In August, Petr Machalik, M.S., joined Be The Match BioTherapies® to support the organization’s international expansion. We spoke to him about key challenges facing cell and gene therapy companies in the EU and how Be The Match BioTherapies is poised to support them.
After spending a number of years as the lead apheresis network manager for Sotio, a European company developing cellular immunotherapies, you recently joined Be The Match BioTherapies to support the organization’s global expansion. Tell us about your work.
As the manager of the International Collection Network, I am developing and maintaining a reliable network of collection centers for clients of Be The Match BioTherapies. I provide guidance to centers on the collection and processing of cells that are compliant not only with client specifications but also with country-specific laws and regulations, in addition to international standards and regulatory requirements.
What drew you to Be The Match BioTherapies?
I had known about the National Marrow Donor Program® (NMDP)/Be The Match® for many years and admired the work that they did in managing allogeneic stem cell transplants for patients around the world. When I learned about the work of Be The Match BioTherapies, I wanted to be part of it and help leverage and support the capabilities established by the organization to accelerate patient access to new cell and gene therapies.
The team is very knowledgeable and experienced, and I’m very happy to have the opportunity to expand Be The Match BioTherapies’ capabilities to deliver international services to our clients.
What are some of the challenges cell and gene therapy companies and collection centers are facing in the EU?
The biggest challenge is the differences in the regulatory environments among European countries. While there are directives negotiated by the EU, each country has the freedom to interpret those regulations and implement their own processes. So the actual regulatory environment can differ from country to country, and can differ quite a lot sometimes.
Be The Match BioTherapies is in a unique position to help cell and gene therapy companies and collection centers navigate these challenges. Through NMDP/Be The Match, we have strong partnerships with organizations worldwide to supply life-saving treatments to patients with cancer and other life-threatening diseases, and we have the established relationships in place to implement services for new and emerging cellular therapy companies.
As part of my role, I’m looking forward to visiting and building relationships with centers and regulatory bodies in the countries that companies are expanding into to discover how we can use our expertise to provide services outside of the US and how we can modify certain existing processes to meet the unique country-specific regulatory requirements.
Additionally, we hope to lead global standardization efforts to ensure that consistent starting material is delivered to a manufacturing facility, whether it is coming from a collection center located in Germany, the UK, France, the United States, or elsewhere.
What is most exciting to you about the cell and gene therapy industry?
The industry is developing so rapidly, and it’s exciting to have the chance to be part of it and to actively participate in cell and gene therapy programs that save lives and improve health globally. This organization has a huge opportunity to continue advancing the industry as a whole; I couldn’t be more excited to be part of furthering the mission across the globe.