Thank you for attending 2024 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.

Julie Aker

VP & GM, 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.

David Allen

Senior Director of Human Health Sciences, International Collaboration on Cosmetics Safety

Rend Al-Mondhiry

Partner, Amin Wasserman Gurnani LLP

Rend Al-Mondhiry, co-chair of Amin Wasserman Gurnani’s Regulatory Group, advises the dietary supplement, food, cosmetic, and over-the-counter medicine industries on a broad range of regulatory and compliance matters. Rend’s practice focuses on reviewing product labeling, ingredients, and advertising to determine compliance with federal and state regulations and assisting companies in matters before the Food and Drug Administration, Federal Trade Commission, and National Advertising Division. She also advises clients on compliance with California’s Proposition 65, U.S. Customs issues, class action defense strategies, and FDA matters, including Warning Letters, recalls, detentions, seizures, and import alerts. Rend is a frequent speaker and author on emerging legal and regulatory issues and is regularly quoted in leading industry trade publications.

Krysmarú (Krys) Araujo Torres, M.D.

Senior Director & Head of Medical Affairs at Nestlé Health Science US

Dr. Krys Araujo-Torres is a highly experienced Medical Affairs Executive with over 15 years of experience in the healthcare industry. She currently serves as US Head of Medical Affairs at Nestle Health Science, where she leads a team of professionals with diverse nutrition and medical backgrounds, in developing and executing medical strategies that support the company’s portfolio of nutritional solutions. 

Dr. Araujo-Torres earned her MD from the Universidad del Zulia in Venezuela, as well as a Master’s Degree in Social and Public Policy from the Universitat Pompeu Fabra and John Hopkins University, in Barcelona (Spain). She began her career in clinical practice in PDVSA, Venezuela, which sparked her interest in planning of public healthcare sector and public policies. 

Throughout her career in industry, she has been dedicated to increased awareness about the unparalleled role of nutrition in promoting and recovering health.

Mike Bailey

Senior Vice President, Regulatory & Scientific Affairs

Mike's Full Bio

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 highly 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. With nearly 40 years in industry prior to joining CHPA, 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 they have three adult children. He works out of CHPA's Washington, D.C. headquarters.

Leonard Baum

RPh, President, Leonard Baum Regulatory Solutions, LLC.

Len Baum RPh has over 45 years of regulatory and R&D experience covering a broad range of Rx and OTC products. Following a career in industry, Len retired from Bayer Consumer Health, where he was Vice President, North American Regulatory Affairs and established the consulting firm Leonard Baum Regulatory Solutions, LLC where he provides clients with strategic and hands-on assistance in planning and implementing product development and life cycle programs, including Rx to OTC switch, including ACUN, product monographs, labeling and product claims development and advertising reviews.

During Len’s career he has had the privilege to be involved in the strategic planning, preparation, including writing and reviewing, of over 50 INDs, NDAs and BLAs, and partnering with FDA and other Health Agencies in support of new products and line extensions.  Len has served as Chair of the CHPA Regulatory and Scientific Affairs Committee and the RSQ meeting and continues to be an active member participating on various committees.

Russell Bradford

M.D., MSPH, Senior Vice President, PEGUS Research, Inc.

Russell D. Bradford, MD, MSPH is Senior Vice President at PEGUS Research, a CRO specializing in consumer behavior research and supporting Rx to OTC switch efforts for more than 3 decades. Russ interfaces directly with clients in the design, development, and advancement of research programs to support program needs, and particularly enjoys the challenge of helping clients solve the inevitable problems that arise. 

Russ attended medical school at the University of Utah. Thereafter he completed residency training in internal medicine and pediatrics followed by a fellowship in pediatric infectious diseases, all at the University of Alabama at Birmingham. Along the way, he earned his MSPH. After serving for some years on faculty in the Departments of Pediatrics and Medicine at UAB, in 2011 he joined PEGUS Research, where he has played a leading role in dozens of programs. Additionally, he continues to care for hospitalized patients in his community.

Nathifa Bradshaw

Senior Quality/Regulatory Manager, BEURER North America LP

Nathifa Bradshaw has over 15 years of experience in the medical device industry. She has successfully managed the full implementation of Quality Management Systems in compliance with ISO 13485 and FDA 21 CFR 820 standards. 

Nathifa has also collaborated cross-functionally with design teams from product conception to market launch. Her expertise includes working with regulatory bodies such as the U.S. FDA, Health Canada, WHO, MDSAP, EU MDR, and IVDR, from initial gap analysis to achieving regulatory compliance.

Nathifa holds a Regulatory Affairs Certification for Medical Devices from the Regulatory Affairs Professionals Society (RAPS) and is certified as a Quality Auditor by the American Society for Quality (ASQ). She earned her Bachelor of Science degree in Biology from Clark Atlanta University and her Master of Science degree in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University. 

Eric Brass

M.D., Ph.D., 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.

