institute on Alcohol Abuse and Alcoholism.

  • 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.

  • Jason  Cober, MPA

    Jason Cober, MPA

    • 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.

  • Linda  Kollmar, MD

    Linda Kollmar, MD

    • Executive Director, Team Lead Medical Consult and Review Physicians
    • Merck & Co., Inc., United States

    Linda Kollmar, MD, FACC is an Executive Director at Merck in Global Medical Affairs, Oncology. She leads the Medical Consult and Review Physician team and the Pan Tumor Global Medical Affairs Team. Prior to this role she was an Executive Director in the Office of the Chief Patient Officer where she was responsible for leading and enabling the planning and execution of patient engagement activities to ensure that the patient’s perspective remained central to Merck’s work in Oncology. Before joining Merck, she worked in private practice as a Non-Invasive Cardiologist. She graduated from Emory University with a Bachelor of Arts degree in Art History. She earned her Medical Degree from Temple University School of Medicine.

  • R.J.  Lewis, MBA

    R.J. Lewis, MBA

    • Founder, President, & CEO
    • eHealthcare Solutions, United States

    R.J. Lewis is Founder and CEO of eHealthcare Solutions (EHS). eHealthcare Solutions delivers audiences and drives digital innovation for both advertisers and publishers. EHS exclusively represents 85 high-quality healthcare publishers. The EHS vision is to aggregate niche audiences for the measurable benefit of both marketers and publishers. EHS has been named a PM360 Trailblazer Company of the Year and Mr. Lewis has been named to the PharmaVOICE 100 list of most inspiring leaders in life sciences. R.J. is a parallel entrepreneur having started Ad-Juster and Tap Native while running eHealthcare Solutions. R.J. earned his MBA in 1999 in Marketing and Information Systems from NYU. Reach R.J. at rlewis@ehsmail.com or on Twitter @rlewis

  • Ritesh  Patel

    Ritesh Patel

    • Chief Digital Officer - Health
    • Ogilvy Health, United States

    As Chief Digital Officer, Ogilvy Consulting, Ritesh is responsible for helping drive Ogilvy’s digital vision as well as providing digital guidance for our Clients. He partners with organizations of all sizes to reimagine and optimize digital capabilities. Ritesh has created innovations for clients from EHR Strategy, to the use of A/R, V/R Chat Bots, AI and voice activated systems for marketers. He also led the creation of the Ogilvy Innovation Lab, which is responsible for showcasing future technologies. Since the early days of the Dotcom bubble, Ritesh has been evangelizing digital. He joined Agency.com and consulted with Fortune 500 companies to evangelize the merits of the World Wide Web.

  • 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). Dr. Sullivan’s research examines the communication of prescription drug information to consumers and healthcare professionals. 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.

  • Twyla  Thompson, PharmD

    Twyla Thompson, PharmD

    • Deputy Division Director, Division of Advertising and Promotion 2, OPDP
    • FDA, United States

    Twyla Thompson is the Deputy Division Director of the Division of Advertising and Promotion Review II in the Office of Prescription Drug Promotion at the Food and Drug Administration. Over the past 12 years, Twyla has held the positions of team leader and reviewer in OPDP. Prior to joining FDA, she worked in regulatory affairs at Bristol-Myers Squibb. Twyla received her Doctor of Pharmacy degree from Florida Agricultural and Mechanical University College of Pharmacy and Pharmaceutical Sciences.

  • Olivia  Walker, PharmD

    Olivia Walker, PharmD

    • Manager, Advertising & Promotion, Regulatory Affairs America
    • Bayer, United States

    Olivia Walker, PharmD is a Manager in Regulatory Affairs Americas, Advertising and Promotion at Bayer Pharmaceuticals. Prior to joining the Advertising and Promotion group, Olivia completed a regulatory training program at Bayer where she supported the regulatory strategy, global labeling, and regulatory advertising and promotion areas. She can be contacted at olivia.walker@bayer.com.

  • Anna  Williams, MS

    Anna Williams, MS

    • Associate Director
    • Alkermes, United States

    Anna Williams is an associate director at Alkermes, Inc. and is responsible for regulatory advertising and promotion in the US. She has a Master of Pharmacology degree from Northeastern University. After spending nearly a decade in microbiology and infectious disease research and development, she explored clinical trial management, and later, commercial regulatory affairs and product labeling. She has led new drug commercial launches for challenging products and her interests involve exploring utilization of new social media platforms in drug promotion.

