Expert Details
API Polymorphism, Salt/Cocrystal selection, Physicochemical characterization, Crystallization and Precipitation Processes
ID: 737886
New Jersey, USA
As a scientist at Eastman Kodak Company for 14 years, engineered new submicron-sized AgX crystals and pioneered nano-sized pharmaceutical crystals for Sterling Winthrop.
In his 14 years at Novartis, had concurrently been a leader of both Salt & Polymorphism and Particle Engineering networks. His responsibilities included salt, co-crystal, and polymorphic form selection for API development; API property characterization, crystal and particle engineering, and optimization and scale up of API crystallization processes. Supervised over 280 API projects dealing with salt/co-crystal and polymorph screening, form selection, and crystallization development. Investigated > 850 polymorphs and solvato-morphs (hydrates and solvates).
Authored/co-authored two monographs, ten book chapters, 27 patents, 40 refereed papers, and >100 papers presented. Just two APIs he co-invented and led their early development (Tasigna® and Entresto®), now bring $3.5 billion annually in revenue
- Provides expert reports on (non)infringement and/or (in)validity, rebuttals, and specialized opinions
- Focuses consulting on polymorphism and solvatomorphism (hydrates and solvates) of active pharmaceutical ingredients (APIs) and topics relating to the development of APIs, salt/co-crystal and polymorph selection, and solid-state properties as determined by XRPD, DSC, TGA, DTA, DVS, Raman, IR, UV-Vis, hot stage microscopy, particle sizing techniques, etc.
- Provided expert consulting services in a variety of settings, including drug development (Biogen, Sanofi, Novartis), specialized training (e.g., Sanofi, UBM-India, Treffen-India), and API patent litigation (ten clients from USA, Canada, UK, and European Union)
- Deposition tested, comfortable in both (in)validity and (non)infringement aspects
- Represented both innovator and generic companies
- Partnered with reputable analytical and organic synthesis laboratories to test samples and/or to confirm/question/disprove the results of patent examples
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1981 | Degree: DSc | Subject: Chemical Engineering | Institution: Wroclaw University of Science and Technology, Wroclaw, Poland (WUST) |
| Year: 1979 | Degree: MS | Subject: Applied Mathematics | Institution: University of Wroclaw, Wroclaw, Poland |
| Year: 1975 | Degree: PhD | Subject: Chemical Engineering | Institution: WUST |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2014 to Present | Employer: Undisclosed | Title: Independent Consultant and Expert Witness | Department: API Development |
Responsibilities:- Provides expert reports on (non)infringement and/or (in)validity, rebuttals, and specialized opinions- Focuses consulting on polymorphism and solvatomorphism (hydrates and solvates) of active pharmaceutical ingredients (APIs) and topics relating to the development of APIs, salt/co-crystal and polymorph selection, and solid-state properties as determined by XRPD, DSC, TGA, DTA, DVS, Raman, IR, UV-Vis, hot stage microscopy, particle sizing techniques, etc. - Provided expert consulting services in a variety of settings, including drug development (Biogen, Sanofi, Novartis), specialized training (e.g., Sanofi, UBM-India, Treffen-India), and API patent litigation (ten clients from USA, Canada, UK, and European Union) - Deposition tested, comfortable in both (in)validity and (non)infringement aspects - Represented both innovator and generic companies - Partnered with reputable analytical and organic synthesis laboratories to test samples and/or to confirm/question/disprove the results of patent examples |
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| Years | Employer | Title | Department |
| Years: 2000 to 2014 | Employer: NOVARTIS Pharmaceuticals Corp., East Hanover, NJ (USA) | Title: Principal Fellow and US Network Leader | Department: Chemical and Analytical Development |
Responsibilities:Led both Salt & Polymorphism and Particle Engineering networks. Was responsible for formal review and approval of all Salt Screening, Polymorph Screening, Polymorphism Program, and Salt Program reports, and laboratory procedures for the final step of API manufacture. Supervised over 280 API projects addressing polymorph and salt/co-crystal screening, form selection and physicochemical properties characterization, and crystallization development. Investigated > 850 polymorphs and solvatomorphs (solvates and hydrates) and analyzed single crystal structures. Contributed to FDA filings. Named author on 24 API crystal form (salts and polymorphs) patents.Salt and Polymorphism Network - Supervised all US polymorph