Campbell Rogers, the chief scientific officer for Johnson & Johnson subsidiary Cordis Corp., knows interventional cardiology from both sides of the clinical trial.
As the former director Brigham & Women’s Hospital’s catheterization lab and principal investigator of the Brigham’s interventional vascular biology laboratory, Rogers led multi-center device and pharmacologic trials before joining Cordis in July 2006.
There he finds himself on the other side of the process as head of Cordis’ research and development team — a role the company created for him.
MassDevice caught up with Rogers after a big week for Cordis. The company had enjoyed a string of positive news during the annual Transcatheter Cardiovascular Therapeutics meeting in San Francisco, with studies showing its Cypher stent outperforming Boston Scientific’s older Taxus line; its Cypher 2.25 stent winning a 510(k) nod from the Food & Drug Administration; and it inking a $716 million deal with BSX to settle a dozen long-standing patent infringement lawsuits.
Rogers spoke about trading the rewards of direct patient care for the ability to better thousands of lives, what Cordis has brewing in its development pipeline and his thought on the value — and limits — of comparative effectiveness research.
MassDevice: You ran the cardiac catheterization lab at Brigham & Women’s Hospital, a very high-profile position in medical circles. What prompted your move into the corporate world?
CR: There were a couple of things. One is that obviously at the Brigham, which is a very academic research-oriented place, a lot of the research I had been involved in in my career was very device-related. Much of it was peer-review-funded from granting agencies, but much of it was funded in collaboration with industry.
Having lived in that world and having done a lot of that work, it was a fairly natural move to get much more directly involved with industry research (my position at Cordis is responsible for the research and development work we do). So it was a fairly natural extension. Obviously it was a big change, because a big part of my life at the Brigham was also direct patient care. Having to leave that behind was certainly a very difficult decision, because that had been such a gratifying part of my career.
I certainly miss taking care of patients. At the same time, the ability to take part in the development of devices that I think will bring great advances to patients in large numbers, in hundreds of thousands or millions of patients, has its own gratification. So it’s a trade-off.
There have been several people who have moved from medicine, in particular from cardiology and interventional cardiology, into the device industry, I’m sure each for different reasons. But I would speculate that all of us in common would say one of the most exciting things was trading off individual patient care for the ability to impact thousands or millions of patients.
MassDevice: What struck you the most about the move to the executive suite?
CR: In terms of things that were surprising or different, within J&J the commitment to quality, to integrity, to providing the absolute clinically best product to the marketplace, is really striking. That actually was a surprise. From the outside, one doesn’t really know what to anticipate with industry, and how much of a focus will be on the business side of things. Within J&J, a vast amount of focus is put on creating clinical, medical value for patients and physicians. That’s probably the most surprising thing, that focus within J&J.
MassDevice: You worked closely at the Brigham with Don Baim, now Boston Scientific’s CMO, and with Medtronic’s Richard Kuntz. Now you’re all working for competitors. Do your paths ever cross? Do you ever sit down over drinks, say at the TCT meeting last week, and talk shop?
CR: They’re both really good friends. I actually did not see either of them at TCT last week — I’m sure we were passing like ships in the night. We stay in touch a little bit as friends, in a social sense. I would say we don’t talk business when we get together, though. They’re good friends, they were good colleagues and partners at the Brigham and it certainly was interesting to see the fairly rapid-succession moves people chose to make, each for their own individual and personal and professional reasons.
From what I understand of the other physicians, I think we probably each have slightly different responsibilities and accountabilities now. In the world of interventional cardiology there has certainly been a pattern, a tradition over time of people being very involved in clinical research and practice for 10 or 15 years or a little longer and then choosing different paths. It’s true for any area of medicine, but I would say perhaps more true for interventional cardiology. I’m not quite sure why, but there you have it.
MassDevice: How did Cordis fare at the TCT meeting? Propitious timing, in that the Cypher 2.25 small-vessel stent won an FDA nod during the week.
