Operational readiness: Aligning people, partners, and process for the first program

  • Creating a shared understanding of clinical development and operational fundamentals for teams rooted in discovery science
  • Leveraging external partners efficiently – CROs, consultants, vendors -especially when in-house experience is limited
  • Building lightweight processes that educate and empower, rather than overwhelm
  • Managing a “learning by doing” culture – iterative planning, open communication, and mentorship across disciplines

Overcoming funding challenges to get your drug to market as quickly and safely as possible

  • Implementing an improved strategy of pipeline focusing on market, time and investment in clinical trials
  • Aligning the reimbursement ecosystem to be operationally efficient
  • Optimizing the funding infrastructure to avoid bankruptcy or being bought out
  • Taking control of finances to deliver seamless trials and getting products approved
  • How is clinical data being presented to investors and shareholders and how does it affect the way they perceive the budgets
  • Bringing in major venture capitalist who work in early stages of clinical trials

CLOSING KEYNOTE: Meeting site challenges with stronger strategies

  • Addressing recent site performance concerns and rebuilding trust when site credibility is questioned
  • Identifying common gaps in oversight, governance to avoid actively monitoring site work
  • Understanding policies and competing with limited resources at sites
  • Enhancing site staff training, culture and accountability of clinical research