Confirmed Speakers

Örn Almarsson, Ph.D.

SVP Formulation and Delivery Technologies

Moderna Therapeutics

Dr. Almarsson heads pharmaceutical R&D group at Alkermes, a global bio-technology company, leading groups in Waltham MA and Athlone Ireland. The group has responsibility for active pharmaceutical ingredients (API), formulations, analytical development and pharmaceutical chemistry in support of proprietary and partnered development programs. Dr. Almarsson joined Alkermes in 2008 from TransForm Pharmaceuticals/J&J, where he led product generation based on high-throughput materials platforms. Dr. Almarsson in an inventor on several patents, and has published widely in areas of pharmaceutical chemistry, materials discovery, solid-state characterization, formulation, drug delivery and biopharmaceutical optimization.

Nabil Joseph Farah, Ph.D.

Director of Technical and Business Development

Gattefossé SAS

Dr. Farah has been working at Gattefossé SAS for more than 20 years with increasing reponsibities overtime: Manager of Pharmaceutical Laboratory, Formulation/Application (1990 – 1997); Head of International Technical / Development Assistance (1997 – 2000); Director of Area Business/Technical Development (Asia, MEast, North of Africa, Latin America, East of Europe) (2000 – 2008); Director of Technical and Business Development (Since 2009).

He has professional membership in APGI, SFSTP, CRS and AAPS. He is the author and co-author for over 30 published articles and is named on 6 patents about sustained release technology using lipid, SMEDDS technology, microemulsion technology and hot melt coating technology.

David Good, Ph.D.

Senior Research Investigator

Bristol–Myers Squibb

Dr.Good is a senior research investigator for Bristol-Myers Squibb in New Brunswick, NJ. His professional interests include crystal screening and selection activities, the solubility and thermodynamic stability of cocrystals, as well as absorption models and simulations for designing oral formulations.

Dr.Good has focused on the rational design of cocrystals and contributed toward methods to measure and predict cocrystal solubility as part of his doctoral studies at the University of Michigan in Naír Rodríguez-Hornedo’s laboratory. At BMS, David has continued to pursue fundamental solution models to advance cocrystal characterization and formulation.

Patrick Gosselin, Ph.D.

VP Pharmaceutical Research and Development

Corealis Pharma

Dr. Gosselin is vice-president, pharmaceutical R&D at Corealis Pharma Inc., where he handles formulation and process development of new chemical entities as well as phase I/II clinical trial material manufacturing since 2005. Dr. Gosselin has extensive experience in formulation, technological transfers, and troubleshooting of oral solid dosage form manufacturing.

Past professional experiences consist of pharmaceutical development consulting to several pharmaceutical companies. He held the position of senior scientist and project leader within the R&D department of the former German multinational firm Ratiopharm acquired by Teva. Therein, he has contributed to the development and the submission of numerous products and was actively involved in the establishment of a centre of excellence in R&D for Ratiopharm International. Finally, he is associate professor at University of Quebec in Montreal and has published several peer-reviewed publications and formulation patents.

Bill Jones, Professor

Department of Chemistry

University of Cambridge

Professor Bill Jones served as Head of the Department of Chemistry from 2007 to 2011. .Professor Jones’s research has dealt with two main areas of solid state chemistry. The first concerns understanding of chemistry of layered inorganic solids and in particular their role as catalysts. The second area of research is in organic solid state chemistry and crystal engineering. In recent times this has developed into an interest in the development of solid pharmaceutical materials with a focus on solid form development for drug delivery. He is co-Director of the Pfizer Institute of Pharmaceutical Materials Science, an institute in Cambridge supported by Pfizer.

He was elected a Fellow of Sidney Sussex College in 1980. For Sidney Sussex College he was Admissions Tutor and then Senior Tutor. He is currently a Professorial Fellow at Sidney. He was elected as an Inaugural Fellow of the Learned Society of Wales in 2010.

Professor Jones has published over 400 peer reviewed articles dealing with solid state chemistry and has edit two volumes on solid state chemistry. The first (Organic Molecular Crystals) was published by CRC press in 1997 and re-published in their electronic series in 2000. The second volume is co-edited with Professor CNR Rao on “Supramolecular Chemistry” was published in 2002 and re-published in paperback form in 2008.

Michael J. Kaufman, Ph.D.

VP Technical Development

Biogen Idec

Dr. Kaufman is the Vice President of Technical Development at Biogen Idec. He is responsible for product development activities including drug substance process development, formulation development, analytical development, and the manufacture of clinical trial materials.

Prior to joining Biogen, Dr. Kaufman was the Vice President of Pharmaceutical Sciences at Millennium Pharmaceuticals, where his group was engaged in the development of cancer therapies such as the breakthrough drug VELCADE. He began his industrial career at Merck where he helped develop a number of innovative therapeutic agents of medical and commercial importance. He is the author of over 30 published articles and is named on 10 patents in the areas of preformulation and formulation.

