SUBJECT:  Response to the OVRR Office Site Visit Review Team Comments


     On May 19, 2006 a team of independent external reviewers conducted a review of the Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER) research program.  The committee provided a global review of the research program management and organization of the OVRR, and made recommendations that could strengthen scientific programs within the Office.  OVRR responses to committee comments are provided below:


1.  Comment on the contributions of OVRR research to the scientific mission of CBER and the FDA and to biological product regulation.


 OVRR could benefit from the development of a more comprehensive strategic plan to address its broad missions more effectively.  Such a plan would enumerate, prioritize, and coordinate common thematic areas such as immunogenicity, safety, and assay development across multiple offices/laboratories.  The strategic plan would also anticipate subject areas which would likely be of particular importance to OVRR (e.g., pandemic influenza).  Decisions regarding recruitment, resource allocation, and research expansion could then be based on the strategic plan.


OVRR RESPONSE:  OVRR participates in CBER and FDA strategic planning.  Table 1 details the goals of the FDA Strategic Action Plan.  Each of the goals is linked to important objectives of the Department of Health and Human Services.  CBER and OVRR have applied these goals and objectives to enhance consumer access to safe and effective biologics, including vaccines.  Each of the four major goals of the FDA Strategic Action Plan published in 2007 contains objectives related to strengthening scientific activities and aligning programs with the regulatory mission of the agency.  An important continuing objective of the Center and Office is to “strengthen the scientific foundation of FDA’s regulatory mission” (Objective 1.1 of the FDA Strategic Action Plan, Table 1).  The National Vaccine Plan is currently being updated by the Department of Health & Human Services to address critical national requirements through 5- and 10-year goals.  These strategic planning documents will help shape the future scientific activities of the Office. 


In FY 2007 OVRR established a new research management system (see Figure 1. The OVRR Research Management Process) that incorporated recommendations from the Office Site Visit Review Committee, CBER’s Research Leadership Council, senior OVRR leadership, and others to support priority setting, the development of research programs relevant to the OVRR regulatory mission and programmatic decision-making.  A key deliverable of this process is the OVRR Research Plan, which is updated annually.  Integrated research plans for the Office were prepared for FY 2007 and FY 2008.  The newly created OVRR Scientific Management Committee provides guidance and oversight over the research planning process, identifies Office research priorities, supports a transparent process for decision-making, establishes processes for evaluating research progress, and makes recommendations concerning the allocation of limited Office resources.  For FY 2009 research priorities, long term goals and specific aims will be established by evaluating the OVRR regulatory workload, receiving input from external groups (such as the National Institutes of Health, FDA and Industry Vaccine Roundtable, international organizations (e.g. WHO, EMEA, etc), and other stakeholders), recommendations from senior OVRR and CBER leadership, evaluation of strategic infrastructural needs, identification of future technology needs, and appraisal of domestic and global public health requirements. 


In FY 2007 four major research priorities were established based upon the regulatory workload, high impact issues, Critical Path challenges, pre- and post-licensure issues and emerging public health issues.  The priorities identified include:


I.  Improve or develop new methods that enhance the safety of vaccines and related products


II. Improve or develop new methods that enhance the effectiveness of vaccines and related products


III. Facilitate the development of new biological products for high-priority public health threats,  including emerging diseases and  BT agents


IV. Develop and evaluate novel scientific technologies and standards to improve biological product regulatory pathways, availability and quality of vaccines and related products


Long term and short term research specific aims linked to Office priorities are identified within individual investigator research plans.  Research plans are developed and reviewed through comprehensive interactions between principal investigators and their laboratory chiefs.  Division Directors and Laboratory Chiefs evaluate proposed research efforts against available resources.  Fiscal and personnel resource targets are established by the Office Director using input from his staff and CBER Office of Management.


When possible, thematic program areas that encompass related research efforts are being established.  Since FY 2007 cross-divisional influenza projects have been consolidated into a single program that addresses scientific priorities related to the development and regulation of seasonal and pandemic influenza vaccines.  Similar programs that focus upon cell substrates, allergenics, and biodefense projects externally funded by the National Institutes of Health have been established.  The specific aims and scientific objectives of these programs have been integrated into OVRR strategic planning.  Additional programs will be organized and aligned with OVRR priority goals based upon shared research objectives for the FY 2009 research program.


2.  Comment on ways to improve visibility of the OVVR research programs and on its integration into the biologics regulation process.


