Collaboration — How J&J Is Preparing For The Biotherapeutic Revolution

By Rob Wright, Chief Editor, Life Science Leader
Follow Me On Twitter @RfwrightLSL

At this year’s BIO International’s 2015 conference in Philadelphia, PA, I had the opportunity to meet with Barry Springer, Ph.D., VP of strategy and external innovation; and Bill Strohl, Ph.D., VP and global head of Janssen BioTherapeutics. During our conversation, Strohl, author of over 120 publications in peer-reviewed scientific journals, and Springer, an awardee of multiple patents and grants for his work in the field of biotechnology, shared their insights on some of the trends and challenges facing the biopharmaceutical industry, as well as Janssen BioTherapeutics. For more on this be sure to check out part 1 of this two part series, How J&J Is Preparing For The Biotherapeutic Revolution . We pick up our conversation with Springer and Strohl, exploring how Janssen BioTherapeutics, JBIO, has been enabling collaborations, as well as the big what if question — what happens if all the biotherapeutics actually make it to market? Will companies like J&J be prepared to manufacture?

LSL: How has the creation of Janssen BioTherapeutics (formerly known as the Biotechnology Center of Excellence) enabled J&J collaborations?

Bill Strohl, Ph.D., VP and global head of Janssen BioTherapeutics

Strohl: “I have a great example. In 2011 I got a flier from a colleague — Janine Schuuman from Genmab — I had met at a meeting. . In the flier, she had written, “We have this new biospecific antibody technology, and we’d be interested in showing you.” We [J&J], in fact, were looking – in those days – at biospecific technologies, and we couldn’t find one that  we liked that was highly manufacturable and stable. Schuuman’s flier was a good-enough teaser, indicating it was all the things you try to get in a biospecific technology. So, I called her up and told her we would like to take a look. We put a CDA (confidential disclosure agreement) in place, and her team presented the whole story. Our jaws dropped. After they walked out, I looked at one of my senior people and said, “I think we found what we were looking for. It was that simple. Of course, we did the due diligence and everything else, and now we have done a second deal with them, to extend the original licensing agreement for use of Genmab’s DuoBody technology platform. We have 20 option pairs. This means that we can use their technology to do 20 biospecific antibodies. That is a lot. Typically in these kinds of deals, you do three, four or maybe five. We’ve got 20, because when we did the collaboration with Genmab, we asked how we could help. Then we shared that info back with them.”

Barry Springer, Ph.D., VP of strategy and external innovation, Janssen BioTherapeutics

Springer: “I have to extend that story a little bit. It was actually at BIO in Washington, D.C., a few years back, where we were meeting with the business development folks at Genmab. We had already informed them that we were really interested in their technology platform, and we had started to build a relationship. They said, “You know all about that. We want to show you some data on a molecule that we’re working on that will get Phase 1 data in the coming months — an anti-CD38 [monoclonal] antibody. This was very interesting, so we pulled in our oncology colleagues. It developed into the drug, daratumumab, which received Breakthrough Therapy Designation by the U.S. FDA for multiple myeloma patients in May 2013.”

Strohl: “That example really highlights how once you start a partnership and develop trust, it paves the way for collaboration. We immediately connected with their chief science officer, Paul Parren, which led us down a path where there was mutual agreement of wanting to work together to try to make a whole portfolio of drugs using this technology.”

LSL: What are the critical components to building trust in a collaboration?         

Springer: “It goes beyond what we say; it’s our actions that tell people that J&J is a company that has a reputation built on trust, and that we are not going to steal their ideas. If we help our collaborators to be successful, we’re going to be successful, and they’re going to turn around and do something else in the future that will be successful. It builds off of each other.”

Strohl: “I think you build trust through respect. It’s very important that when you’re sitting down with a potential partner or a partner who you’ve already done a deal with, you tell them exactly what your company can provide. You don’t overstate it, and you don’t understate it, and you ask them to do the same. That builds respect and the trust you’re looking for. We feel like we’re a very good collaborator that way. For example, we developed a successful collaboration with Victor Torres [department of microbiology associate professor] of NYU. I’ll never forget the day – it was in September of 2013. We were in his office, looking out over the East River in New York, and he said, “If we could do this,” and I went, “Wait, wait,” and went up to the white board, and I drew the molecule on the white board. I said, “That molecule, if you could do this, I think that answers all the questions that we’ve been asking.” He looked at it and he goes, “Wow! That’s it!” In fact, that molecule is exactly what we’ve done — built molecules they could never have dreamed of building on their own. These are really highly engineered molecules, and I’ll tell you, they’re phenomenal. But it is the most complex biotherapeutic we have ever even thought of making It is an incredible molecule, and it was actually borne out of Victor Torres’s research and his ideas and how our ideas and his ideas melded together. It was a real hand-in-hand collaboration. That’s how you build the trust and respect.”

