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DAVID
LAWRENCE STARK |
David Stark, Q.M.E., CCRA, is currently the President and
CEO of Stark-SMO, a Site Management Organization whose services focuses primary
of research of Stem Cells, cord and tissue repositories. Due to his extensive and broad experiences in
the inner workings of the research and regulatory aspects of clinical trials
and FDA approval for Biologics, Dr. Stark brings a unique vision to the
industry, and is a clear, motivated designer of superior approaches to research
challenges. Formerly the Director of the National Institute of Clinical
Research (NICR), he has been fully responsible for the design, organization and
implementation of clinical trials for FDA approval for numerous biological and
stem cell research. He has a broad
background in designing, conducting, and monitoring clinical trials of new
pharmaceuticals and Biologics’. Through
his diverse and devoted networking within the industry, working with such
companies as Genentech, Suni Medical imaging Inc. and UCSF medical school,
Stark-SMO has assembled a wide network of more than 5233 physicians in
hospitals and private practice throughout the
EXPERENCES
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Over fourteen years of deliverable, accountable
experience managing all aspects of the senior clinical biologic management operations
working for such companies as Genentech, and
major institutions such as Catholic Health Care West, Saint Vincent’s Medical
Center, University of Southern California Medical School, and MD Anderson. Director in the regulatory
processes, quality assurance, and control aspects of a diverse array of
clinical (Phase I, II, III and IV) and device research trials in private
division, corporate biotech R&D, large institution, and hospital settings. I
possess a unique ability to apply these hands-on skills to pharmaceutical,
biotech and device companies; from concept to FDA approval.
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In-depth product labeling experience, including
developing end points/concepts, protocol, consent, form, and CRF
development/design with methodologists; from leading and attending FDA start-up
meetings to monitoring audits, IND, NDA,
510(k) applications and filings, (Class II and Class III); SOP
development at all levels; CRO, SMO, and TMO budget negotiations and contracts;
site selection and management; recruitment, training and SAE/AE guidance and
supervision for trial coordinators, monitors, and physicians in conformance
with Good Clinical Practices to assure high quality enrollment, clean data
collection, and solid outcomes.
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Thoroughly familiar with Federal agency compliance
procedures (FDA, NIH, CDER, CBER) and 21 CFR regulations for new labeling of drug
and device approval processes, Forms 482 and 483, and FDA audits, including the
design, development, and control of SOPs, GLPs, and GCPs for all phases of drug
and biologics research, manufacturing, API manufacturing, and quality assurance
and continuous quality improvement applications.
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Established
long-term relationships with the FDA and major pharmaceutical companies such as
Merck, Guidant, Medtronic’s, Johnson & Johnson, Eli Lilly, Genentech,
Chiron,
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Ability
to communicate, teach and be part of a team: renowned as a certified teacher of
research, teaching now over 1300 students, at a private college in a self-created,
all-embracing course the covers everything
from Nuremburg to Belmont; from ICH regulations to SAE/ AE reporting; and
encompassing drug master files and a lot more. This popular course allows me to
develop the ability to communicate and teach complex laws and regulations to a
diverse audience – from the most seasoned academic to the Level I CRA and everyone
else in-between.
Clive Biotech Corporation (August
2007- Present)
Vice President of
Regulatory Affairs and Clinical Trials- Responsible for 6 direct reports, in
both clinical and regulatory affairs, for Stem Cells application for veterinary
use. Responsible for developing and
supporting clinical and regulatory team training; accountability defined by
goals set by President of the company.
Director of Clinical
affairs and FDA regulatory director for cord
blood repository for Stem Cell research, CNS is a major research center am
responsible for the total QA/QC system, FDA, HHS and GMP systems. I am the
direct report for all accountability and standards for national and
international shipment of research Biologics
Solbec Pharmaceuticals Limited, (July
2007 – August 2007)
Regulatory
Reed Hopkins Inc. ( May2006- present)
CEO,
Suni, Inc. (July 2006- March
2007)
Consultant
to evaluate past problematic 510(k) applications and develop new filing and
documentation control systems for flagship product. Responsible for oversight, document
production, and coordination of Third Party Review and FDA 510(k) submission
process.