Lisa Brines

Ph.D., Senior Compliance Manager from our Regulatory Intelligence, Safety, & Compliance (RISC), Amazon

Lisa Brines, Ph.D., is a Senior Compliance Manager at Amazon.  She covers US Health and Personal Care product compliance, including dietary supplements, drugs, cosmetics, and medical devices, for Amazon’s Regulatory Intelligence, Safety, and Compliance (RISC) Legal team. Prior to joining Amazon, Lisa spent a dozen years in regulatory and compliance roles, including as the National List Manager for the U.S. Department of Agriculture’s National Organic Program and product registration at the Washington State Department of Agriculture. She previously served on the U.S. delegation for the Codex Committee on Food Labelling covering organic certification and policy issues. Lisa has a Ph.D. in Inorganic Chemistry from the University of Washington and a Bachelor of Science in Chemistry from Seattle University.

Lisa Burns

Sr. Regulatory Manager, US Regulatory Affairs Medical Device and Cosmetic, Reckitt

Lisa Burns is a senior manager at Reckitt where she leads US Regulatory Affairs Medical Device and Cosmetic 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 its creation in 2018, and now serves as Committee Chairperson.  Prior to joining Reckitt, Lisa had worked for Church & Dwight.

Robert M. Califf

M.D., Commissioner of Food and Drugs, FDA

Dr. Robert M. Califf was confirmed as the 25th Commissioner of Food and Drugs.  

As Commissioner, Dr. Califf oversees the full breadth of the FDA portfolio and execution of the Federal Food, Drug, and Cosmetic Act and other applicable laws. This includes assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices; the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation; and the regulation of tobacco products.

Dr. Califf has had a long and distinguished career as a physician, researcher, and leader in the fields of science and medicine.  He is a nationally recognized expert in cardiovascular medicine, health outcomes research, health care quality, and clinical research, and a leader in the growing field of translational research, which is key to ensuring that advances in science translate into medical care.  

This is Dr. Califf’s second stint as Commissioner.  He also served in 2016 as the 22nd Commissioner.  Before assuming the position at that time, he served as the FDA’s Deputy Commissioner for Medical Products and Tobacco.  

Prior to rejoining the FDA in 2022, Dr. Califf was head of medical strategy and Senior Advisor at Alphabet Inc., contributing to strategy and policy for its health subsidiaries Verily Life Sciences and Google Health. He joined Alphabet in 2019, after serving as a professor of medicine and vice chancellor for clinical and translational research at Duke University. He also served as director of the Duke Translational Medicine Institute and was the founding director of the Duke Clinical Research Institute.  

Dr. Califf is a graduate of Duke University School of Medicine. He completed a residency in internal medicine at the University of California, San Francisco and a fellowship in cardiology at Duke.  

Natalia I. Chalmers

DDS, MHSc, Ph.D., 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.

Lauren Cleary

Chief Client Officer, Idea Evolver

Lauren has spent the past seven years working with sponsors to develop technologies that align with the FDA’s proposed Additional Condition for Nonprescription Use (ACNU) rule.
At Idea Evolver, she has played a key role in guiding projects from initial concept through to FDA submission, focusing on the integration of technical innovation and regulatory compliance.

Her broad experience on these programs has provided valuable insights into the challenges and opportunities within this evolving field.

Greg Collier

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

Moderator

Dr. Greg Collier is a regulatory consultant working with CHPA the Consumer Healthcare Industry on OTC Monograph opportunities and OMUFA 2 reauthorization.  He was recently appointed as Industry Representative to FDA’s Nonprescription Drugs Advisory Committee (NDAC).  Dr Collier retired from The Procter & Gamble Company in 2021 after 34 years, where he served as the Global Vice President of Human Safety and Regulatory Affairs for P&G Oral Care and Personal Health Care.  Dr. Collier also served as the Chair of the CHPA Regulatory and Scientific Affairs Committee from 2015-2019 where he had the privilege to work closely with CHPA and FDA on the development and passage of the Monograph Reform (OMUFA). 

Bob (Robert) Durkin

Partner and Co-Chair of the Regulatory Group, Amin Wasserman Gurnani, LLP

Bob Durkin, co-chair of Amin Wasserman Gurnani’s Regulatory Group, is a preeminent thought leader and subject matter authority in FDA regulation, helping health and wellness companies navigate their most intricate regulatory challenges. With a rich background as a former Acting Director and Deputy Director of the Office of Dietary Supplement Programs (ODSP) in the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), Bob brings a wealth of experience and unique insights to a diverse range of clients, particularly those operating within the dynamic and highly regulated dietary supplement and functional food industry sectors.

Lisa El-Shall

Senior Director for Drug and Device Consulting Services, EAS Consulting Group, LLC

Speaker

Lisa El-Shall is currently the Senior Director of Pharmaceutical and Medical Device Consulting Services at EAS Consulting Group. She has extensive experience in a Consumer Healthcare organization in both Research and Development and Quality and has held leadership positions in the analytical laboratory and Quality. Prior to joining EAS Consulting Group, Ms. El-Shall led the Research and Development Quality group at Pfizer and GSK with global responsibility for areas including new product development and technical transfer, clinical supply production/release, clinical study oversight, and business development quality. She has proven ability in the establishment, implementation, and maintenance of fit for purpose standards, systems, and Regulatory Inspection compliance.

