Proposal
CBER, FDA CDER, FDA CDDS, Georgetown University BIO PHRMA
January 21, 1997
I. INTRODUCTION
This proposal describes an effort, the Collaboration on Drug Development Improvement (CDDI), that is designed to advance the development process for pharmaceuticals and biopharmaceuticals (medical products). The information developed by the Collaboration will be used to support guidance documents for pharmaceutical scientists on efficient, scientifically sound approaches for development of an investigational medical product. Participating organizations in CDDI are: 1) the Center for Biologics Evaluation and Research (CBER)/FDA; 2) the Center for Drug Evaluation and Research (CDER)/FDA; 3) Georgetown University Medical Center/Center for Drug Development Science (GUMC/CDDS); 4) the Pharmaceutical Research and Manufacturers of America (PhRMA); and 5) the Biotechnology Industry Association (BIO).
II. RATIONALE
Modern drug development requires information to support the translation of candidate therapeutic agents into therapeutically useful products. This information is used to document the utility of new medical products and to satisfy societal interests in allowing safe, effective, and well-labeled medical products into the marketplace. Development of the necessary information to document safety, efficacy, and utility, and to support product labeling involves a highly complex set of scientific and administrative activities. These activities are affected by the needs and interests of the patient and the health care professional, by scientific opportunities, by public health objectives, by commercial factors, and by resource constraints. The scientific framework in which development of a medical product proceeds is dynamic in that new approaches may be developed and older ones discarded. The science-based regulatory framework for development of medical products is also dynamic in that public health objectives may change in response to patient needs and societal interests. Given the dynamic character of these factors and also that the process involves many constituencies-pharmaceutical sponsors, the scientific and health care communities, the government, and society at large--a potential synergism exists in which involved constituencies could work collaboratively to improve methods and procedures for development of new medical products.
III. BACKGROUND INFORMATION
Current approaches to the development of useful information about investigational medical products may require excessive time and effort, leading to delay in the availability of needed treatments. In addition, improvements in the way this information is developed could lead to optimal product labeling and use. To address these issues, the Georgetown University Center for Drug Development Science (CDDS), CDER, and the Food and Drug Law Institute sponsored a meeting in June 1996 entitled Drug Development: Who Knows Where the Time Goes. The principal goal of the conference was to explore the process that generates information about new medical products and to consider what barriers and constraints exist in the process. Following a series of presentations from industry, agency and academia representatives, a panel of experts summarized the presentations and proposed a further collaborative effort to improve methods and procedures for development of new medical products. Following the June 1996 meeting, further discussions occurred to consider the proposals arising from the Georgetown Conference. On September 25, 1996, representatives of Georgetown University Medical Center/CDDS, CDER, CBER, PHRMA, and BIO met and agreed to consider formation of a collaborative effort, the Collaboration on Drug Development Improvement (CDDI).
IV. PRIOR FDA EXPERIENCE WITH COLLABORATIVE APPROACHES
FDA has worked collaboratively with extramural constituencies on several occasions. Examples include: 1) the National Center for Food Safety and Technology (Attachment A); 2) the Joint Institute for Food Safety and Applied Nutrition (Attachment B); and, 3) the collaborative product quality research at the University of Maryland at Baltimore (UMAB), which included scientists from FDA, the pharmaceutical industry, and academia (Attachments C and D).
V. PROPOSAL
The mission, scope, goals and objectives, structure, and process of CDDI are discussed in the following paragraphs.
The purpose of CDDI is to improve substantially the development of pharmaceuticals, including biopharmaceuticals.
The scope of CDDI comprises the preclinical and clinical testing phases in the development of pharmaceuticals, including the post-approval phase. Drug development science and science management methodologies will both be considered.
CDDI will study and advance current and new approaches to substantially improve the efficiency of the drug development and assessment processes by: 1) reducing unnecessary studies and activities; 2) increasing useful information; and 3) improving resource utilization and shortening development times.
CDDI will be directed by a Steering Committee. Members of the Steering Committee will consist of the Directors of CBER and CDER, one or more representatives from academia, and representatives from PHRMA and BIO. Steering Committee membership should be composed of individuals with science/technical backgrounds and who also have experience in management.
Six technical committees will be formed to cover the following areas: 1) Nonclinical Studies; 2) Mechanistic Studies; 3) Empirical Studies; 4) Post Marketing Studies; 5) Science Management; and 6) Novel Approaches. The six technical committees will propose, for Steering Committee approval, programs and projects to develop information to support recommendations to pharmaceutical scientists which may be published as guidance (regulatory and non-regulatory) documents. 'Information' in this context is used broadly to include retrospective and prospective investigations, cumulative understanding of current approaches, literature searches, and associated efforts. Technical Committee members shall possess strong science/technical skills and have experience in the management of science projects.
