Faculty – 4th Rx-to-OTC Switch Summit

Susan Lavine Coleman

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Susan Lavine Coleman is President of NCI Consulting and an expert in Rx-to-OTC switch strategy, implementation and commercial maximization. Widely quoted in the media, Susan has supported over half the switches that have occurred in the past 10 years, has worked on 40+ switches over the last 25 years, and has evaluated switch feasibility and the business potential for hundreds of potential switch opportunities.

After completing her MBA at the Kellogg School at Northwestern University, Susan joined Johnson & Johnson where she held a range of leadership positions at McNeil Consumer Products before moving to J&J’s Consumer Products division as head of the Therapeutic Skin Care business unit. She left J&J to join NCI Consulting in 1990 and was named President in 1995. In 2006, Susan acquired NCI Consulting from its parent company, the Publicis Groupe, and took it private.

Today, along with her team of medical, regulatory and commercial experts, Susan supports client companies in:

  • Identifying and evaluating switch opportunities
  • Developing switch regulatory and commercial strategies
  • Identifying and selecting OTC switch commercialization partners
  • Supporting switch submissions
  • Strengthening competitive differentiation and claims
  • Optimizing market entry plans
  • Building innovative life cycle plans to sustain growth

Susan’s clients include 7 of the top 10 global pharmaceutical companies, most of the leading OTC companies and a range of small to mid-sized healthcare-oriented companies, including private equity firms.

Corey Davis
Deputy Director and Staff Attorney, NETWORK FOR PUBLIC HEALTH LAW

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Corey Davis, J.D., MSPH is a Senior Attorney at the National Health Law Program and Deputy Director at the Network for Public Health Law. His work focuses on evaluating the effects of law and policy on the health of underserved individuals and advocating for evidence-based and equity-focused law, policy, and practice.

Sean Griffin
Senior Director of Regulatory Affairs, GALDERMA

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Sean Griffin is Senior Director of Regulatory Affairs for Galderma Laboratories, L.P. and is responsible for managing the Regulatory Affairs and Labeling functions. In this role, Sean oversees regulatory strategy development and execution for drugs, medical devices, cosmetics and dietary supplements. Sean joined Galderma in 2011 after 17 years in Regulatory Affairs at Alcon Laboratories and Bausch & Lomb where he managed ophthalmic drug, device and OTC product regulatory activities in the U.S. and key international markets such as Europe, Canada, Australia, Japan, Brazil, Russia, and China.

Since joining Galderma, Sean successfully led the Differin Gel Rx-to-OTC program which was approved by FDA in July 2016. This Rx-to-OTC switch was the first for Galderma and the first in the acne category – representing a key milestone for acne sufferers in the United States.

Erin E. Haas, MPH

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Erin Haas has fostered expertise in harm reduction policy and programs through eight years of progressive responsibility in the field. She has served in a variety of roles, including volunteer for a syringe services mobile outreach program, overdose prevention trainer, and consultant. Erin holds a Master in Public Health from the University of Pittsburgh Graduate School of Public Health with a concentration in Behavioral and Community Health Sciences and a particular focus in behavior change theory. Erin currently works in a leadership role with the Maryland Department of Health on harm reduction policy development and program implementation, during which she has been instrumental in passing statewide syringe access legislation in 2016 and a naloxone expansion law in both 2015 and 2017 that made naloxone as close to “over the counter” as possible in Maryland. She is also an Associate with the Center for Applied Prevention Technologies and provides technical assistance to other states on harm reduction projects.

Edwin Hemwall, Ph.D.

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Edwin (Ed) is an independent consultant in nonprescription drug development and self-care. His 35-year industry career included a range of clinical and regulatory leadership roles with Merck, J&J, GSK, and Bayer.

Ed first became known as an expert in Rx-to-OTC switch through his role in the first-in-class switch of Pepcid AC in 1995 followed by other U.S. and global switches, most recently with the US switch of Oxytrol for over-active-bladder in 2013. He has published and lectured as a Switch and Self-Care advocate. In recent years 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 WSMI Switch Working Group and as an editor for the Journal Self-Care. He holds BS, MS and Ph.D. degrees in biochemistry and pharmacology.

