The Ever-Increasing Impact of Gene Therapy in Rare Oncology Trials

Clinical Trials, Drug Discovery & Development, Life Sciences,
  • Monday, November 18, 2019 | 11am EST (NA) / 4pm GMT (UK) / 5pm CET (EU-Central)
  • 60 min

The alteration of genetic material held within a person’s cells as a way of treating or preventing disease is the simple, common definition of gene therapy. This type of therapy is rapidly progressing within the world of oncology, for both treatment and prevention of cancers. However, the future of gene therapy presents some unique questions and challenges. Are we heading in the right direction? What are the ethical considerations? And how do we ensure access to these therapies?  

As oncology trials become more complex, scientists are finding that the oncogenic drivers of disease are crafting more discrete patient populations and are therefore turning what was once a very generalized disease state into a rare indication. Now, we are not only working with oncogenic drivers, but also the very genetic code that makes each of us the same, yet different. The impact that oncogenic drivers have on our ability to define a population and ensure equal access to treatment is becoming more critical. 

Join this free webinar to hear a discussion about these challenges , with strategies and real-life solutions to support patients, sites and sponsors.

Speakers

http://Christopher%20Heckman,%20Synteract

Christopher Heckman, Vice President, Oncology Development, Synteract

A visionary leader with more than 23 years in the global clinical research industry, including 20 years supporting oncology drug development, Christopher Heckman holds broad experience in both strategic and operational lines of responsibility. He brings hands-on engagement across all clinical development phases, including the successful leadership of a global registration and inspection project. Mr. Heckman has championed relationships with therapeutically-focused cooperative groups as well as numerous patient advocacy groups. Mr. Heckman has contributed to the successful development of cytotoxics, targeted therapeutics, as well as personalized medicines; most recently with a focus on cell and gene therapy. 

Mr. Heckman’s proven track record in client relationship management rests on a solution-driven approach, in which he effectively communicates new ideas, influences and aligns key stakeholders to drive innovation and growth. Prior to joining Synteract, Chris filled the role of executive director and head of global clinical development at Celerion where he led the development of a new business unit targeting a specific market segment. Previously, he was the executive director of a biotech portfolio with a large contract research organization, where he was directly responsible for the oversight, development and management of more than 250 client relationships across biotech, small and mid-size pharmaceutical companies. Mr. Heckman also held the title of senior director of portfolio management at a large contract research organization where he led a key strategic account and was responsible for leading a corporate initiative to develop the biotech service offering.

Message Presenter
http://Derek%20Ansel,%20Synteract

Derek Ansel, Director, Rare & Orphan Diseases, Synteract

Prior to joining Synteract, Derek Ansel was a clinical strategy lead at the Center for Rare Diseases and a cofounder of the gene therapy working group for a large contract research organization. Ansel has a breadth of clinical research experience spanning from the laboratory through clinical monitoring and project management. He works in a multidisciplinary, cross-therapeutic team, where he applies not only his considerable rare disease experience, but his extensive gene and cell therapy expertise developed through his work on several liver-targeted gene therapy programs. From this experience in gene therapy, Mr. Ansel understands the critical impact of site selection on patient education and engagement throughout the entire study and has consulted with several companies developing novel gene therapies for several lysosomal storage disorders, including Aspartylglucosaminuria, Batten Disease and Pompe Disease.

Mr. Ansel is a member of the ACRP and holds a Certified Clinical Research Associate (CCRA) credential. He is an IRB member at the Thomas Jefferson University in Philadelphia and is also a contributing member of Cochrane, a non-profit organization that promotes evidence-based decision making in healthcare.

Message Presenter

Who Should Attend?

This webinar will appeal to VPs, Directors, Managers, Department Heads, Scientists and Researchers working within:

  • Clinical Affairs
  • Clinical R&D
  • Clinical Research
  • Clinical Pharmacology
  • Clinical Operations
  • Project Management
  • Regulatory Affairs
  • Medical Affairs

What You Will Learn

Participants will gain insights into: 

  • An overview of the impact in which gene therapy innovation has had on rare oncology clinical development today
  • Ethical challenges around patient participation and the complexities involved
  • Challenges that clinical teams face when enrolling patients within rare and specialized populations

Xtalks Partner

Synteract

With employees across 21 countries, Synteract is an innovative, full-service CRO supporting biopharma companies across all phases of drug development to help bring new medicines to market. Synteract has conducted 4,000 studies on six continents and in more than 60 countries, working with more than 26,000 investigative sites and 750,000 patients. Greater than 245 of its 4,000 studies have been in pediatric populations. In addition to pediatrics clinical trials, Synteract offers a notable depth of therapeutic expertise in dermatology, neurodegenerative, oncology and immunotherapy, and rare/orphan disease studies.

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