(BioPharma Product Development Through Non-dilutive Federally Funded Prpoposals)
Significant Federal contracts are issued each year in the areas of therapeutics, vaccines & medical device, amounting to billions of dollars. Unlike most other sources of funding, these dollars are non-dilutive, allowing companies to develop and sell their products without loss of equity.
The complexity of dealing with the Federal Government has left many companies baffled about how to win and execute Agency awards.
Pinnacle Management and Genie Bio-Logic have partnered to support and guide our clients in developing winning proposals and then successfully executing the awarded programs. We help our clients succeed by providing strategic and technical guidance on product development, program management and EVM support for their therapeutic, vaccine and medical device development programs.
Our team’s success comes from understanding what is expected in a winning proposal and performing programs for government agencies. Pinnacle and Genie Bio-Logic have worked with clients pursuing or performing projects for:
We understand how to develop compliant proposals which contain the key elements agencies expect to see, including Product Development Plans, Quality Assurance, Regulatory Compliance, Clinical Development Plans, Pre-clinical Plans, Program Management, Earned Value Management, and Risk Management.
Different Agencies require different structures and content for their proposals. Pinnacle and Genie Bio-Logic understand how these requirements differ across Agencies, and support developing proposals to meet each Agencis expectations. Core elements of a winning proposal include:
- Compliant proposal structure,
- Clear milestones,
- Timelines, Work Breakdowns and Schedules ,
- Go/no-go and decision points,
- Measureable markers of progress,
- and a clear description of the Program Management or Earned Value Management approach
It is not just about winning awards. Truly successful proposals are those that enable a company to then deliver, which comes from good products AND good management. Agencies continually monitor how companies perform. This means continually delivering technical performance, on time and to budget, throughout the course of a program. That only happens with carefully prepared and well thought out proposal plans.
Genie Bio-Logic and Pinnacle Work with our Clients to:
Develop Proposal Plans
- Guiding and navigating the proposal development process based on your specific Agencies requirements
- Defining what needs to be done, by whom, and when. Timelines are always tight.
- Assisting in writing or editing proposal elements. This encompasses many different aspects such as:
- Technical development plans for products and processes, pre-clinical, clinical and non-clinical (animal rule) programs.
- Regulatory strategy, quality management and compliance
- Program management approach, management structure, subcontractor management and risk management
- Mandatory compliance with Federal and Agency requirements
Develop Strong and Compliant Product Development Plans
- This is the core element for the proposal and a successful program.
- Many clients new to US Government work often need help focusing on what is important, realistic and credible to your Agency.
- It has to fit Agency requirements, their timeline and be achievable.
- The PDP is not just a timeline or a Gantt chart; it is all the decision points and success criteria that go with it, and of course - a linked budget!
Define Management Plans
- Agencies need to know that their funded programs will be well managed.. They need to understand who will manage the program and that there is a well-defined Management Plan in line with the Agencies requirements.
- Risk Assessment and Risk Management are very important for US Agencies.
- Solid Risk plans are essential for credibility and setting expectations for changes in Major Milestones and Costs.
- Having a comprehensive, well thought out and documented risk assessment plan with mitigations and contingencies is a way to score high on your proposal evaluation.
- All Agencies focus on how their Suppliers will manage Sub-contractors. This is an area where many companies fail to meet expectations.
- Getting subs lined up, with all the necessary technial and pricing details can take a long time. This is ofen overlooked or left until late in the proposal process.
- Establishing contractual guidelines for Subcontractor reporting is essential. If there is an EVMS requirement, then this is absolutely required. Often companies do not understand this requirement and leave it out in proposals and in contracts.
Handling Interactions with the Agencies, or Clarifying BAAs and RFPs
There are always specialized requests or requirements in these RFP's, and sometimes contradictions.
- There is an art to handling these.
- Know when to ask questions and when not to ask questions.
- Determine what's important, what isn't.
- Address what they are really asking for.
Mandatory Compliance with Federal and Agency Requirements
Government contracts come with a multitude of requirements, all of which need to be addressed in a proposal. Examples of these include:
- Earned Value Management (EVM)
- Human Subjects
- Animal Welfare
- Select Agents
- Security Requirements
- Small business participation
- Reporting requirements