Nicola Ambler Aug 14
An interview with J. Kelly Ganjei, CEO and Chairman of the Board, Cognate BioServices, Inc

Preparing for Commercialisation with the Right CDMO

An interview with J. Kelly Ganjei, CEO and Chairman of the Board, Cognate BioServices, Inc

What is the one thing you’d recommend clients do when evaluating a CMO partner?

Having been on the other side of the table, as a company in development, I would evaluate, in person, what efforts are being made to address commercialization and try to understand the mindset of those who are responsible for making and releasing your product. Developing, and maintaining a commercial mindset is not easy to achieve, and is highly critical, especially in context with the rapid development cycles we’re witnessing today. Products must be manufactured with a higher level of compliance at earlier stages and elements like simplicity, closed systems, modular automation and validation are more important earlier on. If you’re going to develop a product with a CMO that doesn’t have a commercial mindset, you’re most likely going to have to go back to the drawing board when you’re seeking FDA approval. To summarize, face to face relationships are critical.

 

How is Cognate preparing for commercial demand in cell therapies?

There is a huge demand in the industry today with an Incredible number of new clinical trials starting up, so commercial demand is going to skyrocket and require more capacity than currently exists. Cognate has recently opened up 16 additional suites, for a total of 22 suites of manufacturing capacity to support products for both EU and US markets and we’re well on our way to being able to support commercial-scale production.

This new cGMP capacity is strategically located in Memphis, TN USA, which is a worldwide air hub for both FedEx and UPS, enabling us to send and receive shipments from anywhere in the U.S. within 24 hours with all carriers, we can also handle both fresh and frozen cell products of all types.

The planning for this expansion started in 2014, with a design process for the physical construction and then followed by two different rounds of Institutional financing to have both the physical commercial capacity and infrastructure. In parallel with the buildout, we changed the culture within the company starting with developing talent in the staff we had, who have years of experience working with a variety of different types of cells and augmenting that with recruiting top talent to expand our expertise. Next, we rolled out a system and process for continuous improvement that layers on top of our experience within cell therapy, regulatory, manufacturing and commercial scale-up and operations. We are fortunate to have a shareholder and investor base that is perfectly aligned with management on our plans for growth. Having investor support like this sets Cognate up to become the first commercial CMO in the personalized cellular therapies space.

 

Given the recent commercial successes of cell therapies and subsequent lessons learned, what’s the most important factor that developers should look for in a CDMO?

Understand the CDMO’s experience in handling the upstream supply chain, manufacturing and downstream processes of personalized cell therapies. Then gauge that with how focused they are on commercialization.

There are some CDMOs that have handled all of those aspects up and downstream but not necessarily at the scale that’s needed for commercialization or are too focused on making the client use the CDMO's particular IP, which doesn't always work for the client, or they haven't had the breadth of experience in autologous therapies. We know, owing to our extensive phase III autologous experience, where upwards of 90 clinical sites was required, that it is a round-the-clock operation and we know what to expect in these situations when time translates to a patient outcome.

Cell therapy development is very different from traditional pharma, especially when comparing timelines. It's mind-boggling to consider the rate at which cell therapies are being developed these days. What we’ve always had in our back pocket is time, time to develop and improve processes as the drug evolves and matures over what used to be a ten year plus development timeline. This is no longer a reality, with examples like Kite, where they have successfully transitioned from clinic to commercial in just a few years! We no longer have the luxury of time to think about capacity or supply chain. Many of the cell therapy drugs being developed now are going into later stage trials and/or starting combined phase I/II or II/III trials that have very short endpoints further reducing the time to make any such improvements. Developers don't have the time and opportunity to learn from these processes along the way to make sure they’re ready for commercialization.

With cell and gene therapies timelines massively compressed, everyone is racing to get across the goal line first.  We've worked under these incredibly rapid timelines and have had successfully started up clinical programs for clients in the timeframe they hope are possible. Our experience spans from supply chain to clinic, so we understand what it takes not just from a manufacturing perspective but also from the patient perspective. When I say that Cognate Is patient-focused, it’s not just because the products we’re making are ultimately going on to save lives but it’s also because we understand what a patient has to go through during the treatment process. We try wherever possible to ensure that we have a process that meets both the patients and drug developers' needs, to ultimately ensure better outcomes all around.

 

How do you then quantify experience and turn it into a metric if you have a shortlist of CMOs?

There are quite a few C-level surveys in this industry asking the same question and it all boils down to these details in experience; look upstream and downstream of your process and understand what pain points the CDMO has solved in the past. Find out what the CDMO has integrated from their past experience. Put another way, what is the value add and ultimately the key differentiator for this CDMO in my process?  

