|
Dr.
Jessop has nearly 30 years of experience as a toxicologist
and pharmacologist for both FDA and industry.
SUMMARY
OF TOXICOLOGY/PHARMACOLOGY CONSULTING EXPERTISE
FDA
- Expertise
in the drug and biologics regulatory review process (IND,
NDA/BLA)
- Pharmacologist/toxicologist
with extensive experience in Preclinical Pharmacology and
Toxicology review of both biological products and drugs
- Expert
in the development of monoclonal antibodies
- Extensive
experience in the development of prophylactic and therapeutic
vaccines
- Authoring
of policy/guidance documents at the FDA (monoclonal antibodies,
electronic submissions; immunotoxicology)
- Participated
in standard FDA Meetings (pre-IND, end of Phase 2, pre-BLA,
etc.)
- Inspection
of pharmaceutical manufacturers for GLP and GMP compliance
- Principal
investigator for toxicology studies in compliance with the
U.S. GLPs
- Doctorate
in Pharmacology with minor in Immunology; therefore understands
immunological principles as relates to development of biologics
- Directed
basic research at CBER (National Institutes of Health campus)
in immunopharmacology (monocytes, interleukin-1, cytokine
release)
Pharmaceutical
Company
- Director
of all regulatory activities and preparation of FDA submissions
(IND, NDA/BLA, Information Amendments, Annual Reports, etc.)
required for development of NCEs (drugs and biological products)
to market and required to support marketed products
- Served
as core regulatory affairs representative on product teams
tasked with global development of drugs and biologics
- Excellent
knowledge and understanding of both the FDA and industry
perspectives pertaining to the drug and biologics development
process
- Helped
with development of toxicology program for biologics
DETAILED
EXPERTISE
Dr.
John Jessop joined the Biologics Consulting Group in August
1999, after 20 years experience with the FDA and two years
experience with a private pharmaceutical company. His
previous position was as Director, U.S. Regulatory Affairs
with Purdue Pharma, L.P. in Norwalk, CT. Dr. Jessop is a pharmacologist/toxicologist
with a strong and unique background in the regulatory review
and preclinical development of biologics and drugs. His doctorate
is in Pharmacology (Georgetown University), with a specialty
in immunopharmacology, and therefore he is also familiar with
the principles of immunology. He has expertise in both pharmacology-toxicology
and product review of biological products from his work experience
at FDA/CBER. He also has experience as a pharmacology-toxicology
reviewer of drugs in FDA/CDER. He served on a number of CBER
and CDER committees, including the CDER Information Technology
Committee (Electronic Submissions). He has co-authored a number
of FDA Guidance and "Points-to-Consider" Documents,
including a document providing guidance on the development
of monoclonal antibodies as therapeutics and one outlining
appropriate immunotoxicological testing of drugs. While at
the FDA he also carried out GLP inspections of pharmaceutical
companies and conducted toxicology research in compliance
with the U.S. GLPs. Finally, he has worked for both the FDA
and as a Director, Regulatory Affairs for the pharmaceutical
industry. As the Director, Regulatory Affairs, he was responsible
for directing all regulatory aspects of NCE development (both
biologics and drugs) as well as providing regulatory support
for marketed products. Therefore, he is familiar with the
important regulatory issues from the perspective of both the
FDA and the pharmaceutical industry. While working for the
Biologics Consulting Group, he has added to his extensive
experience and expertise in the development of vaccines. He
has worked on projects at all different stages of development
(pre-IND, IND, BLA) for the full spectrum of biologics (vaccines,
cell and gene therapy products, blood products) and biologic
therapeutics (monoclonal antibodies, cytokines, therapeutic
proteins), as well as a number of drugs (small molecules).
He has also written pre-IND, IND, and BLA documents as well
as CTDs for many products, including monoclonal antibodies,
gene therapy products and vaccines, among others. He has worked
on projects involving the Animal Rule on a number of occasions,
and has routinely carried out GLP audits. He has also continued
to attend various meetings (DIA, RAPS, SOT, ACT) in order
to maintain the most current regulatory information. Finally,
he has written a book chapter and an article on the subject
of preclinical pharmacology-toxicology development of biologics
and drugs.