Springer: “Just to be clear, that is a preclinical molecule, and it has a lot of testing before we know if it will really work. But it goes back to that deep expertise. Victor had an idea about how to address this really difficult disease, and Bill had all these ideas on how he could shape the molecule to address all the issues. Bill’s ideas came through years of deep expertise on the related technologies and what you can and can’t do with antibodies.”

LSL: So how did you first connect with Victor Torres, Ph.D.?

Strohl: “It was sort of by accident, to be honest. I have a colleague who is in what used to be Crucell, in the vaccines group. He actually wanted to build a vaccine. He was going to visit Victor and talk with him about using some of his proteins in a vaccine. My colleague had heard about the work we were doing, so he asked if I wanted to go along and see if I could come up with any ideas. Why not? I like New York. It’s worth a train ride up. We went there, and it turns into this three-to-four hour meeting. We get the idea that maybe an antibody would be better than a vaccine. A couple months later, the whole vaccine thing vanished, the result of a funding decision, as you can’t fund every idea. The staph vaccine idea was put on the lower part of that list. My colleague called me to let me know that he wasn’t going to be able to go any further with it, but reminded me about the antibody discussion. So, I called Victor and said we’d like to talk more about the antibody approach, and we have just been building it from there.”

LSL: Do you have any other examples of serendipity rewarding a prepared mind?

Strohl: “How we found Transposagen Biopharmaceutical was more of a detailed search. It was based on the whole CART [pronounced car-T] story. Everybody wants to do CARTs [chimeric antigen receptor T-cells for cancer drugs]. We decided that we didn’t want to do CARTs, because, one, everybody else was doing it; and two, if we were going to start that late, we were going to be behind everybody. But we thought that if we could find the right technology to build an allogeneic CART — an off the shelf-type cell — we’d be willing to go down that path. We put Omid Vafa, Ph.D., [oncology & biotechnology scientific innovation leader at J&J Innovation, London] who works for Barry, essentially on the project.  

Springer: “Sometimes when we’re looking for a specific technology that’s really critical to get us to that next level, it’s a bit like looking for a needle in a haystack. Yes, I’d say there was some serendipity associated with finding the company ended up working with. They were doing some work for a completely different reason within J&J. Someone mentioned to us that they were doing this work, and they had this technology similar to what we were looking for. They had the tools in place, the knowledge, and the knowhow. It made perfect sense for us to partner with them, and we announced that agreement late last year.”

How Being A Former Professor Helps In Creating Collaborations Bill Strohl, Ph.D., is currently the head of Janssen BioTherapeutics, Janssen R&D. But he hasn’t always been in industry. “I was a professor at The Ohio State University for 17 years before being recruited into industry. Having now spent 18 years in industry, I feel that I understand most of the issues that both groups face when it comes to academic-industry collaborations. It is critical for the academics to move their research base forward, to publish results, and to develop students and postdocs. For industry, we are seeking the expertise the academic collaborators have, yet in a focused and directed effort in order to solve a healthcare problem. Over the years, the organizations of which I’ve been a part have had some great collaborations with academia, due in part to this deep understanding. We structure the agreements, and more importantly, the collaborations themselves so that both parties are able to achieve their respective goals (i.e., publications and advancement of science on the academic side, and problem-solving and advancement of science on the industry side). The common thread is the shared goal of advancement of science, which is what makes academic-industry collaborations work well.”

LSL: What if all of the biotherapeutics being worked on get approved? How are you addressing the potential
biotherapeutic lack of manufacturing capacity for what some are describing as a future tsunami of biotherapeutic products?

Strohl: “I came back from Christmas vacation and told some of our people that I was envisioning a [biotherapeutic] tsunami. I actually used the word tsunami, and we have actually developed the solution for addressing this issue — Project Tsunami. I asked the Janssen BioTherapeutics team to model how many clinical candidates we will have over the next 10 years if we continue X number of development candidates per year. I gave them a couple of ranges and a series of parameters to put in the model. They came back a couple weeks later with an idea of what it could look like. The answer was, fundamentally, from 2014, which was our baseline, to 2017, we would double the number of clinical candidates. By 2019, it would be triple. We built a PowerPoint slide deck with the explanation and sent it to our head of preclinical development, head of operations, R&D head — I sent it to everybody. I told them I wanted to talk about this oncoming tsunami of biologics. It eventually made its way to Janssen Supply Chain and our Pharmaceutical Development Manufacturing Sciences [PDMS]. That group actually held an all-day seminar on the biotherapeutic tsunami. It was this free thinking that allowed me to see this coming and then to alert these folks. Now, everybody at J&J is planning for the [biotherapeutic] tsunami. We are already sending people out looking for more reactor space and getting things lined up because we know it is coming.”

Springer: “In the bigger picture, outside of Janssen, the fact is, as an industry, we have so many new, really interesting, and more complex molecules going into the clinical candidate selection process, and hopefully, eventually into the clinic, that this is an issue for the entire field. I think one of the upsides of these kinds of pressures is that it will foster innovation and creative ideas to approach those problems. Now there’s a demand capacity issue that needs to be addressed, and I think you’ll find some creative thinking about how to address that, collaboratively.”