SAN JOSE, Calif.--(BUSINESS WIRE)--Allay Therapeutics, a clinical-stage biotechnology company pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation, today announced the expansion of its Clinical and Scientific Advisory Boards to support the company as it advances its clinical candidate ATX101 and develops its pipeline to support patients, physicians and payors with novel, extended-duration post-surgical pain management solutions.
With the expansion of these advisory boards, Allay has appointed nine preeminent, internationally recognized subject matter experts across pain management, orthopedics, clinical research, drug delivery, pharmacology and anesthesiology to provide strategic guidance around major company initiatives, including the Phase 2B registration trial of Allay’s lead investigational product, ATX101.
Allay’s expanded Clinical Advisory Board (CAB) now includes the following members:
- Sabry Ayad, M.D., M.B.A.
- Ron Burch, M.D., Ph.D.
- David Dalury, M.D.
- Hemant Pandit, FRCS, D.Phil
- Christine Sang, M.D., M.P.H.
Allay’s expanded Scientific Advisory Board (SAB) now includes the following members:
- Christine Allen, Ph.D.
- Ron Burch, M.D., Ph.D.
- Joachim Kohn, Ph.D.
- Louis L. Radulovic, Ph.D., M.P.H.
- Arthur Tipton, Ph.D.
“As we advance further into our late-stage registration trials and progress our ultra-sustained pipeline, we are pleased to have attracted a talented team of distinguished physicians and scientists to our expanded Clinical and Scientific Advisory Boards. We look forward to the significant insights and expertise these thought leaders will bring to Allay based on their diverse experiences in drug delivery and elution, pharmacology, surgical specialties, pain management, and anesthesiology,” said Adam Gridley, Chief Executive Officer at Allay Therapeutics. “The collective knowledge and insights of these appointees will provide welcome guidance as we navigate the complexities of the global clinical trial and regulatory landscapes, work to bring ATX101’s potential to patients in need, and build on our platform technology to develop novel extended-duration solutions to transform pain management for patients, physicians, payors and healthcare systems worldwide.”
Clinical and Scientific Advisory Board Biographies:
Sabry Ayad, M.D. – Clinical Advisory Board
Sabry Ayad, M.D., is a Professor of Anesthesiology at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, a fellow of the American Society of Anesthesiologists, and the President of the Cleveland Society of Anesthesiologists. In addition, Dr. Ayad is also a senior member of multiple medical societies and committees, such as the American Society of Anesthesiologists (ASA), the American Society of Regional Anesthesia and Pain Medicine (ASRA), Society of Ambulatory Anesthesia (SAMBA), Society of Cardiovascular Anesthesiologists (SCA), the Ohio Society of Anesthesiologists (OSA) and the International Anesthesia Research Society (IARS). He has published multiple peer-reviewed manuscripts focused on enhanced recovery after surgery (ERAS), AI and perioperative outcomes, and investigating topics related to postoperative nausea and vomiting, pain management, fluid and hemodynamic management, and anesthetic pharmacology. In 2016, Dr. Ayad was named Fairview Hospital Cleveland Clinic’s Physician of the Year and Safety Champion by the Cleveland Clinic Quality Institute. He earned his M.D. from Alexandria University, M.B.A. from Cleveland State University.
Ron Burch, M.D., Ph.D. – Clinical Advisory Board + Scientific Advisory Board
Ron Burch, M.D., Ph.D., currently serves as Chief Medical Officer of Gate Neurosciences, a company developing products to treat psychiatric disorders. He previously served as Chief Medical Officer at Naurex, a clinical-stage biopharmaceutical company developing novel NMDA receptor modulators, and Pacira, an industry leader in non-opioid solutions for pain. Dr. Burch has served as Chairman of Zeneca Pharmaceuticals’ Global CNS Therapeutics Area Team; co-founder and CEO of AlgoRx Pharmaceuticals, a company that successfully developed a number of therapeutic agents for pain management; CEO of Sanguistat, a medical device company that developed devices that inhibited hemorrhage following serious wounds, CEO and Chairman of Biowave Corporation, a medical device company that successfully launched three neurostimulation products to treat chronic, intractable pain and postoperative pain; and Scientific Advisor of Collegium Pharmaceuticals. He also held various managerial positions with Purdue Pharma, including Vice President of Scientific Evaluations and Immunotherapeutics, Medical Director and Project Manager and Medical Safety Officer for several pain development programs. Dr. Burch was a researcher at the National Institutes of Health, performing research involving neuroreceptor regulation with Nobel Laureate Dr. Julius Axelrod. Dr. Burch obtained a Ph.D. in Pharmacology and M.D. from the Medical University of South Carolina. He holds bachelor’s degrees in chemistry and marine biology from the College of Charleston.
