An Interview with Kerry A. Wentworth at Flexion Therapeutics
Kerry currently serves as the Chief Regulatory Officer at Flexion Therapeutics. Ms. Wentworth has 25 years of experience in both domestic and international Regulatory Affairs that spans early and late development across multiple therapeutic areas. Ms. Wentworth joined Flexion Therapeutics in 2014 where she’s been responsible for leading the company’s first NDA successfully through the FDA approval process. Prior to joining Flexion, Ms. Wentworth served as Vice President, Clinical, Regulatory and Quality at Agenus, Inc., where she was responsible for leading all global regulatory and clinical development efforts for 10 years. Previously, Ms. Wentworth led the Regulatory and Quality function for Genelabs Technologies, Inc. and prior to that held positions of increasing responsibility within Regulatory Affairs at Genzyme. Ms. Wentworth is currently a board member of MassBIO.
1. What is your organization’s interest in the Osteoarthritis Action Alliance? Flexion is a biopharmaceutical company with a focus on discovering, developing and delivering medicines that will improve the lives of patients suffering from musculoskeletal conditions – beginning with OA. Flexion’s interest in the Osteoarthritis Action Alliance is therefore rooted in our shared mission of helping the over 30 million patients in the United States who confront OA understand and manage the debilitating effects of the disease.
2. What is a headline you’d like to see about osteoarthritis in five years? “Bending the curve in OA: Innovative treatments pared with public health education successfully converge to decrease the need for joint replacements.”
3. What do you think is the most important issue today related to osteoarthritis? Probably the most important issue today is the limited awareness and appreciation of the serious health implications associated with ignoring or under-managing the pain and other symptoms of OA. OA is a highly prevalent, painful, progressive and incurable disease which places a tremendous burden on society; however, it is largely seen as simply an inevitable part of aging. The number of people diagnosed with OA is only expected to grow in the years ahead due to several demographic and societal factors, including the aging of the U.S. population, increases in the number of individuals who are overweight or obese, people living sedentary lifestyles, and the long-term effects of knee injuries in aging athletes. Failure to effectively manage OA symptoms can result in a cascade of negative health consequences that not only impact quality of life but can lead to patients with knee OA limiting or avoiding physical activity, which ultimately contributes to an increased risk for comorbidities like cardiovascular disease and diabetes.
4. How does your work connect to issues in osteoarthritis? With our deep research, development and commercialization expertise in OA, we recognize the significant lack of awareness regarding the seriousness of this disease and we are actively partnering with advocacy organizations like the OA Action Alliance and the Arthritis Foundation to bring discussions about OA research, development and regulatory guidance to the forefront of conversations with policymakers. Through these partnerships we aim to lend support in voicing the urgent patient need and why priority should be given to regulatory innovation in OA, including the importance of focusing not just on pain, but functional/quality of life improvement, as well as defining structural endpoints for demonstrating disease modification.
5. What is one interesting fact you’d like people to know about your organization? Since OA is so prevalent, it is not surprising that we have employees who have also confronted the disease and several have benefited from our first approved product for OA knee pain. In fact, the first patient to receive the commercially available product was a Flexion Therapeutics employee.