NEW MEDICINES, NOVEL INSIGHTS
Advancing precision oncology
Download the executive summary
Gwyn Bebb, M.D., BM, BCh, Ph.D.
Senior Vice President, Global Therapeutic Area Head – Oncology
Precision oncology will continue to be a slow unfurling. Patients are our guides and partners in this quest. Ideal precision oncology therapies deliver maximum benefits with minimum off-target effects and are universally accessible. This report examines some obstacles drug developers encounter and describes strategies to help bring precision cancer medicines more quickly and certainly to market—to benefit an ever-increasing proportion of patients.
FEATURED EDITORIAL
We will realize the vision of precision oncology by solving one challenge at a time.
By Gwyn Bebb, M.D., BM, BCh, Ph.D., Senior Vice President and Global Therapeutic Area Head - Oncology
Precision oncology, with its vision of treating each patient with the exact right medicine, is within reach yet still remote. This paradox has forever hung over my career as an academic researcher, oncologist, and biopharmaceutical industry executive.
IN THIS REPORT
SECTION 1
Empowering cancer patients
Patients and society won’t reap the benefits of precision oncology unless we democratize the data. Patients need access to genetic tests and test results and the ability to quickly identify which clinical trials they are eligible for. We could achieve this and empower patients with a few practical improvements to current care pathways.
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SECTION 2
Regulatory Strategies
Co-developing a companion diagnostic and conducting thorough dose optimization studies are but two of the regulatory challenges facing precision oncology drug developers. Sponsors can de-risk their interactions with regulators by systematically removing uncertainties and finding the most efficient, least burdensome regulatory path.
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SECTION 3
Development Discussions
Two forces are increasing efficiency in precision oncology development. Recent advances in multi-omics and computational analytics are expediting the discovery and validation of biomarkers. Expanding clinical trials to regional and community sites is helping sponsors achieve faster enrollment times, more diverse patient populations, and the same high-quality trial data.
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SECTION 4
Market Access
Improving health outcomes for cancer patients increasingly depends on access to biomarker testing. Rapid advancements in biomarker discovery and testing capabilities are at a tipping point that will significantly impact the development of new precision oncology therapies in the pipeline.
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Contributing Experts
Amy Pace, ScD
Vice President, Biostatistics
Angela Qu, M.D., Ph.D.
Senior Vice President, Translational Medicine, Global Head of Biomarkers & Genomic Medicine
Emily Brouwer, M.P.H., PharmD, Ph.D., FISPE
Vice President, Epidemiology & Real-World Science
Gwyn Bebb, M.D., BM, BCh, Ph.D.
Senior Vice President, Global Therapeutic Area Head – Oncology
Jakki James
Senior Director, Patient Communications
Karen McIntyre
Vice President, Global Site Alliances, Launch Excellence
Kristina Reeder
Director, Patient Insights
Matthew Gordon
Vice President, Real-World Evidence Strategy
Mwango Kashoki, M.D., M.P.H.
Senior Vice President, Global Head of Regulatory Strategy
Pengfei Song, Ph.D.
Vice President, Regulatory Strategy
Sinan Sarac, M.D., Ph.D., M.Sc.
Senior Vice President, Head, Regulatory Strategy Europe
Stacy Hurt, M.H.A., M.B.A.
Chief Patient Officer
Contributing Experts
Amy Pace, ScD
Vice President, Biostatistics
Angela Qu, M.D., Ph.D.
Senior Vice President, Translational Medicine, Global Head of Biomarkers & Genomic Medicine
Emily Brouwer, M.P.H., PharmD, Ph.D., FISPE
Vice President, Epidemiology & Real-World Science
Gwyn Bebb, M.D., BM, BCh, Ph.D.
Senior Vice President, Global Therapeutic Area Head – Oncology
Jakki James
Senior Director, Patient Communications
Karen McIntyre
Vice President, Global Site Alliances, Launch Excellence
Kristina Reeder
Director, Patient Insights
Matthew Gordon
Vice President, Real-World Evidence Strategy
Mwango Kashoki, M.D., M.P.H.
Senior Vice President, Global Head of Regulatory Strategy
Pengfei Song, Ph.D.
Vice President, Regulatory Strategy
Sinan Sarac, M.D., Ph.D., M.Sc.
Senior Vice President, Head, Regulatory Strategy Europe
Stacy Hurt, M.H.A., M.B.A.
Chief Patient Officer
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Learn more about how Parexel is advancing precision oncology
The vision of precision oncology—to treat each patient with the exact right medicine—is within reach yet still remote. We will move closer to the long-term vision by solving practical short-term problems and prioritizing innovation. At Parexel, we navigate multi-omics profiling, biomarkers, dose optimization, clinical trial site selection, companion diagnostics, regulatory strategy, and commercialization one challenge at a time while staying focused on improving the patient journey, our North Star.
Our oncology-focused patient advocates, scientists, statisticians, and former regulators are proud to partner with sponsors to advance precision oncology.