David Dalury, M.D. – Clinical Advisory Board
David Dalury, M.D., is an Orthopedic Surgeon specializing in total knee replacement, partial knee replacement and total hip replacement. He is a Clinical Professor of Orthopedic Surgery (Emeritus) at the University of Maryland Medicine and has been Chief of Orthopedics at the University of Maryland St. Joseph Medical Center. He is an active member of The Knee Society, the American Association of Orthopedic Surgeons and the American Association of Hip and Knee Surgeons, among other medical associations. His work has been published extensively in peer-reviewed publications. Dr. Dalury is a graduate of Dartmouth Medical School, and he completed his residency and Fellowship in Total Joint Replacement at the Harvard-affiliated hospitals.
Hemant Pandit, FRCS, D.Phil – Clinical Advisory Board
Hemant Pandit, FRCS (Orth), D.Phil (Oxon) is a Professor of Orthopedic Surgery at University of Leeds and at University of Oxford, UK, and currently practices at Chapel Allerton Hospital, C/O Leeds Teaching Hospitals NHS Trust in the UK. Hemant has a high-volume hip and knee arthroplasty practice and is also a clinical academic. In addition, he holds the post of Deputy Dean in the Faculty of Medicine and Health C/O University of Leeds and is Head of School (Leeds Institute of Rheumatic Musculoskeletal Medicine). Dr. Pandit has published 400+ peer-reviewed articles, written 50+ book chapters and leads a multi-disciplinary team of 20+ colleagues. His research interest is focused on translational research across the entire osteoarthritis spectrum aimed at improving patient outcomes and optimizing their management pathways. Hemant's work on pain relief post knee arthroplasty is well recognized. Hemant is a NIHR Senior Investigator, an elected member of the American Knee Society and European Knee Society and is an MHRA (Medicines and Healthcare Products Regulatory Agency) advisor.
Christine N. Sang, M.D., M.P.H. – Clinical Advisory Board
Christine Sang, MD, MPH, FASA is an Associate Professor of Anesthesia at Harvard Medical School, specializing in both pediatric and adult anesthesiology and acute and chronic pain management. She is the founding director of the Translational Pain Research program at Brigham and Women’s Hospital, which conducts Phases 1a (First-in-Human), 1b/2a (proof-of-concept) and 2b/3 analgesic clinical trials in a variety of pain states and in neurodegeneration. Dr. Sang continues to serve on numerous boards and committees for her institution, leading medical societies, government agencies, publications, nonprofit organizations, and patient advocacy. She is the founding chair of the Medical and Scientific Advisory Committee at United Spinal Association, and served on the board of Praxis Spinal Cord Institute where she was chair of the governance committee. She serves the Department of Health and Human Services as a scientific member of the Interagency Pain Research Coordinating Committee. Dr. Sang obtained her M.D. from the Johns Hopkins University School of Medicine, and her M.P.H. from Harvard T.H. Chan School of Public Health.
Christine Allen, Ph.D. – Scientific Advisory Board
Christine Allen, Ph.D., is a full professor at the University of Toronto and an internationally recognized leader with more than 170 publications in drug formulation and development. She is a member of the Scientific Leadership Team of the Acceleration Consortium, a strategic initiative at the University of Toronto awarded $200M in funding from the Canada First Research Excellence Fund. She has received numerous awards and is a distinguished fellow of prestigious societies including the American Institute for Medical and Biological Engineering, and the Canadian Academy of Health Sciences. In addition, she is a co-founder and CEO of Intrepid Labs Inc., a company that is accelerating pharmaceutical drug development through integration of AI, automation and advanced computing. She is also a co-founder and board member at Nanovista Inc. Her lab at U of T is deeply engaged in industry partnerships, playing a key role in advancing drugs from early-stage research to clinical trials. Her leadership has been pivotal in several scientific societies, notably as President of the Controlled Release Society and the Canadian Society for Pharmaceutical Sciences. In academia, her roles have included the inaugural Associate Vice-President and Vice Provost Strategic Initiatives and Interim Dean of the Leslie Dan Faculty of Pharmacy. Dr. Allen’s commitment to equity, diversity and inclusion (EDI) goes beyond words. In 2019, she founded the Women in STEAM: Leading and Reading book club to create a community that supports women as they advance in their education and careers. She earned her Ph.D. in Chemistry from McGill University, and her Bachelor of Science from University of Ottawa.
