Leadership
The Soleno leadership team has proven success in all phases of drug development and global commercialization of therapies in both rare and large patient populations.
Anish Bhatnagar, MD
Chief Executive Officer
Anish Bhatnagar, MD
Chief Executive Officer
Dr. Bhatnagar has been our Chief Executive Officer since the creation of Soleno in 2017. He is a physician with over 20 years of experience in biopharmaceutical and medical device industries. Dr. Bhatnagar’s experience spans development of biologics, drugs, drug-device combinations and diagnostic as well as therapeutic medical devices. He has been involved in the development of various approved products such as Bexxar (radioimmunotherapeutic for Non-Hodgkins lymphoma), Probuphine (for opioid addiction), Serenz (device for nasal allergies) and CoSense (for neonatal hemolysis). Prior to Soleno, Dr. Bhatnagar served as Chief Executive Officer of Capnia, Inc from February 2014 until March 2017, and held positions of increasing responsibility at Capnia from 2006 . His earlier experience includes working at Coulter Pharmaceuticals, Inc. from 1998 to 2000 and Titan Pharmaceuticals, Inc. from 2000 to 2006. Dr. Bhatnagar is the author of several peer-reviewed publications, abstracts and book chapters and obtained his medical degree at SMS Medical College in Jaipur, India, completing his Residency and Fellowship training in the U.S. at various institutions, including Georgetown University Hospital and the University of Pennsylvania.
Lauren Budesheim
Vice President, People
Lauren Budesheim
Vice President, People
Ms. Budesheim joined Soleno as Vice President, People in January 2024 but had been consulting for Soleno since August 2021. She has more than 20 years of experience in human resources and has held a variety of positions as a human resource professional in various industries, most recently in medical device and biotechnology. 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 has a deep commitment to people development and a proven track record of building teams and cultures that support a company’s mission. She earned a Bachelor of Science degree in Psychology from the Scripps College, and a Master of Science in Organizational Development from the University of San Francisco.
Neil M. Cowen, PhD, MBA
Senior Vice President, Drug Development
Neil M. Cowen, PhD, MBA
Senior Vice President, Drug Development
Dr. Cowen joined Soleno as the Senior Vice President, Drug Development in March 2017, as the result of the acquisition of Essentialis. Previously, Dr. Cowen was part of the senior management team of Essentialis since its founding in May 2003, functioning first as founding CEO and most recently as President and CSO, directing the product development, finance and business development functions. From 2001 to 2003 Dr. Cowen served as VP for Strategic Development at Epicyte Pharmaceutical. From 1986 to 2001 Dr. Cowen functioned in various business development and research management roles in Dow Chemical and its subsidiaries, ending as Global Business Leader for biopharmaceuticals and animal health. Dr. Cowen has a PhD from Iowa State University an MBA from the University of Indianapolis, and BS and MS degrees from Michigan State University. Dr. Cowen also serves on the Board of Regents of Concordia University Irvine.
Dairine Dempsey, PhD
Vice President, Europe
Dairine Dempsey, PhD
Vice President, Europe
Dr. Dempsey joined Soleno as Vice President, Europe in January 2024 but had been consulting for Soleno since January 2019. Dr. Dempsey brings more than 20 years of experience in the pharmaceutical, biologic, and device industries.
Prior to joining Soleno, she was CEO of rare disease start-up, Open Orphan plc (now hVIVO plc) and VP, Strategic Regulatory Affairs at ICON plc. In addition to her time in industry, she 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. In her career, 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. Dr. Dempsey holds a pharmacy degree and a PhD from Trinity College Dublin and a certificate in international business from University College Dublin.
Patricia C. Hirano, MPH
Senior Vice President, Regulatory Affairs
Patricia C. Hirano, MPH
Senior Vice President, Regulatory Affairs
Ms. Hirano is our Senior Vice President, Regulatory Affairs and has over 20 years of regulatory affairs in the biopharmaceutical industry. She joined the Company as Vice President, Regulatory Affairs in January, 2019. From April, 2017 through December, 2018, Ms. Hirano served as Head of Regulatory Affairs and Quality at the Company in a consulting capacity.
