INTERPHEX Keynote Sessions on the Innovation Stage

INTERPHEX will be held in person at the Javits Center, October 19–21, 2021, and—to continue a long-standing tradition—the editors of Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International will moderate Keynote Sessions featuring industry experts. Unique to this year, however, the sessions will be premiered by video on the show floor. Come to the Innovation Stage to watch the following presentations.

Equipment Trends in Advanced Solid-Dosage Drug Manufacturing

Tuesday, Oct. 19, 2021, 10:15 am–noon EDT

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. The session will be moderated by Jennifer Markarian, manufacturing editor, Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International.

Hear insight from industry experts:

• Dave DiProspero, Director Pharmaceutical Process Technology, CRB
• Fernando Muzzio, PhD, Professor of Chemical and Biochemical Engineering at Rutgers University
• Johannes Khinast, PhD, Head of the Research Center Pharmaceutical Engineering (RCPE) at the Graz University of Technology in Austria
• Gernot Warnke, PhD, Head of R&D, JRS Pharma
• Sharon Nowak, Business Development Manager, Coperion K-Tron USA Food & Pharmaceutical Industries.

Advances in Molecule Characterization and Biomanufacturing for Emerging Therapies

Tuesday, Oct. 19, 2021, 1:15–3 pm EDT

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. The session will be moderated by Feliza Mirasol, science editor, BioPharm International, Pharmaceutical Technology, and Pharmaceutical Technology Europe.

Hear from industry experts:

• Gregory Berger, Product Manager, Virus-based Therapeutics—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.

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

Wednesday, Oct. 20, 2021, 10:15 am–noon EDT

With the deadline for complying with the aggregation requirements of the US Drug Supply Chain Security Act (DSCSA) 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:

• Rebecca Mullis, Engineering Project Manager, Catalent
• Staffan Widengren, Director Corporate Projects at Recipharm
• David Bond, Senior Manager, Thermo Fisher Scientific’s Pharma Services
• Steve Wood, President & CEO, Covectra, Inc.
• Alf Goebel, CEO, Advanco
• Géraldine Lissalde-Bonnet, Director Public Policy, GS1 Global Office
• Angela Fernandez, Vice President of Community Engagement, GS1 US.

Moderators:

• Chris Spivey, Editorial Director, Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International
• Meg Rivers, Senior Editor, Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International.
• Felicity Thomas, European Editor, Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International.

The Evolution of Aseptic Processing

Wednesday, Oct. 20, 2021, 1:15 pm–3 pm EDT

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. This session will be moderated by Felicity Thomas, European editor, Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International.

Hear insight from consultants, academic experts, representatives from industry associations, and technical experts from companies supporting aseptic processing:

• Richard Denk, SKAN
• Luke Stockhausen, CRB Group
• Patrick Nieuwenhuizen, PharmaLex
• Rafael Beaus, Azbil Telstar
• Jordi Serrat, Azbil Telstar.

To register for the show and the complimentary conference sessions on the show floor, go to www.INTERPHEX.com .