Explore the key regulatory, scientific, quality and legal issues impacting the consumer healthcare products industry, including how to use new technologies, new ways of thinking, and new regulatory developments to advance consumer self-care. This year’s conference will focus on Consumer Healthcare: Innovating for the Future.

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FEATURED SPEAKERS

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Leonard Brody

Entrepreneur, Best-Selling Author and Emmy-Nominated Media Visionary

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Tom Furphy

CEO and Managing Director, Consumer Equity Partners

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Kevin Lane Keller

E.B. Osborn Professor of Marketing, Tuck School of Business, Dartmouth College

“RIVETING, INSPIRING,

RELEVANT!”

EVENT SCHEDULE

THURSDAY, MAY 17

7:00 – 8:30 a.m.
Continental Breakfast

8:30 – 10:00 a.m.
Opening Session

Welcome
Speaker:
Barbara Kochanowski, Ph.D.
Senior Vice President, Regulatory & Scientific Affairs
Consumer Healthcare Products Association

Overview of Regulatory, Scientific & Quality Conference (RSQ)
Speaker:
Michael Bailey
Head of Regulatory Affairs, North America and Rx-OTC Switch
Pfizer Consumer Healthcare

Regulatory & Scientific Affairs Committee (RSAC) Chair Report
Speaker:
Greg Collier, Ph.D.
Global Director, Healthcare Product Safety and Regulatory Affairs
The Procter & Gamble Company

Product Quality & Manufacturing Committee (PQMC) Chair Report
Speaker:
Bart Shrode
Vice President, Quality Operations
Perrigo Company

FDA Update with Dr. Douglas Throckmorton
Speaker:
Douglas C. Throckmorton, M.D.
Deputy Center Director for Regulatory Programs
Center for Drug Evaluation and Research
U.S. Food & Drug Administration

Dr. Throckmorton will provide an update on FDA’s efforts in the areas of environmental regulatory science and combatting the opioid crisis, as well as other key regulatory initiatives that are relevant to our industry.
10:00 a.m. – 10:30 a.m.
Refreshment Break

10:30 a.m. – 11:30 a.m.
General Session: How Branding Impacts Consumer Decisions

Speaker:
Kevin Keller, Ph.D.
E.B. Osborn Professor of Marketing
Tuck School of Business
Dartmouth College

Dr. Keller will discuss key research on branding with respect to the OTC consumer shopping and choice experience.
11:30 a.m. – 1:00 p.m.
Luncheon

1:00 – 2:15 p.m.
Quality Session #1

Drug Dosage Form and Stability Modeling Innovations in the OTC market

Moderators:
Bart Shrode
Vice President, Quality Operations
Perrigo Company

Aditya Dinge, Ph.D.
Process Development Scientist
Bayer HealthCare LLC

Speakers:
Satish Kamath
Associate Director, Tech Transfer
Bayer Consumer Health

Kenneth Waterman, Ph.D.
FreeThink Founder & CEO
FreeThink Technologies, Inc.

This session explores innovative and alternative dosage forms for the OTC market. Attendees will learn about overcoming technical challenges to make confectionary forms into OTC drug products (gums, gels, lozenges) and developments to meet unmet consumer needs like fast acting or easy to swallow dosage forms. Advanced stability modeling using ASAPprime software approaches that could be applied to these novel dosage forms to improve timing to bring to market, as well as experiences with traditional dosage forms will also be highlighted.
1:00 – 2:15 p.m.
Regulatory/Science Session #1

The Evolution of Self-Care

Speakers:
Tine Hansen-Turton, MGA, JD, FCPP, FAAN (Invited)
Executive Director
Convenient Care Association

Bakul Patel (Invited)
Associate Director for Digital Health
FDA

Jenelle Sobotka
Professor and Director, Online Certificate and Masters Programs in Pharmacy Leadership
University of Cincinnati James L. Winkle College of Pharmacy

The self-care environment is rapidly evolving. What is the pharmacist’s role in counseling patients and delivering care? How is technology (and specifically, mobile apps) impacting consumer decisions? How does all of this impact the regulatory environment? This session will feature presentations and an interactive panel discussion with three experts on these topics.
1:00 – 2:15 p.m.
Legal Session #1

