U.S. Cit // Currently: TX / no relocation availability //
PhD // MBA // BS Chemistry //
Regulatory Affairs // Specialization: CMC //
Biotherapeutics, suspension and placebo, drug-in-bottle, tablets, capsules medical devices
Ph.D.; MS, pharmaceutics, 1990 – 1995; funded all 5 years through research assistantships
University of Wisconsin-Madison School of Pharmacy
MBA, Organization and Management, 1988 (60 credit hour program, part-time through University College); funded through BM(S) tuition reimbursement program
Syracuse University – Martin J. Whitman School of Management
BS, Chemistry, Natural and Synthetic Polymer Option, cum laude, 1979; funded via NY State Regents Scholarship, and work-study program
SUNY State University of New York College of Environmental Sciences and Forestry/Syracuse U.
Biochemistry Lab; Carbohydrate Chemistry Lab. Isolated 12 g of n-acetylneuraminic acid from a natural source (Chinese bird’s nest) and characterized neuraminidase pH/kinetic activity profile by colorimetric assay with UV absorbance. The isolated NANA was used for vaccine development by then postdoc Ron Eby, who eventually was the recipient of the National Medal in 2007 for his work on the Prevnar vaccine, awarded by President G. W. Bush.
SUNY College of Environmental Science and Forestry, Syracuse, NY.
Summers 1977, 1978:
• English (Native), Italian (bilingual proficiency), French (read), Spanish (read)
• Microsoft Office; JMP
• Valid US Passport
• Member of AAPS, ACS; past member of CRS
• Born in Solvay, NY; currently based in Fort Worth, TX
• FDA Redi Annual Conference (online, live); 2019 and 2020
• Using Experimental Design to Increase Predictability, Optimize Processes, and Lower Costs. JMP sponsored training (Dallas, TX); 2019
• 6th annual Due Diligence Summit (Philadelphia); invited speaker; 2019
• Well Characterized Biologics and Biological Assays; 2012 (Boston) and 2018 (Rockville, MD)
• Annual Drug Information Association (DIA) meeting (Chicago); 2017
• JMP Discovery Summit (Cary, NC); 2016
• CASSS WCBP Symposium on BioAnalytical/Regulatory (Washington, DC); 2016
• Statistics in Validation (IVT) 2nd annual conference (Philadelphia); 2015
• USP workshop and short course on Extractables/Leachables; 2014
• Biopharmaceutical Development and Production Conference and Short Course on Biopharm Manufacture, Cell Culture, and Fermentation Bioprocessing (San Diego); 2014
• ANOVA and Regression, Custom DOE, Analyzing Multidimensional Data, Data Exploration, Definitive Screening Designs to Get More Information from Fewer Trials (JMP online short courses 2012-2014)
• AAPS National Meeting (Washington); 2011
• Controlled Release Society (CRS) Annual Meeting (Portland, OR); 2010
• Ongoing: internal SOP/policy training
• Pre-2010: see Publications/Posters/Presentations
Skills and Expertise:
Pharmaceutics (applied physical chemistry), CMC strategy and Regulatory submissions, experimental design (DOE) and statistical data analysis (JMP software), pre-formulation (pH-stability, pH-solubility), formulation development (capsule by wet granulation, nano, lipidic, amorphous by spray-drying), CMC Due Diligence, CMC cross-functional team leader, DS and DP characterization (DSC, TG, vapor sorption etc), cell-based assay method transfer. Emphasis on QbD: risk-based assessments and decision-making. Data-driven, detail-oriented, patient-centric, cost-effective, multidisciplinary, compliant solutions. Strong technical writing skills. Analytical thinking. Team player. Mentor.
• CMC input for Regulatory filings with successful outcomes.
• Statistical data analysis and trending of recent and historical manufacturing data to anticipate or troubleshoot OOT/OOS, to set site transfer comparability limits, and to identify hot spots from EMPQ and help set limits for the new facility.
• JMP Proficiency: ANOVA, ANCOVA (for shelf-life estimation), DOE design/analysis/basic model building, linear and non-linear regression, distribution analysis, partition analysis.
• Successful 96-well plate cell-based assay method validation and transfer.
• SME interface with international CMO’s for analysis (potency, viscosity, preservatives, UV-VIS, HPLC. etc) and manufacture of creams, hydrogels, and ointments sold as wound care devices, OTC, drug products, or cosmetics globally. Change Control.
• Outsourcing for extractables/leachables testing.
• Small molecule, biologics (enzymes by bacterial fermentation, recombinant growth factor from yeast), drug-in-bottle, capsules, tablets.
• Current on ICH/USP/FDA guidance.
January 2012 – Present: SENIOR STAFF SCIENTIST, R&D (CMC)
Provide creative statistical data analysis (JMP) to support wound care cream, gel, ointment, and liquid products in development, and for marketed products for which the manufacture of Drug Substance and Drug Product is outsourced. Provide input for CMC Regulatory submissions and correspondence. Key contributor on site/method transfer; hands-on manufacturing loss investigation at commercial scale; shelf-life extension strategies which enabled an overseas market; DOE design and data analysis/data visualization which anticipated or helped troubleshoot manufacturing issues and led to process optimization. Mentor for junior staff during site expansion.
May 2006 – September 2011: SCIENTIFIC ADVISOR to CMC VP, Global CMC:
Critiqued and summarized scientific documents for CMC VP and Paris, France-based CMC LT.
