Current Research Agenda

Benchmarking the Drug Development Process

  • Assessments by therapeutic class and molecule type

  • Discovery and non-clinical development metrics

  • Regulatory review metrics

  • Return on investment for oncology drugs

  • Biotechnology pipeline: development metrics and trends

  • Vaccines development metrics

  • Precision/personalized medicine, specialty pharma development

  • R&D costs and returns with single-source contract manufacturing

  • Global landscape for new active substances (NASs)

  • Personnel workload and capacity

Improving R&D Efficiency and Productivity

  • Clinical trial operations: start-up procedures, cycle times, best practices

  • Protocol design complexity

  • Investigator site selection and site management practices

  • Study conduct cycle times, patient recruitment and retention rates

  • Pharmacovigilance operations and strategies*

  • Contract service providers

  • Adaptive trial designs

  • Application of comparative oncology

  • Pediatric studies of oncology drugs in development for adults

  • Assessment of end-to-end R&D platforms

  • Adoption and impact of patient engagement initiatives*

  • Real World Evidence (RWE) use in clinical trials*

  • Innovative models to grow awareness, participation of minority populations in clinical trials

Regulatory and Policy Initiatives to Foster Bioinnovation and Patient Access

  • FDA expedited development & review programs (BTD, PRV, Fast Track, Accel Approval)

  • Orphan product designation, R&D challenges, and approval

  • Real World Evidence (RWE) use for Value-Based Pricing (VBP) in global emerging markets

  • Patient access and reimbursement for orphan drugs

  • PDUFA VI and 21st Century Cures Act impact on innovation and the regulatory environment

  • Challenges and solutions in pediatric study compliance

  • Medical countermeasures and the emerging sponsor landscape

  • Harmonization priorities for FDA, EMA, and PMDA