May 2, 2019

Commercial lessons for clinical-phase success, Part I: it all starts with collaboration

In early-phase clinical research, it’s common to think that your science resides within your lab. But when it comes to cell and gene therapy, those four walls fall away fast.

Cell and gene therapies are always highly collaborative and distributed, at any phase. While commercial-phase therapies may operate at greater scale, their highly collaborative nature reflects realities that start with early R&D. In the advanced therapies ecosystem, where every process revolves around the patient, even early-phase research requires constant teamwork and outreach.

autologous clinical journey

That collaboration — or a lack of it — directly affects some of the key hurdles that R&D teams face as they try to drive transformative personalized therapy science with limited resources. Some common challenges include:

  • Fragile, human “raw materials” that are collected and/or handled by a wide variety of teams of stakeholders, many of whom may be outside the sponsor’s organization
  • Complex supply and logistics chains that revolve around the patient
  • Numerous clinical trials that are already running, creating stiff competition for patients and clinical sites
  • Essential clinical and regulatory collaborators who require systems that  promote safety, traceability, and trust
  • Data, networks, facilities, and processes that are distributed, and even global in a growing number of cases
  • Manufacturing capacity and processes that require real-time management (for example, if a patient’s cell collection gets rescheduled, what do you do with that manufacturing slot you booked?)
  • Limited budgets

Even if your R&D or Clinical Operations team is on the smaller side, effective collaboration with the cell and gene ecosystem is possible. But doing so requires disciplined advance planning and early systems thinking. Here are some of the realities you’ll need to address, and some suggestions.

Your very complex science may not always be self-explanatory. What makes sense to you will be much less familiar to busy physicians and nurses, and potentially overwhelming to the very ill patients who are often candidates for early-phase trials. To  motivate physicians and patients to participate, you’ll need to be clear about clinical benefit(s).

You can’t separate the patient, the physician, and the manufacturer. You’ll need to work within the healthcare provider’s world, with minimal disruption. Trying to insert complex new processes and systems, especially ones that are “one-offs,” may not be well-received at busy clinical sites. If your clinical sites are handling cell collection, they are basically providing patient material directly to manufacturing. This process needs to be as simple for clinical sites as possible.

Everyone is living in the same ecosystem, and everyone is sharing the same resources. According to the Alliance for Regenerative Medicine, more than 1,000 advanced therapy clinical trials are underway worldwide with more on the way. Trials are competing for access to clinical sites, as well as for study subjects. If your trial processes and systems are relatively simple — or even better, familiar — to clinical sites, you’ll have a better chance of making your trial stand out. It’s a crowded field, and getting busier. Simpler will win.

The collaboration is constant. Successful cell and gene therapy trials require continuous shared work and integration on every patient product. Your stakeholders need to be able to place orders, schedule cell collections, and manufacturing slots and manage logistics simply. Cell collections, done under regulated GMP processes, need to be as simple and robust as possible. Integrate as much as possible with other systems and solutions for other specialty products. Without collaboration, you’re automatically putting in barriers to your clinical process.

If you understand that your ecosystem is broad and goes beyond your four walls from the beginning, your trial will be off to a much more successful start.

At Vineti, our software platform helps our clinical-phase partners handle collaboration challenges every day. This post is the first of a series on commercial-phase lessons for clinical-phase success, with more tips coming soon. You can also download a related article here.

Heidi Hagen is the Chief Strategy Officer and a Co-founder of Vineti. Over the course of her career, she has overseen the operations and delivery for more than 100,000 doses of cell therapy. If you’d like to learn more about how Vineti’s software platform supports clinical-phase advanced therapies, please contact us to schedule a demo.