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

• f 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.