Dr. David A. Roth is a Vice President at Pfizer in the Oncology Business Unit. Dr. Roth leads Pfizer Oncology’s Early Development Group, a global R&D team that develops all Oncology Business Unit pipeline drugs through the Proof-of-Concept development milestone, with a focus on targeted therapies. His portfolio has included palbociclib, a CDK 4/6 cell cycle inhibitor now in phase 3 development for ER+ breast cancer, which is also the focus of a recent MRA-Pfizer partnership award in melanoma. Prior to entering the biopharmaceutical industry over a decade ago, Dr. Roth was on the full time faculty at Harvard Medical School and Beth Israel Deaconess Medical Center. His research focused on hemostasis and human gene therapy and he had spent nearly 10 years as a hematologist in academic medicine.
Sometimes, you just get a good feeling about a potential collaboration. The first time I talked with MRA’s CEO and heard about the organization’s commitment to advancing the most scientifically promising melanoma treatments, we both saw an opportunity to work together to advance cutting-edge melanoma research and, ultimately, help patients.
Less than a week after meeting with one of my colleagues during the 2012 American Society of Clinical Oncology (ASCO) annual conference in Chicago, MRA CEO Wendy Selig sat across from my desk in Cambridge, Massachusetts. I was struck by her optimism and drive, and we were soon discussing MRA’s Industry Partnership program. The program is built on stakeholder collaboration; MRA and a biopharma company co-fund a competitively-awarded research grant given to academic investigators in the melanoma field.
Pfizer has a strong oncology portfolio and world-class R&D resources, but even we cannot independently evaluate every potential treatment across all disease indications and populations. Palbociclib, a CDK 4/6 inhibitor just given the FDA’s ‘Breakthrough Therapy’ designation for breast cancer, had shown potential in melanoma in the pre-clinical setting, but needed further study. A partnership built around evaluations of palbociclib in melanoma would enable Pfizer and MRA to bring together their resources and further explore the potential application of this promising investigational agent in melanoma.
The collaboration fell into place with remarkable speed. The tone from both Pfizer’s senior leadership and MRA was “How can we make this happen?” and we had our complete agreement and Request For Proposal in place by summer’s end. The entire process required a high degree of trust on both sides.
Our request for proposals yielded such high-quality applications that MRA came back to us and asked if we would consider funding two projects instead of just one. MRA’s leadership was excited by the innovative science in the proposals and found additional funds to cover their contribution to the award. My division secured an internal partner at Pfizer, and we funded the second project as a team.
Our partnership with MRA stands as an example of what can be accomplished by collaborative medical research: We have the best teams of people working with a sense of urgency on the most innovative science, with everyone’s focus on creating the best possible outcome for melanoma patients. This type of novel collaboration is a model for the future.
Steve Brody is a partner in the Washington, DC office of the law firm of O’Melveny & Myers LLP, where he is a member of the Class Actions, Mass Torts and Insurance Litigation practice group and head of the practice’s drug and medical device subgroup. A trial and appellate lawyer, Steve’s practice has frequently touched on policy issues related to the efficient development of new therapies and access to prevention and treatment of cancer and other illnesses. Steve and O’Melveny have provided pro bono legal representation to the Melanoma Research Alliance (MRA) since 2011, and the firm has also supported MRA through generous financial donations during the same time period.
On November 21, 2009, my friend David “Super Dave” Myers died after a difficult battle with melanoma. Super Dave (or “Supe,” for short) and I used pack up our guitars and join a group of close friends every Wednesday night for a free-flowing jam session. Occasionally, we’d even land a slot for a live set at a local bar in DC or the Virginia suburbs.
We had been getting together for Wednesday night jams for years when Supe was diagnosed with Stage IV melanoma in the Spring of 2009. He had noticed a spot on one leg some time before then, but delayed seeing a doctor because he had just started a new job and did not have health insurance. By the time Supe’s leg was examined, it was too late to do much about it. Although Supe's doctors tried aggressive radiation and chemotherapy, his condition deteriorated rapidly. He died the day after his 39th birthday.
My O’Melveny & Myers partner and then firm Chairman A.B. Culvahouse was not aware of my personal connection to melanoma when he introduced me to Wendy Selig, CEO of the Melanoma Research Alliance (MRA), about a year later. AB only knew that my practice was devoted to litigation that often implicated FDA regulatory questions and that I had previously represented the FDA when I worked for the Department of Justice. AB correctly thought this experience would lend itself well to exploring opportunities for the firm to provide pro bono legal support to the Melanoma Research Alliance—something that he and Wendy had discussed. Even without my own exposure to the disease, I would have embraced the opportunity to support MRA. But having seen the impact the disease had on Supe made it all the more meaningful to find ways to contribute to the organization. Indeed, everything that MRA does, from promoting melanoma prevention and early detection to funding research into cutting-edge therapies, will help people facing the same diagnosis Supe faced.
From my initial meeting with Wendy, we have been able to identify more and more ways for O’Melveny & Myers to help MRA. The firm has significant experience in litigation risk assessment, grant agreements, licensing, intellectual property, regulatory approval pathways for new drugs and combination therapies, tax issues, and employment law, among other areas that touch on MRA’s effort to fulfill its mission. At this stage, nearly three years into our work with MRA, I’m pleased to be able to report that my O’Melveny colleagues across a wide range of practice groups have without exception been willing to share their time and their practice-leading expertise with MRA. We have reviewed and revised MRA grant agreements, evaluated regulatory impediments to the development of combination therapies, provided guidance for MRA’s tax and employment questions, revised agreements with important MRA partners to protect MRA’s interests, and contributed legal advice on a wide range of other issues confronting MRA.
Over the course of our work, it has been rewarding to see MRA recognized throughout the cancer research, prevention, and advocacy communities. MRA’s stature has been especially clear to me during MRA’s Annual Scientific Retreats. Listening to researchers present findings from MRA-sponsored research and speaking with many of those attending, I have been impressed not only by the enthusiasm with which researchers engage each other, but the equal excitement MRA’s Board Members and advocacy group leaders show for MRA’s mission. It is clear that MRA will have a long and successful future, and it is a privilege to be able to contribute to it with our pro bono work.