Expert Details

Expert in Pharmaceutical Development

Expert ID: 735397 Connecticut, USA

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He brings 38 career-years’ experience, including service at FDA as a Review Chemist.

He began his career in pharmaceutical research and development with Purdue Pharma (Stamford, CT – MS-Contin®, Uniphyl®, Oxycontin®)(3 years), and continued on to Bayer (West Haven, CT – Mycelex®, Cort-Dome®, Adalat®, Kogenate®, Cipro®) where he served in Quality Control for 5 years. He was hired by the US Food and Drug Administration (Rockville, MD)(FDA) as a Review Chemist in 1992, where he served at Centers for Drugs Evaluation and Research, Office of Generic Drugs, reviewing and granting approvals for Chemistry and Manufacturing Controls (CMC) submissions. The Branch in which he served was dedicated to review and approval of Topicals, Solutions, and Semi-solids as well as low dosage orals. He was the primary reviewer of and issued first generic approvals among others for Timolol Maleate Ophthalmic solutions, Tretinoin creams, and I approved the first generic versions of Xanax® (alprazolam).

He was hired away from the Agency in 1994 to head up as division VP of Regulatory Affairs, the successful brand protection, anti-generic defensive strategies for Sandoz Pharmaceuticals Corporation (East Hanover, NJ), employing the contributions of staff based in the US and in Switzerland. In this role he traveled frequently to Basel to work with and oversee both Regulatory staff and galenical/drug operations in what became the successful abbreviated new drug applications (ANDA) and drug master files (DMF) for Clozapine (Clozaril®) and the 11- (circular) polypeptide chain, Cyclosporine (Sandimmune®). With the merger of CIBA and Sandoz to form Novartis, he formed my own consulting firm, The AquaMarine Group, Inc.

The Expert's company celebrated its 23rd year in business in 2019 as a pharmaceutical regulatory affairs, quality, GxP compliance and due-diligence consulting firm.

A uniquely inter-disciplined 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.

Expert may consult nationally and internationally, and is also local to the following cities: New York City, NY

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Education

Year Degree Subject Institution
Year: 1992 Degree: Master of Business Administration Subject: International Institution: University of Bridgeport
Year: 1988 Degree: Master of Science Subject: Biochemistry Institution: New York Medical College
Year: 1982 Degree: Bachelor of Science Subject: Chemistry Institution: Virginia Commonwealth University
Year: 1980 Degree: Bachelor of Science Subject: Biology Institution: Virginia Commonwealth University

Work History

Years Employer Title Department Responsibilities
Years: 1996 to Present Employer: Undisclosed Title: Principal Department: Responsibilities: For 24+ years as a consultant in his own pharmaceutical development advisory firm, he has furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls, to current Good Manufacturing Practice (cGMP) quality system regulation (QSR) audits for finished dosage, and active pharmaceutical ingredient (API) manufacturing, as well as for device, drug-device combination, and biologic products. Technical and regulatory compliance due diligence services are furnished to institutional investors.

He has contributed to regulatory approvals for over 50 drug and drug/device applications, spanning generic (ANDA) and innovator NDA, BLA, 510(k), PMA, and 505(b)(2) applications, and have provided regulatory compliance remediation services to resolve Form 483, Warning Letter, and Consent Decree issues.

Expert has been deposed, testified in Federal Court, and functioned as a Subject Matter Expert Witness for several cases.

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.
Years: 2002 to 2005 Employer: AlgoRx, Inc. Title: Vice-President Department: Regulatory Affairs Responsibilities: Serving as Vice-President of Regulatory Affairs and Quality Operations for the “virtual” development-stage pain management firm, CMC, Formulation, QA/QC, and Regulatory filing management furnished to out-sourced domestic and international development units for three products in 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 (currently in Phase 3).
• ZingoTM (PowderJect® lidocaine) needle-free anesthetic. Drug-device 505(b)(2). NDA approved, 2007.
• Filing of INDs, CTXs, staffing; external vendor selection, and cGMP compliance oversight, batch record review; international/domestic clinical study supplies management; regulatory strategy and Agency meetings.
Years: 1994 to 1996 Employer: Sandoz Pharmaceuticals Corporation Title: Sr. Associate Director/division VP Department: Regulatory Affairs Responsibilities: 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.

