How J&J Is Preparing For The Biotherapeutic Revolution

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

Entering J&J’s sponsor meeting room at BIO International’s 2015 conference in Philadelphia, PA, I am greeted by the smiling faces of Barry Springer, Ph.D., VP of strategy and external innovation; and Bill Strohl, Ph.D., VP and global head of Janssen BioTherapeutics. Strohl is the author of over 120 publications in peer-reviewed scientific journals, and Springer, who rises to firmly shake my hand, has been awarded multiple patents and grants for his work in the field of biotechnology. As our scheduled appointment is coming on the heels of the recently announced name change of their organization from the Biotechnology Center of Excellence to Janssen BioTherapeutics, I am admittedly skeptical. Will today’s discussion get beyond the semantics of which is a better word to incorporate when naming a company’s biotech R&D discovery organization (i.e., biologic or biotherapeutic) or the trendy feel of Janssen BioTherapeutics nickname, JBIO? Considering that most Big Pharma companies have been increasing the number of biologics in their R&D pipelines, I take a seat, flip open a notepad, press the record button on my digital recorder and pose the first question. My goal, find out how J&J is preparing for what some are calling the biotherapeutic revolution.

LSL: What is the difference between a biologic and a biotherapeutic?

Bill Strohl, Ph.D., VP and global head of Janssen BioTherapeutics	Barry Springer, Ph.D., VP of strategy and external innovation, Janssen BioTherapeutics

Strohl: “There are a lot of biologics that aren’t therapeutics. Actually, there are biologics that are prophylactics. There are biologics that are used to assay things. There are biologics that are used as reagents of types. You can have a diagnostic that’s a biologic; you can have a biomarker that’s a biologic. Those are biologics, and as I said, you can have a therapeutic or you could have a prophylactic. When we talk about biotherapeutics, we’re talking about biologics that we actually want to discover and develop as a therapy, as a therapeutic for a disease state.”

Springer: “The therapeutic part is really going to be a solution to an unmet medical need. I think biologic and biotherapeutic are used interchangeably because now we’re using biologics in so many different ways. You can use biologics as diagnostics, for example. We have a lot of biologics-based assay systems that could be used for small molecule as well as large molecule in drug discovery and development. There are a lot of applications for biologics that aren’t necessarily going to be therapeutics to treat a disease state. That’s probably the distinction.”

Strohl: “If I can add to that, I think I would not want to get hung up too much on just wording, because we use a lot of different wording for things. The fundamental aspect of this is that we’re the discovery engine at Janssen R&D for biotherapeutics. While we may actually get involved in helping to make a diagnostic with something, we actually don’t do much of that. We try to stay a little bit away from biomarkers, because that’s a huge field of its own. We really focus on making biotherapeutics, and we can cover all five therapeutic areas [i.e., cardiovascular and metabolic diseases, immunology, infectious diseases, neuroscience, and oncology]. We’re collaborating with the different therapeutic areas. Look at it like a car, for example. . The therapeutic areas are the steering mechanism, they steer you down a particular path. We want to follow this disease path. We’re the engine. We make the biologic that is going to be used as a biotherapeutic. We design it, test it, and then prepare it for development. With the therapeutic areas, we are collaborators in the development of that molecule.”

LSL: What biotherapeutic trend should biopharma execs be paying attention to and why?

Springer: “We have a real focus on disease interception and trying to find ways to identify people who are more likely to end up with a particular disease state. The sooner we can identify those individuals by a whole host of different technology platforms that are all growing, the better the opportunity to get out in front of that disease and treat it in a specific way. That may be a biotherapeutic or any kind of therapeutic approach, but it even may be lifestyle changes. We want to walk the entire patient journey from very early on so we can help them through that entire process, to either postpone or maybe even prevent the disease.”

Strohl: “Let’s give an example. Say you have multiple myeloma, which is a very deadly disease state. But you also have pre-disease states, for example, smoldering myeloma. Some of the people that have smoldering myeloma progress on to multiple myeloma and some, frankly, don’t, at least over a reasonable period of time. One possibility might be to intercept that disease at the smoldering myeloma state, before it is phenotypically a fulminant disease, and before people are suffering.”

LSL: Why did J&J decide to reduce the number of therapeutic areas on which to focus, and how has this helped its R&D efforts?

 Strohl: “By focusing on a select few, it allows us to better compete in those areas. It also allows us to really dig into a disease state with a deep expertise. With that deep expertise, you’re going to be able to hire more employees with that skillset, much like what we’ve done with Janssen BioTherapeutics.”

Springer: “That deep expertise is so important when working on developing solutions for very complex diseases. You have to have talent, commitment, and focus. That’s why for all our biotherapeutic programs, we pair the deep knowledge of our disease-area experts with the technology platforms necessary to build the molecules.”

LSL: What are the challenges presently facing Janssen BioTherapeutics?

Strohl: “One is that the biologics we’re making today are more complex than just five years ago. We’re making bispecific antibodies. We’re making antibodies that target receptors. For example, five to seven years ago, three-quarters of all of the programs we had were, again, cytokines or soluble proteins. Now, almost 80 percent of the antibodies we make are cell-surface receptors. That immediately increases the complexity of the biology. Interestingly enough, it changes the profile of the types of antibodies that we’re seeing. It has to do with receptor biology. When we put antibodies on receptors, we have to be very careful that we’re not triggering things inside the cell that we don’t want to trigger. If we’re making an antagonist, we don’t want an agonist activity leaking through. That can happen. Likewise, if we’re making an agonist, we don’t want to be shutting down some pathway if there’s a biased ligand-type issue with a particular receptor. As we’re making that biologic, we have to be very careful, so that it reflects exactly what we’re trying to do. We incorporate many more assays and much more sophisticated assays, to make sure that we are hitting the pathways we want to hit, and we’re hitting them in the proper way that we’re trying to hit them.”

Springer: “Another challenge is determining the technology areas we need to continue to invest in and grow. A lot of these we do through partnerships. However, we are constantly scouting for opportunities. Traditionally, we have done this through our own researchers and their travels at conferences and speaking engagements, which is a key part of how we continuously learn from one another. We still do that, but now we’ve expanded that greatly through Janssen BioTherapeutics, Johnson & Johnson Innovation Centers, and JLABS , hosting entrepreneurs and helping them get started with their ideas. We’ve built an incredible network now, throughout all of J&J and Janssen R&D. It’s not uncommon for small company entrepreneurs to approach the innovation centers or us, indirectly, and say, ‘I’m doing this. Are you interested in that? Will that help you solve a problem?’ That begins the process of talking deeper regarding the science. If it looks promising, then we’ll build a partnership around that, which may be co-funded, or it may be leveraged through consortia or other organizations, with the goal of not necessarily owning it all, but finding a way to apply to solve our problems. Some of the technology platforms we find are very cutting edge and not always validated. We have participated directly in helping to validate some of these technologies, before bringing them in-house to be part of our normal package of activities. The innovation centers are completely staffed with disease area experts, some technology experts, and transactional people to help get deals done very quickly. Having centers in those regions that are hotbeds for innovation – San Francisco, Boston, London, Shanghai – helps us keep our eyes and ears open for those next great opportunities. But it’s more than that. By participating directly and building that innovation ecosystem, we now have a presence that we didn’t have in the past. What we’re finding is the academicians, as well as entrepreneurs, are coming to us much earlier, which gives us a chance to participate in developing those technologies even earlier, and then seeing if these will actually work sooner.”

Stay tuned for part 2, of how J&J is preparing for the biotherapeutic revolution with a focus on collaboration.