Leaders in Pharmaceutical Business Intelligence (LPBI) Group

Stuart L. Cantor, PhD

Expert, Author, Writer

   410-900-7109

stubee2@gmail.com

Categories of Research at LPBI:

• FDA Regulatory Affairs
• Stents & Tools
• Nanotechnology for Drug Delivery
• Nutrition
• Pain: Etiology, Genetics & Innovations in Treatment
• Personalized Medicine (Lab-on-a-chip)& Genomic Research

 

SUMMARY

• Pharmaceutical Formulation Scientist with proven technical expertise in developing tablet and capsule products by applying Quality by Design (QbD) principles: chewable and fast dissolving tablets (ODTs), coated tablets and beads (i.e., controlled release and taste-masked).

• Expertise in various unit operations: wet granulation (fluid bed, high shear), coating, and encapsulation.

• Hands-on experience across the product development cycle from pre-formulation, formulation, and process optimization to develop pharmaceutical products meeting a desired quality target product profile (QTPP) with pre-determined critical quality attributes (CQAs).

• Strong background in scientific/CMC regulatory and quality documentation writing. Prepared quality risk assessment reports for pharmaceutical manufacturing/packaging at CMO sites.

• Strong project management skills. Managed writing, compiling, and editing of CMC sections (drug substance/drug product) for two IMPDs (lyophilized biologics: recombinant growth factor and hormone) and BLA (interferon).   Also wrote sNDA, parts of NDA, and IND (small molecules). Authored 10 publications in the pharmaceutical field.

 

PROFESSIONAL EXPERIENCE

 

Agios Pharmaceuticals  Cambridge, MA

09/2015 – Present

Pharmaceutical Scientist (Consultant)              

• Review and provide scientific input on pharmaceutical documentation for tablet/capsule development & manufacturing scale-up (ex. API physico-chemical properties, supplier specs/CoA, R&D reports, formulations, batch records.
• Prepare risk assessment reports during stages of drug development/manufacturing of clinical trial material (CTM). Review and summarize QA CTM investigation reports of root cause analysis.
• Travel to U.S./International CMO sites to oversee GMP tablet and capsule manufacturing operations (blending, roller compaction/milling, tableting, encapsulation, coating) for CTM for Phases 1-2. Capable of resolving pharmaceutical quality issues during production and communicating effectively with production operators and management.

 

Proteus Digital Health    Redwood City, CA

12/2014 – 08/2015

Pharmaceutical R&D Scientist (Consultant)

Company is involved in commercializing digital medical products to improve patient health.

• Wrote R&D development reports and feasibility reports on chemistry/stability for new potential drug products (up to 150 pages/week). Trained/Supervised technicians to conduct pharmaceutical QC tests and prepare batches. Experience working in ISO Class 8 clean rooms.
• Designed/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.
• Prepare stability protocols (HDPE bottles and Blister cards) and manage QC testing of stability samples. Analyze results using JMP and report findings on study progress to management.
• Conduct Quality-by-Design (QbD) CMC risk assessment of product commercialization work to be done at CMO. Identify/document critical quality attributes of formulations and critical process parameters. Provide advice to manufacturing/operations on other CMC risk assessment and quality (design and process FMEA) documentation.

 

Advanced BioNutrition   Columbia, MD

06/2013 – 07/2014

Formulation Scientist

ACCOMPLISHMENTS: (received first raise at 9 months)

• Developed coating systems which significantly improved (by 40%) vitamin stability against oxidation as compared against the competitor’s technology.
• Developed nutraceutical (ex. antioxidants, vitamins) encapsulation technologies.  Informed senior management and project teams on key findings.

 

Food & Drug Administration (FDA-CDER)   Silver Spring, MD

01/2012 – 06/2013

Pharmaceutical Research Scientist

• 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, and PCR for Multivariate Analysis in Unscrambler software. 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. This was presented at AAPS 2012 (part of a grant from the Department of Defense for the Tamiflu-influenza project).

