Dr. Harvey Berger

The key is engaging people at all levels and in all disciplines in new ideas.

 

Dr. Harvey J. Berger, M.D. was recently appointed as the Executive Chairman at Medinol, Inc., a global interventional cardiovascular-device company based in Tel Aviv, Israel. This position brings him full circle back to cardiology, the area he focused on throughout his academic career at Yale and Emory. After graduating from medical school and completing residency training at Yale, Berger began his academic career as a member of the Yale faculty in Internal Medicine and Radiology and as Director of Cardiovascular Imaging. He continued his career as a tenured professor at Emory University School of Medicine, leading a research program on the study of coronary physiology and the development of new noninvasive methods for three-dimensional imaging of the heart.

In 1986, Berger moved to Centocor, Inc. (now Janssen J&J), as the head of R&D, where he led the development of Remicade® (infliximab), a drug for patients with autoimmune diseases such as Crohn’s disease, ulcerative colitis and rheumatoid arthritis, and ReoPro® (abciximab), a drug for patients with ischemic complications of percutaneous interventions in coronary artery disease. Both drugs are widely used throughout the world. He also led the development and initial approval of CA19-9, an in vitro cancer diagnostic-test.

Thereafter, in 1991, Berger founded ARIAD Pharmaceuticals, Inc. and served as its Chairman and Chief Executive Officer (CEO) until 2015 when he became Chairman and CEO Emeritus. Berger led the company from a startup, as the initial employee, to a global, commercial company with over 600 employees based in 15 countries. Under his leadership, the company developed a pipeline of new medicines to advance the treatment of patients with challenging cancers utilizing ARIAD’s platform of computational and structural approaches to design small-molecule drugs that overcame resistance to prior medicines. ARIAD had its corporate and research headquarters in Cambridge, Massachusetts and a European hub near the Swiss Cancer Center Lausanne. He led the development of Iclusig® (ponatinib) for Ph+ leukemias, Alunbrig® (brigatinib) for ALK+ non-small cell lung cancer, AP32788 for lung cancer with novel mutated genetic targets, and rimiducid, a dimerizing drug for use with cellular immunotherapies, such as CAR-T therapies (co-developed with Bellicum Pharmaceuticals, Inc. of Houston, Texas). He also established a partnership with Medinol to use one of ARIAD’s cancer medicines, ridaforolimus, in a novel polymer coating on Medinol’s EluNIR® drug-eluting stent for obstructive coronary disease. Ponatinib, brigatinib and ridaforolimus are now approved and widely available to patients, and AP32788 and rimiducid are in late-stage clinical trials. In 2016, ARIAD was acquired by Takeda Pharmaceuticals, Inc., and ARIAD is now a part of Takeda Oncology.

Over the course of his career in the biotechnology and life-sciences industries, Berger oversaw the development of seven new medicines and an in vitro cancer diagnostic test — six of which have already been approved for use in patients with many difficult-to-treat diseases in cancer, immunology and cardiology.

Berger has long-standing ties to the Dana-Farber Cancer Institute (DFCI) and Harvard Medical School through ARIAD-sponsored research programs and clinical trials of its new medicines and a teaching position in the Harvard-MIT Program in Health Sciences and Technology (HST). He recently was elected to the governing Board of Trustees of the DFCI and the Science Committee of the Board at the DFCI.

Berger published over 150 original papers, editorials, and reviews in scientific and medical journals and was an Established Investigator of the American Heart Association. In recognition of his achievements in the biotechnology field, Berger was awarded the Ernst & Young Entrepreneur of the Year Award in New England and the Gold Stevie Award as Executive of the Year in Pharmaceuticals.

Where did the idea for ARIAD Pharmaceuticals come from?

When I started ARIAD in 1991, the idea of building a biotechnology company around the latest advances in molecular cell biology, organic chemistry and computational sciences was new and unique. In addition, our focus was on targeting pathways inside the labyrinth of the cell, which meant that the drugs needed to be small, highly selective and able to get into the cell (as opposed to working on the cell surface). I came up with the idea for ARIAD based on the discoveries occurring in the early 90’s. The company name, ARIAD, comes from Greek mythology and the story of Ariadne and Theseus, with Ariadne giving Theseus a spool of thread to find his way into and out of the labyrinth to kill the Minotaur. ARIAD is a shortened version of Ariadne. This mythical story mimics the science of ARIAD and creating drugs based on targets in the labyrinth (or “black box”) of the cell.

