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Save the Date for RSQ 2024!

September 17-18, 2024

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 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.

Program as of 9/17/2023 (subject to change)

September 18-20, 2023

Day 1

Monday, September 18, 2023

10:00-11:45 a.m.

CHPA Quality/Manufacturing Committee Meeting (Members only)


10:00-11:45 a.m.

CHPA Regulatory and Scientific Affairs Committee/PPS Meeting (By invitation only)


12:00-3:45 p.m.

CHPA Regulatory and Scientific Affairs Committee (RSAC) Meeting & Lunch (Members only)


4:30-6:00 p.m.

Early Arrivers Reception

Day 2

Tuesday, September 19, 2023

7:00am-4:30 p.m.  

Registration


7:00-8:00 a.m.

Breakfast


8:00-8:15 a.m.        

Welcome Remarks & Award Presentation 

Lisa Parks. Senior Vice President, Regulatory & Scientific Affairs, CHPA

David Campbell, RSQ 2023 Planning Committee Chair and VP & Head of RMSC North America, Bayer Consumer Health 

Lauren Quinn, Head, US Regulatory Affairs, Haleon

 


8:15-9:00 a.m.

General Session: FDA CDER Leadership Update

Moderator

Scott Melville, President, and CEO, CHPA

Speaker

Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation Research, U.S. Food and Drug Administration                       


9:00-10:00 a.m.

General Session: Keynote Session - ChatGPT: Opening Bell for a New Era of AI and Implications for Self-care

This year the rapid rise of ChatGPT and its competitors has been nothing short of astonishing. Public awareness may be new, but ChatGPT represents a subset of AI that has been in development for several decades. “Cognitive computing” was first publicly displayed in game-playing bots able to beat human champions in games as different as Jeopardy and Go. This kind of AI can ingest vast amounts of information and quickly generate comments, reports, or decisions comparable to human effort.  Everything from retail to professional services will be altered by cognitive computing.  Cognitive computing will alter the way healthcare products are developed and sold, as well as how customers receive advice. The new development processes—and surprisingly intelligent support services—will provide both competitive challenges and new opportunities for consumer healthcare. 

Moderator

Duffy MacKay, Senior Vice President, Dietary Supplements, CHPA

Keynote Speaker

Michael Rogers, Columnist, MSNBC's The Practical Futurist, & Futurist-in-Residence of The New York Times

 


10:00-10:30 a.m.

Morning Break

 


10:30-11:30 a.m.

General Session: FTC Update

Join this session and learn more about how recent FTC regulatory actions could impact day-to-day industry operations.  Trends for enforcement activities in the selfcare space will be used to highlight what to and not to do with regards to drugs, medical devices, and dietary supplements.  Finally hear about proposed updates to the FTC green guides from the regulator and stakeholder perspectives.   

Moderator

Carolyn Herrmann, Esq., Deputy General Counsel, CHPA

Speakers

Christine DeLorme, Esq., Attorney, Division of Advertising Practices, Federal Trade Commission

Raqiyyah Pippins, Esq., Partner, Arnold & Porter

Scott Bass, Esq., Partner, Sidley & Austin


11:45 a.m.-12:30 p.m.

Breakouts

Regulatory: Principles of Science Led Self Care

Join this session to learn more about the key principles that enable the discovery and delivery of self-care products based on consumer insights and solid scientific evidence.

Moderator

David Campbell, RSQ 2023 Planning Committee Chair and VP & Head of RMSC North America, Bayer Consumer Health

Speaker

Ricardo Salazar, M.D., Head of Global Medical Affairs, Bayer Consumer Health

Science: Driving Innovation with Real-World Evidence from Consumer Generated Content

In this session, we spotlight the generation of real-world evidence (RWE), particularly sourced from novel data streams like social media and consumer discussions. Understand how these unique data sources facilitate healthcare innovation, enhance regulatory strategies, and inform consumer health product development. Participate to deepen your understanding of how RWE, underpinned by non-traditional data, is reshaping health insights and helping identify white-spaces for innovation.

Speaker

Ali Vahit Esensoy, Ph.D., Vice President, Data Science, Klick Inc.

Quality: FSVP for DS and OTC. The Alphabet Soup of Import Quality Compliance

Failure to comply with FSVP is one of the top deficiencies found by the FDA. Implementing and following FSVP is required for any food or ingredient you are importing into the U.S. Dietary ingredients and other ingredients like flavors and excipients are typically classified and regulated as a food and they must comply with food regulations including FSVP. The FSVP requirements for dietary supplements and dietary ingredients that are different from other types of foods. This session will cover dietary supplement and other ingredient requirements, the latest on enforcement trends, and best practices for compliance.

Moderator

Srini Yandrapu, US LOC Quality Lead, Haleon 

Speaker

Brandon M. Griffin, CEO, Rejimus, Inc.

Sharon Lindan Mayl, Partner, DLA Piper, LLP

Regulatory:  Regulatory Modernization of The Self-Care Aisle – What Is Now and What Is Next?

There have been significant changes to FDA regulated products and supply chains since the Federal Food, Drug, and Cosmetic Act passed in 1938. Consequently, over the past decade new laws have modernized the regulatory framework for foods, OTC medicine, and cosmetics to help FDA catch up with the present-day world. This session will provide a status report on regulatory modernization of CHPA member products including new cosmetic regulations (MoCRA) and updated on OTC regulations (OMUFA), which is approaching re-authorization in 2025. Finally, speakers will explore proposed changes to Dietary Supplement regulations (DSHEA).

Moderator 

Liping Wu, M.D., Ph.D., Global Regulatory Affairs Manager, Kenvue                                        

Speakers

Jerry Masoudi, Partner, Covington & Burling LLP

Diane McEnroe, Partner, Sidley & Austin

 

12:30-1:15 p.m.

Lunch


1:15-2:00 p.m.

General Session: Reagan-Udall Foundation for the FDA Update

Susan C. Winckler, CEO of the Reagan-Udall Foundation for the FDA, will provide an overview of the mission of the foundation and some recent projects that impact self-care and consumer products.

Moderator

Lisa Parks. Senior Vice President, Regulatory & Scientific Affairs, CHPA

Speaker

Susan C. Winckler, RPh, Esq., CEO, Reagan-Udall Foundation for the FDA

 


2:15-3:45 p.m.

Breakouts

Regulatory: Consumer Medical Device Innovation

The COVID-19 pandemic, while unfortunate, also opened new world of possibilities for self-care and the use of medical devices in the home.  Join this session to learn about opportunities for innovation for consumer medical devices, whether it is in combination with over-the-counter medicines or as stand-alone products.

Moderator

Gregory Smith,  Senior Director, Rx-to-OTC Switch, Sanofi                             

Speakers

Patty Post, Founder & CEO, Checkable

Brittany Schuck, Ph.D., Deputy Office Director, FDA

Science: Using Real World Evidence in Selfcare Product Research & Submissions

This session, on real world evidence, builds on the foundation established at the last RSQ.  Hear from leading industry speakers who will address how sponsors should generate real-world evidence (RWE) and real world data (RWD) that is fit-for-purpose for selfcare products.  Attendees will learn when using RWE is appropriate and when it is not, and how it can be used to support regulatory applications. 

Moderator

Doris Roberts, Associate Director, Global Regulatory Affairs, Kenvue

Speakers

Andrew Stewart, Head of RWE and Behavioral Science, Sanofi

Julie Aker, Vice-President & General Manager, Concentrics Research, IQVIA Real World Solutions

Quality: Impurities: Benzene, Nitrosamine & Other Compounds of Interest

Join us for this 90-minute session where we will take a deep dive into how well you know your products. We will cover many of the current (2022-2023) regulatory highlights for compounds of interest.  Several of these compounds are ongoing; however, they received extra coverage in the media and in the lab. We will make sure you know the latest quality news. Benzene in personal care products made a big splash in 2022. Nitrosamines continues to provide quality staff a moving target regarding limits and compounds of concern. Plus, we will address other compounds to consider in your quality profiles.  Our subject matter experts will discuss where do they come from, what to watch for, how to monitor, and potential analytical challenges.  During this session we will focus on potential impurities and how you can apply current knowledge to your manufacturing site quality.

Moderator

Stefanie Rentfrow, Analytical R&D Director, Perrigo Company

Speakers

Grace Bandong, Business Unit Manager, Contaminants and Inorganics, Eurofins Food Chemistry Testing

Nicholas Georges, Senior Vice President, Scientific & International Affairs, Household & Commercial Products Association 

Naiffer Romero, MSc, MPH, Principal Scientist, Scientific Affairs, United States Pharmacopeia 

Francis Godwin, Director, Office of Manufacturing Quality, Center for Drug Evaluation and Research, FDA

Dietary Supplements:  Plant Tissue Culture as a Source for Bioactive Compounds Used in Consumer Health Products.

Plants are used throughout the world to support human health. The health promoting properties of plants are based on their phytochemical components like phytosterols, polyphenols, carotenoids, and others. Phytochemicals are used in drugs, dietary supplements, cosmetics, fragrances, flavors, and dyes. Expanded use of plant bioactive compounds has initiated interest in increasing sustainable production using plant tissue culture (PTC) techniques and optimizing their large-scale production using bioreactors. This session will explore the scientific, regulatory, and quality considerations of PTC ingredients for consumer health products.

Moderator

Katriana Garcia, Senior Regulatory Manager, Bayer Consumer Health  

Speakers

Weslee Glenn, Ph.D., Head of Platform Development, Ayana Bio

Frank Jaksch, Chief Executive Officer, Ayana Bio

Tony Pavel, Deputy General Counsel, Global Food Law, Perfect Day

 


3:45-4:00 p.m.

Afternoon Break


4:00-5:30 p.m.

Breakouts

Regulatory: An Overview of CDRH Regulatory Initiatives

Speakers from the FDA’s Center for Devices and Radiological Health will be invited to share updates on their key initiatives on implementation on the e-Star Program, conversion from QS to ISO for good manufacturing processes, and the use of AI/ML in devices used by consumers. 

