Drug Development Plans
Getting a new drug or biologic from bench to market is a multi-year process involving multiple studies and a set of requirements that must be achieved. To be successful, you must have a solid plan. IMPACT’s team of experts can work with you to design a pharmaceutical drug development plan for your program that will meet the current regulatory standards and align with the current thinking of the regulatory agencies.
IMPACT will work closely with you to prepare a detailed pharmaceutical drug development plan that will cover all technical aspects (eg, clinical, nonclinical, CMC), cost estimates, and timelines. We will rely on our internal experts, as well as our network of MD specialists and ex-FDA regulators, to design the requisite studies to meet the Agency’s requirements.
To assemble a comprehensive and on-target pharmaceutical drug development plan, we will:
- Review any existing clinical studies prior to the development of the strategy to ensure that the proposed strategy is in line with previous studies.
- Suggest potential efficiencies in the development program.
- Define the instances when a study must be conducted to regional guidelines and will subsequently be suitable for submission to either the US or European regulatory authority only.
- Provide brief study synopses detailing the design and rationale of each study in the development plan
- Provide a project plan documenting the schedule of the proposed studies and their inter-relationships with each other.
- Where applicable, the drug development plan will contain study design options which could subsequently be discussed with the regulatory authorities in order to further refine the development plan.
- Identify key risks in the study designs and a strategy for their mitigation.
- Provide estimated timelines and cost projections.
We also understand the importance of engaging Key Opinion Leaders during the drug development plan process and often organize/chair Key Opinion Leader Meetings.