Clozapine Tablets and Drug Master File (SANDOZ Clozaril®) ANDA approved 1995

First US generic product to employ a patient-based bioequivalence study
First time generic product approved in 7 months from its first filing

Cyclosporine Capsules and Drug Master File (SANDOZ Sandimmune®) ANDA approved 2000

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.
Years: 1992 to 1994 Employer: US Food and Drug Administration Title: Review Chemist Department: Office of Generic Drugs (OGD) Responsibilities: Drafting 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) preparation of policy and procedure guides (PPGs) for bioequivalence evaluation of topicals.

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.
Years: 1987 to 1992 Employer: Bayer Pharmaceuticals USA, Miles Laboratories division Title: Associate Scientist Department: Quality Assurance Responsibilities: 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.

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.

Years: 1984 to 1987 Employer: Purdue Pharma Title: Scientist Department: Research and development Responsibilities: 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.
Years: 1982 to 1987 Employer: CLINTON RESEARCH CONSULTANTS, INC. Title: Consultant Department: Responsibilities: 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
• Applications Scientist, IR spectral software programming for a new product launch, the MIRAN 1-B.

SHAW MUDGE AND COMPANY, Fragrance Formulators

• Formulations Chemist, fragrance product development, QA, and rabbit conjunctival irritation studies

Government Experience

Years Agency Role Description
Years: 1992 to 1994 Agency: US Food and Drug Administration Role: Review Chemist Description: Drafting 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) preparation of policy and procedure guides (PPGs) for bioequivalence evaluation of topicals.

International Experience

Years Country / Region Summary
Years: 2011 to 2011 Country / Region: Russia Summary: USAID/WHO/USP Assignment: Expert was sent to Moscow to perform training in “Principles of Current Good Manufacturing Practices (cGMP)” for ROSZDRAVNADZOR (the Russian counterpart to the US FDA) as co-sponsored by the US Pharmacopoeia and World Health Organization.
Years: 2011 to 2011 Country / Region: Ethiopia Summary: USAID/WHO/USP Assignment: Expert was in Addis Ababa, Ethiopia where he was serving on another “Prequalification of Medicines Program” audit project through US Pharmacopoeia /World Health Organization / US Agency for International Development, evaluating nine in-country manufacturing sites for cGMP compliance, and evaluation of quality systems in place to manufacture HIV, AIDS, TB (anti-biotic), and anti-malarial therapies.
Years: 2015 to 2015 Country / Region: CHINA Summary: Due-diligence audit assignment at the API firm Apeloa Pharmaceuticals in Hengdian CHINA (2015).
Years: 2017 to 2015 Country / Region: INDIA Summary: Due-diligence audit assignment at the API firm RA-Chem Pharmaceuticals in Vijayawada, INDIA (2015).
Years: 2014 to 2014 Country / Region: SOUTH KOREA Summary: Due-diligence audit assignment at a peptide API firm Daesang Corporation, (Seoul, SOUTH KOREA)(2014).
Years: 2014 to 2014 Country / Region: CHINA Summary: Mock-preapproval inspection for Novast, a drug product manufacturer in Nantong CHINA (2014).
Years: 2014 to 2014 Country / Region: CHINA Summary: Due-diligence audit assignment at the firm Reyoung Pharmaceuticals in Shanghai CHINA (2014).
Years: 2011 to 2011 Country / Region: CHINA Summary: Conducted a preparatory cGMP pre-audit for SICHUAN LONG MARCH PHARMACEUTICALS in Leshan, Sichuan, CHINA.
Years: 2015 to 2015 Country / Region: Germany Summary: Due-diligence audit assignment at UNIVERSITÄTSMEDIZIN Apotheke, Mainz, Germany – Clinical supplies repackaging, Good Distribution Practice (GDP), warehousing and shipping tracking capabilities assessment