Joachim Kohn, Ph.D. – Scientific Advisory Board
Joachim Kohn, Ph.D. is a distinguished professor emeritus at Rutgers University and the founder and principal investigator of the Kohn Lab, a laboratory dedicated to improving health care and quality of life by developing advanced biomedical products for tissue repair, replacement and the delivery of pharmaceutical agents. Dr. Kohn serves as the director of the New Jersey Center for Biomaterials and has been a principal investigator for numerous federally funded research and development programs. His research focuses on the development of new biomaterials, and he has won numerous awards and honors for his breakthrough studies. Dr. Kohn holds a bachelor’s degree from Hebrew University, a Ph.D. from Weizmann Institute, and completed a postdoctoral fellowship in polymeric drug delivery systems at the Massachusetts Institute of Technology.
Louis Lazo Radulovic, Ph.D., M.P.H. – Scientific Advisory Board
Lous Lazo Radulovic, Ph.D., M.P.H., is an independent consultant who brings significant experience in pharmacokinetics/drug metabolism and toxicology. Previously, Dr. Radulovic worked at Warner-Lamber/Parke-Davis and Pfizer for over 20 years, having held positions of increasing responsibility at both companies. He subsequently started a Michigan office for Fulcrum Pharma Developments, Inc, a multi-national drug development and regulatory consulting company. After leaving Fulcrum, Dr. Radulovic founded two independent nonclinical consulting companies, Drug Development Preclinical Services, LLC and Innovative Pharma Consulting, LLC. His expertise spans medical devices, small molecules, and biologics across several therapeutic areas. Dr. Radulovic has served on in-licensing/due diligence teams, conducted numerous gap analyses on nonclinical packages, and has extensive regulatory submission experience for CNS drugs and antihyperlipidemics. Dr. Radulovic is a retired member of the Society of Toxicology and has served as a member of the editorial board of Drug Metabolism and Disposition. He was also an Adjunct Professor of Toxicology at The University of Michigan and is a graduate of the same institution.
Arthur Tipton, Ph.D. – Scientific Advisory Board
Arthur Tipton, Ph.D., is an independent consultant that aids companies in developing the next generation of drug delivery products. He previously held leadership roles in three drug delivery start-ups and played a key role in each company’s path to a public offering. He was founder and chief executive officer of Brookwood Pharmaceuticals, now part of Evonik. Dr. Tipton holds 43 U.S. patents; his inventive efforts have led to several publications and multiple commercial products. He currently serves as a board member for five organizations and has previous experience on 12 additional boards. His resume also includes induction into the National Academy of Inventors, the College of Fellows for the American Institute for Medical and Biological Engineering and the Controlled Release Society, where he served as president in 2015. Most recently, Dr. Tipton was elected to the National Academy of Engineering in 2021. He holds a Ph.D. in polymer science and engineering from the University of Massachusetts.
About ATX101
ATX101 is a novel investigational configuration of an approved, well-characterized, validated intracellular sodium ion channel blocker, bupivacaine, and a biopolymer that has been designed to provide weeks of pain relief following total knee arthroplasty (TKA, or replacement), a common orthopedic surgery. ATX101 has a high density of drug within its small footprint to allow for ultra-sustained analgesia. It is placed in minutes at the end of standard surgery to deliver its analgesic effect over weeks before eventually dissolving into water and carbon dioxide. The simple procedure does not require specialized training and is intended to replace the existing complex mix of analgesic products used for shorter-term pain management in the post-surgical setting. ATX101 is an investigational product that has not been approved by the U.S. Food and Drug Administration.
About Allay Therapeutics
Allay Therapeutics is pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation for patients and physicians. Our proprietary technology platform combines validated non-opioid analgesics and biopolymers to create dissolvable candidates to deliver pain relief within a targeted site over weeks: an order of magnitude greater than the longest-lasting pain treatments currently available. Our platform and vision were shaped by The Foundry incubator and Lightstone Venture’s Singapore Fund. Allay unites a dynamic, global team of entrepreneurs, scientists, clinicians and innovators in the San Francisco Bay Area and Singapore. Learn more at allaytx.com.