Xiangyang Liu, Professor

College of Materials

Xiamen University

Professor Liu received his Ph.D. degree with cum laude title from Radboud University Nijmegen (Netherlands), in 1993. Prof. Liu is the tenured full Professor in NUS, and currently the State Distinguished Professor for the 1000 Talent Program, Chair Professor of the China MOE Changjiang Scholars Program. His research interests range from biomimetics, crystallization, soft matters, etc.

He has authored numerous books, and about 200 peer prestige papers including Nature., many cited by the top webs and journals. His international stand can be substantiated by his delivery of over 90 plenary/keynote or invited talks in the international conferences, organization of more than 20 international conferences/symposia, numerous awards, and the 5th President of the Asia Association for Crystal Growth and Crystal Technology, the councilor of the IOCG, the guess-Editor-in-Chief of J Crystal Growth, etc. Due to his outstanding contributions to the international academic communities, Professor Liu has received numerous international awards.

Tongbu Lu, Professor

School of Chemistry and Chemical Engineering

Sun Yat-Sen University

Professor Tong-Bu Lu obtained his Ph.D. in Inorganic Chemistry from Lanzhou University in 1993. Following a postdoctoral fellowship at Sun-Yat-Sen University, he joined to the faculty member at the same University, and became a Professor of Chemistry in 2000.

He worked as a postdoctoral fellowship at Texas A&M University and Michigan Technological University. His current research interests are the studies of crystal engineering, including pharmaceutical polymorphs and cocrystals. He has over 140 research publications. He has obtained honors and awards as Distinguished Professor in Guangdong Province and National Natural Science Foundation of China for Distinguished Young Scholars.

Ann Newman, Ph.D.

VP Scientific Development

Crystal Pharmatech

Dr. Newman has over 20 years of industrial research experience in solid-state pharmaceutics. For ten years, she performed characterization studies on a wide range of pharmaceutical systems at Bristol-Myers Squibb, covering drug substance and product scale-up from late drug discovery to launch and manufacturing.

From there, Dr. Newman moved to SSCI as Vice President of Materials Science, overseeing characterization of API and drug product samples, crystallization and polymorph screens, salt and cocrystal selections, quantitative assays, amorphous projects, and problem solving for the pharmaceutical industry. As Vice President of Research and Development at Aptuit, she instituted a companywide R&D initiative over six global sites and covering areas such as API, preclinical (toxicology, safety, pharmacokinetics), formulation, solids, analytical, clinical packaging, and regulatory.

Dr. Newman holds an adjunct faculty position in Industrial and Physical Pharmacy at Purdue University and is author/collaborator on over 40 publications, 80 technical presentations, and 55 webinars. Dr. Newman continues to maintain her consulting firm Seventh Street Development Group.

Nair Rodriguez-Hornedo, Professor

Pharmaceutical Sciences

University of Michigan

Professor Rodríguez received her PhD from University of Wisconsin Madison. She is now associate professor of Pharmaceutical Sciences at University of Michigan. She has developed a research program based on molecular-mechanistic approaches, founded on the premise that the concepts of supramolecular chemistry and crystal engineering can be applied to: (i) design novel pharmaceutical materials with desirable composition, structure and properties, and (ii) understand crystallization pathways and phase transformations that are important in controlling pharmaceutical processes and outcomes.

In 2005 Professor Rodríguez was awarded the Ebert Prize for the best article published in the Journal of Pharmaceutical Sciences. She has served on the FDA Advisory Committee for Pharmaceutical Sciences. She also serves on the editorial boards of Crystal Growth and Design, Molecular Pharmaceutics and Journal of Pharmaceutical Sciences. Professor Rodríguez presently serves on the Scientific Advisory Board for Crystal Pharmatech as an expert in pharmaceutical cocrystal.

Drazen Ostovic, Ph.D.

Founder

KO Pharm R&D

Dr. Ostovic received his Ph.D. in Physical Organic Chemistry from the University of Minnesota. This was followed by postdoctoral studies in Physical Bio-Organic Chemistry at UC Santa Barbara. He started his industrial career in the Preformulation Group at Merck. After more than ten years at Merck he joined Theravance as Associate Director of Process Chemistry and Pharmaceutical R&D.

After rejoining Merck as the Director of the Pharmaceutical Chemistry group, he moved on to Amgen as the Director of the Preformulation group. Shortly afterwards, he was named the Executive Director of the Amgen global preformulation groups responsible for discovery, preclinical and early clinical formulation development, preformulation and material science activities.

During his industrial career he contributed to the development of large numbers of new drug candidates. Several ultimately became commercial products: Crixivan®, Fosamax®, Emend®, Invanz®, Isentress®, Januvia®, and Vibativ®. He authored or co-authored more than 30 research articles in peer reviewed journals, as well as two book chapters. He also holds several patents for approved pharmaceuticals, as well as a number of patent applications. Dr. Ostovic founded KO Pharm R&D, LLC and is currently working as a consultant in the preclinical and early clinical R&D functions, with a focus on CMC areas.

