Pharmaceutical & Nutraceutical Tablet & Capsule Formulation Expert

Expertise

• Nutraceutical and pharmaceutical formulation and manufacturing.
• Formulating hemp Cannabidiol (CBD) products.
• Pharmaceutical Formulation Scientist with prior industry, FDA experience in CMC writing for small molecules and biologics for both FDA and EMA.
• Tablet and capsule formulation, manufacturing, trade secret infringement, product labeling, and patent evaluation.
• Formulation and manufacturing of food, nutraceutical, and pharmaceutical products.
• Intellectual property, market research, and competitive intelligence.
• Product and process development.
• Writing experience in several therapeutic areas: pain, oncology, diabetes, cardiology, HIV, antibiotics, and CNS.
• Ability to write and edit high quality scientific and CMC regulatory documents (IND/NDA/ANDA) for the pharmaceutical industry.
• PXRD, Powder X-ray Analysis, DSC, Differential Scanning Calorimetry MDSC, Modulated Differential Scanning Calorimetry TGA, Thermogravimetric Analysis preparing, evaluating polymorphs, and amorphous materials.

Expert Witness Experience

• Pharmaceutical trade secrets case. Wrote expert report and submitted to legal team.
• Pharmaceutical ANDA Litigation. Retained to opine Pharmaceutical Innovator patent litigation (Tablets). Markman claim interpretation and construction, freedom to operate, and patent infringement.
• Nutraceutical and Pharmaceutical Litigation. Reviewed deposition testimony and writing opinion rebuttal report.
• Court admitted and recognized as expert in formulation and manufacturing in issues for tablets and capsules.

Experience

Undisclosed Company, Principle Scientist. 2016 - Present

Principal Scientist and Manager Transfer Projects, Topical Skin Formulations

• Fulfilled several rolls; Principal Scientist, Manager of Transfer Projects for the tropical skin formulations.
• Managed deliverables for multiple U.S. and international client projects for prescriptions and over the counter pharmaceutical products.
• Developed research and development scale generic formulations for clients (solution, cream, ointment, gel, spray, acne foaming cleanser, glycolic acid facial toner, sunscreens) using a Quality by Design (QbD) approach.
• Involved with technical transfers as products go through scale-up manufacturing to Commercial scale (1300 gal.) or clinical scale (CTM).
• Answered FDA QBR CMC questions (Modules 2 & 3) related to client ANDAs and DMFs for drug substance and drug product.
• Provided CMC information for complete response letters and information requests from FDA in a timely manner, (with practiced writing in ANDA submissions).
• Worked on API and OTC projects involving Clobetasol (Solution, Spray, Ointment), Lidocaine, Desonide, Minocycline, Mupirocin, Nitroglycerin, Selamectin, Spinosad, Ciclopirox, Benzoyl peroxide (BPO), Omeprazole, Erythromycin, Metronidazole, Allantoin, Lidocaine Male Desensitizing Spray, Glycolic acid, and Salicylic acid.
• Trained, supervised and managed the work of junior chemists.
• Conducted experiments using anti-solvents, Rhotovap to decrease crystalline character of APIs. physico-chemical characterization of formulations: rheology, API particle size (Malvern), emulsion stability, Karl Fischer, XRD, and Raman spectroscopy.
• Quality Documentation: wrote bulk, finished product, and stability specifications and master batch records for clients. Wrote QbD and risk assessment documents for drug substance and drug product discussing quality target product profiles (QTPPs), critical quality attributes (CQAs), and critical process parameters (CPPs), product development reports, process development reports, SUPAC manufacturing site change reports (equipment comparisons), manufacturing investigation reports, lab investigation reports (discussing root cause analysis and CAPA), change controls.

Agios Pharmaceuticals, Cambridge, MA, Pharmaceutical Consultant, 2015 - 2016

• Pharmaceutical CMC Consultant; reviewed and provided scientific input on pharmaceutical documentation for tablet and capsule development and manufacturing scale-up (ex. API physico-chemical properties, supplier specifications CoA, research and development reports, drug formulations, microbiological issues, batch records and change controls.
• Traveled to U.S. and international CMO sites to oversee GMP tablet and capsule manufacturing for CTM for Phases 1-2.
• Tablet operations included roller compaction and milling. Batches produced up to 130,000 coated tablets and up to 20,000 capsules.
• Resolved pharmaceutical quality issues during production and communicating effectively with production operators and management.