Moderator

Lisa Burns, Senior Regulatory Manager, US Regulatory Affairs, Intimate Wellness and Personal Care, Reckitt

Speaker

Keisha Thomas, Supervisory Consumer Safety, FDA

Christina Kuhn, Senior Associate, Covington & Burling LLP

Regulatory: The OTC Monograph Under OMUFA – First 3 Years and a Look Ahead

In this session, speakers from both industry and FDA will discuss expectations following the passage of the OMUFA legislation as part of the CARES Act of 2020; highlight progress implementing the provisions of this revolutionary reform; and provide a view into what might be next with the upcoming OMUFA 2 negotiations.

Moderator

Barbara Kochanowski, Ph.D., Former Senior Vice President, Regulatory & Scientific Affairs, CHPA        

Speakers

Karen Murry, MD, Deputy Director, Office of Nonprescription Drugs, CDER, FDA

Lauren Quinn, Head, US Regulatory Affairs, Haleon

Matt Brancazio, PharmD, Branch Chief, Policy and Operations, FDA

Quality: Best Practices for Complaint Handling and AER Reporting for OTC Medicine And Dietary Supplements.

What keeps you up at night? Product complaint handling and serious Adverse Events Reporting (sAER) is a requirement but, in this session, we want to address more than the regulations and standard best practice. Social media introduces an even bigger challenge to complaint handling. We hope to demystify industry best practices for complaints seen via social media platforms and for social media monitoring. Plus, let’s add in the perspective from FDA staff regarding how we (responsible industry) can do better.

Moderator

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

Speakers

Ricardo Carvajal, Director, Hyman, Phelps & McNamara, P.C

Richard Kingston, President, Regulatory and Scientific Affairs and Co-Founder, Safety Call International, LLC 

Liz Jury, Senior Manager of Content Integrity, Bazaarvoice

Nichole Nolan, Branch Chief, Signals Management Branch, Office of Analytics and Outreach (OAO), FDA

Oliver Ou, Consumer Safety Officer, U.S. Food & Drug Administration

Regulatory: Drug Take-Back: What’s The State of Play?

It’s been over a decade since Alameda County, CA, enacted the first mandatory pharmaceutical take-back program, with mandatory programs now covering the West Coast, IL, ME, and Parsons, KS.  Attend this session to learn about: Differences in models among jurisdictions; Key deadlines as IL, ME, and Parsons, KS, come online; The evolution of disposal technology and disposal preferences and The legislative and local landscapes as we look toward 2024.

Moderator

Robert Pineda, Assistant General Counsel, Kenvue

Speaker

John Gay, Vice President of Legislative and Regulatory Affairs, Pharmaceutical Product Stewardship Work Group (PPSWG)

 


5:30-6:30 p.m.

Reception

Day 3

Wednesday, September 20, 2023

7:00 a.m.-12:30 p.m.

Registration


7:00-8:00 a.m.

Breakfast


8:00-9:00 a.m.

General Session: Color Additives and Flavors in OTCs – What You Need to Know

What you need to know when changing an excipient, flavor, or fragrance in a consumer self-care product. Join this session to learn about scientific, regulatory, and quality considerations when you change a color, fragrance, or excipient in a consumer self-care product. Speakers will discuss important considerations such as evaluating safety and what to expect from FDA.

Moderator

Lauren Quinn, Head, US Regulatory Affairs, Haleon

Speakers

Joanna Drake, General Counsel, Flavor and Extract Manufacturers Association

Jessica Dunn, Ph.D., Policy Lead, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA


9:15-10:45 a.m.

Breakouts

Regulatory: Established Ingredients Facing New Scientific, Regulatory, and Legal Challenges

A number of established ingredients/excipients have recently come under increased scrutiny owing to regulatory, scientific and legal challenges. In this session, you’ll hear the latest on topics such as ingredient bans and their implications (titanium dioxide); the safety evaluation processes supporting use (FD&C colors); and the ongoing legal challenges surrounding use of an FDA approved drug (mifepristone).

Moderator

Linda Salerno, Regulatory Manager, Reckitt

Speakers

Mical Honigfort, Ph.D., Branch Chief, Division of Food Ingredients Office of Food Additive Safety

FDA/CFSAN

Benjamin Mundel, Partner, Sidley Austin

Jay West, Senior Director, Chemical Products and Technology, American Chemistry Council

Science: Key Strategies for Enhancing Diversity in Clinical Trials

FDA and other governmental agencies have committed to increasing and enhancing diversity in clinical trials.  Speakers from academia, government, and the OTC industry will share insights into new considerations for study design in ways that successfully accomplish the of enrolling subjects that better reflect the US population.

Moderator

Daniel Brum, Chief Project Manager, FDA

Speakers

Arline Geronimus, M.D., Sc.D, Professor, Health Behavior and Health Education, University of Michigan

Lily Mulugeta, M.D., Division Associate Director, Policy Research Pediatric & Maternal Health, FDA

Clark Richardson, MPH, President & CEO, PEGUS Research, Inc.

Wendy Weber, N.D., Ph.D., MPH, Branch Chief, Clinical Research in Complementary and Integrative Health Branch, NIH

Quality: Protecting the Supply Chain and Product Integrity

During this 90-minutes session we’ll address the risk to public health and safety and your brand reputation when look-alike products hit the market representing themselves as your own. We’ll explore and consider: What are the trends to watch for and the risks? How can you manage and monitor your products post-market?  Plus, the responsibilities for the retailer, distributor, third party logistics provider (3PL), and you as the brand owner. Subject matter experts will provide an insightful perspective for your quality and operations staff.

Moderator

Larisa Pavlick, Senior Director, Regulatory & Scientific Affairs, CHPA

Speakers

Ricardo Carvajal, Director, Hyman, Phelps & McNamara, PC

Rachel Turow, Managing Counsel, Regulated Products, Walmart

Cara Welch, Ph.D., Director, Office of Dietary Supplement Programs, FDA

Dietary Supplements: Developing Beneficial Dietary Supplements for Women

Increasing scientific evidence demonstrates that achieving optimal health is not one size fits all activity. There are different requirements for exercise, sleep, nutrients, and bioactive compounds throughout various stages of life for men and women.  This session will explore the latest in scientific and regulatory considerations when companies develop, and market products marketed for women.

Moderator

Natalie Mazurets, MS, RDN, Senior Manager, US Regulatory Affairs, Centrum Innovation, Haleon

Speakers:

Brandon Casteel, Vice President of Partnerships, SPINS

Susan Hewlings, Ph.D., Vice President of Research Affairs, Radicle Science 

Susan Mitmesser, M.D., VP Science and Technology, Pharmavite


10:45-11:15 a.m.

Morning Break


11:15 a.m.-12:45 p.m.

Closing General Session: FDA Leadership Panel

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

Moderator

David Campbell, RSQ 2023 Planning Committee Chair and VP & Head of RMSC North America, Bayer Consumer Health 

Speakers

Gerald Dal Pan, Director of the Office of Surveillance and Epidemiology, FDA

Theresa Michele, M.D., Director, Office of Nonprescription Drug Products, CDER, FDA

Cara Welch, Ph.D., Director, Office of Dietary Supplement Programs, FDA


12:45-1:45 p.m.

Lunch


1:30-3:00 p.m.

*Pre registration required*  

Register 

Applying the Principles of RWE/RWD: A Hands-on Workshop 

 

RSQ attendees who join for this hands-on workshop will have an opportunity to apply concepts presented during the breakout session on RWE/RWD.  Expert Facilitators, Julie Aker and Andrew Stewart will use case studies to help participants learn the “hows” behind the generating real-world data that is fit-for-purpose to support regulatory decisions.  Gain additional insights on how to use real world data to inform Rx-to-OTC switch programs.   

Speakers

Julie Aker, Vice-President & General Manager, Concentrics Research, IQVIA Real World Solutions

Andrew Stewart, Head of RWE and Behavioral Science, Sanofi

 

Speaker Bios

Julie Aker Headshot
Julie Aker
Vice President and General Manager, Concentrics Research, an IQVIA business

Julie started her career in a large healthcare system in Colorado Springs. Julie attended Ball State University and obtained degrees in medical technology, biology, and chemistry; her MBA work was done at the University of Colorado. She worked in the clinical laboratory and grew into senior management in medical affairs with over 800 healthcare providers. She started a healthcare consulting business within the hospital system that soon grew and became a separate business.

Julie was later recruited by a global CRO, for positions in quality assurance/regulatory affairs and in protocol services as head of the project teams in the U.S. and Switzerland for the Central Laboratory Business. In 1999, Julie was recruited to work at West Pharmaceutical Services and expanded the clinical, consulting, and regulatory capabilities of the company. In 2002, she led a management buy-out with partnership and funding from Bindley Capital Partners and started Concentrics Research.

 

Grace Bandog Headshot
Grace Bandong
Business Unit Manager, Contaminants, Eurofins Food Chemistry Testing

Grace Bandong is the Business Unit Manager for Contaminants for Eurofins Food Chemistry Testing (EFCT). Grace has spent over 30 years in the food and supplement industry specializing in contaminants analysis including elemental analysis, pesticide residue analysis and risk assessments. Over the years, Grace has developed contaminant-testing programs that support supplier verification for food manufacturers and recently, the hemp industry. Grace developed a process for a hazards based chemical risk assessment of ingredients that is used as a guide by companies to respond to global regulatory requirements. She is an expert chemical risk assessment for dietary supplements and food.

Grace’s role at EFCT is to oversee a team of scientists in routine analytical testing and method development. Over the last few years, her team has developed methods for emerging contaminants of concern to the infant formula, dietary supplements and botanicals markets including ethylene oxide, PFAS and adulterants in weight loss, sports nutrition and male enhancement supplements. Grace and her team has also developed methods for the Hemp industry and EFCT in Madison was one of the first laboratories in the country to meet the Colorado Department of Health and Environment’s very stringent requirements for pesticide residue screening. Grace earned her degree in Chemistry from the University of the Philippines and her MSc in Chemistry from the University of Houston.

