​​​​Dose-finding of Small Molecule Oncology Drugs 

On May 18-19, 2015, the U.S. Food and Drug Administration (FDA) and the American Association for Cancer Research (AACR) cosponsored a public workshop titled “Dose-finding of Small Molecule Oncology Drugs.” Slide/audio recordings are now available.​​​

The purpose of the two-day workshop was to provide an interdisciplinary forum to discuss the best practices of dose finding and dose selection for small molecule kinase inhibitors developed for oncology indications. The goal was to promote a movement away from conventional dose escalation trial design and move toward innovative designs that can incorporate key clinical, pharmacologic, pharmacometric data, and when appropriate, non-clinical information to guide dose selection. Ideally, this workshop will propel a movement toward integrating dose finding into the entire life cycle of product development as opposed to confining it to the phase I, first-in-human trial based on short-term safety measures.

View/download the worksh​op agenda.

View/download the speaker bios.

Presentation Slides. Slides from both days of the workshop are now available. Please note that some speakers have asked to have some or all of their slides withheld.

View/download slides from Day 1.
View/download slides from Day 2.

Workshop Transcripts

​View/download the full transcript from Day 1.
View/download the full transcript from Day 2.

​Slides/Audio Recordings - Day 1  

Session I: Small Molecule Characterization  

Natalie Simpson, PhD, FDA


Thomas W. Jones, PhD, Eli Lily & Co. (AUDIO ONLY)


Richard Brennan, PhD, DABT, Sanofi

Donna Dambach, VMD, PhD, Genentech (AUDIO ONLY)


William Kluwe, PhD, Novartis Pharmaceuticals (AUDIO ONLY)


Panel Discussion for Session I

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Session II: Design of Dose-finding Studies 

Nitin Mehrotra, PhD, FDA


Dinesh De Alwis, PhD, Merck Research Labs


Laura Fernandes, PhD, FDA

Stuart Bailey, PhD, Novartis Oncology

Jose Pinheiro, PhD, Janssen

Amit Roy, PhD, Bristol-Myers Squibb

Panel Discussion for Session II

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Slides/Audio Recordings - Day 2

Session III: Dose-exposure Exploration 

Qi Liu, PhD, FDA

Dan Howard, PhD, Novartis

Yazdi Pithalva, PhD, Pfizer


Eric Masson, PharmD, AstraZeneca (AUDIO ONLY)

Jin Jin, PhD, Genentech

Panel Discussion for Session III

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Session IV: Integrating Dose Optimization in Clinical Development 

Geoffrey Kim, MD, FDA


Rajeshwari Sridhara, PhD, FDA


Lilli Petruzzelli, MD, PhD, Novartis (AUDIO ONLY)


Alice Shaw, MD, PhD, Massachusetts General Hospital(AUDIO ONLY)


Pasi Janne, MD, PhD, Dana Farber Cancer Institute


Panel Discussion: Future Considerations and Moving Forward​

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