Personalized Medicine: A Revolution in Our Mindset, Not in Technology

On November 15th, industry leaders will gather in Boston for the much anticipated 12th Annual Personalized Medicine Conference. Leading up to the event, Slone Partners shares its special four-part PMC interview series.

Our third interviewee, Dr. Michael Pellini, offers his unique perspective on the advancement of Personalized Medicine. In this exclusive interview, Dr. Pellini explains the importance of collaboration in the development of a regulatory framework, and the essential role of genomic profiling and data exchange in guiding the precision medicine approach. He also discusses how the Cancer Moonshot 2020 encourages industry, academia, advocacy to come together to fuel development and conversation around the adoption of precision medicine.

Slone Partners: What is the biggest challenge in genomics-driven treatment and how can it be overcome?

Dr. Pellini: We live in an age where precision medicine is no longer a far-away vision, but rather, a rapidly advancing reality with the power to change the way cancer is identified and treated. In recent years, our understanding of cancer has evolved from a disease characterized based on the organ/tissue in which it arises, to a more precise and complex disease of the genome. Physicians today are using precision medicine to help inform cancer treatment based on identifying specific and highly individualized genomic alterations driving each individual’s tumor growth – – in effect, they are working to match the most appropriate targeted therapy or immunotherapy to each patient’s disease.

Expanding patient access to these targeted treatments and importantly, to the comprehensive genomic profiling (CGP) assays, like FoundationOne®, FoundationOne® and FoundationACT™, that help identify patients most likely to respond to these medicines is critically important as precision medicine continues to advance. Increasing access to, and securing reimbursement for, these molecular information assays must be a collective effort among the cancer community. As a community, we must also collaborate towards the development of a regulatory framework that supports the efficient evaluation and streamlined delivery of these therapies and treatment approaches to ensure these options are accessible to everyone who needs them.

We’ve seen progress in recent years, particularly from the FDA and its proactive stance to establish a regulatory framework for laboratory developed tests (LDTs), from the Obama Administration with its Precision Medicine and Moonshot initiatives, and through thought-provoking draft legislation, such as 21^st Century Cures. Each of these is a good start, but there is much more to be done, including ongoing collaboration among industry, academia, and advocacy to advance these efforts. We also recognize that continued sharing of genomic information is essential to the advancement of precision medicine; it’s absolutely necessary to stimulate and inform new research and accelerate the discovery of novel innovations to fight cancer.

Slone Partners: Describe the role of genomic profiling in personalized medicine (in the U.S. and globally) over the next five years.

Dr. Pellini : In the next five years, Foundation Medicine’s goal is to ensure that analytically and clinically validated genomic profiling assays are fully integrated into the cancer care treatment model in order to guide a precision medicine approach to clinical care. The government, the data itself, and especially physicians and their patients will mandate it.

At the same time, data aggregation and analysis from genomic profiling of real-world clinical samples has the potential to accelerate the identification of druggable biomarkers, fuel the development of new targeted and immunotherapies, identify more patients who will respond to existing therapies, and improve clinical trial efficiency, enrollment, and outcomes.

For example, we believe that each tumor analyzed today could help a patient diagnosed tomorrow, and perhaps not just figuratively. In just six years, our company has analyzed more than 90,000 real-world clinical profiles (in addition to the profiles generated from all of our academic and pharma endeavors). This clinicogenomic information, now contained in FoundationCORE™, our knowledgebase for genomic insights from adult and pediatric patient tumors, evolves and expands with each new tumor sequenced. As we add to our knowledge about cancer’s molecular underpinnings, we’ll continue to make important advances and foster new approaches that help improve patient care, including for example, the opportunity to predict the likelihood of relapses to treatment before they occur. Importantly, we are also committed to making sure this data reaches the broadest research community possible.

There is no doubt that the integration and continued utilization of CGP assays like the ones developed by Foundation Medicine will add to our collective knowledge and our quest to change the way cancer is treated.

Slone Partners: What have Foundation Medicine and Roche found as you commercialize your products in the global market? Is there any major difference in adoption, education, etc.?

Dr. Pellini: Foundation Medicine and Roche teamed up in early 2015 to drive a global transformation in cancer care. Our companies share a similar philosophy that molecular insights and information will be the game changer in the march towards precision medicine. Our collaboration with Roche is quite broad, incorporating both R&D and commercial components.