Juby Jacob-Nara
former CMO, and Vice President, Global Clinical Development and Global Medical Affairs, PFIZER

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Dr. Juby Jacob-Nara is a public health physician who has worked in the pharmaceutical industry for over 20 years, across sales, marketing, medical & clinical roles in traditional pharma, vaccines, biologics and consumer products, particularly Rx to OTC switches. In her career, she has launched well over 25 products globally. Her last role was as CMO & VP of Global Clinical Development and Medical Affairs of Pfizer’s Consumer Healthcare Division. Dr. Jacob-Nara was responsible for developing global medical affairs strategy and leading all medical and clinical activities, while also serving as the primary “voice of medical” for Pfizer’s Consumer Division. Some of the flagship consumer products she has been responsible for included Advil®, Nexium® 24HR, Centrum®, Emergen C®, Caltrate®, among many others.

Dr. Jacob-Nara has also held several leadership positions at various major companies including GlaxoSmithKline, Novartis, and Merck & Co. Dr. Jacob-Nara was also pivotal in her role as Head Respiratory Category Physician leading all medical and clinical activities for the Rx to OTC switch of Flonase® at GlaxoSmithKline Consumer Healthcare.

Philip Kantor

former Global Marketing Director, Allergy, GLAXOSMITHKLINE

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Phil Kantor, currently Principal in the IQVIA Consumer Health consulting practice, has over 25 years of strategic marketing experience within leading OTC companies. In addition to leveraging comprehensive insight, positioning, innovation, and activation work to grow major brands, he has led the development and launch of numerous Rx-to-OTC switch products, including Flonase Allergy Relief, Flonase Sensimist, alli, and Lamisil AT. This work has been both domestic and with local affiliates around the world.

Kate Grindlay Kelly, MSPH

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Kate Grindlay Kelly is an Associate at Ibis Reproductive Health, and Project Director of the Free the Pill project, overseeing the implementation of an ambitious program of work to move an oral contraceptive pill over the counter in the United States. She also manages a portfolio of quantitative and qualitative social science research with a focus on improving reproductive health in underserved communities and exploring innovative approaches to increase reproductive health access. Kate has Master of Science degree in Public Health from Harvard University.

James Kenney
Global Brand Marketing Director, GALDERMA

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James works for Galderma Laboratories, a Nestle Skin Health company and a global leader in dermatology products in both the prescription and consumer divisions. He is currently leading the Rx to OTC switch of Differin 0.1% Adapalene Gel, the first Retinoid approved by the FDA for OTC treatment of Acne, and the first of its class. Prior to this he worked with J&J, leading their Global OTC Pain Relief franchise and with their Global Listerine team in both the US and UK, starting with Pfizer Consumer Healthcare. He has been in the US for almost a decade.

Susan B. Levy
Founder and Principal, SUSAN B. LEVY CONSULTING

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Susan has more than 25 years of global, cross-functional experience in the consumer healthcare industry and has worked across many therapeutic categories for industry leaders such as Merck/Schering-Plough, Pfizer/Warner-Lambert and SmithKline Beecham.

In 2011, Susan founded a boutique consulting firm providing strategy, business development and marketing services in the consumer healthcare space. Susan B. Levy Consulting, LLC works with its clients on a brand, category or portfolio basis to develop and implement strategies for growth, including acquisitions, technology search, in-licensing of new technologies, Rx to OTC switch, and effective and efficient marketing programs. Susan has consulted, presented and authored articles on Rx to OTC switches.

