Focus On Integrating Real-World Data Insights Into Clinical Development Across Pfizer Oncology Portfolio
NEW YORK, NY, September 24, 2019 – Pfizer Inc. (NYSE: PFE) and Flatiron Health today announced an expanded strategic collaboration to further integrate and increase the use of real-world data in Pfizer’s development of innovative targeted cancer medicines. Under the terms of the agreement, Pfizer will draw on de-identified, real-world datasets and analytical expertise from Flatiron Health to inform development strategies and activities for a number of clinical development projects across major tumor types, as well as jointly explore other innovative ways to drive clinical development innovation with real-world data.
The collaboration, which was first established in 2014, builds on recent pioneering work by Pfizer and Flatiron Health to incorporate real-world evidence as part of a regulatory submission to expand the area of use for one of Pfizer’s breast cancer medicines.
“Real-world data and evidence, and the technologies that capture and analyze them, are increasingly valuable ways for us to improve medicines development. They can augment the data we collect in traditional trials and enable greater efficiency and effectiveness in our clinical trial design and operations,” said Rod MacKenzie, Ph.D., Chief Development Officer and Executive Vice President, Pfizer. “We are pleased to expand our relationship with Flatiron Health as we continue to work with leading technology companies and transform clinical trials to better deliver breakthroughs to patients.”
The expanded collaboration will be governed by a Joint Steering Committee to set strategic objectives for the collaboration as well as oversee identification and execution of projects in support of these objectives. Collaborative projects will include datasets from tumor types such as non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). Pfizer and Flatiron Health will explore appropriate venues to share learnings from these research projects, as well as broader implications for the application of real-world data, with the scientific and healthcare communities to further explore the role of real-world evidence in regulatory decision making.
“This collaboration is geared toward uncovering valuable insights to inform clinical development within Pfizer’s oncology portfolio, as well as identifying future areas of collaboration that will evolve the role of real-world evidence in bringing innovative cancer treatments to patients,” said Zach Weinberg, president and co-founder, Flatiron Health. “We believe that the use of real-world evidence holds the potential to significantly accelerate cancer research, and we are proud to expand our relationship with Pfizer Oncology, a leader in this space.”
About Pfizer Oncology
At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of patients. Today, Pfizer Oncology has an industry-leading portfolio of 22 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, prostate, kidney and lung cancers, as well as leukemia and melanoma. Pfizer Oncology is striving to change the trajectory of cancer.
Pfizer Inc.: Breakthroughs that change patients’ lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
Flatiron Health is a healthcare technology and services company focused on accelerating cancer research and improving patient care. Our platform enables cancer researchers and care providers to learn from the experience of every patient. Currently, Flatiron partners with over 280 community cancer practices, seven major academic research centers and over 15 of the top therapeutic oncology companies. For more information, please visit www.flatiron.com or follow us @FlatironHealth.
PFIZER DISCLOSURE NOTICE: The information contained in this release is as of September 24, 2019. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about Pfizer Oncology and a collaboration with Flatiron Health to further integrate and expand the use of real-world data in Pfizer’s development of innovative targeted cancer medicines, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the potential benefits of the collaboration; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications for any potential drug candidates may be filed in any jurisdictions; whether and when regulatory authorities in any jurisdictions may approve any such applications, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such potential drug candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of any such drug candidates; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results,” as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.