Pharma Crystallization Summit

Dr. Luca Iuzzolino, Merck & Co.

wpadm — Thu, 29 Sep 2022 04:28:53 +0000

Luca Iuzzolino works as a Senior Scientist in the Computational and Structural Chemistry (CSC) group within Merck & Co., Inc. His work place is in Rahway, NJ. In his role, he provides expertise in solid state modeling and is involved in a variety of drug development projects in close partnership with experimental collaborators. Prior to joining his current company in 2019, Luca received his PhD at University College London (UCL) under the supervision of Sarah L. Price.

Panel Discussion: Gaps and Opportunities in Computational Design and Optimization of Pharmaceutical Crystallization

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Dr. Vivian Bi, Aclaris Therapeutics

wpadm — Mon, 26 Sep 2022 23:05:40 +0000

Dr. Vivian Bi is a Senior Director and Head of Pharmaceutical Development at Aclaris Therapeutics Inc., where she looks after the development of multiple pharmaceutical products from preclinical to phase IIb. She has held various positions at Pfizer Global R&D, Vertex Pharmaceuticals, AstraZeneca Pharmaceuticals and Ashland Specialty Ingredients before joining her current organization. Her research interests are oral and parenteral drug delivery systems for both small molecules and biologics. Dr. Bi has published over 50 research papers, abstracts and patents. She obtained her B.S. degree from Shenyang Pharmaceutical University in China, and completed her Ph.D. in Pharmaceutical Science from Meijo University in Japan.

Panel Discussion: Early Formulation Challenges and Solutions – Discovery to Phase I

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Dr. Veeran Gowda Kadajji, J-STAR Research

wpadm — Mon, 26 Sep 2022 23:02:59 +0000

Veeran Gowda Kadajji, holds a PhD in Pharmaceutical sciences. In his current role, he leads drug product development group at J-STAR Research in Cranbury, NJ. He has close to 20 years’ experience working in different phases of drug product development. His work is focused on using drug enabling technologies to solve solubility and bioavailability challenges and enable transition of molecules from discovery to clinical phase.

Panel Discussion: Challenges and Solutions of Developing Amorphous Solids as Drug Substance

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Dr. Qi Gao, J-Star Research

wpadm — Mon, 26 Sep 2022 22:58:39 +0000

Dr. Qi Gao is a Distinguished Research Fellow of J-Star Research. She received a B.S. degree in Chemical Engineering and Materials Science from Tsinghua University and a Ph.D. in Crystallography from University of Pittsburgh. After postdoctoral research in Biophysics and Structural Biology at MIT, she joined Bristol-Myers Squibb where she worked for 27 years on many molecules and processes of drug discovery and development. With over 35 years of experience in solid-state chemistry and materials science and 30 years of experience in Pharma R&D, she is an SME in crystallization, characterization, and properties of pharmaceuticals related to molecule, solid form and material, and in development of associated intellectual property and regulatory filings.

Workshop: CMC Development Strategies

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Dr. Kaushalendra Chaturvedi (KC), J-Star Research

wpadm — Mon, 26 Sep 2022 22:55:44 +0000

Dr. Kaushalendra Chaturvedi is a Sr. Research Scientist at J-Star Research Inc., in the Center for Pharma Crystallization (CfPC) and Drug Product Development group (DPD). His research is focused on solid state chemistry, crystallization, evaluation of crystal forms for their acceptability as pharmaceutical drug substance, and formulation development to enable rapid early phase development. He is also on the forefront of a pioneering technology developed in J-Star that involves simultaneous development of drug substance and drug product through co-processing and particle engineering. Dr. Chaturvedi received his PhD in Pharmaceutics & Drug Design from the Long Island University, New York. During his PhD tenure he worked on industry and US-FDA sponsored projects focusing on pharmaceutical’s developability and manufacturability. He has published 22 peer-reviewed articles, three book chapters, and currently serving as a reviewer for journals including Pharmaceutics, Drug Delivery & Translational Res., Euro. J. of Pharm. Sci., Pharm. Res., AAPS PharmSciTech, Polymer Bulletin, AAPS-Open, Pharm. Dev. & Tech., Drug Testing & Analysis, and Dissolution Technologies.
Lab Tours: DS/DP R&D Demo Stations: from material sciences to process development

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Dr. John A. Grosso, Arvinas

wpadm — Mon, 26 Sep 2022 22:52:38 +0000

Dr. Grosso is the Senior Vice President of R&D Technical Operations at Arvinas Inc. He is responsible for active ingredient and drug product development, scale-up, manufacturing, and clinical supply logistics in support of Arvinas’ portfolio of PROTACS® (protein degraders) useful in the treatment of cancer and other diseases related to over-expression and protein mutation. He has developed a global supply chain encompassing over 20 CDMOs, spanning 8 countries and 3 continents and has transitioned development programs into commercial facilities for preparation of Ph3 supplies, validation and commercial launch.

Prior to joining Arvinas, Dr. Grosso was Executive Director and Head of Pharmaceutical Development at Vitae Pharmaceuticals where he was responsible for API and DP development and manufacturing as well as Clinical Supply. During the two years spent at Vitae, he advanced two oral RORƴt antagonists and one LXR agonist into the clinic.

Dr. Grosso began his career with Bristol-Myers Squibb in Chemical Process R&D rising to the level of Director and site-head for PR&D over a twenty-year span. He transitioned into Analytical R&D where, as Executive Director, he was responsible for process analytical science, method development and testing for both API and DP, in addition to a number of specialty labs. He finished his tenure at BMS as Executive Director, Drug Product Science and Technology. Over his 32-year career at BMS he played a pivotal role in the development and commercialization of Monopril®, Taxol®, Eliquis®, Sprycel®, and Dapagliflozin®

Dr. Grosso earned his undergraduate degree in Chemistry at New York University, and his Ph.D. in Medicinal Chemistry at Purdue University.