Career Accomplishments

Associations / Societies
MEMBERSHIPS:
Food and Drug Administration Alumni Association
Regulatory Affairs Professional Society
American Association of Pharmaceutical Scientists
American Chemical Society
Publications and Patents Summary
PATENTS AWARDED AND PROVISIONAL PATENTS PENDING (Co-inventor):

Synthesis and Purification of Capsaicin
Synthesis and Purification of Capsaicin
Preparation and Purification of Synthetic Capsaicin (European patent application)
Capsaicinoid Gel Formulation and Uses Thereof
Capsaicinoid Gel Formulation and Uses Thereof

Publications: 1

Additional Experience

Expert Witness Experience
CMC Regulatory Affairs, Former FDA Subject Matter Expert Witness on behalf of the Plaintiff, testimony in deposition regarding regulatory generic labeling requirements. Resolution in favor of Plaintiff. Case settled.

CMC Regulatory Affairs Subject Matter Expert on behalf of the End-payor Plaintiff(s) in the case. Resolution in favor of Plaintiff; as to defendant 1: “agreement in principle,” as to defendant 2: Case settled.

CMC Regulatory Affairs Subject Matter Expert on behalf of the Plaintiff(s) in the case, anti-trust litigation. The work done is confidential. Decision: Case settled.

CMC Subject Matter Expert Witness on behalf of defendant in the case, (Southern District, Houston, TX) being sued for alleged product contamination. Decision: Defendant. Case dismissed

Regulatory Affairs Subject Matter Expert Consultant on behalf of a defendant in the case, liability litigation. Civil Action.

CMC Subject Matter Expert on behalf of plaintiff, (SETTLED in Phila. Cnty. Court of Common Pleas).

CMC Subject Matter Expert on behalf of defendant, (SETTLED in Phila. Cnty. Court of Common Pleas).

CMC Subject Matter Expert Witness on behalf of plaintiff, (PENDING in Southern District, NY).

CMC Subject Matter Expert Witness on behalf of plaintiff, Civ. Action. (PENDING in D. Mass)

CMC Subject Matter Expert Witness on behalf of defendant, (SETTLED in Southern District, NY).

Medical Diagnostic Device Regulatory Affairs, FDA Subject Matter Expert engaged on behalf of the Plaintiff, (arbitration pending in Essex County, New Jersey)
Training / Seminars
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.
Vendor Selection
As acting Vice-President, Regulatory Affairs and Quality, Expert lead filing and licensed partnership regulatory submission management for the 505(b)(2) NDA for ONZETRA™ Xsail™ (partnered with Avenir; sumatriptan nasal powder) NDA approved, January, 2016 and outsourced due diligence, vendor selection, and regulatory strategy for Fluticasone Breath Powered™ Bi-Directional device (Xhance™) NDA approved, September, 2017 (2013, 2014).

Full Due diligence assessment reports completed and submitted for the following potential vendors

o Patheon (Mississauga, Ontario, Canada) – manufacturing and analytical capabilities assessment

o PTI (Royston, GA) – manufacturing, warehousing and analytical capabilities assessment

o CPL Laboratories (Mississauga, Ontario, Canada) – manufacturing and analytical capabilities assessment

o Groupe Parima (Montreal, Quebec, Canada) – manufacturing and analytical capabilities assessment

o Aphena Laboratories (Easton, MD) – manufacturing and analytical capabilities assessment

o Vision Technical Molding (Manchester, CT) – device manufacturing, warehousing and analytical capabilities assessment

o Ximedica (Warwick, RI) – prototype manufacturing, human factors assessments

As acting Vice-President, Regulatory Affairs and Quality for AlgoRx- Anesiva, (Secaucus, NJ, Fremont, CA) the firm received FDA approval for its first NDA, a 505(b)(2) drug-device combination product, marketed as ZingoTM (originally known as Oxford University’s PowderJect® Lidocaine needle-free injection) in August, 2007.

Full Due diligence assessment reports completed and submitted for the following potential vendors

3rd Party Vendor GMP due diligence and selection and API scale up purification including certified reference standards and impurities standards.