 

AOAC (Association of Official Analytical Chemists) Intl.                      

04/2013 – 12/2014

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

 

TreMonti Consulting Fairfax, VA

04/2011-06/2015

• Wrote 40+ reports on assessment of intellectual property for various U.S./Foreign universities and hospitals: Fields of Specialization: Pharmaceutical, Biotechnology, Medical Device, and Chemistry.
• 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 drug delivery
• Genetically engineered microalgae for production of omega 3-fatty acids
• Opiod drugs – Anti-abuse pharmaceutical formulations

Evaluated stage of research, clinical data, commercialization feasibility, market, competitive position, and licensing partners.

 

Pfizer Consumer Healthcare, Richmond VA

10/2009 – 04/2011

Regulatory Analyst/Project Manager (NDA & Monograph products- $1.6 B sales)

• 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: US/Canada, Asia, Europe, Middle East, and Central/South America. The affiliates communicated with their health authorities (HA) and I also advised them on the tests and documentation required for products to be marketed in their home countries.

Examples

• 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, & updated finished product and bottle specifications. At least one lot is 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.
• Preparation H products contained phenylephrine at 0.25% as a vasoconstrictor. However, marketing had received consumer complaints that the product had changed color from off-white to beige. The product was re-formulated to be beige-colored and termed “crème brulee” color according to a color standard. The Korean affiliate did not understand the risk assessment of the change, was not familiar with the term “crème brulee” and initially marked this change as prior approval, which would have delayed shipments. After communicating with her, we determined that there was no regulatory impact of the color change and the only documentation required for their files would be the updated specifications and test methods.
• 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/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. I communicated 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/LATAM market with no HA notification required.
• A change in the formulation of ChapStick products was initiated because the International Fragrance Association (IFRA) determined that a chemical solvent in the formula was not considered as GRAS. This change affected multiple products within the global market for ChapStick. Ingredient formulations needed to be re-calculated and verified for accuracy by me. Another regulatory issue was that the appropriate chemical name appear on the label as different countries had different requirements. Some South American countries required the NGO nomenclature of INCI (Intl. Nomenclature of cosmetic ingredients). I worked with the affiliates in those countries to prepare the labels according to their requirements.
• Cough syrups for the Israel market were reformulated to remove alcohol. Residual solvent specifications for the two active ingredients needed to be updated, and CoA, test method, and validation protocol/results needed to be sent.
• Marketing had received several wholesaler and retailer complaints from their customers that two cough syrups had contained foreign particles. Root cause analysis was done and it was found that one active ingredient crystallized during cold storage stability studies. I provided my regulatory risk assessment to the team. It was decided that no lots would be placed on hold but that the temperature of the product in the trucks must be better controlled to avoid this quality issue in the supply chain
• 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). Pork-derived ingredients were not permitted for products shipped to the Middle East. I placed a hold on shipments for those countries and alerted them that their shipments could be delayed. I provided my regulatory review and assessment of the formulations as well as modified formulations that would be used for products for the Middle East markets.
• 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 & 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 initiative maintained quality & provided cost savings to Pfizer.
• Reduced stakeholder complaints by 20% by processing change controls efficiently.

 

ICON Development Solutions, Ellicott City, MD

06/2008-06/2009

Senior CMC Regulatory Scientist

• Managed writing, compiling, and editing of CMC sections (drug substance/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/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.   Interfaced with Regulatory Affairs and Statistics departments in compiling/writing documents and during client t-cons.

Regulatory consulting: Assumed lead CMC role during client telecons; demonstrated ability to problem solve and provide global clients with regulatory strategy. Provided regulatory advice on ANDA/NDA:

• residual solvents (USP <467>)
• analytical method validation and process validation
• process-related impurities
• meeting potency specifications during product shelf life.
• launch a new dosage strength in the U.S. market
• Handled clinical supply chain management issues (labeling, documents, calculations).
• Wrote/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: Regulation of Oncology and Cardiology drugs
• Impact of Biosimilars on CMC information for US/EU (ICON)

Received raise and performance bonus.