  One approach for increasing the visibility of research efforts at OVRR would be to seek FDA representation on scientific advisory committees of major collaborative groups/centers for relevant research.  An example of such in the HIV vaccine field is the committee which advises the Vaccine Research Center at NIH, the NIAID-sponsored Center for HIV AIDS Vaccine Immunology (CHAVI), and the HIV Vaccine Trials Network (HVTN).  Such advisory representation should entail research interaction, rather than being restricted to regulatory issues.”


OVRR RESPONSE:  OVRR scientific personnel regularly participate as expert and technical advisors on national and international panels and research review committees for the World Health Organization, Pan American Health Organization, National Institutes of Health, the Defense Advanced Research Projects Agency, the Centers for Disease Control and Prevention, and the American Academy of Microbiology.  While the technical advice of the staff is frequently sought, their participation on committees related to regulated products must be limited to avoid regulatory conflicts of interest.  OVRR scientific staffs are open to collaborations and other interactions through a variety of professional organizations.  A representative list of advisory committees and other groups that included OVRR scientists is presented in Table 2. 


3.  Recommend opportunities for research expansion, redirection and new collaboration/leveraging.


 “It is unclear how much work is done with academic institutions, particularly clinical investigators. Making additional linkages with such potential collaborators is likely to be useful and productive.”


OVRR RESPONSE:  Collaborations with academic scientists are managed at the investigator level and reviewed by OVRR senior management.  Currently, OVRR scientists participate in hundreds of academic collaborations.  Significant leveraging and collaborative projects are reported in annual progress reports.  OVRR scientists participate regularly in domestic and international scientific organizations. OVRR scientists are recognized experts in selected products areas related to the development and regulation of vaccines and allergenic products. See Table 3 for a list of academic research collaborations in FY 2007/2008.


4.  Identify research management strategies for anticipating future biological products and related research programs.


 “OVRR appears to lack a well developed strategic plan that overlays all the separate lab programs.  This plan needs to be cross cutting and integrative of expertise and resources in individual labs and use these components to address critical components of the FDA's vaccine mission such as a better understanding of vaccine immunity and safety.” 


OVRR RESPONSE:  Integrated cross-divisional research plans were prepared in FY 2007 and FY 2008. A new research management process was established for the Office in 2007 that supports priority setting, the development of research programs relevant to the OVRR regulatory mission and programmatic decision-making.


“[T]he career pathway in OVRR should be structured to make it more appealing to new members and what components of these very large issues need to be developed to help the individual programs move forward.”


OVRR RESPONSE:  OVRR supports a comprehensive career management process within CBER and the FDA.  The CBER Research Scientist Peer Review Committee provides oversight for scientist advancement within the Center. 


The recruitment, retention, and development of an accomplished scientific research staff are critical for achieving CBER’s and OVRR’s mission.  In support of CBER’s regulatory mission, each CBER research scientist fills a mixed duty position combining both research and regulatory activities. This position is by using two Office of Personnel Management (OPM) position classification guides: the research segment is evaluated using the four factor Research Grade Evaluation Guide (RGEG) and the regulatory segment using the nine factor, Factor Evaluation System (FES) Guide.  Scientific staff are recommended for peer review and promotion through their respective Laboratory Chiefs and Division Directors.  Figure 2 presents a summary of the OVRR scientist career path.  


For appropriate and consistent evaluation of scientists performing the combination of both review and laboratory activities, CBER established the Promotion and Conversion Evaluation (PCE) Committee.  The PCE Committee is charged to evaluate the scientific qualifications and contributions of:  (1) Research-regulator scientists considered for promotion to GS-13 and above; (2) Service Fellows considered for conversion to a permanent research-regulator position at GS-13 and above; (3) Permanent Staff Scientists considered for reassignment as permanent Senior Investigator positions; (4) Outside candidates considered for employment as permanent Staff Scientists/Senior Investigators at GS-13 and above; and (5) Mandatory four year cyclical review of Research-regulator scientists (GS-13 to GS-15).   The PCE Committee will also review such candidates from other FDA Centers as requested by that Center’s leadership.


Laboratory Chiefs and Division Directors are responsible for mentoring the scientific staff within their organizations.  Mentoring is an important performance element in annual supervisor Performance Management Plans.  A CBER-sponsored mentoring program pairs staff with more senior employees and recognizes excellence in this area through an annual award sponsored by the Center Director.


