This highly interactive course on managing challenges in co-development of drugs and diagnostics led by John C. Bloom, Consultant, Office of the Center Director, FDA, will:
- Review the latest advances in translational science and molecular diagnostics that have impacted drug (Rx) and diagnostics (Dx) development;
- Discuss the regulatory-driven processes for developing, registering and commercializing these products;
- Identify the disparate challenges and attributes of the major stakeholders, including Rx sponsors, Dx manufacturers, service providers, research collaborators and regulators;
- Review the emerging role of strategic partnerships critical for successful Dx/Rx development
- Provide the best practices for developing and managing these partnerships.
Upon completing this course participants will:
- Understand the latest advances in translational science and molecular diagnostics that have impacted Rx and Dx development today.
- Understand the regulatory-driven processes for developing, registering and commercializing Rx and companion diagnostics (CDx).
- Recognize the disparate challenges and attributes of the major stakeholders, including Rx sponsors, Dx manufacturers, service providers, research collaborators and regulators.
- Understand the aforementioned critical success factors for co-developing Rx and CDx,
- Learn about the how the rapid evolution of technical analytical platforms and the dynamic vendor environment provide challenges and opportunities for Rx and Dx sponsors.
- Learn the best practices for developing and managing partnerships through examples and interactive discussion.
Who Will Benefit:
This course is designed for professionals in biopharma, pharmaceutical, diagnostics and biotech companies and clinics. The following personnel will find this session valuable:
- Regulatory executive leadership, managers and scientists
- Clinical scientists
- Biopharm clinical development operations and functional leadership
- CRO business development leadership and associates
- Pharmaceutical services leadership and personnel (large and “niche” CROs)
- Specialty analytical service providers
- Diagnostic company leadership and associates
- Academic and government (NCI, NIH) scientists involved in drug discovery and clinical development
- Regulatory scientists in government agencies
- Patient advocacy group representatives
Advances in translational medicine, including our understanding of the molecular basis of diseases and the development of sophisticated molecular analytical platforms, have transformed drug (Rx) and diagnostics (Dx) development and have ushered in a new era of personalized medicine. This has propelled the emergence of highly-targeted candidate Rx, strategies for phase-appropriate biomarker-driven Rx and Dx development, and the need to co-develop, register and commercialize these Rx and companion diagnostics (CDx) in an integrated fashion. Key to the success of the latter has been understanding the rapidly-evolving regulatory science that prescribe the use of these technologies and registration process for CDx, and the ability to establish and manage enabling partnerships.
These challenges and opportunities are best exemplified in oncology Rx development, which has been transformed by the now-universal assumption that cancer must be characterized and treated as a genetic disease. The principal understandings that underpin this include 1) the fact that the genes and pathways that govern proliferation, cell death and metastasis are being characterized in the major cancers and patients; 2) the importance of this is now recognized in the context of genetics, epigenetics and the cancer microenvironment as key influences; and 3) the fact that molecular profiling tools have enabled genetic and phenotypic characterization that can be used to predict the response to treatment, stratify clinical trial subjects and identify opportunities for development of a CDx.
As the need for these applications expands, they pose a myriad of technical and logistical hurdles to both Rx/Dx development and patient care. Critical factors for successfully co-developing Rx and CDx include freedom to operate through enabling intellectual property (IP), effective strategic partnership development and management, access to human specimens, and organizational effectiveness with functional/technical expertise alignment. Effective sourcing models for Rx and Dx sponsors will be increasingly critical. The latter is in the context of changes in today’s R& D environment that are driving aggressive outsourcing strategies with emphasis on strategic partnerships as a practical, and sometimes the only, option.
The evolving regulatory science that influences how these challenges are managed is addressed in recent FDA guidances, including that issued on the Qualification Process for Drug Development Tools (January, 2014) and the preceding white paper the Agency issued, “FDA Report on Paving the Way for Personalized Medicine” (October, 2013).