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Register for RSQ

Join us in beautiful North Bethesda this September.

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.

RSQ 2023 Panelists
RSQ 2023 Attendees in a Session
RSQ Attendees Networking

Program (as of 6.25.24 -subject to change)

September 16-18, 2024

Day 1

Monday, September 16, 2024

10:00-11:45 a.m. 

Quality/Manufacturing Committee Meeting (Members only) 


10:00-11:45 a.m. 

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


10:00-11:45 a.m. 

CHPA Dietary Supplement Committee Meeting 


12:00-3:45 p.m. 

CHPA Regulatory and Scientific Affairs Committee (RSAC)/Consumer Medical Devices (CMD) Committee Meeting & Lunch (Members only) 


4:30-6:00 p.m. 

Early Arrivers Reception 


4:30-6:00 p.m. 

Registration

Day 2

Tuesday, September 17, 2024

7:00 a.m.-4:30 p.m.

Registration


7:00-8:00 a.m.

Breakfast


8:00-8:15 a.m.

Welcome Remarks & Award Presentation 

Mike Bailey, Senior Vice President, Regulatory & Scientific Affairs, CHPA

RSQ 2024 Planning Committee Co-Chairs:

Maria Petrey, Senior Director North America Regulatory Affairs, US Personal Health Care Regulatory Affairs, The Procter Gamble Company

Kersi Vasunia, Senior Director of Oral Care, The Procter & Gamble Company

Award Presentation

Glen Murphy, RSAC Chair & Senior Director Regulatory Affairs, Kenvue


8:15-9:00 a.m.

General Session: FDA CDER Leadership Update

Moderator:

Scott Melville, President, and CEO, CHPA

Speaker:

Coming soon.


9:00-9:45 A.M.

General Session: Oral Health in America

Dr. Chalmers will provide her perspective on this role in CMS, the state of oral self-care in America and how oral care habits may be improved.  

Moderator: 

Kersi Vasunia, Senior Director of Oral Care, The Procter & Gamble Company

Keynote Speaker: 

Natalia I. Chalmers, DDS, MHSc, PhD, Chief Dental Officer, Office of the Administrator, Centers for Medicare and Medicaid Services


9:45 – 10:15 a.m.

Morning Break


10:15 – 11:00 a.m.

General Session: Alternatives to Animal Testing  

New approaches to testing the safety of FDA regulated products hold significant promise in replacing animal tests. Hear from the FDA Acting Chief Scientist about the latest efforts supporting the use of New Approach Methodologies (NAMs) as well an update on the adoption of animal-free assessments of cosmetics, and their ingredients, for human health and environmental safety from the International Collaboration on Cosmetics Safety.

Moderator:  

Coming Soon.

Speaker(s):  

David Strauss, M.D., Ph.D., Acting Chief Scientist, FDA


11:15 a.m.-12:15 p.m. 

Breakouts

Breakout: (Regulatory) Legal Hot Topics

Upcoming Supreme Court decisions in the mifepristone and Chevron cases could change the way the FDA broadly regulates medicines and other products. Learn about potential implications of these cases to health care including possible challenges to FDA decisions and interpretation of laws.

Breakout: (Science) Environment Issues (PLASTICs project, PulPac)

Learn about industry efforts to reduce its environmental footprint through packaging updates. Keith Thornley, Ph.D., PA Consulting, will highlight an effort to develop an innovative production method that can replace single use plastic.  Additional speakers from industry and possibly the Agency will be invited to expand the conversation about extended producer responsibility (EPR) initiatives and ideas.   

Speaker(s):

Keith Thornley, PhD, Head of Dry Molded Fiber Collectives, PA Consulting

Breakout: (Regulatory) Emerging Health Technologies with CTA 

As the host of the global Consumer Electronics Show (CES) where the digital health breakout continues to grow each year, the Consumer Technology Association (CTA) is perfectly positioned to update RSQ attendees on their work to advance healthcare. Learn about CTA’s OTC hearing aid standards and key findings from their 2024 Women’s Digital Health Solutions report. A new initiative to develop a consumer-friendly OTC hearing test will be introduced during this session.