“[A]n active seminar program would be useful to maintain awareness of activities not covered by internal programs and should seek out speakers from company labs as well as from academic/government labs.”


OVRR RESPONSE:  Active weekly seminars are conducted in the Division of Viral Products and Division of Bacterial, Allergenic and Parasitic Products.  Internal and external speakers are invited to provide progress reports on important research and technology advances.  Office and Divisional operating funds have been dedicated to support presentations by outside speakers.  All OVRR employees are invited to participate in work-in-progress or other presentations.  In some cases, seminars are broadcast through the FDA intranet to reach office-based review scientists.  See Table 4 for a list of representative seminars sponsored by our product divisions.


 “Prior to filing an IND, it would be appropriate in some cases to present to CBER staff an overview of a technology and how it applies to an upcoming development program that will come under CBER scrutiny.”


OVRR RESPONSE:  Technology reviews are regularly performed in the context of division work-in-progress seminars. Additionally, many laboratories conduct regular journal meetings that provide overviews of important technology breakthroughs. Product-related presentations can be conducted during the review of specific manufacturer submissions.  CMC and product reviewers provide expert knowledge and technical expertise during the review of sponsor submissions. 


5.  Provide recommendations for attracting, developing and retaining high quality science and medical experts for OVRR.


“Concern was expressed over the possibility that the leadership in OVRR is aging and not being replenished by younger people. …  An overall strategic plan needs to come from senior leadership but it needs input and buy-in from below and needs to be implemented with the understanding that the current structure seems fragile so that one must be careful not to destroy things in the process of improving them.”


OVRR RESPONSE:  OVRR has a robust program to attract fellows into our scientific programs.  Post graduate scientific staff can be trained either through the CBER Service Fellow Program or through the ORISE/IRTA Contract Fellowship Training Program.  OVRR currently has approximately 39 Staff Fellows/Visiting Associates and 82 ORISE/IRTA fellows.  Staff Fellows participate in a structured program that can lead to permanent federal service appointments.  ORISE/IRTA fellows are contractor personnel that can complete for federal positions as they become available.   Peer review of staff fellow scientific and regulatory performance provides OVRR with the highest quality scientific staff.  See Table 5 for a distribution of post graduate fellows by OVRR division.


“One way to attract new talent to OVRR is to implement a system of reward for successful research, either financially or in terms of providing more lab space or research funding, or promotion.”


OVRR RESPONSE:  Scientific staffs are recognized currently for their scientific achievements through two systems of reward. Offices nominate high performing laboratory staff (and other disciplines) for special recognition by the CBER Center Director.  Senior and junior scientific and technical staff can be recognized in individual categories.  Award nominations are reviewed and ranked by a central committee representing diverse disciplines.  Separately, federal employees are evaluated within a structured award system tied to annual performance evaluations.  “Fully Successful” and “Exceptional” evaluations may result in incremental salary increases and annual bonuses.  ORISE/IRTA personnel are recommended for annual salary adjustments based upon performance but can not receive performance bonuses due to federal contracting regulations.  The distributions of laboratory space and other opportunities are restricted by available resources.  Division Directors are responsible for assessing the resource needs of individual laboratories within their areas.  OVRR is considering establishing a small innovative research grant program using internal Office funds in order to reward and encourage the development of new research opportunities and enhance the development of emerging scientific leaders in the Office.


“Research conduct within CBER is similar to the operation of an academic institution; therefore, it is not unreasonable to look for additional ways to follow that model more closely.  Dr. Carbone mentioned creation of core facilities, which reduce the overhead and need for duplication of costly items of equipment.  It may therefore be useful to obtain more information from medical schools on the operation of a combination of research and service activities. For example, an academic institution may have an excellent faculty development program that provides assistance to junior faculty on a wide range of subjects from availability of childcare in the community to creation of a teaching and research portfolio to grant and manuscript writing.”


OVRR RESPONSE:  The OVRR scientific staff is represented on the CBER Biomedical Research Coordinating Committee (BRCC).  The CBER BRCC serves as a forum for discussion of issues pertaining to research activities. Topics may include, but are not limited to, standards of research conduct and ethics, common equipment, Good Laboratory Practice accreditation, mentoring, and policies on service contracts for maintenance of costly research equipment. The CBER BRCC is responsible for creating an environment for better research communication within the Center.  The CBER Research Central intranet also provides opportunities to identify common scientific interests and collaborations.  The BRCC facilitates the activities of special scientific interest groups at CBER, such as genomic, immunology, and scientific computing.  Inter-Center interest groups are sponsored at the agency level.  BRCC meeting topics may include standards of research conduct and ethics, common equipment, Good Laboratory Practice accreditation, mentoring, and policies on service contracts for maintenance of costly research equipment, management of the animal or core facilities, mentoring and training, research support, establishment and maintenance of an up-to-date web-based database of skills and specialties available at CBER, and opportunities for external funding. 

