2021 Keynote Series

Presented by Pharmaceutical Technology and BioPharm International

2021 Keynote Series: Equipment Trends in Advanced Solid-Dosage Drug Manufacturing

Organized by Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International. Equipment and advanced manufacturing approaches to meet the evolving needs for solid-dosage drugs include continuous manufacturing, containment strategies, Industry 4.0 tools, and techniques for optimizing solid dosage form manufacturing. This session will call on industry experts to address the practical approaches, techniques, equipment, and tools needed to adopt these strategies, as well as considering trends and developments for improving quality and operational efficiency. Topics discussed include the following: Industry use and development of continuous OSD manufacturing processes Equipment advances and requirements for solid dosage forms Best practices in equipment design and use Workforce development and training Speakers: Jennifer Markarian, Manufacturing Editor, Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International Fernando Muzzio, PhD, Professor of Chemical and Biochemical Engineering, Rutgers University Johannes Khinast, PhD, Head of the Research Center Pharmaceutical Engineering (RCPE), Graz University of Technology in Austria Dave DiProspero, Director Pharmaceutical Process Technology, CRB Gernot Warnke, PhD, Head of R&D, JRS Pharma Sharon Nowak, Business Development Manager, Coperion K-Tron USA Food & Pharmaceutical Industries

2021 Keynote Series: Advances in Molecule Characterization and Biomanufacturing for Emerging Therapies

Organized by Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International The progression of increasingly complex biological molecules in early drug development poses unique challenges to their analytical characterization, which, in turn, impacts the design and approach of biomanufacturers to the bioprocesses needed to produce these molecules, both in the lab and at scale up/scale out. This session will explore current advances in analytical methodologies and equipment starting at the benchtop and carrying through to process analytics and process development. Topics for discussion include the following: Key issues impacting bioprocessing Analytics Process and equipment Speakers: Feliza Mirasol, Science Editor, BioPharm International, Pharmaceutical Technology, and Pharmaceutical Technology Europe Gregory Berger, Product Manager, Virus-based Therapeutic, Gene Therapy, Sartorius Ahmed Besheer, Head Formulation Development, Lonza Drug Product Services Lowell Brady, Head Drug Product Phys-Chem Analytical Development, Lonza Drug Product Services Sébastien Ribault, PhD, Vice-President and Head of End-to-End Solutions, part of the BioReliance® portfolio, MilliporeSigma Marc Hummersone, Senior Director, Research & Development, Astrea Bioseparations

2021 Keynote Series: Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD

Organized by Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International With the deadline for complying with the aggregation requirements of the US Drug Supply Chain Security Act (DSCSA) just two years away and uncertainties about authentication of medicines in a post-Brexit Europe, questions about compliance—and the security of the drug supply—are at the forefront. In this discussion, global supply chain experts examine implications of the DSCSA’s Nov. 27, 2023, aggregation compliance deadline and topical considerations around the European Union’s (EU) Falsified Medicines Directive (FMD). As the aggregation compliance for the DSCSA—delayed from 2019—approaches, what do companies across the bio/pharmaceutical supply chain need to tackle now, and what can they expect going forward? Within Europe, compliance with the delegated EU FMD regulation has been required since 2019. However, implementation of the delegated regulation has not been smooth sailing. In what position has Brexit left stakeholders with regards to medicines authentication? Has it been/might it be necessary to further update manufacturing and packaging lines to accommodate variances in regulations? Experts from across the global supply chain will provide insight and answers to these questions Speakers: Meg Rivers, Senior Editor, Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International Felicity Thomas, European Editor, Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International Rebecca Mullis, Engineering Project Manager, Catalent Steve Wood, President & CEO, Covectra, Inc. Géraldine Lissalde-Bonnet, Director Public Policy, GS1 Global Office Angela Fernandez, Vice President of Community Engagement, GS1 US Chris Spivey, Editorial Director, MJH Life Science’s Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International David Bond, Senior Manager, Packaging, Engineering, and Serialization Program Lead, Thermo Fisher Scientific Staffan Widengren, Director Corporate Projects, Recipharm Lauren Catalano, Technical Services Manager, Sharp Alf Goebel, CEO, advance

2021 Keynote Series: The Evolution of Aseptic Processing

Organized by Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International The technical demands of aseptic processing have long challenged pharmaceutical companies and contract manufacturers to produce different volumes of safe, effective, drugs in a cost-effective manner. Drug recalls and regulatory actions have underlined the technical and regulatory hurdles. In this keynote session, experts in aseptic processing will discuss the evolution of their field, including specifics on what might be required to transform existing processing lines to comply with new regulatory requirements, the variety of challenges and new solutions available to deal with small-batch processing, and the application of single-use systems and associated issues, such as shortages and sterilization difficulties. Hear insight from consultants, academic experts, representatives from industry associations, and technical experts from companies supporting aseptic processing. Topics for discussion include the following: The regulatory and technical evolution of aseptic processing Processing challenges Potential applications for single-use systems Materials shortages and sterilization challenges Speakers: Feliza Mirasol, Science Editor, BioPharm International, Pharmaceutical Technology, and Pharmaceutical Technology Europe Luke Stockhausen, Lead Process Engineer, CRB Patrick Nieuwenhuizen, PharmaLex Richard Denk, SKAN Rafael Beaus, Global Consultancy Manager, Azbil Telstar Jordi Serrat, Product & Technology Director, Azbil Telstar