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From Concept to Market: Value of MIFD & Simcyp Biopharmaceutics for Streamlined Drug Formulation and Approvals

실시간 웨비나

날짜

2024년 7월 09일 화요일

시간

오전 11시 (동부표준시)

Free Webinar for Biopharmaceutics and Drug Formulation Scientists

Join us for an insightful discussion with Pfizer experts Vivek Purohit, Sr. Director and Pharmacometrics Team Leader for Inflammation and Immunology, and Kazuko Sagawa, Research Fellow in the Biopharmaceutics Group, along with Ioannis Konstandtinidis, Principal Scientist II Modeling & Simulation, PK Sciences at NIBR at Novartis.

We’ll explore the latest advancements in small molecule model-informed formulation development (MIFD) technology, covering topics from early formulation selection to virtual bioequivalence (VBE) assessments.

Participants will gain crucial knowledge on:

Streamlined Development: Learn how Simcyp Biopharmaceutics accelerates formulation identification and refinement, saving time and resources.

Enhanced Decision-Making: Discover how to use Simcyp Biopharmaceutics to make informed choices about incorporating advanced technologies into your workflows.

Broad Applicability: Explore real-world use cases demonstrating the software’s effectiveness from early formulation selection to virtual bioequivalence assessments.

Unique Applications: Gain insights into Simcyp Biopharmaceutics’ innovative features like the Virtual Bioequivalence (VBE) module, advanced GI modeling, and automated safe space identification.

The Power of MIFD: Understand how Model-Informed Formulation Development (MIFD) with Simcyp Biopharmaceutics expedites formulation refinement and increases biowaiver success rates, leading to faster drug development.

This webinar will be most beneficial for:

Biopharmaceutics scientists
Drug formulation experts
Pharmaceutical professionals involved in drug development
Researchers and industry stakeholders interested in innovative formulation strategies

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Presenters and Guest Panelists

Kazuko Sagawa, Ph.D.

Research Fellow, Pfizer Global Research and Development

Dr. Sagawa is a Research Fellow in the Pharmaceutical Science Department at Pfizer Research and Development in Groton Connecticut. As a member of a multidisciplinary team within Pfizer, she has been involved in developing biopharmaceutics strategy for drug product development. The work includes biopharmaceutics risk assessment, PBPK model development, and clinical bioequivalence risk assessment. Dr. Sagawa received her B.Sc in Pharmacy from Tokyo University of Pharmacy and Life Sciences (Tokyo Japan) and her Ph.D. in Pharmaceutical Sciences from the University of New York at Buffalo (Buffalo, NY)

Vivek Purohit, PhD

Sr. Director and Pharmacometrics Team Leader for Inflammation and Immunology, Pfizer

Vivek Purohit, received his Ph.D. degree in Pharmaceutical Sciences from the University at Buffalo, State University of New York, Buffalo in 2005. He has over 19 years of experience in clinical pharmacology/pharmacometrics in various disease areas such as infectious diseases, cardiovascular, rare diseases and inflammation/immunology. He is deeply committed to the application of quantitative approaches to decision making and answer key development questions for efficient drug development. He has extensive experience in the areas of Inflammation & Immunology with a special focus on dermatology indications. He has consistently applied MIDD principles in areas of infectious diseases, inflammation and topical dermatological agents with high impact on development decisions. He is recognized as an SME for topical dermatological agents where he has championed the development and use of innovative MIDD approaches to design patient PK trials and analysis of PK data. He has developed MIDD approaches for efficient conduct of organ impairment trials and conduct of virtual bioequivalence trials using PBPK models. Vivek has authored/co-authored several peer-reviewed publications, book chapters and holds 4 patents.

David B. Turner, PhD

Senior Principal Scientist

David B. Turner PhD is a Senior Scientific Advisor and Head of Mechanistic Oral Absorption Modelling at Certara UK Ltd (Simcyp Division) having joined Simcyp in 2004. He is author or co-author on 44 peer-reviewed papers. His work at Simcyp has mainly focused upon oral absorption modelling but also on physico-chemical aspects of PBPK modelling including tissue distribution and a variety of QSAR models. David was the PI for a recently completed FDA grant to develop modelling tools for handling supersaturating drug products and is co-PI on another FDA grant to look at locally acting drugs in the GI tract. He has a Biochemistry BSc, a Computer Science MSc and a PhD in Chemoinformatics and QSAR modelling all obtained at Sheffield University, UK. Prior to joining Simcyp he worked in a Computational Chemistry Group (Synt:em SA, Nîmes, France) focused mainly upon high throughput in silico discovery and virtual screening projects.

Nikunjkumar Patel, PhD

Senior Director of PBPK Consultancy Services

Dr. Patel is a Senior Director of PBPK Consultancy Services in the Simcyp division of Certara. Nikunj helps clients with advanced PBPK modelling to expedite internal decision making, support biowaivers via virtual bioequivalence assessments, and develop model-informed regulatory strategies for novel products, generic formulations, scale-up and post-approval changes (SUPAC), and justification of dissolution specifications. He has more than 15 years’ experience in computer-aided drug design and PKPD modelling, including 13+ years’ experience focusing on PBPK modelling.