Stuart Schreiber, Ph.D., Professor of Chemistry and Chemical Biology at Harvard (subsequently one of the three founding scientists of the Broad Institute at MIT and Harvard) was immensely helpful to me in founding ARIAD. Work throughout Stuart’s career has led to the establishment of the field of chemical biology – where small molecules are used as probes in uncovering biological functions of fundamental cellular processes such as transcription factors, oncogenes, protein/protein interactions, etc. ARIAD’s research followed along the same paths, especially targeting “driver oncogenes.”

What does your typical day look like and how do you make it productive?

Throughout my years of work at ARIAD, I split my time between science and business. Without a deep understanding of the science underlying the company’s programs and an in-depth involvement in the day-to-day scientific and medical challenges, I would not have been able to ensure a high success rate of our programs. We took five novel programs into clinical trials and were able to obtain regulatory approvals in three and initiate late-stage clinical trials in two on the path to approval. Our goal was to achieve 100% success rate from the clinic to the market.

How do you bring ideas to life?

The key is engaging people at all levels and in all disciplines in the new ideas – scientists, physicians, marketing and sales executives, and others. When faced by a critical decision, a well-known CEO in our industry said, “follow the science,” and the ideas will come alive. Success in the biotech industry requires great commitment and a long-term horizon. I often point out to investors and employees the importance of the 3 P’s – patience, persistence, and perseverance. Entrepreneurs should not expect instant success. The key to success is being surrounded by exceptionally talented and loyal people. A leader’s success and recognition should be based on what his/her team delivers and how patients benefit.

What’s one trend that excites you?

I see the greatest discoveries coming from research at the overlap of divergent fields, such as wearable sensors to provide miniaturized in vivo monitoring of chemistry and physiology within a patient and new computing algorithms based on artificial intelligence (AI) to decipher massive amounts of real-time data coming from patients and clinical trials. It’s only a matter of time before these trends will change the practice of medicine.

What is one habit of yours that makes you more productive as an entrepreneur?

My productivity as an entrepreneur has always been driven by giving credit to my colleagues and encouraging them to strive for the near-impossible. I tried to do this every day, no matter the circumstances.

What advice would you give your younger self?

Be patient, there is virtue in staying in the same organization for many years and building your career by proving yourself and working your way up. Today’s up and coming executives frequently seem to think that the only way to get ahead is by changing jobs and companies every few years and moving to a new environment (“the grass is always greener on the other side”). From 1980 forward, I had two positions in academia and three in industry, but stayed in the same organizations for many years. I was approached by recruiters many times, but I stuck to my belief of not moving around just because someone called.

Tell us something that’s true that almost nobody agrees with you on.

In my experience, activist investors are bad for cancer patients. While good governance is very important to the proper functioning of a public company, I believe that the best way to ensure excellence is not through the interference of an activist shareholder on a company’s board. When activist shareholders serve on boards, their focus tends to be on what is good for them financially or for building their own reputations, not necessarily on what is good for cancer patients. Their efforts can lead to slowing down or stopping drug discovery altogether; cancer patients, in turn, lose access to the fruits of an R&D team that has produced life-saving medicines, such as at ARIAD. From my own experiences, activists do whatever they want to get the outcome they desire, from coercing other directors to pushing for redirection of a company – away from helping cancer patients in need. I have seen activists use their financial clout to force other directors to follow their lead, even if not called for.

As an entrepreneur, what is the one thing you do over and over and recommend everyone else do?

Most importantly, give credit to colleagues, peers and staff at all levels of the organization and remember that patients must come first. Let me provide some examples. Firstly, as head of R&D at Centocor and then as CEO of ARIAD, I prided myself in crediting my team for a job well done. If we failed at something, I took responsibility for the failure. If we achieved something great, I rewarded my colleagues and acknowledged them for their accomplishments. Kudos to all. Secondly, hire the best and brightest and surround yourself with staff who are smarter than you are. Never be held back by how good your colleagues are; build on their capabilities and strengths.

What is one strategy that has helped you grow your business?