  • Deborah A. Wolf, JD

    Deborah A. Wolf, JD

    • Regulatory Counsel, Office of Product Evaluation and Quality, Regulations, Polic
    • FDA, United States

    Deborah Wolf is an attorney and regulatory counsel in the Office of Product Evaluation and Quality in FDA’s Center for Devices and Radiological Health. She offers guidance to staff who address device labeling and advertising regulation. She has worked in CDRH’s promotion and advertising program since 1995 except for a three year period during which she supervised CDRH’s Regulations Staff.

  • Julia  Lake, JD

    Julia Lake, JD

    • 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.

  • David  Bernstein

    David Bernstein

    • Chief Revenue Officer
    • Everyday Health Group Consumer, United States

    David Bernstein serves as the Chief Revenue Officer and SVP of Sales and Strategic Partnerships for Everyday Health Consumer. David has dedicated his 20-year plus career to improving the outcomes of the “patient journey” for all key stakeholders. Prior to joining the Everyday Health Group, David was the Executive Vice President, Head of Sales at Outcome Health, a point-of-care technology and media platform for waiting rooms, exam rooms, and infusion rooms. Previously, David held the roles of Vice President of Business Development at ConnectiveRx partnering with biopharmaceutical manufacturers. Earlier in his career, David spent almost a decade with the global pharmaceutical company GlaxoSmithKline as a Senior Product Manager.

  • 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 and provides consultation pertaining to promotional prescription drug communications. His research has covered topics such as misinformation detection and reporting capabilities among both consumers and healthcare providers, and strategies for improving the communication of prescription drug risks and side effects.

  • Rachael Elizabeth Conklin, MS

    Rachael Elizabeth Conklin, MS

    • Senior Consumer Safety Officer
    • FDA, United States

    Prior to beginning my career at the FDA, I worked as a nurse in inpatient psychiatry and radiation oncology. I have been with the FDA for over seven years now, starting in the consumer affairs branch in CBER and now working with the Office of Prescription Drug Promotion in CDER. As an OPDP reviewer I primarily work with oncology products and I also function as the senior consumer safety officer for professional labeling concerns

  • Meena  Savani, PharmD

    Meena Savani, PharmD

    • Regulatory Review Officer, Division of Advertising and Promotion 2
    • FDA, United States

    Meena Savani joined the Office of Prescription Drug Promotion in 2015 as a reviewer of ophthalmology and transplant drug products. Currently, she oversees the review of prescription drug advertising and promotional labeling for diabetes and obesity products. Prior to joining FDA, Meena completed a two year post-doctoral fellowship at Bayer HealthCare in U.S Regulatory Affairs and has since mentored fellows and served as a preceptor for pharmacy students.

  • Amie  O'Donoghue, PhD

    Amie 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 35 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.

  • Charuni Patel Shah, PharmD

    Charuni Patel Shah, PharmD

    • Regulatory Review Officer, Division of Advertising and Promotion 2, OPDP, CDER
    • FDA, United States

    Charuni Shah graduated from the University of the Sciences, Philadelphia College of Pharmacy with her Doctor of Pharmacy Degree. After graduation, Charuni pursued a career in promotional advertising and currently serves as a Regulatory Review Officer for the Office of Prescription Drug Promotion

  • Melinda  Decker, MBA, MS

    Melinda Decker, MBA, MS

    • Chief Commercial Officer
    • Mymee, United States

    Melinda Decker is Chief Commercial Officer of Mymee, the leading digital health company that empowers those who suffer from autoimmune disease to reclaim their health. Mymee combines an intuitive mobile app, data analytics, and certified health coaches to help identify triggers for disease symptoms to improve quality of life. Melinda also serves as an advisor to MIT’s Health Science & Technology program and to several companies focused on digital health. She previously worked at AstraZeneca and Pfizer, spanning commercial and R&D.

