Fadwa Almanakly, PharmD
Vice President & Head, Advertising and Promotion, Regulatory Affairs Americas, Bayer Pharmaceuticals, United States
Fadwa Almanakly is the Vice President and Head, Regulatory Advertising and Promotion at Bayer, overseeing the review and approval of promotional, educational, and other materials, programs and activities for all prescription products in Bayer portfolio and pipeline. Her over 25 years of pharmaceutical industry experience include roles in Pharmacovigilance, Medical Information and Labeling. She received her Doctor of Pharmacy from University of Paris Sud, France.
Sheetal Patel, PharmD
Vice President, Specialty Compliance, Johnson & Johnson, United States
Sheetal Patel is the Vice President, Specialty Compliance 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.
Heather Banuelos, JD
Counsel, King & Spalding LLP, 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, as well as non-promotional communications, with particular focus on prescription drugs and medical devices. She routinely serves on promotional review committees and medical/scientific review committees, providing practical and insightful advice and recommendations. Heather has over 20 years of experience in food and drug law, including as a former Associate Chief Counsel in FDA’s Office of the Chief Counsel and as senior in-house regulatory counsel for Fortune 500 pharmaceutical companies.
Kimberly Belsky, MS
Reg Policy & Intell and AdPromo, Regulatory Affairs, Independent, United States
Kimberly (Kim) Belsky is the Executive Director of Regulatory Policy & Intelligence, AdPromo and RegOps at Mallinckrodt Pharmaceuticals. 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 and intelligence. Her background includes Rx drug/biologics, OTCs/Nutritionals/Cosmetics, and medical devices. Kim is the co-chair of the DIA AdPromo WG (part of the RegAffairs Community) and is an active member in several industry organizations including RAPS (Board Member). Kim is passionate about networking and collaboration.
Bob Dean, MBA
Head of Global Labeling Strategy & Ad/Promo, EMD Serono, United States
Bob is currently the Vice President of Commercial Regulatory at Myovant Sciences. Prior to that, he was Director/Team Lead at Merck & Co., Inc. in the Office of Advertising and Promotion Review. Prior to joining Merck, Bob was the Director of the Division of Advertising and Promotional Review 2 in the Office of Prescription Drug Promotion (OPDP). During his 15 years at OPDP, he oversaw core functions within FDA including advisory and labeling reviews, as well as investigations and enforcement actions. He co-developed new FDA Policies, Regulations and Guidance documents and led the efforts of the educational outreach program (Bad Ad) to help engage stakeholders in the medical community.
Head of Marketing & Strategic Business Development Ad Promo - Practice Leader, 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 Northport, Michigan with her husband, son and lab retriever where they enjoy spending time outside in all seasons.
Catherine Gray, PharmD
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, labeling recommendations, stakeholder engagement, and operational support to the office as it realizes its mission to protect the public. 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.
Georgina Lee, PharmD
Executive Director, Regulatory Advertising and Promotion, Sage Therapeutics, United States
Georgina Lee is the Head of Regulatory Advertising and Promotion at Sage Therapeutics. Over the past 9 years, her focus in industry has been to develop labeling for small molecules and biologics, including the management of REMS materials, and to oversee the regulatory review for commercial and medical materials across various review committees. Prior to Sage, she worked at Acceleron Pharma, Agios Pharmaceuticals and Biogen serving in similar capacities. She received her Pharm.D. from the University of Southern California.
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.
Global Head, Advertising & Promotion, Global Regulatory Affairs, Sanofi, United States
Mark is Vice President and Global Head of Advertising, Promotion & Labeling within Sanofi's Global Regulatory Affairs organization, with responsibility spanning the General Medicine, Specialty Care, and Vaccine portfolios. In this role, Mark is accountable for regulatory leadership and strategy in developing competitive labeling, supporting impactful product promotion and maintaining strict regulatory compliance in the interest of promoting and protecting patient health. During more than 28 years in industry, Mark has held leadership roles across numerous therapeutic areas, including responsibility for regulatory strategies across the product lifecycle.
