Innovation vs. Regulation: Balancing the Pace of Analytical Technological Advancement with Evolving Regulatory Frameworks
Webinar Overview
The pharmaceutical industry has experienced considerable transformation over the past decade, characterized by a notable shift towards biologics and a revived focus on peptide and oligonucleotide drug modalities. It has also witnessed significant changes in the regulatory landscape, particularly with the recent implementation of Analytical Quality by Design concepts. The full ramifications and impacts of these developments on pharmaceutical quality control are yet to be completely ascertained.
In this expert panel discussion, we will explore how this evolving environment, alongside pressing sustainability concerns, drives and fosters innovation in advanced pharmaceutical analytics. We will deliberate on strategies and analytical solutions designed to address the future of quality control, encompassing both the principles of quality and sustainability.
Thursday June 19
05:00 PM CEST
Key Learning Points
- Evolution of standards and regulatory vision
- Practical integration of innovative technologies
- Cross-functional collaboration and lessons learned from other sectors
Who Should Attend
This session is ideal for Scientific Directors, Analytical Science professionals, Innovation and Sustainability leaders, Quality Control Managers, and Regulatory Affairs experts, as well as anyone involved in pharmaceutical development, compliance, or analytical innovation.
Speakers
Ben Shapiro
Director – Digital Product Development and Marketing, U.S. Pharmacopeia
Ben joined USP in 2020 and is responsible for digital product development aimed at transforming the way scientists receive and consume chemical reference information. Ben developed Quantitative Nuclear Magnetic Resonance (qNMR) software for NMR analysis applications in pharmaceutical R&D, quality control, process chemistry, and analytical chemistry, and is working to develop new categories of integrated digital standards to help scientists ensure the quality of medicines they test. Ben also leads development for the Medicine Supply Map, a supply chain intelligence product that provides visibility of the generic pharmaceutical supply chain and drug shortage risks. Prior to joining USP, Ben was a Senior Product Manager at Mettler-Toledo Autochem, responsible for particle characterization process analytical technology (PAT), where he developed and launched the EasyViewer and iC Vision product lines. Ben is experienced in nurturing technologies, developing new products, and helping life science organizations navigate disruptive innovation, having more than a decade of experience as a product manager and product leader serving the pharmaceutical industry with innovative technologies. Ben holds a master of science degree in materials science and a bachelor of science degree in chemical engineering from the University of Maryland in College Park, as well as an MBA from The Johns Hopkins University Carey Business School.
Charles Heise
Associate Director (BPSD, Process Development), FUJIFILM Diosynth Biotechnologies
Charles Heise is Associate Director in the Bioprocessing Strategy & Development group at FUJIFILM Diosynth Biotechnologies working on developing connected, integrated processes. He has over 15 years of experience in the biologics industry leading the development of cGMP processes for clinical and commercial recombinant protein manufacture and academic research collaborations. He is co-inventor of the award winning SymphonXTM purification skid and the downstream technical lead for FDB’s continuous biomanufacturing platform, MaruXTM. Charles graduated in the UK from the University of Oxford and obtained his doctorate from the University of York.
James Heindl
Principal Scientist at Thermo Fisher Scientific, Patheon
Jim has been at the Thermo Fisher Scientific / Patheon Cincinnati site since 2000. By training he is a Chromatographer, earning his PhD in Separation Science in 1998 from the University of Cincinnati under the guidance of Dr John Dorsey. He began his career on the bench as a lead development chemist then progressed to a laboratory Supervisor, then developed and managed the current analytical client facing team before taking his current role. In his current role he serves as a technical support for all projects (small molecule pharmaceutical) at the Cincinnati site, serves as the site SME for technical guidance for all development proposals, and supports client and regulatory audits. He also supports other sites Thermo Fisher / Patheon network as a technical SME and supported multiple Global team initiatives and PPI / Operational excellence projects.
Dr. Valentin Poirier
Solutions Product Manager BioPharma, Bruker BioSpin
Valentin joined Bruker BioSpin in 2024 as a Solution Product Manager in the BioPharma team. In this role, he collaborates with the pharmaceutical industry to advance Nuclear Magnetic Resonance solutions tailored to drug development and manufacturing, with a strong emphasis on quality control and compliance. A trained chemist, he entered the pharmaceutical industry after completing his Ph.D. Over the past decade, he has managed analytical platforms at CROs (Albhades and Evotec), focusing on NMR and Mass Spectrometry as modern tools for analytical sciences and regulated applications (GMP/GLP). As a technical expert, he has contributed to the development of dozens of analytical projects for pharmaceutical applications and quality control, with a customer-centric and problem-solving approach.