In a related activity, CBER supports a Career Development & Mentoring Program.  Junior scientific staff may work with more senior personnel who guide them in their career development. Mentees have the opportunity to increase knowledge of the organizational dynamics that can affect careers; network with other Center and Agency employees and leaders; identify or refine career goals based on a realistic self-assessment; develop knowledge, skills, and abilities focused at supporting career goals; and develop a plan for achieving career goals based on an understanding of organizational needs.

In addition to the above OVRR supports the training and professional development of postdoctoral fellows and other staff.    Laboratories and divisions provide operational funds for staff training and travel.  Recently, CBER established a training fund that can be used by all civilian FTE staff for professional development.  OVRR set aside additional funding in FY 2008 (up to $ 48,000) to support training opportunities for research and review staff.  Depending upon the availability of funds, our goal is to give scientists the opportunity to attend one professional society meeting per year.  Fellows can also present their work at the annual National Institutes of Health (NIH) Research Festival, in seminar series of the various campus scientific Interest Groups, and in journal clubs and work-in-progress series at CBER.  The following opportunities are also available to our postdoctoral fellows:   

·    CBER training courses that include communication skills, scientific and technical writing, scientific writing for publication, making high-quality presentations, teamwork, managing time and priorities in the CBER environment, and negotiation skills. 

·    NIH training courses in scientific speaking, scientific writing, interview skills, and grant preparation.

·    Courses in the Foundation for Advanced Education in the Sciences (FAES) graduate school in a variety of subject areas.

·    Representation at the NIH Fellows Committee (FelCon), which aims to enhance training opportunities and sponsors many training courses and seminars that FDA and NIH postdoctoral fellows are eligible to attend. 

·    Participation in an annual scientific job fair held as part of the NIH Research Festival

·    Yearly NIH workshops on such subjects as résumé preparation and diverse career options (e.g., teaching, patent office, drug development, academia).

·    Childcare resources

·    FDA Employee Assistance Program

·    FDA TRANSHARE Program (transportation incentive program)

·    Parklawn Health Clinic (selected health services)



“The Committee believes research within OVRR to be of high quality and acknowledges the numerous scientific accomplishments of the research staff.  There is, however, clearly a pressing need for improved funding support and recruitment strategies to recruit talented young scientists in order to maintain the high quality of research, as well as to improve the public’s image of OVRR and the research that it performs. The committee wishes to convey its strong concern that without the addition of substantial and sustained new financial support for the OVRR research enterprise, OVRR runs a serious risk of not being able to accomplish its multiple missions.  In addition, CBER and OVRR, within the limits inherent in the fact that the FDA is a government institution, could consider following models that have been established by academic institutions.  All of these issues could be addressed by the development of a clear strategic plan that incorporates the preceding recommendations and aims at producing a program that is cross-disciplinary between the OVRR divisions and laboratories.”


OVRR RESPONSE:  OVRR appreciates the support and recommendations of the Office Site Visit Review Team.  While internal resources for the program has been austere, the future for OVRR scientific activities is bright as evidenced by the ability of our scientists to win support from competitive internal and external sources of funding.  The FDA Science Board and others have recognized the value of the intramural program to address critical scientific needs of the agency.  Our scientific activities will continue to support the critical pathway to safe and effective vaccines and biologics need to protect the domestic and global public health.



Table 1.  FDA Strategic Action Plan Goals

Goal 1: Strengthen FDA for Today and Tomorrow

Objective 1.1: Strengthen the scientific foundation of FDA’s regulatory mission.
Objective 1.2: Cultivate a culture that promotes transparency, effective teamwork, and mutual respect, and ensures integrity and accountability in regulatory decision making.
Objective 1.3: Enhance partnerships and communications.
Objective 1.4: Strengthen FDA’s base of operations.

Goal 2: Improve Patient and Consumer Safety

Objective 2.1: Strengthen the science that supports product safety.
Objective 2.2: Improve information systems for problem detection and public communication about product safety.
Objective 2.3: Provide patients and consumers with better access to clear and timely risk-benefit information for medical products.
Objective 2.4: Provide consumers with clear and timely information to protect them from food-borne illness and promote better nutrition.