Speaker(s):

Kristen Garrett, Market Research Manager, Consumer Technology Association

Emily Hoefer, Senior Manager, Technology & Standards, Consumer and Consumer Technology Association

Frank Lin, M.D., Ph.D., Johns Hopkins University, Professor & Director, Cochlear Center for Hearing Public Health

Breakout: (Dietary Supplements) FDA, Structure Function Claims

Presentations and panel discussion to delve into the FDA's regulatory framework concerning dietary supplement structure/function claims. Panelists comprise current and former FDA staff members, each bringing expertise and firsthand experience in overseeing structure/function claims. Gain comprehensive insights into compliance strategies and regulatory nuances directly from the experts.

Moderator: 

Kathryn Kramp, Principal Scientist, Regulatory Affairs, The Procter & Gamble Company

Speakers:

Corey Hilmas, M.D. Ph.D., Chief Scientific and Regulatory Affairs Officer, KGK Science, Inc.

Haijing Hu, Ph.D., Chief, Regulatory Implementation Branch, FDA Office of Dietary Supplements Programs (ODSP)


12:15-1:15 P.M.

Lunch


1:15-2:15 P.M.

Breakouts

Breakout: (CMD/Regulatory) CDRH’s Vision of OTC (CMD) Devices 

Agency policy leaders will be invited to give their perspective on regulatory developments related to OTC devices. Does the Agency make a distinction between OTC devices which are within the lower risk categories when contemplating regulatory requirements? If not, should this be a routine consideration? What role might the new Digital Health Advisory Committee play in shaping the development for OTC medical devices, and potentially OTC drugs once the ACNU rule is finalized? Are there ways the Agency make it easier to determine what FDA-regulated devices are available OTC and develop consumer-friendly product code descriptions, which would be useful to not only everyday users of these products but sponsors as well? What role does FDA envision CMD devices playing within its vision for the Home as the Health Care Hub initiative? All these questions and more will be covered during this session.

Moderator: 

Coming soon

Speaker(s):

Coming soon.

Breakout: (Regulatory) OMUFA to Date and Look Ahead

FDA and Industry will review experience with OMUFA I and recap some of the key issues and opportunities discussed for the OMUFA reauthorization.

Moderator: 

Greg Collier, Ph.D., Consultant and Negotiator for Industry for OMUFA I

Speaker(s):

Mike Bailey, Senior Vice President, Regulatory & Scientific Affairs, CHPA

Breakout: (Quality) FDA Records Requests and Quality Assurance 

FDA has greater authority to use records requests as they assess quality and cGMP compliance.  Hear about the pros and cons of this tool and how to be prepared to respond to a request.

Moderator:

Lynn Evans, Vice President, North America Quality & Compliance, Kenvue

Speaker(s):

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

Breakout: (Dietary Supplements) FDA, NDI Guidance, Part 1.

Explore FDA's latest final guidance on 'Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes,' issued on March 5, 2024. Our panel of FDA staff and industry experts will discuss key takeaways and compliance strategies from this final guidance, as well as the pending sections of the 2016 revised draft guidance and other FDA draft guidance that impacts NDIN's. Stay informed on the evolving regulatory landscape of dietary supplements that include NDI's.

Moderator: 

Coming soon.

Speaker(s): 

Shontell Wright, M.S., Chemist, Center for Food Safety and Applied Nutrition 
Office of Dietary Supplement Programs, FDA

 


2:15- 2:30 P.M. 

Afternoon Break


2:30 - 3:30 pm

Breakouts

Breakout: (Regulatory) E-labeling

 One result of the pandemic is that society is now familiar with using technology to access information. Menus at their favorite restaurant, QR codes to check-in for a doctor appointments or lab work, and to access product details.  This session will explore the feasibility of using e-labeling on FDA-regulated products to enhance consumer readability and understanding of label information.

Breakout: (Regulatory) Use of Artificial Intelligence/Machine Learning Initiatives (AI/ML) Within the FDA and Industry

Artificial intelligence (AI) and machine learning (ML) are part of everyday conversation but what does it really mean for the healthcare sector?  Hear how the Agency defines AI/ML and how it is being used in the regulatory review process, safety surveillance, and new initiatives designed to decrease health disparities.  Highlights from the 2023 discussion paper on the "Overview of Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products" will give sponsors insights that can be applied to their innovation programs for drugs and OTC devices.  JJ Mifsud, from Klick, will highlight strategies to leverage artificial intelligence (AI) to augment ongoing activities to accelerate sponsors’ regulatory readiness while preserving safety and compliance. 

Moderator: 

Coming soon. 

Speaker(s):   

JJ Mifsud, Applied AI Architect, Klick

Breakout: (Quality) Hot Topics in Quality Assurance 

Description coming soon.