These groups will supervise the execution of specific projects within a program, work with research site(s) to summarize and report results, and create draft recommendations for further consideration by the supervisory Technical Committee and Steering Committing. Individuals selected for specific working groups should also have strong science/technical skills in specified program/project areas.
The Steering Committee will provide general direction to CDDI and oversight to the Technical Committees, including approval of Technical Committee proposals. The Steering Committee will also review outcomes from programs and projects submitted by a Technical Committee, assess the overall impact of CDDI activities, and determine the need for continuing activities and/or modification in the way the initiative operates.
Technical Committees will define programs and projects within programs, create working groups to focus on these programs and projects, and establish timeframes for completion of work. The Technical Committees will review reports and other information generated from working groups, consider how this information can be used in the drug development and regulatory processes, and make recommendations to the Steering Committee.
Working Groups for specific projects within programs will formulate the intended improvement in drug development as the primary goal of a project. Projects may be executed using academic facilities and staff, industry facilities and staff, and/or agency facilities and staff. Selection of a specific site or sites for conduct of a research project will be the responsibility of the Working Group, with endorsement by the supervising Technical Advisory Committee. Consideration of certain projects may occur competitively via a request for proposal process. A peer review process, executed by the Working Group, with final endorsement by the Technical Advisory Committee, will be established to evaluate competing proposals. After completion of a project, the Working Group will work with the project research site to disseminate the results. Dissemination may occur via publications, workshops, and presentations at meetings of professional societies. Results will also be presented to regulatory agency staff associated with or otherwise interested in the research.
A Working Group will collaborate with the project research site to draft guidance documents for review and endorsement by the Technical Advisory Committee. These will be forwarded to the Steering Committee for concurrence and then to appropriate CBER and CDER policy units for further consideration and, if appropriate, translation into regulatory guidances. Policy units within CDER include the Medical Policy Coordinating Committee and the Pharmacology/Toxicology Coordinating Committee.
Regulatory documents developed by these coordinating committees are submitted to the Director, Regulatory Policy Staff, CDER, and to CDER management for concurrence, finalization, and dissemination. [Need equivalence statements for CBER.] Further review by agency management and counsel is performed as necessary. Regulatory guidance documents developed as a result of an initiative effort will be published in the Federal Register. Efforts by a technical committee and a working group may also lead to non- regulatory policy and publications that may be useful to pharmaceutical sponsors.
Training Programs When appropriate, a Working Group and the project research site may be requested to develop training modules to aid in the implementation of new regulatory policy recommendations. Training may occur for agency and non-agency staff and other interested individuals. The Working Group, the Technical Committee, and the Steering Committee will work to monitor the impact of regulatory and other policy arising as a result of research programs, address certain questions that may arise as a policy based on a research project/program is implemented, and assist in updating policy as appropriate.
VII. ADMINISTRATIVE ISSUES
One or more memoranda of agreement or cooperative agreements may be developed by CDDI to facilitate the generation of information by the collaboration.
Resources to support CDDI activities could occur in the form of contributions of 1) personnel time, 2) space, and 3) equipment. Financial contributions may derive from public funds (appropriated dollars), public funds associated with PDUFA, and contributions from specific members and groups. For the latter, two general approaches may be considered. One approach is based on funding programs/projects by collaboration members who have an identified interest in a specific research program/project and regulatory outcome. A second approach involves regular contributions by interested participants which are not linked to a specific research program. The second approach allows general functioning of the collaboration over a specified period of time.
CDDI deliberations, efforts, and outcomes are expected to be publicly available. The collaboration will develop mechanisms to achieve this objective.
CDDI is not intended to disseminate or impact in any way on confidential commercial or trade secret information developed by a pharmaceutical sponsor.
Cooperative agreements, conflict of interest, intellectual property rights, liability, and other issues, may require consideration by CDDI.
CDDI may work to develop connections with national and international professional societies, academic institutions, and regulatory agencies.
CDDI will develop mechanisms to facilitate communications between participants and to maintain records of its activities.
Improving Drug Development Using Patient Adherence Data
in Clinical Trials, May 6-7, 2008.
Brochure (PDF)
Registration site
Advanced NONMEM workshop – March 17–19, 2008 at Mission Bay Conference Center, San Francisco, CA.
More information >
UCSF-CDDS to launch The American Course on Drug Development and
Regulatory Science- September 2007
More information >
CDDS – Pharmacometric Services is available to drug researchers
More >
Howard Lee, MD, PhD, named Director of CDDS
More >
Lewis B. Sheiner Memorial. Symposium held at CDDS in December 2006
More >
This site will look much better in a browser that supports web standards, but it is accessible to any browser or Internet device. Please upgrade your browser.