NEW YORK--(BUSINESS WIRE)--Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ solutions as prescription medical treatments, today announced the appointments of Randall Kaye, M.D., as Chief Medical Officer and Austin Speier as Chief Strategy Officer. Dr. Kaye and Mr. Speier bring extensive clinical development and regulatory strategy experience, specifically in translating scientific advances into successful products that improve health outcomes and enhance patient experience.
“This is an exciting time to welcome Randall and Austin to our executive team as we continue to rapidly advance our product development pipeline,” said David Benshoof Klein, Co-founder and CEO of Click. “Randall and his success as CMO of Avanir and bringing Nuedexta through development, FDA approval and launch, will provide crucial industry knowledge and leadership. Austin’s extensive strategic consulting and FDA regulatory experience, spanning over 250 life sciences companies and many first-in-class digital products, will be instrumental to Click as the company navigates novel and complex product opportunities with evolving FDA regulatory pathways.”
“Click sits at the forefront of the growing digital therapeutics space, where digital technology is providing an opportunity to address medical treatments in novel and impactful ways,” said Dr. Randall Kaye. “For example, innovative therapeutics are needed to address conditions such as Major Depressive Disorder, where currently available treatments are inadequate or insufficient.”
“Digital therapeutics is a promising new sector in healthcare, one we are excited to help further develop through the design and validation of engaging, personalized treatments that are safe and effective. Patients and healthcare professionals are ready for these new options. FDA, recognizing this need, is now dedicating more time to reexamine its regulatory pathways for software as medical devices to fully support digital therapeutics. We look forward to working with FDA and other key stakeholders to build out this new therapeutic category,” said Mr. Austin Speier.
Randall E. Kaye, M.D., was previously the Chief Scientific Officer for SSI Strategy, where he focused on providing medical and scientific perspectives to the company’s initiatives in medical affairs and pharmacovigiliance. In conjunction with his role at SSI Strategy, he served as Chief Medical Officer for Axsome Therapeutics. Dr. Kaye formerly served as the Chief Medical Officer of Avanir Pharmaceuticals, Inc., acquired for $3.5 billion, where he focused on providing leadership and vision to the clinical development and medical affairs areas while supporting the commercialization of new products from a medical, scientific, regulatory, technical and quality perspective. Immediately prior to joining Avanir, Dr. Kaye was the Vice President of Medical Affairs for Scios Inc., acquired for $2.4 billion, where he built and integrated a Medical Affairs department consisting of 80 professionals. Dr. Kaye also recruited and managed the Medical Affairs department for InterMune Inc., acquired for $8.3 billion. Prior to joining InterMune, Dr. Kaye served for nearly a decade in a variety of Clinical Development and Medical Affairs positions for Pfizer Inc. Dr. Kaye earned his M.D., M.P.H., and B.S. degrees at George Washington University and was a Research Fellow in Allergy and Immunology at Harvard Medical School.
Austin Speier was previously the Vice President, Emerging Technologies at Precision for Medicine, where he advised on the design and execution of development and go-to-market strategies for complex or first-in-class products, especially those with a digital software-based component. In addition, he worked closely with early-stage and venture-backed clients to identify and address the most critical scientific, clinical, regulatory, and reimbursement issues on the pathway to market for their products. Mr. Speier’s experience spans a range of product categories and therapeutic areas including work with numerous cardiovascular, neurology, wound care, gastroenterology, oncology, drug delivery, women’s health, software, mobile health, diagnostic, and consumer products. He previously conducted research at the Brigham & Women’s Hospital Center for Neurodegeneration and Disease, where he focused on characterizing the molecular and cellular pathology of Alzheimer’s Disease. Mr. Speier holds an A.B. cum laude in Biology from Harvard College, where he also completed the interdisciplinary Honors Neurobiology program to receive a certificate in Mind, Brain, and Behavior Studies.
About Click Therapeutics
Click Therapeutics, Inc. develops and commercializes software as prescription medical treatments for people with unmet medical needs. Through cognitive and neurobehavioral mechanisms, Click’s Digital Therapeutics™ enable change within individuals, and are designed to be used independently or in conjunction with biomedical treatments. The Clickometrics® adaptive data science platform continuously personalizes user experience to optimize engagement and outcomes. Following a groundbreaking clinical trial, Click’s industry-leading smoking cessation program is available nationwide through a wide variety of payers, providers, and employers. Click’s lead prescription program is entering into a multi-center, randomized, controlled, parallel-group, phase III FDA registration trial for the treatment of Major Depressive Disorder in adults. For more information, visit ClickTherapeutics.com.