In the face of many opportunities to give up the commercial rights to the new medicines that we discovered and brought to patients, we repeatedly turned away overtures to have a larger company market and sell our products. Many said that big pharma companies would be better at commercializing our cancer medicines, and it was not worth the effort (or cost) to build a commercial infrastructure. Some said that we should limit our commercial aspirations only to the US. Our business strategy was to build a fully integrated biotechnology company starting with drug discovery, leading to global clinical development, and then selling and marketing our breakthrough medicines ourselves in the U.S. and the major markets in the EU. We planned and executed these strategic initiatives. We elected to partner our lead product in Japan and other Asian markets after evaluating the cost and challenges of doing it ourselves. We also partnered with regional and country-specific distributors in certain part of Europe, as well as Australia and Latin America to ensure broad availability of our products to cancer patients in need. We also worked with the MAX Foundation, a not-for-profit organization based in Seattle, WA, which was established by the mother of a young patient who died of chronic myeloid leukemia, the main indication for our first product to make Iclusig available at no cost to patients in low and middle-income countries. Thus, hand-picked patients in countries, such as Vietnam, Thailand, and Brazil were able to receive our life-saving medication. This all supported our mantra of “leave no patient behind.”

What is one failure you had as an entrepreneur, and how did you overcome it?

We became excited about the business prospects of functional genomics and established, along with Hoechst-Marion-Roussel (HMR), the Hoechst-ARIAD Genomics Center, LLC. We thought that by combining our fledgling efforts in genomics with the insights and capabilities of a major pharma company, we could come up with new uses of genomics in drug discovery. While pursuing important science, the two companies had such divergent views of where the venture should lead I believe that our differences overwhelmed the potential benefits. To overcome this shortcoming, we ended up selling our 50% interest in the joint venture back to HMR. This turned out to be an excellent strategic decision, because we were able to use the proceeds of the sale to focus all of our future work from January 2000 on one field – new cancer medicines. Thereafter, we virtually only worked on cancer.

What is one business idea that you’re willing to give away to our readers?

Use of AI to identify biomarkers and genomic profiles to help select patients who are the most likely to respond to new treatments, leading to accelerated and less costly clinical trials.

What is the best $100 you recently spent? What and why?

Perhaps a bit more than $100, but my wife and I recently bought theater tickets for Nicole, our 14-year old daughter, for the London West-End show, Wicked. She is an up-and-coming professional actress, with a passion for musical theater. Nothing is more important to me than my family – my wife and two beautiful and talented daughters. We were all in London on the way to Wales, UK, where Nicole was filming a fantasy-reality movie for all ages.

What is one piece of software or a web service that helps you be productive? How do you use it?

LinkedIn is a particularly useful web service for me, since it provides a community of colleagues with common interests. Through Linkedin, I can access colleagues at all levels and read their postings about topics we both care about. This web service provides a forum for voicing individual’s perspectives on issues affecting our industry, being an entrepreneur and scientific controversies, among many other topics. It also provides a way of keeping in touch with colleagues or recruiting individuals for open positions.

What is the one book that you recommend our community should read and why?

“Getting to Yes: Negotiating Agreement Without Ever Giving In”, William L. Ury and Roger Fisher, Penguin Group USA LLC, Originally published in 1981. While the original version of this book was published over 35 years ago, it was revised in 1992 and then updated on several occasions by the authors, who were members of the Harvard Negotiation Project. They focused on the psychology of negotiation and developed five propositions of principled negotiation. The fifth is perhaps the most important to entrepreneurs – know your best alternative to negotiated agreement. Whether it’s negotiating the terms of your first round of financing or the commercial terms of your first partnership, entrepreneurs need to remember that every business decision has options and that honing negotiating skills is one of the keys to building a successful business. Especially when you are just starting off in an early-stage company, everyone thinks they have leverage over the entrepreneur, making negotiating skills priceless.

What is your favorite quote?

From Hippocrates, the Father of Medicine: “Wherever the art of medicine is loved, there is also a love of humanity.” Hippocrates was a Greek physician, who was born and lived on the Island of Kos. I have visited the Hippocratic ruins on Kos frequently. He wrote the Hippocratic Oath, established medicine as a profession, and greatly advanced the systematic study of clinical medicine. He is known for being the first person to believe that diseases were caused naturally, not due to superstition or the gods.

Key learnings:

• Become an entrepreneur and accept the associated risks early in life.
• Patients always must come first; leave no patient behind.
• Be a mentor to your senior staff and help them grow in their jobs; internal promotion is a virtue.
• Be proud of the success and leadership of your protégées.
• Clinical scholarship and scientific excellence are essential components of a successful biotechnology company.
• Always listen to your inner voice; it almost certainly will lead you to success as an entrepreneur.
• Surround yourself with the best and brightest talent; you will rarely go wrong, if you do.
• Listen to all stakeholders and be responsive to their input, but always keep patients at the forefront.

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