About this Event
Registration: for regular attendees, register at our webiste https://www.pbss.org/eventDetails/1006
Regular attendees: $295; Academic or Self Paying: $45 ($45 registration closes on 11/25/2025); Major Sponsorship: $3000; Vendor Show: $750, Happy Hour Sponsorship: $1,250; Lunch Sponsorship: $1,500; On-site Registration: $500. Please note: Registration may close earlier than the posted deadline once the set number of participants has been reached.
Event Description:
It is well known that a majority of small molecule late discovery and development pipelines are populated by compounds that are poorly soluble, and/or permeable. This has resulted in increasing use of established and emerging technologies to address these limitations. There are multiple ways that enabling technologies are impactful on the overall drug development effort, among them:
- Rendering poorly soluble molecules into tractable entities, with respect to: Solubility, Supersaturation on dissolution, Absorption and PK profile
- Enhancing the ability to efficiently modify and optimize the performance of drug products in response to pre-preclinical, preclinical and early clinical in vivo data
- Helping to ensure that the dosage form(s) used in clinical development are appropriate to the target, with respect to pharmacokinetic (PK) and pharmacodynamic (PD) profiles
The workshop will describe and discuss approaches, with case studies, that address the iterative, interdependent, multidisciplinary nature of effective drug product development, with focus on small molecules that require enabling technologies.
Topics:
- Use of Quality Target Product Profiles (QTPPs) to guide product development strategy (single presentation)
- The state of the art in enabling technologies (SDDs, HME/kinetisol, Lipid-based, nanoparticles, other)
- Translational aspects of formulation development and drug product development
- Use of AI/ML and lab automation to optimize and test attributes and feasibility of pharmaceutical blends
- 3D printing for drug product manufacture
Agenda
🕑: 08:00 AM - 09:00 AM
PBSS Overview
Host: Shichang Miao, PhD, PBSS
🕑: 09:00 AM - 09:15 AM
Welcome and Workshop introduction
Host: Stuart Levy, PhD, SGL Chemistry Consultin
🕑: 09:15 AM - 10:00 AM
IP Considerations for Development and Implementation of Enabling Technologies
Info: Presented by Julia Minitti, PhD, JD, Partner, Wilson Sonsini Goodrich & Rosati
🕑: 10:00 AM - 10:45 AM
Translation of Molecular Properties to Enabling Technologies
Host: David Vodak, PhD, CSO, Bend Bioscience/CoreRx
🕑: 10:45 AM - 10:55 AM
Major Sponsor-Morning Session
Host: Almac Group
🕑: 10:55 AM - 11:15 AM
Break
🕑: 11:15 AM - 12:00 PM
Integrated Development of Advanceable Formulations for Complex Drug Product
Host: Erica Schlesinger, PhD, VP Technical Development, Seran
🕑: 12:00 PM - 01:00 PM
Lunch
🕑: 01:00 PM - 01:45 PM
De-Risking Drug Development with Amorphous Solid Dispersions: From Preclinical
Host: Dave Miller, PhD, CSO, AustinPx
🕑: 01:45 PM - 02:30 PM
AI/ML/Lab Automation to Accelerate Formulation Development
Host: Christine Allen, PhD, Co-founder and CEO, Intrepid Labs;
🕑: 02:30 PM - 02:40 PM
Major Sponsor-Afternoon Session
Host: Thermo Fisher Scientific
🕑: 02:40 PM - 03:00 PM
Break
🕑: 03:00 PM - 03:45 PM
3D Printing Technology as an Enabling Technology
Host: Xiaoling Li, PhD, University of the Pacific; Triastek
🕑: 03:45 PM - 04:30 PM
Molecule Customization vs. Formulation Innovation
Host: Kurt Nielsen, PhD, Expert Insights Consulting
🕑: 04:30 PM - 05:30 PM
Panel Discussion
🕑: 05:30 PM - 06:30 PM
Happy Hour
Event Venue & Nearby Stays
Hilton San Francisco Airport Bayfront, 600 Airport Boulevard, Burlingame, United States
USD 423.34
