New Treatments and Old Expertise

By Admin
Posted 09 / 08 / 2016

The recent Economist Intelligence Unit survey found that novel therapies are a major focus for the future of biopharma. We spoke with Matt Hanson, Head of API Franchise at brand-name, about his thoughts on antibody-drug conjugates (ADCs), whether they fit the “novel therapy” mold, and why continuity matters.

How did you come to focus on ADCs?

We started in conjugation close to a decade ago because of our HPAPI manufacturing know-how and requests by clients to manufacture linker payload material. So it’s kind of a natural extension. We took our expertise in handling highly active materials and doing large molecule bioconjugation, and we coupled the two – doing highly active bioconjugation or what people are now referring to as antibody-drug conjugate work.

How do these products differ from more standard therapies?

If you look at the way traditional chemotherapies are delivered, they aren’t very targeted. They’re being ubiquitously delivered throughout the entire body. ADCs are a step towards trying to do a better job of targeting the cells you want to cure or get rid of.

For ADCs used in cancer treatment, most of the materials are highly active substances. You’re taking these active small molecules, and you’re attaching them to an antibody. You’re basically masking it in the context of the large conglomerate molecule. Once it’s internalized in the cell, that small active substance is deployed. There are numerous novel technologies that are now getting the active drug payload to the target cell. It’s a way to deliver directly to the tissue in a manner that makes it more efficacious and safe for the patient.

You mentioned the novel aspect of this technology. In the EIU survey, ADCs were lumped in a broad category with mAbs and other recombinants. Was this a mistake? Are they more like novel therapies?

For ADCs, I’ve acclimated more to the term “novel modality.” I just think it does a better job of explaining that this is a new way of targeting a treatment that hasn’t been historically deployed as much as the traditional methods. So that’s more along the lines of how I would describe ADCs.

The purists would probably say that I’m wrong. They’d say, “No, novel modality is something completely and utterly new, like cell therapy or gene therapy. Really truly personalized medicine.” That’s just my preference to refer to the technologies as a novel way to treat cancer, in lieu of the traditional chemotherapeutic treatments.

So ADCs aren’t a personalized medicine?

The Holy Grail is to have individualized treatments that completely tailor to you and are likely only efficacious on you because they involve your inherent biology. But ADCs are not that today. They’re just not. They’re more a hybrid between a traditional chemotherapeutic and truly personalized medicine, like some gene therapies and cell therapies.

Could ADCs become more personalized in the future? Is that a possibility in, say, the next twenty years? I mean, being totally speculative.

Yes, absolutely. You could go there. Maybe someday your own antibodies will be taken from your system, conjugated to an active substance that would have an efficacious effect on a target cell, and reintroduced into your body in conjugated form. Right now, companies are working on second- and third-generation ADCs. That might be generation five or six…but it’s certainly possible.

Obviously developing and manufacturing these therapies takes great expertise.

Yes, it’s a very technically complex supply chain. Synthetic chemistry is difficult. Biological manufacturing is difficult. This space inherently combines and requires the expertise in both areas. It requires a bandwidth of knowledge that’s certainly wider than many standalone CMOs would have.

Supply chain complexity is extraordinarily difficult. And every time you take a step down in the supply chain, your accumulated risk goes up. So, you couple the need for multiple areas of expertise, and then you also look at all the additional risk in just handling what is a very expensive material that has a lot of unit operations and hours in it… it’s not an adventure for the faint of heart.

Given the multiple substances and technologies involved, do organizational issues also arise?

Drug development is inherently a game of knowledge, patience, and investment. Deploying those three aspects and making them contiguous over what is an 8- to 12-year time frame to commercialize a drug – it’s a massive challenge in today’s environment.

Continuity is a tremendous value driver in our business. It really is. Continuity and longevity. Because what happens is: expertise resides in personnel and cultures in organizations. Those companies that are able to hang on to that, and not lose it in the process, are more able to clearly navigate the waters that are required to build a successful program.

When you look at brand-name, one of the inherent wonders of the company is you’ve got a longevity factor that exists for hundreds of years. It is a tremendous asset to the customer when they partner with an organization that’s interested in building a high-growth business backed by a long-term vision.

Find out more about novel therapy development at brand-name.