Wuxi

Articles

Speed is a critical factor in early-stage development. Solid state studies within an integrated CMC platform can support formulation development, accelerate timelines to Phase I clinical studies and increase the likelihood of successful clinical trial results.

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

WuXi Sta outlines clear guidance on phase appropriate RSM designation and adaptive RSM strategy for the overall API development roadmap. These solutions will mitigate both quality and regulatory risks, thus increasing the chance of success in IND and NDA filing.

Establishing and Maintaining Phase-Appropriate Regulatory Starting Materials Designation from Development to Commercial Launch Secures Successful New Drug Development 

Gain clear guidance on phase appropriate RSM designation and adaptive RSM strategy for the overall API development roadmap. These solutions will mitigate both quality and regulatory risks, thus increasing the chance of success in IND and NDA filing.

https://www.pharmtech.com/pt/rsm-designation


This webinar will discuss WuXi STA’s practice on overall RSM strategy, focusing on:

Risk mitigation for potential regulatory push-back

The audience can expect clear guidance on phase appropriate RSM designation and adaptive RSM strategy for the overall API development roadmap. These solutions will mitigate both quality and regulatory risks, thus increasing the chance of success in IND and NDA filing.


Mitigate risk for potential regulatory pushback in late-stage new drug development


Senior Director CMC Regulatory Affairs
WuXi STA, a subsidiary of WuXi AppTec

 is the Senior Director of Reg CMC Regulatory Affairs, responsible for all regulatory aspects of CMC. Her group provides STA’s clients with the preparation of regulatory filings, assistance during interactions with health authorities, and the development of robust global regulatory strategies to ensure uninterrupted clinical studies and successful marketing applications. Dr. Mak-Jurkauskas joined STA in 2019 with over a decade of expertise in analytical development, and drug substance and product manufacturing. Dr. Mak-Jurkauskas earned her Ph.D. degree in Physical Chemistry at Brandeis University under the guidance of Professor Judith Herzfeld and her Bachelor of Science in Chemistry at the University of Toronto.


Vice President Late-stage API
WuXi STA, a subsidiary of WuXi AppTec

is Vice President of Late-stage API and has more than 10 years of experience in innovative drug development, specializing in CMC project management. Prior to joining STA, he worked at Evonik Industries AG (Hanau-Wolfgang) and Novartis Pharma AG (Suzhou) as project manager and development unit head. Jianhua holds a Ph.D. degree in Chemical and Biological Science from Scripps Research Institute (La Jolla) and an MBA degree from Peking University.

Webcasts

Webinar Date/Time: Mon, Dec 12, 2022 11:00 AM EST


Securing new drug development by establishing and maintaining phase-appropriate RSM designation from development to commercial launch

How Absorption Prediction Tools Can Optimize Formulation Strategy at the Preclinical Stage

Effective prediction tools—used in the preclinical stage of drug development—can help formulators better understand the rate, extent, and limitations of absorption of a novel drug candidate. These tools—along with 

 animal studies—also can help evaluate the effect of different of formulations to guide formulation selections.

Register for this webinar to learn about tools and technologies that enable cohesive data generation and analysis to lead to informed formulation decisions in the preclinical stage. Cases studies demonstrating applications for the tools will be shared.

Understand the importance of assessing absorption challenges early

Review tools and technologies that have demonstrated cost and time savings

Learn how CDMO/sponsor partnerships can best use developability technologies

Prior to joining BridgeBio, Rick Panicucci was global head of chemical and pharmaceutical profiling at Novartis. His responsibilities included all small-molecule therapeutics across the Novartis portfolio. He received a doctorate in chemistry from the University of Toronto and did a post-doctoral fellowship at University of California, Santa Barbara.

Rick Panicucci is currently the senior vice president of CMC at QED Therapeutics, Origin Biosciences, and Calcilytix Therapeutics, all BridgeBio companies. Prior to joining BridgeBio, Rick served as vice president of pharmaceutical development services at WuXi STA, where he provided scientific leadership in formulation development and GMP manufacturing. From 2004 to 2015, Rick was Global head of chemical and pharmaceutical profiling at Novartis. His responsibilities included all small-molecule therapeutics across the Novartis portfolio. He also led and developed novel drug delivery technologies for small molecules and large molecules. Rick has also led R&D groups at Vertex Pharmaceuticals, Symbollon Pharmaceuticals, Biogen, and Bausch & Lomb. He received a doctorate in chemistry from the University of Toronto and did a post-doctoral fellowship at University of California, Santa Barbara.


Director, Developability and Formulation Research
WuXi STA


Prior to WuXi STA, Liang Mao worked at Novartis for six years on the preformulation team supporting compound developability assessment, physical form screening and selection, and preclinical formulation development. Liang holds a master’s degree in biochemical engineering from Nanjing University of Technology. Liang Mao, currently director at STA WuXi AppTec Shanghai site, joined STA for more than 3 years ago and now manages the developability and formulation research team. Prior to STA, Liang worked at Novartis for six years on the preformulation team supporting compound developability assessment, physical form screening and selection, and preclinical formulation development. He has four years of experience at a research institute and biopharmaceutical company supporting early drug development. He has expertise in drug developability assessment, physical form screening, and bioavailability enhancement technologies. Liang holds a master’s degree in biochemical engineering from Nanjing University of Technology.

Tuesday, June 29, 2021 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST