TIMOTHY A. ANDERSON, MS, MBA

*** ******* **** ****

203-***-****

Redding, CT 06896-1409

acgpft@r.postjobfree.com

http://www.AquaMarineGroup.com

PROFILE

A uniquely interdisciplined individual, melding comprehensive

pharmaceutical industrial R&D, business development, QA/QC, and consultancy

experiences with formal FDA-tenured regulatory credentials.

A recognized professional with demonstrable successes in the guidance and

preparation for final review of regulatory filings, and the rendering of

strategic advisories, bearing upon domestic and international regulatory

and business affairs.

A candidate with accomplished graduate and continuing academic credentials

in both science and business.

EXPERIENCE

1996-Present THE AQUAMARINE GROUP, INC.

Redding, CT

Principal Consultant

As a retained consultant, clients are furnished services in the areas of

global regulatory filing review, writing, Agency negotiation, strategic

advisories, contracted management services, and executive search.

Filing services include review/writing of Chemistry and Manufacturing

Controls (CMC) sections for NDA, ANDA, IND (biologicals and new chemical

entities), 505(b)(2), DMF, 510(k), Type I & II, MAAs/CTX and International

filings. Other services include cGMP (QC/QA), due-diligence, mock pre-

approval inspections, R&D portfolio, and Business Analysis.

Consultative projects have included the following:

. Sr. RA-CMC Consultant and Subject Matter Expert (SME) MEDTRONIC AVE;

Endeavor Zotarolimus drug eluting stent, IDE, CTA, and PMA filings. PMA

approved 2008.

. Sr. RA-CMC SME, NUPATHE Zecuity sumatriptan dual reservoir patch NDA

approved, January, 2013

. Sr. RA-CMC SME, INTELLIJECT/SANOFI Auvi-Q epinephrine injector; NDA

approved August, 2012

. Sr. RA-CMC SME, MILLENNIUM; Module 2 & 3 eCTD services to early stage BLA

candidates (MEPACT )

. Sr. RA-CMC SME, GENZYME; supplement European (EU) eCTD filings, Renvela .

Site change control

. Sr. RA-CMC SME, BMS; Compliance Submissions Initiative; EU filings, eCTD

Type I and II variations.

. Sr. Clinical/pre-Clinical Supplies cGMP Quality Systems SME, BOEHRINGER

INGELHEIM; mock-PAI.

. Sr. Bio-analytical SME, MDS-PHARMA; 5-year retrospective bioequivalence

review mandated by FDA.

. Sr. cGMP RA-CMC SME, US PHARMACOPOEIA; USAID/WHO-funded Promoting the

Quality of Medicines

. Sr. cGMP Compliance SME, CORPAK MEDSYSTEMS; Warning Letter resolution;

medical device

. Sr. cGMP Compliance SME, LONZA BIOLOGICS; Q7 mock-inspection, Warning

Letter remediation

. Sr. cGMP Compliance SME to WYETH (2000), and GSK (2006) Consent Decree

remediation.

. Sr. Quality Systems SME, MEMORIAL SLOAN-KETTERING CANCER CENTER.

Establishment of a regulatory & cGMP compliant quality system/SOPs for 11

Clinical Investigator's and API synthesis labs. IND preparation and

review (biologics, radio-labeled peptides, devices, and new chemical

entities).

. Sr. RA-CMC Project Management Consultant ALLERGAN; redesign of Change

Control systems, RA-Mfg- Quality Change Control Review board; RA

management succession plan, department work-flow re-structuring.

. Expert Witness, Regulatory Affairs on behalf of defendant in the case of

Silverman v. Watson being sued for alleged supply chain related product

contamination. Decision: Defendant. Case dismissed

Contracted and interim-regulatory and quality management services have

included the following:

. As Vice-President of Regulatory Affairs and Quality Operations for the

"virtual" development-stage pain management firm, AlgoRx, Inc. (now,

Anesiva), CMC, Formulation, QA/QC, and Regulatory filing management

furnished to out-sourced domestic and international development units

for three products, Phases 1, 2 and 3:

. Synthetic new chemical entity (NCE); pre-formulation studies --

proof of concept, and first in man trials.

. AdleaTM parenterally administered formulations of ultra-purified,

and synthetic Capsaicin (now in Phase 3).

. ZingoTM (PowderJect( lidocaine) needle-free anesthetic. Drug-

device 505(b)(2) NDA approved, 2007.

. INDs, CTXs, staffing; external vendor selection, and cGMP

compliance oversight, batch record review; international/domestic

clinical study supplies management; regulatory strategy and Agency

meetings.

. Pre-clinical GLP protocol execution and study site auditing in US

(Charles River Labs), Canada (CTBR- Inveresk) and Quintiles

Transnational (Edinburgh, Scotland, UK)

TIMOTHY A. ANDERSON, MS,

MBA, Page 2

The AQUAMARINE GROUP (continued)

. As acting Vice-President, Regulatory Affairs and Quality, OptiNose,

US, Inc. lead filing and licensed partnership regulatory submission

management for company's first 505(b)(2) NDA for Sumatriptan Breath

Powered Powder Delivery system (AVP-825). Outsourced due diligence,

vendor selection, and development of regulatory strategies for

Fluticasone Breath Powered Bi-Directional device (OPN-375).

