CAMBRIDGE, Mass.--(BUSINESS WIRE)--Axcella Health, a biotechnology company pioneering the research and development of novel multifactorial interventions to address dysregulated metabolism and support health, today announced the appointment of Shreeram Aradhye, M.B.B.S., M.D., as Executive Vice President, Chief Development Officer. Dr. Aradhye brings over 20 years of pharmaceutical industry experience in clinical development and medical affairs, most recently as Chief Medical Officer (CMO) and Global Head, Medical Affairs for Novartis Pharmaceuticals. Axcella also announced the appointment of Karen Lewis as Senior Vice President of Human Resources. Ms. Lewis brings over 20 years of experience leading global human resource teams in the biotechnology and technology industries.
“We are at an important stage of the Company’s trajectory, with our first three programs delivering important results and advancing in the clinic,” said Bill Hinshaw, President and Chief Executive Officer of Axcella. “I am delighted to welcome Shreeram and Karen to the team. Both are terrific, proven leaders that were drawn to our innovative approach and efficient development model. Leveraging their extensive experience will be invaluable as we focus on further developing and ultimately bringing our AXA Candidates to market and continue to build our high performing organization.”
“Axcella is an exciting company with a goal to become the preeminent biotechnology company reprogramming metabolism with endogenous metabolic modulators to potentially address a diverse set of complex diseases and support health,” said Dr. Aradhye. “I look forward to leading the Development organization and helping drive the advancement of Axcella’s rich pipeline of AXA Candidates.”
Dr. Aradhye built an accomplished career at Novartis. For over two decades he served in multiple leadership roles of increasing responsibility in Development and Medical Affairs, across multiple therapeutic areas and geographies. In his most recent role as CMO he was a member of the Global Pharmaceuticals Executive Committee which was responsible for leading Novartis’ $20B+ pharmaceuticals business. Additionally, Dr. Aradhye provided medical expertise on portfolio strategy and led governance of medical activities worldwide. Dr. Aradhye was also a Member of the Development Committee of Novartis that oversaw Global development activities across their portfolio. In previous roles at Novartis and Sandoz, he led the clinical development program for Gilenya® in multiple sclerosis, provided functional leadership for clinical development and medical affairs teams working on novel and biosimilar medicines across multiple therapeutic areas, and headed Global Development for Neuroscience where he oversaw a portfolio of programs in multiple sclerosis, Alzheimer’s Disease, neuropathic pain, muscle disease and migraine.
Prior to joining Axcella, Ms. Lewis led the Global Talent Acquisition organization at Biogen where she designed their talent acquisition strategy and developed and implemented high-performance organization and talent management solutions to support the successful achievement of business outcomes. While at Biogen, Ms. Lewis held roles as the Head of Human Resources for U.S. Commercial Operations, Global Commercial Strategy, Global Market Access, and was Regional HR leader for Asia Pacific and Latin America. Previously, Ms. Lewis worked at Amazon and Bristol-Myers Squibb where she held leadership roles in Talent Acquisition, Talent Management and as an HR Business Leader supporting R&D and Commercial functions. Ms. Lewis holds a B.S. in Biology from Rider University and worked as a Research Scientist at a start-up biotech company before entering HR.
“I am thrilled to be joining Axcella at such a transformational time. I look forward to leading the continued development of our people, culture and operational excellence to support our innovative approach to reprogramming metabolism,” said Ms. Lewis.
About Endogenous Metabolic Modulators
Endogenous metabolic modulators, or EMMS, are a broad family of molecules, including amino acids, which fundamentally impact and regulate human metabolism. Our AXA Candidates are anchored by EMMs that have a history of safe use as food. We believe that, unlike conventional targeted interventions currently used to address dysregulated metabolism, EMM compositions have the potential to directly and simultaneously support and modulate multiple metabolic pathways implicated both in complex diseases and overall health.
About Non-IND, IRB-Approved Clinical Studies
Axcella conducts non-investigational new drug application (Non-IND), Institutional Review Board (IRB)-approved clinical studies in humans with its AXA Candidates under U.S. Food and Drug Administration regulations and guidance supporting research with food outside of an IND. In these studies, Axcella evaluates in humans, including in individuals with disease, AXA Candidates for safety, tolerability and effects on the normal structures and functions of the body. Non-IND, IRB-Approved Clinical Studies are not designed or intended to evaluate an AXA Candidate’s ability to diagnose, cure, mitigate, treat or prevent a disease. If Axcella decides to further develop an AXA Candidate as a potential therapeutic, subsequent studies will be conducted under an IND.
About Axcella Health
Axcella is designing and developing AXA candidates, compositions of EMMs engineered in distinct ratios, designed to target and maximize the fundamental role that EMMs play in regulating multiple metabolic functions. Our AXA Candidates are generated from our proprietary, human-focused AXA Development Platform. We believe our expertise and capabilities in EMMs position us to become a preeminent biotechnology company reprogramming metabolism to address a diverse set of complex diseases and support health. Our AXA Development Platform has already produced a pipeline of product candidates in programs targeting liver, muscle and central nervous system. We were founded by Flagship Pioneering.