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Gwyn Bebb, M.D., BM, BCh, Ph.D.

Franchise Head, Oncology

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NEW MEDICINES, NOVEL INSIGHTS

Advancing precision 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.

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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.

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IN THIS REPORT

Empowering cancer patients

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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 Regulatory Strategies

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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 Development Discussions

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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 Market Access

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

Gwyn Bebb, M.D., BM, BCh, Ph.D.

Franchise Head, Oncology

Karen McIntyre

Vice President, Global Site Alliances, Launch Excellence

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 of Oncology Europe, Regulatory Consulting

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

Gwyn Bebb, M.D., BM, BCh, Ph.D.

Franchise Head, Oncology

Karen McIntyre

Vice President, Global Site Alliances, Launch Excellence

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 of Oncology Europe, Regulatory Consulting

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.

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