Board

Neil Desai, PhD
Chairman of the Board and CEO

Neil is the Founder of Aadi Bioscience, Inc. He was former SVP, Global R&D, Abraxis Bioscience; VP, Strategic Platforms, Celgene Corp; Inventor of the nab® technology, Abraxane® and ABI-009. He successfully led the Abraxane team through all development stages. He has over 25 years of experience in novel therapeutic delivery systems with over 100 issued patents, over 40 peer-reviewed publications and book chapters, and over 200 presentations at scientific meetings. He is an active participant in FDA and EU Nanotechnology initiatives and a member of the Steering Committee for the National Cancer Institute (NCI) Alliance for Nanotechnology in Cancer. He holds board and advisory positions in various start-ups. He holds a M.S and Ph.D. in Chemical Engineering from the University of Texas at Austin, USA, and a B.S. in Chemical Engineering from the University Institute of Chemical Technology in Mumbai, India.

Carlo Montagner, Board Member
CEO Specialised Therapeutics, Australia

Carlo has extensive medical and pharmaceutical experience in the United States, Europe, China, Japan and Australia. Before forming Specialised Therapeutics, his roles included President of Abraxis Bioscience Inc; Global Head of Bayer-Schering Oncology; Global Team Leader of Sanofi-Aventis Oncology; Hospital Business Unit Head of Aventis Australia; and Director of the Hospital Business Unit at Rhone-Poulenc Rorer. Carlo holds a Masters of Science (Psychology) from RMIT University in Melbourne, Australia.

Richard Maroun, JD, Board Member

Richard Maroun is an executive partner at Frazier Healthcare Partners, a private equity and venture capital firm specializing in healthcare-focused investments. Before joining Frazier in 2015, Maroun was senior vice president and general counsel of Aptalis Pharmaceuticals from 2012 to 2014. He has also held numerous senior executive roles for APP Pharmaceuticals, Abraxis BioScience and American BioScience Inc. Mr. Maroun has worked with major financial organizations and independent law firms, and has held both legal and financial positions with companies including Merrill Lynch, Deloitte & Touche and McDonough, Holland & Allen. Mr. Maroun currently serves on the board of Leiter’s Enterprises, a private portfolio company of Frazier Healthcare Partners, and the Board of Trustees of John Carroll University. Mr. Maroun holds a J.D. from Santa Clara University Law School and a B.S. from John Carroll University.

Jerry Xiao, PhD, Board Member

Jerry is CEO of HermedCapital, which is a VC fund focusing on the healthcare industry investment. He is Ph.D. in Pharmacology, member of Bio China Advisor Committee, finished his Postdoctoral training in Rochester University, during which he co-founded a pharmaceutical company with Dr. Paul Okunieff, and won STTR support from US government. He was BD head of FosunPharma, the deputy chief of the IPO team for Fosun Pharma Listing in Hong Kong Exchange, the vice general manager of Fosun Pharmaceutical Technological Center, in charge of the evaluation of new technology, R&D and investment, he reviewed more than 150 projects per annum. He also served as a board member of FochonPharma (new drug development), Henlius (Biosimilar, antibody) and BeyondSpring (BYSI, Nasdaq), helping with the financing and technology transfer.

Mahendra Shah, PhD, Board Member

Dr. Shah is a venture partner at Vivo Ventures, a health-care focused venture capital firm. He is the founder and executive chairman of Semnur Pharmaceuticals. He was the founder, chairman, and CEO of NextWave pharmaceuticals, a pediatric focused specialty pharmaceutical company. Prior to founding NextWave Pharmaceuticals, Dr. Shah was the chairman and CEO of First Horizon Pharmaceuticals, which was sold to Shionogi Pharmaceuticals for $1.4B. Dr. Shah had also held various scientific and managerial roles in Fujisawa USA (Astellas), Schering-Plough and Bristol Myer-Squibb. Dr. Shah currently serves as chairman of the board of Essentialis Therapeutics, board member of Fortis Inc., Crinetic pharmaceuticals, and a member of the board of trustees of St. John’s University. He is also a board member and charter member of EPPIC and a charter member of TIE. Dr. Shah received his BS degree in Pharmacy from LM College of Pharmacy in Gujarat, India, and his PhD degree in Industrial Pharmacy from St Johns’s University.