and salt/co-crystal screening activities, salt programs, polymorphism programs, drug substance property evaluation, initial crystallization development studies, single crystal structures, as well as all US-based releases for APIs (five GMP tests: XRPD, FT-IR, DSC, TGA, PSD) - Co-designed with Zinsser Analytic and subsequently implemented an automatic high-throughput screening platform for polymorphs and salts/co-crystals which remarkably increased the dimensions of the experimental space and thus significantly reduced the risk of missing viable polymorph and/or nonoptimal API form selection - Implemented co-crystal screening as a routine complement to salt screening (and the principal screening method for neutral compounds) Particle Engineering Network - Built and supervised new particle engineering capabilities in US with the state-of-the-art equipment and PAT tools (automated parallel crystallization stations; on-line turbidity, on-line video-microscopy, on-line particle size distribution, and on-line IR for crystallization monitoring; automatic solubility measurements; etc.). |
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| Years | Employer | Title | Department |
| Years: 1986 to 2000 | Employer: EASTMAN KODAK Company (EK), Rochester, NY (USA) | Title: Member of the Senior Research Staff and Consultant | Department: Research Laboratories |
Responsibilities:- Made significant contributions to the control of the reactive batch precipitation process for silver halides (AgX) and enabled morphology manipulations of AgX imaging materials. Developed a rational AgX crystal size control via the design of the reagent addition rate vs. time profile. Built mathematical models for the growth of cubic, octahedral, and tabular AgX crystals; and for dopant incorporation into the AgX crystal lattice.- Pioneered scientific and experimental work (1991-1994) on nanoparticulate pharmaceutical materials for therapeutical and diagnostic applications (for Kodak’s subsidiary Sterling Drug/Sterling Winthrop). Produced first ever nanoparticulate pharmaceutical materials for APIs and iv contrast agents via direct, controlled microprecipitation (no milling) applying both batch and continuous processes. |
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| Years | Employer | Title | Department |
| Years: 1975 to 1986 | Employer: 3 universities (Poland and 2 in USA) | Title: Chemical Engineering Faculty | Department: Chemical Engineering |
Responsibilities:An effective educator in Chemical Engineering at three universities. Taught Unit Operation Lab, Fundamentals of Momentum, Heat and Mass Transfer undergraduate courses; and Mass Transfer, Separation Phenomena, Crystallization, Mathematical Methods in Chemical Engineering graduate courses. Sole advisor of 4 Ph.D. and 19 MS theses.Developed a two-step crystal growth model adapted by crystallization/precipitation scientists around the world, now found in handbooks - Was first to separate contributions of bulk diffusion and surface reaction in crystal growth and use the rate constants of these two component processes to explain the effect of various process variables on crystallization/precipitation - Developed equations to calculate a supersaturation-generating property rate vs. time profile ensuring crystal size control in seeded and unseeded batch crystallization and precipitation processes. Investigated the effect of temperature, hydrodynamics, cooling rate, reagent addition rate, antisolvent addition rate, moment of seeding, etc., on the quality of crystalline product. - Was first to design and implement automatic nephelometric device for detection of nucleation events and measurement of the metastable zone width in crystallization (in 1974!). 35 years later, this principle has been now widely used by renowned vendors that include Mettler Toledo, Avantium, Thermo Scientific, etc. |
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Career Accomplishments
| Publications and Patents Summary |
|---|
| Authored/co-authored two monographs, ten book chapters, 27 patents, 40 refereed papers, and >100 papers presented. |
Additional Experience
| Expert Witness Experience |
|---|
| Provided expert consulting services in a variety of settings, including drug development (Biogen, Sanofi, Novartis), specialized training (e.g., Sanofi, UBM-India, Treffen-India), and API patent litigation (ten clients from USA, Canada, UK, and European Union) - Deposition tested, comfortable in both (in)validity and (non)infringement aspects - Represented both innovator and generic companies |
| Training / Seminars |
|---|
| Numerous workshops, seminars. List available upon request. |
Language Skills
| Language | Proficiency |
|---|---|
| English | Fluent |
| Polish | Native |