Goal 3: Increase Access to New Medical and Food Products

Objective 3.1: Increase the number of safe and effective new medical products available to patients.
Objective 3.2: Improve the medical product review process to increase the predictability and transparency of decisions using the best available science.
Objective 3.3: Increase access to safe and nutritious new food products.

Goal 4: Improve the Quality and Safety of Manufactured Products and the Supply Chain

Objective 4.1: Prevent safety problems by modernizing science-based standards and tools to ensure high-quality manufacturing, processing, and distribution.
Objective 4.2: Detect safety problems earlier and better target interventions to prevent harm to consumers.
Objective 4.3: Respond more quickly and effectively to emerging safety problems, through better information, better coordination and better communication.


Figure 1.  OVRR Research Management System



























Table 2.  OVRR Participation on Advisory Groups and Committees


ATCC Standards Development Working Group on Standardization of in vitro Assays to Determine Anthrax Toxin Activities

CDC Advisory Committee for the Elimination of Tuberculosis

DHHS Biotechnology Engagement Program, Peer Review Panels

Gates Foundation for Medical Research, Scientific Advisory Panels

International Association of Biologicals (IABs) Human Vaccines Scientific Committee

International Panel for the Nomenclature of Hepatitis C

Intragovernmental Select Agents and Toxins Technical Advisory Committee

National Academy of Science Panel for International Grant

National Vaccine Program Office Award, Peer Review Panel

NIAID Biodefence Study section: Animal Models for Radiation Injury, Protection, and Therapy

NIAID/NIH Animal Models for Hepatitis C Virus Infection, Peer Review Panels

NIAID/NIH Leadership for HIV/AIDS Clinical Trials Networks, RFP Review Panel

NIAID/NIH special emphasis panel, Opportunistic Infections and Malignancies in AIDS

NIAID/NIH Viral Hepatitis, Peer Review Panels

NIAID/NIH, AIDS Special Emphasis Panel: HIV Vaccine Design and Development Teams

NIAID/NIH, AIDS Special Emphasis Panel: HIV Vaccine Program Project Grants

NIAID/NIH, AIDS Special Emphasis Panel: HIV Vaccine Research & Design

NIAID/NIH, AIDS Special Emphasis Panel: Innovation Grant Program for approaches in HIV vaccine Research

NIAID/NIH, AIDS Special Emphasis Panel: Integrated Preclinical AIDS Vaccine development program

NIAID/NIH, HIV/AIDS Vaccine, Peer Review Panels 

Parenteral Drug Association Mycoplasma Task Force

Scientific Advisory Board, ATCC Expert Panel on the Development of Standards for Biodefense

Scientific Advisory Board, Middle Atlantic Regional Center of Excellence for  Biodefense and Emerging Infectious Disease Research

Scientific Advisory Panel, International Vaccine Institute, Seoul, Korea

U.S. Military HIV Research Program, External Review Panel

Weapons of Mass Destruction Medical Counter Measures Product Tools Development Working Group

Wellcome Trust Programme Project, Peer Review Panels

WHO Expert Panel on Hepatitis A Vaccines
Table 3.   OVRR Academic Collaborations



Akashi Hospital/Kyoto Medical School

Albert Einstein College of Medicine

Colorado State University

Drexel University

Eidgenössische Technische Hochschule (ETH), Zurich

Georgetown University

Harvard University

Hunter College, New York

Institute of Poliomyelitis and Viral Encephalitides, Moscow

Johns Hopkins University

London School of Tropical Medicine and Hygiene

LSU Eye Center, New Orleans, LA

Ludwig Institute for Cancer Research

Mayo Clinic

Monash University, Australia

Ohio State University

Pennsylvania State University

Purdue University

Queens University, Belfast, UK

Rockefeller University

Roswell Park Memorial Institute

S. Kimmel Cancer Center

Saint Jude Children’s Research Hospital

Saitama University

Southern Research Inst., Frederick, MD

Southern Research Institute, Birmingham, AL

Stanford Medical Center

State Research Center of Virology and Biotechnology, Russia

Stockholm University

Stony Brook University Medical Center

UMDNJ-New Jersey Medical School

Uniformed Service University of Health Sciences

University of Michigan

University of Vienna

University of Ottawa

University of Alabama

University of California Davis

University of California, Santa Barbara

University of California, San Francisco

University of Cincinnati

University of Florida

University of Illinois

University of Iowa Medical School

University of Kansas Medical Center

University of Maryland Medical School

University of Maryland, Baltimore

University of Maryland, College Park

University of Minnesota

University of Napoli, Italy

University of New Mexico

University of North Carolina-Chapel Hill

University of Oxford, United Kingdom.