Lisa serves on the Board of Directors of ASQ and is an ASQ Certified Quality Auditor as well as a certified ISO 13485 Lead Auditor. She holds a B.S. in Chemistry from the University of North Carolina at Chapel Hill and a M.S. from the University of California, Los Angeles in Biochemistry. 

Lynn Evans

Vice President, North America Quality & Compliance, Kenvue

Lynn is currently the Vice President of North America Quality and Compliance. Lynn is responsible for the end to end quality function for Kenvue North America. 

Prior to joining Kenvue, Lynn was Head of Quality Risk Management and Quality Planning & Strategy in Bioresearch Quality & Compliance (BRQC) Janssen where she led a global team to identify and mitigate quality risk in the Janssen and Med Tech R&D portfolios.

Lynn was the Compliance Officer for the External Manufacturing Audit program in Johnson & Johnson Regulatory Compliance (JJRC). Lynn has over 28 years of experience in Quality & Compliance supporting Pharmaceutical Research & Development, Medical Device and Consumer products. She has extensive experience managing highly complex, heavily scrutinized quality projects and has successfully led the corporate compliance oversight of the McNeil Consent decree. Lynn also has a history of establishing and implementing risk management framework and strategy, such as her leadership of a risk categorization of suppliers across the Johnson & Johnson Enterprise. She has held a variety of quality leader positions and strengthened key stakeholder interaction and improved the quality culture, such as her prior role supporting new product development teams for J&J R&D. Prior to joining J&J, Lynn held quality leadership positions at Merck, Omnicare and Integra Life Sciences.

Lynn holds a Bachelor of Science degree in Chemistry from the University of Maryland and a Master of Science degree is Quality Assurance/Regulatory Affairs from Temple University. Lynn lives in New Hope, Pennsylvania with her husband and 2 children where she enjoys traveling and fitness in her spare time.

Jill Furman

JD, Director, Office of Compliance, CDER, FDA

Jill Furman, J.D., serves as the Director of the Office of Compliance in the Center for Drug Evaluation and Research (CDER). The Office of Compliance is charged with protecting the public from poor quality, unsafe, and ineffective drug products through proactive compliance strategies and risk-based enforcement actions.
Ms. Furman joined FDA in 2020 as the Office of Compliance Deputy Director after more than 22 years with the U.S. Department of Justice’s (DOJ) Consumer Protection Branch, where she handled a wide range of consumer protection matters, including civil and criminal litigation under the Food, Drug, and Cosmetic Act. In her last eight years at DOJ, Ms. Furman served as the Deputy Director of that office, supervising litigation, and providing leadership and direction to attorneys and staff.
Before joining DOJ, Ms. Furman served as an Assistant District Attorney with the Suffolk County District Attorney’s Office in Boston, Massachusetts, where she prosecuted criminal cases in state appellate and trial courts.
Ms. Furman earned her law degree from Boston University School of Law and her bachelor’s degree from the University of Pennsylvania.

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.

Sydney M. Gibson

Ph.D., Associate Principal, Regulatory Science & Study Innovation, IQVIA

Sydney M. Gibson, PhD, is an Associate Principal with IQVIA's Regulatory Science & Study Innovation team, supporting clients in the design and execution of studies that leverage real-world evidence for regulatory decision making.  A biomedical engineer by training, she has over 8 years’ experience in the pharmaceutical and device spaces, spanning regulatory affairs, R&D, and commercial strategy. She previously served as a lead reviewer at FDA's Center for Devices and Regulatory Health, including the review for pre- and post-market submissions.

Angela Granum

Director, Division of User Fee Management, CDER, FDA

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.

Owen Griffin

Director, R&D Microbiology, Rapid Micro Biosystems

Owen has 14+ years of experience working in and leading laboratories for contract research organizations (CRO), contract development and manufacturing organizations (CDMO), and drug product manufacturing companies. During his career he has worked in both sterile and non-sterile GMP facilities, leading teams that support API, excipient, and fill finish manufacturing activities. Over his career he has supported the design of manufacturing cleanrooms and processes, environmental monitoring programs, implemented contamination control strategies, designed microbial method validations, and led global initiatives as a Microbiology subject matter expert (SME). 

Owen earned a B.S. in Microbiology and Laboratory Technology from Auburn University. He is currently the Director, R&D Microbiology at Rapid Micro Biosystems. In this role his team is responsible for new product development activities and customer applications services. 

Susan J. Hewlings

Ph.D., RD, VP Research Affairs, Radical Science

Dr. Susan J. Hewlings, PhD, RD, serves as the Vice President of Research Affairs at Radicle Science and is a Co-Founder of Substantiation Sciences. Dr. Hewlings brings over two decades of extensive experience in research, teaching, and medical writing in nutrition, sports nutrition, and scientific consulting for the dietary supplement, food, beverage and medical industries. Dr. Hewlings has been instrumental in bridging the gap between science and product development, marketing, and sales for numerous leading brands.  Her academic achievements include a PhD in Nutrition, an MS in Exercise Physiology, and a BS in Nutrition from Florida State University. She is a registered dietitian and completed a research fellowship in protein metabolism at the University of Texas Medical Branch, as well as earning a graduate certificate in cannabis science from the University of Vermont Medical School.