Does the CMO have established relationships with technology vendors, shipping and logistics providers, patient tracking? Are they a center of excellence in using a piece of equipment that my product uses? Have they identified areas in the process where a simple change, a small modular automation can affect product viability? It could even be their past experience helping set up relationships with the clinical sites to ensure starting materials are handled properly and arrive on time, in the right condition. Is the CMO trying to over-automate your process? How well does the CMO listen to your needs and what level of collaboration are you feeling during the evaluation process? I would also re-emphasize the importance of making a face visit to the facility. This will go a long way in your ability to quantify the value-add and assess these points.

Let me give you a little more detail background on why a face visit will help quantify our experience. 15 years ago, when I was developing software, one of my mentors in the sales field said ‘no more spaghetti demos’, as we all looked puzzled he explained that Many people in our field are, like some old school chefs, throwing spaghetti at the wall to see what sticks. It's one thing to show a client a theoretical outcome, It’s another thing altogether to demonstrate to them how to achieve that outcome.

Instead of putting out conceptual possibilities, we put a lot of effort and time into evaluating their processes and understanding what current and future manufacturing process looks like. Then our proposals spell out specific details so that our clients can understand how we work with them through various development cycles, including but not limited to technology transfer timelines, dedicated or shared personnel pricing, and reality-based scheduling that involves integration with clinical, logistics and manufacturing organizations. These should be a fit for their needs and ultimately provide insight into key aspects of how a full manufacturing services agreement is structured.

I'd also try to look at some of the more subtle aspects of the CMO's responses to your RFP. They can tell quite a bit if you look a little deeper, for example:

  • Is the CMO pushing their own proprietary materials or reagents, or some aspects of their IP or are you free to use whatever Is best for your particular product?
  • Did the RFP response provide a list of all possible services for you to select from or did it spell out the specific details of your process and how it will work on context with your specific manufacturing needs?

Of course, following that up with a site visit and meeting the team and specifically, those who have taken the time to evaluate your process and see how well you are able to engage with the team on a collaborative basis is an important evaluation exercise.

To me, while all of these things are critical, meeting the team and getting to look those in the eye who are actually going to be making your product is what will really enable you to quantify things.

 

What innovations do you think will have the biggest impact on cell therapy development and commercialization in the coming years? How will Cognate play a part in that?

I believe innovations that address capacity and manufacturing at commercial scale and volumes will have the biggest impact. While I certainly believe automation is Important, it's just not the biggest driver at the moment in my opinion. We partially addressed the urgent need for capacity by building out more suites that are both US and EU compliant and expanded our focus on delivering commercial scale production. We’re also working on being able to offer a more complete service, including innovations developed internally and externally via partnerships that will enable modular automation and other improvements that will increase product viability and volumes. We have several big things in the works that will address multiple aspects of product development and manufacturing that I wish I could discuss at the moment but can’t. All I can say is please stay tuned.

 

Can you give any further insight into these partnerships and why they are important?

The details of some of our partnerships are proprietary but I can speak to why we place importance on strategic partnerships and how, ultimately, this is what will get treatments to patients quicker. We partner in order to add to our existing capabilities in a variety of ways, both upstream and downstream, including the supply chain, manufacturing and logistics side of things.

Outside of the traditional manufacturing technology, the areas where we’re looking to partner are those that will improve communication when you look at manufacturing from a patient perspective. If you look at the overall process, we’re involved in a wide range of touchpoints. We’re coordinating with clinical sites to receive multiple types of starting material; tracking the starting material and processing the starting material; carrying out assessments internally that could be patient-specific and, finally, coordinating with clinical sites to ship that back out. Anything that facilitates better communication and coordination across all of that is something we feel is critically important and will support the patient’s journey.

 

It’s a pretty competitive market for a CDMO in the cell therapy space, is it fair to say that Cognate has flown under the radar for many years? Can you give us some background on that?

For several years, we were at capacity manufacturing product for one of the largest phase III clinical trials, providing products to nearly 90 clinical sites. We have since expanded twice, growing our capacity by more than four times. In fact, we’ve been taking on new clients since 2014 in preparation for the new capacity coming online and look forward to making more public appearances following our recapitalization and management-led buyout that we completed in Q1 2018.

 

How important is experience in the success of cell therapy manufacturing? At what parts of Cognate’s organizational chart is cell therapy experience critical for accelerating therapies to market?

I think it’s absolutely critical. Experience in a variety of complementary areas within a cohesive team is what brings success to the table for our clients. I started out over 23 years ago in the lab of cellular and molecular immunology at NIH studying T-cell receptor-induced apoptosis. Years later I joined a small company that was developing an allogeneic chondrocyte for use in patients with osteoarthritis that is now being marketed in Asia and is starting its phase III trial in the US. All through the organization, we can tell similar stories, with some taking part in several PAIs for a variety of types of products, some having solid experience in the clinical operations side or operations and supply chain, others in all aspects of regulatory, from clinical to compassionate use to commercial.

