Collaboration amongst various entities across the research and development continuum are becoming more varied within the field of oncology. It is common for pharmaceutical companies to collaborate on clinical trials that test the effects of various drug combinations, or to partner to share commercial sales and marketing efforts. We are now also seeing these same companies partner with government agencies like the Food and Drug Administration (FDA) and National Institutes of Health (NIH). One such example is The Biomarkers Consortium, a research partnership managed by the Foundation for the National Institutes of Health. This public-private biomedical research alliance is working on advancing drug development by discovering and qualifying biomarkers.
Additionally, patient advocacy groups such as Multiple Myeloma Research Foundation or the Leukemia and Lymphoma Society are partnering with pharmaceutical companies to fund and conduct clinical trials. And, many of the most recent advances in cancer research have come from collaborations between companies and academic research institutions.
Open source clinical data is one of the most exciting and promising results of collaboration. In this effort, companies are pooling their collective clinical trial data and making it available to others. Sharing data will hopefully lead to a more streamlined clinical trial process, which will lead to faster and better drug development.
Collaborations are very important to Astellas. We have collaborated with Medivation to bring new treatment options to market to fight prostate cancer; and with Roche to bring treatment to patients with Non-Small Cell Lung Cancer. We have also recently partnered with Daiichi Sankyo to create a shared compound library. Through this alliance approximately 400,000 selected compounds are available to Astellas and Daiichi Sankyo that can be accessed quickly and used to develop innovative new drugs.
It is collaborative efforts like these that may hopefully lead to new treatments for cancers of all types. Working in a vacuum cannot produce the innovation needed to tackle the problem and luckily, more and more partnerships are forming amongst various entities. Along with innovators and researchers across the globe, we couldn’t be more excited about what the future holds for patients who rely on us for treatments.
Joshua Schafer is Vice President, Oncology Global Marketing Strategy at Astellas Pharmaceuticals, which a global top 20 pharmaceutical company. In his current role Mr. Schafer is responsible for global strategy and commercial leadership for Astellas Pharmaceuticals’ oncology portfolio with revenues of approximately $1.5B. Most recently he led the global launch of Xtandi for prostate cancer. He is a member of the Oncology Leadership team responsible for long term strategic planning, portfolio asset prioritization, development planning, and investment decisions including licensing and acquisitions. He was instrumental in the company’s $4B acquisition of OSI Pharmaceuticals, as well as the in-licensing and commercialization of Xtandi (Medivation), tivozanob (AVEO Oncology), and Tarceva (Roche/Genentech).
Previously, Mr. Schafer was Director of Specialty Marketing at Takeda Pharmaceuticals where he was responsible for providing commercial leadership for Takeda’s oncology and renal pipeline, and served a pivotal role in the $9B acquisition of Millennium Pharmaceuticals. He held a variety of roles including New Product Development, Business Development and Marketing. Prior to working at Takeda Mr. Schafer held positions within global medical affairs at Searle (now Pfizer). He started his career in management consulting, with Andersen Consulting (now Accenture).
Mr. Schafer holds a MSc and an MBA from Northwestern University and received his undergraduate degree from the University of Notre Dame. He was named one of Crain’s Chicago Business 40 under 40 for 2010 and an Emerging Pharmaceutical Leader by Pharmaceutical Executive in 2013. Mr. Schafer is active in the Chicago business community and is a member of Chicago Innovation Mentors, a joint program between Northwestern University, University of Chicago and University of Illinois to stimulate innovation in the Chicago area.
The crosstalk between all parties in the process of discovery, development and commercialization of medicines has undergone significant evolution in the recent past. Not so long ago, it was incredibly rare to see competing pharmaceutical companies working together to develop combinations of medicines, even when there was compelling rationale. Collaborations between industry and academia have been common but there have often been misalignments about objectives and incentives. Relationships between the government and pharmaceutical companies have been mostly confined to regulatory interactions in the context of drug approvals.
It’s exciting, then, to see that in just a few years, many of those dynamics are changing. Advances in scientific understanding of cancer biology, coupled with societal demands for higher therapeutic value have led to collaborations among industry to develop therapeutic combinations that work in synergy and circumvent resistance. Here are just a few examples. Today GSK is working with Merck, Pfizer, Astra Zeneca and Amgen on the development of combination therapies in oncology. So far collaborations among industry have not reached sufficient maturity to result in commercialization, but it is likely that we will see those types of agreements in the coming years.
With regards to academic-industry collaborations, last year we formed a consortium with six of the best cancer centers in the world, located at academic and global research institutions. And we’ve partnered with the National Cancer Institute to share cancer cell lines that can be mined by researchers. Industry has increased interactions in recent past with regulators and academia, particularly in the context of multi-party discussions to inform regulatory policy. For example, GSK and Pfizer are collaborating to evolve companion diagnostics from single analyte kits to multiplex systems that simplify testing across multiple markers and products in oncology.
