There are more than 2,600 ongoing regenerative medicine clinical trials, with nearly 1,200 companies actively developing these therapies. While the number of product approvals is trending upwards – 18 decisions expected over six geographies this year – the total number of commercial therapies remains low, with 9 cell-based immunotherapy, 8 gene and 17 cell therapy products having received market approval.
The realities of developing these products are well known. At clinical stages, the supply chain needs to be built so that it can scale to commercial complexity and the associated challenges that arise. Often, this is more patients across wider geographies, further away from manufacturing centers – but the product retains the same time and temperature requirements.
An integrated, adaptive logistics and patient-centric approach can account for the complexities that arise as the ATMP supply chain scales up and out. Successful clinical trial phases can support the move to commercialization and beyond, prioritizing the patient experience.
Join this webinar to learn more as the speakers discuss the adaptive logistics approach of:
- How to get the therapy to the patient
- How to get the patient to the therapy
- Home care for patients as part of the trial
Speakers
Samuel Gal Alterovich – Director of Strategic Services and Alliances, Oximio
Gal leads the Strategic Services and Alliances at Oximio (previously SMO Group) which includes the strategy and development of emerging logistics solutions to support advanced therapies, decentralized trials and patient-centric services.
He has extensive experience in the field of clinical trials, including end-to-end regulatory, financial, commercial, legal and compliance activity to ensure that patients receive the right product, at the right time.
Message Presenter
David Schwicker – Founder, ORPHA Strategy Consulting
David specializes in accelerating clinical development and marketing authorization, time to launch, early patient and market access for orphan and advanced therapy medicinal products (ATMPs).
He is the author and co-author of numerous peer-reviewed publications, a trainer in patient centricity and patient-reported outcomes, rare diseases, orphan drugs, as well as in gene and cell therapies, and speaker at international meetings (ISPOR, RAPS EU Congress, Orphan Drugs Development and Commercialization).
Message PresenterWho Should Attend?
- Clinical operations leaders (Heads, VPs, Directors) at cell and gene biotech organizations
- Supply chain and logistics leaders (Heads, VPs, Directors) involved in single, or multi-country ATMP trials
- Emerging small and mid-tier cell and gene biotech organizations (CEO, CMO, COO)
What You Will Learn
- A definition for adaptive and integrated logistics
- How to ensure patient focus
- The solution applied in the real world (a case study)
- How adaptive logistics can prioritize the patient experience while meeting complex scientific and regulatory requirements
Xtalks Partner
Oximio
Oximio is a clinical trial services provider contributing to research to find effective treatment and cures for all living beings, globally. Oximio works hard to convert the ever-changing face of investigational medical products into new medicines, bringing over 16 years of service excellence to the clinical trial industry. The company provides a direct connection to several patient communities of over 500 million people by being present in the United Kingdom, Eastern Europe, Western Asia, and South Africa. Oximio’s large and loyal client base ranges from start-ups to major international organizations, pharmaceutical and R&D companies. Oximio is in the front line of servicing clinical trials with its own warehouses and, through licensed partner sites, offers an end-to-end cold-chain control system in all premises. By combining its’ ‘best-in-class’ depot network with a highly experienced and qualified workforce, Oximio is thoroughly conversant with both global and local procedures for clinical trials, ensuring the highest standards of operation. Oximio has the following capabilities: supply planning and consulting, comparator sourcing, patient centricity, advanced therapy solutions, import & export regulations, relabeling, warehousing, distribution and courier services, return & destruction.
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