Prior to this, she was an independent regulatory consultant since April, 2010, providing regulatory affairs, project management, and clinical operations expertise to biopharmaceutical and biosimilar companies. Her experience encompasses the development of pharmaceuticals, biologics, and drug-device combination products for the treatment of oncology, cardiovascular, neurology, pulmonary/allergy, and endocrine/metabolic diseases. Prior to 2010, she held various positions of increasing responsibility at the Company, Titan Pharmaceuticals, Inc., PRTM (now PWC), CV Therapeutics, Inc. (acquired by Gilead), and Matrix Pharmaceutical, Inc. (acquired by Chiron Corp). She has also been the coordinator of the Bay Area Compliance Discussion Group since 1998. She has been a Director at The Big C Society since April 2014. She earned a Bachelor's degree in physical education from the University of California, Berkeley, and Master of Public Health degree from San Jose State University.
Charles Horn
Vice President, Quality
Charles Horn
Vice President, Quality
Mr. Horn joined Soleno in January 2022 as the Vice President of Quality. He has over 20 years’ experience working for pharmaceutical companies supporting commercial manufacturing and clinical development programs. Prior to joining Soleno Mr. Horn worked at several companies including Gilead Sciences, Novartis and Revance. He has quality operations and compliance experience having previously worked at solid dose, biologic and parenteral manufacturing facilities with global regulatory oversight and distribution. Mr. Horn has a Bachelor of Science degree in biology from the University of Redlands, CA.
Michael Huang, MD
Senior Vice President, Clinical Development
Michael Huang, MD
Senior Vice President, Clinical Development
Dr. Huang joined the Company as Senior Vice President, Clinical Development in November 2023. He has a history of successfully advancing small molecules, biologics, and oligonucleotide therapies through all phases of clinical development. He was involved in marketing authorizations for several therapeutics including Potiga®, Zevalin®, Uceris®, Ruconest®, and Austedo®. Prior to joining Soleno, Dr. Huang held CMO roles at AmMax Bio, Inc. and Spruce Biosciences, where led their respective rare disease clinical development programs through proof-of-concept and successful rounds of financing. Earlier in his career, Dr. Huang held leadership roles at Regulus Therapeutics, Auspex Pharmaceuticals (until its acquisition by Teva), and Santarus, Inc. (until its acquisition by Salix). Dr. Huang received his bachelor’s degree in molecular and cell biology from the University of California at Berkeley, his medical degree from the Chicago Medical School at Rosalind Franklin University, and his post-graduate internship and residency training from the University of California at Irvine / Long Beach Memorial Medical Center. Dr. Huang is the author or co-author of numerous peer-reviewed journal articles, abstracts, and scientific publications.
Jim Mackaness
Chief Financial Officer
Jim Mackaness
Chief Financial Officer
Mr. Mackaness joined Soleno as our Chief Financial Officer in November 2019, initially on a consulting basis and most recently on a full time basis. He has been a partner at FLG Partners, a leading Silicon Valley chief financial officer services and board advisory consultancy, since September 2019. Prior to joining FLG, Mr. Mackaness served as Chief Financial Officer for Invuity, Inc (NASDAQ: IVTY) sold to Stryker Corporation. He has also served as Chief Financial Officer and Chief Operating Officer of IRIDEX Corporation (NASDAQ: IRIX), Chief Financial Officer of NextHop Technologies, Inc., and Chief Financial Officer of Infogear Technologies Corp. which was sold to Cisco Systems, Inc.. Mr. Mackaness began his career at Ernst & Young LLP., received his B.A. with honors in Psychology from the University of Warwick, England and is a Chartered Accountant.
Scott Madsen
Vice President, CMC
Scott Madsen
Vice President, CMC
Mr. Madsen joined Soleno as our Vice President, CMC in January 2022. Mr. Madsen has over 20 years of experience in the pharmaceutical industry, including increasing responsibilities in formulation and process development, clinical and commercial supply chain, and quality control and quality assurance with a focus on small molecule controlled-release formulations. In his most recent role prior to joining the Company, he oversaw manufacturing and supply chain for Adamas Pharmaceuticals and helped achieve an NDA and multiple sNDA approvals as well as a robust supply chain, enabling the successful commercialization of Gocovri™.
He is an inventor on six controlled release formulation patents as well as an author of a book chapter on pediatric formulations. He earned a Bachelor of Science degree in Medical Microbiology and Immunology and MBA Certification from the University of Wisconsin, Supply Chain certification from the University of California, Irvine, and is a Certified CAPA investigator.
Meredith Manning, MBA
Chief Commercial Officer
Meredith Manning, MBA
Chief Commercial Officer
Meredith Manning, MBA 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 MBA from the University of Chicago Booth School of Business and a BA in political science from Colorado College.