Most recently Senior Director, Strategy Development for Merck & Co., Inc., Susan worked directly with Merck’s CEO and his leadership team to develop breakthough strategies that would transform Merck from a global pharmaceutical company to a global healthcare company. Previously, Susan was Senior Director, Global New Ventures and Strategic Commercial Development for Schering-Plough Consumer Healthcare. In this role she was responsible for pursuing profitable external growth opportunities, including new technologies, Rx to OTC switches, acquisitions and alliances for the $1.9B+ Consumer HealthCare division of Schering-Plough. Susan personally managed more than six development and exploratory phase switch programs with a total value exceeding $800MM.

Prior to joining Schering-Plough in 2006, Susan worked at Pfizer Consumer Healthcare. In her final role there, she established a business model to manage the division’s first Rx drug, Nicotrol, and developed a strategy to expand the Rx platform within the consumer business. From 2000 to 2002, Susan managed the Visine brand on a global basis, delivering double-digit top and bottom line growth; she also launched the brand in Brazil. Susan was a member of both the Switch Selection Team and Switch Steering Team.

Susan began her career in R&D at Unilever before joining Beecham Products in New Product Development (later SmithKline Beecham). As Manager, Portfolio Analysis, Susan provided strategic business support for the Gastro-Intestinal, Respiratory Tract, Analgesic and Diagnostic Categories and New Business Development, including portfolio evaluation and project prioritization of Rx to OTC switch opportunities.

Susan received her B.A. in chemistry from Cornell University and attended NYU’s Stern School of Business for her MBA.

Randall Thornton
Clinical Pharmacist, EMORY HEALTHCARE

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Randall is a Georgia native and UGA graduate with clinical and administrative background in retail, consulting and institutional pharmacy. He holds a BCPS certification and is actively working with a skilled team of professionals at Emory Healthcare in the area of neurology and psychiatry. Randall has a long history of providing patient care and promoting self-care. He holds an MBA in business from Florida International University – College of Business Administration and has demonstrated results in service, profitability and controlling costs. He is a member of GPhA, APhA, ASCP, GSHP, ACCP and CPNP which are pharmacy organizations. Randall is a strong supporter of pharmacists gaining provider status and of controlling healthcare costs through RX to OTC changes. He is married and enjoys his family, politics, music and golf.

Randy Vogenberg, Ph.D., R.Ph.
Principal, Institute for Integrated Healthcare, Fellow, Foundation of HealthSmart Consumers, Lead Collaborator, NATIONAL INSTITUTE OF COLLABORATIVE HEALTHCARE

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Dr. Randy Vogenberg is Principal, Institute for Integrated Healthcare, Greenville, SC; Co-Founder of Access Market Intelligence; and former National Health Benefits Thought Leader for Aon Consulting.

Dr. Vogenberg currently is the Pharmacy Advisor and Co-Project Leader with the Midwest Business Group on Health National Employer Biologics & Specialty Pharmacy Initiative. With Access Market Intelligence, he provides consulting on applying healthcare management intelligence to your strategic and tactical business decisions in solving complex health care system reform challenges.

A frequent speaker and author focusing on integrated health strategies and contemporary managed care or health system issues, Dr. Vogenberg has authored several books, including “Pharmacy Benefits: Benefit Design and Management” and an eLearning program on “Specialty Pharmacy and Biotechnology Medication Coverage” for the International Foundation of Employee Benefit Plans used by HR and benefit consultants now available through the HBI Institute.

He is an Editorial Board member of several publications, including Managed Healthcare, P&T, and American Health & Drug Benefits. As a nationally recognized expert on health (medical & pharmacy) benefits and quality, he is an Adjunct Professor at both the University of Rhode Island College of Pharmacy and Presbyterian College School of Pharmacy, Adjunct Assistant Professor in the Department of Health Economics Research at the University of Illinois College of Pharmacy, and was a Senior Fellow with the Jefferson School of Population Health as well as the Department of Health Policy, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA..

Dr. Vogenberg holds a Bachelor of Science degree in Pharmacy and a Doctorate in Health Care Management. Additionally, he completed an Accredited Pharmacy Residency at the Brigham & Women’s Hospital/Harvard Medical School, Boston.