January Event
“Workshop: Small-Molecule Formulation for Discovery & Early Development”

Jointly with PBSS and Syner-G

About the Topic
As the field of drug development continues to evolve, the formulation of small synthetic molecules remains a critical component in the journey from discovery to early clinical trials. This workshop aims to deepen participants' understanding of the key strategies and challenges in preclinical and early clinical formulation development. Experts will share their insights on the physicochemical properties of APIs, approaches to formulation screening and characterization, and the transition from preclinical to clinical stages. Attendees will also explore enabling formulation strategies to overcome exposure challenges with difficult molecules, ensuring a comprehensive grasp of the formulation process.

Time (PST) and Topic-Presenter(s)
8:45 – 9:00 am
PBSS Welcome and Overview – Minli Xie, PhD, Senior VP, Erasca and PBSS-SFBay Committee member
9:00 – 9:10 am
Workshop Objectives and Introduction – Edward Yost, Scientist 4, Synthetic Molecule Pharmaceutics, Genentech
9:10 - 10:00 am
Formulation – A Bridge from the Chemist’s Flask to the Patient’s Bedside – Dan Yin, PhD, Senior Director, Formulation and Process Development department, Gilead Sciences
10:00 - 10:50 am
Preclinical Formulation Development of Small Molecules – Jing Ling, PhD, Associate Principal Scientist, Discovery Pharmaceutical Sciences, Merck
10:50 - 11:00 am
Major Sponsor Presentation – AustinPx
11:00 - 11:20 am
Break and Vendor Show
11:20 am - 12:10 pm
Formulating Safety: Delivery Strategies for Effective Toxicology Studies – Dennis Leung, PhD, Director and Senior Principal Scientific Manager of Discovery Pharmaceutics, Genentech
12:10 - 1:10 pm
LunchSponsor TBD
1:10 - 2:00 pm
Accelerating Early Oral Formulation Development for First-in-Human Trials: Fit-for-Purpose Strategies and Innovative Approaches – Mayuri Mutha, MS, Consultant I, Technical, Syner-G BioPharma Group
2:00 - 2:50 pm
Comparing Oral Drug Delivery Systems: Tablets vs. Capsules in Early Clinical Development – Edward Yost, Scientist 4, Synthetic Molecule Pharmaceutics, Genentech
2:50 - 3:00 pm
Major Sponsor Presentation – Catalent Pharma Solutions
3:00 - 3:20 pm
Break and Vendor Show
3:20 -4:10 pm
Practical Parenteral Drug Formulation Development for Phase 1 – Mei Lai, PhD, Principal, Web Pharma
4:10 - 5:00 pm
Impact of Formulation on PK Performance – Jennifer Yang, PhD, Independent DMPK/Clinical Pharmacology Consultant
5:00 - 5:30 pm
Panel discussion and/or interactive session – All presenters
5:30 - 6:30 pm
Happy HourSponsored by Collaborative Drug Discovery

About the Speakers

Daniel Yin, PhD, is a Senior Director in the Formulation and Process Development department at Gilead Sciences based in Foster City, CA. With over 23 years in leading pharmaceutical companies including Merck and Johnson & Johnson, he has managed teams across vaccines, biologics, and small molecules, focusing on sterile and oral drug product development. His contributions include multiple marketed products and 24 research publications, along with patents and invited presentations. Dan holds a PhD in Biochemistry and completed a postdoctoral fellowship in Pharmaceutical Chemistry from the University of Kansas, following his B.S. in Chemistry from Peking University, China.

Jing Ling is an Associate Principal Scientist in discovery pharmaceutical sciences at Merck. She graduated from the School of Pharmacy from Huazhong University of Science and Technology in 2010, and a PhD in Industrial and Physical Pharmacy from Purdue University. She led the drug candidate selection in discovery and early development via a wide range of solid state and solution chemistry tools and drug delivery techniques. She is recognized as a subject matter expert in oral peptide delivery. Jing is a past chair of AAPS-BDAG, an editorial advisory board member in AAPS PharmSciTech, an industrial representative in CRS Skin & Mucosal Delivery, and a scientific advisor to the Editors of the Journal of Pharmaceutical Sciences.

Dennis Leung is a seasoned researcher and leader in pharmaceutical sciences with a focus on drug delivery and formulation. He holds a PhD in Chemistry from UC Berkeley and a B.A. in Chemistry, Philosophy, and Classics from Cornell University. Currently a Director of the Discovery Pharmaceutics group at Genentech, he has extensive experience in small molecule and peptide drug discovery, having held various scientific and managerial roles at Genentech and Merck. Dennis has authored numerous high-impact publications and patents. He is active in professional organizations, serves on editorial boards, and has received multiple awards for his contributions to the field.

Mayuri Mutha is a drug product development scientist with extensive experience in formulation and process development of oral solid, topical, transdermal, and semisolid dosage forms of small molecules. She is highly skilled at enabled formulation technologies such as amorphous spray dried dispersion to overcome exposure challenges of poorly soluble compounds. As a Consultant at Syner-G BioPharma Group, Mayuri has successfully supported various client programs across all phases of development. Her areas of expertise include preformulation, pre-clinical and clinical formulation development, process optimization and scale up, technology transfer, CRO/CMO selection and management, and authoring CMC sections for regulatory filings (IND/IMPD).

Edward Yost, a Scientist 4 in Synthetic Molecule Pharmaceutics at Genentech, is a versatile Pharmaceutical Scientist with over 20 years of expertise in small molecule formulation, particularly in immediate-release tablets and dry powder inhalers. Currently at Genentech, he has led the development of multiple drug candidates from discovery to commercial launch. Edward is recognized for his leadership in material-sparing tablet development, CDMO management, and innovative use of compaction simulators. He has authored numerous peer-reviewed papers and holds key patents in the field. Edward is also an active member of AAPS and AIChE, contributing to scientific outreach and community initiatives.

Dr. Mei Lai is an expert in Chemistry, Manufacturing and Control (CMC) with 25+ years of experience in global pharmaceutical development and contract manufacturing from lead optimization to commercialization of parenteral and oral products and drug substances. Dr. Lai has contributed significantly to the success of 8 marketed products and preparation of 10+ NDA/MAA/ANDA at companies such as Bristol-Myers Squibb, Celgene, Array Biopharma, and Clovis Oncology. She is currently a technical and regulatory CMC consultant helping clients translate technical data, regulatory requirements, and business goals into practical CMC strategies, plans and priorities from pre-clinical to market authorization.

Dr. Jennifer Wang has over 25 years of experience in the pharmaceutical industry in DMPK and Clinical Pharmacologyy. Most recently she was an Executive Director of DMPK and Clinical Pharmacology at Erasca focusing on oncology programs from drug discovery to Clinical Development. Prior to Erasca, she held positions of increasing responsibility with Ultragenxy, Incyte, Ardea, Vertex and Merck. She made significant contributions to Ivacaftor and Tezacaftor IND filing, Lesinarad and Pemigatinib IND/NDA filing, and was the inventor of Lumacaftor. Jennifer earned her PhD in Chemistry from Washington University in St. Louis.

Date: January 22, 2025; 8:45am - 5:30pm PT
Foster City, CaliforniaCrowne Plaza, Foster City, CA
Regular attendees: $295; Academic/Students/Postdocs/Out-of-Pocket: $45
Register at: https://www.pbss.org/aspx/eventInfo.aspx?eID=916