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Rx-to-OTC Switch Resource List
Last updated July 30, 2021.
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3D Communications Cynthia DiBiasi, Co-Founder and Partner, 202.236.4625 |
For more than 20 years, 3D Communications has transformed executives to become effective and persuasive communicators — regardless of the complexity of the subject, the controversy surrounding the issue, or the challenges from the audience. Our expertise is in high-stakes communications whether in-person or virtual. A global leader in healthcare communications — 3D has expertise in Consumer Healthcare. 3D has supported more than 350 FDA Advisory Committee meetings — including more than 30 Non-Prescription Drug Advisory Committee and Rx-to-OTC switch meetings. Our team of 65 full-time colleagues also prepares teams for EMA/CHMP meetings, product launch and value communications, and Market Access negotiations. |
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Chesapeake OTC Regulatory Strategies Dan Keravich, President 443.745.4200 |
Chesapeake OTC Regulatory Strategies is a consulting company that provides consumer healthcare companies assistance with regulatory policy, regulatory strategy, operations, and compliance. Chesapeake OTC Regulatory Strategies has over 30 years of pharmaceutical industry experience that includes regulatory leadership roles at FDA, NIH, and GlaxoSmithKline Consumer Healthcare. Chesapeake OTC Regulatory Strategies specializes in providing regulatory policy, strategies and support associated with Rx-to-OTC switch and OTC Monograph Reform. Mr. Keravich, as the Principal, was actively involved with OTC switch and OTC Monograph when he served as a Regulatory Project Manager within the OTC Division at CDER, FDA. While at the Agency, Mr. Keravich provided was the project lead for numerous successful OTC switch approvals that include Prilosec OTC, Imodium, Pepcid Complete, Plan B, Abreva, and Colgate Total. While at GSK, he was actively involved in multiple successful OTC switch projects that included Alli, Flonase, Sensimist, and Voltaren OTC Pain Relief. Mr. Keravich has significant industry policy and management experience. He was the US regulatory lead for the GSKCH US Wellness Category Team from 2012 to 2015. He provided regulatory oversight for operations and compliance for both NDA and Monograph products. He also served as a Director for US Regulatory Policy for 18 years. Chesapeake OTC Regulatory Strategies is an industry leader for OTC Monograph reform. While at GSK, Mr. Keravich was involved in industry strategy from the beginning of negotiations through passage and implementation. He continues to work on the Monograph reform working group within CHPA where he has assisted CHPA with multiple strategy and policy issues concerning ingredient defense and product innovation. Mr. Keravich earned his MBA at Loyola College, Selinger School of Business and Management in Baltimore, MD. He has a Master of Science (MSc) in Pharmacy and completed his undergraduate education at Northeastern University College of Pharmacy and Allied Health Profession, Boston, MA where he earned his Bachelor of Science in Pharmacy. Mr. Keravich completed an American Society of Hospital Pharmacist residency program at the Brigham and Women’s Hospital, Boston MA. In addition, he completed his Regulatory Affairs Certification (RAC) in 2013 for US Regulatory Affairs. |
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Concentrics Research LLC Julie L. Aker, President and Chief Executive Officer Julie.Aker@concentricsresearch.com 317.706.3200 |
Concentrics specializes in providing patient and consumer-focused research to pharmaceutical, medical device, and nutritional/dietary supplement companies. We are a recognized leader in designing and conducting Rx-to-OTC Switch programs. This includes label comprehension, self-selection, self-diagnosis, and actual use studies. We also conduct Phase II-IV clinical trials, REMS studies, healthcare provider research, and studies leveraging real-world data. Device studies include human factors and usability. Concentrics is also experienced in designing and conducting programs that include novel technology solutions. |
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Douglas Bierer Consulting Douglas Bierer, Ph.D., President 513.272.0094 |
Douglas Bierer Consulting, LLC, consults on regulatory affairs and product development issues for nonprescription drugs and cosmetic products, Rx-to-OTC switch, FDA advisory committee presentations, and strategic planning. |
| Edwin Hemwall Consulting, LLC. |
Edwin (Ed) Hemwall, Ph.D. brings over 35 years of global pharmaceutical industry experience in providing consulting services in OTC drug product development. His focus is on Rx-to-OTC switch, medical claims, regulatory strategy, and FDA Advisory Committee preparation. Ed first became known as an expert in Rx-to-OTC switch in 1995 through his role in the first-in-class switch of Pepcid AC followed by other US and global switches, such as the US switch of Oxytrol for over-active-bladder in 2013. His clients range from well-known global corporations to private equity firms and smaller business entities. Ed has published and lectured as a Switch and Self-Care advocate and advised on client switch programs leading to FDA approval as recent as 2020. His prior industry career spanned nearly 35 years in a range of clinical and regulatory leadership roles with Merck, J&J, GSK, and Bayer, retiring in 2016 as a vice-president on the worldwide R&D team at Bayer Consumer Care. Ed has served on the US FDA’s Clinical Pharmacology and Pharmaceutical Sciences Advisory Committee, the Board of Directors of the U.S. Consumer Healthcare Products Association (CHPA), as Chair of CHPA’s Regulatory and Scientific Affairs Committee, as co-chair of the Global Self-Care Federation Switch Working Group and as an editor for the Journal Self-Care. Ed has earned BS, MS, and Ph.D. degrees in biochemistry and pharmacology and is based in Villanova, PA. |
