Catching Up with the Genomic Era in Oncology: Key Considerations for Incorporating Genomics into Oncology Drug Development

This webinar will provide insight into key genomic concepts and technologies that have shaped our contemporary understanding of the biology, treatment, and drug development opportunities in oncology.

The integration of genomics into the process can be considered a third revolution in drug development in cancer. The first iteration was characterized by the development of classic cytotoxics such as aklylating agents. A second wave of change came with development of agents targeting specific molecular markers in the cancer cell such as Herceptin® for the over-expression of HER2. Today, the emerging understanding of the complex interplay of genomic alterations has led to a need to more fully understand the landscape of oncogenic drivers and drug targets present in an individual’s tumor. This complexity, and the genomic technologies developed to address it, present challenges to traditional drug development experts as well as clinicians. Quintiles’ experience has taught us that there is a need for drug developers to improve and expand their working understanding of genomics concepts and technologies in order maximize its value in drug development.

This webinar is intended to help oncology drug developers better understand key genomics concepts, technologies, and considerations for utilizing these approaches in their oncology programs, specifically:

• Application of genomic DNA sequence profiling to help patient selection and speed timelines in oncology clinical trials
• Technologies available for less invasive follow on testing, disease recurrence assessment, and patient management
• The role of understanding RNA sequencing and expression microarrays in deciphering target mechanisms of action and pathway deregulation at the gene expression level
• Platforms available for validating results and scaling up including 3rd generation sequencing platforms, high throughput genotyping platforms, and digital PCR

The audience can expect to gain the following insights:

• The impact of genomics on the oncology clinical development process
• Tangible opportunites and benefits of leveraging genomics in oncology clinical development
• Key considerations for incorporating genomics into your oncology clinical programs
• An understanding of the role of biomarkers in oncology clinical development and how cutting edge genomic technologies are being used to assess biomarkers
• Technical considerations for selecting genomics platforms and addressing biological questions
• An appreciation for the scope of bioinformatics needed to support genomics and key challenges of interpreting and managing genomic data

Speakers

Philip Breitfeld, MD, Vice President, Therapeutic Strategy, Oncology, Quintiles

What he does: Dr. Breitfeld has over 25 years of work experience in oncology, including 20 years of experience in academic medical institutions in the US, and 7 years of experience in the pharma industry focused exclusively on oncology drug development and execution of clinical programs. Prior to joining Quintiles he held senior oncology clinical development positions at BioCryst and Merck Serono. He has around 50 peer-reviewed publications in the scientific literature, and was a Visiting Scientist at the Whitehead Institute at MIT.

Experience and Expertise: Clinical oncology, clinical trial design, clinical program design and leadership, clinical science-operational delivery integration; background in molecular biology and informatics

Education: Dr. Breitfeld received his undergraduate degree from Princeton, his MD from the University of Rochester, and was a clinical and research fellow (Pediatric Hematology-Oncology) at the Dana-Farber Cancer Institute at Harvard. He completed a second fellowship in Medical Informatics sponsored by the National Library of Medicine. He was a Visiting Scientist at the Whitehead Institute at MIT.

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Jeff Fitzgerald, Product Specialist Director, Global Laboratory Solutions, Quintiles

Jeff brings to EA – Quintiles over a decade of successful sales and support experience in the genomics tools sector. In his current position he supports the integration of genomic technologies to address biomarker analysis in sponsors’ clinical trials.

Previously while at RainDance Technologies he cultivated new business opportunities in research and clinical markets through the use of its sequence enrichment solutions in conjunction with various next generation sequencing platforms. In previous sales and support roles at Affymetrix, he supported key genome and academic research centers in the use of expression, resequencing, and genotyping microarrays. Prior to his commercial experience, Jeff sought to identify molecular markers responsible for tumor progression while performing research in the Department of Pathology at Brigham and Women’s Hospital and Harvard Medical School.

Jeff holds a Bachelor of Science from the University of Vermont in Microbiology and Molecular Genetics.

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