 

Matt Brancazio Headshot
Matt Brancazio, PharmD
Branch Chief, Office of Management, Division of User Fee Management, Policy and Operations Branch, CDER, FDA

CAPT Brancazio is the Branch Chief for CDER’s Office of Management, Division of User Fee Management (DUFM), Policy and Operations Branch. His Branch is responsible for user fee policy, Division-wide operations, and program management. In collaboration with colleagues in DUFM, CDER, and FDA’s Office of Financial Management and Office of Chief Counsel, FDA assesses more than $1.9B in user fees for the 5 CDER-led user fee programs. He received his Pharm.D. in 2002, Master in Business Administration with a concentration in Healthcare Administration in 2015, and currently holds the Regulatory Affairs Certification.

 

Scott Bass in suit and tie
Scott Bass, Esq.
Partner, Global Life Sciences head, FDA and Enforcement Partner, Sidley & Austin LLC

Scott Bass, a partner in New York and Washington, D.C. offices of Sidley Austin LLP, is the founder of the firm’s Global Life Sciences and Food and Drug Law practices in the United States, China, and Europe. He provides seasoned strategic guidance on critical innovation, compliance, and enforcement issues, including in the Good Manufacturing Practice (GMP), pharmacovigilance, and FDA/FTC promotion and litigation arenas. Using his experience as a lead drafter of the Dietary Supplement Health and Education Act, Scott has authored three books and is co-author of a recent New England Journal of Medicine article on necessary changes to that law. He advised U.S. FDA on its first dietary supplement website, and he serves as General Counsel to the global OTC drug association and as Dietary Supplement Counsel to CHPA.

 

Daniel Brum Headshot
Daniel Brum
Chief of Project Management Staff, Office of Regulatory Operations Nonprescription Drugs, FDA

Dan Brum is Chief of the Project Management Staff in the Office of Regulatory Operations Nonprescription Drugs 1 at FDA. He oversees the regulatory staff who manage the drug review process for OTC drugs. He also provides regulatory advice to the pharmaceutical industry to help bring safe and effective drugs to the OTC market. CAPT Brum received his BS from Haverford College and PharmD and MBA degrees from the University of Florida. He obtained his Regulatory Affairs Certification and is a Board Certified Pharmacotherapy Specialist.

 

Lisa Burns Headshot
Lisa Burns
Senior Regulatory Manager, US Regulatory Affairs, Intimate Wellness and Personal Care, Reckitt

Lisa Burns is a senior manager at Reckitt where she leads US Regulatory for Intimate Wellness and Personal Care brands.

Lisa obtained a BS in Integrated Science & Technology from James Madison University, and a MS in Quality Assurance/Regulatory Affairs from Temple. She received her RAPS RAC-Devices Certification in 2022.

Her industry experience for the past 15 years has been end-to-end Regulatory oversight for US consumer products across multiple product categories, with a particular passion for medical devices. Lisa has been actively participating with the CHPA CMD Committee since it’s creation in 2018, and now serves as Committee Chairperson. Prior to joining Reckitt, Lisa had worked for Church & Dwight.

 

David Campbell Headshot
David Campbell
SVP and Head of Regulatory, Medical, Safety and Compliance, North America, Bayer Consumer Healthcare

David Campbell, VP and Head of Regulatory, Medical, Safety, and Compliance, North America. In this role, David is accountable for delivering regulatory and medical evidence generation strategies to support the approval of Bayer’s products while providing differentiating, consumer relevant claims.

A seasoned Regulatory and business leader with over 28 years of pharmaceutical/healthcare industry experience, David joined Bayer in July 2019 as the NA Regional VP and Head of Regulatory Affairs Responsible for providing leadership, strategic direction and managerial oversight to the country based regulatory teams. Prior to joining Bayer, David spent the previous 10 years at Reckitt and Pfizer Consumer Health as the Regional Head of Regulatory Affairs where he left his impact on iconic brands like Mucinex and Advil. He holds a BS in Chemistry and Criminalistics as well as an MBA and MS in Regulatory Affairs.

 

Brandon Casteel Headshot
Brandon Casteel
Vice President of Partnerships, SPINS

Brandon Casteel is the Vice President of Partnerships for SPINS – he leads the teams responsible for Brokers/Distributors/Ingredient Supplier/Co-Manufacturer Partnerships, Strategic Partnerships, and Financial Partnerships for SPINS. He has been at SPINS for almost 4 years and prior to that had long stints in the Staffing/Recruiting and Telecommunications Industries. He has 5 children and 6 pets and is based in the Atlanta, GA area.

 

Ricardo Carvajal Headshot
Ricardo Carvajal
Director, Hyman, Phelps & McNamara, P.C.

Ricardo Carvajal is a director at Hyman, Phelps & McNamara, PC, a law firm based in Washington DC. His practice focuses on regulation of dietary supplements and other foods by FDA, FTC, and USDA. He advises clients ranging from start-ups to multinational companies at all points in the supply chain, including bulk ingredient manufacturers, distributors of packaged foods, and retailers. He counsels clients on the regulatory status of ingredients and finished products and provides advice on compliance with labeling and advertising requirements. He also helps clients interpret and comment on the implementation of new requirements, and the application of existing requirements to novel products and technologies. In enforcement matters, he counsels clients on managing inspections, responding to warning letters and other enforcement actions by federal and state regulators, and resolving import detentions. He also helps clients navigate product recalls and related corrective actions. His approach to counseling clients draws on insights gained in his former role as an Associate Chief Counsel for foods at FDA, where he counseled the agency on a variety of rulemaking and enforcement activities and policy initiatives.

 

Patrizia Cavazzoni Headshot
Patrizia Cavazzoni, M.D.
Director, Center for Drug Evaluation and Research, FDA

Patrizia Cavazzoni, M.D., is the director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration. The Center's mission is to ensure that safe, effective and high-quality drugs are available to the public. To achieve this, CDER regulates the medical products under its jurisdiction throughout their lifecycle, oversees the development of new and generic drugs, evaluates applications to determine whether drugs should be approved, monitors the safety of drugs after they are marketed, conducts research to advance regulatory science and takes enforcement actions to protect the public from harmful products. Dr. Cavazzoni joined the FDA in January 2018 as CDER's Deputy Director for Operations where she has led several key initiatives on behalf of the organization. She also served as Acting Principal Deputy Commissioner of Food and Drugs from January 2019 to February 2019.

Dr. Cavazzoni received her medical degree at McGill University and completed a residency in psychiatry and a fellowship in mood disorders at the University of Ottawa. During her training, she was an investigator in clinical trials of novel antipsychotic and antidepressant medications and became a research collaborator within the International Group for the Study of Lithium Treated Patients. She subsequently received a full-time appointment to the Faculty of Medicine at the University of Ottawa, and joined the Mood Disorders Program at the Royal Ottawa Hospital, where she treated patients suffering from severe mood disorders, taught students, and conducted research on genetic predictors of bipolar disorder as part of a multidisciplinary international collaborative effort, authoring numerous peer-reviewed scientific publications.

After her tenure in academic medicine, Dr. Cavazzoni worked in the pharmaceutical industry for several years and held senior executive positions in clinical development, regulatory affairs, and safety risk management in large companies across multiple therapeutic areas, until she joined the FDA.

Dr. Cavazzoni obtained certification by the American Board of Neurology and Psychiatry in 1997 and 2008 and is a fellow of the Canadian Royal College of Physician and Surgeons. She is a fellow of the Canadian College of Neuropsychopharmacology and a recipient of the American College of Psychiatrists' Laughlin Fellowship.

 

Christine Lee DeLorme Headshot
Christine Lee DeLorme, Esq.
Attorney, FTC Division of Advertising Practices

Christine Lee DeLorme is an attorney in the FTC Division of Advertising Practices, where her work focuses on investigating health-related advertising claims. Christine previously served as attorney advisor to FTC Commissioner Rebecca Kelly Slaughter, former Commissioner Terrell McSweeny, and former Chairman Jon Leibowitz, advising the Commissioners on a wide range of consumer protection issues including advertising, privacy and data security, and financial fraud. Before joining the FTC in 2004, Christine was a trial attorney with the National Criminal Enforcement Section of the U.S. Department of Justice Antitrust Division. Ms. DeLorme received an A.B. in History and a B.S. in Biology from Stanford University in 1996 and a J.D. from Harvard Law School in 2000.

 

Joanna Drake Headshot
Joanna Drake
General Counsel, Flavor and Extract Manufacturers Association of the United States

Joanna Drake serves as General Counsel to the Flavor and Extract Manufacturers Association of the United States. With more than a decade of flavor industry experience, her work with the association has covered a variety of regulatory and legal issues, including flavor and finished product labeling. Ms. Drake has given presentations to FEMA and other organizations on the current labeling implications of flavor, anticipated federal administrative action regarding “natural” labeling and the litigation landscape involving ingredient and food labeling. Prior to joining FEMA, she served as Assistant Counsel to WILD Flavors, Inc., where she worked on a variety of transactional issues and provided strategic legal counsel on product labeling and compliance matters.

 

Jessica Dunn Headshot
Jessica Dunn, Ph.D.
Policy Lead, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA
LCDR Dunn is a Policy Lead for CDER’s Office of Pharmaceutical Quality, Office of Policy for Pharmaceutical Quality. In this role, she develops and provides recommendations for science and risk-based policies and standards related to human drug quality, including application assessment and inspection. LCDR Dunn has a combined 10+ years of public service at FDA in both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) with expertise in current good manufacturing practices (CGMPs) and drug manufacturing. She received her undergraduate degree in Biological Sciences from the University of Delaware and her PhD in Microbiology and Immunology from Virginia Commonwealth University School of Medicine.
 

Ali Vahit Esenoy Headshot on purple background
Ali Vahit Esensoy, Ph.D.
VP, Consulting, Data Science, Klick Inc.
Ali is a senior member of the Klick Consulting team and leverages over 15 years of experience in health data science, health economics and outcomes research to help clients build solutions to address clinical and business challenges and pursue growth. Ali has extensive practical experience in building advanced analytics solutions spanning various care sectors for consumer health, neurology, oncology, nephrology, diagnostic imaging, emergency medicine, and mental health. These solutions were used to evaluate the economic and clinical effectiveness of screening and treatment programs, predict clinical needs at the patient level and optimize resource allocation within payor budgets. Ali holds master’s and PhD degrees and continues to be active in research and teaching as adjunct faculty in the School of Public Health at the University of Toronto.
 