Corey Hilmas

MD, Ph.D., 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

Ph.D., 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.

B. Y. MiRa Jacobs

Ph.D., Division Director, Division of Digital Health Policy, Digital Health Center of Excellence at FDA

Dr. MiRa Jacobs is the Division Director for the Division of Digital Health Policy, which is part of the Digital Health Center of Excellence at the FDA. She has worked at the Agency since 2018, first as Lead Reviewer in the Office of Product Evaluation and Quality, where she provided support for software and cybersecurity review in addition to her work as a lead reviewer on the neurointerventional devices team. She joined the Digital Health Center of Excellence in 2020 and has since contributed to numerous programs and initiatives with a focus on developing and implementing policy for AI-enabled medical devices, the maturation of Predetermined Change Control Plans, and international harmonization on approaches to Software and AI-enabled devices. Prior to joining the FDA, Dr. Jacobs earned her Ph.D. in biomedical engineering from the University of Florida.

Michael Kaminski

Ph.D., Principal Scientist of Regulatory Affairs, The Procter & Gamble Company

Michael is a Regulatory Affairs Principal Scientist at Procter & Gamble. In this capacity, Michael has responsibility for compliance activities and strategy setting for Procter & Gamble’s diverse group of consumer health care products spanning various regulatory classifications - OTC monograph drugs, medical devices, cosmetics, natural health products.

During his 25-year tenure at Procter & Gamble, Michael has contributed to the success or their Oral Care Division through his strong technical mastery and creative thinking. Michael is sought out by his peers from across the company for this technical and regulatory expertise.  Since joining P&G Michael has been active in CHPA as a member of numerous Committees, Working Groups and Task Forces and most recently as one of the industry representatives participating in the OMUFA II negotiations. Michael obtained his MS and Ph.D. in Reproductive Physiology and Endocrinology from the University of Kentucky and North Dakota State University, respectively.

Constantinos Katevatis

Associate Director, Life Sciences AI/NLP at IQVIA

Barbara A Kochanowski

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

Barbara's Full Bio

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.

Kathryn Kramp

Principal Scientist, Regulatory Affairs, The Procter & Gamble Company

Kathy Kramp has been employed by P&G for 34 years, serving in a variety of roles within Global Product Stewardship with a focus within Regulatory Affairs.  She is currently a Principal Scientist , Personal Health Care Regulatory Affairs Manager,  responsible for compliance of dietary supplement product in both digestive wellness and sleep and respiratory product categories. Currently, she is the FSMA expert at P&G for dietary supplement requirements.   In previous roles at P&G, she was responsible for OTC drug-cosmetics,  antibacterial cleansing products, cosmetics and global aerosol regulations.  She has significant experience in setting and executing Regulatory strategies for these categories. 

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.

Edward Ladwig

President, Eurofins Food Chemistry Testing

Ed Ladwig is the President of Eurofins Food Chemistry Testing, where he leads the largest third-party food and dietary supplement testing lab in North America. With over 25 years of industry experience, Ed oversees a team of over 400 chemists and food science professionals, conducting hundreds of thousands of nutritional and contaminant chemistry tests annually. Under his leadership, Eurofins is a key player in the dietary supplement and OTC industry, offering testing services that ensure product safety, efficacy, and regulatory compliance.

Ed was pivotal in the development of the Eurofins' state-of-the-art 110,000 square foot dietary supplement, OTC, and food testing facility in Madison, WI. This laboratory, operational since January 2021, handles over 400,000 samples annually and utilizes various analytical methods to support the dietary supplement sector. The lab’s infrastructure has played a crucial role in advancing standards and practices within the industry.

Additionally, Ed serves as a board member of BioForward Wisconsin, an organization dedicated to growing bio health companies. He also holds a BS in Biology from the University of Wisconsin-Madison.

Irene Laurora

Pharm.D. Senior Director, Global Scientific Affairs, Perrigo Company

Irene Laurora, PharmD is Sr Director, Scientific Affairs with Perrigo Women's Health. In this role, Irene leads the strategic planning and implementation of global development programs, clinical trials design and execution, and the Scientific Affairs function.  Dr Laurora has a 30-year career in the pharmaceutical industry where she most recently led the team to the successful Rx to OTC switch of Opill, the first daily oral contraceptive approved in the US. Previous roles include leading Global Medical Affairs and Global Drug Safety functions and leading US Medical Affairs for foremost Consumer Healthcare companies including Pfizer Consumer Care and Bayer Healthcare, and as the Global R&D Category Leader for Bayer's Analgesic and Cough & Cold franchise.  

Dr. Laurora received her Bachelor’s of Pharmacy degree from St John’s University in New York and her Doctor of Pharmacy degree from the Medical College of Virginia in Richmond, Virginia and completed a post-doctoral fellowship at Rutgers University, New Jersey.

