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Consumer-Driven Self-Care: Opportunities in Today's Self-Care Landscape

About RSQ

CHPA’s Regulatory, Scientific & Quality Conference (RSQ) brings together leaders from industry, regulatory authorities, and academia across the consumer healthcare landscape to focus on the self-care space.

The RSQ agenda offers something for everyone with key legal, regulatory and scientific, and product quality sessions over the course of two days. Hear from FDA, USP, industry, and academia on some of the timeliest topics affecting the consumer healthcare marketplace.

COVID-19 Policy

PROOF OF VACCINATION CURRENTLY NOT REQUIRED

The health and safety of our attendees is our top priority. As the pandemic continues to recede, CHPA has opted to suspend the requirement that conference attendees must show proof of COVID-19 vaccination or a negative test. We are continuing to monitor infection rates across the country, and CDC and local health guidelines. As such, the vaccine/negative test requirement is subject to reinstatement at any time. We will continue to keep attendees informed about any changes to this policy.

Face coverings are not mandated in MD, and we will not require masks to be worn during the conference, but please do if it makes you feel safer and more comfortable around others. We strongly encourage attendees to continue to wear a face covering indoors if you have a weakened immune system, or if you are at increased risk for severe COVID-19 disease due to age or underlying health conditions, or if you are unvaccinated. All attendees must comply with on-site pandemic protocols and the code of conduct.

CODE OF CONDUCT / PERSONAL RESPONSIBILITY

By attending the 2022 CHPA Regulatory, Scientific & Quality Conference, you agree to the following:

  • I agree not to travel or attend the CHPA Regulatory, Scientific & Quality Conference if I or a member of my household is sick.
  • I will not attend if I test positive for COVID-19 or have been exposed to someone with symptoms or someone with suspected or confirmed COVID-19.
  • If I begin to feel ill after arriving at the conference, I will isolate myself immediately. I understand the symptoms of COVID-19 include fever, chills, cough, shortness of breath, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, and nausea or vomiting.
  • I will frequently wash and sanitize my hands while attending the conference.
  • I will follow social distancing guidelines and foot traffic flow signs.
  • I will respect and greet everyone in a safe and professional way.
  • I will follow all safety protocols in place at the conference, in the hotel, and all local, state and federal public health guidelines and laws.
  • I acknowledge that an inherent risk of exposure to COVD-19 exists in any public place where people are present and that CHPA cannot guarantee conference participants will not become infected with COVID-19.  
  • By attending, I voluntarily assume all risks related to exposure of COVID-19.
  • I agree to cooperate with CHPA, its conference venues and public health officials regarding investigations and reporting of COVID-19 infections or suspected infections prior to, during and after the conference.

We are continuing to monitor the ongoing developments and policy changes concerning pandemic safety. We are working closely with our venues and suppliers to ensure we provide an environment that complies with local, state and CDC guidelines. Instructions and protocols are subject to change and we will continue to update you.

Program (as of August 18)

September 19-21, 2022

September 19, 2021

Day 1

10:00 a.m.-4:00 p.m. 

Regulatory & Scientific Affairs Committee Policy and Planning Subcommittee and Regulatory & Scientific Affairs Committee Meetings (Members only) 


4:30-6:00 p.m. 

Early Arrivers Reception  

September 20, 2022

Day 2

7:00-8:00 a.m. 

Breakfast and Networking 


8:00-8:15 a.m. 

Welcome Remarks 

Livestreamed

Barbara Kochanowski, Ph.D., Senior Vice President, Regulatory & Scientific Affairs, Consumer Healthcare Products Association (CHPA) 

Valerie L. Gallagher, Vice President Consumer Self-Care Americas, Regulatory Affairs, Perrigo Company, RSQ Program Committee Chair


8:15-9:00 a.m. 

Impact of COVID-19 on Consumer Behavior 

Livestreamed

Moderators: Anita Brikman, Senior Vice President, Communications & Public Affairs, and Executive Director, CHPA Educational Foundation, CHPA; Evren Attilasoy, M.D., Senior Director, North America Medical/Clinical Affairs, Johnson & Johnson Consumer, Inc.

Speaker: Mindy Albuck, Principal, Market and Shopper Intelligence, IRI

IRI will present an in-depth analysis of the impact of the COVID-19 pandemic on the consumer healthcare products' market and on trends in consumer behavior. 


9:00-9:45 a.m. 

General Session 

Livestreamed

Moderator: Lauren Quinn, J.D., Vice President, US Regulatory Affairs, Haleon

Speaker: RDML Richardae Araojo, Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity, U.S. Food and Drug Administration (invited)

With health equity, access, and health literacy at the forefront of our industry, RDML Araojo will highlight her office’s key priorities, and how they relate to the consumer healthcare industry. 


9:45-10:15 a.m. 

Morning Break


10:15-11:45 a.m. 

Breakouts

Application of Real World Evidence in the Self-Care Industry 
Livestreamed
Regulatory

Moderator: Marcia D. Howard, Ph.D, CAE, Vice President, Regulatory & Scientific Affairs, CHPA 

Speakers: Andrew Stewart, Head of RWE and Behavioral Science, Sanofi Consumer Healthcare; Joe B. Franklin, J.D., Ph.D., Product Counsel, Verily Life Sciences 

Regulators, product manufacturers, and other stakeholders are all keenly aware of the value real world evidence (RWE) can play in product development and approval, and monitoring the safety and effectiveness of OTC healthcare products. Experts will share their views on new ways that real world data (RWD) from consumers can become RWE supporting regulatory approvals, guiding R&D programs, and augmenting existing data sources.  

Ingredient Innovation 
Dietary Supplements and OTC Medicines 

Moderator: Marielle Weintraub, Ph.D., Analytical Services Manager, Eurofins  

Speakers: Menas G. Kizoulis, Scientific Engagement Director, Johnson & Johnson Consumer, Inc.; Tony Pavel, Deputy General Counsel, Global Food Law, Perfect Day Foods, Sustainable Animal Free Dairy and Protein; Ivan Wasserman, Managing Partner, Amin Talati Wasserman LLP

Innovation requires companies to keep pace with changing consumer preferences. This session will look at old ingredients being reinvented in new ways, followed by legal and regulatory considerations when introducing new form factors into regulated self-care categories. 

Quality Metrics 
Quality 

Moderator: Larisa Pavlick, Senior Director, Product Quality and Technical Affairs, CHPA

Speakers: Nelson Webb, Director, QA External Engagement, The Procter & Gamble Company; Jennifer Maguire, Ph.D., Deputy Director, Office of Quality Surveillance, U.S. Food and Drug Administration

FDA will provide the latest updates on the FDA Metrics program and anticipated next steps. The audience will also learn about the recently completed Quality Management Maturity Pilot program. This session will include a review of ISPE’s Advancing Pharmaceutical Quality Program and the growing list of guides and tools available now. The ISPE work is industry-led and serves to advance pharmaceutical quality by providing practical tools and approaches that enhance the effectiveness of the Pharmaceutical Quality System. Speakers will share insights on the latest pharmaceutical industry operational excellence benchmarks, and practical strategies for building cultural excellence to support enhanced quality outcomes that go beyond compliance.  


11:45 a.m.-12:45 p.m. 

Lunch Break


12:45-1:30 p.m. 

FDA CDRH Leadership General Session  

Livestreamed

Moderators: Kathleen Blieszner, Ph.D., Global Product Stewardship, Regulatory Affairs, FemCare, The Procter & Gamble Company; Scott Melville, President and CEO, CHPA

Speakers: Jeffrey Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration

During the COVID-19 pandemic, the importance of self-care was magnified. Consumers purchase products as part of their self-care regimen, often without awareness of whether they are purchasing an OTC medicine, dietary supplement, or medical device. CHPA’s 2020 vision expanded the association’s representation to include consumer medical devices in addition to OTC medicines and dietary supplements. For the first time, RSQ attendees will hear from the head of FDA’s Center for Devices and Radiological Health (CDRH) about its short and long term regulatory priorities, key elements from MDUFA reauthorization impacting OTC devices, and innovation opportunities for OTC diagnostic tests.  


1:30-2:45 p.m. 

Breakouts

Diagnostics & Digital Health: Now and In the Future 
Livestreamed
Regulatory 

Moderator: Marcia D. Howard, Ph.D., CAE, Vice President, Regulatory & Scientific Affairs, CHPA

Speakers: Adam N. Vasquez, Head of Quality, Regulatory & Health Compliance, Google, Inc.; John Tamerius, Ph.D., Special Advisor, Quidel 

Digital health is all around us…from our connected watch to the pulse oximeter used at home and everything in-between. The pandemic has increased the level of care that families perform in their homes, potentially expanding the types of conditions that can be addressed without first seeking a doctor. During this session, learn from one of the developers of the OTC COVID-19 test kits that are now a critical part of managing infections and new in vitro diagnostic tests that are just on the horizon. Hear insights from a leading technology company to help your innovation teams prepare for the coming new digital health products for the at-home and self-care space.   

DSHEA Reform 
Dietary Supplements 

Moderator: Mike Tringale, Vice President, Communications & Public Policy, CHPA 

Speakers: Diane McEnroe, Partner, Sidley Austin LLP; Camilla Sorensen, Director, Regulatory Affairs, Johnson & Johnson Consumer, Inc.; Chris D’Adamo, Ph.D., Director, Center for Integrative Medicine, University of Maryland School of Medicine

The Dietary Supplement Health and Education (DSHEA) was passed in 1994 to balance consumer access to dietary supplements with consumer safety. Twenty-eight years later the market has grown significantly and so has the number of non-compliant companies that have introduced adulterated and misbranded products to the market. Congress has written legislation intended to strengthen the framework that regulates dietary supplements, which has resulted in a renewed discussion on the need for DSHEA reform. Attendees of this session will get the latest updates from industry and other stakeholders at the forefront of legislative discussions regarding where these efforts may be headed.  

Impurities I 
Quality  

Moderator: Amy Roe, Principal Toxicologist, The Procter & Gamble Company 

Speakers: Susan P. Felter, Ph.D., Research Fellow, The Procter & Gamble Company; Sarah E. Parker, Ph.D., Managing Scientist, Exponent  

Impurities in a drug or cosmetic product can arise due to multiple factors. Analytical methods can be challenging and risk assessment for product safety needs to account for exposure. This session will cover benzene, an impurity recently found in some spray products as well as the issues with determining exposure, including less-than-lifetime exposure and how it might be applied to nitrosamine exposure assessments.  


2:45-3:15 p.m. 

Afternoon Break


3:15-4:45 p.m.  

Breakouts

Hot Topics in the World of Consumer Medical Devices 
Regulatory 

Moderator: Kathleen Blieszner, Ph.D., Global Product Stewardship, Regulatory Affairs, FemCare, The Procter & Gamble Company 

Speakers: Wade Ackerman, Partner, Covington & Burling; Kristin R. Davenport, Partner, Covington & Burling; John "Web" Leslie, Associate, Covington & Burling

During this session focused on medical devices, experts from Covington & Burling will highlight recent activities by regulators & legislatures that impact oversight of these products with a focus on aspects most relevant to OTC devices.  