Moderator:

TBD  

Speaker(s):

TBD

3:45 – 4:30 P.M.

General Session: Real World Evidence

Julie Aker and Andrew Stewart return to the RSQ stage to help further the discussion about the appropriate way to design, interpret, and use the types of real-world evidence that can support the safety and efficacy of OTC products, whether it is a drug, device, or dietary supplement.

Moderator: 

Pelin Thorogood, Cofounder & Executive Chairwoman, Radicle Science

Speakers:

Julie Aker, President and Chief Executive Office, Concentrics Research, an IQVIA Business

Andrew Stewart, Head of RWE and Behavioral Science, Sanofi


4:30-4:45 P.M.

Chair Closing Remarks


5:00-6:00 P.M.

Reception

Day 3

Wednesday, September 18, 2024

7:00 A.M.−12:30 P.M. 

Registration 


7:00−8:00 A.M. 

Breakfast


8:00−8:45 A.M. 

General Session: Advancing Dietary Supplement Science and Fostering Public Health Knowledge 

The importance of public private partnerships to advance science and health. COSMOS clinical trial: An important partnership across academia, government, and industry to further nutrition science and health  

Moderator

Alpa Shah, MS, RDN, US Wellness Medical & Scientific Affairs Lead, Haleon  

Speakers

Stefan Pasiakos, PhD, FACSM, Director, Office of Dietary Supplements (ODS), NIH  

Howard Sesso, ScD, MPH., FAHA, Associate Director, Division of Preventive Medicine, Associate Professor of Medicine, Harvard Medical School, Associate Epidemiologist, Brigham and Women’s Hospital


8:45−9:30 A.M. 

General Session: State of OTC Switches

Attendees will hear from a leading industry consultant and researcher, Eric Brass, M.D., Ph.D., professor emeritus at UCLA's School of Medicine. Dr. Brass will address key questions about the limitations of self-selection studies for nonprescription drug candidates and recommend ways to improve the design of these critical consumer research studies unique to OTC medicines.  Experts with insights from recent OTC drug switches for naloxone and Opill®, will discuss these case studies to inform future switch programs.

Moderator: 

Bernard Simone, President, Simone Consulting

Speakers:

Russell Bradford, M.D., Senior Vice President, PEGUS Research, Inc. 

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

Irene Laurora, Pharm.D., Senior Director, Global Scientific Affairs, A Perrigo Company


9:30−10:00 A.M. 

Morning Break 


10:00–11:00 A.M. 

Breakouts


 

Breakout: (Quality) Impurities and Degradants in OTC Medicines 

Understanding impurities and degradants is critical to producing high quality OTC medicines.  This session will address nitrosamines, degradants in cough/cold APIs and benzene. 

Moderator: 

Coming soon.

Speaker(s): 

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

Breakout: (Science) OTC Medication – Prevalence of Use Survey  

Data on the prevalence of use of OTC medicines is critical to supporting CHPA advocacy work and ingredient defense and it is important that relevant up-to-date information supporting these areas is available. Participants in this session will learn about the prevalence and trends of OTC and prescription medication use among adults in the US collected via three separate survey launches involving over 20,000 individuals.

Speaker: 

Jody L. Green, PhD, FAACT, Chief Scientific Officer Uprise Health

Breakout:  (Regulatory) An Update on ACNU

Hear from the FDA and industry representatives as they highlight the newest pathway for regulatory approval for OTC medicines.  The Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU) final rule is pending and once finalized will offer sponsors the opportunity to go beyond traditional labeling to seek approval for Rx-to-OTC switch candidates. Having additional tools to assist consumers in making appropriate selection and use decisions will hopefully lead to new OTC medicines that can treat chronic conditions and address health disparities in underserved and rural communities. 

Moderator:

Coming soon.

Speakers:

Coming soon.

Breakout: (Dietary Supplements) Hot Science in Review

Session featuring dietary supplement experts discussing the most impactful new scientific publications. Delve into the realms of nutrition, vitamins, minerals, botanicals, and bio actives as our panel dissects the top scientific studies shaping the dietary supplements field. Experts unpack the implications and applications of these findings. Designed for scientists and formulators, this session is designed to ignite fresh perspectives and innovative ideas. 


11:15 A.M.−12:15 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:

Maria Petrey, 2024 RSQ Program Planning Committee Co-Chair & Senior Director, North America Regulatory Affairs, US Personal Health Care Regulatory Affairs, The Procter & Gamble Company.