Panel Discussions: Early Formulation Challenges and Solutions – Discovery to Phase I

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Dr. Jian Wang, J-Star Research

wpadm — Mon, 26 Sep 2022 22:43:49 +0000

Dr. Jian Wang is an expert in API crystallization, with comprehensive knowledge of the science and technologies required to meet the needs of small molecule drug development. She has over 30 years of R&D experience in API crystallization and reaction engineering, and has been providing R&D services since 2005 to pharmaceutical clients around the globe.

Dr. Wang received her Ph.D. degree in Chemical Engineering in 1994, from the University of Pittsburg with Prof. Donna Blackmond and Prof. Irving Winder. She published 20 peer-reviewed articles and 6 patents (5 related to API crystallization) before getting into technical services.

During her 11-year tenure at Merck since 1994, Jian became an expert in API process R&D and a champion in implementing science-based and technology-enabled approaches. She promoted the application of PAT tools in process R&D serving as a consultant at Mettler Toledo AutoChem during 2005-2010. In 2011-2013, Jian took the responsibility as VP of Crystallization Development at Crystal Pharmatech, helping a diverse client base in solving API crystallization problems. To better assist new drug development programs, Jian started up a state-of-the-art crystallization center at J-Star Research in the beginning of 2014 complementing its strong API Process Research. She now leads the Center for Pharma Crystallization at J-STAR as Senior Vice President, addressing a wide range of challenges associated with API isolation from early to late developmental stages. Working closely with drug formulation experts, Jian also has been driving the establishment of drug formulation services at J-Star that are well integrated with API crystallization R&D.

Session 2: Physical Property Based Crystallization Process Development

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Dr. Harsh S. Shah, J-Star Research

wpadm — Mon, 26 Sep 2022 22:37:59 +0000

Harsh S. Shah is working as a senior scientist at J-Star Research Inc. (Cranbury, NJ), where he leads “fit-to-purpose” research projects in drug discovery and drug product development. He is focused on helping to advance by searching physicochemically stable solid forms of new chemical entities, develop and optimizing efficient processes and preformulation studies using advanced analytical and computational techniques. His prior experience includes working at Lachman Institute for Pharmaceutical analysis at Long Island University, collaborative projects with the United States Food & Drug Administration (FDA), Bristol Myers Squibb, Triclinic Labs, Vertex Pharmaceuticals and Amneal Pharmaceuticals. He employs eclectic research approaches to address the challenges encountered throughout drug product development and scale-up. Dr. Shah is a recipient of nationally and internationally recognized awards which include “Research Excellence Award – 2020” by InSc, “PhD Outstanding Student Award – 2020” at Long Island University, and “Academic Research Award – 2019 – 2nd place” at AAPS NERDG annual conference. He has published 17 research papers in Peer-Reviewed Journals and more than 20 abstracts in National & International Conferences. Dr. Shah is an editorial board member for AAPS Open, Asian Journal of Pharmaceutics and International Journal of Science and Pharma Innovations. He is an active member in various professional societies including AAPS, Rho-Chi, IPSE, and ACS.

Lab Tour: DS/DP R&D Demo Stations: from material sciences to process development

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Dr. Changquan Calvin Sun

wpadm — Wed, 07 Sep 2022 00:08:08 +0000

Dr. Sun is Professor of Pharmaceutics in the Department of Pharmaceutics, University of Minnesota, USA. Dr. Sun’s research focuses on formulation development of tablet products through appropriate application of materials science and engineering principles. Two areas of current research are 1) crystal and particle engineering for superior pharmaceutical properties, e.g., powder flowability, tabletability, dissolution, and stability; 2) fundamental understanding of pharmaceutical processes, e.g., milling, blending, granulation, and tableting. As of September 2, 2022, he had published more than 230 papers in these areas with more than 11,000 citations (H-index = 56).

Dr. Sun currently serves on the editorial advisory boards for AAPS Open, CrystEngComm, Frontiers in Chemistry, Int. J. Pharm., J. Pharm. Sci., Mol. Pharmaceutics, and Pharm. Res. He has served on the Expert Committee in Physical Analysis of the United States Pharmacopeia since 2010. Dr. Sun is an AAPS Fellow and a Fellow of Royal Society of Chemistry.

Keynote Presentation: Spherical Cocrystallization of Pharmaceuticals

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Spherical Cocrystallization of Pharmaceuticals

wpadm — Wed, 07 Sep 2022 00:05:18 +0000

By Prof. Changquan Calvin Sun, Pharmaceutical Materials Science and Engineering Laboratory, University of Minnesota

The development of a quality tablet product requires overcoming deficiencies in pharmaceutical properties of an active pharmaceutical ingredient (API) to meet several performance standards. APIs with poor aqueous solubility present a challenge in tablet development for meeting the desired dissolution performance to assure adequate bioavailability. If it can be adequately controlled for robust manufacturing performance, direct compression is preferred among common manufacturing processes, because of its economy. Cocrystallization is an effective crystal engineering approach for overcoming deficiencies of APIs, e.g., solubility, tabletability, and stability. Spherical crystallization is an established particle engineering technique for improving powder properties to enable direct compression. Spherical cocrystallization holds the potential to simultaneously improve both key pharmaceutical properties and powder properties to enable direction compression of tablets with both robust manufacturability and superior in vivo performance. In this talk, examples of spherical cocrystallization of APIs and their use in developing direct compression tablet formulations will be presented.

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