May 2012, Vol 1, No 1

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Accelerating Personalized Medicine Approaches in Multiple Myeloma: An Interview With Kathy Giusti and Deborah Dunsire, MD


In the attempt to bring personalized treatment to multiple myeloma patients, the Multiple Myeloma Research Foundation (MMRF) began its CoMMpassSM (Relating Clinical Outcomes in Multiple Mye lo ma to Personal Assessment of Genetic Profile) study – a landmark study designed to uncover the molecular segments and variations in multiple myeloma. The most ambitious study of its kind in multiple myeloma and the cornerstone of the MMRF’s larger Personalized Medicine Initiative, the study will collect and analyze tissue samples and genetic information from approximately 1000 multiple myeloma patients over the next 5 years. Companies such as Millennium: The Takeda Oncology Company and Onyx Pharmaceuticals have entered into collaboration with the MMRF to support this initiative.

Personalized Medicine in Oncology had the pleasure of sitting down with Kathy Giusti, Founder and CEO of the MMRF, and Dr Deborah Dunsire, President and CEO of Millennium, to talk about the definition of personalized medicine, improving patient care, and the current and predicted future landscape of personalized medicine in multiple myeloma.

Since 2005, Dr Dunsire has led Millennium and the efforts around its advancing oncology pipeline that consists of over 20 compounds in various stages of development and the further development of the company’s flagship cancer drug, Velcade (bortezomib), which is approved for the IV treatment of patients with multiple myeloma. Velcade is also approved for the treatment of patients with mantle cell lymphoma who have already received at least 1 prior treatment, and most recently (January 2012) for subcutaneous administration of the drug in all approved indications.

Ms Giusti is the Founder and Chief Executive Officer of the Multiple Myeloma Research Foundation (MMRF) and the Multiple Myeloma Research Consortium (MMRC). Together, the two organizations have developed innovative models that serve to rapidly break down barriers slowing multiple myeloma research and accelerate the development of next-generation treatments. Chief among these are an integrated clinical network of leading centers that collaboratively conduct early-stage clinical trials, as well as a stateof- the-art tissue bank that has advanced the science of biobanking and genomic studies and provides a foundation for the organizations’ pursuit of personalized medicine.

PMO Thank you for taking the time to talk with us. We’d like to start by asking each of you how you define personalized medicine in oncology.

Ms Giusti When we’re talking with patients, we try to keep the definition as simple as we can and say that it’s about finding the right drug for their type of disease at the right time in their disease. We also know that in myeloma it can be complicated because the disease is so heterogeneous and uncommon.

Dr Dunsire One person’s multiple myeloma might be driven by a different genetic mutation than another person’s, and it might make sense then to try and identify what combination of medicine is the most effective for a given genetic driver. That’s the foundation of personalized medicine – really understanding the biology of a particular patient’s disease versus calling it one large disease entity, multiple myeloma, for instance, and then targeting the therapy to the drivers.

PMO Unfortunately, personalized medicine in oncology remains sporadic and occurs mainly at wellfunded academic centers or is driven by physicians who understand the molecular biology behind multiple myeloma. How do we bring the research and the science to the community oncologists so that we can affect the largest numbers of patients?

Ms Giusti One thing we have found is that if you are going to understand personalized medicine, you have to be able to reach out to the community doctors, because they’re the ones seeing those patients right when they’re diagnosed, before their treatment even begins, and it’s that early biopsy, that early tissue sample that we so desperately need. So you have to bring the community oncologists in so that you get access to the patients and access to that early tissue. And then you want to follow those patients longitudinally over time.

Although academic scientists also see patients, they also play a critical role in their ability to look at the science translationally and help us to understand what we’re seeing in the data. And what’s so special about the MMRF initiative is that we’re also working with industry, because the more teams we have looking at our data across patients longitudinally, the more likely we are to get to a cure faster. Many great minds are better than fewer.

Dr Dunsire As we gather data on newly diagnosed myeloma patients followed longitudinally, we’ll be able to target groups of patients that have similar genetic drivers if we find a new therapy that’s specific to those. So we might be able to speed up the clinical research over time. It is going to take time to build the databases. But patients, community physicians, academics, organizations like the Multiple Myeloma Research Foundation, and industry need to be engaged together.

PMO It sounds like both of you are talking about the CoMMpass trial, which I know is very near and dear to your hearts. Perhaps you can share with us your perspectives on how you think the CoMMpass trial is going to impact the development of new treatments for multiple myeloma.

Ms Giusti The joy of the CoMMpass trial is that over time it looks at 1000 patients and studies them from that very first bone marrow biopsy through 5 years, looking at their data longitudinally. We’re banking the tissue, we’re looking at all the molecular data, and we’re looking at all the clinical data. And what’s critically important is to see how a patient’s myeloma changes over time. That’s really important, because the disease gets more and more heterogeneous.

