(WASHINGTON, DC) – The Consumer Healthcare Products Association (CHPA) today announced the appointment of Lisa Parks, RPh, to serve as its Senior Vice President of Regulatory & Scientific Affairs. Parks will succeed Barbara Kochanowski, Ph.D., who is retiring in July after nearly four decades of regulatory leadership in the consumer healthcare industry. Parks will begin her work at CHPA on June 5, 2023. As a member of the association’s senior management team, she will report to CHPA President and CEO Scott Melville.
Parks comes to CHPA with more than three decades of experience practicing pharmacy in retail and institutional settings, managing extensive cross-Center organizational change initiatives at the U.S. Food and Drug Administration (FDA), and serving as the vice president of scientific and regulatory affairs at the generic industry’s Association for Accessible Medicines (AAM). Most recently, she served as a senior vice president of regulatory policy at Greenleaf Health, a leading FDA regulatory consulting firm. Throughout her career, she has developed an expert understanding of FDA regulatory requirements and has significantly influenced regulatory strategy by serving as primary lead for the Generic Drug User Fee Amendments (GDUFA II & III) and her work on the regulatory and policy framework governing Abbreviated New Drug Application (ANDA) submissions.
“I am extremely pleased Lisa will be joining CHPA at this important juncture for our industry and association,” said President and CEO Scott Melville. “Lisa brings extensive regulatory experience both as an FDA manager and special assistant, but also as a trade association executive, regulatory consultant, and practicing pharmacist. Her wide-ranging experience will be enormously helpful as CHPA develops and implements regulatory strategies that will protect and promote self-care options on behalf of its member companies. Her leadership and expertise will be enormously beneficial as we approach reauthorization of the Over-the-Counter Monograph Drug User Fee Program (OMUFA), seek to enhance the Rx-to-OTC switch pathway, and continue working to modernize the regulatory framework for dietary supplements. Lisa will lead a talented and experienced regulatory and scientific affairs team at CHPA and build upon the successes achieved over the last 14 years under the leadership of retiring SVP Dr. Barbara Kochanowski. It’s an honor to welcome Lisa to the CHPA team, and I look forward to working together in pursuit of our mission to expand choice and availability of consumer healthcare products.”
During her time at AAM, Parks served as the primary lead and strategist for GDUFA and the Biosimilar User Fee Act (BsUFA) reauthorizations and implementation. Additionally, she served as the primary contact, subject matter expert, and facilitator for discussions and actions between member companies and the FDA on scientific and regulatory initiatives, policies, and inspections, and as the lead on all FDA matters related to the review and approval processes for generic and biosimilar medicines. Parks has also served as a consultant to CHPA on issues including nitrosamine impurities and OMUFA reauthorization.
While at FDA, Parks worked closely with the Center for Drug Evaluation and Research’s (CDER) executive leadership in implementing GDUFA I, reorganizing CDER to establish the Office of Pharmaceutical Quality, and improving review processes for the Office of Generic Drugs.
“It’s an honor to be joining CHPA’s regulatory and scientific affairs team,” said Parks. “Fostering a constructive regulatory environment is vital to CHPA’s mission of preserving and expanding choice and availability of consumer healthcare products, and I hope to use my industry and FDA experience from the generic and biosimilars space to help continue that mission. Having started my career practicing pharmacy in a retail setting where I helped inform consumers about their medications, including over-the-counter recommendations, I very much look forward to bringing that experience full circle by supporting increased access to a range of products that are becoming increasingly important to American consumers.”
Parks graduated with a Bachelor of Science from the Massachusetts College of Pharmacy. She is the recipient of several awards, achievements, and honors, including Pharmacist of the Year, several CDER team excellence awards, and was also selected to serve on CVS’s Red Robin Round Table Group, which targets individual pharmacists who possess superior management and leadership skills.