"Intellectual Responsibility" In Drug Development
By Louis Garguilo, Chief Editor, Outsourced Pharma
In comes a program from a university upon which you are betting the house.
You start up a biotech, collect early investors, hire a few key professionals internally, and search for the best external partners out there.
As Michael Kelly, CEO, NervGen Pharma said in part one of our recent discussion, “The university sends you a molecule. You have to turn it into a pharmaceutical.”
“We are undertaking that process development now,” he says. “To be accurate, converting the molecule for human administration is a laborious activity that's still underappreciated by a lot of people.”
Kelly, who took the reins as CEO some three months ago to lead the 5-year-old organization, informed us of how NervGen identified and now works with its external partners on it's lead compound in-licensed from Case Western Reserve University, NVG-291.
The effort needed that Kelly describes above is clearly understood by NervGen’s team of 11 employees, and at the India-based CDMO they have selected, he says.
The professionals at NervGen are assisting their external partner in development by designing experiments that are then outsourced to CROs with specialized expertise, based in North America and Europe. When the data and results from those experiments are returned, NervGen then consults with their CDMO to make improvements and adjustments.
So far, so good.
NVG-291 is nearing a Phase 1b/2a proof of concept study, in individuals with spinal cord injuries.
“Internally, we have a head of preclinical and a head of CMC,” explains Kelly, “and it’s an iterative process with our external partners.”
“These preclinical experiments help inform what you ultimately want to do, and particularly potential changes in the molecule. You communicate these activities with the CMC-devoted folks: ‘Here’s the problem we're trying to solve. How do we work together?’
“It's our combined internal and external teams [at the CROs and CDMOs]. But it is quarterbacked from inside NervGen.”
Not Quite Football
If you follow football in the U.S., you’ll know this is an apt analogy.
The QB has to coordinate and lead the plan of action, and decides when the “ball” gets handed off or passed to the other players.
I ask Kelly how much the external partners do interact with each other – after all, all team members need to be on the same page.
Here our analogy breaks down a bit.
“It's typically the CRO talks to us, and the CDMO talks to us,” he replies. But the external partners to each other … not so much
He says there’s an important rational for that.
External partners are working on several other projects. “It’s their business model, and sponsors have to accept that – no matter how good the relationship is. Their time is valuable, and minutely measured.”
Therefore the synthesis of all the parts in the development process, “should come out of the central nerve of NervGen.”
The combining of information, initial knowledge synthesis, and the data/analytical communication has to be on the side of the sponsor, Kelly stresses.
“In this situation, the CROs typically aren't talking to the CDMO. The CROs are talking to us, we're doing the relay. I have done it other ways, but this approach is actually simpler.”
“More importantly,” he adds, “this is not specifically a matter of IP – although that is a component – it comes down to a calculus of ‘intellectual responsibility.’
A Higher Calling
“That’s what I'll call it; the intellectual responsibility falls on NervGen," he iterates.
“It's our product. We are responsible as stewards to make sure we can get this through clinical trials and to patients as quickly as possible.”
Kelly clarifies that at certain points, in certain situations and for certain programs, there are times when the entire ecosystem of developers and manufacturers in your supply chain can and should communicate directly.
“I'm not saying they can't ever do that, but I am cognizant that’s just not the core responsibility of our external partners,” he says.
“Ultimately, their core responsibility is to their own organizations, and concentrating on the essence of what they need to do as a business.”
And that, thinks Kelly, is as it should be.
The intellectual responsibility on the part of the partner, if you will, is demonstrated by playing their position to the best of their capabilities. You can have only one quarterback, to go back to the football of drug development.
This playing of your position to the best of your ability leads to all partners "getting behind the projects and the specific activities they are undertaking."
Everyone focuses on their core talents, and with a highly communicative sponsor at the helm, the iteration process Kelly mentions above takes place.
“If you have a product candidate like we do,” he concludes, “one that has the potential to help the body repair nerve damage of all kinds, and you communicate the importance of the work being done and what you are trying to accomplish for patients, everyone can get behind the goal and work together.”
Intellectual responsibility in drug development is a team sport. But it always starts and ends with the key player – the drug sponsor.