Impurities II — Nitrosamines  
Quality 

Moderator: John Brown, Senior Director of Quality, Perrigo Company 

Speakers: Deborah Johnson, Lifecycle API Branch Chief, U.S. Food and Drug Administration; Aloka Srinivasan, Ph.D., Principal & Managing Partner, Raaha, LLC; Jeffrey Moore, Senior Director Scientific Affairs & Strategy, The United States Pharmacopeial Convention 

Impurities in a drug substance or a drug product can arise from a number of factors or conditions including starting materials (active ingredients, excipients, or reagents), the manufacturing process (synthetic intermediates), degradation products, via contact with the drug packaging, inadequate storage conditions or contamination. Nitrosamine impurities have recently been detected in some types of medications resulting in product recalls. Speakers in this session will discuss when and where nitrosamine impurities may become present in drug products, summarize methods for detecting and preventing unacceptable levels of nitrosamines (e.g., FDA Guidance) and review new compendial engagement models for addressing impurities in drug products (USP). Participants will gain a perspective of the lessons learned to date and hear about industry risk assessment activities and suggestions for future considerations. 

Principles of GRASE Determination Under OMUFA – Oral Care Ingredients as an Example 
Livestreamed
Regulatory

Moderator: Greg Collier, Ph.D., Consultant, The Procter & Gamble Company  

Speakers: Todd J. Banks, PharmD, R.Ph., Senior Regulatory Affairs Manager, The Procter & Gamble Company; Richard F. Kingham, Esq., Senior Counsel, Covington & Burling; Richard Sullivan, Ph.D., Worldwide Director, Global Knowledge Management, Colgate-Palmolive Company

Panelist: Frederick Hyman, D.D.S., MPH, Dental Officer, U.S. Food and Drug Administration

Under the OTC Monograph User Fee Act (OMUFA) many active ingredients will be evaluated by FDA to determine whether they are Generally Recognized As Safe and Effective (GRASE). Using ingredients marketed under Oral Care monographs as examples, speakers in this session will provide an overview of the historical key principles surrounding GRASE determinations (including a history of safe use); discuss how these principles were employed by the FDA expert panel in their rigorous review of active ingredients under the Antigingivitis/Antiplaque monograph which resulted in a Category I designation in the 2003 Advanced Notice of Proposed Rulemaking (ANPR); and provide an overview of the general principles surrounding required product performance testing for oral care ingredients under the monograph, including the role of scientific advancements in testing. A panel discussion will follow the talks.   

Product Innovation: Using Digital Technology to Expand Frontiers of Self-Care and OTC Switch  
Regulatory

Moderator: Marcia D. Howard, Ph.D, CAE, Vice President, Regulatory & Scientific Affairs, CHPA 

Speakers: Paul A. Wardle, Founder & Principal, Beacon Associates, LLC; Alfred Whitehead, EVP, Applied Sciences, Klick Inc.; Clark A. Richardson, President & Chief Executive Officer, PEGUS Research, Inc.; Sarah Farnsworth, Ph.D., Vice President, Scientific Affairs, PEGUS Research, Inc. 

The ongoing pandemic is fundamentally changing how self-care is delivered. The use of telehealth visits, at-home diagnostics, ubiquitous QR codes and a proliferation of personal smart health devices is altering how consumers think about and gain access to care. This session will explore new ways the marketplace is evolving to expand and re-define nonprescription access, how technology can be most effectively deployed in consumer behavior research leading to Rx-to-OTC Switch, and developing new digital tools to support safe, ongoing consumer selection and use.  


5:00-6:00 p.m. 

Networking Functions

September 21, 2022

Day 3

7:00-8:00 a.m. 

Breakfast and Networking 


8:00-9:30 a.m. 

Breakouts

High Profile Dietary Supplement Studies
Dietary Supplements 

Moderator: Duffy MacKay, Senior Vice President, Dietary Supplements, CHPA 

Speakers: Mark A. Espeland, Ph.D., Professor, Gerontology and Geriatric Medicine, Wake Forest School of Medicine; Michael Grandner, Ph.D., Director of the Sleep and Health Research Program, University of Arizona  

Historically, the results from high profile scientific studies profoundly shape the dietary supplement market. Categories have been amplified by strong science and softened by null results. Hear from leading clinical researchers as they discuss the latest in high impact dietary supplement science. Speaker 1: Mark A. Espeland, Ph.D., Cocoa supplement, and multivitamin outcomes study for the MIND: COSMOS-Mind. Speaker 2, Michael Grandner, Ph.D., sleep expert to discuss JAMA research letter Trends in Use of Melatonin Supplements Among US Adults, 1999-2018 and the CDC report on Pediatric Melatonin Ingestions – United States 2012-2021. 

Using New Technologies in Consumer Research: Consumer Insights about Rx-to-OTC Switch
Regulatory 

Moderator: David Spangler, Senior Vice President, Legal, Government Affairs & Policy, CHPA  

Speakers: Susan B. Levy, Founder & Principal, SBL Consulting Group, Charles Miller, Jr., President & Chief Executive Officer, Persuadable Research Corporation; Elisabeth Walther, PharmD, J.D., Acting Associate Director for Strategic Initiatives, U.S. Food and Drug Administration 

The pandemic forced brands to find new ways to talk with consumers using technologies which allow people to participate without leaving their home or office.  Marketers have used online tools for nearly two decades, and now these tools include machine learning methodologies which enable researchers to qualitatively interview hundreds of people at the same time. Hear how an Rx-to-OTC Switch expert and her research partner used a machine-learning methodology to explore consumer understanding of the Rx-to-OTC switch process. 

Sustainability  
Livestreamed
Regulatory 

Moderator: Jay Sirois, Ph.D., Vice President, Regulatory & Scientific Affairs, CHPA  

Speakers: James Laurenson, Senior Environmental Officer/Toxicologist, U.S. Food and Drug Administration; Alyssa Harben, Ph.D., Project Manager, Sustainable Packaging Coalition; Geoff Waite, Partner, M.Sc., PA Consulting 

Panelist: Carlos Gutierrez, Vice President, State & Local Government Affairs, CHPA

Attendees will hear about state legislation efforts related to Extended Producer Responsibility (EPR), which more frequently impact FDA-regulated products, including drugs, dietary supplements, and consumer medical devices, as well as their packaging. FDA will present information related to environmental risk assessments and what will be required from sponsors. Market forces shaping the EPR discussion (including consumer consciousness) met by new business models, technologies and materials science, impacting circular and sustainable healthcare propositions will also be reviewed. A panel session will include the perspective of CHPA testimony addressing state legislation on sustainability efforts.

OTC Drugs & Stability Testing 
Quality 

Moderator: Larisa Pavlick, Senior Director, Product Quality and Technical Affairs, CHPA

Speakers: Jing Capucao, Stability Manager, Johnson & Johnson Consumer, Inc.; Lisa El-Shall, Director of Drug and Device Services, EAS Consulting Group, LLC

OTC Monograph drugs have stability testing requirements and expiration dates are often projected using accelerated testing. Our speakers will explain FDA's expectations when establishing expiration dates for OTC Monograph drug products. 


9:30 a.m.-10:30 a.m. 

General Session 

Livestreamed

Moderators: Ed Kuffner, M.D., Chief Medical Officer, Johnson & Johnson Consumer, Inc.; Barbara Kochanowski, Ph.D., Senior Vice President, Regulatory & Scientific Affairs, CHPA 

Speaker: Leana Wen, M.D., MSc., Research Professor of Health Policy and Management, George Washington University Milken Institute School of Public Health 

Dr. Leana Wen is an emergency physician, former Baltimore health commissioner, CNN medical analyst, and Washington Post contributing columnist who has lived on the front lines of public health – the opioid epidemic, infectious disease, maternal and infant mortality, and COVID-19 disinformation. Her family’s struggle as immigrants provided direct experience about the importance of access to quality healthcare and to self-care. Dr. Wen will provide attendees with key insights on the future of self-care and its vital impact on public health. 

 


10:30-11:00 a.m. 

Morning Break


11:00 a.m.-12:30 p.m. 

Closing General Session: FDA Leadership 

Livestreamed

Moderator: Valerie L. Gallagher, Vice President Consumer Self-Care Americas, Regulatory Affairs, Perrigo Company 

Speakers: Donald Ashley, Director, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Theresa Michele, M.D., Director, Division of Nonprescription Drug Products, Office of Drug Evaluation IV, CDER, U.S. Food and Drug Administration; Elizabeth Miller, PharmD, Acting Commissioner, Office of Medical Products and Tobacco Operations, U.S. Food and Drug Administration; Cara Welch, Ph.D., Director, Office of Dietary Supplement Programs, U.S. Food and Drug Administration

FDA leadership will provide updates on their organizations and priorities and will take questions from attendees. 


12:30-1:30 p.m. 

Lunch and Networking


Committee Reports (available through app) 

Consumer Medical Devices Committee Chair Report 

Speaker: Kathleen Blieszner, Ph.D., Global Product Stewardship, Regulatory Affairs, FemCare, The Procter & Gamble Company 

Dietary Supplements Committee Chair Report 

Speaker: Russell Michelson, Global Regulatory Head, VMS, Reckitt  

Product Quality & Manufacturing Controls Committee Chair Report 

Speaker: Nelson Webb, Director, QA External Engagement, The Procter & Gamble Company  

Regulatory & Scientific Affairs Committee Chair Report 

Speaker: Lauren Quinn, J.D., Vice President, US Regulatory Affairs, Haleon

Speakers

Wade Ackerman, J.D. Headshot
Wade Ackerman, J.D.
Partner, Covington & Burling
Speaker

Wade Ackerman, J.D.

Wade Ackerman is a partner in Covington's FDA Regulatory group and serves as one of the leaders of Covington's cross-practice Digital Health Initiative. Wade advises companies, trade associations and industry alliances on complex FDA issues that require coordinated legal, regulatory, and policy strategies. Through his previous positions at the Senate HELP Committee and FDA's Office of Chief Counsel, Wade has acquired unique insights into the evolving legal and regulatory landscape facing companies that are developing and marketing innovative medical products. While at the Senate HELP Committee, Wade served as Senior FDA Counsel to the current Chair Patty Murray (D-WA) and was involved in all major FDA legislative initiatives, including the 21st Century Cures Act of 2016. Before taking his Senate role, Wade served for more than five years as Associate Chief Counsel within the FDA’s Office of Chief Counsel (OCC).

 

Mindy Albuck Headshot
Mindy Albuck
Principal, Market and Shopper Intelligence, IRI
Speaker

Mindy Albuck

Mindy Albuck is a client insights principal and team lead with 20+ years in in IRI's healthcare practice.

