191_The Strategic CMO Poster - MAPS 2018 - FINAL_v2_CROP 1.pdf (521.8 kB)
The Strategic CMO
poster
posted on 2018-02-25, 18:15 authored by Randall Kaye, Madhav Gurijala, Sukumar NagendranObjective: The Strategic CMO drives clinical
and product development strategy supporting
commercialization and impacting corporate
valuation through key internal and external
stakeholder and investor interactions. Clinical
Development designs and maintains currency
of all studies; works cross‐functionally to
incorporate and balance regulatory
requirements, payer data needs, and
operational constraints in study designs.
Clinical Operations operationalizes study
designs for data generation to support
registrational submissions. Medical Affairs
focuses on data analysis, distillation, and
dissemination so all stakeholders get the most
current and accurate information on safety,
efficacy, method of action, and differentiation
of the company’s products.
Challenge/problem: An experienced medical
professional becomes CMO at a pre‐IPO gene
therapy company – an exciting opportunity
with challenges. How does the CMO remain
strategic and prevent relegation – addressing
urgent operational issues instead of building
out a well thought‐through medical office?
The CMO leveraged external partners focused
on Medical Affairs, Pharmacovigilance and
Clinical Development to help build the function
and execute the strategy.
Solution: Start Lean. Build a scalable
framework. Expand with triggers.
Outcome: Hire effectively to focus on value
generating pieces. Leverage contractors and
consultants for short‐term SME needs.
Develop growth plans, models, and strategic
frameworks. Identify potential new hires in
advance to prepare for growth. Driven by
corporate, regulatory, and competitive factors,
expand the medical organization accordingly.
Switch contractors and consultants to FTE’s
once the role is proven valuable and needed.
Benefits: One of the most successful newly
launched companies, on its way towards
becoming a leading gene therapy company