William Henry Smith III, PhD

475 Dolores Street Apt. #8

San Francisco, CA 94110

415-701-7715 (h)

415-309-9138 (c)

Drwiliwil@gmail.com

SUMMARY Twenty years pharmaceutical and biotechnology industry

experience in Regulatory Affairs, Medical Affairs, and Worldwide Product
Safety. Ph.D. in Educational Psychology, specializing in evaluation of research
programs, projects, and policies using experimental design methods and applied
statistics. Highly motivated, proven medical writing skills with strong
organizational, decision-making, and strategic thinking abilities including
development team leadership.

PROFESSIONAL INSITE VISION INC. Alameda, CA (2005-2007)

EXPERIENCE

Senior R.A. Manager, Regulatory Liaison, Regulatory Affairs / Quality

Assurance

Key Accomplishments:

1. Successfully lead both Project Team and NDA team. Resolved development issues and created
first NDA for an ophthalmologics drug company with no prior NDA experience, and no
approved products on market. Stimulated teamwork, organization, accountability and
productivity. Conducted an NDA training camp, which I offered with syllabi, twice per week,
each week during the NDA authoring, revising, and publishing stages. Met NDA target
submission date enabling a commercialization partnership formation. The NDA AZASITE
(azithromycin ophthalmic solution) for the treatment of bacterial conjunctivitis was approved
on its PDUFA action date. Established and facilitated a clinical strategy subteam for the NDA
 (in absence of a senior clinical leader). Identified and helped resolve issues regarding ISS/ISE,
study reports, clinical overviews and summary sections of NDA.
2. Authored and submitted a successful application for a PDUFA fee waiver providing the
company just under $900,000.00. This refund application incorporated clinical and preclinical
research data from the NDA with financial information summarized from SEC 10(k) filings.
3. Managed a staff of 2 RA associates, 1 RA document coordinator, and 1 RA administrative
assistant, handling routine IND submissions and regulatory correspondence. Also managed
several temporary and contract employees brought in to ensure the timely completion of the
NDA submission. Assisted in preparation of marketing claims binder, and provided both
marketing and regulatory input toward the draft prescribing information. Developed metrics to
evaluate stages of NDA preparation to benchmark for future submissions. Moved company
from manual hard copy file archival system to a PDF-based electronic file storage and retrieval
system. Sat on CEOs senior management team. Gave departmental updates (projects, future
staff hiring requirements, budget planning, due diligence preparation, corporate strategy),and
gave quarterly presentations to the board of directors.

GENENTECH, INC. South San Francisco, CA (2001-2005)

Regulatory Affairs Manager, Regulatory Affairs / Clinical Development

Managed extensive labeling negotiations with FDA on supplement to optimize

patient selection for HERCEPTIN therapy using an in-vitro diagnostic test.
Provided strategic regulatory guidance to key development assessments
(identified risks, estimated probabilities, and developed risk management
strategy) resulting in development candidates, and expansion of corporate
portfolio in Autoimmune diseases. Represented Regulatory Affairs on
international joint project team with counterparts from Roche Labs for
HERCEPTIN (targeted monoclonal antibody therapy for breast cancer), and
with Biogen Idec for RITUXAN (targeted B-cell monoclonal antibody therapy
investigated for autoimmune disorders). Contributed regulatory input on product
development teams and on core teams to determine go/no status of established
and early development candidates (respectively).

Performed lead FDA liaison function for all assigned development and
commercial compounds. Communicated with Oncologic Products staff at CDER
and CBER, including preparation for an FDA advisory committee (ODAC). Also
communicated regularly with FDA staff in Division of Therapeutic Biological
Internal Medicine Products regarding immunology and cardiovascular programs.
Managed regulatory associates in the filing, maintenance and supplementation of
Biologics License Applications (BLA/sBLA), Investigational New Drug
Applications (IND) and routine submissions. Assisted in the creation of the
Regulatory Research (RR) function within RA, and performed RR assessments
of key development issues. Led regulatory subteam within assigned projects to
facilitate coordination between clinical/pre-clinical, CMC, and commercial
 regulatory functions. Contributed to the development of departmental
immunology training.

BRAINBENCH.COM Chantilly, VA (2000)

Test Validation Consultant

Through employment by a virtual company ("dot.com"), validated test items for

a battery of instruments designed to evaluate the competency and familiarity of
individuals in the regulation of the manufacture of pharmaceutical products (i.e.,
cGMP). Suggested revisions to test developers as appropriate to propose items
that were most relevant to regulatory affairs professionals. Performed and
completed work assignments on-line through an Internet web site as a consultant.

