Axcella Appoints Shreeram Aradhye, M.B.B.S., M.D., as Executive Vice President, Chief Development Officer

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.

Contacts

Company Contact
Alison Williams
[email protected]
857-320-2204
or
Media
Contact
Stefanie Tuck
MacDougall Biomedical Communications
[email protected]
781-235-3060