Patient-centered outcomes (PCO) research is
crucial to successful product development in the pharmaceutical/biotechnology
industry. PCO research scientists seeking to pursue a career aligned with this
industry should understand the product development process, the product
lifecycle, the scientific communication process and interactions with key
industry stakeholders – both internal and external (i.e., regulators and
payers).
This training is aimed at individuals who are:
- Pursuing a PCO research career
- New to the pharma/biotech industry
- Looking to gain a better understanding of PCO research-related activities within the pharma/biotech industry (e.g., may currently be working in a medical affairs team)
- Pursuing a career that works closely with the pharma/biotech industry (e.g., regulatory authorities, payer/health technology appraisal organizations, consulting companies)
- Mentors in academia who help students make career decisions
Learning Objectives:
- Discuss the different stages of drug development.
- Discuss the pharma/biotech product lifecycle and PCO research needs associated with different stages.
- Review the roles, responsibilities and scientific deliverables of a PCO research scientist in the pharma/biotech industry.
- Develop awareness of different functions in the pharma/biotech industry that are key internal stakeholders in the drug development process and partners for PCO research scientists.
- Define key PCO research industry terms, business deliverables and related responsibilities.
- Discuss types of regulatory interactions that may involve PCO research and the preparation process for regulatory interactions, with a focus on FDA and EMA.
- Discuss market access considerations for PCO research.
- Understand PCO research communications and the importance of outreach to various audiences, including patients and physicians.
Recording Policy
Photography, video or audio recording (including screen capture) of ISOQOL courses, sessions, digital materials, or ISOQOL graphics without written permission from ISOQOL is strictly prohibited.
Note that photographs and video recordings taken by or on behalf of ISOQOL is the property of ISOQOL.