CR: That’s a very big deal for us and I think for the marketplace. The only 2.25mm coronary stent which had been approved previously was a paclitaxel-eluting stent. There’s general recognition that paclitaxel is probably not the drug to be using on a stent. There’s a lot of data that came out at TCT, not related to the 2.25, but again pointing out the deficiencies of paclitaxel in terms of clinical outcomes, from a bunch of different studies.
We were very pleased with the 2.25 coming out. It’s an area of practice which has proven really hard to treat, it’s sort of enriched with patients with diabetes who tend to have smaller arteries and require smaller stents. They’re very hard to treat, with very high restenosis rates and failure rates with other techniques. So for a bunch of reasons, it hopefully will provide a real value to physicians and obviously thereby to patients. It’s the first new stent we’ve had approved in the U.S. since the Cypher in 2003.
MassDevice: What’s on the horizon for Cordis? Aside from stents and coils, are there other device markets the company’s looking to penetrate?
CR: Our focus in the coronary stent world is in two areas. One is to continue to generate clinical evidence to support broader indications for Cypher. So we’re pursuing those in the U.S., in stent restenosis and chronic total occlusions and perhaps others.
And then in terms of the development of devices, our big focus is on a device called the Nevo stent, which does have a biodegradable component. It’s a real departure, because it uses technology that came to us from the acquisition of Conor MedSystems, a California company we purchased almost three years ago. It uses that technology, which doesn’t coat the surface of the stent but rather fills reservoirs within the body of the stent with polymer and drug. It overcomes a large number of challenges with all of the current surface-coated drug-eluting stents, in terms of both acute success and also, we believe likely, in terms of long-term safety.
In other areas, we have a lot of interest in peripheral vascular disease in the leg and in abdominal aneurysms and quite a bit of work going on to develop new treatments for abdominal aneurysms.
There are two forms of treatment now. One is open abdominal surgery to put in a graft within the aneurysm. It’s a very common operation done by vascular surgeons. It’s incredibly morbid, with high morbidity and high mortality rates. That has been replaced, largely over the last 10 or 15 years, with catheter-based approaches, so-called endovascular aneurysm repair. They are pretty widespread now, done mostly by vascular surgeons, but in the catheterization lab the challenges have been twofold. One is that the size of the current devices are really large, so they require big access to the arteries in the leg and carry the risks associated with that. The second is that the durability of the devices has been suspect, so over time wear-and-tear promotes recurrent aneurysms and leaks.
We think we have a device which overcomes both of those. It will be, by far, the smallest device on the market and the competitive testing we’ve done to date shows as good or better durability than other devices.
We’re still working through dates and so forth. We’re anticipating initiating clinical trials some time over the next few months with the device. I don’t think we have an external name for it yet.
MassDevice: Where do you see the next breakthroughs coming from, in terms of technologies that could be game-changing?
CR: The cardiovascular device space and probably devices as a whole are becoming more and more pharma-like in the regulations and reimbursement policies, in the complexity of the devices. If you take our drug-eluting stents, for example, they’re very complex drug-device combinations. I think that evolution is already pretty well under way.
If you look at some of the proposed regulatory changes in areas of scrutiny, if you look at the Institute of Medicine’s list of areas for particular competitive effectiveness focus, all of those things speak to more high-evidence-requiring, pharma-like development processes. At J&J, with a big pharma sector, it’s something we know pretty well and have a reasonable anticipation of what will be required to succeed and grow in that environment.
MassDevice: One of the studies out of the TCT meeting showed that, five years out, the differences between various stents seem to even out. One hypothesis is that, as the different drug coatings wear off, the stents begin performing more or less identically.
CR: That’s possible, but it’s a whole different discussion because a lot of the data that underlies that hypothesis is a little bit suspect. In other words, you had trials which were powered to look at a specific endpoint. As you look at later and later time-points, the populations are harder and harder to distinguish.
But that doesn’t mean there isn’t an effect. The analogy I use for people is, if you had a trial where you showed a reduction in death with some treatment, and you wait long enough, that reduction goes away because everyone eventually dies.
That whole late-catchup discussion is a different one, the hypothesis is far from proven.