Dr Laurora served on the Board of Trustees of Autism NJ, a non-profit organization that works to help those with autism and their families connect to necessary resources. She enjoys spending time with her two adult children, who have autism, and her husband of 32 years.  

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.

Duffy MacKay

Senior Vice President, Dietary Supplements

Duffy's Full Bio

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.

Vahini Manivannan

Manager Regulatory Affairs Associate, Kenvue

Vahini Manivannan works as Manager of Regulatory Affairs at Kenvue. She brings over nine years of industry experience to her role. Her journey in the self-care space began as a Regulatory Lead at Reckitt. Vahini is a proud alumnus of Rutgers, holding a master's degree, and RAC certification. Her expertise is complemented by a strong foundation and commitment to maintaining the highest standards of integrity in her work. Her approach combines a deep scientific understanding with a commitment to innovation, collaboration, and adherence to regulatory standards.

Natalie Mazurets, MS, RDN

Senior Manager, US Regulatory Affairs, Centrum Innovation, 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.

Diane C. McEnroe

Partner, Sidley Austin

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

President and CEO

Scott's Full Bio

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.

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.

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.

Tina Morrison

Ph.D. Director Office of Regulatory Science and Innovation Senior Science Advisor to FDA Chief Scientist

Glen Murphy

RSAC Chair & Senior Director Regulatory Affairs, Kenvue

Glen joined Johnson & Johnson in 2001 with the Diabetes Care Franchise in Canada and has since held various positions in Canada, EMEA and the US including, Director of Quality and Regulatory Compliance for Johnson & Johnson Medical Products and Director of Regulatory Affairs for the Diabetes Care Franchise in EMEA where he spent 5 years in the UK and Zug.  During this time, he developed and led the execution of the Diabetes Care Franchise strategy for implementation of the J&J Quality Standards across EMEA and managed the global project team establishing Zug as the new legal manufacturer for LifeScan products.

Glen joined J&J Consumer Health/Kenvue in 2014 overseeing Regulatory for Canada, and in 2018 transitioned to the NA Regulatory leadership role for Self-Care when he, along with his wife and two daughters relocated to Doylestown, PA  from Toronto.

Currently Glen leads Regulatory Affairs for US Self Care as well as Global Pain & Allergy. He is also the current Chair of the PPS and RSAC Committees at the Consumer Healthcare Products Association (CHPA).

In his free time, Glen enjoys playing hockey, listening to live music, fishing and travelling with his family.

Glen has over 25 years of Regulatory and Quality experience and holds a Bachelor of Science Degree from the University of Guelph, Canada. Prior to joining J&J/Kenvue he held various RA and Quality positions with BD, STERIS and SC Johnson.

Joe Muscat

Ph.D., Environmental Stewardship and Innovation Senior Director, Haleon

Since joining Haleon in July 2021, Joe has worked with colleagues across their business to develop and implement Haleon’s Packaging Sustainability Strategy. This aims to reduce Haleon’s consumption of virgin petroleum-based plastics, make their packaging recycle-ready and to look for opportunities to partner with other organizations (whether they be competitors, suppliers, waste management etc) to collect, sort and recycle their packaging at scale by 2030. 

Joe graduated with a BSc and PhD in Chemistry from the University of Manchester before joining Unilever in 2002 to lead R&D teams in developing the next generation of products that were both loved by consumers, as well as being more sustainable. Joe is passionate about the role science and technology can play to find sustainable solutions and the power of collaboration to make these come alive with Haleon’s consumers.

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 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.

Paul Phillips

Director, Office of Program Operations, FDA

Mr. Phillips joined the FDA in 2008 as a Regulatory Health Project Manager (RPM) in the Division of Dermatology and Dental Products (DDDP). Over time, he took on various roles in DDDP with increasing responsibilities including, Safety RPM, Team Leader, and Acting Chief, Project Management Staff. In early 2017, he joined what was then the OND Immediate Office Regulatory Affairs Team, with responsibility for the CDER Formal Dispute Resolution program, workload analysis, and the Expanded Access program. In October 2018, he began leading the program management staff within the Regulatory Affairs Team, and in October 2019 during an OND reorganization was selected as permanent Director of that staff, which became the Program Development, Implementation and Management Staff (PDIMS). In that role, Mr. Phillips worked with his staff to provide representation on a variety of intra and inter-center working groups and initiatives as well as manage various cross-cutting regulatory programs within OND. Subsequently, in November 2019, Mr. Phillips was named acting Director of the Office of Program Operations (OPO) in OND. Then in 2020, Mr. Phillips was selected as the permanent director of OPO. As part of his responsibilities, he has been involved in several user fee negotiations (PDUFA VII, BsUFA III, and OMUFA II), and has served in various capacities including as the implementation lead for all pre-market commitments from PDUFA VII, and as a negotiator on the FDA OMUFA II negotiation team. Mr. Phillips is also a member of the OND Senior Management Council. 