I am currently on-call for further consulting as new developments
warrant.
Raster Builders, Inc. (September 2006- 2008)
Exclusive
consultant to setup a compliant Quality System for tissue registry medical
software development, and to evaluate an existing software device and file a
510(k). Responsible for extensive
business intelligence, document production, and coordination of Third Party
Review and FDA 510(k) submission processes.
I am currently involved in developing and maintaining a real-time
Quality System.
Colonair, Inc. (March 2005- July
2007)
Exclusive
consultant to develop a protocol and all regulatory systems for a new
proprietary medical device. (Startup
Company) Responsible for an incredible
volume of free advice, extensive business intelligence, document production,
and advisement re Third Party Review and FDA 510(k) submission process. The
owner of this company was thoroughly educated and prepared at his request to
continue developing his device without further assistance.
Gopalganj & Patuakhali, Bangledesh, Womans Free
Clinic (January 2006- August 2007)
Director
of regulatory affairs, Project Management, Working with Dr. Iftkher Mahmood, at
a free clinic with private funds and grants,
I currently work as the director of research and development, site development
and implementation. Develop research contract agendas, projects set up, SOP
development, implement ICH and form relations and PR campaigns for government
official.
Genentech,
Senior
project manager (CONSULTANT) specialty Biotherapeutic (Oncology), management of
a ($15 million plus) out sourcing project, consisting of four major trials. Reviewed and managed CRO proposals and
selected CRO, assessment of development of protocol, developed timelines,
investigator selection and management of overall trial progress. The Lytics
program was put on hold on February 10, 2006, due to competition.
Dr. Chuck Wiseman,
Vice
President of Research, Oncology vaccine project with Merck, and Novartis joint
cancer vaccine development. I was the direct manager for
building group infrastructure and strategic processes for multiple trials in
oncology. I remain the direct report for the implementation, selection,
aligned, managed CROs and other vendors, development of timelines, and was the
directly responsible for all aspects of projects management’s levels and the
clinical study. I also remain the straight report from CRO, FDA and CBER.
Accredited Professor, State of
California, teaching a self-created, five-day (8 hours a day)
extensive course in regulatory processes
and laws of clinical research, GCPs, and
related ethical principles, including the Belmont Report, ICH laws (sections
E6, E2A, and E8), IRB laws and regulations, and protocol and consent
development. In addition, my course includes extensive training based on 21 CFR
11, 50, 54, 56, 803, 812, 814, 820, and CFR title 45, 46 and 164
regulations. I also coach auditing and
monitoring skills, site selection, CRO and SMO negotiation, and the delicate
“real-life” operations regarding research and site management.
STARK SMO,
Founder & CEO of this Regulatory Site
Management Organization specializing in the design, implementation, and
management of clinical research projects for the development and testing of new
pharmaceuticals and medical devices.
Client projects include teaching regulatory laws and principals’,
clinical research monitoring, GCP application, and coordination of client
procedures. Other services range from
auditing and monitoring for national or international trials, to being a guest
speaker at DIA, ACRP, FDA, DOD and other national conventions, to development
and filing of 510k applications.
Past projects have included:
§ Chinese
Government, Beijing, Zhejiang, and Shenzhen Provinces - GCP-ICH and USA
Regulatory Consultant: – I provided expertise for three months in various
Provinces teaching GCPs, supervising and auditing Phase I facilities, running
research and SOP development for academic clinical research, and interpreting
CFR laws and regulations for local device and pharmaceutical business
ventures. Mentorship included how to get
Drugs and Devices through the FDA obstacles at major Chinese teaching hospitals,
academic centers, and institutions. I
was selected out of 400 applicants for this position, which was a true honor in
my career. I completed my teaching in
June of 2004.
