NEW MEDICINES, NOVEL INSIGHTS
Advancing precision oncology
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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
Angela Qu, M.D., Ph.D.
SVP, Biomarker Genomic Medicine
Gwyn Bebb, M.D., BM, BCh, Ph.D.
Senior Vice President, Global Therapeutic Area Head – Oncology
Karen McIntyre
Vice President, Global Site Alliances, Launch Excellence
Mwango Kashoki, M.D., MPH
Senior Vice President, Global Head of Regulatory Strategy
Pengfei Song, Ph.D.
VP, Regulatory Strategy
Sinan Sirac, MD, Ph.D., MSc
VP, Technical - Regulatory Strategy
Stacy Hurt, MHA, MBA
Chief Patient Officer
Contributing Experts
Angela Qu, M.D., Ph.D.
SVP, Biomarker Genomic Medicine
Gwyn Bebb, M.D., BM, BCh, Ph.D.
Senior Vice President, Global Therapeutic Area Head – Oncology
Karen McIntyre
Vice President, Global Site Alliances, Launch Excellence
Mwango Kashoki, M.D., MPH
Senior Vice President, Global Head of Regulatory Strategy
Pengfei Song, Ph.D.
VP, Regulatory Strategy
Sinan Sirac, MD, Ph.D., MSc
VP, Technical - Regulatory Strategy