Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Chris Spivey

We have been living through a period where institutions and rules are being questioned. I am proud to work in an industry where colleagues, rules, and institutions have stood up well through this conversation. Some rules were deliberately broken, some barriers reduced. One concrete example comes from FDA guidance documents on abbreviated new drug applications where bioequivalence studies for generic drugs resupply with expired batches were deemed permissible “as long as sufficient evidence can be provided to demonstrate the acceptability of the test product batch” (1). Supply chain contingencies immediately transformed from an abstract concept to a concrete process for most of us.

Regarding investments in technology, a survey from Zebra Technologies reported that 86% of patients agree that increased technology spending would provide a competitive edge in managing pharmaceutical supply chain stability, security, and traceability (2). That number rises to 92% when answered by industry decision makers. Of these decision makers, 96% then consider supply chain visibility confers on them a competitive advantage. Key areas targeted for future spending for these decision makers are location technology, temperature monitor and sensors, temperature sensitive labels, prescriptive analytics, and machine learning. The findings continue, stating, “compliance remains an issue for the pharmaceutical industry. About one third of industry decision makers surveyed rank compliance among the top five challenges facing their industry today. Among the pharmaceutical industry verticals, manufacturing experiences the most significant lag in compliance.” Institutions and rules held up well during this time of emergency. We have learned what areas of our manufacturing supply chain held up, while also learning which areas we need to strengthen.

While not everything went smoothly over the past two years, we have manufactured great outcomes from alarming adversity. Nearly eight billion doses of COVID-19 vaccines have now been administered (3). We have broken rules, invented new ones, and engineered stronger institutions and supply chains that will serve us better going forward.

Development of Abbreviated New Drug Applications During the COVID-19 Pandemic—Questions and Answers, Guidance for Industry

Pharmaceutical Supply Chain Vision Study: Technology-led Transparency Drives Resiliency

Bloomberg, “More than 7.84 Billion Shots Given: COVID-19 Tracker,” Vaccine Tracker, Last Updated Nov. 25, 2021.


Volume 45, Number 12
December 2021
Page: 10

When referring to this article, please cite it as C. Spivey, “Breaking the Rules,” 

Articles

We have broken rules, invented new ones, and engineered stronger institutions and supply chains that will serve us better going forward.

Breaking the Rules

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD was part of a keynote series at INTERPHEX 2021. This is part four, 

serialization from a regulatory perspective

Watch part 1: serialization from a manufacturing perspective

Watch part 2: serialization from a packaging perspective 

Watch part 3: serialization from a software perspective

With the aggregation considerations for the US Drug Supply Chain Security Act (DSCSA) on the horizon 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 (specifically serialization and aggregation) and topical considerations around the European Union’s (EU) Falsified Medicines Directive (FMD). 

As the aggregation considerations for the DSCSA 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.

 is the vice president of community engagement at GS1 US. GS1 is a not-for-profit organization that develops and maintains global standards for business communication. Angela is responsible for driving broader adoption of GS1 Standards to help industries achieve their goals for improved traceability, information transparency, and data quality.

 leads the GS1 Healthcare Global Public Policy Work Team, which has the mission to interact with decision-makers globally and to provide strategic leadership on the use of GS1 standards in the healthcare sector.

Watch other videos in this keynote series

Equipment Trends in Advanced Solid-Dosage Drug Manufacturing

Advances in Molecule Characterization and Biomanufacturing for Emerging Therapies

Global supply chain experts examine implications of the DSCSA as well as topical considerations around the EU's FMD in this serialization video series ft. manufacturing, packaging, software, and regulatory experts.

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD – Regulatory | Part 4

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD was part of a keynote series at INTERPHEX 2021. This is part three of four, 

serialization from a software and data management perspective

Watch part 4: serialization from a regulatory perspective 

 is the CEO of advanco, provider for Level 3 and Level 4 Item Level Serialization. Alf has more than 25 years of enterprise software industry experience. He has strong operational experience, specializing in high-growth businesses in Europe and the United States.

 is the president and CEO of Covectra, a leader in track and trace solutions. Steve has more than 30 years of experience in international business development and program management.

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD – Software and Data Management | Part 3

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD was part of a keynote series at INTERPHEX 2021. This is part two of four, 

serialization from a packaging perspective

Watch part 4: serialization from a regulatory perspective

 is a technical services manager at Sharp, a provider of pharmaceutical contract packaging services. In her role, Lauren is responsible for supporting the development, documentation, implementation, and enhancement of Sharp’s serialization services platform.