 

BRISTOL MYERS SQUIB 

2007

Summer Intern, New Brunswick, NJ           

• Prepared wet, foam, and MADG granulations of Metformin, Aspirin, APAP, and Atazanavir. Studied differences in particle size, morphology, and surface area.

• Studied mechanical properties of the different API granulations using Hiestand Indices. Manuscript published in Powder Tech. (first author).

 

CAPRICORN PHARMA (now IZEEN Pharma), Frederick, MD                  

07/2000–06/2003

Start-up pharmaceutical company.   Managed 4 technicians. Promotions: Senior Manager: 2001

Senior R&D Manager

• Successfully took nutraceutical & OTC products from lab concept to manufacturing scale-up (900# batches). Developed sugarless softchews, bars & rapid dissolve Dextromethorphan tablet. Chews licensed to Bristol Myers Squibb (BMS) & launched nationally under Choice DM
• Developed taste-masked encapsulations of OTCs/nutraceuticals. Scaled-up flavor & sweetener encapsulations to 3000# (purchased by companies in Holland & Turkey).

Company awarded $ 1,800,000 for achieving milestones within timetables..

• Developed and scaled-up Dextromethorphan tablets for BMS (API encapsulation, Wet Granulation, Compression).   Wrote Master Batch Records & Stability Reports. Effectively taste-masked drug using a hot-melt wax coating.
• Business Development – Wrote Marketing literature, Presented prototype products to senior management at Fortune 500 companies. Filed 2 provisional patents as co-inventor.
• Responsible for all phases of Project Management including cost control and timetables.

 

TIC GUMS, Inc., Belcamp, MD – Spray drying & agglomeration technology

11/1992–07/2000

Food Chemist/Sr. Technical Services Representative

• Gained experience working with hydrocolloids to create flavor emulsions, suspensions, semi-solid formulations. Worked with vitamin-mineral premixes to create a variety of beverage products. Evaluated stability of emulsions via accelerated studies, and particle size using Coulter counter.
• Provided technical assistance on gum formulations to food/pharma clients & salesforce. Set specifications on over 140 blends and conducted a variety of USP/FCC analytical tests.
• Operation/Troubleshooting of HPLC. Used HPLC for competitor blend matching. Conducted size exclusion chromatography during ingredient development/commercialization.
• ISO 9001 Lead Auditor -Audited Manufacturing & QC. Wrote 40 SOPs/work instructions.

 

EDUCATION

Ph.D. in Pharmaceutics/Industrial Pharmacy

University of Maryland, Baltimore, May 2008

Advisors: Drs. Augsburger/Hoag

GPA: 3.70

MSc. Food Science      

University of Georgia, Athens

GPA: 3.82

Thesis: Postharvest Changes of Pectic Substances in Chill-injured Peaches.

BSc. Chemistry

State University of New York, Oneonta.

 

RESEARCH Domains

• Published book chapter on the Use of Binders in Wet Granulation (Informa Healthcare).Design & Characterization of a Compacted Multiparticulate System for Modified Release.
• NIR spectroscopy: developed models to predict tablet hardness and content uniformity.
• Studied effects of bead coating (Surelease/Eudragit NE30D) on theophylline/cimetidine release from tablets and the mechanical properties of coated/uncoated beads.
• Pre-formulation: Hot stage microscopy, particle size (laser diffraction).
• Improving solubility: Pharmaceutics challenges of Benzodiazepines (paper).
• Optimization of Piroxicam tablets by varying wet granulation parameters.
• Preparation/analysis of Carbamezepine polymorphs using DSC. Studied T_g of ethylcellulose using MDSC
• Fractionation of pectins according to their charge distribution using FPLC and ion-exchange chromatography. Quantification of pectin fractions and sugars using UV-VIS spectroscopy.

