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The recent breakthroughs in understanding the molecular biology of cancer have led to an unprecedented number of new targets in oncology drug development. There are more cancer drugs in the research pipeline than any other type of therapy, corresponding directly with the number of oncology clinical trials. Why do phase III clinical trials in oncology fail so often? One simple answer does not exist to this critically important question. Success of an oncology trial depends on many factors: scientific, organizational, biostatistical, regulatory, ethical and economical.  The second annual Oncology Clinical Trials is designed to provide a comprehensive coverage of many of these components as well as present case studies of successful clinical trials.

Wednesday, February 13

7:00 am Registration and Morning Coffee

 

Plenary Keynote Session 

8:00 – 9:40 am Plenary Keynote Presentation - Personalized Oncology – Fulfilling the Promise for Today's Patients

In honor of the 20th anniversary of the Molecular Medicine Tri-Conference, CHI and Cancer Commons will present a plenary panel on Personalized Oncology. Innovations such as NGS and The Cancer Genome Atlas have revealed that cancer comprises hundreds of distinct molecular diseases. Early clinical successes with targeted therapies suggest that cancer might one day be managed as a chronic disease using an evolving cocktail of drugs.Representing all five conference channels, Diagnostics, Therapeutics, Clinical, Informatics, and Cancer, a panel of experts will lead a highly interactive exploration of what it will take to realize this vision in the near future.

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9:40 Refreshment Break in the Exhibit Hall with Poster Viewing

 

Cancer Drug Resistance and its Impact
on Oncology Clinical Development 

11:00 Chairperson’s Opening RemarksBranimir I. Sikic, M.D., Professor of Medicine, Division of Oncology, Stanford University School of Medicine 

11:10 KEYNOTE PRESENTATION: Challenges in Understanding Resistance to Targeted Therapies

Jamey Skillings, M.D., Vice President, Global Medical Affairs, Pfizer

This presentation will describe the evolution of clinical and molecular data which describe resistance to Xalkori. Case examples from this program and other targeted therapies will be used to discuss how evidence can be developed to support treatment decisions after RECIST progression.

11:40 Epithelial to Mesenchymal Transition (EMT): Diagnostics, Drug Resistance and Impact in Clinical Trials

Branimir I. Sikic, M.D., Professor of Medicine, Division of Oncology, Stanford University School of Medicine

EMT is associated with stem cell markers in cancer cells, as well as resistance to various chemotherapies. Characteristic biomarkers of EMT include decreased E-cadherin, and increased vimentin, fibronectin, MMP2 and MMP9. Among the consequences of EMT is an upregulation of TUBB3, the beta tubulin isoform that confers resistance to microtubule stabilizing drugs such as taxanes.

12:10 pm Combining BRAF Inhibitor and Adoptive Cell Immunotherapy Increases Antitumor Activity and Reduces Risk of Resistance in Metastatic Melanoma

Richard C. Koya, M.D., Ph.D., Assistant Professor, Department of Surgery, Surgical Oncology, Member, JCCC Tumor Immunology Program Area

Recently various targeted kinase inhibitors showed promising outcomes in metastatic melanoma patients, but recurrence is still an issue. Adoptive transfer of anti-melanoma reactive T cells can induce long-term response in selected patients, thus a combination of both is an attractive therapeutic approach our group is pursuing.

12:40 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own

1:45 20th Anniversary Cake in the Exhibit Hall with Poster Viewing

2:15 Chairperson’s RemarksPatrick Schnell, M.D., Safety Risk Management Lead, Pfizer 

2:20 Translational and Clinical Pharmacologic Considerations for Combination Therapy Development in Oncology

Stephanie Faucette, Pharm.D., Ph.D., Senior Manager, Clinical Pharmacology, Millennium Pharmaceuticals

 

Adverse Events Reporting and Pharmacovigilance 

2:50 NCI’s Approach to Expedited and Routine Adverse Event Reporting as it Relates to the New FDA Guidance on AE Reporting for IND Agents

Pamela Harris, M.D., Senior Investigator, IDB, CTEP, National Cancer Institute

3:20 Drug Safety Monitoring of an Emerging Compound – The Crizotinib Experience

Patrick Schnell, M.D., Safety Risk Management Lead, Pfizer

3:50 Q&A with Speakers

4:20 Networking Reception in the Exhibit Hall with Poster Viewing (Sponsorship Opportunities Available)

5:20 Breakout Discussions in the Exhibit Hall

Regulatory Compliance in Drug-Diagnostics Co-Development

Moderators:
Pamela L. Swatkowski, Director, Regulatory Affairs, Abbott Molecular, Inc.
Maham Ansari, MS, RAC, Senior Associate, Regulatory Affairs, Strategic Regulatory Services, OptumInsight, Inc. (UnitedHealth Group) 

-  Brainstorm new regulatory pathways to facilitate co-development of drug/diagnostics
-  Explore areas where additional FDA guidance is needed for co-development of drug/diagnostics
-  Propose incentives for innovation and risk-based approaches to contemporaneous development of drug/diagnostics

Methodology of Biomarker-Driven Clinical TrialsModerator: Donald Berry, Ph.D., Professor, Department of Biostatistics, The University of Texas MD Anderson Cancer Center

Acquired Resistance to Targeted Cancer TherapiesModerator: Jamey Skillings, M.D., Vice President, Global Medical Affairs, Pfizer

-  Why majority of patients using targeted agents develop resistance over time?
-  What is its impact on clinical trials?
-  What are the ways to overcome resistance?

6:20 Close of Day

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