Going beyond Z: The Challenge Grant-Joint Ventures in Biomedicine and Biotechnology Program

Article excerpt

Case Study

Abstract

Product development, matching funds, milestones...these key words and phrases describe the new Challenge Grant - Joint Ventures in Biomedicine and Biotechnology Program. This new initiative intends to promote joint ventures between the National Institutes of Health (NIH) and the biotechnology, pharmaceutical and medical device industries.

It will involve 1:1 matching, performance-based grants and milestones for federal dollars by qualified entities to facilitate rapid implementation of R&D activities in biomedical research or biotechnology. The commercialization potential is great for accomplishing research in promising therapies.

The National Institute of Allergy and Infectious Diseases (NIAID) was chosen to implement this new initiative and identified five areas where successful product R&D, combined with existing infrastructures and Challenge funding, could impact a major health or medical problem, within three years. MAID seeks to stimulate progress in these research areas: medicines for malaria and tuberculosis; vaccines for influenza and emerging and resistant infections; and therapeutics for emerging and resistant infections.

MAID wisely decided to implement the program with a new cooperative agreement activity (UCI). The following paper presents an overview of the process involved in developing this new initiative.

Introduction

Every now and again in NIH Grants Management there is an experience that captures the temper of the times, and this moment may have come this budget season.

The impetus for Congress to promote this new style of NIH grant program, aside from a period of fiscal plenty, is not apparent but it clearly supports joint product development in areas of high need and high risk. Whatever the congressional intent, the new initiative is exciting to career grant managers.

The last time NIAID grants management came so tantalizingly close to developing a totally new grant program may have been the AIDS program and development of AIDS clinical trials in the 1980s. The Challenge Grant is something innovative and the questions it raises present administrative challenge.

It was clear from the beginning that conceiving and implementing a $20 million program in nine months was not going to be easy. This was venturing into new territory with 1:1 matching within performance-based grants. Matching funds on research grants at NIH was unheard of - even for many of the `old timers' in grants management. A performance-based grant program is another area that breaks new ground. This would need the development of definition of a domestic organization for the NIH Grants Policy Statement.

Unusual Features

The project broke ground by investigating those with experience who could guide the team through inquiries. These contacts ranged from pharmaceutical company attorneys, to lieutenant colonels from the Department of Defense. Staff was interviewed from the National Endowment of the Humanities (the legislation mentions them as a model for this program) and individuals of familiarity with matching funds on construction grants. Participants developed close working relationships with the NIH Legal Advisor and the MAID Office of Technology Transfer. In addition, we reviewed the General Administrative Requirements under 45 CFR (Code of Federal Regulations) Parts 74.23; 92.24; HHS Grants Policy Directive 3.02; and HHS Transmittal 99.02. All of these chapters address the policies for matching or cost sharing, pre- and post-award requirements.

Working on this project turned out to be a watershed experience in understanding grants management policy in its purest legalistic sense. As one division director said, "we'll all be attorneys before this is over."

Performance-Based Applications and Milestones

Challenge Grants are performance-based, unlike traditional research grants that are based on a principal investigator's (PI) continued scientific progress. …