EDUCATION:
| Ph.D. |
|
Georgetown
University School of Medicine; Pharmacology/Immunopharmacology
(1986) |
| M.P.H. |
|
Tulane
University School of Public Health; Public Health
(1977) |
| B.S. |
|
State
University of New York, Brockport; Biology (1973) |
|
| EXPERIENCE: |
CURRENT
POSITION: Aug. 1999 to present |
|
Director,
Pharmacology/Toxicology,
Biologics
Consulting Group, Inc. Roanoke, VA
-
Responsible for the scientific, regulatory and preclinical
pharm/tox review, planning and analysis of a wide
range of biologics and biological therapeutic products
at all stages of development, from pre-IND through
post-marketing
- Provide
a full line of pharm/tox consulting services, including
regulatory, scientific and pharm/tox guidance and
support, develop product- and facility-related regulatory
documents for submission, review SOPs, review pharm/tox
packages, interface with toxicology CROs, plan/review
preclinical pharm/tox programs and protocols, do GLP
audits and analysis of toxicology study results
- Provide
a unique perspective in that I have CBER experience
with both product and pharm/tox review
- Knowledge
of both pharmacology and immunology; provides a unique
understanding of the biologics, mainly designed to
interact with the immune system
- Years
experience as a pharm/tox reviewer at CDER, allow
me to offer pharm/tox expertise in the development
of drugs as well as biological products.
- This
experience is especially important in light of
the recent transfer of the CBER therapeutic biological
products to CDER.
- With
experience as the Director, Regulatory Affairs in
a pharmaceutical company, I have an excellent understanding
of the drug development process and issues important
to the FDA as well as to the industry.
- This
level of experience allows me to plan optimal
pharm/tox programs on a case-by-case basis for
the various biologics, therapeutic biologics and
drugs as well as to develop regulatory documents
(pre-IND, IND, BLA, CTD) that provide the information
required by the FDA in a clear and concise manner.
- Current
in my knowledge of the role of pharmacology/toxicology
in product development through continuing participation
in scientific and regulatory meetings.
- Developed
extensive experience and expertise in the pharm/tox
requirements for development of vaccines
- Wrote
an article and a book chapter on the subject of preclinical
pharmacology-toxicology development of biologics.
Recent experience includes:
- Plan
appropriate pharm/tox programs and specific study
protocols for vaccines, gene therapy products,
monoclonal antibodies, cytokines, and others.
- Write
and/or review pre-IND, IND, BLA and CTD pharm/tox
sections for gene therapy products, vaccines,
monoclonal antibodies and other biologics.
- Participate
in the development of counter-bioterrorism vaccines
utilizing the Animal Rule.
- Obtain
cost estimates and interface with various toxicology
CROs in the planning and completion of pivotal
GLP toxicology studies.
|
|
Nov.
1997
to Aug. 1999 |
|
Director,
US Regulatory Affairs, Purdue
Pharma, LP, Norwalk, CT.
-
Directed all regulatory activities and provided regulatory
guidance associated with the development of NCEs (biological
products and drugs) and support of marketed products.
- Directed
the preparation and filing of all FDA submissions,
including IND, NDA, amendments, protocols, etc. related
to development of NCEs and support of approved products.
- Acted
as liaison with the FDA for all meetings, teleconferences,
and other FDA communications.
- Directed
company efforts to globalize development of NCEs.
- Provided
expert consultation on pharm/tox issues related to
biological products and drugs.
- Provided
expert consultation regarding manufacturing issues
related to biological products.
|
|
Apr.
1994
to Nov. 1997 |
|
Senior
Regulatory Pharmacologist, FDA/CDER/ODE1, Division
of Neuropharmacological Drug Products
- Senior
pharmacology/toxicology reviewer of INDs/NDAs; also
expertise in immunotoxicology.
