Quality Management
Resume:
TIMOTHY A. ANDERSON, MS, MBA
Redding, CT 06896-1409
*******.********@***************.***
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.
Contact this candidate