Micheline Awad, MBA
Regulatory Affairs Professional, United States
Micheline Awad leads the Advertising & Promotion and Labeling functions at Turning Point Therapeutics. She has over 20 years of Biotechnology/Pharmaceutical industry experience, including Regulatory Affairs (RA) strategy, RA - Advertising & Promotion, and recently RA Labeling. Micheline’s Regulatory experience includes Biologic, Drug, and Device, with 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 in Biotechnology from George Mason University.
Executive Director, Office of Promotion and Advertising Review, 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 thirty years of experience across the healthcare spectrum; including 23 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.
Cynthia Collins, PhD
Executive Director, Regulatory Affairs, Gilead Sciences, United States
Executive Director, Regulatory Affairs Advertising and Promotion at Gilead Sciences.
Heather Entenmann, MPH
US Public Health Engagement Lead, Sanofi, United States
Managing Director, SVP, Strategic Planning, Eversana Intouch, United States
Michael is an end-to-end marketer who has developed a portfolio of leadership experiences across healthcare, CPG, QSR, e-commerce, and software design for the world's most complex brands. His blend of technology, media, and behavior design has reoriented top healthcare companies to create brands worth sharing. This has generated the two largest, most-engaged therapeutic area communities globally, and exponential business results for brands. Recently featured as having authored a global strategic best practice by WARC (2020) and Cannes Lions keynote presentation (2021), Michael architects teams to achieve unparalleled success, including the first-ever healthcare brand to win a platform-wide Shorty Award in social media.
Joshua Oyster, JD
Partner, Ropes & Gray, United States
Josh Oyster is a partner in Ropes & Gray’s Life Sciences Regulatory & Compliance practice. He steers clients through a wide range of FDA regulatory issues to help them bring innovative products to market while also ensuring regulatory compliance. Josh routinely helps companies navigate FDA inspections and other compliance and enforcement matters. He is frequently tapped to analyze clients’ toughest questions related to complex or ambiguous regulatory requirements, drawing on his extensive experience with key policy and enforcement priorities, including medical product promotion, digital health, and data integrity. In addition, Josh assists clients in assessing regulatory risks associated with potential acquisitions and investments.
Moulakshi Roychowdhury, JD, PharmD
Global Head, Regulatory Affairs, Advertising & Promotion, Allergan Aesthetics, AbbVie, United States
Moulakshi Roychowdhury, PharmD, JD is Global Head of Regulatory Advertising & Promotion at Allergan Aesthetics, an AbbVie Company and leads a team of professionals who advise the company on how to comply with regulations while being competitive & exceeding business goals. She is passionate about finding creative & compliant ways to communicate with customers to optimize their knowledge in making healthcare decisions and believes if intentions are ethical and in support of public health, compliant paths forward must exist. She is dedicated to growing and empowering the next generation of professionals. Moulakshi’s favorite saying is by Pablo Picasso: “Learn the rules like a pro, so you can break them like an artist.”
Gillian Marum Russell, JD
Counsel, FDA and Life Sciences, King & Spalding, United States
Gillian Marum Russell is counsel in King & Spalding’s FDA & Life Science Practice Group, advising clients on a wide range of regulatory, compliance and enforcement issues for drugs, devices and cosmetics. Gillian has significant experience advising on a wide variety of advertising and promotion activities in connection with new product launches, physician and DTC advertising, and social media. Gillian regularly acts as primary legal counsel on companies’ Medical, Legal, Regulatory (MLR) and Promotional Review Committees (PRC), advising on promotional and non-promotional communications and activities.
Chief Technology Officer, Papercurve, Canada
Lisa Stockbridge, PhD
Branch Chief, Advertising and Promotional Labeling Branch, OCBQ, CBER, FDA, United States
Lisa Stockbridge, Ph.D., has been with FDA for 30 years, during which time she has worked in CDRH, CDER, and CBER. With a background in Psychology, Medical Physiology, and Neuroscience, she has held researcher, reviewer, project manager, program manager, and supervisory positions. The last 12 years, she has been Chief of the Advertising and Promotional Labeling Branch (APLB) in CBER's Office of Compliance and Biologics Quality.
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.