Prior to joining the FDA, Mr. Phillips worked in pharmaceutical research and development for 9 years in academic labs as well as pharmaceutical and biotechnology start-ups. He received a Bachelor of Science in Biology from the University of Utah, and a Master of Science in Bioscience Regulatory Affairs from John’s Hopkins University. He has also received post-graduate certificates in 1) Patient and Product Safety from the University of Southern California, Los Angeles, and 2) Operations Management from Cornell University.

Rachele Pojednic

Ph.D., Director of Scientific Research, Restore

Dr. Rachele Pojednic is an international authority on nutrition, supplementation and physical activity interventions for muscle physiology, performance and recovery. She received her PhD from Tufts University Friedman School of Nutrition Science and Policy and completed her postdoctoral training at Harvard Medical School at the Joslin Diabetes Center and Spaulding Rehabilitation Hospital. 

In addition to serving as Restore’s Director of Scientific Research and Education, she has a faculty appointment at Stanford University and holds research appointments at The Institute of Lifestyle Medicine at Harvard Medical School, and Edith Cowan University’s Nutrition and Health Innovation Research Institute. She has received NIH research funding from the National Heart Lung and Blood Institute (NHLBI) and the Vermont Biomedical Research Network (VBRN), an NIH IDeA Network of Biomedical Research Excellence (INBRE) program. She currently serves on the Board of Governors for the American College of Sports Medicine (ACSM) Exercise Is Medicine® initiative. 

Dr. Pojednic has been an active fitness professional for over 20 years as a nutrition educator and coach for Olympic, Division I sports, and tactical athletes. She has a passion for science communication and is regularly featured in outlets such as NPR, Sirius Doctor Radio, Time, the Wall Street Journal, STAT News, Popular Science, Self, Shape, Women’s Health, Forbes, and Runners World.

Ollithodi Pradeep

B. Pharm, M. Pharm, Vice President, Reference Standards Laboratory, US Pharmacopeia

Ollithodi Pradeep has more than 28 years of experience in the pharmaceutical and regulatory industry. Before joining United States Pharmacopeia, he worked with several pharmaceutical industries in different capacities including establishing and managing analytical laboratories. Prior to joining USP, he was responsible for managing the analytical laboratory of Biovail (Valeant) corporation. During his career, he also worked with Core Healthcare, Ranbaxy Research Laboratories, and a division of Sun Pharma US operations.

His main area of expertise is Analytical chemistry, compliance, and regulatory filing (ANDA, NDA, IND, NCE) and drug applications. He is well versed with FDA, ISO, and ICH guidelines and implementations. He is currently responsible for the Reference Standards Characterization program and other new initiatives at United States Pharmacopeia. He holds a B. Pharm and M. Pharm degree from Dr. MGR Medical University, India.

Catherine Pugh

Director, Digital Health, Consumer Technology Association

Catherine joined the Consumer Technology Association (CTA) in April 2022, focusing on federal digital health policy. Prior to joining CTA, Catherine served as the Assistant Vice President of Policy for Executives for Health Innovation (EHI). At EHI, she led the organization’s Policy Steering Committee and served as the primary liaison to Capitol Hill and the administration on digital health issues including telehealth, digital health equity, consumer health data privacy, regulation of digital health, and health data interoperability.

Catherine also served as Senior Director, Government Affairs at Horizon Government Affairs, where she also managed the Health Innovation Alliance. Through numerous coalitions and clients at HGA, Catherine worked on landmark digital health legislation and regulations including the 21st Century Cures Act, the Bipartisan Budget Act of 2018, and the Medicare Access & CHIP Reauthorization Act (MACRA).

Catherine began her career at the Parkinson’s Action Network (now a part of the Michael J. Fox Foundation for Parkinson’s Research), where she managed federal policy initiatives and advocacy strategies to advance better treatments and a cure for Parkinson’s disease.

Lauren Quinn

J.D., Vice President, US Regulatory Affairs, Haleon

Lauren Quinn is a regulatory affairs executive with over 20 years of experience navigating the complex landscape of US consumer healthcare regulations. As the Principal Consultant and Founder of Touchpoint Regulatory Affairs Consulting, Lauren provides expert guidance on regulatory strategy, compliance, product development, and business strategy to clients across the consumer health industry.

Prior to founding Touchpoint, Lauren held senior leadership positions at prominent consumer healthcare companies, where she led regulatory teams and oversaw a diverse portfolio of products and issues. Her expertise spans a wide range of therapeutic categories and issues that affect the consumer healthcare industry.

Throughout her career, Lauren has been an industry champion for access and self-care.  Within CHPA, she has served on numerous committees and working groups focused on advancing these causes, including in her role as a former Chair of the Regulatory and Scientific Affairs Committee. Today, Lauren continues to engage e in shaping industry policy and promoting the importance of accessible and effective self-care options.

Lauren holds her undergraduate degree from Rutgers University and her law degree from Seton Hall University School of Law.

Tammi Schaeffer

DO, Director, North America Medical Safety (Self Care), Kenvue

Tammi Schaeffer, DO is Director, North America Medical Safety at Kenvue where she leads the oversight and strategy for safety associated with the Self-Care portfolios.  She joined the company in 2020 and prior to her current role, she was the Medical Safety Officer for the analgesic portfolio and the Self Care Stronghold Lead. 
 