  • James  Dvorsky, PharmD

    James Dvorsky, PharmD

    • Team Leader, Division of Advertising and Promotion 2
    • FDA, United States

    James Dvorsky is a Commander in the US Public Health Service and serves a Team Leader in the Office of Prescription Drug Promotion at the Food and Drug Administration. He manages the therapeutic areas of cardiovascular, anti-infective, medical imaging, transplant and ophthalmology products. CDR Dvorsky joined the FDA in 2010 and has worked his way from reviewer to subject matter expert and now team leader. Prior to FDA, he completed a regulatory affairs fellowship through Rutgers University with Merck and Co. CDR Dvorsky is a pharmacist by education and has his Regulatory Affairs Certification, is Certified in Public Health, and is pursuing his Masters in Public Health concentrating in Epidemiology.

  • Samuel  Skariah, PharmD

    Samuel Skariah, PharmD

    • Team Leader, Division of Advertising and Promotion 1, CDER/DDMAC
    • FDA, United States

    Sam Skariah is a Team Leader in the Division of Advertising and Promotion Review 1 (DAPR 1) of the FDA's Office of Prescription Drug Promotion (OPDP). In this role, he is responsible for leading OPDP's review efforts of promotional communications for the antivirals, anesthetics, addiction, and pain medicine products. Prior to becoming a Team Leader, he spent 5 years as the primary reviewer of healthcare directed promotional materials for the metabolic endocrine drug products. During his time in OPDP, he has also covered promotional review work for other therapeutic areas including oncology, gastroenterology, and pulmonary drug products.

  • Lisa  Hubbard, PharmD, RPh

    Lisa Hubbard, PharmD, RPh

    • Deputy Division Director, Division of Advertising and Promotion 1, OPDP
    • CDER, FDA, United States

    Ms. Hubbard is a Group Leader for professionally-directed drug promotion at CDER’s Division of Drug Marketing, Advertising, and Communications and a member of their electronic submissions group. She is a graduate of the Philadelphia College of Pharmacy and a current Excellence in Government Fellow.

  • Matthew  Falter, PharmD, RPh

    Matthew Falter, PharmD, RPh

    • Team Leader, Division of Advertising and Promotion 2, OPDP, CDER
    • FDA, United States

    Matthew (Matt) Falter, Pharm.D., is a Lead Consumer Safety Officer with the Office of Prescription Drug Promotion (OPDP), Division of Advertising and Promotion Review 2 at the U..S. Food and Drug Administration. He joined OPDP as a reviewer in 2011. In his current role, Matt leads a team of review staff assigned to oversee the promotion of dermatology, dentistry, osteoporosis, reproductive and women's health, and urology products. Prior to joining FDA, Matt was a Clinical Staff Pharmacist at Manatee Memorial Hospital in Bradenton, Florida. He holds a B.S. in Pharmaceutical Sciences from The Ohio State University in Columbus, Ohio, and a Doctor of Pharmacy degree from Shenandoah University in Winchester, Virginia.

  • Dhara  Shah, PharmD

    Dhara Shah, PharmD

    • Regulatory Review Officer, Division of Advertising and Promotion 1
    • FDA, United States

    OPDP Neurology Reviewer primarily working on anticonvulsants, migraine, anti-Parkinson, anti-spasticity, nerve gas antidotes.

  • Sapna  Shah, PharmD

    Sapna Shah, PharmD

    • Regulatory Review Officer, Division of Advertising and Promotion 1, OPDP, CDER
    • FDA, United States

    Sapna Shah joined the FDA as a Regulatory Review Officer in FDA’s Office of Prescription Drug Promotion (OPDP) where she works across various neurology drug products, primarily focusing on rare diseases. She has a passion for making a positive impact on public health and improving medical communication. Prior to working at the FDA, Sapna has worked in both outpatient and inpatient pharmacy, medical communications, and late phase research. She graduated from the Philadelphia College of Pharmacy and completed a 1 year post-graduate ASHP residency at The Valley Hospital in Ridgewood, NJ.

  • Christine  Bradshaw, PharmD, RAC

    Christine Bradshaw, PharmD, RAC

    • Regulatory Review Officer, Division of Advertising and Promotion 1, OPDP, CDER
    • FDA, United States

    Christine Bradshaw is a Regulatory Review Officer in FDA's Office of Prescription Drug Promotion (OPDP) where she primarily reviews drug advertising and promotion for neurology and psychiatry drug products. She received her Doctor of Pharmacy degree from Shenandoah University's Bernard J. Dunn School of Pharmacy.

