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ARON FARREL STEIN, Ph.D.
858-523-9215 (Office) 858-523-0280 (Fax)
SUMMARY:
Over 20 years of pharmaceutical experience with demonstrated ability to lead, build, mentor, develop, and manage in both small and large organizations. Broad areas of management responsibilities include Toxicology, Regulatory and Medical Affairs, and Quality Assurance. Strategic FDA initiatives involved partnering with the Agency to develop CDER Guidance and reintroduction of marketed products. Project specific regulatory strategies have led to rapid registration for multiple drug products including DOXIL for ovarian cancer, VIAGRA, TIKOSYN, and multiple supplements for DIFLUCAN, ZITHROMAX, and NORVASC. Served as Study Director conducting toxicology GLP studies in support of new therapeutics entering clinical trials. Utilized scientific training and expertise on early staged compounds to assume a broader role in drug development. Directed and/or supervised the management of FDA interactions for preclinical, CMC, and clinical activities in Phase 1 through 3 development programs. These responsibilities applied to as many as 40 INDs at a given time and across a variety of review divisions including Oncology, Neuropharmacology, Cardio-Renal, Dermatology, Anti-Infective, Anti-Viral, Gastrointestinal, Metabolic and Endocrine, Anesthesia and Rheumatology, and Cellular, Tissue, and Gene Therapy. Chemical classes of compounds include small molecules, natural products, oligonucleotides, and recombinant proteins. Experience outside of the US includes conduct of clinical trials under the EU Clinical Trial Directive and leading key meetings held with Health Authorities to obtain agreements for two marketing applications. PROFESSIONAL EXPERIENCE:

STEIN CONSULTING, LLC
Founder and President (April 2005 to present)
Provide biotechnology companies with seasoned experienced guidance and
expert assistance in regulatory and new product development. Participate as a
member of the management and project teams to establish regulatory strategies
and overall development plans. Provide direction on the design, implementation,
and interpretation of preclinical toxicology programs as well as the preparation of
associated study reports and IND integrated summaries. Serve as project leader,
as respected liaison with FDA to ensure effective interactions with health
authorities as a means to optimize drug development activities.
ISIS PHARMACEUTICALS, INC, Regulatory Affairs and Quality Assurance,
Carlsbad, California
Vice President and Corporate Officer (September 2002 to April 2005)
Responsible for the development and implementation of global regulatory
strategies for all development programs including: Oncology, Metabolism, and
Inflammation. Functional groups reporting to this position include; Regulatory
Liaison, Operations, Quality Assurance (GMP), Pre-clinical (GLP) and Clinical
Compliance (GCP). In addition, this position serves as a member of the
Executive and Development Management Committees which are responsible for
driving the corporate and development direction of the company.
This position ensures regulatory manufacturing compliance inclusive of pre-
approval and ongoing inspections by regulatory authorities and corporate
partners. Accomplishments in these areas include successful commissioning of
new manufacturing suite, FDA district inspections, and hosting FDA review
chemist visits under CDER’s summer education initiative.
Isis Pharmaceuticals, and its partners, have Phase 1 through 3 development
programs in the US, Canada, and the EU. Primary goals include the
development of internal resources that provide regulatory and quality
representation on project teams, establishment of preferred provider in the EU to
meet recent requirements set forth in the Clinical Trial Directive for regulatory
applications and pharmacovigilance, as well as senior regulatory influence on
R&D direction and initiatives.
ABBOTT LABORATORIES, Hospital Products Division, Medical and Regulatory
Affairs, Abbott Park, Illinois
Divisional Vice President (September 1999 to September 2002)
Responsible for the development of strategy and organizational structure to
ensure registration, safety, and appropriate use of division-wide products
worldwide. Specific responsibilities include:
Drug and Device Safety, and Postmarketing Clinical Research Regulatory Affairs and Clinical Compliance Device Medical Development and Postmarketing Research Act as advisor/liaison to Division President and/or senior management in order to plan, evaluate, and recommend overall medical, regulatory, and compliance strategy. The Hospital Products Division business focused on high acuity therapeutic areas for both pharmaceutical and device products. Key product areas were cardiovascular, renal, and pain management. Due to the success of the division, this department grew from 45 to 120 professionals. Primary goals were to build organizational infrastructure, drive key marketed product enhancements, and to closely collaborate with the Center of Biologics at FDA to negotiate the successful return of ABBOKINASE to the medical community. SEQUUS PHARMACEUTICALS, INC., Regulatory Affairs, Menlo Park, California
Vice President and Corporate Officer (April 1997 to September 1999)
Responsible for providing worldwide regulatory strategy for developmental and
marketed drugs, regulatory submissions, and all interactions with Health
Authorities. Functional groups reporting to this position include Strategy,
Operations, Quality Assurance (GMP), Clinical Compliance (GCP), Medical
Safety, and Labeling.
Specific project oversight for DOXIL’s solid tumor registration program which
involved setting regulatory precedence on accelerated approval regulations in
the U.S. and requirements in Europe. Additional registration activities include
AMPHOTEC and liposomal-cisplatin.
Registration strategy, compliance audit, and preparation of marketing
applications in U.S. and ex-U.S. were successfully completed for DOXIL and
AMPHOTEC. Responsible for review of promotional materials, training of sales
force, and interactions with DDMAC for these two marketed products.
Serve as a member of the Executive Management Committee. This committee
formulates and implements Sequus vision, mission, and strategic planning to
advance the business needs of the corporation.