Proteus Digital Health, Redwood City, CA, Pharmaceutical R&D Consultant, 2014 - 2015

• As a Pharmaceutical, Research and Development Scientist and Consultant that commercialized digital medical products to improve patient health.
• Designed and conducted formulation experiments for developing tablet, tablet-in-tablet (core coating), and capsule prototypes containing an embedded FDA-cleared ingestible semiconductor sensor (moisture-sensitive) medical device. Developed blends to modify disintegration time or improve tablet compactibility, generated compression profiles.
• Wrote research and development reports and feasibility reports on chemistry and stability for new potential drug products.
• Trained and supervised technicians to conduct pharmaceutical QC tests and prepare batches.
• Worked with ISO Class 8 clean rooms.
• Prepared stability protocols (HDPE bottles and Blister cards) and managed QC testing of stability samples. Analyzed results using JMP and report findings on study progress to management.
• Conducted Quality-by-Design (QbD) CMC risk assessment of product commercialization work to be done at CMO.
• Identified and documented critical quality attributes of formulations and critical process parameters.
• Provided advice to manufacturing and operations on other CMC risk assessment and quality (design and process FMEA) documentation.

TreMonti Consulting, Fairfax, VA, Pharmaceutical IP Consultant, 2011 - 2016

• Intellectual Property Consultant for this Pharmaceutical and Biotechnical company that authored over 50 reports on the assessment of intellectual property for various universities for subject matters:
• Biologics to treat various forms of cancer and rheumatoid arthritis;
• Medical device for diabetes utilizing NIR spectroscopy;
• Epinephrine treatment of anaphylaxis;
• Nanoparticle technology for targeted anti-cancer drug delivery, pediatric HIV treatment;
• Genetically engineered microalgae for production of omega 3-fatty acids;
• Opioid drugs - Anti-abuse pharmaceutical formulations;
• Evaluated stage of research, clinical data, commercialization feasibility, market, competitive position, and licensing partners.

Handbook of Pharmaceutical Excipients, London UK, 2011 - 2015

• Invited to serve as a writer and editor for both the 7th and 8th editions of this reference book used in pharmacy schools internationally. Wrote/edited eight excipient monographs for ingredients used in the pharmaceutical industry.

Advanced BioNutrition, Columbia, MD, Formulation Scientist, 2013 - 2014

• Patented and licensed various biotechnology-based innovative technologies for commercialization.
• Developed coating systems which significantly improved (by 40%) vitamin stability against oxidation as compared against the competitor's technology.
• Validated process and developed proprietary coating formulation which significantly and consistently improved bacterial survival between 60-70%.
• Developed Nutraceutical (ex. antioxidants, vitamins, and probiotic bacteria) encapsulations and nano-emulsions utilizing varied technologies.
• Utilized fluid bed coating and lyophilization techniques to protect biological activity. Inform Senior Management and Project Teams on key findings.

J. AOAC, (Association of Official Analytical Chemists), 2013 - 2014

• Invited to serve as scientific editor for the journal.
• Edited 60 manuscripts from foreign universities; for content as well as aspects of pharmaceutical chemistry, spectroscopic analysis, and analytical method validation.

Food & Drug Administration (FDA-CDER), Silver Spring, MD, Pharmaceutical Scientist, 2012 - 2013

• Formulated Orally Disintegrating Tablet (ODT) containing taste-masked clindamycin beads. Developed using the fluid bed coater.
• Monitored coating process using on-line NIR spectroscopy. Publication submitted.
• Utilized HPLC, particle size, surface area, DSC/MDSC, TGA, FTIR, NIR, Raman, UV-VIS spectrometers, types I&II Dissolution, and PXRD to evaluate API and formulations.
• Proficient with using PCA/PLS/PCR for Multivariate Analysis in Unscrambler.
• Conducted HPLC analytical method validation on drugs.
• Conducted spectroscopic and analytical work to analyze melamine. Wrote report on the public health impact of product adulteration.
• Devised stability studies to evaluate the interaction of gelatin capsules with various excipients using different temperature/humidity levels. Presented at AAPS (part of a grant from the Department of Defense for the Tamiflu-influenza project).