- CDER
committees:
1)
Chairman, Information Technology Committee; co-author
guidance for format and content of electronic
submission of pharmacology/toxicology information
contained in INDs/ NDAs.
2)
Immunotoxicology Committee; co-authored guidance
document for the review of drug products with
respect to immunotoxicology issues
|
|
Apr.
1993
to Apr. 1994 |
|
Senior
Regulatory Pharmacologist, FDA/CBER/OTRR, DARP,
Hybridoma and Hematological Products Branch
- Scientific
reviewer of INDs/PLAs for biologicals in the areas
of product-related issues and pharmacology/toxicology;
expert in the pharmacology of monoclonal antibody
therapies.
- Co-authored
"Points to Consider for Use of Monoclonal Antibodies
as Therapeuticals" guidance document.
- Speaker
at professional meetings: regulation of monoclonal
antibodies as therapeutics
|
|
Oct.
1988
to Apr. 1993 |
|
Senior
Scientist, Immunopharmacology, FDA/CBER/Division
of Hematology, Laboratory of Cell Biology
- Regulatory:
scientific review (product-related issues and pharmacology/toxicology)
of IND/PLAs for new biological therapies, with emphasis
on monoclonal antibody therapies.
- Scientific:
principle investigator; original basic research in
the areas of immunopharmacology (mechanisms of monocyte
function, interleukin1 release and potential pharmacological
intervention) and neuroimmunology (effects of opioids
and opioid peptides on immune function).
|
|
Aug.
1980
to Oct. 1988 |
|
Research
Scientist, Pharmacology, FDA/CFSAN, Division of
Toxicology
Principle
investigator:
1)
GLP studies examining toxic effects of food additives
and contaminants on immune system.
2)
Studies to examine effects of various stressors (animal
housing, light-dark cycle, water deprivation, foot-shock)
and opioid peptide release on immune function.
|
|
Aug.
1978
to Aug. 1980 |
|
Researcher,
Microbiology, FDA/Bureau of Foods, Division of Microbiology
- Developed
Defect Action Level guidelines for regulation of microbial
and insect contamination of various food products.
- Implemented
studies identifying microbial and insect-related food
contaminants and evaluating the health significance
of these contaminants.
|
|
Sept.
1977
to Aug. 1978 |
|
Consumer
Safety Officer, FDA/Baltimore District, Washington
Resident Post
- Responsible
for inspection of facilities regulated by the Food
and Drug Administration for compliance with the Federal
Food, Drug and Cosmetic Act, including pharmaceutical
companies (GLP & GMP), blood banks, and food manufacturing
facilities.
|
| HONORS
AND AWARDS |
| Apr.
1995 |
Achievement
Medal-CBER |
| Jan.
1993 |
PHS
Unit Commendation-CBER |
| May
1991 |
PHS
Citation Award-CBER |
| |
Commissioned
Officer, U.S. Public Health Service |
| PROFESSIONAL
SOCIETIES |
- Regulatory
Affairs Professional Society (RAPS)
- Drug
Information Association (DIA)
- American
College of Toxicology (ACT)
|
|
FDA Regulatory Committees: |
- Product
Licensing Application (PLA) Committees within
CBER to review and formulate recommendations for regulation
of new biological products
- New
Drug Application (NDA) Committees within CDER
to review and formulate recommendations for regulation
of neuropharmacological drugs.
|
FDA "Other Regulatory Activities":
|
- Formulation
of Agency Policy:
1)
co-author of the guidance document entitled "Points-to-Consider
for Use of Monoclonal Antibodies as Therapeutics".