Speaker

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

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


12:15−12:30 P.M. 

Co-Chairs Closing Remarks


12:30−1:15 P.M. 

Lunch 


1:15−3:00 P.M. 

Workshop

2024 Speakers

Julie Aker Headshot
Julie Aker
President and Chief Executive Officer, 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.

 

Mike Bailey
Senior Vice President, Regulatory & Scientific Affairs

Mike Bailey is CHPA's Senior Vice President of Regulatory & Scientific Affairs. He oversees all aspects of regulatory and scientific affairs at CHPA, including leading task groups, working groups, and committees; strengthening relations with FDA leaders, centers, divisions, and offices; and additional regulatory priorities for the association while leading a very seasoned and talented department at CHPA. 

Mike graduated from West Virginia University with a bachelor's degree in animal science and a master's degree in business from Johns Hopkins University. He is an experienced member of multiple leadership and management boards, research and development leadership teams, and global regulatory affairs leadership teams. He resides in Lafayette, New Jersey, with his wife of 34 years and three adult children. He works out of CHPA's Washington, D.C. headquarters.

 

 

Eric Brass Headshot
Eric Brass
Professor of Medicine, David Geffen School of Medicine UCLA

Dr. Eric Brass received his M.D. and Ph.D. (Pharmacology) degrees from Case Western Reserve University. He completed an internal medicine residency and clinical pharmacology fellowship at the University of Washington. After holding faculty positions at the University of Colorado and Case Western Reserve University, Dr. Brass moved to the UCLA School of Medicine where he was Chair of the Department of Medicine at the Harbor-UCLA Medical Center from 1994-2000. He is currently Professor Emeritus of Medicine, David Geffen School of Medicine at UCLA. Dr. Brass has long-standing interests in drug discovery, development and regulation, with a particular focus on the challenges of prescription to OTC switches. He served as a member, and then as Chair, of the FDA’s Nonprescription Drugs Advisory Committee. Subsequently he has served as a consultant to a number of companies on nonprescription drug development strategies. Dr. Brass has authored over 200 scientific papers, including several related to nonprescription drug development and regulatory issues.

 


Natalia I. Chalmers Headshot
Natalia I. Chalmers
DDS, MHSc, PhD, Chief Dental Officer, Office of the Administrator, Centers for Medicare and Medicaid Services

Dr. Chalmers is a board-certified pediatric dentist, oral health policy expert, and public health advocate who brings more than 20 years of clinical, research, industry, and regulatory experience to CMS in her role as Chief Dental Officer in the Office of the Administrator. Previously, Dr. Chalmers served as a Dental Officer at the US Food and Drug Administration. Dr. Chalmers has devoted her career to transforming scientific and health care data and information into actionable insights to address equity, improve care, and better inform policy and funding. Dr. Chalmers completed her Doctor of Dental Surgery degree at the Faculty of Dental Medicine of the Medical University of Sofia, a residency in pediatric dentistry at the University of Maryland School of Dentistry, and a Ph.D. in oral microbiology from the Graduate Partnerships Program of the University of Maryland School of Dentistry and the National Institute for Dental and Craniofacial Research at the National Institutes of Health, Post-doctoral Fellowship at the Forsyth Institute, and Clinical Research Fellowship at the National Institute for Dental and Craniofacial Research, National Institutes of Health. Dr. Chalmers holds a Master’s degree in Clinical Research from Duke Medical University and a Certificate in Drug Development and Regulatory Science from the University of California San Francisco School of Pharmacy. Her research has translated into action, improving oral care and advocating for the role health policy can play across the lifespan—particularly when it embraces dental well-being as a facet of care for the whole person.


Kristen Garrett Headshot
Kristen Garrett
Manager of Market Research at the Consumer Technology Association (CTA)

Kristen Garrett is a Manager of Market Research at the Consumer Technology Association (CTA), which produces the Consumer Electronics Show (CES). Kristen is responsible for managing the execution of consumer and B2B market research studies, both domestic and international, spanning many topics and areas. Kristen is most passionate about digital health and works with industry stakeholders to publish research aimed at improving digital health technology and public awareness and education. Kristen graduated with a B.S. in Sociology and a minor in psychology from Virginia Tech.

 

 

 

 


Nicholas Georges Headshot
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.