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Envisage Consulting LLC Doreen Frank, President 908.236.8550 |
Envisage Consulting, LLC provides consulting on regulatory affairs and development of regulatory strategy for nonprescription drugs and cosmetic products, Rx-to-OTC switch, 505(b)(2)s, and labeling/advertising. |
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International Research Services, Inc. Stephen R. Schwartz, President and Chief Executive Officer 914.937.6500, ext. 116 |
International Research Services, Inc., Clinical testing of OTC & Rx products; expertise in dermatologics, pediatrics, G.I., analgesics, diet/weight loss & oral care preparations; specialization in combining large clinical panels with high-tech analysis including, thermography and skin surface image analysis; has extensive computerized panel basis in New York. |
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Leonard Baum Regulatory Solutions Leonard Baum, President 609.240.3797 |
Leonard Baum Regulatory Solutions, LLC provides consulting on regulatory science, product development, strategy, and issues resolution covering Rx, OTC, nutritional products, and Rx-to-OTC switch programs. Extensive experience with FDA meetings, submissions, presentations, labeling and claims, M&A, and product license activities, including due diligence and integration. |
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Pinney Associates, Inc. Lucy Owen, Senior Vice President 301.718.8440 |
For over 25 years, Pinney Associates has helped healthcare companies achieve success with their Rx-to-OTC Switch programs and consumer healthcare product portfolios. We offer unparalleled regulatory, scientific, commercial, and management expertise with a team that collectively has over 150 years of hands-on experience in Rx-to-OTC Switch and supporting consumer healthcare products. When companies are considering a switch, we help them to make well-informed strategic decisions based on a thorough evaluation of a product’s regulatory hurdles and commercial opportunities. When companies are pursuing a switch, we help them to identify and manage the regulatory risks and achieve regulatory approval on favorable terms with optimized product labeling, well-designed consumer studies, and a compelling data-based benefit vs. risk case for FDA and other key stakeholders. We help companies develop, optimize, and execute their commercial opportunities, whether through switch or acquisition, to maximize the opportunity’s potential. We also provide Project Management for Rx-to-OTC switch initiatives from planning to launch. At Pinney Associates, we are passionate about helping companies to switch and market consumer healthcare products that make a difference in people’s lives and enhance companies’ growth initiatives. |
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Susan B. Levy Consulting, LLC Susan B. Levy, Founder & Principal susan@susanblevyconsulting.com 908.654.1054, ext. 102 |
Susan B. Levy Consulting, LLC is a boutique consulting firm that works with consumer health and wellness companies to develop and implement growth strategies, including Rx to OTC switches. We develop and implement strategies to gain approval for and maximize the value of Rx-to-OTC switches, including projects to assess and enhance the likelihood of success and commercial potential. Since our founding in 2011, our team has worked on over 50 Rx-to-OTC switch programs, spoken internationally, and provided thought-leadership at conferences and in industry publications. |
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The Goldstein Group Terri Goldstein, CEO & Founder 212.842.2887 |
TGG is a brand identity and package design firm that utilizes strategic design and digital techniques to achieve bottom-line results. Their offerings include graphic and industrial design, copywriting, research, IP protection, and digital strategy. Through a working partnership with Amazon expert Elemerce, TGG has developed a revolutionary approach that incorporates e-commerce marketing strategies and a proprietary understanding of consumer shopping psychology/behavior into every stage of the design process — a comprehensive solution that builds enduring brand value and ensures optimization and conversion both on-shelf and online. Located in NYC, TGG is led by Visual Brand Strategist, Terri Goldstein. For over 25-years, TGG has delivered high ROI for clients like Bayer, Merck, Sanofi, Carma Labs, Randob Labs, ProFoot, PLX Pharma, Perrigo, and GSK. The firm specializes in OTC, Rx-to-OTC switch, and new products searching for an identity in today’s omnichannel marketplace. |
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