Katriana Garcia Headshot
Katriana Garcia
Senior Regulatory Manager, Bayer US LLC

Katriana Garcia is a Senior Regulatory Manager at Bayer US LLC. She has experience working across multiple product categories such as infant nutrition, digestive health drugs and dietary supplements and has been with Bayer since 2018. She graduated from Cedar Crest College with a degree in Biochemistry with a concentration in Forensic Science but fell in love with the Regulatory field early on in her career. She is passionate about innovation and sustainability. In her free time, she loves to hike, backpack, and travel the world. You can always find her immersing herself in new cultures and experiences.

 

John Gay Headshot
John Gay
Vice President, Legislative and Regulatory Affairs, Pharmaceutical Product Stewardship Work Group; Client Legislative and Regulatory Affairs Director, Association Management Strategies, Inc.

John Gay is Vice President, Legislative and Regulatory Affairs of the Pharmaceutical Product Stewardship Work Group, and is Client Legislative and Regulatory Affairs Director at Association Management Strategies, Inc. John has over 30 years of experience in advocacy and association management. He served as Executive Director and CEO of the Natural Products Association; and led the government affairs programs of the National Restaurant Association, the Consumer Healthcare Products Association, and the International Franchise Association. He also served as Chair of the National Immigration Forum, a coalition of organized labor, immigrant advocates, religious groups, and business working together to advance sound federal immigration policy. He has a B.A. in American Government from the University of Virginia.

 

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Nicholas Georges
Senior Vice President, Scientific & International Affairs, Household & Commercial Products Association

Nicholas Georges is the Senior Vice President, Scientific & International Affairs of the Household & Commercial Products Association (HCPA). Georges leads HCPA’s activity on aerosol products and industrial & automotive products, as well as multiple scientific and regulatory areas both domestically and internationally such as air quality. Georges has a monthly column in Spray Technology & Marketing and often contributes to other publications such as World Aerosols and Aerosol Europe. Before joining HCPA, Georges was the Director of Regulatory Affairs at PLZ Aeroscience and the Technical Director at Nyco Products Company. Georges has a B.S. in Chemistry from the University of Illinois Urbana-Champaign.

 

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Arline T. Geronimus, M.D., Sc.D
Professor, University of Michigan

Arline T. Geronimus, MD, is a professor in the School of Public Health and a research professor in the Institute for Social Research at the University of Michigan, where she also is affiliated with the Center for Research on Ethnicity, Culture, and Health.

An elected member of the National Academy of Medicine of the National Academies of Science, Dr. Geronimus received her undergraduate degree in Political Theory from Princeton University, her doctorate in Behavioral Sciences from the Harvard School of Public Health, and her postdoctoral training at Harvard Medical School. Winner of many awards throughout her career, most recently she was the 2022 recipient of the James S. Jackson Distinguished Career Award For Diversity Scholarship from the National Center for Institutional Diversity.

 

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Weslee Glenn, Ph.D.
Head of Innovation, Ayana Bio

Weslee “Wes” Glenn looks at society’s biggest challenges with resolve and optimism, buoyed by the great promise of biotechnology. He has spent his career studying plants–how they make molecules we co-opt as medicines, how they respond to stress, and how they can be protected from insects. To date, he has co-authored several patent applications and scientific publications, including work that Plant Physiology designated as a “Breakthrough Technology.”

As Head of Innovation at Ayana Bio, Wes designs cellular technology to produce plant bioactives. His goal is to develop modern clean methods that harness nature’s nutrients and conserve the environment.

Prior to joining Ayana Bio, Wes was the Director of Metabolic Engineering at Provivi, where he led a team of strain engineers and bioinformatics scientists to develop natural pest control molecules. There, he also volunteered with several service groups, including the Environmental Advisory Commission for the City of Pasadena, California. Wes earned his Ph.D. from MIT in the Laboratory of Professor Sarah O’Connor with work that was supported by a National Science Foundation Predoctoral Fellowship. Following his doctoral work, he joined the Laboratory of Professor David Tirrell at Caltech as a Ford Foundation Postdoctoral Fellow and a UNCF/Merck Postdoctoral Fellow.

When Wes isn’t focused on building cellular platforms with his team at Ayana Bio, you can find him jogging around the South Shore, writing at bookstore cafes, or enjoying the local arts scene. Staying active and engaging with his community informs and inspires his work.

 

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Francis Godwin
Director of the Office of Manufacturing Quality, Office of Compliance, CDER, FDA

Francis Godwin received his undergraduate degree from MIT in Chemical Engineering in 2001. After graduation he worked as a process engineer designing, building, and optimizing chemical plants. He was certified as a Black Belt in Six Sigma performing quality improvement projects and teaching Six Sigma principals. He then worked in pharmaceutical process validation for both batch and continuous processes for APIs and finished dosage manufacturing operations. Later, he managed an analytical chemistry laboratory conducting analyses for production, QA, and research testing. In 2009 he received an MBA from Georgetown University and since then, has been working at FDA in CDER's Office of Compliance. He has served in various functions within compliance and is currently the Director of the Office of Manufacturing Quality, overseeing regulatory and enforcement actions for both foreign and domestic drug CGMP cases.

 

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Brandon M. Griffin
CEO, REJIMUS, INC.

Brandon Griffin is the co-founder and CEO of REJIMUS, INC. and founder at Reclinica Corporation. With REJIMUS, INC. a specialty regulatory management consultancy, he leads the overall growth and corporate strategy execution for quality and compliance services to the Food, Dietary Supplement, Cosmetic and OTC/Homeopathic industries in the US marketplace for hundreds of companies. With over 20 years of experience in contract research/testing and manufacturing service sectors, he and his team have built up on a set of best compliance practices that enable clients, large and small-to-virtual, to resolve compliance deficiencies faster with less overall risks, achieve efficient compliance practices and documentation, and source highly focused training based on those applicable regulations. Mr. Griffin holds a B.Sc. in Genetics and Plant Biology from U.C. Berkeley.

 

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Deputy General Counsel

Carolyn Herrmann is responsible for providing legal advice and recommendations to Association staff and members on key issues affecting the OTC, dietary supplement, and consumer medical device industries, representing industry interests on a range of food and drug law regulatory matters, assisting with Association policy development, and managing various industry projects through direct engagement with member company representatives.

Carolyn previously served in this role from 2012 through 2019. From 2019 – 2023 she worked as Associate General Counsel for Nestle Infant Nutrition, supporting the infant and toddler food, supplement and formula businesses and then as Deputy General Counsel, Standards at the U.S. Pharmacopeia in a global leadership team role.

Prior to initially joining CHPA in June 2012, she was an attorney at Shook, Hardy & Bacon LLP, practicing in the Pharmaceutical and Medical Device Litigation Division, where she focused primarily on counseling and defending product-liability actions against pharmaceutical and medical device manufacturers.

Carolyn is a member of the D.C. Bar Association and the Food and Drug Law Institute. She resides in Northern Virginia with her husband, three boys and two dogs.

 

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Susan J. Hewlings, Ph.D. RD
Vice President of Research Affairs, Radicle Science

Dr. Susan Hewlings brings a lifetime commitment to health and fitness along with over 20 years of research, teaching and medical writing experience in nutrition, sports nutrition and scientific consulting for the dietary supplement and medical industries. She has a PhD in Nutrition, a MS in Exercise Physiology, and a BS in Nutrition from Florida State University. She is a Registered and Licensed Dietitian. Dr Hewlings completed a research fellowship in protein metabolism at the University of Texas Medical Branch. She has more than 10 years of experience providing scientific and nutrition expertise for the dietary supplement, food, beverage, and companion animal nutrition industries helping companies connect science to marketing and product development. She has supported many of the leading supplement brands in the industry. She is part of the team that created the industry award winning website collaborative VitaminD&me. In addition, Dr Hewlings has over 20 years of experience in higher education including former faculty positions at Stetson University, University of Central Florida College of Medicine and Central Michigan University, and currently adjunct professor at Nova Southeastern University. She is the author of Nutrition: Real People, Real Choices and has published multiple articles on dietary supplements, pharmacokinetics, and nutrition in peer-reviewed medical journals. She recently earned a graduate certificate in Cannabis Science from the University of Vermont Medical School. She is founder and director of a non-profit 501c3 animal rescue The ARF Shack Inc. Susan lives in the Florida Keys and is a distance runner by heart, but also enjoys aerial arts, weightlifting, yoga and paddleboarding with her dogs.

 

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Mical Honigfort, Ph.D.
Ph.D. Branch Chief, Division of Food Ingredients, Office of Food Additive Safety, FDA

Dr. Mical Honigfort received her BA in chemistry from Washington and Jefferson College and her PhD in polymer chemistry from the University of Akron. Dr. Honigfort started at FDA’s Center for Food Safety and Applied Nutrition as a regulatory scientist in the Office of Food Additive Safety/Division of Petition Review in 2002 and became a supervisor in 2012. She has served as Branch Chief for the Regulatory Review Branch in the Office of Food Additive Safety/Division of Food Ingredients since May 2019. In her current role, she supervises a group of regulatory review scientists who manage regulatory submissions for food ingredients and handle food ingredient regulatory and policy issues. During her time at FDA, she has managed the review of food and color additive petitions, generally recognized as safe (GRAS) notifications, and has worked on a variety of issues related to food ingredient safety.

 

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Frank Jaksch
CEO, Ayana Bio

Frank Jaksch serves as Ayana Bio’s Chief Executive Officer and is a member of its Board of Directors. As founder and former CEO of ChromaDex (NASDAQ: CDXC), Frank has more than 25 years’ experience developing consumer products in the life science, food, beverage, and dietary supplement spaces. He has built an ingredient and end consumer product business from the ground up, taking the company to financial profitability before launching a successful initial public offering.
 
