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Preclinical Development

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SRI's Role in Translational Development

SRI offers comprehensive contract services for drugs and biologics—a one-stop solution to take your drug candidate through discovery and preclinical development. SRI not only performs and manages the tasks necessary for filing an Investigational New Drug Application (IND), but we can assist you in planning and executing the most efficient path.

During drug discovery, as one approaches the selection of a development candidate, it is essential to plan the path to clinical trials. SRI has extensive experience in the preparation of Preclinical Development Plans (PDPs) that provide a detailed path from discovery to clinic.

SRI prepares PDPs for an extensive client base including: start-up companies, small and virtual companies, entrepreneurs, academic researchers, foundations, and venture capital and other funding sources. The PDP is an invaluable tool for resource planning, timing, fund raising, and execution of a successful development strategy.

SRI can design a PDP that is specifically tailored to the needs of your unique drug candidate.

Originally created for SRI's PharmaSTART® consortium with several top academic institutions, the PDP was later adopted by several NIH institutes to support NIH RAID and other programs. PDPs prepared by SRI were initially used to determine if potential academic investigators had a viable path to the clinic for their therapeutic drug candidate. SRI has subsequently expanded this program and now regularly prepares PDPs for NIAID and NINDS to support the preclinical development of a wide variety of therapeutics. SRI PDPs have become the NIH gold standard for development plans for therapeutics and vaccines.

Download the table of contents for a sample SRI-prepared Preclinical Development Plan.

Frequently Asked Questions:

What is a PDP?

• A PDP is document that provides a strategy to take a candidate therapeutic or vaccine from the discovery stage through to an IND to support a Phase I clinical trial. A PDP typically includes:
• Descriptions of required tasks with study outlines
• Tool for Budgeting, Scheduling and Planning
• Starting point for a Pre-IND document and other Regulatory information

What are the contents of the PDP?

• A proposed Target Product Profile
• Study Outlines for Pharmacokinetics, Genetic Toxicology and Safety/Toxicity
• Manufacturing Overview
• Clinical Trial Material of Phase I Drug Product
• Regulatory information
• Cost Estimates
• Schedule

What are the benefits of a PDP?

• Planning and Budgeting Tool
• Fundraising
• Regulatory approach
• Milestones for go/no-go decisions
• Document for future reference or Collaboration

What experience does SRI have with PDPs? For whom have they been provided or commissioned?

• As an NIH contractor, SRI has generated PDPs for
• NIAID-DMID Infectious Disease Program
• NINDS CounterAct Program
• NCI Developmental Therapeutics Program
• PharmaSTART® consortium members
• Commercial and new or emerging companies
• Venture capitalists
• NIH RAID

Does SRI offer a full preclinical development package of services?

• Yes, click here for an overview

Does SRI provide an option for integrated preclinical and clinical drug development?

• Yes, SRI works with preferred partners to provide seamless integration of preclinical and clinical drug development
• This includes planning and execution with integrated project management
• Our preferred clinical collaborator can provide Phase I clinical information for the PDP

Download the table of contents for a sample SRI-prepared Preclinical Development Plan.

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       Last Updated Feb 25, 2010