 

RDML Richardae Araojo Headshot
RDML Richardae Araojo
Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity, U.S. Food and Drug Administration
Speaker

RDML Richardae Araojo

Rear Admiral Richardae Araojo serves as the Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity at the U.S. Food and Drug Administration (FDA). In this role, RDML Araojo provides leadership, oversight, and direction on minority health and health disparity matters for the Agency. RDML Araojo previously served as the Director of the Office of Medical Policy Initiatives in FDA’s Center for Drug Evaluation and Research (CDER), where she led a variety of broad-based medical and clinical policy initiatives to improve the science and efficiency of clinical trials and enhance professional and patient labeling. RDML Araojo joined FDA in 2003, where she held several positions in CDER. RDML Araojo received her Doctor of Pharmacy Degree from Virginia Commonwealth University, completed a Pharmacy Practice Residency at University of Maryland, and earned a Master’s degree in Pharmacy Regulation and Policy from the University of Florida.

 

Donald Ashley Headshot
Donald Ashley
Director, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Speaker

Donald Ashley

As Director of CDER’s Office of Compliance, Donald D. Ashley, J.D., leads efforts to shield the American public from unsafe, ineffective and low-quality drug products through measures designed to assist industry-wide compliance with federal standards for quality and safety, as well as regulatory and enforcement measures to address violations of those standards.
 
Mr. Ashley joined FDA after more than 18 years of criminal enforcement and investigation experience with the Department of Justice. His positions included serving as a Trial Attorney in the Office of Consumer Litigation (now the Consumer Protection Branch), prosecuting consumer fraud offenses and violations of the Food Drug and Cosmetic Act, as Associate Director of the Office of International Affairs, and as the DOJ Attaché stationed at the U.S. Embassy in Rome and at the U.S. Embassy in Manila, Philippines.
 
Before joining DOJ, Mr. Ashley served as senior litigation associate with a major D.C. law firm, representing clients under investigation for FD&C Act violations. He also served on active duty as an Army captain assigned to the Office of General Counsel, Department of the Army. Mr. Ashley was an adjunct professor of law at Georgetown, George Washington, American and Catholic Universities.
 
Mr. Ashley earned his law degree from Harvard Law School.

Evren Attilasoy, M.D. Headshot
Evren Attilasoy, M.D.
Senior Director, North America Medical/Clinical Affairs, Johnson & Johnson Consumer, Inc.
Moderator

Evren Attilasoy, M.D.

Evren is the Head of North America Medical Affairs, Johnson & Johnson Family of Consumer Companies, where he provides medical oversight and works with his team of dedicated health professionals to address the health needs of consumers and HCPs like yourselves. He is currently a member of the US board at Fort Washington.

Evren received his B.A. degree in history at Long Island University in New York and his medical degree from the University of Pennsylvania. He completed his residency in Internal Medicine at University Hospitals of Cleveland which is affiliated with Case Western Reserve University. He completed his GI fellowship at St Luke's Hospital in NYC.

Prior to joining Johnson & Johnson, Evren spent 6 years working as a gastroenterologist/hepatologist at Mount Sinai Medical Center in New York and then assumed various roles in Clinical Research and Medical Affairs at Bristol Myers Squibb and Novartis. During the past 10 years at Johnson & Johnson, in addition to his focus in OTC/Self-Care, he has worked across the consumer sector supporting clinical research activities across our oral care, baby and beauty franchises.

Evren has also authored numerous publications, including many involving acetaminophen.

 

 

Todd Banks, PharmD, R.Ph. Headshot
Todd Banks, PharmD, R.Ph.
Senior Regulatory Affairs Manager, The Procter & Gamble Company
Speaker

Todd Banks, PharmD, R.Ph.

Todd Banks joined The Procter & Gamble Company in 1984 and has spent the past 38 years supporting Product Development, Process & Formulation, Medical Affairs, and Regulatory Affairs/Regulatory Intelligence. He is experienced in all phases of product development, from concept to commercialization and post-approval activities, encompassing a wide range of therapeutic areas (Oral Care, Respiratory, Gastrointestinal, Analgesic, Insomnia, Women’s Health, Personal Care) and product classifications.

Dr. Banks currently serves as a Senior Regulatory Affairs Manager of Procter & Gamble’s Oral Healthcare Products Division, responsible for developing regulatory strategies for upstream product innovations in the areas of OTC drugs, medical devices, and cosmetic products. His work in and with the pharmaceutical industry is primarily in regulatory consultancy where he advises on optimal regulatory strategies and their implementation, regulatory compliance, risk analysis and mitigation, and managing interactions with regulatory authorities.

Dr. Banks has led numerous scientific advisory meetings on first-in-class product innovations, supported three successful Rx-to-OTC drug switch programs, and has successfully managed numerous pre-IND, IND and OTC drug programs across a variety of therapeutic areas. Dr. Banks is the author of Procter & Gambles’ submission to the Antigingivitis/Antiplaque OTC Drug Monograph call for data in support of cetylpyridinium chloride (CPC) and stannous fluoride (SnF2) as safe and effective ingredients. Todd is also an active member of the Consumer Healthcare Products Association Oral Care Task Group on OTC Drug Monograph Reform.

Dr. Banks is a registered pharmacist, holds a doctorate degree in Clinical Pharmacy with undergraduate degrees in Instrumental Chemistry, Organic Chemistry, Natural Science and Pharmacy, all from the University of Cincinnati.

 

Kathleen Blieszner, Ph.D. Headshot
Kathleen Blieszner, Ph.D.
Global Product Stewardship, Regulatory Affairs, FemCare, The Procter & Gamble Company
Moderator

Kathleen Blieszner, Ph.D.

Kathleen has over 25 years regulatory experience in pharmaceuticals and medical devices. She has successfully managed and executed pharmaceutical and 510(k) submissions and developed regulatory strategy for project teams to insure successful product development and compliance with regulations for both in market and upstream products. Kathleen builds regulatory capacity by mentoring and training within the P&G Global Product Stewardship organization. She develops SOPs, regulatory guidance documents and processes in close collaboration with the QA organization to insure seamless adoption of new regulations and successful government agency audits. She has provided company and industry comments to the FDA on proposed regulations. In early 2020, Kathleen accepted the position of first Chair of the newly formed CHPA Consumer Medical Devices Committee. Kathleen holds a Ph.D. in Organic Chemistry from The Ohio State University.

 

Anita Brikman Headshot
Senior Vice President, Communications & Public Affairs, and Executive Director, CHPA Educational Foundation

Anita Brikman

Anita Brikman joined CHPA in 2016 and is responsible for leading the association’s communications and public affairs functions, as well as leading the CHPA Educational Foundation. She is a member of the senior management team and responsible for establishing and directing the organization’s communications strategies and goals. Anita leads all external and internal association communications and public affairs campaigns. In addition, she directs the CHPA Educational Foundation, including working with its board of directors to establish priorities, achieve financial independence and growth, and ensure successful execution of the foundation’s consumer education campaigns.

Prior to joining CHPA, Anita served as Senior Vice President, Communications and Outreach, at the National Hospice and Palliative Care Organization (NHPCO) where she led communications and marketing for the association and its affiliates, including the National Hospice Foundation.

For more than two decades prior to her association work, Brikman worked as a news anchor and health reporter in the major television markets of Philadelphia, Pa., (WPVI 6ABC) and Washington, D.C., (WUSA 9), where she served as chief medical correspondent directing coverage on a wide range of healthcare issues.

 

John Brown Headshot
John Brown
Senior Director of Quality, Perrigo Company
Moderator

John Brown

John Brown began his career at Perrigo over 20 years ago, as a Quality Control Analyst. Since then, John’s background includes various management roles in Quality Control, Technical Operations and Quality Assurance across multiple Perrigo sites; both domestically and internationally.

Currently as Senior Director of Quality Operations, he has responsibility for all the Quality Control and Quality Assurance functions for Perrigo’s Consumer Self Care operational sites in Michigan. These sites provide a wide range of products covering multiple regulatory frameworks, and his responsibilities span the entire product lifecycle.

John holds a Bachelor of Science in Chemical Engineering from Michigan State University, and a Master Business Administration from the University of Notre Dame.

 

Jing Capucao Headshot
Jing Capucao
Stability Manager, Johnson & Johnson Consumer, Inc.
Speaker

Jing Capucao

Carmelinda (Jing) Capucao has enjoyed multiple lifetimes as a chemist, starting as a chemistry instructor in the Philippines. She earned her masters and doctoral degrees in synthetic organic chemistry from Florida State University and worked as an environmental analyst for the State of Florida. Her transformation over the past 24 years into a pharmaceutical stabilitarian was achieved through the various roles and responsibilities she held over 14 years within Merck in R&D, manufacturing site and global stability groups, supporting small molecule pharmaceutical products, with a brief stint supporting vaccines. Since 2012, Jing has supported the commercialization and life cycle stability requirements for OTC/self-care drug products as Stability Manager for McNeil Consumer Healthcare and J&J Consumer Inc. She chaired the Consumer Healthcare Products Association (CHPA) Stability Subcommittee between August 2016 and January 2021, spearheading multiple benchmarking activities amongst the member companies. She is currently the Stability SME leading the Global Self-Care Federation ICH Q1 Peer Support Group (shadow group), gearing to participate in upcoming updates to the ICH stability guidance documents. Jing enjoys the creative challenge and collaborative endeavor of ensuring stability requirements are met through the interplay of science, compliance, and the needs of the business.

 

Greg Collier Headshot
Greg Collier, Ph.D.
Consultant, The Procter & Gamble Company
Moderator

Greg Collier, Ph.D.

Greg Collier, Consultant and Distinguished Fellow, The Procter & Gamble Company, retired from P&G in 2021 after 34 years, where he served as the Global Vice President of Human Safety and Regulatory Affairs for Oral Care and Personal Health Care. Dr. Collier chaired the CHPA Regulatory and Scientific Affairs Committee from 2015-2019 where he had the privilege to work closely with CHPA and FDA on the development and passage of the Monograph Reform. Dr. Collier remains active, consulting with the CHPA Oral Care Task Group working on OTC Monograph opportunities.

Kristin Davenport, J.D. Headshot
Kristin Davenport, J.D.
Partner, Covington & Burling
Speaker

Kristin Davenport, J.D.

Kristin Davenport advises medical device companies regarding premarket strategies and pathways, the premarket submission process, advertising and promotion, compliance and enforcement matters, and import/export issues.

She has extensive experience with 510(k) premarket notifications, de novo petitions, premarket approval applications, investigational device exemptions, device modifications, 513(g) Requests for Information, MDR reporting, device recalls, and Part 806 reports.

Kristin regularly prepares 513(g) Requests for Information to obtain FDA’s views regarding the classification and applicable regulatory requirements for novel devices, such as mobile medical applications. She develops successful premarket strategies for clients, and frequently participates in pre-submission meetings with CDRH. Kristin navigates issues that arise during the premarket review process, and has successfully represented device companies in administrative appeals.

She also assists and represents clients in compliance and enforcement proceedings, including responding to FDA Form 483s and Warning Letters.