Having been immersed in the world of natural products for decades, Frank understands the significant challenges encumbering space. To date, sourcing health and wellness natural products from agriculture has proven unsustainable and unwieldy; and product quality has suffered from adulteration largely owing to supply scarcity and costly development expenses. At the helm of Ayana Bio, Frank seeks to modernize the health and wellness sector and in so doing provide affordable and reliable ingredients. He believes that Ayana Bio’s technology platform is key to developing a scientific solution to reliability and cost.
 
When he isn’t busy trying to make the world better with science, you can find Frank shredding the trails on his mountain bike or first tracking the slopes of Mammoth with his family.
 

 

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Liz Jury
Senior Manager of Content Integrity, Bazaarvoice

Liz Jury is the Senior Manager of Content Integrity at Bazaarvoice. Her teams have been responsible for the moderation and authentication of over 5 billion pieces of syndicated user-generated content, across 12,000 brand and retail sites, since 2007. This solution has been covered in the Wall Street Journal, Washington Post, PBS Newshour, and other publications. Currently, Liz manages the teams’ operations, policy, strategy, investigations, and analysis, and she serves as Bazaarvoice’s subject-matter expert in regulatory requirements for health, beauty, and OTC products.

 

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Rick Kingston, PharmD
Co-Founder, President, Regulatory and Scientific Affairs, and Sr. Clinical Toxicologist, SafetyCall International L.L.C.

Rick Kingston PharmD is Co-Founder, President, Regulatory and Scientific Affairs, and Sr. Clinical Toxicologist at SafetyCall International L.L.C., a multidisciplinary healthcare firm academically affiliated with the University of Minnesota and focused on providing consumer product manufacturers’ services in the area of post-market medical surveillance, regulatory reporting support for adverse events, and product safety. His professional and academic career spans over 40 years including previously serving as co-founder and Director of the Minnesota Regional Poison Center and serving as a full Professor in the Department of Experimental and Clinical Pharmacology at the University of Minnesota, College of Pharmacy where he continues to serve as a Clinical Professor. He also holds an Adjunct appointment at the Rank of Professor at the University of Mississippi College of Pharmacy and its National Center for Natural Product Research which is co-funded by the US FDA. He has published and presented extensively in the field of clinical toxicology and regulatory policy, and serves on numerous scientific panels, advisory boards and non-profit professional organization scientific committees advising on issues of product stewardship, science, and safety. His professional expertise spans the areas of consumer product post-market surveillance, poisoning epidemiology, natural product toxicology, clinical toxicology and pharmacology, injury prevention, poison control and product safety regulatory policy.

 

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Barbara A Kochanowski Ph.D.
Former Senior Vice President, Regulatory & Scientific Affairs, CHPA

Barbara Kochanowski was most recently Sr. VP, Regulatory & Scientific Affairs, CHPA, where she was responsible for regulatory affairs activities, including cooperative programs with the U.S. Food and Drug Administration, ingredient safety, and dietary supplement programs at CHPA. She retired from CHPA in July 2023 and currently serves as a consultant to 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.

In March 2023, Kochanowski received CHPA’s esteemed Regulatory & Scientific Affairs Career Achievement Award for her nearly four decades of outstanding contributions and service to the consumer healthcare industry. She is a member of the American Society of Nutrition. , and also serves on the board of directors of the American Foundation for Pharmaceutical Education.

 

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Christina Kuhn
Senior Associate, Covington & Burling LLP

Christina Kuhn is a senior associate at Covington & Burling LLP, where she advises medical device, diagnostic, digital health, and life sciences companies on a broad range of FDA regulatory strategy and compliance matters for cutting edge medical technologies. She frequently helps clients successfully navigate the premarket regulatory process, advising companies on regulatory classification, product development, clinical strategy, and agency interactions. Christina also has significant experience counseling clients on postmarked compliance requirements, including those related to advertising and promotion, quality systems and manufacturing, medical device reporting, registration and listing, recalls, and FDA and DOJ enforcement actions. Christina also regularly assists clients on FDA policy matters, such as commenting on FDA guidance documents and rulemaking, as well as drafting and analysing federal legislation. Her clients span early-stage start-ups to multinational companies and trade associations. She is a graduate of the New York University School of Law and holds Bachelor of Science degree from Princeton University.

 

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Senior Vice President, Dietary Supplements

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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Sharon Lindan Mayl
Partner, DLA Piper

Sharon Lindan Mayl is a Partner at DLA Piper in Washington DC., having recently joined the firm after more than 25 years at the Food and Drug Administration. As a Senior Advisor for Policy in FDA’s Office of the Commissioner, Sharon has a deep wealth of knowledge in the areas of food safety, imports, third-party audits, nutrition, dietary supplements, and cannabis products. She played a leading role in the implementation of the FDA Food Safety Modernization Act (FSMA) and developing strategic approaches to imports for the agency. In particular, she served as a lead for the import provisions of FSMA, including the Foreign Supplier Verification Program (FSVP), Voluntary Qualified Importer Program, Accredited Third-Party Certification Program. Sharon earned her undergraduate degree at Cornell University and her law degree at Harvard Law School.

 

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Natalie Mazurets, MS, RDN
Senior Manager of Regulatory Affairs, Haleon

Natalie Mazurets is a senior manager of regulatory affairs at Haleon where she leads US Innovation for Centrum.

A regulatory professional with a BA in Food & Nutrition and a MS in Clinical Nutrition, Natalie is also a Registered Dietitian Nutritionist.

She has extensive expertise in functional foods and dietary supplements. With over 25 years in the industry that spans the areas of formulation and product development, she found her passion in regulatory which has been her focus for the last 15 years. Natalie is an innovative regulatory strategist and trusted advisor who is proactive in ideation generation, new ingredient and product assessments. Prior to joining Haleon, Natalie had worked for 12 years at Pfizer Consumer Healthcare. In addition, she has worked at Reckitt, Avon and Vitaquest.

 

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Diane McEnroe
Partner, Sidley Austin LLP

Diane McEnroe has established long-standing relationships with domestic and international companies in the food, dietary supplement, drug, medical device, and cosmetic industries. She leads the New York Healthcare and Food, Drug and Medical Device practice group and is a member of the firmwide Food, Drug and Medical Device Regulatory practice.

Diane provides clients strategic counsel on Food and Drug Administration (FDA) regulatory questions on a broad range of issues, including product formulation and positioning, ingredient safety, claims substantiation, over-the-counter drug monograph and Monograph Reform issues, and post-marketing obligations, including adverse event reporting and food registry postings. She also has extensive experience advising on drug sampling programs, track and trace systems, and the interplay between federal and state laws on drug distribution. Diane supports clients in responding to FDA Warning Letters, during facility inspections and recalls, and in addressing product integrity issues. In addition to her FDA advisory role, she has also assisted clients with Federal Trade Commission investigations and claims substantiation obligations relating to the full range of consumer products.

With Diane’s deep knowledge of foods, including functional and medical foods, and dietary supplements, she 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 the recent passage of the OTC Monograph Reform Act of 2020, and the Modernization of Cosmetic Regulation Act of 2022, Diane is currently advising domestic and international companies on how to meet their obligations for products marketed within these new legal frameworks.

Diane supports Sidley’s transactional practice group, leading on most of the consumer product due diligence for firm clients. She also assists Sidley’s class action practice group, when defending clients facing litigation which raises FDA regulatory arguments.

 

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, Office of Nonprescription Drugs, Office of New Drugs, Center of Drug Evaluation and Research, FDA

Dr. Theresa Michele is currently the Director of the Office of Nonprescription Drugs (ONPD) in the Office of New Drugs, Center of Drug Evaluation and Research (CDER), at the Food and Drug Administration (FDA). Prior to joining FDA in the Division of Pulmonary and Allergy Drug Products, she spent 10 years in industry, with clinical research experience across a variety of therapeutic areas in both commercial and development stage companies. 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.

 

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Susan Hazels Mitmesser, Ph.D.
VP, Science & Technology, Pharmavite

Dr. Mitmesser, PhD, provides scientific leadership at Pharmavite to advance innovation and new product development strategies, and to ensure the scientific integrity of all products made under its brand portfolio. She has a passion for nutrition and wellness and leverages her ability to communicate scientific findings to consumers and the marketplace.

She brings 20+ years of extensive experience in research and nutritional biochemistry across various industries and sectors, including food, dietary supplements, academia and clinical settings. She serves on the Editorial Board of four peer-reviewed journals: Advance Journal of Food Science and Technology, Journal of Pediatric Intensive Care, World Journal of Clinical Pediatrics, and Journal of the International Society of Sports Nutrition. In addition, she has published in many peer-reviewed journals and is a contributing author for book chapters relating to nutrition in adult and pediatric populations.

Dr. Mitmesser is an active member of the American Society of Nutrition, the American Association for the Advancement of Science, and the New York Academy of Sciences. She also serves on the Senior Scientific Advisory Council for the Council for Responsible Nutrition.

Dr. Mitmesser is also an adjunct professor in the Department of Nutrition Sciences at the University of Connecticut and in the Gerald J. and Dorothy R. Friedman School of Nutrition Science and Policy at Tufts University. She holds a PhD in Nutrition Biochemistry from the University of Nebraska and a Master’s degree from the University of Nebraska Medical Center.

 

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Yeruk (Lily) Mulugeta, M.D.
Associate Director for Policy and Research, Division of Pediatrics and Maternal Health, FDA

Lily Mulugeta is an Associate Director for Policy and Research in the Division of Pediatrics and Maternal Health at the FDA. She engages in scientific review and regulatory research related to pediatric drug development. Dr. Mulugeta serves as a representative for the Division on the FDA Pediatric Review Committee (PeRC). Prior to joining the Division in 2017, Lily was the Scientific Lead for Pediatrics in the Division of Pharmacometrics at the FDA. Prior to joining the FDA, Dr. Mulugeta practiced as a Critical Care Specialist and conducted clinical pharmacology research at Children’s National Medical Center (CNMC) in Washington D.C. She also served as a faculty member in the Department of Pediatrics at the George Washington School of Medicine and in the Department of Pharmacy at the University of Maryland. Dr. Mulugeta received her Pharm.D. degree from the University of Kentucky College of Pharmacy and completed a pediatric residency at Inova Fairfax Hospital in Falls Church, Virginia.

