More than just a drug development plan.
It is within the Strategic Development Plan that the details of your novel discovery, current project status, target market, development plan and costs coalesce into one document, which captures the excitement and commercial potential of the product.
DEVELOPMENT EXPERIENCE
Success starts with a great plan and an experienced team to implement it.
Experience at all stages
The team members have 30+ years experience working with projects from discovery through preclinical and clinical to regulatory approval and have out-licensed products at both early and later stages of development.
Major Therapeutic Areas
We have experience in a broad range of therapeutic areas including cancer, immunology/inflammation and orphan indications, in selecting lead indications, mapping out overall development programs as well as designing individual clinical trials.
Templates & Tools
B4D has developed a customizable Strategic Development Plan template for its clients. For project management we have successfully used online collaboration tools for timelines and virtual meetings supplemented by management reports to keep on top of action items and minimize delays.
B4D Solutions
Service 1: Strategic
B4D’s Strategic Development Plan summarizes the current stage of your program and outlines the regulatory pathway, clinical and product development timelines and cost estimates to approval in the selected indication. B4D consultants review all available data on your product and assess the competitive landscape and clinical/regulatory environment to help you better understand the commercial potential of your product and the challenges that lie ahead.
The plan includes appropriate therapeutic area information and summarizes completed and planned preclinical, clinical and drug manufacturing/QA activities. It includes sufficient detail to facilitate project management to the next major milestone. Information on market size and competitive landscape is also included along with financial plans and budget to support valuation modeling which is useful for both investors and potential licensees.
Product development and commercialization is a long and expensive process with many steps and plenty of opportunities to make the wrong decision. In addition to a great plan you need an experienced team to successfully implement the plan. B4D has the experience to manage the project and troubleshoot issues that inevitably arise along the way.
