Time

Scientific Topic

Speaker(s)

8:30 - 9:00 am

Coffee, Continental Breakfast, Introductions

Deena Conrad-Vlasak

9:00 - 9:45 am

Introducing Electron Diffraction for Pharma

Dr. Gustavo Santiso-Quiñones, Ph.D.

9:45 - 10:30 am

Case Studies: Using Electron Diffraction in Pharmaceutical Applications

Dr. Gustavo Santiso-Quiñones, Ph.D.

10:30 - 10:45 am

Break

10:45 - 11:45 am

Three Things You Need to Know About Protecting Your Pharmaceutical Intellectual Property

Dr. Aeri Park, Ph.D. & Dr. David E. Bugay, Ph.D.

11:45 - 12:30 am

Rapid Screening and Development of Amorphous Solid Dispersions (ASD)

Dr. Nico Setiawan, Ph.D. & Dr. David E. Bugay, Ph.D.

12:30 - 1:30 am

Lunch, Networking, and Discussions

Gustavo Santiso-Quiñones, Ph.D.

Founder, ELDICO Scientific AG

Dr. Gustavo Santiso-Quiñones was born in Guatemala City where he obtained his university degree in Chemistry (1997). He went to Germany to the Free University of Berlin where he obtained a Master degree in Chemistry (04/2000) and later his Ph. D degree (01/2005) in fluorine chemistry in the group of Prof. Dr. K. Seppelt. He has done Post-doctoral research activities in the University of Freiburg and RWTH-Aachen, Germany, and at the EPF-Lausanne, and ETH-Zürich, Switzerland. With more than 20 years of experience in the field of synthesis, crystallization and handling of sensitive or reactive materials and as many years of experience in the field of crystallography, he became independent in 09-2014 founded in Switzerland his own company Crystallise! AG. Since 2014 he offers to the Pharma-, Agro-, and Chemical industries crystallographic services, including the crystallization of the compounds.

Gustavo is also a founder of ELDICO Scientific AG, company which has been established in Switzerland since 2019. In collaboration with Dr. T. Grüne and others, their ideas and crystallographic approach to use Electron Diffraction (microED) for organic compounds, got a Science nomination for “Breakthrough of the year 2018”. The realization of an Electron Diffractometer dedicated to the Pharmaceutical industry, is now a reality where industry is profiting from this technology and device. At the present time Gustavo is Founder and CTO of Crystallise! AG and Founder and Senior Scientist of ELDICO Scientific AG. (https://www.eldico-scientific.com/)

 David E. Bugay, Ph.D.

Chief Scientific Officer, Triclinic Labs, Inc.

Dr. Bugay, an AAPS Fellow, has over 35 years of experience in pharmaceutical development and associated intellectual property. Since receiving a Ph.D. in Physical Chemistry, he held advancing positions in the Analytical R&D Department of Bristol-Myers Squibb, was Senior VP of Analytical Chemistry at SSCI, Inc., and was Managing Director of the Legal Services group of Aptuit Consulting. His expertise includes vibrational and NMR spectroscopy, thermal analysis, X-ray diffraction, microscopy, chemometrics, and scientific/expert witness aspects of Paragraph IV patent litigation. Dr. Bugay has been an invited speaker at dozens of conferences and has taught numerous courses worldwide. In addition, he has published many peer-reviewed scientific papers, written book chapters, authored his own book, and served on the USP General Chapters Expert Committee from 2005 to 2010. 

 Aeri Park, Ph.D.

Chief Operating Officer, Triclinic Labs, Inc.

Dr. Park received her Ph.D. from the University of Oklahoma and is a recognized industry expert in API solid form screening and selection, solid-state characterization of APIs, intermediates, and drug products, crystallization method development, patent prosecution support, and frequently acts as an expert witness in Paragraph IV litigation matters both domestically and internationally. Dr. Park will lead Triclinic's efforts in physical and analytical chemistry services as well as contribute to its patent prosecution and litigation expert services practice. Dr. Aeri Park, was formerly Director of US Operations for The Almac Group and established and grew a US-based analytical laboratory for the firm. Prior to joining Almac, Dr. Park was instrumental in the growth and scientific success of SSCI, a solid-state development group.

 Nico Setiawan, Ph.D.

Analytical Chemistry Group Leader, Triclinic Labs, Inc.

Dr. Nico Setiawan received his Ph.D. in Pharmaceutical Science from the University of Kentucky. Nico is an expert in the preformulation space of API development, including solid form screen and selection, solid-state and physicochemical characterization, crystallization process development, development of enabling formulation for poorly soluble compounds, and biorelevant dissolution method development for orally administered compounds. His research focuses on integrating properties of API and physiological barriers to deliver efficacious drug products. Dr. Setiawan has published papers in peer-reviewed journals and presented at national conferences. He is also an active reviewer of several peer-reviewed journals.