 

AWARDS                                                                

FDA- Medical Counter Measures – Best Technical Poster Award, 2013

Phi Kappa Phi & Rho Chi Honor Societies, 2007

AAPS Maryland Student Chapter Travel Award, 2006

PDA Pharmaceutics Fellowship: $10,000  8/05-8/06

GRASP 2005, Brooklyn, NY: Best research poster, 2005

 

PUBLICATIONS: 58

NUTRACEUTICALS:

 

1. Vitamin D: A Versatile Nutrient; 2014. Prepared Foods, NS-3-NS15.

 

2. Probiotic Powerhouses; 2014. Prepared Foods, 10:84-90.

 

3. Vitamin-Mineral Premixes: Jump into the Mix; 2014. Prepared Foods, 1:89-93.

 

4. Food for Thought: Products that Improve Cognitive Health; 2013. Prepared Foods, 9:21-31.

 

5. Designing Products for the Diabetic Market; 2013. Prepared Foods, 4:52:57.

 

6. Special Delivery: Options with Tablets & Capsules; 2012. Nutritional Outlook, 5:48-52.

 

7. Diabetes Management: Turning to Alternatives; 2012. Nutritional Outlook, Jan/Feb. 1:72-76.

 

8. Nutraceuticals Build Sales of Baked Foods; 2001. Baking Management. 10:30-34.

 

9. Micronutrients for Value-Added Designer Foods;1997. Food Product Design. 2: 53-67.

 

10. The Age of Man (Trends in Men’s Health); 2015. Prepared Foods. 1:43-60.

 

11. Formulating Food Products with Vegetable-based ingredients; 2015. Prepared Foods.

9:98-112.

 

12. Digestive Dynamos. Prepared Foods; 2015. 11:28-43.

 

13. Weight Management, Immunity, & Health. Prepared Foods; 2016 (submitted).

 

14. Latest Trends in Diabetes. Prepared Foods; 2016 (submitted).

 

REGULATORY/POLICY: (DSHEA)

15. Industry objects to FDA’s proposed redefinition of disease for dietary supplement

claims. Food Labeling & Nutrition News. August 11, 1999, 7 (44): 4 – 5.

 

FOOD PRODUCT DEVELOPMENT/INGREDIENTS:

 

16. Using Science to Create Beneficial Fermented Ingredients, 2014. Food Processing

8:55-59.

 

17. The Future of Dairy Ingredients; 2013. Food Processing, 11:30-36.

 

18. Snack Trends 2013: Health and Indulgence Square Off. Food Processing, 3:41-47.

 

19. Product Development: Bakery Product Trends Emphasize Healthier Eating, 2013,

Food Processing, 5:23-29.

 

20. Clean Labels Add Sales Appeal; 2008. Baking Management. 7:40-42.

 

21. Adding Value with Nuts & Seeds; 2006. Baking Management. 4: 26-30.

 

22. Nutrition in a Nutshell; 2005. Baking Management. 5:28-32.

 

23. Intensify Flavor & Function with Nuts & Seeds; 2004. Baking Management. 8:26-32.

 

24. Getting the Most Out of Fruit & Fruit Fillings; 2004. Baking Management. 9:36-40.

 

25. Through Thick and Thin; 2003. The World of Food Ingredients. 6: 33-36.

 

26. Using Sourdough Starters to Create Flavorful Breads; 2003. Baking Management. 4:26-29.

 

27. Capitalizing on the Sweet Life; 2003. Baking Management. 10: 26-30.

 

28. Protective Coatings: Using Encapsulated Ingredients; 2003. Baking Management. 6:34-38.

 

29. Getting in Shape with Dough Conditioners; 2002. Baking Management. 3:26-30.

 

30. Gums & Starches Enhance Appearance & Product Texture; 2001. Baking Management.

9:28-32.