 

 

Jody L. Green, Ph.D. FAACT, Chief Scientific Officer, Uprise Health
Jody L. Green
Ph.D. FAACT, Chief Scientific Officer, Uprise Health

As the Chief Scientific Officer for Uprise Health, Dr. Green provides strategic direction for drug safety research design, generation and analysis of real-world evidence, and data dissemination activities for postmarked studies of prescription and nonprescription medications. Prior to joining Uprise Health she was the Director of Research at the Rocky Mountain Poison and Drug Center, where she was the principal investigator on over 40 studies ranging from clinical trials to observational studies, primarily focused on pharmaceutical and consumer product safety. Dr. Green is a Fellow of the American Academy of Clinical Toxicology and a current member of the Prevention of Overdoses and Treatment Errors in Children Taskforce (PROTECT) of the Centers for Disease Control and Prevention (CDC), an assembly of experts to develop strategies to keep children safe from unintentional medication overdoses. Dr. Green has over 20 years of research experience aimed to advance patient and consumer safety, authoring or co-authoring over 90 manuscripts in peer-reviewed journals, including co-authorship of the Annual Report of the National Poison Data System from 2006 to 2010.

 

orange CHPA favicon
Corey Hilmas, MD, PhD
Chief Regulatory Officer, KGK Science

Dr. Corey Hilmas is a respected scientist, medical doctor, and former U.S. federal food regulator. After having completed his medical degree and doctorate in toxicology, working as a principal investigator for a very large institute, he was employed on behalf of the US government at US FDA. He served as an NDI notification reviewer and branch chief within the Division of Dietary Supplement Programs (today the Office of Dietary Supplement Programs). In addition to his expertise in food safety, setting structure function claim policy, labeling, GMPs and health fraud, he served as an expert witness for FDA, DOJ and AUSA, resulting in an FDA Award of Merit from former FDA Commissioner Margaret Hamburg. As a recognized regulatory expert with intimate knowledge of the dietary supplement industry, Dr. Hilmas has made significant contributions toward building and re-shaping the global food regulatory landscape after leaving FDA through drafting over 70 comments to US federal and state agencies, as well as global food health directorates on topics ranging from soy to supplements and CBD to China’s overhaul of their Food Safety Program. Today Dr. Hilmas heads up KGK Science’s Client Services Division, which helps regulatory clients gain access to the North American market by offering GRAS, NDIs, consulting advice, labeling reviews, structure function claim substantiation files, citizen petitions, and other regulatory work products.

 

Haijing Hu Headshot
Haijing Hu
Chief of the Regulations Implementation Branch, Center for Food Safety and Applied Nutrition, FDA

Dr. Haijing Hu joined the FDA in 2010 and has served in several roles and positions. Her current role is the Chief of the Regulations Implementation Branch (RIB) in the Office of Dietary Supplement Programs (ODSP) within the Center for Food Safety and Applied Nutrition (CFSAN) at the FDA. She leads a multi-disciplinary team to review industry submissions and inspectional findings on labeling and CGMP compliance. She also collaborates with other FDA offices in the development of compliance policies and enforcement actions. Haijing has been in this position for four years. Prior to joining ODSP, Haijing was a senior microbiologist in CDER’s Office of Compliance with a focus on pharmacy compounding. She also conducted microbiological assessments for sterile drug manufacturing in CDER as well as sterilization and disinfection assessments for medical devices at CDRH. Haijing obtained her Ph.D. in 2003 as a food microbiologist. She has more than 10 years of experience in microbiological research prior to joining the FDA.

 


Barbara Kochanowski Headshot in grey blazer and black blouse
Former Senior Vice President, Regulatory & Scientific Affairs, CHPA

Barbara Kochanowski was Sr. VP, Regulatory & Scientific Affairs, CHPA, from 2009 – 2023, where she was responsible for regulatory affairs activities with the U.S. Food and Drug Administration, including OTC Monograph reform, ingredient safety, and consumer medical devices. She retired from CHPA in July 2023 and currently serves as a consultant to CHPA for special projects, including OMUFA II. Prior to 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. 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 actively engaged in alumni activities at Penn State University and University of Illinois.


