PinneyAssociates Welcomes Dr. Judy Ashworth, Analgesic Drug Development Expert, and Bernie Simone, Rx-to-OTC Switch and Consumer Product Marketing Executive

Tuesday, October 23, 2018 General News
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BETHESDA, Md., Oct. 22, 2018 /PRNewswire/ -- PinneyAssociates is pleased to welcome Judy

Ashworth, M.D., as Chief Medical Officer and Bernie Simone as Vice President, Client Strategy and Rx-to-OTC Switch.

Judy Ashworth has nearly two decades of experience

in the development of novel analgesics and abuse-deterrent formulations.  While at Grünenthal GmbH, she led the clinical team during the EU and US regulatory submission and approval of tapentadol and most recently was head of their EU Innovative Medicines Unit hub in Leiden, Netherlands.

"Judy Ashworth brings with her a broad understanding of drug development, from translational medicine to market access and commercial strategies – especially in the area of analgesics and abuse deterrent formulations," said Joe Gitchell, President of PinneyAssociates. "Her unique understanding of bringing medicines from inception to the market place is of great relevance to our clients."

Bernie Simone has over 30 years of experience in the OTC industry, including in Rx-to-OTC Switch, product marketing, and business development.  While at Sanofi Consumer Healthcare, Bernie led the first-in-class switch of Nasacort Allergy 24HR and the switch of Xyzal Allergy 24HR.  While at Bayer, he held several positions including Director roles in business development, marketing and global category management.  Bernie led high growth strategic initiatives for the Aleve and Alka-Seltzer franchises, and global CardioAspirin, as well as multiple Rx-to-OTC switch initiatives. His experience spans over 40 therapeutic categories in OTC medicines, prescription drugs, medical devices, and dietary supplements. 

"Bernie Simone has led teams from the identification and evaluation of numerous Rx-to-OTC switch candidates through to the successful first-in-class switch of Nasacort Allergy 24HR," said Lucy Owen, Senior Vice President at PinneyAssociates. "Together with his experience in developing and implementing marketing strategies for OTC products that have effected high incremental growth for his companies, Bernie will help our clients achieve regulatory and commercial success."

PinneyAssociates is also pleased to announce two promotions.

Lucy Owen has been promoted from Vice President, Program Operations and Rx-to-OTC Switch to Senior Vice President.  With a primary focus on Rx-to-OTC Switch, Lucy works with our clients to develop and execute science-based strategies to address the concerns of regulators and other key stakeholders in order to facilitate regulatory approval for new products and maximize product acceptance.

Karen Gerlach, Ph.D., M.P.H. has been promoted from Co-Director, Clinical and Behavioral Research, to Director, Population Health Surveillance. An expert in public health and health policy, Karen applies her training and practical experience in epidemiology to meet our clients' challenges in post-market surveillance, risk management program design and implementation, and product labeling assessments.

PinneyAssociates is a science-based health consulting firm with unique resources and broad experience in scientific, medical, public health, regulatory and commercial aspects of prescription and consumer healthcare products. PinneyAssociates' scientists include internationally respected leaders at the intersection of public health, behavioral science, and medicines.  We help our clients to manage issues and enhance the scientific and policy environments to gain regulatory approval of, and maximize acceptance of, pharmaceutical and consumer healthcare products. PinneyAssociates' experts have extensive expertise and experience in medicines with abuse potential, Rx-to-OTC Switch and consumer healthcare products.

For more information about PinneyAssociates, please contact us at +1.301.718.8440 or, or learn more about our work at   

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