Kristin advises on jurisdictional questions and assists clients with combination product issues, including submitting Requests for Designation

to the Office of Combination Products.

 

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Lisa El-Shall
Director of Drug and Device Services, EAS Consulting Group, LLC
Speaker

Lisa El-Shall

Lisa El-Shall has a B.S. in Chemistry from the University of North Carolina at Chapel Hill and a M.S. from the University of California, Los Angeles in Biochemistry. She has extensive experience in a Consumer Healthcare organization in both Research and Development and Quality and has held leadership positions in the analytical laboratory and quality. For the past 11 years she led the Research and Development Quality group at Pfizer and GSK with global responsibility for areas including development, clinical supply production/release, clinical study oversight, and business development quality. She has proven ability in establishment, implementation, and maintenance of fit for purpose standards, systems, and Regulatory Inspection compliance.

 

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

Sarah Farnsworth, Ph.D.

 

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Susan Felter, Ph.D.
Research Fellow, The Procter & Gamble Company
Speaker

Susan Felter, Ph.D.

Dr. Susan Felter is a Research Fellow in Procter & Gamble’s Central Product Safety organization. She holds a B.S. in Biology from the Massachusetts Institute of Technology and a Ph.D. in Toxicology from the University of Cincinnati. Dr. Felter’s primary professional interest is in methods for human health risk assessment with an emphasis on cancer risk assessment. In this area, her focus is on methods to evaluate and incorporate data on mode of action and human relevance to improve the reliability and applicability of assessments to human health. Prior to joining P&G, Dr. Felter worked for TERA (Toxicology Excellence for Risk Assessment), a nonprofit science organization in Cincinnati, and the U.S. Environmental Protection Agency in the Office of Research and Development). Dr. Felter currently serves on the Board of Scientific Counselors for the National Toxicology Program.

 

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Joe Franklin, J.D., Ph.D.
Product Counsel, Verily Life Sciences
Speaker

Joe Franklin, J.D., Ph.D.

Joe Franklin is a Product Counsel at Verily Life Sciences, where he works on legal, regulatory, and policy components of Verily’s clinical evidence generation program. Before joining Verily, Joe held a variety of positions at FDA, including as senior advisor on data and evidence initiatives. Joe built and led the biosimilars policy staff in the Office of New Drugs and served as an attorney in the chief counsel’s office for multiple periods during his career at FDA. Joe has a PhD in cell biology from his early career as a bench scientist.

 

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Valerie Gallagher
Vice President Consumer Self-Care Americas, Regulatory Affairs, Perrigo Company
Moderator

Valerie Gallagher

Valerie has been employed by Perrigo Company for 25 years, serving in a variety of roles with increasing management responsibility within Regulatory Affairs. She is currently Vice President, Consumer Self-Care Americas, Regulatory Affairs, the department responsible for cradle-to-grave management of activities related to over-the-counter NDA/ANDA Drug products, Rx-to-OTC Switch products, Monograph Drug products, Medical Device products, Cosmetic products, and Personal Care products for US and Canadian markets. She has significant experience in setting and executing Regulatory strategies for these categories as well as DEA functions.  She has been very active within the pharmaceutical industry and is currently Chair, CHPA Regulatory & Scientific Affairs Committee (RSAC).

 

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Michael Grandner, Ph.D.
Director of the Sleep and Health Research Program, University of Arizona
Speaker

Michael Grandner, Ph.D.

Dr. Grandner is a licensed Clinical Psychologist certified in Behavioral Sleep Medicine, Director of the Sleep and Health Research Program, and Associate Professor of Psychiatry, Psychology, Medicine, Nutritional Sciences, and Clinical Translational Science at the University of Arizona. His clinical work focuses on non-medication treatments for sleep disorders. His research examines the relationship between sleep and obesity, diabetes, heart disease, daytime functioning, and longevity. His work has received awards from the Sleep Research Society, American Academy of Sleep Medicine, American Heart Association, and other organizations. He is author or co-author on over 250 academic publications. He has served on grant review panels for the Department of Defense and the National Institutes of Health, both the mental health and sleep and wellness task force for the NCAA, and the mental health consensus committee for the International Olympic Committee. He is a frequent consultant and speaker on the issue of sleep health and has been invited multiple times to the US Congress to discuss the role of sleep in health and functioning. Dr. Grandner’s work has been featured in television, radio, and print media, in over 50 countries. Learn more about his work at michaelgrandner.com.

 

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Alyssa Harben, Ph.D.
Project Manager, Sustainable Packaging Coalition
Speaker

Alyssa Harben, Ph.D.

Dr. Alyssa Harben joined the Sustainable Packaging Coalition in June 2021. She has a PhD and MS in Packaging from Michigan State University’s School of Packaging, and a BS in Business Administration from Cal Poly San Luis Obispo. During her time in graduate school, she developed a passion for consumer packaging and labeling research using applied psychology methods and continues to research and educate about packaging, labeling, and sustainability as a project manager.

 

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Vice President, Regulatory & Scientific Affairs

Marcia Howard, Ph.D., CAE

As CHPA Vice President of Regulatory & Scientific Affairs, Marcia D. Howard, Ph.D., CAE, provides support to the Regulatory & Scientific Affairs Committee (RSAC), is the staff liaison for the Consumer Medical Device (CMD) Committee, and works to further policy objectives with the U.S. Food and Drug Administration (FDA) for drugs and medical devices. Howard assumed the role of scientific liaison for the CHPA Pediatric Cough Cold Task Group in 2009 and continues to lead this key initiative. She also assists with over-the-counter medicine issues and plays a critical role in coordinating the association’s annual Regulatory, Scientific & Quality Conference (RSQ). Howard coordinates many of CHPA’s internal and external meetings with members, regulators, and other stakeholders.

Howard joined CHPA in 2004 from the Department of Physiological Sciences at the Oklahoma State University College of Veterinary Medicine. Prior to Oklahoma State, she worked at the School of Pharmacy at the University of Louisiana at Monroe; State Farm Insurance Company; and the Frederick Cancer Research Facility at Program Resources, Incorporated.

Howard has degrees in biochemistry and pharmaceutical sciences. She is a member of the Drug Information Association (DIA), Regulatory Affairs Professional Society (RAPS), Society of Toxicology (SOT), and the American Society of Association Executives (ASAE). In 2016, she was named as an ASAE Diversity Executive Leadership Program (DELP) scholar (class of 2016-2018) and received her designation as a certified association executive (CAE) in January 2018. Howard currently serves on the ASAE CAE Professional Conduct Committee (2019-2020). She is also a member of the Southern Regional Educational Board (SREB) Chapter of the Institute for Teaching and Mentoring, and serves on the American Foundation for Pharmaceutical Education (AFPE) Planning and Education Committee.

 

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Fred Hyman, D.D.S., MPH
Dental Officer, U.S. Food and Drug Administration
Panelist

Fred Hyman, D.D.S., MPH

Fred Hyman has been a dental officer with the Food and Drug Administration’s Center for Drug Evaluation and Research since 1993. He received his DDS from University of Maryland in 1981 and practiced general dentistry prior to obtaining a Master in Public Health from Johns Hopkins Bloomberg School of Public Health in 1990. He then completed a 3-year United States Public Health Service Epidemiology Fellowship. His focus at FDA has been to facilitate the Center’s mission of protecting and promoting public health by helping to ensure that human drugs are safe and effective for their intended use. In that role, his primary functions include evaluating new drugs with oral indications for approval; monitoring post-marketing safety of these drugs; and providing consultation to staff regarding drugs with other indications that impact on oral health. His experience has included review of clinical data to support approval of drugs to diagnose, treat or prevent oral health conditions including caries, periodontal diseases, salivary dysfunction (xerostomia and hypersalivation), and oral mucositis. His publications and presentations include the topics of regulatory science, adverse events monitoring, and clinical trial design among others.

 

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Deborah Johnson
Lifecycle API Branch Chief, U.S. Food and Drug Administration
Speaker

Deborah Johnson

 

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Dick Kingham, Esq.
Senior Counsel, Covington & Burling
Speaker

Dick Kingham, Esq.

Richard Kingham is a senior counsel assigned to the Washington and London offices of Covington & Burling LLP. Since joining the firm in 1973, he has concentrated on regulation of drugs and other consumer products. He has advised the Consumer Healthcare Products Association and its predecessors since the 1970s and worked with CHPA and its member companies on numerous proceedings under the Food and Drug Administration’s Over-the-Counter Drug Review. He has also participated in Rx-to-OTC switches, including the successful defense of a legal challenge to FDA’s approval of ibuprofen for nonprescription use, as well as administrative and legislative proceedings relating to attempts to force switches of second-generation antihistamines. Working with CHPA and its member companies, he was closely involved in the negotiation and drafting of the OTC monograph reform legislation that was included in the CARES Act in March of 2020. He has been an adjunct professor at the Georgetown University Law Center since 2003, teaching a course on law and regulation of drugs, biologics and medical devices, and he was formerly a lecturer at the University of Virginia School of Law and universities in the United Kingdom.

 

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Menas Kizoulis
Scientific Engagement Director, Johnson & Johnson Consumer, Inc.
Speaker

Menas Kizoulis

Menas G. Kizoulis is the Director of Scientific Engagement for Skin Health at Johnson & Johnson Consumer Companies, Inc. He is responsible for driving scientific leadership, education and advocacy with healthcare professionals, consumers, and other critical stakeholders. He develops multi-channel programs that translate scientific, clinical, and real-world evidence into impactful scientific communications for diverse audiences. He is a graduate of Cornell University where he studied biology and conducted microbiology research. Mr. Kizoulis began his career with Johnson & Johnson Consumer Health in 1999 in the Skin Research Center. Over his 23-year career, he has studied skin biology, developed new skincare innovations and conducted clinical research. He has co-authored a variety of publications in prestigious journals including Science, Journal of Investigative Dermatology, and the British Journal of Dermatology. He is also an inventor of multiple granted patents. In 2020, he was awarded the Johnson’s Medal which is the most prestigious award given for research and development excellence within Johnson & Johnson. Mr. Kizoulis currently resides in New Jersey with his wife and two children. He spends most of his free time on soccer fields and baseball diamonds watching his kids play sports.

 

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Senior Vice President, Regulatory & Scientific Affairs

Barb Kochanowski, Ph.D.

Barbara Kochanowski is responsible for regulatory affairs activities, including cooperative programs with the U.S. Food and Drug Administration, ingredient safety, and dietary supplement programs at CHPA.

Prior to joining CHPA in 2009, Kochanowski worked for more than 23 years in R&D at The Procter & Gamble Company (P&G), retiring in December 2008 as director, global personal health care, oral care, and feminine care product safety and regulatory affairs and corporate microbiology. She is experienced in pharmaceutical, medical device, and dietary supplement regulatory affairs, Rx-to-OTC switch, product safety, clinical research, and pharmacovigilance. While at P&G, Kochanowski was very active in CHPA activities, serving as chair of the Scientific Affairs Committee from 2007-2009, which brought with it an ex officio position on the CHPA Board of Directors for the same period.