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD – Packaging | Part 2

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD was part of a keynote series at INTERPHEX 2021. This is part one of four, 

serialization from a manufacturing perspective

Watch part 2: serialization from a packaging perspective

 is a senior manager (packaging engineering) and serialization program lead with Thermo Fisher Scientific’s Pharma Services, a contract development and manufacturing organization. David has 25 years of experience in the pharma industry, including manufacturing, validation, packaging, engineering, and serialization.

 is an engineering project manager for Catalent Biologics, a contract development and manufacturing organization. Rebecca has more than 13 years of experience in the pharmaceutical industry and project management. Rebecca is responsible for managing the design, implementation, and qualification of large capital projects within the biologics business.

 is the director of corporate projects at Recipharm, a contract development and manufacturing organization. Staffan has between June 2015 and April 2019 acted as program manager for the Recipharm global serialization project and part of a global steering committee that is working closely with Recipharm’s clients to ensure they plan and implement changes that comply with pending regulatory requirements for drug serialization.

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD – Manufacturing | Part 1

Advances in Molecule Characterization and Biomanufacturing for Emerging Therapies was part of a keynote series at INTERPHEX 2021. This is Part 2 of 2.

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.

Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International

Gregory Berger, Product Manager, Virus-based Therapeutics—Gene Therapy, Sartorius

Greg is part of the Viral Based Therapeutic product management team at Sartorius bringing a wealth expertise in viral vector/cell line development, vector production in bioreactors and development of appropriate analytical tools for characterization and functionality assessment. Greg obtained his PhD in Virology and Immunology from the Ecole Normale Superieure de Lyon (ENS Lyon) in France, focusing upon the development of new Lentiviral vectors for the development of Dendritic cell-based immunotherapy. He then joined the department of Immunobiology and Infectious Disease at King’s College London as a post-doctoral researcher where his work focused predominantly on viral vector integration and immune cell dysfunction upon transduction. Prior Joining Sartorius, Greg worked at the Cell and Gene Therapy Catapult where he led the development of an End-to-End AAV manufacturing platform to address the current challenges regarding viral vector manufacturing.

Ahmed Besheer, Head Formulation Development, Lonza Drug Product Services

Ahmed Besheer has extensive experience in drug product development, with ten years of industry experience. Before joining Lonza in 2018, Ahmed worked at Novartis and Merck Serono in parenteral formulation development as DP project lead and later as head of NBE formulation development. At Lonza, Ahmed leads a team that develops drug products of monoclonal antibodies, recombinant protein, fusion proteins, bioconjugates, antibody fragments, nanobodies, and viral vectors. He has extensive experience in the formulation of liquid and lyophilized early- and late-phase Drug Product for various administration routes.

Ahmed earned his pharmacy degree from Ain Shams University, Cairo (EG), holds a PhD in pharmaceutical technology from the University of Halle (DE), and worked as an assistant professor at the University of Munich (DE)

Lowell Brady, Head Drug Product Phys-Chem Analytical Development, Lonza Drug Product Services

Lowell Brady leads the Phys-Chem analytical development team at Lonza Drug Product Services, which is responsible for analytical method development and support of specification setting and the analytical control strategy for customer products. Prior to joining Lonza, Lowell worked in analytical and CMC roles at large biotech and pharmaceutical companies. Lowell has a broad range of expertise ranging from in-depth characterization of protein therapeutics using mass spectrometry to the development of routine quality control methods for product release and stability testing. Lowell has experience defining strategies for supporting all stages of product and process development, from early pool/clone screening through BLA filings.

Sébastien Ribault, PhD, Vice-President and Head of End-to-End Solutions, part of the BioReliance® portfolio, MilliporeSigma

Sébastien joined MilliporeSigma in 2005 and is vice-president and head of End-to-End Solutions and the managing director of the Biodevelopment Center located in Martillac, France, where he leads the CDMO branch dedicated to large molecules within MilliporeSigma. Sébastien also supports the development of new and innovative biomanufacturing technologies and solutions in collaboration with the company’s process development team.

Prior to joining MilliporeSigma, he was a gene therapy development scientist at Transgene and was head of the R&D laboratory and member of the board of directors at Hemosystem, an in-vitro diagnostics company. Sébastien received his microbiology engineer degree from the Engineer School of Luminy, Marseille, France and his PhD in molecular and cellular biology from the University of Strasbourg.

Marc Hummersone, Senior Director, Research & Development, Astrea Bioseparations

Marc Hummersone has over 20 years of project and managerial experience in both big and small technology companies, including industry leaders AstraZeneca, General Electric Healthcare, and Cytiva. He has a broad experience base across a wide range of technologies including the development of novel chromatographic media for the purification of complex biological feed streams as well as drug discovery and development. He was a key contributor to the development of the Fibro chromatography family of products which resulted in the acquisition of Puridify, by GE Healthcare in 2017. Additionally, he was a key part of the management team who validated the concept of synthetic lethality and who identified and developed Lymparza, which is an approved drug for the treatment of BRCA-mutated advanced ovarian cancer which resulted in the acquisition of KuDOS Pharmaceuticals in 2005, by AstraZeneca. Marc has held positions including Company Director, Chief Scientific Officer and Department Director.He gained a PhD and Post-Doctoral experience in chemistry which was focused on the total synthesis of complex natural products at University College, London.

Watch other videos in this keynote series:

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

Part 2—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius provide insight and examples about solving critical challenges in both analytics and process development for emerging therapies.