Collectively, throughout Cognate, you will find a broad range of complementary experience, with a commercial mindset being led by people who have successfully run commercial operations before with a core culture of continuous improvement and lean management.

 

Cell therapy manufacturing is a highly skilled profession and there seems to be a something of a talent shortage. How do you acquire and keep talent?

From the top, at an executive level, we made a commitment to develop our staff first and then when we identify gaps, we acquire talent to strengthen the collective experience. We’ve developed a culture of change and I think it’s really interesting what one of our manufacturing staff, recently said, “Cognate can be a chose your own adventure experience, because as an individual you can grow into opportunities as opposed to growing out of them…”. This and other examples are what make Cognate the place to be, we support growth, diversity and develop change agents. It's part of our story that has helped develop and acquire talent. The other part, that sells Itself, is our ability to help our clients impact patients’ lives at a commercial scale.

 

If there is one thing that sets Cognate apart from other CMDOs, what is it?

For me, what sets Cognate apart is our ability to work in collaboration with our clients to achieve their goals. Collaboration, in practice, has demonstrated many times over our inherent flexibility with our clients, in a field where many service providers are particularly rigid. Flexibility applies to all aspects of the product development and we have worked with clients in a number of ways that the competition is not equipped to. Everyone at Cognate knows, ultimately, the products we make for clients are going to patients often in critical medical need and time is of the essence. Over the years I’ve seen my team come together to pull off miracles to get product out the door when a patient needs it, and this absolutely requires flexible working with the client to pull this off. Challenges definitely come up when making products for critically sick patients, and knowing what your options are is key, but requires flexibility and collaboration. This level of commitment is rarely seen in the industry and we take pride in working with the client in this manner.

 

I understand you have a growing clinical operations group. That’s pretty unique. Can you tell us about the team’s role?

Of course, personalized medicine is quite different than your traditional medicines and/or therapeutics so it often requires multiple starting materials and/or intermediates, some of which may or may not be patient biomaterials. Understanding that “garbage in is garbage out” we have developed a team of individuals who have developed optimized systems and processes for ensuring clinical sites are properly educated on the handling of these products. Becoming fully integrated with the clinical and/or commercial sites is a critical differentiator in the business of personalized therapies. I believe the combination of talent at Cognate is definitely unique, and our clinical operations team is just one example.

 

How does this level of integration with clinical sites help clients who are thinking about launching their product(s)?

It provides a more cohesive development plan and can help to solve a major scheduling hurdle that rears its head pretty early in the development of personalized therapies. It’s one less thing for our clients to worry about and makes them more confident that their development efforts will be a success. Clients who are developing products all have a commercial end-game, it’s a bit of a tragedy however when companies develop products in earlier stages without thinking about this. Putting my client hat on for a moment and thinking about some of the other ancillary services related to clinical operations and personalized therapies, it’s easy to think ‘I’ll have to deal with that later’, it’s too expensive now, but it doesn’t have to be. It’s about planning and making sure that things don’t have to be redone, or done under an unplanned rush. As long as you can continue to improve the process thing will be fine. It’s the big changes, which come as a result of things not being thought through at the beginning that creates the big issues.

 

Can you tell us about you and how you came to Cognate and what excites you most about your role?

Of course, I started my career 23+ years ago in the T-Cell molecular biology unit of the lab of cellular and molecular immunology at NIH, after several years In the lab, having a lot of fun, I left NIH to join a startup focused on anorexia and bulimia where I got heavily involved in the IT side of things. I was happily poached by a software vendor of the anorexia company and went on to create R&D automation software with them for several years. Next, I joined a small startup company that was developing an allogeneic chondrocyte for use in patients with osteoarthritis that is now being marketed in Asia and is now starting its US phase III clinical trial. I left the cell-mediated gene therapy company to start my own company focused on Alzheimer’s and traumatic brain injury which eventually went public. In late 2007 I was recruited to the venture capital firm that had invested in Cognate and after taking over as CEO in 2010/2011 we kept our head down manufacturing one of the worlds' largest phase III clinical trials until we built out our new capacity and started taking on new clients. Most recently, as you know, we completed our management-led buyout earlier this year and we have a lot of momentum building for some exciting things going on in the future.

Cognate has grown from about 30 people when I took over to nearly 230 people now and I am confident that we have now assembled a world-class team to accomplish our vision for the future. I am most excited about the way in which the team has come together to create a culture of change, since "Nothing changes if nothing changes". We’ve assembled an incredibly unique combination of experience that our clients are eager to tap into for their own product development and manufacturing. I am very confident in our team’s ability to help our clients commercialize product and more than happy to lead this team into the next development milestones of the company.

 
 
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