Medichem Laboratories/deCODE Genetics (Woodbridge, IL)
Girindus US (Cincinnati, OH)
Girindus AG (Kuensebeck, GERMANY)
PharmEco (Devens, MA)
UCB Pharma (Braine-l’Alleud, BELGIUM)
Prometics (Douglas, Isle of Man, UK)

3rd Party Vendor due diligence and selection for formulation development and cross country tech transfer

Formatech (Andover, MA)
Micro-Test Laboratories (Agawam, MA)
The Specials Laboratories (Newcastle-on-Tyne, Northumberland, UK)

3rd Party Vendor GLP due diligence and selection for analytical method development (US), and product assay verification in the UK.

Prova Laboratories (Camberley, Surrey, UK)

3rd Party Vendor GLP due diligence and selection of bioanalytical assay method development, international clinical sample plasma shipment and storage.

MDS Pharma (Lincoln, NE)

3rd Party Vendor GCP due diligence and selection for domestic and UK-US based clinical supplies labeling, warehousing, and distribution.

Brecon Laboratories (Hay-on-Wye, WALES, UK)
Prometics (Phoenixville, PA)

3rd Party Vendor due diligence and selection of UK-based regulatory filing service for preparation of CTX.

QuadraMed (Midhurst, Surrey, UK)

3rd Party Vendor due diligence: Device mold forming

Sovrin Plastics (Slough, Berkshire, UK)

3rd Party Vendor due diligence: Device subassembly

GKD-Gebr. Kufferath AG (Düren, GERMANY)
BOC (Leatherhead, Surrey, UK)

3rd Party Vendor due diligence: Pre-clinical Safety/tox study site selection

Charles River Laboratories (Spencerville, OH)
Quintiles Transnational (Edinburgh, Herriott-Watt, Scotland, UK)

3rd Party Vendor due diligence: Terminal Sterilization assessment
Isotron (Swindon, Wiltshire, UK)

3rd Party Vendor due diligence: Clinical site selection and CRO management

Harley Street Clinic, (London, UK)
Charing Cross Hospital, (London, UK)
Lekaren –Syndipharma (Kosice, SLOVAKIA)
Pharm-Olam (Warsaw, POLAND)
Instytut Pomnik Centrum Zdrowia Ddziecka (Wroclaw, POLAND)
Chesapeake Research Group, L.L.C. (Pasadena, MD)

3rd Party Vendor selection: API powder sizing and aspect ratio assurance

Powdersize, Inc. (Quakertown, PA)


Other 3rd Party Technical Due Diligence Assignments include

Sr. RA CMC SME Mass Biologics (Mattapan, MA)

Full Due Diligence assessment on behalf of investors, <<>>, for scale-up vaccine and gene therapy manufacture toward establishing long-term suitability for accommodating full CMO capability for manufacture of clinical scale as well as commercial scale biologics.

Sr. RA CMC SME Cytovance (Oklahoma City, OK)

Full Due Diligence assessment on behalf of M&A investors, <<>>, for assessment of suitability for manufacture of clinical scale as well as commercial scale biologics.

Sr. RA CMC SME Synthetic Genomics (Torrey Pines, CA)
Currently serving as regulatory advisor to early stage gene-therapy products and Phase 1 cGMP
Full Due diligence assessment report completed and submitted for

o Phasex (Andover, MA) – supercritical fluid API purification manufacturing, warehousing


Sr. RA CMC SME CureTx (New York City, NY)
Full Due diligence assessment reports completed and submitted for

o Hercon Laboratories, Inc. (Emigsville, PA) drug patch manufacturing due diligence

o Copperhead Chemical, Inc. (Tamaqua, PA) API manufacturing due diligence

Sr. RA CMC SME SCIELE-SHIONOGI (Atlanta, GA and Florham Park, NJ)
Full Due diligence assessment report completed and submitted for

o FERRO- PFANSTIEHL (Waukegan, IL) – API manufacturing, warehousing and analytical capabilities assessment

Sr. RA CMC SME <>
Full Due diligence assessment report completed and submitted for

o ORACEUTICALS (Lee, MA) – manufacturing, warehousing and analytical capabilities assessment


Sr. RA CMC SME WARRICK PHARMACETICALS (Union, NJ)
Full Due diligence assessment report completed and submitted for

o Automated Liquid Packaging (Arlington Heights, IL) – blow-file-seal solution packaging, solution manufacturing, warehousing.

