Drug Development Course

Period of Performance 3 December 2024 to 4 December 2024 Place of Performance Constitution Center, Washington, DC Product Service Code (PSC) U099 - Education/Training North American Industry Classification System (NAICS) Code 611430 = Professional and Management Development Training (size standard $15 million) NOTE: All prospective contractors must be registered in the System for Award Management (SAM.gov) database to be awarded a contract. Request for Information: The Center for the Biomedical Advanced Research and Development Authority (BARDA) is seeking potential contractors that can provide an in person, instructor-led course focused on the regulatory, commercial, and scientific considerations required to bring a drug successfully to market, based on the below learning objectives. The Contractor will provide a qualified instructor for the course. The requested Period of Coverage is from 3 December 2024 to 4 December 2024. Scope: Contractor will perform in-person, instructor led training on the topic of Drug Development for Scientists. The course will be for up to 30 attendees in the Constitution Center Washington DC. Course materials (ex. PowerPoint Slides; workbooks) are the responsibility of the Contractor and must follow 508 compliance. (https://www.section508.gov/). Final Course materials should be submitted to the CO at least 2 business days prior course commencement. A copy of the Statement of Objectives (SOO) is attached to this RFI. Learning Objectives: • Discovery pathway for o Large and small molecules o Gene therapy o Vaccines • Drug target identification and validation • Discovery flow to identify drug candidate, lead candidate, and lead candidate optimization. o Preclinical development o Decision milestones and go/no go criteria. o Target product profile o Nonclinical studies o Toxicology, Pharmacokinetics/Pharmacodynamics o Phases of clinical trials; what data is generated and how does that inform subsequent trial design? o Drafting a drug label and package inserts • Difference between academia and industry • US patents and exclusivity • Understanding the drug approval path and regulatory agencies o IND preparation o NDA submissions o Animal Rule The following information should also be included: o Resumes and credentials of proposed trainers. Trainers must have 5+ years of experience working on drug development including all topics covered above including educational and field experience. Trainers should have a master’s degree or higher in a related fields to the course subject. RFI Questions: 1. Are you capable of providing in person classroom training on the above topics as required? YES or NO 2. Do you have any relevant past performance providing similar trainings? 3. Are you available in the specified timeframe to provide an onsite training in Washington DC? (3-4 December 2024) YES or NO 4. Please provide an estimated price for up to 30 attendees. The estimated price should include material cost, instructor travel cost and other pertinent costs. This is an RFI so this price only needs to be an estimate. 5. Do you currently have contracts or a GSA schedule with this type of course? YES or NO 6. Please include the resume for proposed trainers to demonstrate their relevant experience in this field. Please send all responses by 8 October 2024 by 2:00 PM EST to: Contract Specialist - Janet Alvanzo, [email protected] Contracting Officer – Devin FitzMaurice, [email protected]