SENIOR MANAGER, Product and Process Development: Managed a group of 5 responsible for Phase I/II small molecule iv/oral/inhalation formulation development. CMC representative for 19 corporate Due Diligence evaluations, and on Wound Care and Fibrosis team. Cross-functional CMC project team coordinator and hands-on formulator (fluid-bed wet granulation capsule) for Ambien follow-on candidate.
May 1999 – May 2006: SENIOR RESEARCH INVESTIGATOR I (Early Development):
Hands-on formulator for first-in-human (FIH) drug-in-bottle (DIB) for suspension (and matching placebo), and capsule manufactured by wet granulation, for Alzheimer’s candidate. This project had a very tight timeline and high visibility in the investor community, as it was the first BMS candidate for the indication. Wrote the manufacturing batch records, proposed specifications, developed the HPLC method, participated in clinical manufacture of the capsule, and was present for constitution and dosing of the DIB suspension at the clinical site in Hollywood, CA. This was the first BMS DIB used in the clinic for any indication and set the precedent. Obtained excellent human PK agreement between suspension and capsule of this poorly soluble small molecule drug candidate. The DIB suspension approach enabled a wide dose-range from 15 mg to 5 g to be dosed in the clinic. SENIOR RESEARCH INVESTIGATOR II (Drug Delivery): Provided nanosuspension formulations for over 15 preclinical PK studies (in-house technology licensed from Elan); developed lipidic (licensed from Gattefosse’) and spray-dried formulations (in-house technology) to enhance oral bioavailability. Technical liaison with external drug delivery companies. Member of Drug Delivery Scouting group; member of R&D recruiting committee. Representative on Discovery Interface teams and cross-functional Early Development teams. Both positions had supervisory responsibilities (1 to 3 direct reports). 2 Patents; 2 book chapters (pharmaceutical salt forms; particle engineering).
May 1997 – May 1999: PHARMACEUTICAL TECHNOLOGIES TEAM MEMBER
Hands-on analytical and formulation scientist. Participated in a pilot-scale formulation DOE (Design Expert) which successfully solved a stability issue of one of the company’s top selling cardiovascular tablets manufactured by fluidized bed wet granulation; the study involved in-house manufacture of amorphous lactose by spray-drying which was compared to crystalline lactose. Performed pre-formulation studies; GMP release and stability testing including dissolution and HPLC. 1 patent; 1 poster.
August 1995 – May 1997: SENIOR SCIENTIST
Surgical Formulation/Device Group. Formulation development of viscoelastic hydrogels using Krieger mixer; rheological characterization of non-Newtonian behavior of hyaluronic acid and HPMC based gels; provided input for agency responses; key contributor for retroactive NDA for marketed ocular irrigating solution.
June 1990 – July 1995: GRADUATE RESEARCH ASSISTANT
Investigated interconversion of ranitidine polymorphs by calorimetry; co-authored article used in the global patent litigation between ranitidine innovator (GSK) and generic companies.
May 1979 – May 1990: RESEARCH SCIENTIST
Drug Metabolism and Pharmacokinetics; Analytical R&D; Pre-formulation group of Product Development. Mostly small molecule OEB 5 anticancer, HIV. Responsible for methods transfer and release/stability testing for hyaluronic acid intra-articular injection for racehorses. Hands-on HPLC method development and validation. USP wet chemistry testing of finished product (iodometric titration, optical rotation, absorption analysis for Pt in cancer patient fluids). Hands-on PK studies in mice, rats, rabbits, monkeys, and ferrets, including radiolabelled drug dosing and analysis of plasma, urine, feces for mass balance studies of an H2-receptor antagonist on a fast development track; at the time, cimetidine was the only marketed drug in class.
Continuity: My employment history has been continuous apart from 2 months in 2011 following severance from Sanofi. Worked for BM(S) a total of 18 years: 11 years at Bristol Laboratories division of Bristol-Myers company in Syracuse, NY as a bench chemist (in pre-formulation, AR&D, and DMPK) prior to resigning to attend graduate school. Obtained MBA from SU part-time while working full-time as a bench chemist for Bristol Labs. Recruited to rejoin BMS 10 years later as a Sr. Research Investigator I then II for 7 years, ultimately heading up a small drug delivery group devoted to nanosuspensions, lipidic, and spray-dried formulations for early development feasibility, and supercritical CO2 crystallization. Recruited to work for Sanofi-Aventis and resigned BMS which was undergoing severe downsizing (workforce of over 50k was almost halved). Joined S+N after severance from Sanofi due to RIF.
• Member of ACS, AAPS; past member of CRS
• Abstract screener for AAPS annual meetings 2003-2015; past reviewer for J. Pharm. Sci. and Pharm. Res.
• “Symphony” management training, sanofi-aventis, France, 2008
• Member of Gattefosse’ L’Academie des Alpilles (St. Remy, France, 2003)
• Moderator / organizer (1999 and 2000 AAPS Eastern Regional Mtgs; 2004 Annual Mtg):
o “Nutraceuticals: Quality and Related Regulatory Issues” Symposium
o “Development of Amorphous Pharmaceutical Systems” Symposium
o “Particle Engineering” Short Course
o “Form Transformation of API During Drug Product Manufacture” Roundtable
• Member 1996 Physical Chemistry Delegation to China (People to People Citizen Ambassador Program)
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