Pfizer Consumer Healthcare, Richmond, VA, Consultant-Manager, 2009 - 2011

Regulatory Analyst, Project Manager and Consultant for the NDA and Monograph Products

• Provided scientific and regulatory assessment of a variety of manufacturing plant post-approval change controls and communicated information to stakeholder affiliates in key global markets: U.S., Canada, Asia, Europe, Middle East, Central American, and South America, (with successful, $1.6 billion in sales).
• The affiliates communicated with their health authorities (HA), as advisor briefed on the tests and documentation required for products to be marketed in their home countries.

Completed Reports

• Plant was changing their supplier of PET resins and colorant for bottles of OTC cough syrups. Line trials and stability studies were required in the plant. Communicated with Middle East affiliates: HA required prior approval before shipments allowed. Required validation report, accelerated 3 mo. stability data with commitment for 1 year under ambient conditions, and updated finished product and bottle specifications.

One lot to be stored horizontally so that the product contacts the container/closure system. Other countries only required HA notification of the plant change and shipments could start after 30 days. Products were shipped as per schedule.

• Cost savings: a contract vendor previously prepared glycerin 95% by diluting 99.7% with water and shipping in drums (for OTC cough syrups for the Mexican and LATAM market). Pfizer management decided that it would no longer use this contractor. The manufacturing process would be to start from bulk 99.7% and dilute with water in the plant. Identified the risk assessment of this change to the Mexican/LATAM affiliates. Satisfactory accelerated stability data pre- and post-change showed that no long-term stability tests or validation data would be required as the formulation did not change. The products were approved to ship to the Mexican and LATAM market with no HA notification required.
• A change control was initiated due to a third-party vendor in South America manufacturing bulk soft gels for shipment back to the US for packaging. The gelatin in the formulation was actually a combination of beef and pork (for improved tensile strength).
• Authored Submission-Ready Regulatory Documents for electronic filing for different country markets. Managed renewals and new product registrations in different countries. Obtained CEPs for APIs and provided documents for free sales certificate (CPP) from FDA.
• Updated various product registration databases for documentation management for 130 products to ensure QA compliance.
• Provided input to the Raw Materials testing team on which analytical tests are critical to the quality of the finished products. This reduced testing initiatives that maintained quality and provided cost savings to Pfizer.
• Reduced stakeholder complaints by 20% by processing change controls efficiently.

MedTech Insight, Consultant, 2009

• Wrote and edited Market Research chapters on Pain Management Therapies for:
• Rx and OTC drugs: sales, CAGR, and clinical aspects.
• Complementary and alternative medicine.
• Pain Management Medical Devices (i.e., spinal cord stimulators, TENS, NMES, patient-controlled analgesia devices), and pain management clinics. Summarized clinical trial results.
• ISO 13485, CE marking, and CFR Part 820 for Medical Devices.
• Wrote Market Research chapters on Age-related Macular Degeneration (AMD) and diabetic retinopathy.
• Covered clinical aspects, market forecast, and strategic pharmaceutical product analysis.

ICON Development Solutions, Ellicott City, MD, Senior CMC Regulatory Scientist, 2008 - 2009