PFIZER, INC CentraL Research, Drug Regulatory Affairs-Liaison, Groton
Connecticut 1991-1997

Director (December 1995 to April 1997)
Responsible for the daily operations, management, and administration of a group
of ten, including five Ph.D. level Associate Directors. Responsible for providing
worldwide regulatory strategy for developmental drug candidate programs,
regulatory submissions, and all Central Research interactions with the FDA and
HPB. Therapeutic responsibilities are focused on cardiovascular,
metabolic/endocrine, reproductive, and oncology. Oversight on registration
programs and applications for VIAGRA, TIKOSYN, and NORVASC.
Senior Associate Director/Group Leader (January 1994 to December 1995)
Responsible for the daily operations, management, and administration of
approximately thirty total staff, including nine Ph.D. level Associate Directors.
Responsible for providing worldwide regulatory strategy for developmental drug
candidate programs, regulatory submissions, and all Divisional interactions with
the FDA and HPB across all therapeutic areas.
•Regulatory management for approximately 40 active IND programs including eight
global Phase III development programs.
•Directed submission/approval of nine NDAs/sNDAs for significant supplemental programs for DIFLUCAN and ZITHROMAX. •Member of Pfizer Senior Management Committee for oversight of all US Phase
I and II drug candidate programs. Subcommittee member on internal initiatives
to expedite early drug development programs.
•Authored PhRMA-RAC “Mock IND” which formed the basis of FDA’s Guidance
for Industry on IND content and format.
Senior Associate Director (August 1993 to January 1994)
Responsible for providing worldwide regulatory strategy and oversight for Pfizer's
late stage drug development portfolio. This included the management of Ph.D.
level Associate Directors and the document submission group.
Associate Director II (January 1993 to August 1993)
Associate Director I (August 1991 to January 1993)
Responsible for coordination of internal activities related to the filing of the IND,
NDA, and NDS. Act as liaison with FDA and HPB. Compile responses to
regulatory questions, monitor progress IND programs and NDA review, maintain
logs of interactions, review IND and NDA submissions, attend regular candidate
management meetings and FDA Advisory Committee meetings.
DU PONT MERCK PHARMACEUTICALS, Wilmington, Delaware 1986-1991
Manager, Drug Regulatory Affairs (May 1989 to August 1991)
Responsible for the development of worldwide regulatory strategies,
management of regulatory submissions, knowledge of clinical evaluation of
investigational drugs and expertise in US drug regulations and guidelines for
INDs/NDAs. This position requires a comprehensive understanding of
pharmaceutical sciences through the review of current literature, attendance at
FDA Advisory Committee meetings, and interaction with consultants to address
regulatory issues as well as act as liaison with the FDA.
Specific project support was provided on ETHMOZINE NDA approval,
CARDENE IV advisory committee meeting, and joint development team with
Merck on COZAAR through the End of Phase II meeting.
Research Toxicologist, Drug Safety Department (January 1986 to May 1989)
Primary responsibility of this position was to serve as Study Director for acute
and subchronic toxicity studies performed according to the FDA's Good
Laboratory Practices. This included the evaluation and interpretation of all
toxicology findings and for the preparation of final reports. Preparation of
toxicology sections that were submitted to the FDA in support of safety claims.
Significant interaction with contract laboratories for primate, chronic and
reproductive studies. Represented the Toxicology department in the
development of CNS active compounds at working group and management
meetings.

EDUCATION/TRAINING:

1980 - B.S., Biomedical Science
Texas A&M University; College Station, Texas
1983 - Ph.D., Toxicology
Texas A&M University; College Station, Texas
1986 - NIH Fellow, Toxicology
University of Kansas Medical Center; Kansas City, Kansas

SOCIETY MEMBERSHIP:

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