Harvey J. Berger, M.D. – an American Physician-Scientist, Biotechnology Executive, Entrepreneur, and Philanthropist with over 40 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 its Chairman and CEO Emeritus through 2019. Dr. Berger led the Company’s growth from a start-up to an integrated global-oncology company that served patients worldwide. The Company’s vision was 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. 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 utilized state-of-the-art computational and structural approaches to design small-molecule drugs that overcome resistance to existing cancer medicines. ARIAD’s business strategy was to commercialize its oncology products through its own marketing and sales organizations in the U.S. (based in Cambridge, Massachusetts) and the EU (based in Lausanne, Switzerland) and through partners and distributors in other markets. In 2016, the Company elected to refocus its commercial efforts and shift its European operations to a partnership with Incyte Corp.
ARIAD brought Iclusig® (ponatinib) – a novel BCR-ABL tyrosine kinase inhibitor with Breakthrough Designation from the FDA – to the market initially for use in the treatment of patients with Philadelphia-chromosome positive (Ph+) leukemias. Ponatinib is approved in patients with resistant or refractory CML, including those with the otherwise untreatable T315I mutation. 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 and Takeda then obtained regulatory approvals throughout Asia and other regions. Recently, the indications for Iclusig were further expanded to include Ph+ ALL, a form of leukemia with limited treatment options.
Alunbrig® (brigatinib) – a novel ALK tyrosine-kinase inhibitor with Breakthrough Designation – was approved in early 2017 in the U.S. for use in patients with ALK+ non-small cell lung cancer (NSCLC) who had failed first-line therapy. ARIAD also filed for regulatory approval in the EU, and Alunbrig was approved in the EU in late 2018 for a similar indication. With the results of the ALTA front-line clinical trial available, Alunbrig was approved in early 2020 for patients with first-line ALK+ NSCLC. Takeda received priority review by the FDA for Alunbrig in first-line patients in early 2020 and approval for these indications in the same year. Alunbrig now is available throughout the world.
Exkivity® (mobocertinib) – a novel EGFR tyrosine-kinase inhibitor with Priority Review designation by the FDA – completed a positive expanded phase 1/2 clinical trial in patients with NSCLC and exon-20 insertion mutations. A pivotal phase 3 trial of Exkivity in patients with first-line exon-20 insertion NSCLC led by Takeda met its primary endpoints, leading to approval in this indication. Exkivity is now available in major markets throughout the world, and further trials are ongoing to expand its indications.
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 latest generation drug-eluting stents by ARIAD partner, Medinol, Ltd. for use in patients with coronary artery disease (CAD). Registration trials involving over 2,200 patients with CAD were completed and became the basis for regulatory approvals in major markets. Medinol’s EluNir® stent, the first elastomeric drug-eluting stent, was approved in the EU in mid 2017 and in the U.S. in late 2017. The stent utilizes Medinol’s proprietary quality-surface technology that ensures uniform coating of ridaforolimus and predictable drug release. Approval in Japan and other Asian countries occurred in 2022 becoming the first novel drug-eluting stent approved in Japan in many years.
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. Several advanced clinical trials are ongoing.
Dr. Berger oversaw the broad clinical development of ARIAD’s oncology products focusing on their use in earlier lines of treatment and the implementation of a business strategy to achieve sustained profitability. He maintained strong morale of employees in all regions and stability of senior leadership throughout his tenure as CEO; he prided himself in mentoring scientists, physicians and executives and ensuring their career development. Since ARIAD’s acquisition by Takeda, virtually all of the members of its senior team have assumed important leadership positions at other biotechnology companies.
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 was expanding worldwide. He worked 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. He retired from Medinol at the end of 2018, but continues to work with Medinol executives on select projects.
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) – a monoclonal antibody GP IIb/IIIa inhibitor – for the prevention of ischemic complications in patients with CAD undergoing percutaneous interventions and the anti-TNF monoclonal antibody Remicade® (infliximab) for the treatment of autoimmune diseases such as Crohn’s Disease, ulcerative colitis and rheumatoid arthritis. Both of these biologicals have been approved globally. He also led the development and obtained regulatory approval by Centocor of CA 125, one of the first cancer diagnostics for use in monitoring patients with cancer, particularly women with ovarian cancer.
In January 2018, Dr. Berger became a governing trustee at the Dana-Farber Cancer Institute in Boston, Massachusetts. He has worked with the Institute throughout his career, starting at Centocor and subsequently at ARIAD, relying heavily on the expertise of the DFCI faculty in the development of their targeted cancer medicine. He now is Chair of the Trustee Science Committee and a member of the Executive Committee of the Board. In 2021, Dr. Berger was elected to the board of directors of The Cameron Boyce Foundation whose mission is to cure epilepsy. The Foundation was established to memorialize the late Cameron Boyce’s legacy by sponsoring epilepsy research, education, and awareness campaigns and supporting causes that were most meaningful to Cameron who passed away at age 20 from complications of epilepsy (known as SUDEP).
Early in his academic career, 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 technetium-99m sestamibi. While a faculty member at Emory, he led a joint product and software development program with General Electric Medical Systems for cardiovascular SPECT imaging. These methods became the basis for systems used widely throughout nuclear medicine. He has also held senior academic and administrative appointments (with tenure), including as a Professor of Medicine and Radiology, 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.
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 full-time Yale faculty. He is Board-certified in Nuclear Medicine and led Yale’s multimodality cardiovascular imaging program. Dr. Berger was a member of the Dean’s Council of Yale School of Medicine from 2011 to 2017. Dr. Berger is completing his final term as a member of the Board of Trustees at Concord Academy, an independent secondary school in Concord, Massachusetts.