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BI Academy - Challenges in Oncology Drug Development Translation

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Crossing the Chasm – Challenges in oncology drug development translation.

Despite marked advances in our understanding of cancer, cancer therapeutics have reflected these gains in understanding. That is, despite what we have learned, it has not translated into better, more effective medicines. Much of the disconnect stems from translational disconnects that don’t seem to traverse adequately from animal model to human trials, resulting in costly failures. Translational difficulties span multiple problems ranging from early discovery all the way to approvals and reimbursement. For example, focusing on a cancer target without fully appreciating the microenvironment may lead to an incomplete understanding of biology, resulting in disappointing results. Predictive models that don’t adequately predict drug responses and clinical safety and efficacy can lead to failed clinical trials. At the other end of the spectrum, regulatory inconsistencies – “which may inadvertently create irrational approaches to drug development and contribute to high failure rates…”[1] – force companies to adopt strategies that are costly, slow, and expose patient to potential risk, with minimal benefit.

This panel will look at ways that collaboration and partnering offer a way to sidestep or leapfrog the chasm of translational science in drug development in the oncology space. Through collaborative business models, “complementary expertise and collaborative approaches”[2] to combination therapies can be leveraged to overcome regulatory and reimbursement hurdles, and; ultimately produce improved patient outcomes.


Moderator: Scott DeWire, Director, Business Development & Licensing, Immuno-Oncology

Panelists:

  • Khalid Shah, Ph.D., Vice Chair of Research, Department of Neurosurgery. Director, Center for Stem Cell Therapeutics and Imaging, Brigham and Women's Hospital.
  • Ari Brettman M.D. - Clarus Ventures
  • Markus Warmuth Ph.D., CEO, H3 Biopharmaceuticals
  • Michael Boretti, VP, Business Development, Epizyme


[1] Anticancer drug development: the grand challenges. Pg 253., Nature Reviews|Drug Discovery, vol. 9, April 2010.

[2] Anticancer drug development: the grand challenges. Pg 254., Nature Reviews|Drug Discovery, vol. 9, April 2010.

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MassBio

300 Technology Square

8th Floor

Cambridge, MA 02139

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