Mitchell Nagao, PharmD, MBA
Senior Vice President of Medical Affairs
Mitchell Nagao, PharmD, MBA
Senior Vice President of Medical Affairs
Dr. Nagao joined Soleno as the Senior Vice President of Medical Affairs in 2024. He brings over 20 years of experience in the biotech and managed care industries with a history of successful product launches in both rare and specialty therapeutic areas. Prior to Soleno, he served as Vice President, Head of Medical Affairs at Myovant (until its acquisition by Sumitomo Pharma), where he led the Medical Affairs team through three successful launches in Prostate Cancer and Women’s Health. Previously, Dr. Nagao held senior roles at Prothena Biosciences, where he served as Head of Market Access, and at Actelion (acquired by Johnson & Johnson), where he was Head of Medical Affairs for Tracleer, Opsumit and Valchlor. At Actelion, he played a key role in seven launches across rare disease areas, including Pulmonary Arterial Hypertension, Cutaneous T-Cell Lymphoma, and Gaucher’s Disease.
Dr. Nagao began his healthcare career at Aetna as a Pharmacy Director. He holds a Doctor of Pharmacy from the University of the Pacific, and an MBA from The Wharton School.
Jesse Schumaker
General Counsel
Jesse Schumaker
General Counsel
Mr. Schumaker joined Soleno as General Counsel in October 2024 but had previously acted as outside counsel to the company for several years while at Wilson Sonsini. He has more than 15 years of experience representing life sciences companies in the Bay Area. Prior to Wilson Sonsini, Mr. Schumaker was an AGC at Bio-Rad Laboratories (NYSE: BIO) and started his career at Pillsbury Winthrop Shaw Pittman. He holds a JD from New York University and a BA from the University of California, Berkeley.
Raymond Urbanski, MD, PhD
Chief Development Officer
Raymond Urbanski, MD, PhD
Chief Development Officer
Dr. Urbanski joined Soleno as the Chief Development Officer in 2024. He is a physician, scientist, and pharmaceutical executive who has been a transformational leader in the field of clinical development over the past three decades. Dr. Urbanski’s robust experience in oncology clinical development, clinical research and clinical practice contributed to the development of numerous new medications across a wide range of therapeutic areas, including oncology, hematology, cardiovascular, endocrinology and neurology.
At Soleno, Dr. Urbanski oversees the teams responsible for clinical and drug development, CMC, clinical operations, medical affairs, quality and regulatory. Prior to joining the company, Dr. Urbanski served as the Head of Clinical Development and Medical Affairs, Product Safety and Risk Management, Regulatory Affairs, and Quality Assurance for PharmaEssentia where he drove development and regulatory efforts that led to approval of ropeginterferon in the United States for polycythemia vera. Prior to PharmaEssentia, Dr. Urbanski served roles of increasing responsibility culminating in his appointment as Chief Medical Officer for biotechnology and global pharmaceutical companies.
While in private practice, Dr. Urbanski co-founded and served as President of Clinical Studies Associates (CSA, Inc.), a site management organization. Additionally, in clinical practice and in his early career in the pharmaceutical industry he served as the Principal Investigator, Sub-Investigator, or Medical Director of over 100 clinical trials across multiple therapeutic areas culminating in numerous publications and presentations at key international conferences.
Dr. Urbanski earned his medical degree from the New Jersey Medical School and completed his residency and fellowship at T. Jefferson University Hospital. He received his Ph.D. in Pharmacology from the UMDNJ Graduate School of Biomedical Sciences GSBS.
Kristen Yen, MS
Senior Vice President, Clinical Operations
Kristen Yen, MS
Senior Vice President, Clinical Operations
Ms. Yen has over 20 years of clinical research experience in the pharmaceutical and medical de vice industries. She joined the Company 2006, and currently serves as the Senior Vice President of Clinical Operations. Prior to joining the Company, she managed multiple U.S. and global clinical studies in oncology and held various positions of increasing responsibility at Titan Pharmaceuticals. She began her career in the industry as a clinical employee at PRA International. She has served as a team member and managed clinical studies in neonatology, neurology, pulmonary/allergy, cardiovascular disease, endocrine/metabolic disease, and oncology. She earned a Bachelor of Science degree in mathematics from the University of California, Davis, and a Master of Science degree in cell, molecular and neurosciences from the University of Hawaii, Manoa.
Developing novel therapeutics for the treatment of rare diseases