REDWOOD CITY, Calif., Jan. 24, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced the appointments of Meredith Manning, M.B.A as Chief Commercial Officer, Dairine Dempsey, Ph.D. as Vice President, Europe and Lauren Budesheim, M.S. as Vice President of Human Resources. The Company also announced the appointment of key advisors with Shamim Ruff, M.S. joining as Chair of the Development Advisory Board and James (Jim) Geraghty, J.D., M.S. as a Board Advisor. “As we move into the next phase of Soleno’s growth, we are delighted to welcome seasoned biopharmaceutical leaders Meredith, Dairine and Lauren as part of our leadership team as well as Shamim and Jim as key advisors,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “Together, their wealth of industry knowledge and proven track records will significantly strengthen our capabilities in both the U.S. and Europe as we build towards becoming a commercial-stage company. We look forward to leveraging their collective expertise as we advance DCCR toward NDA and MAA filings and potential approval in Prader-Willi Syndrome.” Meredith Manning, M.B.A. brings over 25 years of experience in global commercialization of biopharmaceuticals and medical devices. Her expertise spans U.S. and global commercialization, brand building, and go-to-market strategies for products at all lifecycle stages, with significant experience in rare diseases. Prior to joining Soleno, she served as President of the Americas and a member of the U.S. Board of Directors at PharmaEssentia, where she led the U.S. regulatory approval and commercial launch of PharmaEssentia's first product, BESREMi®. Prior to PharmaEssentia, Ms. Manning served as the Chief Commercial Officer at resTORbio and as a vice president of marketing for a seven-brand hemophilia portfolio at Baxter BioScience (now Takeda). She previously held senior marketing and field leader roles at Vertex and Pfizer. Ms. Manning holds an M.B.A. from the University of Chicago Booth School of Business and a B.A. in political science from Colorado College. Dairine Dempsey, Ph.D., brings over 20 years of experience in the pharmaceutical, biologic, and device industries. She has been a consultant to Soleno since 2019. Prior to consulting, she founded and led the start-up phase of Open Orphan, a company specializing in orphan drugs. Prior to Open Orphan, she served as Global Vice President, Strategic Regulatory Affairs at ICON, where she navigated and resolved significant regulatory and compliance challenges in clinical development and post-marketing programs across the US, EU, and Asia. Dr. Dempsey previously spent nine years at the Irish Health Products Regulatory Authority (HPRA) working with both the European Medicines Agency (EMA) and the European Commission on technical issues and policy development. She also led the establishment of the National Health Regulatory Agency for Pharmaceutical Products in Bahrain. She has been involved in the successful global clinical development and post-marketing management of over 10 pharmaceutical products across multiple therapeutic areas, many for rare diseases. She is a board member at Fighting Blindness and the FutureNeuro Research Centre in Ireland. Dr. Dempsey holds a Ph.D. from the School of Pharmacy at Trinity College and a Certificate in International Business from UCD Smurfit Business School. Lauren Budesheim, M.S. has over 20 years of experience and has held a variety of positions as a Human Resources professional. She is deeply committed to developing people and leveraging data and technology to modernize operations and to create a strong company culture in which employees are empowered and engaged. She previously served as Head of People at Neurona Therapeutics, where she built and implemented strategies, programs, and infrastructure to develop, engage, and retain the best talent. Prior to joining Neurona, Ms. Budesheim was Senior Director of Human Resources at Invuity where she was instrumental in developing a strong purpose-driven employee culture that fostered employee engagement and development. Prior to Invuity, Ms. Budesheim was the Senior Manager of Human Resources at Triton Container International where she was responsible for general operations of the Human Resources department. Additionally, she has led two successful integrations as a result of acquisitions. She has a B.A. in Psychology from Scripps College and a M.S. in Organizational Development from the University of San Francisco. She also received her Senior Professional Human Resources certification in 2008. Shamim Ruff, M.S. brings more than 25 years of experience in the biopharmaceutical industry, with expertise in both domestic and international regulatory affairs spanning early and late development across multiple therapeutic areas. She is currently the Chief Regulatory Affairs Officer and SVP, Head of Quality Assurance at Stoke Therapeutics and until recently, she served on the Board of Directors of Reata Pharmaceuticals until their acquisition by Biogen. Prior to Stoke, she served as Chief Regulatory Affairs Officer at Sarepta Therapeutics, where she built the company’s regulatory affairs and quality organizations and was responsible for leading and defining the regulatory strategy for the company’s rare and infectious disease pipelines. Prior to Sarepta, Ms. Ruff served as Vice President, Head of Regulatory Affairs Oncology at Sanofi-Genzyme, leading the global, European and CMC regulatory affairs teams. She has also held increasing senior regulatory roles at Amgen, Abbott and AstraZeneca. She holds a bachelor’s degree in chemistry and biology from the University of Leicester, UK, and a master’s degree in analytical chemistry from the University of Loughborough, U.K. James Geraghty, J.D., M.S. is an industry leader with over 30 years of strategic and leadership experience focused on the development and commercialization of innovative therapies. Mr. Geraghty serves as the Chairman of the Board of Directors for Orchard Therapeutics plc, Pieris Pharmaceuticals, Inc., and OMass Therapeutics. He is also a member of the Board of Directors for Voyager Therapeutics, Inc., and Fulcrum Therapeutics, Inc. He served as an entrepreneur-in-residence at Third Rock Ventures from 2013 to 2016. Prior to Third Rock Ventures, he served as Senior Vice President, North America Strategy and Business Development at Sanofi, which he joined upon its acquisition of Genzyme. During his 20-year tenure at Genzyme, Mr. Geraghty held pivotal roles such as Senior Vice President of International Development, President of Genzyme Europe, and founding president and CEO of Genzyme Transgenics. He holds a J.D. from Yale Law School, M.S. from the University of Pennsylvania and a B.A. from Georgetown University. About Soleno Therapeutics, Inc.Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company’s lead candidate, DCCR extended-release tablets, a once-daily oral tablet for the treatment of PWS, recently completed its Phase 3 development program to support a planned NDA submission. For more information, please visit www.soleno.life. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the timing of any regulatory process or ultimate approvals and determining a path forward for DCCR for the treatment of PWS. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including the risks and uncertainties associated with market conditions, as well as risks and uncertainties inherent in Soleno’s business, including those described in the company's prior press releases and in the periodic reports it files with the SEC. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Corporate Contact:Brian RitchieLifeSci Advisors, LLC212-915-2578
