Harvey J. Berger, M.D. – an Entrepreneur, Physician-Scientist, Biotechnology Executive and Philanthropist with over 35 years of professional experience – founded ARIAD Pharmaceuticals, Inc. in 1991 and served as its Chairman and Chief Executive Officer from 1991 to 2015. He then became advisor to the Board through mid-2016 and now is Founder, Chairman and CEO Emeritus. Dr. Berger led the Company’s growth from a start-up to an integrated global-oncology company that serves patients worldwide. The Company’s vision has been to transform the lives of cancer patients with breakthrough medicines. In early 2017, Takeda Pharmaceuticals, Ltd. acquired ARIAD for $5.2 billion in cash, becoming part of Takeda Oncology.
Under Dr. Harvey Berger’s leadership, ARIAD developed a pipeline of new medicines to advance the treatment of various forms of chronic and acute leukemia, lung cancer and other difficult-to-treat cancers. ARIAD utilizes computational and structural approaches to design small-molecule drugs that overcome resistance to existing cancer medicines. ARIAD’s business strategy has been to commercialize its oncology products through its own marketing and sales organizations in the U.S. and the EU (based in Lausanne, Switzerland) and through partners and distributors in other markets. In 2016, the Company decided to refocus its commercial efforts and divest its European operations to Incyte Corp.
ARIAD brought Iclusig® (ponatinib) – a novel BCR-ABL tyrosine kinase inhibitor – to the market for use in the treatment of patients with Philadelphia-chromosome positive leukemias. Since its approval in 2012, ARIAD launched Iclusig in the U.S. and the EU itself and through third parties in other regions. ARIAD and its partner, Otsuka Pharmaceutical Co., Ltd., together filed for regulatory approval of Iclusig in Japan in early 2016 resulting in regulatory approval later in 2016. Otsuka is pursuing approvals in other Asian markets.
Alunbrig® (brigatinib) – a novel ALK tyrosine-kinase inhibitor with Breakthrough Designation from the FDA – was approved in early 2017 in the U.S. for use in patients with ALK+ non-small cell lung cancer (NSCLC). ARIAD also filed for regulatory approval in the EU. ARIAD’s third internally discovered novel tyrosine-kinase inhibitor – AP32788 – is in a Phase 1/2 clinical trial in genetically defined patients with NSCLC and a validated class of novel mutated targets; its potential uses also include similarly defined patients with breast cancer. Initial clinical results are expected in 2017.
Dr. Berger oversaw the broadened clinical development of ARIAD’s oncology products focusing on their use in earlier lines of treatment and the implementation of an operating plan to achieve sustained profitability. He maintained strong morale of employees in all regions and stability of senior leadership. The Company’s strategic plan included pursuit of all business options aimed at maximizing shareholder value – both near-term and long-term.
ARIAD developed two additional small-molecule drugs that it licensed to companies with special capabilities and complementary technologies. Ridaforolimus – a novel mTOR inhibitor – has been incorporated into next-generation drug-eluting stents by Medinol, Ltd. for use in patients with coronary artery disease (CAD). Registration trials involving over 2,200 patients with CAD have been completed and are the basis for regulatory filings in major markets. Medinol’s EluNIR™ stent was approved in the EU in August 2017. Approval in the U.S. is anticipated by the end of 2017.
Rimiducid – a small-molecule chemical-dimerizer drug – has been used with cellular immunotherapies developed by Bellicum Pharmaceuticals, Inc. for use in patients with cancer, hematopoietic stem cell transplants, and CAR-T cellular immunotherapies. Phase 3 clinical trials are ongoing.
In recognition of Dr. Berger’s achievements during his tenure as ARIAD’s leader, in 2013, he received the Ernst & Young Entrepreneur of the Year Award in New England and the Gold Stevie Award as Executive of the Year, Pharmaceuticals. He was chosen for inclusion in many editions of Who’s Who in the World, Who’s Who in Medicine and Healthcare and Who’s Who in America, among other editions.
In January 2017, Dr. Berger joined Medinol, Inc. as Executive Chairman, focusing on business development and global strategy, new business and technology initiatives and efforts to expand operational efficiency as the company expands worldwide. He is working with Medinol’s core business of interventional cardiovascular devices, as well as its new businesses developing sub-millimeter implantable sensors, unique percutaneous aortic valves and other complementary products.
Since late 2015, Dr. Berger became a member of the CEO Founders Network of Hudson Executive Capital LP. The Hudson team shares a common commitment to delivering value for their investors through fundamental analysis, industry knowledge, managerial experience and operational expertise on the strategic issues that companies in their industries face. Dr. Berger is one of six healthcare CEOs in the Network.
From 1986 to 1991, Dr. Berger held a series of executive management positions at Centocor, Inc., including Executive Vice President and President of the Research and Development Division. At Centocor, he led the development of ReoPro® (abciximab) for the prevention of ischemic complications in patients with CAD undergoing percutaneous interventions and Remicade® (infliximab) for the treatment of autoimmune diseases such as Crohn’s Disease, ulcerative colitis and rheumatoid arthritis, both of which have been approved globally.1
He has also held senior academic and administrative appointments, including as a professor, at Emory University, Yale University and the University of Pennsylvania, and he was an Established Investigator of the American Heart Association, Inc. Dr. Berger published over 150 original papers, editorials, reviews and chapters in scientific and medical journals. Dr. Berger and his academic and industry collaborators developed novel techniques for quantitative radionuclide imaging of the heart, including single-photon emission computed tomographic (SPECT) imaging of myocardial perfusion with thallium-201 and sestamibi. While at Emory, he led a joint development program with General Electric Medical Systems for cardiovascular SPECT imaging.
Dr. Berger has been a member of the Dean’s Council of Yale School of Medicine. He received his A.B. degree in Biology from Colgate University and his M.D. degree from Yale School of Medicine and did further medical and research training at the Massachusetts General Hospital and Yale-New Haven Hospital prior to joining the Yale faculty.
Dr. Berger resides in Palm Beach with his wife Chrysanthi and his daughters Nicole and Isabella. Nicole Berger has appeared in several movies including Two for One, directed by Jon Abrahams.