• Managed wrote, compiled, and editor of CMC sections (drug substance and drug product) for two IMPDs (lyophilized biologics: recombinant growth factor and hormone) and BLA (interferon).
• First IMPD required major revisions to transform document into CTD format, gap analysis, and substantive editing. Made over 300 scientific, regulatory, and technical comments.
• Wrote and compiled sNDA (semisolid) to support manufacturing site change (SUPAC).
• Wrote IND for small molecule psychiatric drug (capsules) and parts of NDA for controlled-release tablet product.
• Regulatory consulting: Assumed and lead CMC role during client calls; conducted problem resolutions and provided global clients with regulatory strategy. Provided regulatory advice on ANDA/NDA for the following:
• residual solvents (USP <467>);
• analytical method validation and process validation;
• process-related impurities;
• meeting potency specifications during product shelf life;
• launched a new dosage strength in the U.S. market.
• Handled clinical supply chain management issues, (labeling, documents, calculations).
• Wrote and reviewed label proofs of vials from subcontractor for accuracy.
• Assisted in resolving shipping issues of CTM. Approved CTM ordering and destruction of expired materials.
• Managed client project timelines to ensure on-time and on-budget deliverables.
• Excellent project management skills which resulted in increased client satisfaction.
• Published two articles: 'Drug Regulations: Oncology and Cardiology and Biosimilars impacts on CMC information for US/EU (ICON).'
• Received recognition for work including compensation.

Capricorn Pharma Inc., (IZEEN Pharma), Frederick, MD, Management, 2000 - 2003

Promotion: Senior Manager, 2001

• Consultant to a start-up pharmaceutical company that managed technicians.

Senior Research and Development Manager

• Successfully took nutraceutical & OTC products from lab concept to manufacturing scale-up (900# batches).
• Developed sugarless softchews, bars, rapid dissolve Dextromethorphan tablet, and cough drops.
• Chews licensed to Bristol Myers Squibb (BMS) and launched nationally under Choice DM brand.
• Developed taste-masked encapsulations of OTCs and nutraceuticals using a variety of fats and waxes. Scaled-up flavor and sweetener encapsulations to 3000# (purchased by companies in Holland and Turkey).
• Company awarded $ 1,800,000 for achieving milestones for BMS within timetables.
• Developed and scaled-up Dextromethorphan tablets (OTC) for BMS (API encapsulation, wet granulation, compression).
• Effectively taste-masked drug using a hot-melt wax coating.
• Developed formulation for high-shear wet granulation that was scaled-up to 200 kg.

Honors & Publications

Credentials

Thesis and Focused Studies

• The Compacted Multiparticulate System for Modified Release: Design - Characterization
• Developed models to predict tablet hardness and content uniformity-NIR Spectrocopy..
• Hot stage microscopy, particle size (laser diffraction); Pre-formulation
• Improving solubility: Pharmaceutics challenges of Benzodiazepines (paper).
• Piroxicam tablets optimization through varying wet granulation parameters.
• Preparation and analysis; Carbamezepine polymorphs using DSC. Studied Tg of ethylcellulose using MDSC.
• Fractionation of pectins' per charge distribution using FPLC and ion-exchange chromatography. Pectin fractions and sugars quantification using UV-VIS spectroscopy.

Languages

• Spanish: Reading writing and speaking

Academic and Professional Affiliations

• American Chemical Society-ACS
• American Association of Pharmaceutical Scientists-AAPS

Awards

• FDA- Medical Counter Measures - Best Technical Poster Award
• 'Phi Kappa Phi & Rho Chi Honor Societies
• AAPS Maryland Student Chapter Travel Award
• PDA Pharmaceutics Fellowship
• GRASP 2005, Brooklyn, NY: Best research poster

Publications

• Authored over 50 publications -- includes 10 publications in the pharmaceutical field.
• Author - book chapter-Healthcare; Use of binders.
• Other publication and works: Nutraceuticals (food formulation, vitamins and minerals, product design in the diabetic market).
• Regulatory and Policy Publications (DSHEA)
• Food product development-Ingredients: (Fermented, diary, snacks, fruit and fruit fillings, nuts and seeds, sourdough, coatings, gums and starches, dressings, soft drinks, and lowfat cheese)
• Pharmaceuticals-Evaluation, Formulation Mechanical Properties, (Extrusion-Spheronized Beads & Multiparticulate Systems, Modified Release of Water-Soluble Drugs, High Drug Load Formulations: Wet Granulation vs. Novel Foam Granulation, Taste-Masked Orally Disintegrating Tablets, and Biosimilars on CMC information for U.S and Europe.

Education

• Ph.D. Pharmaceutics-Industrial Pharmacy, University of Maryland Baltimore, MD
• M.S. Food Science, University of Georgia, Athens, GA
• B.S. Chemistry, State University of New York, Oneonta, NY