 

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Benjamin Mundel
Partner, Sidley & Austin

Ben Mundel represents clients in their most important trial and litigation matters. Law360 recognized Ben as one of five Rising Stars in his practice area. This award recognizes top legal talent under the age of 40 that practice at a level “usually seen from veteran attorneys.”

Ben has represented leading pharmaceutical, telecommunications and financial services firms at trial and arbitration. Ben excels at presenting highly technical issues and specialized scientific evidence in ways that persuade judges and juries. In addition to his trial practice, Ben has successfully argued a number of dispositive motions in federal courts, state courts and bankruptcy courts. Ben has contributed to several articles featured in leading legal publications. He received his J.D., magna cum laude, from Harvard Law School and holds undergraduate degrees from the University of Pennsylvania.

 

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Karen Murry, M.D.
Deputy Director, Office of Nonprescription Drugs, FDA

Dr. Karen Minerve Murry serves as Deputy Director of the Office of Nonprescription Drugs at FDA. After receiving an Army scholarship to attend the University of Texas Southwestern Medical School, Dr. Murry completed her residency in Internal Medicine and fellowship in Endocrinology, Diabetes, and Metabolism at Walter Reed. She served at Walter Reed and as Chief of Endocrinology at Eisenhower Army Medical Center. During her FDA tenure, she has served as clinical lead on numerous projects, including the proposed rule for an Additional Condition for Nonprescription Use, the Naloxone Model Drug Facts Label project, and multiple areas of implementation of the monograph reform provisions of the CARES Act. She has served as FDA signatory for a wide range of nonprescription therapeutic areas, including reproductive, analgesic, ophthalmic, antiseptic, gastroenterologic, sleep, otic, oral healthcare, obesity, opioid overdose reversal, and coronavirus indications. In her role as Deputy Director for Nonprescription Drugs, she works on multiple innovative and strategic initiatives with the goal of improving self-care for Americans through expanded availability of safe and effective nonprescription medicines.

 

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Nichole Nolan
Branch Chief, Signals Management Branch, Office of Analytics and Outreach (OAO), FDA

Nichole Nolan is the Signals Management Branch Chief in the Office of Analytics and Outreach (OAO) at the Center for Food Safety and Applied Nutrition (CFSAN.) Her team proudly supports the adverse event reporting and Reportable Food Registry(RFR) programs for FDA.

Before coming to FDA, Nichole served the Maryland Department of Health and Mental Hygiene and the Naval Medical Research Center Biological Defense Research Directorate. She received her BS in Cell and Molecular Biology from University of Maryland and her MPH from Johns Hopkins Bloomberg School of Public Health.

 

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Oliver Ou
Program Coordinator, CFSAN Adverse Event Reporting System

Oliver currently serves as the Program Coordinator for the CFSAN Adverse Event Reporting System (CAERS). In this role, he triages CAERS reports and coordinates across CFSAN and other FDA Centers/federal agencies to facilitate review and assessment of incoming reports. Oliver was commissioned as a Scientist Officer in the US Public Health Service (USPHS) Commissioned Corps in 2013. He served as a regulatory scientist with the USDA, Food Safety and Inspection Service (FSIS) from 2013 to 2020. He joined the FDA CFSAN in March 2020. He received his PhD in pharmacology from State University of New York (SUNY)-Buffalo. He subsequently completed 5 years of postdoctoral training at the University of Maryland, Baltimore and National Institutes of Health.

 

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Gerald Dal Pan
Director of the Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA

Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. In this capacity, he is involved in both the premarket and postmarket regulation of drugs and therapeutic biologics, and in the implementation of the drug safety provisions of the Food and Drug Administration Amendments Act and other initiatives. He is a member of the World Health Organization Advisory Committee on the Safety of Medicinal Products, and has served on working groups of the Council of International Organization of Medical Sciences (CIOMS) and the International Council on Harmonisation (ICH). He received his MD from Columbia University College of Physicians and Surgeons and his Master of Health Science in Clinical Epidemiology from the Johns Hopkins University School of Hygiene and Public Health. He completed residency training in Internal Medicine at the Hospital of the University of Pennsylvania and in Neurology at the Johns Hopkins Hospital. He is board certified in both Internal Medicine and Neurology. He joined FDA in 2000 as a medical reviewer in the Center’s Office of New Drugs. Before working at FDA, he was a faculty member in the Department of Neurology at Johns Hopkins and worked in the pharmaceutical industry.

 

Lisa Parks, SVP, Regulatory and Scientific Affairs
Senior Vice President, Regulatory & Scientific Affairs

Lisa Parks, RPh, is responsible for CHPA’s regulatory affairs activities, including cooperative programs with the U.S. Food and Drug Administration, ingredient safety, and product quality-related matters. Prior to joining CHPA in 2023, Parks served as Vice President of Sciences and Regulatory Affairs at the Association for Accessible Medicines (AAM), a leading generic and biosimilars trade association in Washington, D.C. In this role, she developed and promoted regulatory and scientific affairs initiatives, internal and external communications and relations, and training and knowledge-sharing opportunities for member companies. Parks was AAM’s primary liaison with the FDA and facilitated discussions and efforts with the FDA, lawmakers, and industry stakeholders on numerous topics that impacted the generic and biosimilars industry. She was industry’s lead negotiator for the Generic Drug User Fee Amendments (GDUFA) II and III negotiations and co-lead for the Biosimilars User Fee Act (BsUFA) II and III for AAM. In addition, Parks led the implementation phase of both GDUFA II and BsUFA II programs for AAM. Parks career with the FDA’s Office of Generic Drugs (OGD) began in 2008 in the regulatory affairs division. Her keen ability to facilitate discussions and build consensus around intricate regulatory policy issues was quickly recognized by the Center for Drug and Evaluaon Research (CDER) leadership, and she was appointed to lead the implementation of the newly authorized GDUFA I user fee program for OGD. Parks was later appointed to work on planning for and standing up of the Office of Pharmaceutical Quality (OPQ) and other modernization initiatives for CDER. In 2022, Parks joined Greenleaf Health, a leading FDA regulatory consulting firm as Vice President of Regulatory Policy to provide strategic and technical guidance to pharmaceutical and biotechnology companies researching, developing, and manufacturing innovative solutions to global public health challenges. Parks holds a pharmacy degree from the Massachusetts College of Pharmacy in Boston, MA.

 

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Senior Director, Product Quality and Technical Affairs

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

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.

 

Robert Pineda Headshot
Robert Pineda
Assistant General Counsel, Kenvue

Robert (“Rob”) Pineda is Assistant General Counsel in the Kenvue Law Department. Kenvue is a publicly traded global consumer health company that separated from Johnson and Johnson earlier this year and markets and manufactures well-known consumer brands such as TYLENOL, ZYTREC, NEUTROGENA, LISTERINE, among many others.

He is a member of the department’s Regulatory Law Group and provides regulatory legal support and counseling to many of the company’s brands. Rob represents Kenvue as an active member of various task forces convened by the trade association Consumer Healthcare Products Association (CHPA). He also regularly participates in meetings held by the Pharmaceutical Product Stewardship Working Group (PPSWG) and its Communications, Industry Relations and Policy (CIRP) committee. In that capacity, he can learn about and assess burgeoning state take-back legislation and regulation with other member companies.

Rob is a graduate of Georgetown University Law Center and Georgetown University. Rob currently lives in a suburb outside of Philadelphia, PA with his wife and 2 young daughters. He enjoys Philadelphia professional sports, North Carolina Tar Heel basketball, trivia, running 5Ks, reading, tennis and golf.


Raqiyyah Pippins Headshot
Raqiyyah Pippins, Esq.
Partner, Arnold & Porter

Raqiyyah Pippins is a partner at Arnold & Porter, and co-leads the firm's Consumer Products Practice Group and the Consumer Products & Retail Industry Team. She focuses her practice in FTC and state regulation of the marketing and sale of consumer products. Raqiyyah represents companies that are engaged in the development, marketing, import and export of consumer products, including conventional food, dietary supplements, drugs, cosmetics, apparel and appliances. She also represents consumer product companies in advertising challenges (including numerous challenges before the National Advertising Division (NAD) of the Advertising Self-Regulatory Council), and defends companies in investigations conducted by the FDA, FTC, and state agencies regarding product marketing practices. Raqiyyah has particular experience assisting companies develop promotional strategies that account for the federal and state regulations governing direct-to-consumer product promotion.

 

Patty Post Headshot
Patty Post
Chief Executive Officer, Checkable

Patty Post, the visionary Founder and compassionate Chief Executive Officer of Checkable, leads an innovative healthcare revolution aimed at empowering moms to save time and reduce the cost of care through innovative at-home testing kits. In 2019, Patty launched Checkable, providing an innovative platform that offers accurate at-home tests, easy access to telemedicine and prescription providers through a user-friendly app, and the ability to make clinical, evidence-based decisions from the comfort of home. Based in North Dakota, Patty is a parent of three kids and is passionate about educating and equipping moms to take charge of their and their family's health while enjoying precious moments with her own family.

 

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

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 Voltaren, Advil, Centrum and Flonase. Ms. Quinn is a graduate of Rutgers University and Seton Hall School of Law.

 

Stefanie Rentfrow Headshot
Stefanie Rentfrow
Analytical R&D Director, Perrigo

Stefanie Rentfrow is currently an Analytical R&D Director at Perrigo supporting the U.S. Consumer Self-Care Over-the-Counter (OTC) Research and Development division. She has worked for Perrigo for over 25 years supporting material characterization and development of finished drug, dietary supplement and cosmetic products. Stefanie is currently leading the Perrigo U.S. nitrosamine impurity team and serves as the CHPA Nitrosamine working group lead. Stefanie earned a Bachelor of Science in chemistry from Western Michigan University and graduated from the Lee Honors College with American Chemical Society certification. She has also received her certification as a Lean Sigma Greenbelt and has led many multi-site and function continuous improvement programs.