§ CoVAC- Coalition for Vaccine against Cancer,
§ BetterChem
LLC - Consultant for API, GMP and FDA Regulatory Processes for GMP: In charge of Quality Assurance for
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Saint
Vincent’s Immunotherapy Oncology Group, Los Angeles, CA,) - Regulatory
Consultant for FDA Audit, GCP and Site Auditing: In charge of gene cell line and responsible
for the NDA management, monitoring, and auditing for the testing and marketing
of three new soft tissue myeloma vaccines.
Developed SOPs for the group’s research office, cath lab, and Data
Safety Monitoring Board (DSMB).
Supervised monitoring of numerous clinical cohort trials (six small cell). Successfully stewarded all necessary
regulatory details and application paperwork through the FDA’s Center for
Biological Environmental Research, and its Center for Drug Environmental
Research. Procured approval for four
INDs, five NDAs, and three FWAs.
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Dr. F. Bahri,
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Independent Review Consulting (a Central
Institutional Review Board, or IRB),
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California Neural Science Institute, Oxnard, CA
(Dr. Oleg Kopyov, MD, Ph.D)- Regulatory and IRB Consultant and Research
Monitor: Stem
cell research, SOP, GLP GCP development and implementation, SAE review and
follow up. Developed standard operating
procedures compliant with CFR 21 regulations for investigators and
coordinators. Trained and supervised
multiple teams of coordinators and investigators in conformance with GCP, GLP,
and GDP laws and regulations. Organized
IND Class III device research for Medtronic’s for DBS and Parkinson’s, along
with Phase I and II research on neuron-progenitor cells (Stem Cells). My responsibilities were to review all
protocols, all regulatory FDA and IRB submissions, as well as FDA, NDA, and
investigative drug applications. In
addition, I developed GLP-compliant SOPs for the stem cell lab and their
internal QA-QC department. I am currently still the Auditor for this site, for
quarterly review, for the IRB
BioCerax,
Site Manager and Director of Research
Development: Lead by (Dr. Jill Adler More,
Directed all toxicology and preclinical work research
efforts for this emerging biotech company ( Molecular Biology). Managed a team of twelve scientists
conducting research of liposome research and applications in the treatment cardiovascular
disease. Oversaw site selection,
investigator appointment and training; including toxicology models. Collected all scientific data for
National Institute of
Clinical Research, St. Vincent’s Hospital,
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Managed
a team of 20 investigators in a 3,000 patient international device trial for
cardiac and organ transplant.
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Developed
unique internal query resolution process for design and investigative protocols
trials.
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Demonstrated
a broad range of capabilities among pharmaceutical companies resulting in many
diverse trial contracts.
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Created a physician
research network, which included a revenue-sharing model.
State of
Qualified Medical Examiner: Reviewed
cases for
Chief Doctor and CEO:
Co-founded and directed this high-volume, multi-specialty private
practice, which featured osteopathy and chiropractic treatment in addition to
traditional medicine. Performed all the
typical duties of a licensed chiropractor and Qualified Medical Examiner. Personally specialized in worker’s
compensation injuries and thoracic cervical conditions and traumas. Maintained and managed a practice serving
more than 1000 patients annually.
PH.D. studies in clinical research administration,
(application at
Q.M.E. and D.M.E., (Qualified Medical Examiner,
Disability Medical Evaluator) California State-appointed
Postdoctoral: Internship in Forensic Medicine, State of
M.S.,
B.S., Biology, Palmer
Certification
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Certified Instructor,
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Certified Management
Consultant, IMC
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Certificate
in training, Project Management for Drug Development, IVT Institution of
Validation Technology
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Licensed Chiropractor and
Qualified Medical Examiner, license #CA DC14507
Member of the
Food and Drug Institute 2003
Member of
Association of Clinical Research professional, 2002
Certified Merck
Research Management, 1999
Certified
Clinical Research Coordinator (CCRC), 1998 (expired)
Industrial Disability Evaluator, 1990
American Board of Thoracic
Trauma Certification, 1987
American Back
Society Fellow, 1985
State of