Organizational Development Consultant, The Leadership Edge, United States
Maura brings over 20 years of years of experience in organizational development, change management, culture transformation, talent management and executive coaching in both internal HR roles and as a consultant. Her passion lies in helping companies realize their vision and strategy by collaboratively designing custom solutions that address their unique business needs and are grounded in their cultural aspirations. Most recently, she was the Chief Human Resources Officer for Akcea Therapeutics, a global, commercial-stage biotechnology company.
Nicol Lorraine George, PharmD, RPh
Vice President, Promotional & Labeling Services, ProPharma Group, United States
Nicol George, Pharm.D., R.Ph., is the Vice President, Promotional Review Services & Labeling at OneSource Regulatory (OSR) a ProPharma Group Company, where she manages the Regulatory& Medical Review staff & provides review & consulting services including process improvements, electronic review system implementations & Advertising and Promotion Training. Before joining OSR, Nicol was at Baxter Healthcare where she held the position of Director, Global Regulatory Affairs Labeling, Advertising & Promotion & led an international team for 5 years (2012-2017). Nicol has been in the industry for over 20 years with pharma, biologic & device experience in Medical (Med Info & Medical Science Liaison) & Regulatory Affairs.
Managing Director, Business Transformation, Health Sciences & Wellness, Ernst & Young LLP, United States
Shannon is currently a Managing Director at EY where she focuses on helping clients improve their engagement with customers through omnichannel programs leveraging data and technology. She is also the co-leader of EY's services to support enhancements to the promotion material review process, including the technology-enabled service EY Smart Reviewer. Prior to EY, Shannon has experience in industry at BMS, a boutique consulting firm called Rosetta and also ran a digital agency called Razorfish Health. Shannon lives in Princeton, NJ with her husband, Glenn. They have 5 adult children and 2 very spoiled dogs.
Jen Horonjeff, PhD
Founder and CEO, Savvy Cooperative, United States
Jen Horonjeff, PhD, is a patient advocate and the founder & CEO of Savvy Cooperative, the first and only patient-owned co-op that helps innovators connect directly with diverse patients to get the insights they need to build better and more inclusive healthcare solutions. Jen was named one of the 50 Most Daring Entrepreneurs of 2018 by Entrepreneur Magazine for her work at Savvy. She grew up with multiple autoimmune conditions and survived a brain tumor as an adult. She is also a patient-centered outcomes researcher, a human factors engineer, and a former FDA advisor. Jen strives to give patients a platform to have their experiences be heard, included, and equitably valued.
Senior Associate, DLA Piper, United States
Kayt Leonard, MA
Global Health Care and Life Sciences Strategic Advisor, SAS Institute Inc., United States
Kayt Leonard is the Global Health Care and Life Sciences Strategic Advisor at SAS, an organization working to transform the world through the power of advanced analytics. Kayt is dedicated to understanding the challenges that patients, payers, providers, drug developers, and regulators face, and conducts academic and industry-based research on global access to health care and international health disparities. Working all over the world to increase access to care for diverse, underserved, and underrepresented populations, Kayt’s work has been recognized by the World Health Organization, the Food and Drug Administration, the European Medicines Agency, the Centers for Disease Control, and the U.S. Agency of International Development.
Nikki Reeves, JD
Attorney, King & Spalding LLP, United States
Nikki Reeves is an FDA and healthcare regulatory compliance lawyer who has been advising life sciences companies on FDA regulatory matters for more than 22 years. Nikki co-chairs King & Spalding’s Life Sciences and Healthcare Industry Group, which is comprised of more than 400 lawyers across the firm. She counsels life sciences companies and investors on an array pre- and post-market FDA regulatory compliance and enforcement matters, and she has been the lead FDA regulatory advisor to her clients on 250+ transactional matters.
Deborah Wolf, JD
Regulatory Counsel, OPEQ , Regulatory Policy, CDRH, FDA, United States
Deborah Wolf has been a regulatory counsel in CDRH since 1995, focusing primarily on issues related to labeling and advertising. She advises staff in many parts of CDRH on a broad range of device-related policy and regulatory issues.