 

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

Clark Richardson leads as President & CEO at 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 US FDA. He is a frequent speaker and presenter to industry, and advocates for new tools and technologies to enhance communication of critical drug-related, consumer-oriented information. After 26 years of OTC research at PEGUS, Clark brings a wealth of practical knowledge and experience to timely dialogue about re-envisioning mechanisms for expanding access to important new medications.

 

Doris Roberts Headshot
Doris Roberts
Associate Director, Global Regulatory Affairs, Kenvue

Doris Roberts is an Associate Director in Global Regulatory Affairs at Kenvue. Kenvue is a publicly traded global consumer health company that separated from Johnson and Johnson earlier this year and markets and manufactures consumer brands such as TYLENOL®, ZYTREC®, NEUTROGENA®, and LISTERINE®, among many others.

She joined Johnson & Johnson Consumer Healthcare in 2011, initially leading the Regulatory Publishing Team. During 2015, Doris joined the Regulatory Affairs Team initially supporting the TYLENOL® brand. Doris has been responsible for the regulatory strategy and innovation for the MOTRIN® adult and pediatric portfolios for the past eight years. She has worked with multidisciplinary teams in bringing several innovative Motrin® products to market. Prior to joining Johnson & Johnson, Doris held various regulatory roles at GlaxoSmithKline, supporting pharmaceutical and vaccine products. She holds a BS degree in Biology with a concentration in Chemistry and Business.

Doris is passionate about health and wellness, mentoring, and exploring innovative concepts and ideas.

 

Michael Rogers Headshot
Michael Rogers
Author

Michael Rogers is a best-selling author, technology pioneer and futurist, who most recently served as futurist-in-residence for The New York Times. His most recent book is Email from the Future: Notes from 2084. Michael is a dynamic speaker who addresses audiences worldwide and is a regular guest on radio and television. He has worked with companies ranging from FedEx, Boeing and NBC Universal to Microsoft, Pfizer and Siemens, focusing on how companies can think about the future in useful ways.

Michael began his career as a writer for Rolling Stone magazine. He co-founded Outside magazine and then launched Newsweek’s technology column, winning numerous journalism awards including the National Press Club award for his coverage of September 11. For ten years he was vice president of The Washington Post Company's new media division, leading both the newspaper and Newsweek in the digital world and earning patents for multimedia technology. Michael is also a best-selling novelist whose books have been published worldwide, chosen for the Book-of-the-Month club and optioned for film. He studied physics and creative writing at Stanford University, with additional studies in finance and management at the Stanford Business School Executive Program. He lives in New York City and is currently working on book and television projects.

 

Naiffer Romero, MSc, MPH Headshot
Naiffer Romero, MSc, MPH

Naiffer has more than 20+ years of pharmaceutical industry experience. In his 15 years tenure with USP, he has served several roles: Lead scientist in performance testing compendial reference standards development, Manager in charge of LATAM Compendial engagement and education with stakeholders and national regulatory bodies. Naiffer is also a certified USP Education instructor.

Naiffer joined USP’s Scientific Affair performance cell in 2020, where he leads scientific global outreach and technical engagement on national health priority topics. His combined pharmaceutical expertise includes Analytical development, salt and polymorph selection, Development of novel dissolution methods, IVIVC modeling, and impurity analytical strategy. Naiffer is a recognized subject matter expert in Nitrosamines Impurities, he also serves as a member of USP’s Nitrosamine workstream Committee and community manager to ‘Nitrosamine Exchange’, a knowledge community hosted by USP in All-things Nitrosamines Impurities.

Naiffer also liaises technical discussions on pharmacopeial collaboration, including the International Meeting of World Pharmacopeias (part of WHO), international compendial discussion groups, and several regional regulatory agencies’ nitrosamines working groups.

 

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Ricardo Salazar, M.D.
SVP, Global Medical Affairs & Evidence Generation Head, Bayer Consumer Health

Dr. Ricardo Salazar. Mexican Medical Doctor with a master’s degree in health system administration, BrAPP Postgrad in Pharmaceutical Medicine. With professional experience in the private and public sectors. More than 17 years of experience in the pharmaceutical industry, the last 10 years have been dedicated to Consumer Health and since May 2022 he is leading the Medical Affairs and Evidence Generation Organization for Bayer Consumer Health.

 

Linda Salerno Headshot
Linda Salerno
Regulatory Manager, Healthcare, Reckitt Benckiser LLC

Linda Salerno is a Regulatory Manager, Healthcare at Reckitt Benckiser LLC. She has over 20 years regulatory experience working across multiple consumer product categories such as oral care, cough & cold, sunscreens and consumer medical devices and has been with Reckitt since 2020. Prior to joining Reckitt she held regulatory roles at Prestige Consumer Healthcare, Colgate-Palmolive, L Brands & Edgewell Personal Care (formerly Playtex Products & Energizer Holdings). She holds a B.S. in Business Administration and the Regulatory Affairs Certification for drugs.

 

Brittany Schuck Headshot
Brittany Schuck, Ph.D.
Deputy Office Director, FDA

Brittany Schuck, Ph.D. is a Deputy Office Director in the Office of Health Technology 7 (OHT7), Office of In Vitro diagnostics (OIVD) at the Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA). In her current position, Dr. Schuck helps oversee the total product life cycle regulatory review of in vitro diagnostic devices. Dr. Schuck joined FDA as a scientific reviewer in the Division of Chemistry and Toxicology Devices in OHT7, OIVD in 2017. Dr. Schuck served in various leadership roles in OHT7, OIVD, including as an acting Branch Chief for the Chemistry Branch of DCTD, acting Policy Advisor in the OHT7, OIVD front office, and SARS-CoV-2 Serology Team Director, before taking a position as a Senior Policy Advisor in CDRH’s Office of the Center Director in 2021. Dr. Schuck returned to OHT7, OIVD as a Deputy Office Director in 2022.

Prior to joining the FDA, Dr. Schuck completed her Ph.D. in Pharmaceutical Sciences at the University of North Carolina at Chapel Hill Eshelman School of Pharmacy and then completed a postdoctoral fellowship at the National Institutes of Health’s National Center for Advancing Translational Sciences.

 

Gregory Smith Headshot
Gregory Smith
Senior Director, Global Regulatory Affairs, Sanofi Consumer Healthcare

Greg has been at Sanofi Consumer Healthcare since Jan 2018 where he is Senior Director within the Global Regulatory Affairs team, responsible for Rx-to-OTC switch. Previously he was at Reckitt Benckiser for 3 ½ years where he was the Director of US Regulatory & Government Affairs for Healthcare. Greg also spent almost 17 years at GlaxoSmithKline Consumer Healthcare (GSK CH), where he held various roles in Regulatory Affairs, Regulatory Operations, and Project Management. While at GSK CH, he was instrumental in the Rx-to-OTC switch of Flonase. In total, Greg has spent the past 25+ years working in the OTC Pharma industry.

Greg has been active within the industry, serving as the Industry Chair for the joint CHPA/FDA Seminar Team in the past. He has also been a previous member of several RSQ Planning Committees and has served on various Task Forces and Special Committees within CHPA. He served the 2020 RSQ Planning Committee Chair and help successfully lead CHPA’s first-ever virtual RSQ.

Greg, along with Dan Brum from FDA, is a founding member of the RSQ Band “Full Switch”. The band represents a unique opportunity to share a love of music while collaborating with fellow industry and Agency colleagues.

Greg has a BS in Biology from Rutgers University and a Masters in Public Health from the NJ School of Public Health.

 

Andrew Stewart Headshot
Andrew Stewart
Head of Real-World Evidence and Behavioral Science, Sanofi Consumer Healthcare

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 worked as Sanofi since 2013, originally developing evidence strategies targeted at payers for rare diseases and has been leading real-world evidence generation efforts for Sanofi Consumer Healthcare since 2017. Andrew has a Master of Public Health degree from Boston University, specializing in Health Policy and Management, and is originally from Iowa where he graduated from the University of Iowa with Honors in Integrative Physiology, and Honors Commendations in Biology and Interdisciplinary Studies.

 

Keisha Thomas Headshot
Keisha Thomas
Associate Director for Compliance and Quality, Center for Devices and Radiological Health, FDA

Keisha Thomas is the Associate Director for Compliance and Quality in FDA’s Center for Devices and Radiological Health. She provides strategic oversight, coordination and guidance over medical device quality, compliance, and enforcement efforts. Ms. Thomas is a coauthor of the recently proposed amendment to 21 CFR 820, “Quality Management System Regulation (QMSR)”—incorporating the requirements of ISO 13485:2016; and is spearheading CDRH’s implementation efforts for the proposed regulation. She has been at CDRH for 20 years and has an extensive regulatory, compliance, and enforcement background. Ms. Thomas has held multiple positions in CDRH, including: Deputy Office Director for OPEQ/OHT1, Deputy Director for the Division of Premarket and Labeling Compliance, and Deputy Director for the Division of Enforcement A, and Quality System Team Lead in the former Office of Compliance, CDRH.

 

Rachel Turow Headshot
Rachel Turow
Managing Counsel, Regulated Products, Walmart

Rachel Turow is Managing Counsel, Regulated Products at Walmart. In this role she leads a team of regulatory lawyers advising the business on legal issues related to sales of highly regulated products. Rachel also serves as lead counsel and subject matter expert on FDA regulatory questions and legal issues.

Rachel has over 17 years of experience as an FDA regulatory lawyer, with expertise in the healthcare and pharmaceutical industries. She also spent five years at FDA. She and her team provide regulatory legal advice to Walmart’s business on OTC drugs, dietary supplements, medical devices, and food safety as well as counsel on other regulatory issues affecting these products as they arise.

Prior to joining Walmart, Rachel was Associate General Counsel, Regulatory Law & Policy; and Head of U.S. Regulatory Policy at Teva Pharmaceuticals where she focused on legal and policy issues affecting the approval and uptake of innovative medicines, generic drugs, and biosimilars. She also served as Director of Regulatory Policy for Novo Nordisk, a leading global healthcare company, where she strategically responded to FDA policy and regulatory issues related to the company’s pipeline of products. During her five years at FDA, Rachel focused on drug and medical device regulation. She served as Special Assistant to the Center Director at the Center for Devices and Radiological Health, and as Regulatory Counsel at the Office of Regulatory Policy in the Center for Drug Evaluation and Research. At the start of her career, Rachel was a corporate lawyer at United Therapeutics.