Specifically, Roche is our partner to commercialize our molecular information products outside the United States. Each ex-US market is very different from the perspectives of embracing precision medicine, integrating molecular profiling, and establishing the requisite regulatory frameworks to achieve personalized care. One commonality is the need for HCP (Health Care Provider) education, specifically in the area of genomics and its dramatic impact towards achieving improved clinical outcomes. In addition, we have clearly seen that each country presents its own set of challenges and opportunities with regard to the local regulatory and payer environment. In fact, it’s hard to imagine expanding into more than 15 countries over the course of 2016 and 2017 without our Roche partners! They bring a level of expertise and infrastructure in each country that would take us many years to build on our own.

Slone Partners: Why did the Cancer Moonshot become a focus for Foundation Medicine, and what role will the 18,000 genetic profiles that you donated have in its success?

Dr. Pellini: Our participation in the Cancer Moonshot and Precision Medicine initiatives are a natural fit for us because these patient-centric tenets are central to our mission to transform cancer care. By virtue of our business, we have been at the leading edge of precision medicine working to integrate this approach into clinical practice since the founding of our company.

Foundation Medicine has always contemplated the public release of our data over time, and we were honored to collaborate with the NCI to contribute a selection of real-world clinical profiles from FoundationCORE™ to the NCI’s Genomic Data Commons (GDC) portal. This contribution more than doubles the size of the GDC database and complements the research-based information in the portal from TCGA and other sources. (The NCI launched the portal with approximately 14,000 genomic profiles). We believe the release of this data will facilitate collaboration and accelerate research towards precision medicine therapeutics, including targeted agents and immunotherapies, which will ultimately contribute to significant advancements in patient care. Perhaps, it will even open the door for other companies to release their data as well.

Slone Partners: In your opinion, how will the Cancer Moonshot impact cancer care for healthcare providers & patients?

Dr. Pellini: We believe the National Cancer Moonshot and Precision Medicine Initiatives will advance the achievement of precision medicine in cancer, and we’re pleased to support these important programs. The Moonshot has already realized part of its goal by bringing together industry, academia, advocacy and other groups to stimulate the important conversations, to encourage collaboration and novel data sharing, and to decide how collectively we can and will knock-down barriers to wide-scale adoption of precision medicine.

Data exchange and ongoing sharing of information between academic researchers and clinicians, as well as diagnostics and pharma companies, are key components to achieving the longer-term goals of the Moonshot and Precision Medicine initiatives. This belief was the impetus behind our release of data to the NCI database which, as mentioned previously, will help provide the global oncology community with access to information that can accelerate research and development toward targeted therapies to treat cancer.

In so many ways, Vice President Biden did us all a great favor by developing Moonshot and putting cancer care in the spotlight once again. I believe we owe it to the Vice President and his family to return the favor by proving him right, namely by making 10 years of progress in cancer care in only five years. It requires a revolution in our mindset, not in the available technology and medicines.

About Michael Pellini

Dr. Pellini joined Foundation Medicine in May 2011, bringing a breadth of experience in life sciences and the clinical diagnostics and laboratory industries to the company. Dr. Pellini came to Foundation Medicine from Clarient, a GE Healthcare Company, where he held the position of President and Chief Operating Officer. Dr. Pellini joined GE Healthcare through the integration of Clarient, Inc., where he worked with the company’s leadership team to drive operational excellence and reimbursement strategies in parallel with the development and commercialization of multiple diagnostic tests. Dr. Pellini’s leadership was instrumental in building Clarient to the highly successful acquisition by GE Healthcare in October 2010.

Prior to his tenure with Clarient, Dr. Pellini served as Vice President, Life Sciences at Safeguard Scientifics, Inc., where he leveraged his business and medical expertise to explore new market opportunities and to support Safeguard’s partner companies. Prior to Safeguard, he was Executive Vice President and Chief Operating Officer at Lakewood Pathology Associates, a national molecular pathology services company, which was acquired by Water Street Healthcare Partners in 2006. Previously, Dr. Pellini was an Entrepreneur-in-Residence at BioAdvance, where he was responsible for identifying early-stage life science opportunities. He also served as President and Chief Executive Officer of Genomics Collaborative, Inc., a Boston-based biotech firm that was acquired by SeraCare Life Sciences, Inc. in 2004.

Dr. Pellini received a BA from Boston College, an MBA from Drexel University and an MD from Jefferson Medical College of Thomas Jefferson University. He is a board member of the Personalized Medicine Coalition and the Massachusetts Biotechnology Council and serves on the President’s Leadership Council of Jefferson Medical College.

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