Amy Toscano, PharmD, CPA, RPh, RAC
Senior Director, Myovant Sciences, United States
Amy Toscano, PharmD, RAC, is a Senior Director in commercial regulatory affairs at Myovant Sciences. She has over seven years of experience in the pharmaceutical industry , specializing in advertising and promotion in regulatory affairs. Prior to working in the pharmaceutical industry, she worked for over ten years as a reviewer and a team leader at the FDA’s Office of Prescription Drug Promotion. Dr. Toscano completed a post-doctoral industry fellowship through Rutgers University and Bristol Myers Squibb Toscano in Medical Information. She holds a B.S. in accounting and a PharmD, both from Rutgers University.
Marc Benjamin, MBA
CEO, Convergence Point Media, LLC, United States
Marc Benjamin is founder and CEO of Convergence Point Media (CPM), an independent specialty media planning and buying agency serving pharmaceutical and life science brands since 2007. In 2021, in advance of the national Covid vaccine rollout, Marc founded Face2Face America to combat misinformation fueling widespread vaccine hesitancy. A pro bono alliance of healthcare marketing firms and health endemic media companies, Face2Face featured accounts from frontline providers and members of vaccine hesitant communities to promote vaccine education and adoption. In 2022, Marc launched an industry initiative to raise donated ad inventory to support Direct Relief in providing essential medicines to millions of Ukrainians displaced due to the war.
Torrey Cope, JD
Partner, Sidley Austin LLP, United States
Torrey Cope advises and represents clients in a full range of regulatory, enforcement, litigation, and transactional matters involving FDA issues. He has been recognized as a “Life Sciences Star” in the FDA: Pharmaceutical category by LMG Life Sciences since 2016 and has been included in The Best Lawyers in America for FDA Law since 2018. He was also named a “Rising Star” for Life Sciences in LMG's 2017 and 2018 Expert Guides.
Bryant Godfrey, JD, MHA
Partner, Co-Chair, FDA Practice , Foley Hoag, United States
Bryant M. Godfrey is a partner in the Washington, D.C. office of Foley Hoag and is Co-Chair of the firm’s Healthcare and Life Sciences and FDA Practice Groups. He advises companies and organizations across all FDA-regulated industries on a broad range of FDA regulatory, policy, compliance, enforcement, and strategic matters. His experience encompasses a wide range of issues relating to advertising and promotion, labeling, scientific exchange, investigations of off-label marketing, among many others. Mr. Godfrey served in several senior regulatory and policy positions at FDA, including as Senior Lead Regulatory Counsel for FDA’s Office of Prescription Drug Promotion and Senior Counsel/Special Assistant to the Principal Deputy Commissioner.
Senior Vice President and Head, Consumer and Brand Integration, Green Room Communications, United States
Editorial Manager, U.S.Content Operations, GSK, United States
CEO and Founder, SecureCHEK AI, United States
Ilyssa is an entrepreneur who challenges the status quo. Her current brainchild, SecureCHEK AI, an AI-powered software that transfers manual marketing tasks from humans to technology for maximum efficiency. She started her career in adpromo where she launched and ran several promotional agencies specializing in pharmaceuticals. She launched the 1st online regulatory compliance university certificate program currently offered by BIO. She received the President Award from the Healthcare Businesswomen's Association for conceiving and launching the industry’s 1st Certificate Program for Digital Innovation Focused on Commercial and Compliance Partnerships. She was named one of the industry's 100 Inspiring People by PharmaVoice Magazine.
Engagement Director, McCann Heath Australia, Australia
Meet Tristan Reid, the Engagement Director at Ward6 Australia. With extensive experience in healthcare media, social media, digital media, and emerging technologies such as AR/VR and AI, Tristan brings a wealth of knowledge and expertise to DIA’s Advertising and Promotion Regulatory Affairs Conference. As a thought leader in omnichannel strategy, marketing technology, design thinking, customer journey design, and data visualization, Tristan will be discussing the latest innovative platform in the industry, SecureCHEK.AI, an AI platform that will revolutionise the way pharmaceutical companies approach content production and MLR review.
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