Kochanowski is a member of the American Society of Nutrition. She also serves on the board of directors of the American Foundation for Pharmaceutical Education.

 

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Ed Kuffner, M.D.
Chief Medical Officer, Johnson & Johnson Consumer, Inc.
Moderator

Ed Kuffner, M.D.

Ed is the Chief Medical Officer for Johnson & Johnson’s Consumer Healthcare sector. He leads a global team of medical and safety professionals (e.g. doctors, nurses, pharmacists, PhDs, scientists) whose focus, independent of business or other objectives, is patient and consumer safety. He is a member of the J&J Office of Chief Medical Officer (OCMO), leads the Office of Consumer Medical Safety (OCMS), is part of the Consumer Heathcare R&D Leadership team and the J&J Bioethics Committee.

Ed and the safety team partner with R&D and others to embed safety into the entire product lifecycle, from new product development to monitoring and enhancing the safety of marketed medicines, cosmetics, devices and other selfcare products. He is a champion of research and using data and new technologies to advance our collective understanding of safety topics to help shape product attributes and labeling, new legislation and foster trust, teamwork, and shared accountability in enhancing public health.

In his career leading global teams (e.g. medical affairs, clinical research, toxicology, regulatory and safety), he has always enjoyed working with a broad range of internal and external stakeholders (e.g. health care professionals, professional & consumer organizations, regulators, public health agencies, other companies) to tackle complex public health issues. He leads and participates in numerous initiatives aimed at preventing avoidable harm from medication errors, accidental unsupervised ingestions, misuse, abuse and overdose. Ed is passionate about learning, teaching and helping others grow, develop and succeed.

Dr. Kuffner received his B.A degree in German Language and Literature from the State University of New York and his M.D. from the State University of New York Health Sciences Center at Brooklyn. He trained in Emergency Medicine at New York University and Bellevue Hospital Center where he was a Chief Resident. He completed a medical toxicology fellowship at the Rocky Mountain Poison and Drug Center in Denver, Colorado. He is board certified in both emergency medicine and medical toxicology.

Prior to joining J&J, Ed spent 10 years working in Colorado as an emergency physician and medical toxicologist. He’s held academic teaching positions at University of Colorado Health Sciences Center and Denver Health, was the Assistant Director of the Rocky Mountain Poison and Drug Center and was a Medical Director of an emergency department.

Dr. Kuffner has authored numerous publications, including many involving OTC medicines.

Ed lives in Pennsylvania with his wife, Heather, and three children – Kalle, Margaret, and John. The Kuffners enjoy sports (soccer, hockey, swimming, lacrosse) outdoor activities (skiing, hiking, camping, going to the beach) and travel.

 

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James Laurenson
Senior Environmental Officer/Toxicologist, U.S. Food and Drug Administration
Speaker

James Laurenson

 

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John "Web" Leslie
Associate, Covington & Burling
Speaker

John "Web" Leslie

Web Leslie provides strategic advice and counsel on cybersecurity preparedness, cyber and data security incidents, healthcare privacy and security, cross-border privacy law, and government investigations, and helps clients navigate complex policy matters related to cybersecurity, national security, and critical infrastructure protection.

Web previously served in various roles at the U.S. Department of Homeland Security, including at the Cybersecurity and Infrastructure Security Agency (CISA), where he specialized in cybersecurity and critical infrastructure, public-private partnerships, and interagency cyber operations. He also served as Special Assistant to the Secretary of Homeland Security.

 

Susan B Levy
Susan B. Levy
Founder and Principal, SBL Consulting, LLC

Susan B. Levy

Susan B. Levy has over 35 years of global, cross-functional experience in the consumer healthcare industry and has worked on Rx-to-OTC switches since the mid ‘90s at SmithKline Beecham where she was involved with the Tagamet and Nicorette switches. At Warner-Lambert/Pfizer from 1996 to 2004 she served on the Switch Selection Team and the Switch Steering Team. Later, at Schering-Plough, Susan personally managed more than six development and exploratory phase switch programs with a total value exceeding $800MM; she consummated the deals to secure both Zegerid and Oxytrol for Schering-Plough.

In 2011, Susan founded her own consulting firm, SBL Consulting Group, LLC which works with consumer health and wellness companies to develop and implement growth strategies. The firm provides strategic marketing and business development services in addition to consulting on Rx-to-OTC switch. Now in its second decade, SBL Consulting Group is a proud Associate Member of the Consumer Healthcare Products Association (CHPA).

Since 2011, Susan and her team have worked on over 50 switch projects and have:

  • Led the strategy, planning and program implementation of multiple first-in-class Rx to OTC switch candidates, from both a commercial and regulatory standpoint
  • Assessed Rx-to-OTC switch potential for multiple Rx products and NCEs
  • Analyzed factors most likely to determine marketplace success
  • Assisted companies with Rx-to-OTC in-licensing and out-licensing strategies
  • Accelerated timelines for existing Rx-to-OTC programs

In 2020, Susan was recognized as a Top Woman in Health and Wellness by DrugStore News.

Susan received her BA in Chemistry from Cornell University and attended NYU’s Stern School of Business for her MBA.

 

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Senior Vice President, Dietary Supplements

Duffy MacKay

Duffy MacKay, ND, is the Senior Vice President of Dietary Supplements at the Consumer Healthcare Products Association (CHPA), where he leads the association’s dietary supplement scientific, policy and legislative initiatives. Dr. MacKay’s career in supplements spans over 25 years and includes serving as a senior executive and scientist at leading dietary supplement companies, including CV Sciences, Nordic Naturals, and Thorne Research.

In addition, he worked for 10 years with the Council for Responsible Nutrition (CRN) in Washington, D.C., where he served as Senior Vice President of Scientific & Regulatory Affairs and led the association’s scientific and regulatory affairs department. He is also an editor for the Natural Medicine Journal and Integrative Medicine: A Clinician’s Journal, and an associate editor for the Journal of Dietary Supplements and serves on the Advisory Board for the American Botanical Council.

Dr. Mackay started his career as a naturopathic doctor working in a private medical practice. He earned his naturopathic medical degree from the National University of Natural Medicine in Portland, Oregon, and his undergraduate degree in Marine Biology from the University California Santa Cruz.

 

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Jennifer Maguire, Ph.D.
Deputy Director, Office of Quality Surveillance, U.S. Food and Drug Administration
Speaker

Jennifer Maguire, Ph.D.

Dr. Jennifer Maguire is the Director of the Office of Quality Surveillance/OPQ/CDER/FDA. The office assesses intelligence throughout the drug product lifecycle to inform stakeholders about the state of pharmaceutical quality and uses data analytics to drive surveillance decisions. During her tenure at the agency, Dr. Maguire has contributed to multiple initiatives aimed at advancing the regulation of pharmaceutical manufacturing and product quality including Question-based Review, Quality by Design, ICH Q12, Site Selection Model Program, Quality Metrics and Quality Management Maturity. Prior to joining the agency in 2010, she worked in industry on the development and scale-up of drug substance manufacturing processes and the manufacturing of drug product clinical and stability supplies. Dr. Maguire has a BS in Chemical Engineering from the University of Virginia and a PhD in Industrial and Physical Pharmacy from Purdue University.

 

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Diane McEnroe
Partner, Sidley Austin LLP
Speaker

Diane McEnroe

Diane McEnroe has established long-standing relationships with domestic and international companies in the food, drug, medical device and personal care industries. As a member of the Food, Drug and Medical Device Regulatory practice, she provides clients strategic counsel on Food and Drug Administration regulatory questions on a broad range of issues, including product formulation and positioning, ingredient safety, claims substantiation, over-the-counter drug monograph issues and post-marketing obligations, including adverse event reporting and food registry postings. Diane also has extensive experience advising on drug sampling programs, track and trace systems, and state licensure issues. She supports clients in responding to Warning Letters, during facility inspections and recalls, and in addressing product integrity issues. In addition to her FDA advisory role, Diane has also assisted clients with Federal Trade Commission investigations relating to consumer products.

With her deep knowledge of foods, including functional and medical foods, and dietary supplements, Diane has guided clients through the implementation of significant legislative amendments, including the Nutrition Labeling and Education Act, the Dietary Supplement Health and Education Act, the Organic Foods Production Act, the Food Allergen Labeling and Consumer Protection Act, the Bioterrorism and Drug Preparedness Act and the Food Safety Modernization Act. With FDA’s announcements on Nutrition Innovation and Responsible Innovation in Dietary Supplements, she is supporting clients in assessing what the future might look like from a regulatory perspective for those marketing in the food, medical food, foods for special dietary use and dietary supplement markets.

She regularly trains in-house counsel and regulatory teams on FDA compliance issues and assists companies in strengthening internal procedures to minimize compliance risks. In addition, Diane often leads FDA, DEA, FTC, and state pharmacy due diligence reviews for food and drug companies on behalf of major industry leaders and investment firms. She also closely coordinates with Sidley litigators nationwide to defend consumer fraud and product liability litigation targeting consumer products.

Diane is recommended in the top-tier rankings for Healthcare: Life Sciences in The Legal 500 US 2013–2016 and in Who’s Who Legal: Life Sciences 2015 and 2016. She is also recognized in the 2016–2019 editions of The Best Lawyers in America. Additionally, Diane is an Adjunct Professor of Law at Fordham University Law School, teaching Food and Drug Law.

Pro Bono

Through Sidley’s Emerging Enterprises Pro Bono Program, Diane works with The Alliance of African Shea Associations, which represents shea producers in Ghana, Nigeria, Burkina Faso, Mali, Benin and Côte d’Ivoire, assisting the Alliance in accessing the U.S. chocolate market and with efforts to permit the use of shea butter as an equivalent ingredient to cocoa butter. The goal of this pro bono initiative is to enhance the incomes of approximately four million women farmers who collect shea nuts in West Africa.

Also through the Sidley Emerging Enterprises Pro Bono Program, Diane has provided food safety advice to the Bangladesh Shrimp and Fish Foundation, which represents some 600,000 shrimp farmers in Bangladesh who primarily export to the European Union and the United States.

 

Scott Melville

Scott Melville is the president and chief executive officer of CHPA and leads the organization’s efforts to empower consumer self-care by preserving and expanding choice and availability of consumer healthcare products, including OTC medicines, dietary supplements and consumer medical devices.

Prior to joining CHPA, Melville served as senior vice president of government affairs and general counsel for the Healthcare Distribution Alliance (formerly HDMA), representing pharmaceutical wholesale distributors.

Melville previously served in various public affairs and legal roles for the pharmaceutical and biotechnology companies Sterling-Winthrop, Hoffmann-LaRoche, and Cephalon. Melville began his professional career as a legislative assistant and appropriations committee associate on the staff of retired U.S. Congressman Jerry Lewis (R-Calif.).

He earned his bachelor’s degree in economics and political science from Bucknell University, and his juris doctorate from George Mason University’s Antonin Scalia School of Law. He serves on the boards of the Global Self-Care Federation, and the CHPA Educational Foundation.

