A Look at Cancer Drug Development with Dr. Harvey Berger

In recent years, the number of new cancer drugs on the market has risen quite rapidly, with many more in development and actively being tested in clinical trials around the globe. But drug development can take many years to see the idea of a new therapy in a lab to a tested, approved treatment on the market to hopefully extend a patient’s survival.

Dr. Harvey Berger, Executive Chairman at Medinol, Inc., a global interventional cardiovascular-device company, has had a lengthy and varied medical career helping to develop innovative medicines for cancers that are difficult to treat. As founder and CEO of ARIAD Pharmaceuticals, Inc., he led the development of a number of new cancer drugs, including immunotherapies.

“Over the course of my career in the biotechnology and life-sciences industries, I am proud to say that I 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 challenging diseases in cancer, immunology and cardiology,” Dr. Berger told the Mesothelioma Cancer Alliance (MCA).

We recently sat down with Dr. Berger to learn more about cancer drug development and what lies ahead for cancer research.

Clinical Trials and Cancer Drug Development

During his lengthy career with ARIAD Pharmaceuticals, Dr. Berger has been involved in the clinical development of eight new drugs, including several for lung cancer and leukemia. He led the development of drugs like Iclusig® (ponatinib) for Ph+ leukemias, Alunbrig® (brigatinib) for ALK+ non-small cell lung cancer (NSCLC), and rimiducid, a dimerizing drug for use with cellular immunotherapies, such as CAR-T therapies.

Immunotherapy has been an important aspect of cancer research, especially in recent years. Through his own and others’ research, Dr. Berger reasoned that there has been a huge shift in cancer drug development to more personalized therapies based on specific genetic mutations. Many of the drugs he was involved in, as well as in many other clinical trials, proved their efficacy against certain genomic profiles, with researchers having a much better understanding of biomarkers than ever before. This type of research can lead to huge treatment breakthroughs.

Progress in cancer drug research, however, rests heavily on patients volunteering and seeking out participation in clinical trials.

“The only way to learn how new diagnostic tests or new therapies work is to study them in patients with the diseases for which they were designed. Studies in the lab or in animals are inadequate. At this point in time, the course of cancer can only be studied effectively in clinical trials,” Dr. Berger emphasized.

Additionally, Dr. Berger hopes to see more education and training designed specifically around clinical research to continue improving the drug development process. “In any case, there is a science to conducting clinical trials, and they must be carried out with the same attention to detail as experiments in the lab. Several medical schools, such as Yale Medical School, have set up programs to train clinician scholars – physician-scientists who can be leaders of clinical research initiatives. I am a very strong believer in this type of educational effort,” explained Dr. Berger, who began his medical career at Yale School of Medicine.

With a concerted effort around improving the clinical trial process, cancer research will continue to progress and see breakthroughs even for rare cancers like mesothelioma.

The Future of Cancer Research

Precision or personalized medicine has been a bigger focus of cancer research, with many researchers stating their belief that personalized medicine is the key for a cancer cure.

“Looking back, we have witnessed extraordinary progress in the development of molecularly targeted medicines, such as inhibitors of tyrosine kinases, DNA repair, and cancer-cell metabolism and immune regulators in which a patient’s own immune system is used to treat cancer, such as inhibitors of checkpoint pathways and CAR-T cell therapies,” Dr. Berger explained.

Though progress has been made in exploring these therapies and others, like personalized cancer vaccines, there is still a lot of work ahead, with exciting developments underway. Dr. Berger has seen a lot of efforts behind utilizing artificial intelligence and cancer genomics to better differentiate tumors and develop new cancer therapies.

For Dr. Berger specifically, who was recently elected to the governing Board of Trustees of the Dana-Farber Cancer Institute (DFCI) and the Science Committee of the Board at the DFCI, he hopes to continue helping patients have even more opportunities to participate in groundbreaking clinical trials as a trustee.

“Without question, the Dana-Farber Cancer Institute is one of the preeminent cancer centers in the world. What distinguishes the institution from most others is the balanced focus on excellence in patient care and cutting-edge research, both basic laboratory studies and clinical trials,” Dr. Berger said. “The institution is interested in taking more of its discoveries from the laboratory to the clinic and offering patients even greater opportunities to participate in clinical trials of the fruits of its labors in the lab. I am working with the leadership of the DFCI to help make this even more achievable than in the past.”

With so much varied research and opportunities in the oncology field, hopefully a cure is in the not so distant future.