NCATS Advisory Council June 2015 Concept Clearance R&D - PowerPoint PPT Presentation

NCATS Advisory Council June 2015 Concept Clearance R&D CONTRACT SUPPORT FOR NCATS TRANSLATIONAL SCIENCES ANTON SIMEONOV

Goal To obtain access to R&D services in various pre-clinical and clinical therapeutic development areas. These services would complement internal scientific and acquisition resources within NCATS . S ervices may include:  Lead opt imizat ion  Animal disease model development  Assay and process design and validat ion  Chemist ry, Manuf act uring, and Cont rols (CMC) development  Biologics manuf act uring  Invest igat ional New Drug (IND)-enabling saf et y st udy complet ion  Regulat ory st rat egy and f iling  Clinical t rials conduct (in accordance wit h t he NCATS mission and congressional aut horizat ion)

Outcome Wit h it s own cont ract s t he Cent er can independent ly advance promising science when privat e sect or funding is inadequat e. The cont ract s will aid in de-risking promising t arget s and t herapeut ics. NCATS has leveraged cont ract resources previously t o: • Ident ify and develop new candidat e t herapeut ics • Generat e dat a for IND filings • Conduct clinical st udies S uccess will be measured by t he advances enabled by t he cont ract s, e.g. publicat ion of new approaches, achievement of regulat ory milest ones, and out -licensing of t echnologies.

Initiative Highlights • DPI would issue RFPs for medicinal chemistry, animal model development, CMC, PK/ Tox, regulatory and clinical services • The awarded contracts would empower current and future NCATS programs to meet their missions  DPI programs such as TRND, BrIDGs, Chemist ry Technology and Mat rix S creening current ly leverage ext ernal sources for R&D study execut ion.

Highlights Continued • The awarded contracts would increase the flexibility and efficiency of these programs  S t anding cont ract s may permit more rapid init iat ion of st udies  NCATS -managed cont ract s would avoid reliance on scope- limit ed contract s managed by ot her ICs. • The awarded contracts would solidify the non-dilutive nature of NCATS collaborations and resource awards  NCATS contracts will include Determination of Exceptional Circumstance clauses. DECs protect third party IP from the threat of dilution.

Highlights Continued • The awarded contracts would complement internal capabilities and other acquisition mechanisms  CROs would be used when in-house resources are insufficient (e.g. GMP/ GLP st udies) and when t ime, cost , expert ise, and capabilit y considerat ions ident ify CROs as t he best opt ion.