University of Rochester

University of Sassari, Sassari, Italy

University of Texas at Austin

University of Texas at Tyler

University of Texas, Galveston

University of Victoria

University of Virginia, Charlottesville

University of Colorado

University of Edmonton, Canada

VU Medical Center, Amsterdam, Netherlands

Wright State University, Dayton, OH

Table 4.  Selected OVRR Invited Speakers, 2008


Invited Speaker

Seminar Topic

Speaker Affiliation

Charles Arntzen

Plant-based Vaccines

Biodesign Institute

Arizona State University

Donald Jarvis

Protein Glycosylation using Baculovirus- Applications to Influenza Vaccines

University of Wyoming

Yves Aubin

Comparison of Protein Structure by 2D-NMR

Center for Biologics

Health Canada

Ram Sasisekharan

Human Adaptation of Influenza Virus Hemagglutinin


Hiroyuki Yokote

LC16m8 smallpox vaccine update


Dennis Metzger

Antibacterial defense during influenza infection

Albany Medical Center

Charles Lebaron

Waning measles immunity


George Rohrmann

Baculovirus retroviruses

Oregon State University

Dan Henderson

Adenovirus vectors


Nancy Sullivan

Adenvirus vectors for Ebola


Julia Lynch

Adenovirus vaccines for military recruits





Table 5.  OVRR Staff Fellows/Visiting Associates and ORISE/IRTA Fellows

OVRR Division

Staff Fellows /Visiting Associates


Director’s Office



Division of Product Quality



Division of Viral Products



Division of Bacterial Products.









Table 6.  The OVRR Scientist Career Path


The ORISE/IRTA Contract Fellowship Training Program provides practical scientific training for domestic and foreign scientists and physicians having a background or interest in medical, biological, chemical, toxicological, mathematical/statistical, physics, or other related sciences. ORISE/IRTA fellows receive guest appointments at CBER but are not federal employees.  Appointments are reviewed annually and may be extended for seven for U.S. citizens (or U.S. permanent residents) or 5 years for foreign nationals.  Foreign nationals may not be extended beyond the duration of their visa.


Staff Fellow/Visiting Associate.  This track is a four (4) year program for Staff Fellows and Visiting Associates (SF/VA) to obtain research experience and learn FDA regulatory processes in order to reach the level required for possible conversion to a permanent Staff Scientist position. Service Fellows in the SF/VA Track are doctoral level individuals who perform research and regulatory activities under the supervision of a Senior Investigator.


Extended Staff Fellow/Visiting Associate:  Individuals who have completed a four (4) year Staff Fellow/Visiting Associate (SF/VA) Track appointment performing research and regulatory duties may apply to the Extended-Staff Fellow/Visiting Associate (Ext-SF/VA) Track. This track provides the candidate an additional three (3) years to increase their research/regulatory experience to reach the level required for possible conversion to a permanent Staff Scientist position. Service Fellows in the Ext-SF/VA Track are doctoral level individuals who perform research and regulatory activities under the supervision of a Senior Investigator.


Staff Scientists: Staff Scientists (SS) are doctoral or non-doctoral research-regulators, GS-13 and above, who are permanent employees possessing exceptional technical skills or unique scientific or biological product expertise, performing important collaborative work within an existing research/regulatory program under the supervision of a Senior Investigator.


The Senior Investigator (SI) Track is a seven (7) year program that provides an opportunity for outstanding doctoral level Service Fellows to develop their skills as independent research/regulators in order to be considered for conversion to a permanent Senior Investigator position. SI Track Service Fellows are provided with independent laboratory space, personnel resources and funding for laboratory supplies. SI Track Service Fellows perform research/regulatory activities including: publishing peer reviewed original scientific documents; providing technical advice and guidance to other researchers and consulting with others about ongoing research/regulator projects; leadership activities; organizing conferences and workshops; teaching; attending professional meetings; applying for and receiving contracts, grants, interagency agreements, developing  Cooperative Research and Development Agreements (CRADAs), and leveraging other resources to support their research projects.


Permanent Senior Investigators are independent scientists.