Prior to joining Kenvue, Tammi had a long career in clinical medicine as an academic Medical Toxicologist and Emergency Physician. She received her B.A degree in Psychology from Rutgers University in New Jersey and her medical degree from the University of New England in Biddeford, ME. She completed her residency in Emergency Medicine at Morristown Medical Center in Morristown, NJ where she also was Chief Resident. She completed a medical toxicology fellowship at the Rocky Mountain Poison and Drug Center in Denver, Colorado.
 

While in Colorado, she held academic teaching positions at the University of Colorado Health Sciences Center and Denver Health Medical Center. While in Maine, she was the Medical Director of the Northern New England Poison Center in Portland ME and the Director of the Division of Toxicology at Maine Medical Center, Portland ME with an academic teaching appointment at Tufts University School of Medicine in Boston, MA.
 

Howard D. Sesso

ScD, MPH, FAHA, 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

M.S., 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. 

Bernard Simone

President, Simone OTC Consulting

Bernie has over 40 years of experience in the OTC industry spanning a range of responsibilities across Regulatory, Commercial and Operational functions. Bernie has worked for major pharmaceutical consumer health companies and most recently as a consultant for smaller pharmaceutical companies. He pioneered a number of first-in-class Rx-to-OTC switches including Nasacort – the first intranasal steroid, Icy Hot Smart Relef – the first OTC TENS unit and the near-first naloxone product – RiVive®, a life-saving OTC product. He specializes in shepherding new-class and new-category switches through the FDA approval process and the commercialization process.

Bernie has extensive senior leadership experience in Marketing, Consumer Research and New Business Development across major US brands such as Aleve, Bayer Aspirin, the Alka-Seltzer franchise and several other iconic brands. He was most recently the Chief Operating Officer of Harm Reduction Therapeutics and is now an independent consultant in the OTC industry. 

Gregory D. Smith

MPH., Senior Director, Rx-to-OTC Switch, 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.  He is currently the Switch Science lead for the switch of Tamiflu.

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) – now Haleon, 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.

Greg Sperla

Partner, DLA Piper LLP (US)

Greg Sperla is a litigator and regulatory attorney protecting clients in complex litigation and compliance matters. He is one of the few attorneys to have obtained a post-trial judgment requiring a Proposition 65 "bounty hunter" to pay costs to a defendant. He is focused on the science of consumer products of all types, particularly food, drugs, and cosmetics, and is broadly experienced in domestic and global regulation of consumer goods and disputes. Mr. Sperla has advised companies of all sizes in dozens of industries on matters involving California's Proposition 65, consumer class actions, product labeling and marketing rules, administrative and regulatory enforcement proceedings, permitting and licensure, hazardous waste, and commercial disputes, among other issues.

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.

Peter Stein

M.D., Director of CDER’s Office of New Drugs (OND), FDA

Peter Stein, M.D., is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products. OND provides guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters.

A nationally recognized leader in pharmaceutical research and development, Dr. Stein joined CDER in 2016 as the OND Deputy Director. Before coming to FDA, he served as Vice President for late-stage development, diabetes, and endocrinology at Merck Research Laboratories. He also served as Vice President, head of metabolism development at Janssen. He has more than 30 years of academic, clinical, and industry experience.

Dr. Stein holds a bachelor’s degree in history from the University of Rochester in New York and a medical degree from the University of Pennsylvania. He trained at Yale University and Yale-New Haven Hospital in internal medicine and in endocrinology and metabolism.

Tony Sulsona

Vice President of Sales & Marketing, Nuheara Limited

Tony is an accomplished sales and marketing executive with over 25 years of sales leadership, senior-level management, and business development expertise at established and startup healthcare and medical device companies, with proven success executing commercialization, marketing initiatives, customer service, and managing strategic stakeholder relationships.  

His hearing healthcare experience spans 20 years of launching the “World’s First Disposable Hearing Aid”, the “World’s First Middle-Ear Implantable Device”, currently with Nuheara, the “World’s First FDA-Cleared Self-Fitting OTC Hearing Aid”, and previously 13 years as Vice President of Sales with Swiss hearing aid manufacture Bernafon where he also served as Sales & Marketing Strategic Advisor and US Brand Strategy Think Tank delegate.

Tony also serves in Board and Sales & Marketing Advisor roles for AudioCardio, Audiology Exclusive, and the Intelligent Health Association.