Seeing a medicine at the end
Traditionally, academia has led with basic discoveries, particularly in the US, with research funding coming from federally funded agencies, and pharmaceutical companies have leveraged those discoveries into therapeutics. As our understanding of therapeutic targets, cancer genetics and epigenetics, pathway resistance, and host immune tolerance evolves, the complexity of the field now demands a closer partnership in the early discovery and target validation process between academia and industry. This has been aggravated by limitations in basic research funding in many geographies coming from governmental sources.
The medicines of the future will likely come from the emergence of basic scientific discovery at industry and academic laboratories working in close partnership. To this end, both parties will need to work towards the common goal of leveraging scientific discoveries into therapies that improve patient lives.
Rafael Amado is Senior Vice President, Oncology R&D at GlaxoSmithKline. He is accountable for integrating oncology R&D efforts from drug target identification through late-stage development and registration globally.
Rafael joined GSK in 2008 as Vice President, Medicine Development Leader for Votrient. In that capacity he was responsible for developing and executing the asset’s development strategy globally. He served in positions of increasing responsibility as Vice President, Oncology Solid Tumors and Senior Vice President, Oncology Development, to his current role of head of Oncology R&D. During his tenure, he has overseen the development and registration of indications globally of multiple products including Votrient, Tykerb/Tyverb, Promacta/Revolade, Arzerra, Mekinist, and Tafinlar, and has led the development of a pipeline of products in novel areas of cancer biology.
Prior to joining GSK, Rafael was Executive Director in the Therapeutic Oncology Area at Amgen where he was responsible for development activities of several assets, including global registration for Vectibix. An area of his interest is biological characterization of tumors for patient selection, which he successfully applied to targeted drug development with EGFR inhibitors in colorectal cancer. Rafael trained as a Hematologist/Oncologist at the University of California, Los Angeles, where he remained as faculty until joining Amgen in 2003.
A native of Spain, he holds an M.D. from the University of Seville School of Medicine. He performed his residency in Internal Medicine at Michael Reese Hospital, a University of Chicago Affiliated Hospital, and his fellowship in Hematology/Oncology at the University of California, Los Angeles. He has published extensively in his field, and is a member of multiple professional societies.
Like both sides of a coin, there are two sides in the battle against cancer. We are making huge strides in preventing, slowing and in some cases beating many forms of cancer, but there are still considerable roadblocks to reaching our ultimate goal of a world free from cancer.
Let’s start with the good news. For most of the 20th Century a diagnosis of cancer was seen as a death sentence – but no longer. Our early understanding of the related biological processes was relatively minimal as researchers initially believed cancer was a monolithic disease. Today, however, researchers in academia, the government and biopharmaceutical companies have come to better grasp the molecular and genetic underpinnings of many cancers, which is providing countless new roadmaps and opportunities to identify new treatment approaches.
Since the 1970s, the five-year survival rate for cancer has risen from 58 percent to 83 percent. According to the Journal of Health Economics, medicines have been at the forefront, even more so than early detection, in the battle against cancer. Each new cancer medicine, whether it extends a life for six months or six years, has helped researchers open a new set of doors into drug discovery.
Globally, there are over 3,000 cancer medicines in development around the world, with 80 percent having the potential to be first-in-class treatments. Although the vast majority of these projects will not result in approved medicines for patients, they represent an exciting new scientific chapter in progressing our knowledge towards a cure.
Every innovation in cancer treatment – many involving precision or personalized medicines linked to a diagnostic that helps determine whether a patient will be more likely to respond to a medicine – offers tremendous hope for new treatment options. There are, however, ways we can do even more. Part of that starts with improving the drug discovery and development process. Currently, it takes an average of 10-15 years and over $1.2 billion to bring a drug to market and that’s with a failure rate of 99 percent.
Collaborative efforts are underway across the biopharmaceutical ecosystem to build better efficiencies into the R&D process. For example, we are working to improve the clinical trials process through efforts such as I’m In, a campaign designed to increase awareness and participation in clinical trials among traditionally underrepresented populations, and Project Data Sphere, an independent initiative of the CEO Roundtable on Cancer's Life Sciences Consortium. Project Data Sphere, which launched just a couple of months ago, creates a platform for researchers from industry and academia to responsibly share and analyze patient-level phase III cancer data. The goal is to facilitate improved trial design, reduce duplication and develop broad data standards.
These are exciting times for cancer innovation. Thanks to continued advances in basic research and unique partnerships that translate new knowledge about human biology and disease into safe and effective therapies for patients, we are on the cusp of unprecedented progress against the many forms of cancer that affect us all.
Salvatore (“Salvo”) Alesci, M.D., Ph.D. joined PhRMA in December 2011 as Vice President, Scientific & Regulatory Affairs. In this role, Dr. Alesci serves as the primary expert for PhRMA on scientific and medical issues. He carries overall responsibility for establishing PhRMA as a “go to” source for input on policies and legislation related to innovative approaches to biopharmaceutical discovery and development. Dr. Alesci brings to PhRMA over ten years of combined academia/government/industry research experience and multi-disciplinary expertise in Translational Medicine.