 

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Theresa Michele, M.D.
Director, Division of Nonprescription Drug Products, Office of Drug Evaluation IV, CDER, U.S. Food and Drug Administration
Speaker

Theresa Michele, M.D.

Dr. Theresa Michele is the Director of the Division of Nonprescription Drug Products (DNDP) in the Office of New Drugs, Center of Drug Evaluation and Research (CDER), at the Food and Drug Administration (FDA). Previously the Director of the Division of Nonprescription Clinical Evaluation (OTC products regulated via the New Drug Application process), Dr. Michele oversaw the merger of that division with the Division of Nonprescription Regulation Development (OTC drugs regulated via the monograph process) to form DNDP. Prior to joining FDA, she spent 10 years in industry, with clinical research experience across a variety of therapeutic areas in both commercial and development stage companies. Dr. Michele left industry in 2007 to join the FDA in the Division of Pulmonary and Allergy Drug Products, where she served as both a clinical reviewer and team leader. She is board certified in internal medicine, pulmonary medicine, and critical care medicine, completing her training at Johns Hopkins University, where she currently serves on the faculty. She obtained her BS in Integrated Life Sciences from Kent State University and MD from Northeastern Ohio Universities College of Medicine as part of a 6-year combined program.

 

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Charles Miller
President and CEO, Persuadable Research Corporation
Speaker

Charles Miller

After graduating from Western Carolina University in 1998, Charles began his post-college career at Persuadable Research Corporation in business development. In 2004, Charles was promoted to VP of Sales and led the company’s evolution into a full-service marketing research company.

On January 1st, 2013, he purchased the company and took the reins as President & CEO of the company.

During his 20+ years in marketing research, Charles has worked with hundreds of brands, brand champions, and advertising agencies. He has led the company through multiple evolutions: from telephone research to online surveys, online focus groups, in-home usage testing, in-depth interviews, and most recently, introducing hybrid studies powered with machine learning (AI). He is a certified qualitative moderator via the Burke Institute.

Charles’ leadership role within the company focuses on nurturing a culture of quality, trust, and support within the team. He continues to serve as the business development lead, working to build and maintain the relationships which keeps the company thriving and the friendships which make the work fun.

Persuadable Research’s 10+ year membership with the CHPA represents its deepest, and proudest, association connection.

 

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Elizabeth Miller, PharmD
Acting Commissioner, Office of Medical Products and Tobacco Operations, U.S. Food and Drug Administration
Speaker

Elizabeth Miller, PharmD

Dr. Elizabeth Miller recently rejoined the US FDA in March 2020.  In her role as the Assistant Commissioner for Medical Products and Tobacco Operations, Dr. Miller provides leadership and managerial direction to ORA’s Office of Biologics Products Operations, Office of Pharmaceutical Quality Operations, Office of Medical Device and Radiological Health Operations, Office of Bioresearch Monitoring Operations, and the Tobacco Operations Staff.
 
Dr. Miller comes returns from the U.S. Pharmacopeia (USP) where she helped guide USP’s working relationship with the FDA.  At USP, Dr. Miller was vice president, US Public Policy & Regulatory Affairs, with responsibility to deliver executive leadership for developing and achieving USP’s US regulatory science and intelligence, government affairs, and public policy programs’ goals. She also created strategic change focused on impacts and results resulting from engagement with federal, state, and international regulators, as well as senior leadership in industry, academia, and patient-focused alliances.
 
Before rejoining USP in 2016, Dr. Miller began her federal career with FDA’s Center for Drug Evaluation and Research (CDER) in 2007 in the Office of Unapproved Drugs and Labeling Compliance (OUDLC).  She began her CDER career working on online pharmacy and health fraud issues, and ultimately served as the director for OUDLC’s Division of Nonprescription Drugs & Health Fraud.
 
Prior to federal service, Dr. Miller worked at USP as a scientific liaison on medication safety standards for nomenclature, labelling, and packaging, and as the director of drug information for the USP Drug Information publication.  She started her pharmacy career working as a clinical pharmacist at MedStar Washington Hospital Center in Washington D.C.
 
Dr. Miller holds a bachelor’s degree in biology from The Johns Hopkins University and received her Doctor of Pharmacy degree from the University of Maryland.

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Jeff Moore
Senior Director, Scientific Affairs & Strategy, The United States Pharmacopeial Convention
Speaker

Jeff Moore

 

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Sarah Parker, Ph.D.
Managing Scientist, Exponent
Speaker

Sarah Parker, Ph.D.

Dr. Parker is a Managing Scientist with Exponent, a technical consulting company. She is a chemist who specializes in understanding how composition and formulation affect the performance of complex chemical systems and practical materials. She consults in the areas of fuel, oil, and lubricant formulations for automotive and industrial applications, as well as cosmetics and personal care products, pharmaceuticals, medical devices, paints and coatings, and industrial and specialty chemicals including fluorinated substances (PFAS). Dr. Parker has experience analyzing product composition and identifying potential contaminants through standardized and non-standard methods, and uses her expertise to help clients determine the source and potential impacts of chemical contamination in a range of products. Dr. Parker has also consulted for parties involved in intellectual property disputes, including trade secret and patent litigation.

 

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Tony Pavel
Deputy General Counsel, Perfect Day Foods, Sustainable Animal Free Dairy and Protein
Speaker

Tony Pavel

Tony Pavel serves as Deputy General Counsel, Global Food Law at Perfect Day, a consumer biology company on a mission to create a kinder, greener tomorrow by developing new ways to make the foods you love today — starting in the dairy aisle. In his role, he oversees regulatory legal matters for Perfect Day, bringing his food law experience to a significant period of growth for the company.

Tony brings over 20 years of experience as a counselor to the food industry and has handled a broad range of issues including obtaining the authorization of new food ingredients, complying with manufacturing requirements, labeling and advertising, and regulatory compliance in the global supply chain. Tony has been named one of the leading food lawyers in the US by Chambers and Partners, and Law360, as well as Top Corporate Counsel by DCA Live.

Prior to joining Perfect Day, Tony led the Global Food Law Team at Cargill, Incorporated, a global food, agriculture, financial and industrial products provider. Tony was responsible for food law across Cargill’s global businesses, including partnering with the QA function for Food Safety Modernization Act implementation at Cargill’s domestic and global manufacturing facilities; R&D ingredient approval strategy; M&A/JV regulatory diligence implementation and execution; labeling, advertising, and communications compliance; as well as advising the Government Relations function on food regulatory matters.

Prior to Cargill, Tony served as the Deputy Chair of the FDA Practice at Morgan Lewis & Bockius, a leading global law firm working with a broad range of food, feed and agricultural technology companies. In addition, Tony served as the General Counsel and Secretary to the Enzyme Technical Association. Tony has also served on a number of advisory boards including the World Food Law Institute, the Food Protection and Defense Institute, and as the past Chair of the Institute of Food Technologists Food Laws and Regulations Division.

Tony received his Honors degree in Zoology from the University of Western Ontario, and Law degree from Loyola University Chicago. He is passionate about the future of animal-free dairy and its vision of building a more equitable, resilient, and diverse food system for all of us.

 

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Senior Director, Product Quality and Technical Affairs

Larisa Pavlick

Larisa Pavlick serves as the leader on quality, technical and manufacturing issues and leads the Product Quality & Manufacturing Controls Committee. She joined CHPA in June 2022 as Senior Director of Quality Assurance and Technical Affairs. She joins with over 25 years of combined industry experience where she specialized in product development, quality, regulatory, and successfully held various positions in operations including as a senior buyer. Her background includes 12 years in the dietary supplement industry and six years working for a trade association, plus nearly eight years at United States Food and Drug Administration (FDA).

Previously, Pavlick held a position at United Natural Products Alliance (UNPA) as the Vice President of Global Quality and Compliance since November 2016. At UNPA Larisa supported membership in the areas of quality and regulatory compliance and served as the liaison between industry media partners, FDA, and various industry based quality initiatives. Pavlick developed the training and education program focused on simplifying U.S. regulations and providing members with potential solutions. Courses were designed to address common deficiencies found during regulatory inspections. She provided assistance in the interpretation and implementation of FDA and FTC rules within a manufacturing operation and for brand owners utilizing contract manufacturing.

At FDA, Pavlick worked as Consumer Safety Officer/Investigator in the Denver District Office and was recognized as a resource and subject matter expert for dietary supplements. At FDA she primarily conducted domestic and international inspections and investigations for dietary supplement firms and ingredient suppliers. Pavlick was also trained and qualified to conduct general food GMP inspections as well as specialized, technical food inspections including Juice HACCP, Seafood HACCP, Low Acid Canned Foods, and Acidified Foods. She also received additional FDA training for drug investigations including all five courses required for a pharmaceutical inspectorate (PI): Basic Drug School, Pre-Approval Inspections, Process Validations of Drug Manufacturing Operations, Active Pharmaceutical Ingredient Manufacturing, and Industrial Sterilization.

Pavlick graduated from the University of Colorado-Denver where she received a bachelor’s degree in Biology. Outside of work, Pavlick and her husband are very active. Some of their favorite activities include time with the family, snowmobiles, riding motorcycles, gardening, and reading. She never misses an opportunity to enjoy the great outdoors including kayaking, hiking, biking, and camping.

 

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Lauren Quinn, J.D.
Vice President, US Regulatory Affairs, Haleon
Moderator

Lauren Quinn, J.D.

Lauren Quinn is Vice President, US Regulatory Affairs at Haleon.  Lauren has more than 20 years experience in Regulatory Affairs, across multiple regulatory classifications - prescription, over-the-counter, dietary supplements, medical devices, and cosmetics. In her role she leads the regulatory strategies for iconic brands such as Centrum, Emergen-C, Advil and Flonase. She is a graduate of Rutgers University and Seton Hall School of Law.

Clark Richardson headshot
Clark Richardson
President & Chief Executive Officer, PEGUS Research, Inc.
Speaker

Clark Richardson

Clark Richardson leads PEGUS Research, an entity focused almost entirely on developing and testing new over-the-counter Drug Facts Labels, including the label comprehension, self-selection, actual use and other studies that support sponsors’ applications for OTC approval. Clark routinely assists pharmaceutical clients in program development and interactions with the U.S. FDA. He is a frequent speaker and presenter to industry, and is an advocate for new tools and technologies to enhance communication of critical drug-related, consumer-oriented information. After 25 years of OTC research at PEGUS, Clark brings a wealth of practical knowledge and experience to timely dialogue about re-envisioning the mechanisms for expanding access to important new medications.