In terms of the polymer, there certainly is a school of thought that surface polymers are linked with long-term late thrombosis or late events, and the Nevo stent we think will really be the first step forward since Cypher in terms of something fundamentally different as a platform.
MassDevice: What’s the biggest leadership lesson you’ve learned since moving to Cordis, and how and where did you learn it?
CR: It’s the value of really careful consideration of getting the best people matched with the best jobs in an organization. J&J spends a lot of time, and I’ve learned a huge amount, around the discipline of planning careers. Collaborating with associates to plan their careers, where it is that they want to go, what are the steps to get them where they want to go and what opportunities within J&J can enable those steps. For our associates, there are a lot of opportunities if they want to acquire skills and experience in other areas, in other businesses and other sectors, to do such things.
That’s pretty different from the world of medical careers, which are just managed differently. It’s not better or worse, it’s just different. In terms of leadership and the time required to do that on the part of leaders, to spend time with associates doing that, thinking it through — it’s a substantial time commitment and obviously it has a tremendous impact.
Of course, in medicine there are all sorts of very deep mentor and mentee relationships that develop, which are also gratifying ,but it’s different to think of the broader organization, to think of all the associates in it and to think that each one of those people has a real development plan that’s been discussed with them and meets their needs and meets the company’s needs. It’s just more overarching in some way.
MassDevice: What strategies and tactics have you adopted to deal with the economic downturn, and what’s your forecast for short- and long-term prospects?
CR: No one has a crystal ball for what direction things are going to go, for our area of the economy and the potential effects of healthcare reform on our business and on patient care, on our customers and patients. Cordis is probably a little more insulated than some other areas, because most of the procedures for which we supply devices are not really elective, they’re not cosmetic, they’re things people really need done. That being said, I think globally there has been a slowing down or a least a plateauing in the number of procedures done in the vascular and coronary disciplines, which may reflect the access of patients to care. Given the economy, I can’t give you any numbers, I don’t know any numbers, but I expect that’s less than has been seen in other area of devices and medical care.
MassDevice: What long-term effects will the recession have on your business? Will those lessons stay with your company, or can you wait out the storm and go back to business as usual?
CR: There are probably some lessons or changes that will persist; they’re probably more related to anticipated changes in healthcare financing and in reimbursement for devices. As an example, we have a tremendous focus now on how much information there is around reimbursement for a device. Let’s say somebody’s developing a device and they say, “Is this of interest to Cordis or J&J?” One of the very first questions is. “How much have you done to assess the reimbursement you’re going to be able to garner for your device?” A couple of years ago, that would have been one of the last questions asked, maybe as an afterthought. Now its really front-and-center and that’s not something which is going to go away anytime soon.
MassDevice: How do you see comparable effectiveness affecting the stent business, for example if studies demonstrate that CABG delivers better outcomes than stenting procedures?
CR: Anytime there’s an opportunity for doing real-world clinical trials that answer questions about the best form of treatment, it should be embraced. It’s something that J&J has embraced.
J&J is actually in a strong position. It requires resources to gather that sort of information and J&J has the capabilities to do big clinical trials to get the right information. That, in times like this, may actually be a competitive advantage for us.
Trials like that absolutely should be done. In terms of how much they ought to be used to really prescribe therapy to physicians, thats a whole different question because there is so much art to medicine. It’s really hard to say, “You’re going to end up practicing based on a treatment algorithm from some enforced guideline of some kind.” That’s really hard to imagine.
MassDevice: How has the Massachusetts gift ban affected Cordis’ operations in the Bay State?
CR: The policies both in Massachusetts and Vermont are obviously pretty significant departures from what has been the case. I think that there’s pretty strong suspicion that other states are going to follow suit.
It’s certainly a change. Needless to say, J&J has an incredibly robust compliance process and the expectation from every single person is 100 percent compliance. The practicality of having different states with different rules — it’s certainly possible that what’s going to happen is that companies, possibly including J&J, will just default to the most stringent rules to avoid any risk of a breach.
Picture a function somewhere which is compliant for some states and not others. Whatever company was hosting that function would be in the position of checking IDs at the door, which is obviously just not practical or desirable in any way, shape or form.