ASTRA MERCK INC, (ASTRA) Wayne, PA (1994-1999)

Regulatory Project Manager, Drug Development / Regulatory Affairs

Communicated with FDA by phone, in writing, and in meetings to provide

information, and respond to requests and/or questions. Interacted with GI,
Pulmonary, and OTC Divisions of CDER. Provided expertise regarding FDA
regulations and guidelines to product development teams. Coordinated the
dissemination of information regarding regulatory issues throughout the
organization, and facilitated the problem resolution process. Managed the timely
preparation (review, edit, finalize, assemble) of NDAs, sNDAs, INDs, etc. using
project management skills and tools in a team environment. Employed focused
regulatory research, and facilitated the creation and maintenance of product
labeling. Provided strategic regulatory input that resulted in significant labeling
amendments and expanded market opportunities for PRILOSEC, including the
Rx-to-0TC switch. Led a PRILOSEC product development team.

CONSULTANT, Philadelphia, PA (1993-1994)

 Technical Writing Consultant, Medical Affairs (Wyeth-Ayerst
Laboratories)

Drafted, routed for review/comments, and incorporated FDA mandates for

revisions to product labeling. Proactively suggested labeling revisions as
necessary. Performed literature searches, utilized internal data, and interfaced
with appropriate personnel. Reviewed and analyzed data from clinical studies in
the development of general medical reports and protocol synopses. Reviewed
summary bases of approval, and wrote product-related briefs and technical
bulletins.

Evaluation Outcomes Measurement Consultant (J. Christman Planning For

Action)

Reviewed project proposals for multi-million dollar science research program.

Suggested amendments, and followed implementation by performing on-site
visits to multiple locations. Observed participants and interviewed key
individuals. Maintained field journal to generate final evaluation report. Included
assessment of effectiveness and recommendation for improvement of program.

SMITHKLINE BEECHAM PHARMACEUTICALS, Philadelphia, Pa (1986-

1993)

Senior Scientist, Transnational Regulatory Affairs / Worldwide Labeling

(1990-1993)

Reviewed and approved worldwide product package inserts with attention to

scientific accuracy and logic. Researched medical literature and wrote papers in
development of amendments to international prescribing information. Negotiated
all revisions as member of labeling project team and managed timely submission
of data sheets for market launches.

Monitored compliance of countries to corporate product safety labeling

standards. Evaluated draft clinical research protocols, and provided in-depth
summary reports focusing on scientific and statistical content. Served on
executive-level committee as under-secretary with responsibility for providing
technical background information to members, and producing official minutes.
Proposed new agenda topics, and tracked completion of action items for all
members.
Medical Writer, U.S. Regulatory Affairs / Product Professional Services
(1988-1990)

Partnered with sales managers to assist in field information dissemination.

Executed literature searches for drug information, including competitor studies.
Wrote and edited medical letters in support of Clinical and Marketing efforts,
and in response to unsolicited queries from physicians and pharmacists. First-
line contact with health-care personnel in the generation of adverse event reports
to FDA.

Clinical Data Analyst, U.S. Medical Affairs / Clinical Data Systems (1986-
1987)

Reviewed completed case report forms (CRF) for compliance with the clinical
protocol. Validated and maintained database for reporting critical elements in
clinical studies from

CRF. Generated reports in response to FDA queries, developed AE coding

dictionary.

TEMPLE UNIVERSITY SCHOOL OF MEDICINE, Philadelphia, PA (1985-

1986)

Microbiology Research Associate, Microbiology and Immunology

Cultured and identified anaerobes, performed antibiotic susceptibility testing

using tube dilution and agar diffusion methods, generated laboratory reports.
 EDUCATION University of Southern California, Pasadena, CA

Certificate, Executive Management Program in Pharmacoeconomics, 1995

University of Pennsylvania, Philadelphia, PA

Ph.D., Educational Psychology, 1994

Specialization in Policy Research, Evaluation, and Measurement

University of Pennsylvania, Philadelphia, PA

M.S.Ed., Organizational Leadership, 1991

Temple University School of Medicine, Philadelphia, PA

Matriculated in M.D. curriculum 1985-86 and 1986-87. Awarded Eli Lilly Scholarship.

Franklin and Marshall College, Lancaster, PA

B.A., Biology, 1984 Minor concentration in foreign languages. Awarded

American Association of University Professors Scholarship, and Deans List

PRESENTATIONS Manuscript entitled The Cultural Perspective of Health Care

Delivery and Worldwide Biomedical Education Presented at the 1991
PUBLICATIONS Annual Conference of American Medical Writers Association
(AMWA) in Toronto, Canada; Published in AMWA Journal 7(2):8-
AFFILIATIONS
11, 1992.

Paper entitled Scientific Literacy and Public Responsibility: Concerns

for Science Education in a Modern SocietyPresented at the 1992
AMWA conference in Houston, Texas.
Memberships: American Medical Writers Association, Regulatory
Affairs Professionals Society, Drug Information Association,
American Evaluation Association, and American Psychological
Association.