A flexible, capital-efficient model to fill a valuable role for emerging life science companies
While the guidance of a seasoned Chief Medical Officer (CMO) is valuable to early-stage life science companies, this expertise can be gained without the costs of a full-time role.
We have aggregated highly qualified, industry proven talent in this space to help companies access specialized knowledge in a flexible way – whether part-time or project-based – scaling as needed. These professionals can be a critical asset as programs move from research into development.
Key Considerations
- Early stage input can help ensure the right path. We engage with life science companies at earlier stages of drug candidate program development – when senior strategic drug development talent may be cost-prohibitive to in-source, or to augment the expertise of scientific advisors.
- Deep therapeutic expertise and sector knowledge help to jumpstart strategy. We can provide experts in distinct therapeutic areas and technologies, who are well versed in the development approach endorsed by big bio/pharma. In addition, our leaders are well versed in board of directors interactions, scientific/medical communications for investors and due diligence activities.
- Our consultants have broad networks of academic collaborators they can introduce to client companies. They are a credible resource for clinical investigators and CROs, and can help open doors with selective clinical investigators.
How Danforth Can Help
Clinical guidance for translational, early development and IND planning
We can provide guidance on overarching clinical strategy as well as lead indication selection specifying a distinct development path, and lead the target product profile (TPP) process. We provide input and guidance into the interpretation and translation of the IND enabling studies, ultimately supporting the clinical development plan. We partner with regulatory on IND planning and submissions.
Strategic partnership with commercialization
Our consultants have worked across the drug development continuum and are able to provide medical affairs strategy and plans for compounds approaching Phase 3 and commercialization.
Strategic augmentation and leadership of clinical development resources
We can provide expertise in early clinical development to
determine proof of concept, as well as design and advise across the continuation of Phase 1 – Phase 4 clinical trials. We also provide leadership of the medical team which may include drug development professionals, project management and clinical operations. Our pool also includes physicians experienced in medical monitoring of trials in case CRO oversight is needed.
How else can we help?
Learn about our additional capabilities