Frank Lin, M.D., Ph.D.
Frank Lin, M.D., Ph.D.
Johns Hopkins University, Professor & Director, Cochlear Center for Hearing & Public Health

Frank R. Lin, M.D., Ph.D. is a Professor and the Director of the Cochlear Center for Hearing and Public Health at Johns Hopkins University. As an otologic surgeon & epidemiologist, Dr. Lin has translated his clinical experiences caring for patients with hearing loss into foundational public health research and federal policy in the U.S. His research established the association of hearing loss with cognitive decline & dementia and served as the direct basis for the Lancet Commission on Dementia conclusion that hearing loss is the leading modifiable risk factor for dementia. Based on this research, he initiated the ACHIEVE study in 2014, and the results of this landmark randomized trial that were released in 2023 established that treating hearing loss reduces loss of thinking and memory abilities by 48% among older adults at increased risk for cognitive decline. In parallel, Dr. Lin has collaborated with the National Academies, White House, and Congress to develop policies to ensure hearing loss can be effectively and sustainably addressed in society. These efforts directly resulted in bipartisan passage of the Over-the-Counter Hearing Aid Act of 2017 which Dr. Lin testified on before Congress and final enactment of federal regulations for OTC hearing aids in the U.S. on October 17, 2022. Dr. Lin has subsequently collaborated with the Consumer Technology Association to develop the standard for a consumer-facing hearing metric based on the PTA4 (Hearing Number) to empower consumers to track, monitor, and act on their own hearing. As the director of a public health research center, Dr. Lin’s academic efforts are focused on reshaping the rules and assumptions underlying the global hearing care market in order to ensure the market is optimized to advance public health.

 

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 Health in Hand Foundation.

 

JJ Mifsud Headshot
JJ Mifsud
Applied AI Architect, Klick

JJ Mifsud is an Applied AI Architect at Klick Health with over a decade of experience in the healthcare industry. He excels at building and exploring generative AI solutions that bridge the gap between cutting-edge technology and regulatory compliance. JJ's expertise lies in making complex AI technologies accessible while championing responsible development and implementation. He developed a patented HCP simulator that predicts market reactions to healthcare marketing materials. He has a deep understanding of industry regulations and standards, ensuring that his solutions align with the necessary requirements. JJ envisions a future where AI safely and effectively revolutionizes the healthcare regulatory landscape without compromising risk or safety.

 

Theresa Michele, M.D.
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.

 

 

 

 

 


   Stefan Pasiakos, Ph.D Headshot
Stefan Pasiakos, Ph.D.
FACSM, Director, Office of Dietary Supplements (ODS), NIH

Stefan M. Pasiakos, Ph.D., was named Director of the Office of Dietary Supplements at the National Institutes of Health in July 2023. In the months that followed, Dr. Pasiakos led efforts to develop a new strategic vision that builds upon the office’s successful history and positions ODS as the premier organization, authority, and convening body for advancing the study of dietary supplements across the federal government. His vision emphasizes objectivity, scientific curiosity, and innovation. It prioritizes collaboration and coordination across NIH while maintaining the office’s long-standing partnerships with other federal agencies, research institutions, and dietary supplement trade organizations. Dr. Pasiakos is committed to the American public as the honest broker for advancing dietary supplement science and fostering public health knowledge to optimize health across the lifespan. Dr. Pasiakos’ research interests and expertise include nutrition and dietary supplements, muscle physiology, human performance, and bioenergetics of exercise metabolism. His research has spanned multiple disciplines, including basic sciences, population level analyses, randomized controlled trials, and military field studies in austere environments. Before joining ODS, Dr. Pasiakos held multiple positions at the United States Army Research Institute of Environmental Medicine from 2008 to 2023. Most recently, Dr. Pasiakos served as the Chief of the Military Performance Division, where he led a multidisciplinary research program and scientific team to develop evidence-based solutions to limit musculoskeletal injuries and optimize physical and cognitive performance in military training and operational environments. From 2012 to 2021, Dr. Pasiakos was a Research Physiologist in the Military Nutrition Division. The author of more than 150 scientific publications, journal articles, and book chapters, Dr. Pasiakos’ work to refine dietary and supplemental protein recommendations for soldiers is internationally recognized. He has received numerous awards for his contributions to military medicine and was awarded the Vernon R. Young International Award for Amino Acid Research from the American Society for Nutrition. He is also a Fellow of the American College of Sports Medicine. His research highlighting the fundamental relationship between energy balance and essential amino acid utilization for the protection of skeletal muscle mass during strenuous military operations has informed nutrition policy for the Department of Defense and the development of next generation combat ration products. Dr. Pasiakos received his Ph.D. in nutritional science in 2008 from the University of Connecticut. He also holds a M.A. and B.S. in exercise physiology from Adelphi University and Southern Connecticut State University, respectively. He completed a postdoctoral fellowship in the Military Nutrition Division at the United States Army Research Institute of Environmental Medicine in 2012 as a United States Army Medical Service Corps officer.