o Magellan Laboratories (Chapel Hill, NC) Analytical and stability laboratories

Sr. RA CMC SME EDENBRIDGE PHARMACEUTICALS (Parsippany, NJ). Due diligence involving ANDA application review and cGMP compliance assessment for 4 SOLID ORAL DOSAGE <> products.
Full Due diligence assessment reports completed and submitted for::

o Mirror Pharmaceutcals (Fairfield, NJ) – manufacturing, warehousing and analytical capabilities assessment

o Excillium Pharmaceuticals (Fairfield, NJ) – manufacturing, warehousing and analytical capabilities assessment

o Apicore, (Somerset, NJ) – manufacturing, warehousing and analytical capabilities assessment

o PCI Synthesis (Newburyport, MA) – manufacturing, warehousing and analytical capabilities assessment
Other Relevant Experience
INTERIM MANAGEMENT and MATERNITY COVERAGE

1. Interim Director, Regulatory Affairs (Maternity coverage), BOEHRINGER INGELHEIM (Ridgefield, CT); site-change, and co-formulation CTD Module 2 and 3 for sNDA’s for Micardis®-HCT Tablets

2. Interim Sr. Manager, Regulatory Affairs (Maternity coverage), GENZYME (Framingham, MA); preparation of supplemental European (EU) eCTD Module 2 and Module 3 filings, Type 1 and 2 Variations; Change control management, supporting manufacturing changes, based upon approved US submissions for Renvela® Tablets

3. As acting Director of Regulatory Affairs for a radio-pharmaceutical diagnostic client, <>, strategy development for PET diagnostic, Galliprost® and Technetium Tc99m Succimer for Injection (MPI DMSA KIDNEY REAGENT), negotiated continued importation under FDA Drug Shortage discretion (2018).

4. As acting Manager, Regulatory Affairs Furnished contracted regulatory management services to INDIVIOR (Richmond, VA) negotiating with Canadian authorities, preparing, and filing Canadian Product monograph for their flagship product, Suboxone®. (2015)

5. As acting Project Manager, Regulatory Affairs, ALLERGAN (Santa Ana, CA), redesign of Change Control systems, RA-Mfg- Quality Change Control Review board; RA management succession plan, department work-flow re-structuring; RA team work flow management and coaching.

6. As acting Vice-President, Regulatory Affairs and Quality for OPTINOSE, US, Inc (Yardley, PA). I lead filing and licensed partnership regulatory submission management for the 505(b)(2) NDA ONZETRA™ Xsail™ (partnered with Avenir; sumatriptan nasal powder) NDA approved, January, 2016, and outsourced due diligence, vendor selection, and regulatory strategy for Fluticasone Breath Powered™ Bi-Directional device (Xhance™) NDA approved, September, 2017 (2013, 2014).

7. As acting Vice-President, Regulatory Affairs and Quality for ALGORX-ANESIVA, (Secaucus, NJ, Fremont, CA) the firm received FDA approval for its first NDA, a 505(b)(2) drug-device combination product, marketed as ZingoTM (originally known as Oxford University’s PowderJect® Lidocaine needle-free injection) in August, 2007.

8. As Acting VP Regulatory Affairs TARO PHARMACEUTICALS, (Hawthorne, NY, Haifa, IS, Toronto, CA)

a. Submission of US, Canadian, and International filings, and primary liaison for negotiations with Office-level regulatory bodies on bioequivalency standards, CMC, and application deficiency resolution.
b. Selection and staffing of mid-level and Senior Regulatory management in NY, Canada, and Israel, including Manger through VP levels.
c. Amendments, supplements, annual reports. International Rx and OTC approvals
d. Obtained first generic approvals for Taro’s vertically integrated Israel-sourced products and APIs (e.g., Carbamazapine, Warfarin)
e. Approvals for 19 other ANDAs, and 2- 510(k)s, 10 original DMFs, and an MAA for UK.