 

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Amy Roe
Principal Toxicologist, The Procter & Gamble Company
Moderator

Amy Roe

Dr. Roe has 22+ years of experience as a practicing toxicologist in government, pharmaceutical and consumer product industries, through positions at both the FDA and The Procter & Gamble Company. Her professional experience is in general, descriptive, and regulatory toxicology as well as specialized expertise in drug/xenobiotic metabolism and pharmacokinetics. Her industry experience is quite broad and includes toxicology support of drugs, medical devices, herbal/dietary supplements, foods, and water filtration devices. As a project leader, she has led multi-disciplinary drug development teams. Dr. Roe is a board-certified toxicologist (DABT) and a Fellow of the Academy of Toxicological Sciences (ATS). She is well-recognized externally in her field as evidenced by her service on a number of professional boards and committees including USP Dietary Supplement Admission Evaluation & Labeling Expert Committees and Probiotic Expert Panel, SOT Regulatory & Safety Evaluation Specialty Section (Past-President), Food Safety Specialty Section (Vice-President Elect) and an NIH/NCCIH Expert Advisory Panel related to natural product-drug interactions. Dr. Roe is currently serving as co-chair of the hepatotoxicity/ADME sub-committee of the HESI Botanical Safety Consortium. She also serves on the Editorial Board of Applied In Vitro Toxicology.

 

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Jeffrey Shuren, M.D., J.D.
Director of the Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration
Speaker

Jeffrey Shuren, M.D., J.D.

Jeffrey Shuren, M.D., J.D. is the Director of the Center for Devices and Radiological Health (CDRH) at FDA. He previously served as Acting Center Director. Dr. Shuren has held various policy and planning positions within FDA from 1998 to 2009, including Acting Deputy Commissioner for Policy, Planning, and Budget; Associate Commissioner for Policy and Planning; and Special Counsel to the Principal Deputy Commissioner. Dr. Shuren is board certified in Neurology and served as an Assistant Professor of Neurology at the University of Cincinnati. In 1998, Dr. Shuren joined FDA as a Medical Officer in the Office of Policy. In 2000, he served as a detailee on the Senate HELP Committee. In 2001, he became the Director of the Division of Items and Devices in the Coverage and Analysis Group at the Centers for Medicare and Medicaid Services. From 1998 to 2003, he served as a Staff Volunteer in the National Institutes of Health’s National Institute of Neurological Disorders and Stroke Cognitive Neuroscience Section supervising and designing clinical studies on human reasoning. Dr. Shuren returned to FDA as the Assistant Commissioner for Policy in 2003, and assumed his current position in September 2009.

 

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Vice President, Regulatory & Scientific Affairs

Jay Sirois, Ph.D.

Jay Sirois is responsible for regulatory and scientific affairs activities, including cooperative programs with the U.S. Food and Drug Administration, ingredient safety, and dietary supplement programs at CHPA.

Prior to joining CHPA in October 2011, Sirois was employed at Pharmaceutical Development Group as director, Scientific Research and Clinical Studies. He is experienced in pharmaceutical, medical device, and dietary supplement regulatory affairs, pharmacovigilance, Rx-to-OTC switch, product safety, and clinical research.

Sirois is a member of the Regulatory Affairs Professionals Society and is an ad hoc reviewer for the Neurotoxicology journal.

 

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Camilla Sorensen
Director, Regulatory Affairs, Johnson & Johnson Consumer, Inc.
Speaker

Camilla Sorensen

Camilla Sorensen Myers has held increasingly senior positions within the dietary supplement and food industry over her 15 + year career. She joined Johnson & Johnson Consumer Health in 2019 as Director of Regulatory Affairs, Dietary Supplements overseeing all dietary supplement activities with focus on the Zarbee’s business. She is also the co-lead for the company's dietary supplement external advocacy and policy. Prior to joining J&J she held the position of Director, Regulatory Affairs with USANA Health Sciences, and earlier worked for Herbalife Europe based in the UK where she was responsible for regulatory compliance across EMEA.

Camilla has experience in international and US food and dietary supplement regulations and has served on multiple committees with national and international trade associations.

Camilla graduated from London South Bank University with an B.Sc. Honors in Food Sciences and Technology.

 

David Spangler Headshot in suit and red tie
Senior Vice President, Legal, Government Affairs & Policy

David Spangler

David Spangler leads the association’s team of eight across legal, government affairs, and policy functions. He has particular expertise in regulatory matters.

Spangler joined CHPA in 1984 as a legislative analyst. He subsequently served in a number of roles for the association in the president's office, project management, international affairs, and, after completing law school in 1995, the association's legal department. Spangler was named a vice president in 1997, and a senior vice president in 2006. His responsibilities were expanded to his current role in 2019.

Spangler is a member of the District of Columbia Bar as well as the American Society of Association Executives. He authored the chapter on OTC medicines in "Modern Pharmaceutical Industry: A Primer" (Jacobsen and Wertheimer, eds., 2009) and has served on a range of committees and working groups for the Food and Drug Law Institute and the Global Self-Care Federation. Spangler earned his Certificate in Organizational Management in 1991 from the U.S. Chamber of Commerce's Institute for Organization Management.

 

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Aloka Srinivasan, Ph.D.
Principal & Managing Partner, Raaha LLC
Speaker

Aloka Srinivasan, Ph.D.

Aloka Srinivasan, Ph.D., the Principal and Managing Partner of RAAHA LLC (www.raahallc.com) brings more than two decades of experience in the pharmaceutical industry, including nine years of progressive experience with the U.S. FDA in the Office of Generic Drugs, Lupin Pharmaceuticals, Lachman Consultants and PAREXEL International. She provides strategic guidance to the pharmaceutical industry on regulatory and chemistry, manufacturing, and controls (CMC) for drug products and drug substances at all stages of development and for all types of regulatory submissions.

Dr. Srinivasan has supported the development of several new drugs and generics during her tenure in PAREXEL and Lachman from the CMC and regulatory perspective. Dr. Srinivasan has worked closely with the industry and FDA related to development and approval of several complex 505(b)(2) applications as well as complex generic applications. Dr. Srinivasan spearheaded the foundation of a division in FDA related review of drug master files (DMF) for drug substances under GDUFA and played a pivotal role in writing of the FDA Guidance for Industry: Initial Completeness Assessments for Type II API DMFs Under GDUFA and a QbR document for drugs substance, which is part of FDA Mapp. 5015.10. Dr. Srinivasan was one of the main authors of the QbR-QOS (Question based Review-Quality Overall Summary) for ANDAs, which is the current basis of review of generis at CDER/FDA.

Dr. Srinivasan is one of the world class experts in the area of nitrosamine impurities based on her research background and has been supporting the industry in addressing these carcinogenic impurities in the drugs.

Dr. Srinivasan received her Ph.D. from University of Missouri, Columbia under Dr. Richard N. Loeppky of nitrosamine fame. Her thesis was titled “A study of putative intermediates involved in the activation of beta-oxidized nitrosamines and nitrosation of N-substituted aziridines”. Dr. Srinivasan also spent seven years as a scientist in National Cancer Institute, working for Dr. Larry K. Keefer, researching on nitrosamines in potential nitric oxide donor drugs.

Dr. Srinivasan champions the regulatory efforts of RAAHA’s clients based on her extensive experience and in‐depth knowledge of chemistry and U.S. FDA’s regulatory requirements.

 

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Andrew Stewart
Head of RWE and Behavioral Science, Sanofi Consumer Healthcare
Speaker

Andrew Stewart

Andrew Stewart is currently the Head of Real-World Evidence and Behavioral Science at Sanofi Consumer Healthcare where he leads a team of subject matter experts across real-world evidence, data and analytics, as well as behavioral science. He has been leading real-world evidence generation efforts for Sanofi Consumer Healthcare since the beginning of 2019 and has worked in consumer healthcare at Sanofi driving real-world evidence strategies since 2017.

Andrew has worked at Sanofi since 2013, originally developing evidence strategies targeted at payers for rare diseases. Here, he developed and conducted studies not only focusing on real-world evidence, but also health economics and behavioral research. This gave him a diverse background in creating and implementing targeted evidence generation strategies, as well as a myriad of study designs to develop evidence that is meaningful to payers and patients. This experience helped Andrew to develop a more “patient-centric” mindset, and ultimately got him interested in consumer healthcare where the consumer is the physician, patient and payer all in one. He has carried this mindset into his current role where, as he puts it, “he develops evidence from the consumer, for the consumer.”

Andrew has a Master of Public Health degree from Boston University, specializing in Health Policy and Management. He also has an undergraduate degree from the University of Iowa where he graduated with Honors in Integrative Physiology, and Honors Commendations in Biology and Interdisciplinary Studies. He has multiple publications spanning various study designs in both the rare disease and consumer healthcare spaces.

 

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Richard Sullivan, Ph.D.
Associate Director, Technology, Colgate-Palmolive Company
Speaker

Richard Sullivan, Ph.D.

Rich Sullivan is currently the Worldwide Director of Knowledge Management at Colgate-Palmolive. He received his doctoral degree from the University of Illinois, Urbana-Champaign in physical inorganic chemistry. Rich has over 30 years of experience working in oral care for Colgate Palmolive and is considered one of Colgate’s senior technical experts in the area of oral care research and development. He has led technical teams that developed many Colgate oral care products currently in the market today and has been responsible for conducting numerous studies to illustrate and document the benefits of many oral care products. As the current head of Global Knowledge Management, Rich and his team interacts closely with the legal, regulatory, marketing and R&D functions to ensure all claims for products marketed by Colgate-Palmolive are fully substantiated. Rich is one of Colgate’s representatives for CHPA task force and has been highly involved in activities to propose alternatives to animal caries testing.

 

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John Tamerius, Ph.D.
Special Advisor, Quidel
Speaker

John Tamerius, Ph.D.

Dr. John Tamerius graduated from the Univ. of Washington (Seattle, Washington) with a Ph.D. in Microbiology and Immunology. He performed graduate and postdoctoral research in tumor immunology at the Fred Hutchinson Cancer Center (Seattle) before joining the Scripps Clinic and Research Foundation (San Diego, California) as a Research Associate in the Dept. of Molecular Immunology; here he studied inflammation and the complement system and was a National Arthritis Fellow. In 1983 he cofounded a company in San Diego (Cytotech, Inc.) where he led the development of 9 FDA-cleared products, approx. 100 research products and five research-use-only (RUO) kits for studies of immune complexes, inflammation, and the complement system. Cytotech was acquired by Quidel Corporation in 1989. During his ensuing tenure at Quidel he has held several important leadership roles, including Head of Quality Assurance, VP of R&D, General Manager of Quidel’s northern California division, Sr. VP of Clinical & Regulatory Affairs, and Sr. VP of Strategic & External Affairs. While head of R&D, Dr. Tamerius was in charge of the development of the QuickVue Influenza A/B lateral flow test—the first CLIA-waived rapid antigen test for diagnosis of influenza. More recently he was responsible for the clinical trials and FDA submissions that led to the FDA clearances and CLIA waivers for the immunofluorescence-based Sofia analyzer and the Sofia Influenza A+B Fluorescence Immunoassay (FIA), the Sofia RSV FIA, the Sofia Strep A+ FIA, and the Sofia hCG FIA. He also was responsible for the field studies leading to the validation of the Virena wireless communication and surveillance system. He worked with the teams that developed the Sofia SARS Antigen FIA and the QuickVue POC and QuickVue OTC tests for detection of SARS-CoV-2 antigen. Dr. Tamerius now serves as Special Advisor to the CEO of Quidel.