. As acting Vice-President, Regulatory Affairs, Taro Pharmaceuticals,

USA, Inc US, Israel, Canada regulatory functions were coordinated,

toward submission of US, Canadian, and International filings.

Approvals obtained for 19 ANDAs, and 2- 510(k)s, 10 original DMFs, and

an MAA for UK. . Accomplished senior level (i.e., Director and VP)

staffing of regulatory departments for Taro in Canada and NY.

. As acting Director, QA/Regulatory GMP/GLP, Oread, Inc. (acquired by

Emisphere Technologies, 2000), starting-up Oread's Rapid Response

Laboratory, including SOP review/revision/composition, senior staff

sourcing, establishment of laboratory GLP/GMP compliance systems,

client support, regulatory liaison/advisory.

Partnering with and acquisition (1998) of Clinton Research Consultants,

Easton, CT

Critical analysis of new product proposals for scientific feasibility and

domestic/international marketability, profiling novel formulary and

therapeutic preparations. Evaluation of marketing plans and new product

proposals for anti-viral, anti-thrombotic, polypeptide, enzymatic, new

chemical entities, biotechnology products, and unique formulation systems

as well as authored and promoted novel contraceptive, glucose metabolism,

and palatable cold symptom relief therapies.

1994-1996 SANDOZ PHARMACEUTICALS CORPORATION

East Hanover, NJ

Creighton Pharmaceuticals Corporation

division

Senior Associate Director, and division Vice-President, Drug Registration

and Regulatory Affairs

Successfully guided, educated, and project managed the domestic and

international regulatory and manufacturing functions within Sandoz, toward

preparation and timely submission of Abbreviated New Drug Applications

(ANDAs) and Drug Master Files (DMFs) to the FDA for Sandoz products, which

have and/or are due to come off-patent.

Set the standard for review of competing generic filings through

preparation of five first-of-their-kind original ANDAs for Clozapine,

Cyclosporine, and Bromocriptine dosage forms, as part of a larger strategy

to promote Sandoz brand protection.

Filed landmark citizen's petition in conjunction with preparation of first-

of-their-kind patient-based clinical bioequivalence studies (Clozapine) to

set the industry standard for review by the Agency; similar legal and

strategic advisories rendered for the other flagship products. Coordinated

the activities of outside consultants.

Regulatory advisories in the areas of cGMP compliance, Chemistry and

Manufacturing Control documentation and bioequivalency standards, from

first-hand knowledge of FDA/OGD expectations. Business development and

licensing advisories provided in the context of OTC switches, joint

ventures, site changes, and new products. Promotion from Associate

Director to Senior Associate Director for Drug Registration and Regulatory

Affairs (DRRA) for Sandoz and awarding of the title of Vice-President of

DRRA for the Creighton Pharmaceuticals generics division.

1992-1994 UNITED STATES FOOD AND DRUG ADMINISTRATION

Rockville, MD

Review Chemist (ranking), Branch 4, Division 1, Office of Generic Drugs,

Centers for Drug Evaluation and Research

Employed superior communication skills in drafting coherent deficiency or

approval letters in the course of thorough review of chemistry and

manufacturing controls sections of original and supplemental ANDAs and

DMFs, resulting in fewer required review cycles for applicants. Sought and

obtained expanded assignments at other FDA offices within the Centers for

Drug Evaluation and Research (CDER), reviewing INDs and supplemental NDAs.

Delegated with branch supervisory duties in the absence of the branch

chief. Contributions to several policy-crafting CDER committees: Chemistry

and Manufacturing Controls Coordinating Committees (CMCCC), prepared policy

and procedure guides (PPGs) for bioequivalence evaluation of topicals.

Contributions to drug monographs performed in conjunction with preparation

of FDA guidances for presentation to the International Conference on

Harmonization (ICH).

Appointed to position of Program Manager for the industry visitation

initiative. Serving on the Committee for Continuing Training and

Educational Development, headed up favorably received visitations to 16

sites planned and scheduled on behalf of 40 OGD review staff to broaden

reviewers' technological exposure and to promote industry-Agency dialog.

Program slated to expand to include other CDER offices.

TIMOTHY A. ANDERSON, MS, MBA

Page 3

1987-1992 BAYER, USA, Miles, Inc., Pharmaceuticals division

West Haven, CT

Associate Scientist (ranking)

Group leadership responsibilities, including the training and coordination

of the assigned workloads of 8 technicians for the finished product and raw

materials Quality Assurance laboratory. Recommendations implemented for

equipment upgrades; delegated with laboratory supervision in the absence of

managers. Increased group productivity, efficiency, and time savings by

training staff in instrumentation troubleshooting techniques and

maintenance toward safe and effective operation of standard equipment and

automated control devices (HP-3350A).

Sharpening existing and new methods for clarity and editing / validation of

analytical methods for NDA and IND submissions accomplished, conforming

European (Bayer AG) methods to USP protocols.