Maria Petrey Headshot
Maria E. Petrey
Senior Director, North America Regulatory Affairs, US Personal Health Care Regulatory Affairs, The Procter & Gamble Company

Maria E. Petrey leads the North America Regulatory Affairs organization within the Procter & Gamble Personal Health Care business. Maria oversees a team of regulatory affairs managers that are responsible for a wide range of brands across a variety of regulatory classifications such as OTC monograph drugs, OTC drugs approved under an NDA/ANDA, dietary supplements, conventional foods, cosmetics, medical devices, and consumer goods. These brands include Vicks NyQuil, DayQuil, Sinex, ZZZQuil, Metamucil, Nervive, Prilosec OTC, Pepto Bismol, and Align among many others. Maria has worked at Procter & Gamble for over 25 years, joining Procter & Gamble Pharmaceuticals as a molecular and cellular biologist in 1998. Maria worked at Eli Lilly Pharmaceuticals and Dow Chemical prior to joining Procter & Gamble Pharmaceuticals, as well as at Warner Chilcott Pharmaceuticals. Maria obtained her undergraduate degree in biological sciences from Indiana University, a graduate degree in molecular and cellular biology from the University of Cincinnati, and a Regulatory Affairs Certification from the Regulatory Affairs Professional Society.


Howard Sesso Headshot
Howard D. Sesso
Associate Director, Division of Preventive Medicine, Associate Professor of Medicine, Harvard Medical School, Associate Epidemiologist, Brigham and Women’s Hospital

Dr. Howard D. Sesso is an Associate Epidemiologist at the Division of Preventive Medicine at Brigham and Women’s Hospital, Associate Professor of Medicine at Harvard Medical School, and Associate Professor of Epidemiology at the Harvard T.H. Chan School of Public Health. He designs and conducts randomized clinical trials and epidemiologic studies, focusing on dietary supplements, nutrition, and lifestyle factors to prevent cardiovascular disease (CVD), hypertension, and other aging-related outcomes. Dr. Sesso is the Associate Director of the Division of Preventive Medicine and Director of Nutrition and Supplement Research at the Osher Center for Integrative Medicine. Dr. Sesso helps lead the Physicians’ Health Study, consisting of two trials testing aspirin, beta-carotene, vitamin E, vitamin C, and a multivitamin on aging-related outcomes in 29,071 men. Dr. Sesso is also examining vitamin D and fish oil supplements on blood pressure, hypertension, and other outcomes in the Vitamin D and Omega-3 Trial (VITAL). Finally, Dr. Sesso is Co-Principal Investigator of the Cocoa Supplement and Multivitamin Outcomes Study (COSMOS), a recently completed trial testing cocoa extract and multivitamin supplements in the prevention of CVD and cancer in 21,442 older women and men. He has published more than 350 papers, teaches courses on clinical trials and epidemiology, and enjoys mentoring students and junior faculty.

 


Alpa Shah
Alpa Shah, MS, RDN
Medical Lead, US Wellness Medical Affairs, Haleon

Alpa V. Shah leads U.S. Wellness Medical & Scientific Affairs within R&D at Haleon. She oversees a team of nutrition scientists responsible for the science and research behind well-known nutritional/dietary supplement brands such as Centrum, Caltrate, and Benefiber. Alpa is a nutrition professional with over 20 years of experience in the application of nutrition science in a variety of settings including patient care in clinical practice, community nutrition and health programs, academia, and industry. She obtained her undergraduate and graduate degrees in Nutritional Sciences from Rutgers University in New Jersey, and she is a Registered Dietitian/Nutritionist. Alpa has had extensive clinical experiences in the areas of diabetes management, perinatal nutrition, HIV nutrition as well as in human vitamin/mineral nutrition and healthy aging. Alpa is passionate about the role of nutrition in promoting health and wellness especially for underserved and vulnerable populations and hence has focused much of her career on the interpretation, translation, and communication of nutrition science for practical use in the betterment of 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, Behavioral Science and Data Platforms at Sanofi Consumer Healthcare where he leads a team of subject matter experts across real-world evidence, behavioral science, as well as data and analytics. 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.