f. ANDAs for SOLID ORAL Dosages include

1. AMIODARONE TABLETS
2. CARBAMAZAPINE TABLETS
3. ETODOLAC TABLETS
4. WARFARIN TABLETS
5. ENALAPRIL MALEATE
6. CHLORAZEPATE DIPOTASSIUM TABLETS
7. ACETAZOLAMIDE TABLETS

g. ANDAs for TOPICAL Dosages include

1. MICONAZOLE NITRATE CREAM; VAGINAL
2. TERCONAZOLE SUPPOSITORY; VAGINAL
3. BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED; TOPICAL, Gel, Lotion, cream
4. BETAMETHASONE VALERATE CREAM
5. CLOBETASOL PROPIONATE Gel
6. CLOTRIMAZOLE CREAM; TOPICAL and Solution
7. DESONIDE CREAM; TOPICAL Ointment
8. DESOXIMETASONE CREAM; TOPICAL, GEL;
9. DIFLORASONE DIACETATE CREAM; TOPICAL; OINTMENT;
10. FLUOCINOLONE ACETONIDE CREAM; TOPICAL; OINTMENT; SOLUTION
11. FLUOCINONIDE CREAM; TOPICAL GEL; TOPICAL; OINTMENT; SOLUTION
12. HYDROCORTISONE CREAM; TOPICAL LOTION; OINTMENT; TOPICAL
13. HYDROCORTISONE ACETATE; UREA CREAM; TOPICAL
14. HYDROCORTISONE BUTYRATE CREAM; TOPICAL OINTMENT; TOPICAL SOLUTION;
15. HYDROCORTISONE VALERATE CREAM; TOPICAL OINTMENT;
16. KETOCONAZOLE CREAM; TOPICAL
17. METRONIDAZOLE GEL; TOPICAL
18. MOMETASONE FUROATE CREAM; TOPICAL LOTION;
19. TRIAMCINOLONE ACETONIDE CREAM; TOPICAL

h. DMF Filings include

a. Clozapine
b. Cyclosporine
c. Ketoconazole
d. Triamcinolone Acetonide
e. Clobetasol Propionate
f. Mometasone Furoate
g. Amiodarone
h. Carbamazapine
i. Miconazole Nitrate
j. Betamethasone Dipropionate
k. Terconazole
l. Warfarin
m. Fluocinonide

9. As acting Director, QA/Regulatory GMP/GLP, OREAD, INC (Farmington, CT) -acquired by Emisphere Technologies, 2000), starting-up Oread's Rapid Response Laboratory, including SOP review/revision/composition, Change Control oversight, senior staff sourcing/leadership, establishment of laboratory GLP/GMP compliance systems, client support, regulatory liaison/advisory.

VC-FUNDED PHARMA "START-UP" SUCCESS:

He was invited to serve in the capacity of Vice-President of Regulatory Affairs and Quality Operations for the "virtual" early stage start-up pharmaceutical development firm, AlgoRx, Inc (Fremont, CA, Secaucus, NJ). The company’s CEO was Ronald M. Burch, MD, PhD, (currently Chief Executive Officer for Sanguistat, Inc, https://sanguistat.com/). AlgoRx enjoyed three series of funding tranches: Series A: $10MM, Series B: $25 MM, Series C: $100 MM (over-subscribed). The funding tranches for AlgoRx were headed by JP Morgan/Chase (led by Rod Ferguson), Sofinnova, and InterWest (Palo Alto, CA) (led by Arnie Oronsky).

In this role, he built a cross-functional team, hired, and managed Regulatory, R&D, and Quality employees on both East and West US coasts. We performed our first studies in the UK at Charing Cross Hospital, and Harley Street Clinic, LONDON, which continued to continental Europe and eventually to the US.

He identified and oversaw domestic and internationally situated outsourced partners for clinical supplies R&D and manufacture at The Specials, Newcastle-on-Tyne, NORTHUMBERLAND, analytical development at PROVA, Camberley, SURREY, sterilization at Isotron, SWINDON, and product release, QP services, warehousing and distribution at Brecon Pharma, HAY-ON-WYE, WALES – all of which were accomplished under stringent compliance with the expectations of Current Good Manufacturing Practices (cGMP). He trained clinical personnel protocol execution, reconciled and audited studies and supplies as a part of closure of pre-clinical and clinical studies, and led pre-clinical through Phase 2 regulatory filings to the point of AlgoRx's acquisition by CorGenTech.