OTC Legal 101: Evolving Legislation—Changing Laws and Regulations Impacting OTC Products

Speakers:
Todd Halpern, Esq.
Partner
Venable LLP

Raqiyyah Pippins
Counsel
Arnold & Porter Kaye Scholer LLP

As regulatory and legal experts for OTC products, it is key to understand the laws and regulations impacting nonprescription medicines marketed in the US. While industry experts will be familiar with the Federal Food, Drug & Cosmetic Act (FD&C Act), new statutes and policies are enacted to ensure governmental oversight is up-to-date. At the end of this session, attendees will have a clear understanding of the:

  • Differences between monograph and NDA, ANDA drug product requirements,
  • The changing FDA regulatory requirements beyond the FD&C Act for OTC drug products (such as FDARA, FDAAA, and 21st Century Cures), and
  • Best practices and avoidable missteps key to maintaining regulatory compliance.
  • 2:15 – 2:45 p.m.
    Refreshment Break

    2:45 – 4:00 p.m.
    Quality Session #2

    From Icebox to Oven: OTC Products and Temperature Fluctuations Throughout the Supply Chain

    Moderator:
    Lillian Tan
    Manager, North America Analytical Outsourcing & Offshoring
    Governance/Compliance/Central Testing Team
    Johnson & Johnson Consumer Inc.

    Speakers:
    Robert Seevers
    Senior Advisor
    Pearl Pathways

    Jing Capucao, Ph.D.
    R&D Stability Manager
    Johnson & Johnson Consumer Inc.

    Attendees will obtain a perspective on good distribution practices and requirements per USP <659> and USP <1079> and learn how OTC companies are developing quality systems around temperature control during distribution. Highlighting the session will be a retailer perspective on processes, experiences and insights on product handling from distribution center to store shelf or customer mail box, focusing on temperature control issues and how they are resolved.
    2:45 – 4:00 p.m.
    Regulatory Session #2

    Finding Your Way with MAPPs

    Speakers:
    Celia Peacock
    Senior Regulatory Project Manager
    U.S. Food and Drug Administration

    Mark Land
    Vice President, Operations & Regulatory Affairs
    Boiron, Inc.

    Lost in a regulatory maze? Find your way with CDER MAPPs and www.fda.gov website! This session will provide an overview of how FDA uses MAPPs, and how industry can benefit from using them. Including both an FDA and an industry perspective, the focus will be on two selected MAPPs: 4000.2 Office of Regulatory Policy (Developing and Issuing Guidance) and 6030.1 Office of New Drugs (IND Process and Review Procedures, including Clinical Holds).The session will also feature an interactive demonstration of the FDA website to help you improve your skills in navigating the site.
    2:45 – 4:00 p.m.
    Regulatory Session #3

    The Consumer Study Experience: “Choose Your Own Adventure”

    Speaker:
    Clark Richardson
    President
    Pegus Research, Inc.

    This highly interactive session will provide attendees with practical experience and understanding about consumer behavior research for OTC switch by following one or more key communication messages (for a single OTC candidate product) throughout the consumer research life-cycle. During this session, participants will:

  • Learn how key indication, safety and dosing messages from Rx labeling get translated to “consumer-friendly” Drug Facts Label (DFL) language,
  • Design intuitive, effective comprehension questions to assess consumer understanding of the DFL key communication messages, and
  • See how the key communication messages tested in label comprehension help drive later consumer research (in studies like human factors, self-selection or actual use).
  • 4:00 – 4:15 p.m.
    Break

    4:15 – 5:15 p.m.
    Keynote Session

    The Great Rewrite

    Speaker:
    Leonard Brody
    Entrepreneur, Best-Selling Author and Emmy-Nominated Media Visionary

    We are living in a unique moment in history, when revolutionary change in all sectors is occurring at a frenzied pace. This massive scale of disruption has understandably left organizations on shaky footing, struggling to engage consumers and employees alike and stay relevant. Those that learn to adapt, those that allow themselves to be “rewritten” for the modern day, will survive and prosper. Those that do not will collapse. Leonard Brody explains how to deal with the questions the future holds, and how organizations can harness the uncertainty they’re faced with and turn it into excitement, innovation, and success.
    5:15 – 6:00 p.m.
    Reception

    FRIDAY, MAY 18

    7:00 – 8:00 a.m.
    Continental Breakfast

    8:00 – 9:15 a.m.
    Quality Session #3

    Data Integrity in the OTC World

    Moderator:
    Catherine Vicente, Senior Scientist, Research & Development
    Johnson & Johnson Consumer Inc.