 

Mike Tringale Headshot in suit and tie
Vice President, Communications & Public Affairs

Mike Tringale

Mike Tringale is responsible for providing strategic direction and oversight for external and member communications, media relations, strategic ally development, and key public affairs initiatives.

Prior to joining CHPA in January 2016, Tringale served as senior vice president of external affairs at the Asthma and Allergy Foundation of America (AAFA) for more than a decade, where he led development, public affairs, and public relations. He managed AAFA’s partnerships with Global 2000 companies in sectors such as pharmaceuticals, consumer products and manufacturing, directed consumer research, and developed the Asthma & Allergy Friendly™ Certification Program.

Prior to AAFA, Tringale worked at the Brookings Institution, Georgetown University Medical Center, MHI Global/Huthwaite Consulting, and W.J.Kircher Associates, an advertising, marketing and public relations firm serving trade associations.

Tringale is a member of the American Marketing Association, recently serving as chair of the DC chapter nonprofit section, and he is a member of the Public Relations Society of America.

 

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Adam Vasquez
Head of Quality, Regulatory & Health Compliance, Google, Inc.
Speaker

Adam Vasquez

Fueled by a passion for the convergence of healthcare and technology that started in the hospital space, then migrated to consumer wearables with Fitbit now Google, where he's had the privilege to work with pioneers who are closing the gap between consumer electronics and medical devices. Adam's education as a lawyer and diversified roles have given him a unique perspective of how to navigate the quickly evolving digital health space. Adam presently oversees Regulatory Affairs, Quality Engineering, and Health Compliance at Google.

 

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Geoff Waite, M.Sc.
Partner, PA Consulting
Speaker

Geoff Waite, M.Sc.

Geoff is a Partner within PA's Design & Engineering cluster, with a responsibility for bringing new physical and digital technologies to product innovation. PA is a trans-Atlantic Innovation, R&D, engineering and manufacturing consulting firm with deep roots in the healthcare and life sciences and consumer sectors, dedicated to a creating a better human future through our ingenuity. Sustainability in all its forms is a significant portion of PA's work, including within R&D topics such as development of several novel materials, waste valorization and carbon capture.

Recent work that he will share includes the development of plastic-free single use diagnostic devices, and how organizations are incorporating of sustainability into the very fabric of R&D in order to drive more responsible outcomes, as well as some insights into consumer and corporate behaviors.

Geoff has been active in R&D and innovation for 35 years with PA, Sagentia, TTP, Warwick University and the British Technology Group in areas as diverse as manufacturing automation; consumer, industrial and professional products; medical diagnostics

Education:

  • B.S. Physics, University of Warwick, UK
  • M.S. Engineering, Warwick Manufacturing Group, University of Warwick, UK
 

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Elisabeth Walther, PharmD, J.D.
Acting Associate Director for Strategic Initiatives, US Food & Drug Administration
Speaker

Elisabeth Walther, PharmD, J.D.

 

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Paul Wardle
Founder & Principal, Beacon Associates, LLC
Speaker

Paul Wardle

Paul is the founder of Beacon Associates, a strategic marketing consultancy focused on delivering consumer centric solutions to advance availability, access and adoption of innovative healthcare solutions. With over 25 years of healthcare marketing & sales experience Paul has directed over 25 successful product and brand launches globally with brand creation expertise forged in leading healthcare companies (GlaxoSmithKline and Pfizer) along with experience in a start-up environment. His experience spans multiple therapeutic categories across iconic Rx and OTC brands such as Viagra, Advil, Lipitor, & TUMS. Paul is a champion of the patient in clinical development & recruitment, customer experience, advocacy and brand creation by distilling the science to create meaningful innovation, advertising and communication programs. In addition, Paul has led many prescription to over-the-counter (Rx-to-OTC) programs, a key lifecycle management strategy to enable consumer self-care and create enduring brands.

Paul received Master’s Degrees in Mathematics and Theoretical Physics from the University of Cambridge and also now teaches both Healthcare Marketing & Statistics at New York University.

 

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Ivan Wasserman
Managing Partner, Amin Talati Wasserman LLP
Speaker

Ivan Wasserman

Ivan Wasserman is the Managing Partner of the law firm Amin Talati Wasserman LLP, one of the nation's leading regulatory and intellectual property law firms with offices in Chicago, Los Angeles, and Washington, D.C. Ivan and his boutique firm is dedicated to providing “white glove” service to companies in the food, dietary supplement, cosmetic and medical device industries, including FDA/FTC compliance (labeling; advertising; manufacturing); patents and trademarks; NDI/GRAS analyses and submissions; Class Action and Prop 65 defense; NAD challenges; commercial litigation; and customs clearance. Ivan is a frequent speaker and author on regulatory issues, and has been included in Best Lawyers in America from 2007 to 2022.

 

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Nelson Webb
Director - QA External Engagement, The Procter & Gamble Company
Speaker

Nelson Webb

A 35 year veteran with Procter & Gamble, Nelson has worked in QA and operations roles across foods, cosmetics, and drugs. He has worked on capability and systems building with particular focus on data integrity, deviation investigations, and consumer complaints in recent years. Nelson is currently P&G's External Engagement Leader and in this role led the Company's participation in the recently completed Quality Management Maturity Pilot.

 

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Marielle Weintraub, Ph.D.
Analytical Services Manager, Eurofins
Speaker

Marielle Weintraub, Ph.D.

Dr. Marielle Weintraub is an Analytical Services Manager (ASM) for Eurofins Food Chemistry Testing in Madison WI. In this role Marielle supports the GMP, OTC, and contaminants testing by being a resource and subject matter expert for both customers and Eurofins employees. Prior to joining Eurofins, Marielle was the Director of Research and Development for a Texas-based consumer products company, where she developed plant-derived supplements, cosmetics, and RTD products. Marielle is very active in many dietary supplement and natural product industry trade associations. She volunteers as the President of the Board of Directors for the U.S. Hemp Authority (USHA) Certification Program, an active member on Expert Review Panels and Working Groups for AOAC International's-Cannabis Analytic Science Programs, and a member of the American Herbal Products Association- Cannabis and Sustainability Committees.

Dr. Marielle Weintraub earned her M.S. and Ph.D. in Behavioral Neuroscience focusing her research on inflammation and Alzheimer’s disease pathology.

 

Cara Welch Headshot
Cara Welch, Ph.D.
Director, Office of Dietary Supplement Programs, U.S. Food and Drug Administration
Speaker

Cara Welch, Ph.D.

Cara Welch, Ph.D., is the Director of the Office of Dietary Supplement Programs in FDA’s Center for Food Safety and Applied Nutrition. Dr. Welch has been with FDA since 2014 in different roles working on regulatory, compliance, and scientific matters for the agency’s regulation of dietary supplements. She also worked in the Office of the Commissioner as the Acting Special Assistant to the Deputy Commissioner for Policy, Legislation, and International Affairs providing expertise on agency level food policy issues. Prior to joining FDA, Dr. Welch was the Senior Vice President of Scientific and Regulatory Affairs at the Natural Products Association. Welch earned her Ph.D. in Medicinal Chemistry from Rutgers University working with traditional medicinal African plants.

Leana Wen, M.D., MSc. Headshot
Leana Wen, M.D., MSc.
Research Professor of Health Policy and Management, George Washington University: School of Public Health
Speaker

Leana Wen, M.D., MSc.

Research Professor of Health Policy and Management

George Washington University: School of Public Health

Dr. Leana Wen is an emergency physician, CNN medical analyst, and op-ed columnist for The Washington Post, where she writes a weekly column and anchors the Post newsletter, "The Checkup with Dr. Wen". She is also a professor of health policy and management at George Washington University, a nonresident senior fellow at the Brookings Institution, and author of two books, When Doctors Don’t Listen: How to Avoid Misdiagnoses and Unnecessary Tests and Lifelines: A Doctor’s Journey in the Fight for Public Health.

Previously, she served as Baltimore's Health Commissioner, where she led the nation’s oldest continuously operating health department in the U.S. to fight the opioid epidemic, treat violence and racism as public health issues, and improve maternal and child health.

Dr. Wen obtained her medical degree from Washington University School of Medicine and studied health policy at the University of Oxford, where she was a Rhodes Scholar. She completed her residency training at Brigham & Women's Hospital & Massachusetts General Hospital, where she was a clinical fellow at Harvard Medical School. 

A member of the Council on Foreign Relations, Dr. Wen has received recognition as one of Governing's Public Officials of the Year, Modern Healthcare's Top 50 Physician-Executives, World Economic Forum’s Young Global Leaders, and TIME magazine's 100 Most Influential People. 

Dr. Wen lives with her husband and their two young children in Baltimore.

 

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Alfred Whitehead
EVP, Applied Sciences, Klick Inc.
Speaker

Alfred Whitehead

Alfred is one of Klick’s senior consultants, with over 15 years of experience in using data within the healthcare and life sciences industries. He leads Klick’s Applied Science practices. He is a core member of Klick Consulting's Rx to OTC Switch practice. Previously, he has headed up Klick’s Data Science team and he was SVP Technology at Klick, overseeing a team of over 100 software developers. His past experience also includes massively multi-user web architecture (for a website in the top 50 worldwide by traffic volume), information security, and the defense of high-profile targets against active threats.

Registration

How to Register for the Conference

  • Member Early Bird Registration Fee (until August 5, 2022) - $995
  • Member Regular Registration Fee (after August 5, 2022) - $1,095
  • Non-Member Registration Fee - $2,945
  • Virtual Registration Fee - $595
  • Non-Member Virtual Registration Fee - $1,195
  • Government Registration Fee - $225 (in person or virtual)
  • Non-Profit Registration Fee - $595

Registration is now Open. Phone registrations are NOT accepted.

Virtual Registration

The Virtual Registration option will provide livestreams of the (5) general sessions and (4) selected breakout sessions. The livestreamed sessions are listed on the Livestream Schedule at a Glance

Registration Cancellation

Cancellations received by August 19, 2022 will receive a full refund. Cancellations received after August 19, 2022 will result in the forfeiture of the entire registration fee. Cancellations must be made in writing and emailed to Meetings@chpa.org. 

Registration & Logistics Questions

 

Hotel and Travel

Hyatt Regency Bethesda

One Bethesda Metro Center

7400 Wisconsin Avenue

Bethesda, MD 20814

301-657-1234

  • The CHPA 2022 RSQ Group Rate is $229.00.
  • This discounted rate is available until 3:00 p.m. Monday, August 29, 2022, or sooner if the room block sells out.

Check-In and Check-Out

Check-in: 4:00 p.m.

Check-out: 11:00 a.m.

Cancellation Policy Cancellations must be received 48 hours prior to your arrival date to avoid a penalty fee of one night’s room and tax.

Hotel Amenities

Please visit the hotel website for a full list of amenities and features.