He continued in a consulting capacity through the acquisition, and hired in my replacements. Under the combined firm's new name, Anesiva, the firm received FDA approval for its first NDA, a 505(b)(2) drug-device combination product, marketed as ZingoTM (originally known as Oxford University’s PowderJect® Lidocaine needle-free injection) in August, 2007. Product is now marketed by Marathon Pharma (2014).

Anesiva’s Adlea TM (ultra-purified capsaicin for injection) is currently in Phase 3 trials (knee replacement, bunionectomy indications). He is named on 5 of the patents (US and EU) for AdleaTM.

Noteworthy in the context of AdleaTM is the comparatively brief time (8 months) which transpired from first successful API purification, to first-in-man clinical studies done in the UK. In this short time he accomplished the following:
1. Vendor due diligence and selection and API scale up purification including certified reference standards and impurities standards.
2. Vendor due diligence and selection for formulation development and cross country tech transfer
3. Vendor due diligence and selection for analytical method development (US), and product assay verification in the UK.
4. Vendor due diligence and selection of bioanalytical assay method development, international clinical sample plasma shipment and storage.
5. Vendor due diligence and selection for domestic and UK-based clinical supplies labeling, warehousing, and distribution.
6. Vendor due diligence and selection of UK-based regulatory filing service for preparation of CTX.
7. API and formulation stability studies, accelerated and RT
8. Formulary in-use bench stability studies.
9. Successful scale up sterile formulation for clinical supplies and release qualification accomplished under cGMP.
10. Training of UK-based pharmacy technicians in cGMP handling of clinical supplies and final formulary bench protocol execution prior to patient dosage administration in the surgical theater.

While he typically bills himself primarily as a CMC Subject Matter Expert, one might likely be expected to have a working knowledge of the clinical side of things, as well. Specifically on the clinical side and particularly that which involved direct FDA interaction, he also presents the following:

a. Bio-analytical, bioequivalence/bioavailability study review and vendor due diligence and selection of CROs management of their activities
b. Written CMC portions of clinical Investigator’s Brochures for several firms, small molecule and biologics products
c. Written IND sections, which include formulary instructions for clinical pharmacies and clinical investigators
d. Trained clinical supplies managers, clinicians, and investigators in those same instructions at the clinical study-site
e. Performed Clinical Study close-outs, hospital inventory, clinical supplies repatriation and managed local QP involvement
f. Prepared relevant portions of Briefing Packages for FDA meetings
Negotiated CMC issues with FDA resulting in successful lifting of clinical holds for ZingoTM and Adlea TM

WARNING LETTER, 483 and CONSENT DECREE REMEDIATION PROJECTS:

Examples of regulatory remediation projects beginning with Warning Letters appear below

1. Warning Letter remediation KRS Biotechnologies (2016)
2. Warning Letter remediation CORPAK MedSystems (2013)
3. Warning Letter remediation CisPharma, Inc. (2013)
4. Warning Letter remediation Lonza Biologics (2012)
5. Warning Letter remediation MDS Pharma (2005 -2006)
6. Warning Letter close-out and bi-annual FDA inspection Sichuan Long March Pharmaceuticals (China) (2011)
7. Warning Letter close-out and NSF inspection FoodState (2013)
8. 483 response for NatureCom (2016)
9. 483 response and remediation Cody Laboratories (2011)
10. 483 response and remediation for PowerLine Packaging (2010)
11. Consent decree remediation team Wyeth (2000)
12. Consent decree remediation team GSK (2006)
13. Consent decree remediation team Hill Dermaceuticals (2011)
14. His firm has fielded teams of consultants on the following projects
a. J&J/McNeil Consent Decree remediation (2012)
b. Schering-Plough Consent decree remediation (2003)
c. Hospira Warning Letter resolution project (2011-2013)
d. AndRx Warning Letter and OAI remediation (2005)


Language Skills

Language Proficiency
English Native

Fields of Expertise

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