Question 1

Why are CellServe's services important?

Accepted Answer

Cellular therapy is a new form of treatment with a set of clinical, operational, quality, and regulatory standards that differ from those in the pharmaceutical industry.
The complexity of cellular therapy is present at all levels:

- Clinical: It requires very specific knowledge of adverse reactions that almost exclusively occur in cellular therapy.

- Operational: The complexity in the manufacturing process, including cell collection, shipping cells for genetic engineering, etc. requires a team of people with specific training for each of these steps and a high level of communication and coordination that requires training and time. Therapy is very time-sensitive, as the patients who receive the treatment often have cancers that require timely intervention. Failure in any of these steps can result in the loss of the cellular product and with that, the life of a patient.
 
- Quality: All processes in cellular therapy, from the patient to the lab, and back to the patient, must follow the highest quality standards to ensure that the treatment is delivered to the patient safely. This requires very specific expertise that can only be acquired over years of experience

- Regulatory: The regulatory structure for cellular therapy is evolving rapidly and is another area of high complexity and specific expertise.

- Financial: Reimbursement of services related to cellular therapy is also evolving and has been limited the academic centers.

Question 2

Why haven’t academic centers expanded into the community yet?

Accepted Answer

•Existing providers may have the expertise, but they already have a full-time job.

•Setting up a team to enable selection of centers and  implementation requires hiring several positions with niche expertise in different aspects of cellular therapy. Qualified providers and staff are in high demand - if at all available. Hiring one MD is not enough!

•All of this requires a substantial investment in different resources, many of which may only be used for the initial phases of the set-up.

•The regulatory and reimbursement aspects of cellular therapy are just now being designed, which generates a great deal of uncertainty.

Question 3

I already have a Cellular Therapy Program, can CellServe assist with expansion and growth?

Accepted Answer

Absolutely. We set up Cellular Therapy Programs and also expand and grow existing ones.

Question 4

Can I choose from a menu of CellServe services or do I have to use all of them?

Accepted Answer

You can choose one or more services. Our goal is to customize our services to your needs.

Question 5

Can CellServe provide investment opportunities in innovative and promising cellular therapy products?

Accepted Answer

Yes, we select partners committed to making cellular therapy better and more accessible to everyone. We can guide you through these investment opportunities.

Question 6

What aspects of a clinical trial can CellServe help with?

Accepted Answer

We support all aspects of clinical trials, from writing the clinical trial to select CRO (Contract Research Organization) services. We also offer regulatory guidance, assistance with insurance, etc. in the U.S. and globally.