Shefali AGARWAL, MD
Before joining Valerio Therapeutics, Dr. Shefali Agarwal was Chief Medical Officer at Epizyme, Inc., a clinical-stage company developing novel epigenetic therapies for cancer and other serious diseases, where she leads the global clinical development and regulatory strategy for tazemetostat for the treatment of cancer. Prior to joining Epizyme in 2018, Dr. Agarwal held leadership positions across medical research, clinical development, clinical operations and medical affairs. She most recently served as chief medical officer at SQZ Biotech, where she built and led the clinical development organization, which included clinical research operations and the regulatory function. Before SQZ Biotech, Dr. Agarwal also held leadership positions at Curis and Tesaro. At Curis, she oversaw the Phase 2 study for its dual HDAC/PI3K inhibitor in diffuse large B-cell lymphoma, and the Phase 1 study in solid tumors for its oral checkpoint inhibitor. At Tesaro, she led the NDA and EMA submissions for ZEJULA(r) (niraparib) in ovarian cancer. Dr. Agarwal has also held positions of increasing responsibility at Covidien, AVEO Oncology and Pfizer. In addition to receiving her medical degree, Dr. Agarwal holds a master’s of public health and a master’s of science in business.
Shefali AGARWAL, MDPRESIDENT AND CHIEF EXECUTIVE OFFICER
Dr. Jiang has more than 25 years of extensive pharma and biotech experience. Huiping began her pharmaceutical career at AstraZeneca prior to joining Boehringer Ingelheim heading Genomics and Genetics group before transitioning to Regulatory affairs.
Prior to joining Valerio Therapeutics, she served as Senior Vice President/Head of Regulatory Affairs at Epizyme, Inc., and board member/Interim President at Qx Therapeutics.
Dr. Jiang brings to us drug development experience from early discovery to marketing authorization in both big pharma and small biotech settings. Most recently she led the regulatory submissions and approvals of 2 NDAs within six months for TAZVERIK which also include a successful ODAC and a preapproval inspection.
She received her B.S. in biochemistry from Nanjing University and her Ph.D. in cell and molecular biology from Clarkson University and conducted postdoctoral research at California Institute of Technology.
Huiping JIANGCHIEF REGULATORY OFFICER
Ashish Gulati has more than 20 years of experience in the healthcare field: after a career in research at the All India Institute of Medical Sciences in New Delhi in 2000, he joined Roche as a Medical Manager in Oncology and Rheumatology. After 8 years at Roche, he joined AstraZeneca as Senior Global Medical Officer in Gaithersburg. He then joined Abbvie in 2018 as Medical Director specialized in Myeloid & MM and finally Takeda Oncology in 2020 as Global Medical Leader, specialized in lung cancer. During his career, he participated in the global launch for key molecules in Solid Tumor and Hematological Malignancies: (Venetoclax for AML, Mobocertinib for exon 20 ins NSCLC, Avastin for GBM, mRCC, Nanoxel for MBC, Benralizumab for SA, Tocilizumab for RA)
Ashish Gulati first obtained a doctorate in medicine at the University of Aarhus. He then went on to Berkeley, Harvard and King's College to study leukemia, particularly Myeloid Malignancies. As previously mentioned, he was also a resident at the All India Institute of Medical Sciences in New Delhi.
Ashish GULATIVICE-PRESIDENT MEDICAL AND CLINICAL DEVELOPMENT
Robin Sutherland brings over two decades of executive leadership experience, with 12 years of HR leadership within the biotech industry. Immediately prior to Valerio Therapeutics, Robin was founding Head of Human Resources and Clinical Research for Renovia in 2017, a company founded to create diagnostics and treatment for women’s pelvic health. Prior to Renovia, Robin has led HR and operations for organizations as diverse as Ironwood Pharmaceuticals and Fidelity Investments’ Veritude, was Chief Operating Officer for Epoch, and was in clinical practice at Massachusetts General Hospital and Lahey Clinic early in her career prior to moving into executive leadership roles. She has edited and published in peer reviewed journals including Work: The Journal of Rehabilitation, SPINE and Neurourology & Urodynamics. Robin has been an active member of Bridgewell’s Board of Directors since 2013 and served as Board Chair for three years. A graduate of Tufts University, she completed coursework with Simmons University (MHA) and Cornell University (Master’s Program in HR Management).
Robin SUTHERLANDVICE PRESIDENT - GLOBAL HEAD OF HUMAN RESOURCES
Donna CABRAL-LILLY, PhD
Donna Cabral-Lilly has over 20 years of experience in the pharma and biotech space, with a proven track record for transitioning proof of concept pharmaceutical candidates through clinical development, marketing approval and post-marketing studies. Her particular expertise encompasses the areas of global CMC regulatory strategy and execution. Prior to joining Valerio Therapeutics in 2023, Donna held Head of CMC positions with Oryn Therapeutics, Origin Biosciences (a Bridgebio company), Taaneh and Celator Pharmaceuticals. She contributed most recently to approvals for Nulibry and Vyxeos. She received her BA in Chemistry from Case Western Reserve University and her Ph.D. in biochemistry from Boston University.
Donna CABRAL-LILLY, PhDVice President – Head of CMC
Joyce Carey brings 30 years of finance and accounting experience to Valerio Therapeutics. Her experience ranges from small biotechs to large pharmaceutical and CRO organizations. Joyce has been a key member of teams that implemented forecasting systems and ERP accounting and tracking systems. Her expertise in long range forecasting models for both commercial revenues and operational expenses, with a focus on clinical trials, is an asset for Valerio Therapeutics.
Joyce CAREYExecutive Director Finance - Head of FP&A
Wael JDEY, PhD
Prior to joining Valerio Therapeutics, Wael Jdey was a junior scientist at Gustave Roussy Cancer Center (Villejuif, France) and then with the Research Team “DNA repair, Radiations and Innovative cancer therapies” at the Institut Curie Research Center (Orsay, France). Wael is best known for major experimental and conceptual contributions to the development of a new class of anti-cancer treatments, the DNA Decoy Therapeutics. In particular, he provided profound insights into the links between DNA repair exhaustion in cancer cells and the abrogation of acquired resistance to several targeted therapies, including PARP inhibitors. Based un this original mechanism of action, Wael was a founding member of the plaTONTM platform, Valerio Therapeutics’ proprietary DNA Decoy Technology Platform.
Wael JDEY, PhDHead of Preclinical
Pam SLATCHER, MHS, MT, PA
Pam SLATCHER, MHS, MT, PA
Pam, a recognized industry leader, joins Valerio Therapeutics with over 20 years of experience in safety profile characterization and risk management preceded by 10 years of clinical practice in internal medicine. Most recently, as Vice President of Pharmacovigilance and Risk Management at Epizyme, Pam provided PV leadership through two NDA approvals and successfully implemented the post marketing enterprise. Her experience spans both pharma and biotech, including senior positions at Pfizer, Merck KgA, AVEO, TESARO, Immunogen and others in the areas of oncology, neurology, and endocrinology. Proven successes, through which she led PV thru development, market authorization and market surveillance include, TAZVERIK®, Varubi®, Zejula®, Erbitux®, and Rebif®. Pam has a Masters in Public Health (MHS) and a Masters in Medicine, Physician Assistant (PA) from Duke University School of Medicine, a Masters in Clinical Pathology (MT), a BS in Microbiology and executive MBA coursework.