Board

October, 6 2017, The U.S. Food and Drug Administration today announced that it has awarded 15 new clinical trial research grants totaling more than $22 million over the next four years to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry across the country. “Given the often small number of patients facing certain rare diseases, there can be limited resources devoted to researching new drugs and unique challenges with recruiting and conducting the clinical trials needed to develop medicines targeted to rare conditions,” said FDA Commissioner Scott Gottlieb, M.D. “For more than 30 years, the FDA has been committed to investing in trials of potentially life-changing treatments for patients with rare diseases, especially in situations where commercial incentives may not be enough to foster the collection of quality data that can ultimately support efficient development and FDA-approval of treatments for patients who lack effective alternatives. By helping to support the cost of development of these potential new drugs, and reduce some of the financial risk, we also hope that these grants will lower the cost of the capital needed to develop these products, boost competition and translate into lower prices for successful medicines. This can help increase access to resulting therapies.” The FDA awarded the grants through the Orphan Products Clinical Trials Grants Program (https://www.fda.gov/forindustry/developingproductsforrarediseasesconditions/whomtocontactaboutorphanproductdevelopment/ default.htm), funded by Congressional appropriations, to encourage clinical development of drugs, biologics, medical devices, or medical foods for use in rare diseases. The grants are intended for clinical studies evaluating the safety and effectiveness of products that could either result in, or substantially contribute to, the FDA approval of products targeted to rare diseases. Approximately 33 percent of the new grant awards fund studies to accelerate cancer research by enrolling patients with rare forms of cancer. Sixty percent of these studies target devastating forms of brain and peripheral nervous system cancers, including glioblastoma and anaplastic astrocytoma. One study recruits children as young as one year old with a particularly aggressive form of neuroblastoma. Other studies span a broad range of diseases and address unmet needs like treating hyperphagia in Prader-Willi syndrome, a genetic disease that primarily affects children, and idiopathic osteoporosis in premenopausal women. Two studies recruit patients with unmet need in sickle cell disease. In addition, one study evaluates a new combination of existing antibiotics to treat pulmonary tuberculosis (TB), including multidrug-resistant TB. TB is a leading killer of HIV-positive patients, and, though not as common in the United States, one-third of the world’s population is infected with TB. “The clinical trials grant program is an important part of the FDA’s ongoing commitment to encouraging and supporting the development of safe and effective therapies for rare diseases,” said Rachel Sherman, M.D., M.P.H, FDA’s principal deputy commissioner. “The grants awarded this year will support needed research in a range of rare diseases that have little, or no, treatment options for patients.” A total of 76 grant applications were received for this fiscal year, with a funding rate of 20 percent. The grant recipients for fiscal year 2017 are the following: • AADi, LLC (Pacific Palisades, California), Neil Desai, Phase 2 Study of ABI-009 for the Treatment of Advanced Perivascular Epithelioid Cell Tumors — about $2 million over four years • Albert Einstein College of Medicine (Bronx, New York), Caterina Minniti, Phase 2 Study of Topical Sodium Nitrite for the Treatment of patients with Sickle Cell Disease & Leg Ulcers — about $2 million over four years • Albert Einstein College of Medicine (Bronx, New York), Eric Hollander, Phase 2 Study of Oxytocin for the Treatment of Hyperphagia in Prader-Willi Syndrome — about $1.5 million over three years • Alkeus Pharmaceuticals, Inc. (Cambridge, Massachusetts), Leonide Saad, Phase 2 Study of ALK-001 for the Treatment of Stargardt Disease – about $250,000 over one year • CereNova, LLC (Durham, North Carolina), Daniel Laskowitz, Phase 2A Study of CN-105 for the Treatment of Intracerebral Hemorrhage — about $1 million over two years • Columbia University Medical Center (New York), Elizabeth Shane, Phase 2 Study of Teriparatide for the Treatment of Idiopathic Osteoporosis in Premenopausal Women — about $1.9 million over four years • Columbia University Medical Center (New York), Gulam Manji, Phase 2 Study of PLX3397 + Sirolimus for the Treatment of Malignant Peripheral Nerve Sheath Tumors — $2 million over four years • Dana-Farber Cancer Institute (Boston), Steven Dubois, Phase 1 Study of dual PI3K/BRD4 Inhibitor SF1126 for the Treatment of Neuroblastoma — $750,000 over three years • Duke University (Durham, North Carolina), Allan Kirk, Phase 2 Study of Belatacept, Alemtuzumab, and Sirolimus in Renal Transplantation — about $1 million over three years • Johns Hopkins University (Baltimore), Susan Dorman, Phase 2a Study of Rifampin, Merrem and Augmentin for the Treatment of Pulmonary Tuberculosis — about $2 million over four years • New York Medical College (Valhalla, New York), Mitchell Cairo, Phase 2 Defibrotide for the Prevention of Complications in High-Risk Sickle Cell Disease Patients Following Allogeneic Stem Cell Transplantation – about $1.75 million over four years • Protalex, Inc (Florham Park, New Jersey), Richard Francovitch, Phase 1/2 Study of PRTX-100 for the Treatment of Immune Thrombocytopenia — about $500,000 over two years • Sloan-Kettering Institute for Cancer Research (New York), Ping Chi, Phase 2 Study of MEK162 & Imatinib for the Treatment of Gastrointestinal Stromal Tumors — $2 million over four years • Tocagen Inc. (San Diego), Asha Das, Phase 2/3 Study of Toca 511 +Toca FC versus SOC in Recurrent Glioblastoma and Anaplastic Astrocytoma — $2 million over four years • University of California, San Francisco (San Francisco), Marshall Stoller, Phase 2 Study of Lipoic Acid for the Treatment of Cystine Nephrolithiasis — about $2 million over four years Since its creation in 1983, the Orphan Products Clinical Trials Grants Program (https://www.fda.gov/forindustry/developingproductsforrarediseasesconditions/whomtocontactaboutorphanproductdevelopment/ default.htm) has provided more than $390 million to fund more than 600 new clinical studies. At least 60 grants have supported the marketing approval of more than 55 orphan products. Three of the studies funded by this grants program supported product approvals in 2016 alone, including much needed treatments for aortic wall injury in patients with coarctation of the aorta and severe hepatic veno-occlusive disease (also known as sinusoidal obstructive syndrome). The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.