CMC Manager, Cleave Biosciences
Associate Principal Scientist, Merck & Co., Inc.
Principal Scientist, Amgen Inc.
Research Scientist, Bristol-Myers Squibb Company
Albert has over 20 years of experience in the pharmaceutical industry working on various stages of the drug development process. His expertise is in the formulation development and testing various pharmaceutical dosage forms, which include parenteral solutions; oral suspensions, solutions, tablets and capsules; and topical creams and ointments. In addition to a strong development background, he has experience with clinical and commercial manufacture and testing of various dosage forms and developing regulatory strategies for early and late stage clinical products. Albert obtained his BS in Chemistry from the University of California at Davis in 1992. Currently, he is the CMC manager at Cleave Biosciences responsible for all CMC activities, including formulation development and optimization of preclinical and clinical compounds.
Mr. James Ormes is an Associate Princpal Scientist at Merck & Co. Inc. James holds a B.S. in Chemical Engineering from the University of Minnesota and a M.S. in Pharmaceutical Chemistry from the University of Kansas. James has been in the pharmacuetical industry for 12 years focusing on preformulation and discovery formulation support. He is a co-author on 11 publications/patents. James has been on >30 discovery programs, has transitioned 11 preclinical candidates into development and has designed 5 Ph I formulations. James has an avid interest in amorphous solubilization strategies for poorly soluble compounds to support preclinical and early clinical applications. He has six years of experience with small scale spray drying of amorphous dispersions for preclinical and early clinical applications. James is also acitive with AAPS-NERDG and external research collaborations with large research universities.
Haruki is a molecular cell biologist who specializes in investigating the processes of in vivo protein folding and intracellular trafficking of therapeutically important proteins. His main research interests are: (1) elucidating cargo-specific biosynthetic mechanisms for broad classes of proteins (both drug targets and biotherapeutics); (2) determining the fate of proteins in intracellular and extracellular space after the synthesis; and (3) translating the findings into effective protein expression strategies, novel assay designs, and mechanistic understanding of disease biology. After receiving a Ph.D. in Molecular Cell Biology from the University of Michigan, Haruki undertook a postdoctoral training at the National Institutes of Health, Bethesda. His first in-depth pharma experience came from the Assay Development group in Bayer’s Kyoto Research Center where he developed biochemical and cell-based HTS assays by “gene to assay” approaches. In Amgen, Haruki works closely with disease area specialists, geneticists, and assay technology experts to advance early exploratory projects from target validation and proof-of-concept studies to lead selection and optimization. He also collaborates with scientists in process development and formulation groups to characterize antibody therapeutics and the mAb-producing recombinant CHO cell lines.
Madhavi graduated with a Chemistry degree and has been working with Bristol-Myers Squibb for the past 10 years. She has extensive experience on developing and validating methods using HPLC and Dissolution methodologies and has become a subject matter expert in Karl Fischer technology. As a project manager for the past 6 years, Madhavi coordinates activities at various contract research organizations, conducts technology transfers and is a key contributor for Regulatory filings and correspondences. More recently, Madhavi focuses on the development and analytical activities for pediatric monotherapy and fixed dose combination products. She works closely with the formulators to understand and design pediatric formulations and to improve the taste masking ability of a bitter tasting API without sacrificing the bioavailability of the drug. Madhavi is also currently assisting in designing experiments in Bio-relevant mediums to understand the impact of formulation changes.
Vice President, Boehringer Ingelheim Pharmaceuticals Inc.
Professor, University of Kentucky
Senior Scientist, Ipsen Biosciences
Robert K. Prud'homme
Professor and Director Program in Engr. Biology, Princeton University
Keith Horspool is Vice President of Material and Analytical Sciences at Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT. His department develops and applies scientific methods and tools to generate improved product and process understanding and robustness. This is a new organization and the goal is to apply physical/material sciences-based approaches (e.g. crystal engineering, structural analyses, physical characterization, predictive modeling) throughout the duration of the drug development and commercial lifespan of a product supporting the implementation of effective, cost efficient processes for the manufacture of drug product and drug substance.
Prior to joining BI, Keith worked at Pfizer and Astra Zeneca. He has ~27 years experience during which he has managed preformulation, product development, drug delivery and materials science. He has a B.Sc. in Pharmacy, and a Ph.D. in Pharmaceutical Chemistry.
Eric Munson is currently the Patrick DeLuca Endowed Professor in Pharmaceutical Sciences at the University of Kentucky. He received his B.A. degree from Augustana College in Sioux Falls, South Dakota, in 1987. After studying one year in Munich, Germany, on a Fulbright Fellowship, he received his Ph.D. in 1993 from Texas A&M University, and was a postdoctoral fellow at the University of California, Berkeley in 1994. He was in the Chemistry Department at the University of Minnesota before moving in 2001 to the Pharmaceutical Chemistry Department at the University of Kansas, and finally to the Pharmaceutical Sciences Department at the University of Kentucky in 2010. His research program is focused on the characterization of pharmaceutical solids using a variety of analytical techniques, with an emphasis on solid-state NMR spectroscopy. Dr. Munson is a coinventor on two patents and has published more than 100 research, review, and book chapters.
Dr. Liping Zhou is currently a senior scientist at Ipsen Biosciences at Cambridge, Massachusetts in United States of America. She is in charge of the early and novel formulation effort, characterizing drug candidates, assessing their solubility and stability, supporting all the US research and development projects. Prior to joining Ipsen, she worked for Novartis for 11 years. For the first seven years, Dr. Zhou was the head of solubility and physico-chemical characteristics lab, responsible for eADME profiling and physico-chemical properties assessment of drug candidates, supporting all the Novartis research projects in US and Asia. Together with her colleagues, she developed a new high throughput solubility assay addressing equilibrium solubility measurement in both aqueous buffer and simulated intestinal fluid. Later, Dr. Zhou joined the Chemical and Pharmaceutical Profiling group of Novartis as a principal scientist. Her work was to characterize and assess developability of new chemical entities(NCEs). She collaborated with different drug discovery and development line functions in selecting NCEs and improving the probability of success in developing these NCEs. Dr. Zhou co-authored many peer-reviewed research publications in the leading biomedical journals and book chapters.
Dr. Zhou obtained her PhD degree in analytical chemistry from University of Connecticut. Her research work then focused on the development of a geno-toxicity biosensor using micro-balances and electrochemistry detection. She received her MS and BS degrees from University of Cincinnati and Peking University respectively.
Professor, Chemical Engineering, Biomedical Engineering, University of South Carolina
Dr. Jabbari is a tenured Full Professor of Chemical and Biomedical Engineering and Director of Drug Delivery and Regenerative Medicine Laboratory at University of South Carolina. After earning his PhD from Purdue University and his post-doctoral training at Monsanto Corp. and Rice University, he began his independent career as an Assistant Professor in the Departments of Biomedical Engineering and Orthopedic Research at Mayo Clinic. His research focuses on engineered nanomaterials for drug and protein delivery in cancer therapy and regenerative medicine. He received the Berton Rahn Award from AO Foundation in 2012, Stephen Milam Award from Oral-Maxillofacial Surgery Foundation in 2008, and he was elected to the College of Fellows of AIMBE in 2013. He has published >250 peer-reviewed journal articles and presented >250 seminars at scientific meetings. He currently serves as the academic editor of the prestigious journal of PLOS ONE. He has mentored >120 students and scholars.