Jian Wang, Ph.D.

VP Crystallization Development

Crystal Pharmatech

Dr. Wang holds a B.S. and a Ph.D. degree in Chemical Engineering from Zhenjiang University and University of Pittsburgh, respectively. In 1994, Dr. Wang joined Merck and worked for 11 years in both manufacturing and research divisions. During her tenure at Merck, she focused on tackling bottle-neck challenges in API process development, involving understanding, design, optimization and scale-up of processes for API crystallization and catalytic reactions.

Her technical expertise lies in the development and scientific understanding of reproducible, scalable and efficient processes. In addition to numerous successes in design and development of challenging API crystallization processes at Merck, she was an early pioneer in applying various process analytical technologies (PAT), e.g., FT-IR, Raman, FBRM and PVM, for understanding and developing API crystallization and milling processes.

In 2005, she joined Mettler-Toledo AutoChem where she contributed directly to developing broader applications and new generation of PAT tools. Between 2009 and 2011, she worked as independent consultant on technology and application. She has strongly promoted broad PAT applications across the industry through her publications, presentations and training seminars. During her earlier research efforts in heterogeneous catalysis, she gained skills and experience in preparing nano- crystalline particles. She has co-authored 19 peer-reviewed journal articles, 1 book chapter and 3 patents, and given over 20 presentations at international conferences and global seminars.

Conrad Winters, Ph.D.

Director of Drug Product Development

Hovione

Dr. Winters has a background in solid state pharmaceutics with a PhD in Pharmaceutical Technology from University of Bradford, UK and 20 years experience in the Pharmaceutical industry. He has worked on a number of programs that became marketed drugs and has extensive experience in particle design, materials characterization and formulation development. He has worked on oral, parenteral, topical and inhalation formulations while always focusing on material properties, interactions and the effects of processing. Conrad leads the Drug Product Development group at Hovione, in Portugal.

Prior to joining Hovione, Conrad led the Compound Properties group at Xenon Pharmaceuticals in Vancouver and spent thirteen years in Pharmaceutical Research and Development with Merck in Canada and the U.S. He was an invited speaker at conferences in Canada, U.S. and Europe and has presented to the FDA and MHRA.

Robert N. Young, Professor

Department of Chemistry

Simon Fraser University

Professor Young holds a Ph.D. degree in University of British Columbia in (1971). He was a Post Doctoral Fellow at Imperial College of Science and Technology, University of Adelaide and University of British Columbia from 1971 -1976. He was research associate at the Institute de Chimie des Substances Naturelles in Gif-sur-Yvette, France (1976-77). He worked at Merck Frosst, Canada from1977 until 2006 in various capacities including Vice-President and Head of Medicinal Chemistry at the Merck Frosst Centre for Therapeutic Research from 1993 until taking early retirement in 2006. He is now Professor of Chemistry and Merck Frosst-B.C. Leadership Chair in Pharmaceutical Genomics and Drug Discovery in the Chemistry Department at Simon Fraser University and chair of the Division of Medicinal Chemistry of the Center for Drug Research and Development (CDRD), and consultant for a number of Pharmaceutical companies through Promorpheus Consultants Inc.

Dr. Young was a past member of the Natural Sciences and Engineering Research Council of Canada and recipient of the Order of Canada as well as being elected a fellow of the Royal Society of Canada among other honors and recognition. Dr. Young is currently president of the Canadian Society for Pharmaceutical Sciences.

Dr. Young’s career has focused on the design and synthesis of novel drugs for asthma, inflammation, osteoporosis and related disorders and he is perhaps most noted for his part in the discovery of SingulairTM , TredaptiveTM , ArcoxiaTM and PrecicoxTM. His work on osteoporosis research led to the discovery of an investigational drug, odanicatib, currently in phase 3 clinical development. Author of more than 200 publications, review articles and patents his current research is focused on the design and use of novel pharmacological probes and proof of concept molecules for the discovery and validation of new drug targets and the design of new drugs to treat bacterial infections, cancer, inflammatory and bone diseases.

Lian Yu, Professor

Pharmaceutical Sciences and Chemistry

University of Wisconsin

Professor Yu received his Ph.D. degree in Physical Chemistry at Ohio State University. His group study solids of organic molecules. These soft materials are being explored for applications in pharmaceutical and electronic technologies, and exhibit properties and physical phenomena unknown for hard materials. In his laboratory, physical measurements and crystallization experiments are performed to understand the formation, properties, and transformation of molecular solids.

Professor Yu’s major techniques are crystallography, calorimetry, spectroscopy, and microscopy. Three areas of current research are polymorphism, crystallization of organic glasses, and molecular motions in solids. He has obtained numerous awards which include: David Grant Research Achievement Award in Physical Pharmacy, American Association of Pharmaceutical Scientists(2011), Invited Visiting Professor at University of Manchester, UK ( 2009), Elected Fellow at American Association of Pharmaceutical Scientists (2006) and Lilly Research Laboratories President's Award (2003).