WuXi STA, a WuXi AppTec Company

What does it take to make an API into a drugproduct? Learn advanced solid state studies and formulation development technologies that can accelerate early phase drug development.

Pave an Expressway to Phase I –Strategies That Accelerate Your Early Phase Programs

The success of any new drug development starts in its early phase. The probability of success of a molecule increases dramatically after it passes first-in-human (FIH) and proof-of-concept (POC) studies. Building a comprehensive understanding of the molecule is crucial to successful early phase development. API salt form and formulation selections are also key factors to successful phase I studies. Effective CMC strategies can significantly enhance the speed of early phase development and ultimately the chance for success in late-stage development.

Solid state studies not only provide a fundamental understanding of a molecule but also serve as a platform that leverages the knowledge from API development and manufacturing, which can further enhance the speed of early-phase development. With more than 70% of new chemical entities being poorly soluble, having a comprehensive bioavailability enhancement toolbox and strategies is critical to success in the early phase. This webinar will present our experience in using the integrated API and drug product platform and formulation technologies to accelerate early-phase development to phase I and beyond.

Key considerations in early stage drug development

The role of salt form and polymorph screening in early stage development

Formulation strategies to accelerate the path to phase I with a better chance of success.

Executive Director, Head of Solid
State Development
WuXi STA



 joined WuXi STA in 2018 and established Solid State Development (SSD) team. As part of STA integrated CMC platform, the team focuses on solid form screening, solid state characterization, powder characterization, and material science. It provides solutions to drug substance and drug product development in preclinical, clinical, and commercial stages. He has more than 10 years of experience in form selection, solid state characterization, crystallization, drug development, and organic chemistry. Before joining WuXi STA, Dr. Wang was a solid state expert in Novartis. He has multiple patents in various areas and published more than 10 papers in peer-reviewed scientific journals.



worked as a postdoctoral researcher in chemical biology at the Eshelman School of Pharmacy, University of North Carolina at Chapel Hill. He received his Ph.D. in Organic Chemistry from the University of Cincinnati, Master’s and Bachelor’s degrees in Environmental Engineering from the Nanjing University of Science and Technology.



Vice President, Head of
Formulation Development
WuXi STA



 is the Vice President and the head of formulation development at WuXi STA, a subsidiary of WuXi AppTec since 2017. He leads formulation teams in Shanghai and Wuxi, China, responsible for formulation development and clinical trial materials of new chemical entities from global clients (US, Europe, and Asia).Before joining WuXi STA, he worked at MSD in the US (PA/NJ) for 18 years in the Pharmaceutical Sciences group. He has extensive experience in formulation development and material characterization.



 obtained his B.S. in Chemical Engineering from the University of California at Berkeley and his Ph.D. in Chemical Engineering from Princeton University.

Webcasts

Webinar Date/Time: Thu, Apr 6, 2023 11:00 AM EDT


Articles

Process Robustness and Product Quality for Late-Stage API Crystallization Using a Standardized Project Flow

https://www.pharmtech.com/pt_w/project_flow

API quality must be sufficiently controlled for drug efficacy and patient safety; however, this quality control cannot be achieved without a reliable control strategy and robust API crystallization process.

Advanced technologies including in-line and offline process analytical technologies, process simulation software, and 

 software are tools to aid understanding of the crystallization process. However, it is the systematic investigation that ensures a robust process control.

Following a standardized project flow will make sure that thorough understanding is built throughout the late-stage development.

How crystallization can control critical quality attributes of the drug substance

The benefits of a structured workflow to develop a robust API crystallization process

Typical challenging case studies in crystallization development and possible solutions

Bjorn Gielen, PhD, Senior scientist, Crystallization Technology Unit (CTU), Janssen Pharmaceutica

Haojuan Wei, PhD, Director, Process Engineering Enabling Technology (PEET), STA Pharmaceutical, a WuXi AppTec Company (WuXi STA)

Wednesday, November 4, 2020 at 11am EST| 8am PST| 4pm GMT| 5pm CET

On demand available after airing until Nov. 4, 2021

***Live: Wednesday, November 4, 2020 at 11am EST| 8am PST| 4pm GMT| 5pm CET ***Looking for best approach to control the critical quality attributes of your API? Hear experts from Janssen and WuXi STA describe current technologies in API crystallization and their experience in building robust processes.***On demand available after airing until Nov. 4, 2021


Ensuring Process Robustness and Product Quality in Late-Stage API Crystallization by a Standardized Project Flow

Integrated Preformulation Studies for Fast Advancement of Drug Candidates to Human Clinical Studies

http://www.pharmtech.com/pt_w/practical_considerations


	New drug innovators face key challenges to advance their compound to clinical trials. An investigational new drug (IND) submission is a key milestone for every drug candidate. This webcast will discuss the best practices to advance small-molecule drug candidates quickly from discovery to IND filing, including safety assessment and chemistry, manufacturing, and controls (CMC) programs with real-world case studies.

		Key considerations for bringing a drug candidate to Phase I clinical trials

		Best practices for advancing small-molecule drug candidate CMC programs

		A comprehensive roadmap for successful global IND submissions

Philip Jones, PhD, Vice President Therapeutic Discovery, MD Anderson Cancer Center

	Cliff Yin, PhD, Executive Director of CMC Project Management, STA Pharmaceutical, WuXi AppTec Company (WuXi STA)

	Xin Zhang, PhD, Vice President, Head of Integrated Services, Laboratory Testing Division, WuXi AppTec

Wednesday, May 27, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

	On demand available after airing until May 27, 2021

Looking for the right approach to advance your small molecule drug candidate? Philip Jones from MD Anderson Cancer Center shares thoughts on how to bring drug candidates to Phase I clinical trials.

Live: Wednesday, May 27, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

On demand available after airing until May 27, 2021

Register free

