SCHEDULE

WEDNESDAY, MAY 16

10:00 a.m. – 12:00 p.m.
RSAC/PPS Meeting

(Invitation only)

12:00 – 5:00 p.m.
RSAC Meeting

(Registration required. Please contact Mary McDonald at mmcdonald@chpa.org)

5:00 – 6:00 p.m.
Early Arrival Reception

(Open to all attendees)

THURSDAY, MAY 17

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

8:30 – 10:00 a.m.
Opening Session

Welcome
Speaker:
Barbara A. 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, M.B.A.
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
Office of Drug Evaluation IV/Division of Nonprescription Drug Products
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

Moderator:
Greg Collier, Ph.D.
Global Director, Healthcare Product Safety and Regulatory Affairs
The Procter & Gamble Company

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

Building on an understanding of OTC consumer choice and shopping experiences, Professor Keller will offer some key principles for OTC branding.
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, M.B.A
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). These developments are directed to meet 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 demonstrated.
1:00 – 2:15 p.m.
Regulatory/Science Session #1

The Evolution of Self-Care

Moderator:
Cmdr. Daniel Brum, Pharm.D.
Chief, Project Management Staff
Center for Drug Evaluation and Research
Office of Drug Evaluation IV/Division of Nonprescription Drug Products
U.S. Food and Drug Administration

Speakers:
Bakul Patel, M.S., M.B.A.
Associate Director for Digital Health
Center for Devices and Radiological Health
U.S. Food and Drug Administration

Tine Hansen-Turton, MGA, JD, FCPP, FAAN
Executive Director
Convenient Care Association

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

The self-care environment is rapidly evolving. What is the pharmacist’s role in counseling patients and delivering care? How is technology, including 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

Moderator:
Carolyn Herrmann, Esq.
Deputy General Counsel
Consumer Healthcare Products Association

Speakers:
Todd Halpern, Esq.
Partner
Venable LLP

David Horowitz, Esq.
Partner
Hogan Lovells U.S. LLP

Raqiyyah Pippins, Esq.
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 U.S. While industry experts are familiar with the Federal Food, Drug & Cosmetic Act (FD&C Act), new statutes and policies have been enacted to ensure governmental oversight is up-to-date. At the end of this session, attendees will have a clear understanding of:

  • The changing FDA regulatory requirements beyond the FD&C Act for OTC drug products (such as 21st Century Cures and PREA),
  • The The potential challenges and opportunities for nonprescription drugs should OTC monograph reform legislation become law, 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:
    Jing Capucao, Ph.D.
    R&D Stability Manager
    Johnson & Johnson Consumer Inc.

    Steven A. Greer
    Corporate Quality Assurance External Engagement Leader
    The Procter & Gamble Company

    Robert Seevers
    Senior Advisor


    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 an industry survey on processes, experiences and practices on product handling from distribution center to store shelf, focusing on temperature control issues and how they are resolved.
    2:45 – 4:00 p.m.
    Regulatory Session #2

    Finding Your Way with MAPPs and Compliance Policies

    Moderator/Speaker:
    Judy Doyle
    Director - Regulatory Affairs
    Sanofi Consumer Healthcare

    Speakers:
    CAPT Melissa Burns
    Senior Program Manager
    Office of Combination Products
    U.S. Food and Drug Administration

    Mario Cruz-Rivera, Ph.D.
    Senior Director of Global Clinical Research & Rx-to-OTC Switch
    Pfizer Consumer Healthcare

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

    Helen Lee, Pharm.D.
    Regulatory Project Manager
    Center for Drug Evaluation and Research
    Office of Drug Evaluation IV/Division of Nonprescription Drug Products
    U.S. Food and Drug Administration

    Lost in a regulatory maze? Find your way with CDER MAPPs, compliance policies, and the FDA’s website! This session will provide an overview of how FDA uses MAPPs and compliance policies in their day-to-day work, and how industry can benefit from using them. Hear from Agency experts as they discuss how regulators use the IND Development and Review and Refuse to File MAPPs, and key points from the recently released compliance policy on post-marketing safety reporting requirements for combination products. Industry representatives will give suggestions for how to incorporate concepts from these documents into company procedures. The session will conclude with an interactive demonstration of the FDA website to help you improve your navigational skills.
    2:45 – 4:00 p.m.
    Regulatory Session #3

    The Consumer Study Experience: “Choose Your Own Adventure”

    Moderators:
    Kimberly Anderson, M.P.H.
    Vice President, Clinical Operations
    PEGUS Research, Inc.

    Russell Bradford, M.D., MSPH
    Vice President, Medical Affairs
    PEGUS Research, Inc.

    Sarah Farnsworth, Ph.D.
    Vice President, Scientific Affairs
    PEGUS Research, Inc.

    Speakers:
    Amanda H. Pike-McCrudden
    Social Science Analyst
    Center for Drug Evaluation and Research
    Office of Drug Evaluation IV/Division of Nonprescription Drug Products
    U.S. Food and Drug Administration

    Clark Richardson, M.P.H.
    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

    Evening entertainment provided by Full Switch

    Band Members:
    CHPA Member: Saul Gylys
    FDA: Scott Abernathy, Dan Brum, Francis (Frank) Becker
    USP: Tim (Mit) Greiner

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

    Tom Himmelsbach
    North America Regional Quality Director
    Johnson & Johnson Consumer Inc.

    Carmelo Rosa, Psy.D.
    Director, Division of Drug Quality I
    Center for Drug Evaluation and Research
    U.S. Food & Drug Administration

    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

    Considerations for Developing OTCs Using Drug Facts Labeling and Technology

    Moderators:
    Doug Bierer, Ph.D.
    President
    Douglas Bierer Consulting, LLC

    LaMont Bryant, Ph.D.
    Senior Director, Regulatory Affairs
    Johnson & Johnson Consumer, Inc.

    Speakers:
    Julie Aker, BS, MT (ASCP)
    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 nonprescription 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 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, Esq.
    Counsel
    Arnold & Porter Kaye Scholer LLP

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

    Mary K. Engle, Esq.
    Associate Director of Advertising Practices
    U.S. 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 directly from the regulators about their expectations, so 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

    Moderator:
    Scott Melville
    President and CEO
    Consumer Healthcare Products Association

    Speaker:
    Tom Furphy
    CEO and Managing Director
    Consumer Equity Partners

    Everyone is talking about online retailers. 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, Furphy will challenge attendees 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 online retail evolves.

    Closing Panel
    Moderator:
    Michael Bailey
    Head of Regulatory Affairs, North America and Rx-OTC Switch
    Pfizer Consumer Healthcare

    Speakers:
    Donald D. Ashley, JD
    Director, Office of Compliance
    Center for Drug Evaluation and Research
    U.S. Food and Drug Administration

    Richard Cleland, Esq.
    Assistant Director, Advertising Practices
    U.S. Federal Trade Commission

    Theresa Michele, M.D.
    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.
    Vice President, U.S. Regulatory Affairs
    U.S. Pharmacopeial Convention

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

    “VERY THOUGHT-PROVOKING

    TOPICS.”