Scheduling of analytical testing for parenterals, cremes, ointments,

lotions, otic solutions, tableted products, and raw materials and timely

coordination with manufacturing toward negotiated product and packaging

release timetables.

1984-1987 PURDUE-FREDERICK RESEARCH CENTER

Yonkers, NY

Scientist, Experimental Formulations

Development of stability protocols and bioassay methods and validations,

employed to determine drug and metabolite levels in plasma and serum in pre-

clinical animal and clinical patient studies for newly developed drug

formulae (Phases I and II). Preparation and group presentations of

technical reports, detailing data, which linked chemistries to critical

pharmacokinetic studies; editing of test methods of European subsidiaries

to conform to USP protocols. Participation in DEA and FDA audits.

Acquired comprehensive credentials in industrial pharmacy: Tableting and

granulating techniques (experimental and clinical sustained release

narcotic, antibiotic, and vasodilator formulations), film coating, freeze

drying, Accelocoata fluid bed drying, and Glatt mixing equipment.

1982-1984 CLINTON RESEARCH CONSULTANTS, INC.

Easton, CT

Contracted consumer products, applications research, and development

services

NABISCO BRANDS, INC., Technology Center

Wilton, CT

. Research Technologist, product development, surfactant, pilot

plant, and sensory studies.

THE FOXBORO COMPANY, Analytical Instrumentation

Norwalk, CT

. Applications Scientist, IR spectral software programming for a new

product launch, the MIRAN 1-B.

SHAW MUDGE AND COMPANY, Fragrance Formulators

Stamford, CT

. Formulations Chemist, fragrance product development, QA, and rabbit

conjunctival irritation studies

PATENTS AWARDED AND PROVISIONAL PATENTS PENDING (Co-inventor):

Synthesis and Purification of Capsaicin (Serial No. 10/821,473), April 8,

2004

Synthesis and Purification of Capsaicin (Serial No. PCT/US04/10745) April

8, 2004

Preparation and Purification of Synthetic Capsaicin (European patent

application 04749854.8-2117-US2004010745)

Capsaicinoid Gel Formulation and Uses Thereof (Serial No. 60/630,577)

November 24, 2004

Capsaicinoid Gel Formulation and Uses Thereof (Serial No. 11/286,059,

docket No. 900.1034US) November 23, 2005

TIMOTHY A. ANDERSON, MS, MBA, Page

4

EDUCATION

MASTER OF INTERNATIONAL BUSINESS ADMINISTRATION UNIVERSITY OF

BRIDGEPORT

Bridgeport, CT 5/92

GPA: 3.6/4.0

Thesis: "ECONOMIC NEW WORLD ORDER, Global models structured after those

of the EC toward continued international economic integration: the

Commonwealth approach for the emancipation of command economies and the

historical and geographical bases for regional free trading zones in the

furtherance of competitive interdependence."

MASTER OF SCIENCE, BIOCHEMISTRY

NEW YORK MEDICAL COLLEGE

Valhalla, NY 5/88

GPA: 3.4/4.0

Thesis: "Synergistic reduction in proliferation of the histiocytic

lymphoma cell line, U-937, by the combined action of recombinant interferon

beta-ser and retinoic acid, and the associated changes in 2'-5'

oligoadenylate synthetase and ribonuclease L activities."

BACHELOR OF SCIENCE, CHEMISTRY VIRGINIA

COMMONWEALTH UNIVERSITY

Richmond, VA

5/82

BACHELOR OF SCIENCE, BIOLOGY VIRGINIA

COMMONWEALTH UNIVERSITY

Richmond, VA 12/80

CONTINUING EDUCATION IN BUSINESS

LEADERSHIP-4 PERFORMANCE MANAGEMENT: Charter Oak Consulting Group

COMMUNICATION AND TEAM BUILDING: Gatto Training Associates

POSITIVE POWER AND INFLUENCE: Situation Management Systems

CONTINUING EDUCATION IN SCIENCES AND REGULATORY AFFAIRS

BIOEQUIVALENCE, BIOAVAILABILITY, AND THERAPEUTIC SUBSTITUTION: Technomic

Publishing

BIOTECHNOLOGY: Centers for Drug Evaluation and Research Staff College

ISO 9000/Q90 DOCUMENTATION STANDARDS: Quality Alert Institute

EDUCATIONAL DEVELOPMENT MODULES IN PHARMACEUTICS: University of Maryland

Capsule Formulation, Filling and Manufacture; Dissolution and

Bioavailability; Metered Dosage Inhalers; Creams, Ointments, and Lotions

Formulation; Sustained Release Formulation; Parenterals; Packaging.

PUBLICATION:

"A flow injection analysis/mass spectrometry method for the quantification

of polyethylene glycol 300 in drug formulations," Zhang, J., Lin, J.,

Anderson, T.A., International Journal of Pharmaceutics, 282(1), pages 183-

187 (2004)

MEMBERSHIPS

Food and Drug Administration Alumni Association

Regulatory Affairs Professional Society

American Association of Pharmaceutical Scientists

American Chemical Society

INTERESTS

Current events, Music composition, Marine aquaria, British (MG) sportscars.

Sports: soccer, volleyball, baseball, chess.

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