Rachel currently serves on the Board of the Food and Drug Law Institute. She holds a degree in Human Biology from Stanford University and earned her Juris Doctor and a Master of Public Heath from the University of Michigan. She lives in McLean, Virginia, with her husband and three children.

 

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

Nelson has 35 years with Procter & Gamble in manufacturing management and quality assurance positions for food, drug, and cosmetic products. He has extensive experience in deviation investigations, data integrity, and consumer complaint systems. Nelson’s current position is Director, Corporate Quality Assurance – External Engagement.

 

Wendy Weber Headshot
Wendy Weber, N.D., Ph.D., MPH
Branch Chief, Clinical Research in Complementary and Integrative Health Branch, Division of Extramural Research, NCCIH

Wendy J. Weber, N.D., Ph.D., M.P.H., is Branch Chief for the Clinical Research in Complementary and Integrative Health Branch in the Division of Extramural Research at NCCIH. She joined NCCIH as a program director in 2009. The Clinical Research Branch is responsible for the oversight of NCCIH-supported clinical trials. Dr. Weber is coordinator for NCCIH’s Clinical Trial Specific Funding Opportunity Announcements (FOAs) and point-of-contact for natural product-related clinical trial FOAs. Dr. Weber is the programmatic lead for the Trans-NIH Pragmatic Trials Collaboratory and the program officer for the Coordinating Center. She Co-Chairs the Translating Research to Practice for the Treatment of Opioid Addiction Team within the Helping End Addiction Long-Term (HEAL) Initiative and oversees the Pragmatic and Implementation Studies for the Management of Pain (PRISM) Program. Dr. Weber is also a member of the planning and oversight team for the NIH-DoD-VA Pain Management Collaboratory and project scientist for its Coordinating Center. Dr. Weber serves on several Trans-Agency committees including serving as one of the NIH Representatives to the Leadership Council for the HHS Office of the Secretary Patient Centered Outcomes Research Trust Fund, and a member of the CMS-NIH Opioid Working Group and leads the subgroup on Evidence for Non-Pharmacological Treatments.

At NCCIH, Dr. Weber oversees a portfolio of pragmatic clinical trials, natural product clinical trials, studies of complementary medicine to promote healthy behavior, and complex complementary/integrative medicine intervention research. Dr. Weber’s interests include the use of complementary medicine interventions for common pediatric conditions, mental health conditions, promoting healthy behaviors, and health services research. Dr. Weber earned a doctorate of philosophy in epidemiology and a master of public health from the University of Washington. She earned a doctorate of naturopathic medicine (N.D.) from Bastyr University. Prior to joining NCCIH, she was a research associate professor at Bastyr University, where her research included the study of herbal treatments for pediatric conditions.

She has published on treatment of pain with complementary health approaches, echinacea’s effect on colds in children, naturopathic treatment of children, and complementary medicine treatments for attention-deficit hyperactivity disorder. Her articles have appeared in Mayo Clinic Proceedings, JAMA: The Journal of the American Medical Association, The Journal of Alternative and Complementary Medicine, and Pediatrics.

 

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

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.

 

Jay West Headshot
Jay West
Senior Director, Chemical Products and Technology, American Chemistry Council

Jay West is Senior Director, Chemical Products and Technology, at the American Chemistry Council (ACC) in Washington, DC, where he manages the national, state, and international activities of several ACC sector groups, including the Titanium Dioxide Stewardship Council.

 

Susan Winckler Headshot
Susan Winckler, RPh, Esq.
CEO, Reagan-Udall Foundation

Susan C. Winckler, RPh, Esq, is CEO of the Reagan-Udall Foundation for the FDA. She has 30 years of experience in the FDA and healthcare community and has worked with members of regulated industry across FDA’s portfolio; with healthcare professionals, associations, patient organizations, consultants in this community; and other governmental and quasi-governmental organizations. She has served as chief of staff at the agency and in helping the commissioner and FDA navigate routine and emergent situations both domestic and international; leading the Food and Drug Law Institute to speak, write, and convene discussions of food and drug law issues; driving the policy, regulatory, and communications agenda of the American Pharmacists Association, and advising regulated industry (drug, device, biologic, and food companies) and others in the health care sector while at Leavitt Partners, the health care consulting firm founded by former HHS Secretary Michael O. Leavitt. Winckler earned a Bachelor of Science degree from the University of Iowa College of Pharmacy and a law degree magna cum laude from Georgetown University Law Center. She can be reached at swinckler@reaganudall.org

 

Liping Wu Headshot
Liping Wu, M.D., Ph.D.
Global Regulatory Affairs Manager, Kenvue

Dr. Wu is the global regulatory affairs manager with Kenvue. She has been a regulatory professional working in the healthcare industry for over 18 years and is certified by RAPS for both Global and US Scopes. She obtained her Medical Degree in Clinical Medicine from Capital University of Medical Sciences in China and completed Medical Internship from Beijing Friendship Hospital. Dr. Wu received a Ph.D degree in Interdisciplinary Toxicology from the University of Arkansas for Medical Sciences. And she obtained a Digital Health Collaboration Certificate from HBA.

Dr. Wu’s regulatory experience spans various categories across industries and worked in multiple geographic locations. She managed registration of imported medical device for Tyco Healthcare under the first established MD regulations in China before she moved to the US in 2002 to pursue her Ph.D degree. Following her advanced education, Dr. Wu spent 7 years working for J&J Surgical Group in Ohio and led global regulatory strategies and FDA submissions for minimal invasive surgical devices. Then she broadened her professional route by joining the Beauty & Self-Care industry and relocated to Singapore in 2014 to support the growth of J&J Asia-Pacific Consumer business. In 2017, Dr. Wu moved back to the US for a global role based in J&J Consumer headquarters.

In recent years, Dr. Wu has engaged in OTC category by working with trade associations on important policy developments, such as OTC Monograph Reform and FDA Sunscreen Proposed Administrative Order. Dr. Wu is also passionate about nutritional territory and has been leading and enabling new launches of dietary supplements under the newly transitioned Kenvue organization.

Beyond professional life, Dr. Wu advocates for diversity and inclusion. She strongly believes in the value of uniting talents with different backgrounds and cultural competency for unique contributions to business and community, eventually benefiting consumers and patients.

 

Srini Yandrapu Headshot
Srini Yandrapu

With over 20 years of experience in Quality and Regulatory Compliance, Srini has worked in various roles within the Pharmaceutical, OTC, and Dietary Supplements industries. At Haleon, Srini leads the US Quality team, responsible for Supply Chain Quality, Health Authority inspections and interactions, Post-marketing Quality, and Customer Quality support.

Before joining Haleon, Srini held various quality roles at Dr. Reddy's Laboratories and Ohm Laboratories. Throughout his career, he has focused on enhancing quality systems related to R&D Quality, Supply Chain Quality, data integrity, CMO operations, stability management, and product life cycle management.

After joining Haleon, Srini obtained his FSVP certification and successfully led his organization to complete the FDA's FSVP inspection.

Srini has a bachelor's degree in science and a master's degree in Organic Chemistry.

 

Hotel Information

Bethesda North Marriott Hotel & Conference Center 
5701 Marinelli Road 

Rockville, Maryland, 20852 
301.822.9200 

Hotel Reservations  

CHPA has reserved a block of rooms at the Bethesda North Marriott Hotel & Conference Center. The room block is closed. Please see the alternative hotels below. 

 

Check-In and Check-Out 

Check-in: 4:00 p.m.  
Check-out: 12:00 p.m. 

Cancellation Policy  

Cancellations must be received 72 hours prior to your arrival date in order 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. 

Travel Information

Airport Information 

  • Ronald Reagan Washington National Airport (DCA) is approximately 20 miles/33 minutes.  

  • Washington Dulles International Airport (IAD) is approximately 25 miles/35 minutes. 

Ground Transportation 

  • Amtrak train service is available to Washington, D.C. Union Station (WAS) and the Rockville Station (RKV). 

  • Closest metro stop is North Bethesda (formerly White Flint) Metro Station - Red Line. You can find out more about the DC metro system at www.wmata.com

Parking

  • On-site hotel guest parking with in/out privileges is $19 daily. 

  • Center day guests: 2.50 hourly, max of 30 per day. 

Registration Information

Registration Fees 

  • $995 – Early-Bird Member Registration (through July 11, 2023) 

  • $1195 – Standard Member Registration (after July 11, 2023) 

  • $2955 – Nonmember Registration 

  • $225 – Government Registration (this rate is only available for government agencies) 

  • $595 – Non-Profit Registration (this rate is only available to non-for-profit companies who are not government agencies)  

  • $285 – Student Registration (this rate is only available for those currently registered as a full-time student with a college or university) 

Register online. Phone registrations are NOT accepted. 

Online registration  

  • A log-in and password are required to register online 

  • New to CHPA? You must create a contact record first 

  • A log-in and password will be sent to you after creating a contact record  

Cancellation Policy 

Cancellations received by August 7, 2023, will receive a full refund. Cancellations received after August 7, 2023 will result in the forfeiture of the entire registration fee. Substitutions are always accepted. 

Registration & Logistics Questions 

Thank You to Our Sponsors

2023 RSQ Sponsors

CHPA Regulatory & Scientific Affairs Career Achievement Award

The CHPA Regulatory & Scientific Affairs Career Achievement Award recognizes transformational leaders whose outstanding careers of service in the consumer healthcare products industry have created a long-lasting impact in support of public health. This award is bestowed upon crusaders within our industry, who have made significant contributions in support of improved consumer health.

Submit Nominations for 2023

View Past Winners

Please contact Allegra Bartscherer with questions about this award.

Add to Calendar 2023-09-18T10:00:00 2023-09-20T13:45:00 Regulatory, Scientific & Quality Conference 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.