Development of Human Anti-Influenza Monoclonal Antibodies for Treatment of Flu

Information

• Research Project
• 8535115

• ApplicationId

  8535115

• Core Project Number

  N01AI000000

• Full Project Number

  272200900060C-4-0-1

• Serial Number

• FOA Number

• Sub Project Id

• Project Start Date

  8/15/2009 - 15 years ago

• Project End Date

  8/14/2014 - 10 years ago

• Program Officer Name

• Budget Start Date

  -

• Budget End Date

  -

• Fiscal Year

  2012

• Support Year

• Suffix

• Award Notice Date

  -

Organizations

• Crucell Holland B.V.

The overall objectives and scope of this contract is to advance the development of human monoclonal antibody (mAbs) products for treatment of Influenza A viral infections. The scope of work for this contract includes nonclinical, preclinical, and clinical development activities to: (1) perform studies to characterize and validate lead mAbs using in vitro and in vivo approaches; (2) develop manufacturing and formulation processes and analytical testing procedures for lead Flu mAb candidates and manufacture GMP clinical materials; (3) perform enabling activities to file the Investigational New Drug (IND) applications with the Food and Drug Administration (FDA); and (4) perform clinical trials to evaluate the safety, tolerability, pharmacokinetics, and the proof of efficacy in humans of the candidate drug products.

IC Name

• Activity

  N01

• Administering IC

  AI

• Application Type

• Direct Cost Amount

• Indirect Cost Amount

• Total Cost

  8118206

• Sub Project Total Cost

• ARRA Funded

  False

• CFDA Code

  855

• Ed Inst. Type

• Funding ICs

  NIAID:8118206\

• Funding Mechanism

  Non SBIR/STTR Contracts

• Study Section

• Study Section Name

• Organization Name

  CRUCELL HOLLAND, BV

• Organization Department

• Organization DUNS

  415960780

• Organization City

  LEIDEN

• Organization State

• Organization Country

  NETHERLANDS

• Organization Zip Code

  2333 CN

• Organization District

  NETHERLANDS