 

David Strauss, M.D., Ph.D. Headshot
David Strauss, M.D., Ph.D.
Director, Division of Applied Regulatory Science, FDA

Dr. David Strauss serves as the Acting Chief Scientist for the US Food and Drug Administration to promote, leverage, and lead cross-cutting, collaborative activities and initiatives that catalyze FDA science, innovation, and research to help the agency address its most pressing regulatory and public health questions and respond to emerging issues. Prior to serving as Acting Chief Scientist, he served as the Director of the Division of Applied Regulatory Science in the FDA’s Center for Drug Evaluation and Research (CDER) where he led efforts to move new science into the FDA regulatory process and address emergent regulatory and public health questions by engaging stakeholders in mission-critical laboratory, computational, and clinical research. This work brought him in contact with many of the complex and varied scientific and regulatory issues the agency faces. He also has spent five years in the FDA’s Center for Devices and Radiological Health; eight years in CDER and worked with all of the FDA’s regulatory product centers and offices on a variety of applied research projects and cross-agency committees.

Andrew Stewart is currently the Head of Real-World Evidence, Behavioral Science and Data Platforms at Sanofi Consumer Healthcare where he leads a team of subject matter experts across real-world evidence, behavioral science, as well as data and analytics. 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.


Pelin Thorogood Headshot
Pelin Thorogood
Co-founder & Executive Chair, Radicle Science

Pelin Thorogood is the Cofounder and Executive Chair of Radicle Science, an AI-driven HealthTech pioneer recognized as a “World Changing Idea” by Fast Company for powering the future of Personalized Wellness with proof.  Her category-defining efforts earned her the INC 200 Female Founder award in 2023. Previously, Pelin held pivotal C-level roles, including CEO, in both public and private companies, establishing herself as a MarTech trailblazer.  Pelin is a prolific writer and speaker on topics ranging from AI, analytics, entrepreneurship, women’s health and precision medicine, including in Fast Company, Forbes, SXSW, TED, Montgomery Summit, ABC News and Cornell Enterprise.  Deeply committed to impact, education, and community, Pelin serves as Trustee and Vice Chair of the UC San Diego Foundation and as Chair of the UC San Diego Chancellor’s Council for Innovation and Entrepreneurship. Pelin holds a B.S., M.Eng and MBA, all from Cornell.

 

Shontell Wright, M.S. Headshot
Shontell Wright, M.S.
Chemist, Center for Food Safety and Applied Nutrition Office of Dietary Supplement Programs, FDA

Shontell Wright, M.S. is a chemist in the Office of Dietary Supplement Programs (ODSP) within the Center for Food Safety and Applied Nutrition (CFSAN) at the U.S. Food and Drug Administration (FDA). She is a member of the Identity and Status Branch (ISB) in the Division of Research and Evaluation (DRE) where she reviews the identity, manufacturing, and specification information provided in new dietary ingredient (NDI) notifications; determines the regulatory status of dietary ingredients and supplements; responds to consumer and industry inquiries; assists with the development of guidance documents; and provides scientific rationales for the development and assessment of FDA’s actions related to the safety of dietary supplement products.

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 CHPA 2024 Group Rate is $269.00.
  • This discounted rate is available until 3:00 p.m. Friday, August 23, 2024, or sooner if the room block sells out.

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

For a full list of amenities and features, please visit: Bethesda North Marriott Hotel & Conference Center

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). Visit: www.amtrak.com

The 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

  • $1095 – Early-Bird Member Registration (through July 11, 2024)
  • $1395 – Standard Member Registration (after July 11, 2024)
  • $3295 – Nonmember Registration
  • $225 – Government Registration (this rate is only available for government agencies)
  • $895 – Non-Profit Registration (this rate is only available to non-for-profit companies who are not government agencies
  • Student Registration (this rate is only available for those currently registered as a full-time student with a college or university) Please contact meetings@chpa.org if interested in a student registration. 

Register online 

Phone registrations are not accepted, please register online.

  • 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, 2024, will receive a full refund. Cancellations received after August 7, 2024 will result in the forfeiture of the entire registration fee. Substitutions are always accepted.

Registration & Logistics Questions

Thank You to Our Sponsors

2024 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 2024

View Past Winners

Please contact Tatiana Tolentino with questions about this award.

Add to Calendar 2024-09-16T10:00:00 2024-09-18T15:00:00 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.