  • Jean-Ah  Kang, PharmD

    Jean-Ah Kang, PharmD

    • Special Assistant to the Director, Office of Prescription Drug Promotion, CDER
    • FDA, United States

    Jean-Ah Kang, Special Assistant to the Director in the Office of Prescription Drug Promotion (OPDP), has over 20 years of experience in prescription drug promotion. She focuses on policy/guidance development and communications, with a special interest in social media/accelerated approval issues. Prior roles include senior consultant at SAIC, team leader in the Division of Drug Marketing, Advertising, and Communications (DDMAC), and DDMAC oncology reviewer. She began her career as an assistant professor at Shenandoah University after completing a drug information residency at the University of Pittsburgh Medical Center. She earned a Pharm.D. from the University of Maryland and B.A.’s in Biochemistry and Music from the University of Virginia.

  • Lynn  Panholzer, PharmD

    Lynn Panholzer, PharmD

    • Regulatory Review Officer, Division of Advertising and Promotion 1, OPDP, CDER
    • FDA, United States

    Lynn Panholzer has over 16 years of experience as a Regulatory Review Officer in FDA's Office of Prescription Drug Promotion (OPDP). She currently reviews the promotion of oncology products, and previously reviewed the promotion of antiviral, dermatology, dental, and reproductive products. She also coordinates reviewer continuing education and training in OPDP. Prior to joining the FDA in 2002, Lynn practiced in retail and managed care pharmacy for 13 years, and holds a BS in Zoology and a Pharm D from the University of Maryland.

  • Nazia  Fatima, PharmD, MBA

    Nazia Fatima, PharmD, MBA

    • Consumer Safety Officer, Division of Advertising and Promotion 1, Office of Pres
    • FDA, United States

  • Trung-Hieu Brian Tran, PharmD, MBA

    Trung-Hieu Brian Tran, PharmD, MBA

    • Team Leader, Division of Advertising and Promotion 1, OPDP, CDER
    • FDA, United States

    Trung-Hieu Brian Tran, Pharm.D/MBA, is a Lead Consumer Safety Officer/Team Leader in FDA's Office of Prescription Drug Promotion (OPDP), Division of Advertising and Promotion Review 1 (DAPR1). Shortly after graduating in 2013, he joined OPDP as a Regulatory Review Officer and was responsible for reviewing the promotion of urology and osteoporosis products. In 2016, he was promoted to his current position where he leads a team of Regulatory Review Officers for one of the three oncology teams at OPDP.

  • Nima  Ossareh, PharmD, RAC

    Nima Ossareh, PharmD, RAC

    • Regulatory Review Officer, Division of Advertising and Promotion 1
    • FDA, United States

    Nima Ossareh, Pharm.D., RAC, is a Regulatory Review Officer with the Office of Prescription Drug Promotion (OPDP), Division of Advertising and Promotion Review 1 at the U..S. Food and Drug Administration. He joined OPDP in 2017. In his current role, Nima reviews the promotion of anti-virals and addiction treatment products. Prior to joining OPDP, Nima was a project manager in CDER's Office of Pharmaceutical Quality and Office of Compliance. He holds a B.S. in Biology from San Diego State University, and a Doctor of Pharmacy degree from Howard University in Washington, DC.

  • Susannah  O'Donnell, MPH, RAC

    Susannah O'Donnell, MPH, RAC

    • Team Leader, Division of Advertising and Promotion Review 1
    • FDA, United States

    Susannah O'Donnell is currently a team leader for one of the oncology promotional review teams in CDER's Office of Prescription Drug Promotion, where she has spent the last 12 of her almost 20 years with FDA. Susannah received her Bachelor of Science degree in microbiology from Michigan State University, her Master of Public Health degree in epidemiology from the Rollins School of Public Health at Emory University, and is certified in U.S. Regulatory Affairs.

Contact us

Registration Questions?

Send Email
1.888.257.6457


Preconference Short Courses

Drug and Medical Device Ad Promo Primer