The healthcare industry is in the formative stages of a new era of medicine — the advent of advanced therapeutic medicinal products (ATMPs). This paradigm shift has the potential and promise to cure debilitating disease states but equally necessitates the need to overcome key bottlenecks in the manufacturing and logistics that arise therefrom. At the forefront of ATMPs, cell and gene therapies are making headlines with curative results in patients, while newer studies are revealing the capabilities of other novel modalities like radioligand therapy, mRNA therapies, prime-/base-edited therapies (e.g., CRISPR) and conventional cell and gene therapies.

The success of ATMPs is pushing the boundaries of traditional research, manufacturing, storage and distribution. Stakeholders are demanding shorter production, development and approval timelines, in addition to a higher level of visibility and touch for these new treatments both in manufacturing and in transit. The added complexity is the ability to navigate inevitable disruptions that occur from vein-to-vein due to factors such as weather events and geopolitical events. Given the temperature-sensitivity and time-criticality the therapies are subject to, collaboration is needed to develop innovative solutions to reduce complexity and improve reliability across the entire ATMP supply chain.

Attendees will learn more about:

Types of ATMPs currently in development, the promise of new modalities and ongoing research to diversify targeted diseases
Evolution of regulatory framework for ATMPs as it keeps pace with rapid advancements in the field
Approaches towards maintaining resilience and mitigating disruption for hyper-sensitive, personalized drugs in the supply chain

Keywords:

Speakers

Rohin Iyer, Senior Director Cell and Gene Operations, Marken

As Senior Director of Cell and Gene Operations, Dr. Rohin Iyer leads Marken’s advanced therapies division, managing the critical distribution of both clinical and commercial personalized medicines. Leveraging Marken’s unique cell and gene therapy (CGT) portfolio as its flagship premium service offering, he oversees the complex logistics across a diverse array of advanced therapeutic modalities ranging from nucleic acid therapies to CAR-T therapy, as well as the raw materials used to manufacture them. Dr. Iyer’s team provides specialty logistics solutions to both emerging and highly established biopharmaceutical developers in the field and leverages an extensive global cryogenic and operational network, specialized control tower oversight with advanced visibility and interventional tools, and dedicated project management and operational excellence staff to deliver innovative solutions for clients and patients.

His leadership expertise includes over a decade in CGT development and over 15 years of hands-on laboratory work focused on stem cells, tissue engineering, immunotherapy development and regenerative medicine at large pharma organizations. With extensive experience in portfolio management, process development and bioprocess optimization in CGT and immunotherapy, he has played an instrumental role in supporting the clinical research and development of regenerative medicines. Rohin obtained his Bachelor of Applied Science and his Doctor of Philosophy (PhD) in Biomedical Engineering at the University of Toronto.

Message Presenter

Wayne Chester, President, CEO and Chairman, Sendum

Wayne Chester is President, CEO, and Chairman of Sendum, which he co-founded in 2001, pioneering real-time supply chain visibility. Under Wayne’s leadership, over 800 CGT clinical trials and 40% of all approved CGT therapies currently utilize Sendum solutions, reducing product loss by up to 70%.

Before Sendum, Wayne significantly contributed to Glenayre’s success in the wireless products division and led groundbreaking projects in electronic medical charting at Westech System. His career began at Electronic Data Systems, where he started as an assembly programmer on IBM mainframes and then transitioned to account executive in financial services, demonstrating his versatile expertise in technology and business development.

Wayne is a veteran of both the US and Canadian armies. He holds an MBA from Queens University and a BSBA from the University of Colorado, Colorado Springs.

Wayne’s passion for helping accelerate the world’s transition to Advanced Therapy Medicinal Products continues to guide his vision for Sendum and the industry, making him a respected voice in supply chain visibility and ensuring product integrity.

Message Presenter

Who Should Attend?

Senior professionals who are involved with:

Pharmaceutical companies
Biotechnology companies
Central labs
CMOs
CROs
CDMOs

What You Will Learn

In this webinar participants will learn about:

Industry Trends
- Types of ATMPs currently in development and the promise of new modalities, in addition to ongoing research to diversify targeted diseases
- How stakeholders are adapting processes and innovation towards supporting the transport, storage and distribution of hyper-sensitive materials
- Technological advances and digital integration that are critical for delivering these groundbreaking treatments
Challenges and Considerations of the Supply Chain
- Evolution of regulatory framework for ATMPs as it keeps pace with rapid advancements, and the collaboration between regulators and industry stakeholders as a key to streamlining approval processes
- Addressing scalability, affordability and equity, as well as the potential for making ATMPs more accessible and cost-effective
- Allogeneic vs. autologous approaches, and what is being done to assess and streamline the viability of both processes
Strategic Approach and Innovative Solutions
- Optimizing ATMP efficacy, monitoring safety and predicting patient response using digital technologies, AI and automation
- Approaches to maintaining resilience and mitigating disruption for hyper-sensitive, personalized drugs in the supply chain

Xtalks Partner

Marken

Marken is the clinical precision logistics and advanced therapy subsidiary of UPS Healthcare. The UPS Healthcare network consists of 200+ locations worldwide. Marken offers a state-of-the-art, GMP compliant depot network and logistic hubs for clinical drug product storage and distribution in 49 locations worldwide, while maintaining the leading position for cell and gene therapy services, direct-to-patient and home healthcare services, biological sample shipments and biological kit production. Marken’s dedicated 2,600+ staff members manage 200,000 drug product and biological sample shipments every month at all temperature ranges in more than 220 countries and territories and have orchestrated 16,000+ home healthcare visits. Additional services such as ancillary material sourcing, storage and distribution, shipment lane verification and qualifications, as well as GDP, regulatory and compliance consultancy add to Marken’s unique position in the pharma and logistics industry.