    Speakers:
    Carmelo Rosa, Supervisory Consumer Safety
    Food & Drug Administration

    Jennifer Ahearn, Director of Regulatory & Compliance
    Engineering Systems Inc.

    This session will focus on recent inspection findings from firms regarding Data Integrity. Speakers from FDA, Industry and GMP consulting practices will discuss best practices on data integrity (GMP, lab practices, data collection, electronic signatures, etc). Participants will hear a discussion of inspection findings and the expectations and impact of the new data integrity guidance.
    8:00 – 9:15 a.m.
    Regulatory Session #4

    NSURE

    Speakers:
    Julie Aker
    President and CEO
    Concentrics Research, LLC

    Eric Brass M.D., Ph.D.
    Professor Emeritus of Medicine
    David Geffen School of Medicine at UCLA
    ZnCu Consulting, LLC

    Edwin Hemwall, Ph.D.
    Principal
    Edwin Hemwall, LLC

    OTC products must demonstrate that a consumer can correctly self-diagnose, self-treat, and self-manage the condition without the intervention of a health care professional. With innovative inputs to current Prescription to OTC switch pathways, the goal of improving patient access to a wider range of medications will be reached. In this session, attendees will hear from leading industry experts as they highlight key questions for consideration as sponsors develop R&D programs which use of technology in conjunction with the Drug Facts label.
    8:00 – 9:15 a.m.
    Regulatory Session #5

    Consumer Healthcare Advertising in the Age of Social Media

    Moderator:
    Raqiyyah Pippins
    Counsel
    Arnold & Porter Kaye Scholer LLP

    Speakers:
    Laura Brett
    Director
    National Advertising Division
    Council of Better Business Bureaus, Inc.

    Mary K. Engle (Invited)
    Associate Director of Advertising Practices
    Federal Trade Commission

    In order to compete in today’s marketplace, consumer healthcare product companies are increasingly using social media and influencers to reach their consumers. Understanding the laws and regulations concerning social media marketing is a necessity in order to successfully navigate the digital landscape. Hear from the regulators directly what their expectations are, so that you can avoid the pitfalls of litigation and enforcement actions.

    At the end of this session, attendees will have a clear understanding of:

  • Who or what is an influencer?
  • The laws and regulations surrounding social media marketing, and
  • What to expect when you are not compliant.
  • 9:15 – 9:45 a.m.
    Refreshment Break

    9:45 – 11:45 a.m.
    Closing Session

    Online Retail and the Consumer Healthcare Industry: An Inside Perspective

    Speaker:
    Tom Furphy
    CEO and Managing Director
    Consumer Equity Partners

    Everyone is talking about Amazon. How are they impacting the consumer healthcare marketplace now and what can we expect in the future? Tom Furphy, a former Amazon executive, will provide an insider’s view of the Amazon model and its potential. He’ll share his unique perspective on how the company innovates, how they approach new markets and businesses, and how they grow new categories once established. During this interactive session, he’ll challenge us to raise questions and concerns specific to the regulatory, scientific and quality community and help frame how these issues might be addressed by Amazon as this category evolves.

    Closing Panel
    Speakers:
    Ashley Boam (Invited)
    Director, Office of Policy for Pharmaceutical Quality
    Center for Drug Evaluation and Research
    U.S. Food & Drug Administration

    Richard Cleland
    Assistant Director, Advertising Practices
    Federal Trade Commission

    Theresa Michele, M.D. (Invited)
    Director, Division of Nonprescription Drug Products
    Office of Drug Evaluation IV
    Center for Drug Evaluation and Research
    U.S. Food & Drug Administration

    Elizabeth Miller, Pharm.D. (Invited)
    Vice President, U.S. Regulatory Affairs
    U.S. Pharmacopeial Convention

    A distinguished panel of leaders from FDA, USP and FTC will close out the RSQ conference with an overview of their priorities and an interactive dialogue about opportunities for collaboration.