 

31. Fruity Ideas; 1999. The World of Ingredients. 9: 30 – 34.

 

32. Dressing & Sauce Savvy; 1999. The World of Ingredients. 7:18 -20.

 

33. Cereals Dash for Growth; 1999. The World of Ingredients. 5: 26 – 30.

 

34. Designing Sweet Confections; 1999. The World of Ingredients.   1: 16 -22.

 

35. Today’s Tasty Trends; 1998. Food Ingredients & Analysis International. 12: 25-30

(invited to cover the Natural Products Expo – exhibitors/products).

 

36. Success in a Bottle: Liquor Industry Trends; 1998. New Product Sightings. 12: 10-12.

 

37. Dairy & Chilled Desserts Formulation; 1998. Food Ingredients & Analysis International.

9: 28 -32.

 

38. Soft Drinks Formulation; 1998. Food Ingredients & Analysis International.   8:23- 28.

 

39. The Way Forward in Fruit Preps; 1998. Food Ingredients & Analysis International.

3:37-49.

 

40. Healthful Attributes Spur Soy Consumption; 1997. Prepared Foods. 8: 107-110.

 

41. Health Foods Market Continues Mainstream March; 1997 Prepared Foods. 11: 75-76

(invited to cover the Natural Products Expo – exhibitors/products)

 

42. Health Beverages for the Ages; 1997. Food Product Design. 6:40-69.

 

43. The Lowdown on Lowfat Cheese; 1997. Prepared Foods. 6: 37 – 39.

 

44. Functional Polymers for the Next Millenia; 1997. Prepared Foods. 5: 123 -124.

 

45. Kernels of Truth: Formulating Value Using Nuts; 1997. Food Product Design. 4: 58-72.

 

46. Juicing-Up Products with Fruit-Based Ingredients; 1996. Food Product Design. 12: 59-71.

 

47. The Diversity of Gums in Food Products; 1994. Vegetarian Journal. 7:10- 11.

 

48. Postharvest Changes of Pectic Substances in Chilled Peaches; 1992.
49. of Food Biochemistry. 16:15-29.

 

PHARMACEUTICALS:

1. Evaluation of the Mechanical Properties of Extrusion-Spheronized Beads & Multiparticulate Systems, Drug Development & Industrial Pharmacy (DDIP) (Online, 04/2008).

 

2. Formulation & Characterization of a Compacted Multiparticulate System for

Modified Release of Water-Soluble Drugs –Theophylline & Cimetidine

(Online: DDIP– 10/2008).

 

3. Cardiology and Oncology Drug Development & Regulation. Drug Delivery

Technology, March 2009, 3:68-72.

 

4. Formulation and Characterization of a Compacted Multiparticulate System for

Modified Release of Water-Soluble Drugs – Part 1 Acetaminophen (DDIP) –

March 2009, 35(3):337-351.

 

5. Evaluation of the Physical & Mechanical Properties of High Drug Load Formulations:

Wet Granulation vs. Novel Foam Granulation (Online: Powder Technology, 05/2009).

 

6. NIR Spectroscopy Applications in the Development of a Compacted Multiparticulate

System for Modified Release (Online- AAPS Pharm Sci Tech. 01/2011).

 

7. Development and Optimization of Taste-Masked Orally Disintegrating Tablets (ODTs) of

Clindamycin Hydrochloride for Pediatric Use. (Online: Drug Development and

Industrial Pharmacy, June 2014).

 

8. Analytical Methods for the Evaluation of Melamine. (Online: Journal of Pharmaceutical Sciences,

December 2013).

 

PHARMACEUTICALS (Book Chapters):

 

9. Analytical Testing and Quality Standards of Capsules. Lead author/editor

and have collaborated with another Professor of Pharmaceutics. Completion: Q2 2014.

 

10. Pharmaceutical Granulation Processes, Mechanism, and the Use of Binders; 2008.

Lead author/editor and collaborated with two professors and a consultant.

         (Book chapter in: Pharmaceutical Dosage Forms: Tablets (sold on Amazon.com)