Product Development Strategy & Plans
Atheln’s experts have significant operational experience
Creating integrated product development strategies and plans is critical for the future success of development programs. Just as important is incorporating the ever-changing needs of prescribers, patients, payers, while understanding how market dynamics and the competitive landscape can impact development strategies.
Atheln experts have significant operational experience in developing products from concept to regulatory submissions to post launch and life cycle management. They understand how decisions in very early development can impact the longer-term probability of regulatory approval, fundability, partnerability, and commercial success. With the inherent high risk of product development, Atheln experts focus on risk mitigation strategies and plans from the get-go.
One core management team ensures an integrated product strategy, gated decision-making, portfolio asset management and continuous project go/no-go assessments.
Atheln’s Product Development Strategy & Plans services include:
- Gap analysis of existing development plans and/or data packages
- Top-level development plans and budgets to support non-dilutive and dilutive fundraising activities
- Top-level integrated development plans for PIND meetings
- Detailed integrated development strategies, plans, and estimated timelines and budgets for all areas of a program (CMC, nonclinical, regulatory, clinical)
- Integration of commercial considerations and drivers into development strategies
- Cross-functional project leadership of development programs