Michelle Tarver

M.D., Ph.D., Acting Director and Chief Transformation Officer, Center for Devices and Radiological Health (CDRH), FDA

Dr. Michelle Tarver is a visionary public health executive, board-certified in ophthalmology with a doctorate in epidemiology, who serves as the Acting Director of the Center for Devices and Radiological Health.  She has spent more than 15 years as a medical device regulator, driving strategic initiatives, conducting clinical research, and changing organizational culture.  Dr. Tarver has held various leadership positions while at FDA, including the Deputy Director of the Office of Strategic Partnerships and Technology Innovation and the Program Director of Patient Science and Engagement.  Over the course of her career, she has conducted laboratory-based and epidemiological studies, clinical trials, and surveys to capture patient preferences, as well as developed registries and patient-reported outcome measures. Dr. Tarver has extensive policy experience in crafting regulations, guidances, and conducting premarket and postmarket reviews. She most recently served as the Deputy Center Director for Transformation, steering the development, implementation, and direction of CDRH’s transformative projects and strategic initiatives. Under her leadership, CDRH has launched efforts to amplify the perspectives of people living with medical conditions, foster collaboration across the healthcare ecosystem, and stimulate creative evidence generation pathways.  Dr. Tarver received a B.S. in Biochemistry from Spelman College in Atlanta, GA and completed the M.D./Ph.D. program at The Johns Hopkins University School of Medicine and Bloomberg School of Public Health.  As a dedicated clinician, she continues to care for people living with inflammatory eye conditions.

Keith Thornley

Ph.D., Head of Dry Molded Fiber Collectives, PA Consulting

Keith Thornley is one of the senior leaders of PA Consulting’s Dry Molded Fiber (DMF) business, working hand-in-hand with our technology partner PulPac to develop more sustainable single-use packaging solutions for the Consumer Health, FMCG, and Pharmaceutical industries.  Keith’s current role is the Commercial Program Head for both the Bottle and Blister Pack Collectives, where he has the immense privilege of working directly with several of the world’s leading brands to develop the world’s first DMF bottle and tablet blister pack.  

Prior to his work with DMF and sustainable packaging, Keith had 10+ years of experience as a strategy and innovation consultant for PA, 4iNNO, and McKinsey & Company.  His expertise was helping R&D-driven firms accelerate the development of new-to-the-world technologies, products, and business models.  Keith earned his Ph. D. in Biological Chemistry from the University of North Carolina at Chapel Hill and his B.S. in Chemistry from The Ohio State University.

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.

Rachel Turow, J.D.

Senior Lead Counsel, 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.

Jerry Valentine

Senior Director Commercial Innovation, AstraZeneca

Accomplished and entrepreneurial healthcare leader with >25 years of experience driving innovation across the digital health technology, consumer selfcare, and pharmaceutical industry. Skilled in connecting with industry thought leaders and delivering novel digital solutions (ACNU) to FDA leadership to influence public policy and deliver a positive impact in the healthcare space.

Recognized as a trusted advisor and strategic problem solver with a proven track record of delivering creative solutions to complex business challenges.  
In Jerry’s current role as Senior Director Commercial Innovation, he has a Commercial leadership role that spans across app development, marketing strategy, and innovative business partnerships.  Jerry often serves as a bridge between Clinical and Commercial during research/development stages.

Kersi Vasunia

Ph.D., Senior Director of Oral Care, The Procter & Gamble Company

Kersi Vasunia is at the helm of Global Regulatory Affairs and Human and Environmental Safety at Procter & Gamble Oral Care business. With a global team, Kersi oversees a diverse group of products including dentifrice, toothbrushes, denture adhesives, oral OTC drugs, cosmetic rinses, teeth whitening solutions, and dental floss. These products, sold worldwide under brand names like Crest, Oral-B, Glide, Scope, and Fixodent, adhere to various regulatory classifications such as OTC monograph drugs, medical devices, cosmetics, natural health products, hygiene products, etc.

With a 25-year tenure at Procter & Gamble, Kersi has lent his expertise to the Safety and Regulatory organizations across several business domains, spanning Personal Health Care, Beauty Care, Feminine and Baby Care, and Fabric and Home Care.  Kersi obtained his Ph.D. in Molecular Toxicology from the University of Cincinnati Medical Center.  From the United States to Asia and Europe, Kersi's contributions have solidified his standing as an authority in the Regulatory and Safety field.

Nelson Webb

Director, QA External Engagement, The Procter & Gamble Company

Nelson has 36 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.

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.

Wendy Wilson-Lee

Ph.D. is a Deputy Office Director in the Office of Quality Surveillance (OQS), within CDER’s Office of Pharmaceutical Quality (OPQ).

She joined FDA in September 2006. Wendy earned her Doctorate in Pharmaceutical Science at the University of Maryland – Baltimore under Dr. Larry Augsburger.  She holds dual Bachelor of Science degrees in Chemical Engineering and Chemistry from North Carolina A&T State University.  In addition to her academic honors, Wendy also is a graduate of the Partnership for Public Service Excellence in Government Leadership Program. 

Dr. Wilson-Lee is currently using her role as Deputy Office Director to help shape the culture and surveillance operations of OQS and OPQ. She also serves as the program lead for the Drug Quality Sampling and Testing (DQST) program.  Wendy is a wife and a mother and enjoys sharing her love of S.T.E.M and leadership development as a speaker and coach for elementary, middle, and high school girls.

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.

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 is closed.

Save the date for September 9 - 10, 2025. We'll see you next year!

Registration & Logistics Questions

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.