2)
develop policy for utilization of monoclonal antibodies
to prepare purified blood factors.
|
- Author
of Intercenter Agreement: authored guidance document
for CBER and CDRH for regulation of antibody test
kits to evaluate immunogenicity of biologicals.
|
- Invited
speaker: International Business Communications (IBC)
Symposium on "Commercializing Human Monoclonal
|
FDA Special Committees: |
- Chairman,
CDER Information Technology Committee: develop policy
regarding format and content of electronic IND/NDA
submissions.
|
- CDER
Immunotoxicology Committee: co-authored internal guidance
document for review of IND/NDAs with respect to immunotoxicology
issues; Center advisory committee on immunotoxicology
issues.
|
- Chairman,
CDER PTCC (Pharmacology-Toxicology Coordinating Committee)-GRP
(Good Review Practice) Committee: co-authored Pharmacology
and Safety Pharmacology sections of Good Review Practice
document.
|
- "First
Initiative" Committee: develop internal Agency
searchable database of electronic toxicology reviews
from all the Centers within the FDA.
|
- CBER
Sepsis Committee: formulate guidance for regulation
of biological products for treating sepsis.
|
Recent Scientific/Regulatory Meetings:
|
| March
2007 |
|
Society
of Toxicology, ToxExpo ‘07, Charlotte, NC |
|
|
|
| November
2006 |
|
American
College of Toxicology Annual Meeting, Indian Wells, CA |
|
|
|
| April
2006 |
|
BIO
2006, Chicago, IL |
|
|
|
| November
2005 |
|
American
College of Toxicology Annual Meeting, Williamsburg, VA |
|
|
|
| June,
2005 |
|
Annual
DIA Meeting, Washington, D.C. |
|
|
|
| February
2005 |
|
DIA/FDA
Meeting, "Follow-On Proteins", Crystal City,
VA. |
|
|
|
| October
2004 |
|
Annual
RAPS Meeting, Washington, D.C. |
|
|
|
| July,
2003 |
|
Annual
DIA Meeting, San Antonio, TX. |
|
|
|
| June
2003 |
|
ASGT
Meeting, "Clinical Gene Transfer Review Course"
and "6th Annual ASGT (Gene Therapy) Meeting",
Washington, D.C. |
|
|
|
| December
2002 |
|
SOT
Meeting, "Workshop on Nonclinical Safety Evaluation
of Preventive Vaccines", Crystal City, VA. |
|
|
|
| December
1-3, 2002 |
|
"SOT
Workshop on Nonclinical Safety Evaluation of Preventive
Vaccines", Marriott Crystal City, Crystal City, VA |
|
|
|
| October
2002 |
|
DIA
Worldwide Clinical Meeting, "Worldwide Preclinical
Development of Biotechnology-Derived Products", Bethesda,
M.D. |
|
|
|
| October
20-22, 2002 |
|
"DIA
Meeting: Worldwide Preclinical Development of Biotechnology-derived
Products", Bethesda Hyatt Regency, Bethesda, MD |
|
|
|
| September
10-11, 2001 |
|
"PDA/FDA
Joint Regulatory Conference: Emerging Global Regulatory
Issues", Hyatt Regency Washington on Capitol Hill,
Washington, DC |
|
|
|
| March
6-7, 2001 |
|
"Safety
Considerations in the Use of AAV Vectors in Gene Transfer
in Clinical Trials", Doubletree Hotel, Rockville,
MD |
ARTICLES
AND PRESENTATIONS
-
Presentation on "Unique Aspects of the Safety Evaluation
of Biologic Cancer Agents", Berlin, Germany, 2005.
-
Presentation on "Preclinical Pharmacology/Toxicology
Development of Biologics and Drugs" for the Tri-State
SBIR Forum Meeting, Roanoke, VA, 2005.
- FDA
Regulatory Affairs, A Guide for Prescription Drugs, Medical
Devices and Biologics. Chapter 6. Biologics, James G. Kenimer
and John J. Jessop. Eds. D. Pisano and D. Mantus, CRC Press,
Boca Raton, FLA, 2004.
- Jessop,
J. The IND (Investigational New Drug) Application: Is Our
Product Safe to Administer in the Clinic? GOR Vol. 5:2,
41-43, 2003.
Paged
Updated:
July 25, 2007
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