The objective of the study is to look at the myeloma world and start segmenting those patients. Myeloma is not 1 disease, it’s more like 10, 15 – we don’t know how many – and over time begin to understand what hypotheses we are starting to see in terms of the treatments that might be appropriate for patients at low, medium, and high risk. And hopefully over time, as we accumulate more and more data, we’ll be able to look at those data and understand more about biomarkers and new targets in the disease. So the MMRF, being a trusted third party, could bring everybody together. I think it was critically important to us, and we were thrilled to work with companies like Millennium to get it started.

Dr Dunsire I think the trial is a great initiative, and it appears to be alone in its class right now. Many times when we test new medicines, they’re tested in patients who have relapsed and gone through all of the standard tested therapies, and that’s appropriate, but it means we’re testing new therapies in patients whose disease has many more mutations than perhaps the disease in a newly diagnosed patient might have.

If we get these longitudinal data sets, we’ll be able to understand how patients’ disease evolves over time and potentially how to bring effective therapies earlier in the disease than the traditional therapeutic development might allow.

Everybody can benefit. Patients benefit by potentially getting new therapies sooner and by getting a therapy that’s most likely to benefit their particular disease. And if their disease is not likely to benefit, they’re not exposed to an ineffective therapy and all its side effects. So that’s really the goal, to increase that benefit-to-risk ratio.

PMO As you’ve both pointed out, multiple myeloma is a very heterogeneous disease. Does that produce any special challenges with respect to the CoMMpass trial?

Ms Giusti Absolutely. I think when you have a disease that is heterogeneous and uncommon, that’s when you have to build collaborative models like this one, because you’re not seeing enough patients at any one center to get a database of 1000 patients to study over time. So if you’re trying to look at segmentation, you have to have that critical mass.

PMO And as new molecular biomarkers are discovered and developed that have an impact on multiple myeloma, how is that going to impact the CoMMpass trial?

Ms Giusti It’s so interesting in myeloma right now because we don’t have validated targets or validated biomarkers, and the truth is when you look at proteasome inhibitors like Velcade or drugs like Revlimid, they are so effective in myeloma patients that almost every patient is likely going to be on a Velcade-based drug or on an IMiD [immunomodulatory drug]. So what you’re really looking at over time is what else is changing in these patients.

And what we’re finding are mutations like BRAF – and what that means for the combinations of drugs. I think our hunch is that you’ll often have myeloma patients who will be on a proteasome inhibitor and IMiD, and what are we adding? What are we adding over time that’s really going to help them?

So I think as we move to that world, we really have to understand how we’ll begin to work with diagnostic companies and how we’ll start to build out the field of myeloma.

Dr Dunsire You can think of it at both ends of the disease. So if you can bring the right combination at the time of the patient’s diagnosis, that’s your highest chance of ultimately curing disease, and at Millennium that’s our aspiration.

But, as Kathy mentioned, new mutations emerge that you might not have expected or perhaps wouldn’t have seen a decade ago. We can bring new combinations of therapy because now we have in our arsenal a growing number of molecularly targeted therapies, for instance, against BRAF.

Science is moving as fast as it can to get ahead of the ingenuity of the cancer cell.

PMO FISH [fluorescence in situ hybridization] testing today is certainly an important tool in establishing prognosis in patients with multiple myeloma, and it may in turn drive therapy. But in most cases the current evidence base doesn’t allow matching a unique cytogenetic profile with a specific therapeutic regimen.

Do you see that changing as a result of the CoMMpass trial or some of the other research that’s going on? How is that going to change over time?

Dr Dunsire Our sincere hope is to better understand from a population database what the real trends are and which trends matter, because sometimes you see changes that don’t necessarily have a driving capability. So you have to discern which ones are drivers and which aren’t, and the only way you can do that is with a large amount of data. Under these circumstances, we may ultimately have the ability to specifically target groups of patients. I doubt it’ll ever be for only 1 patient because patients share some commonality.

Ms Giusti Yes, absolutely. You’re going much deeper than just FISH. The greatest challenge we have in CoMMpass is not only getting great tissue samples and keeping track of all these patients but taking all of those data and making them publicly available on IT systems where everybody can use them and study them.

So as we started developing the IT system, the challenge has been: are we developing this for bioinformatics individuals, are we developing it for translational individuals, or are we developing it for the community oncologist or even the educated patient? And the truth is we have to develop it for everybody. And that has been at least an 18-month process for us to start to build that system out. It is not available today.

And we look at these systems and ask: “Can you make a system that’s as easy to follow as Amazon, so that when people go in they can start really looking at the information?”

PMO Personalized medicine for multiple myeloma depends to a large extent on laboratory testing and identifying and characterizing these molecular biomarkers. There have been a lot of data published talking about some of the drawbacks and talking about some of the issues associated with laboratory testing. For example, FISH testing for deletion 17p where it may be at a different level at different times in the patient’s disease. Are Millennium and the MMRF doing anything to work with the diagnostic end of things to begin to standardize it and improve testing for some of these molecular biomarkers?

Dr Dunsire I think we’re in the infancy of doing that in this particular disease. That has certainly happened in other diseases, lung cancer being one of them with the EGFR mutation and ALK mutation, both of which have specific therapies. So I think in some ways there’s a feedback loop between the emerging science and emerging therapies that drives the need for much more standardization, for availability of companion diagnostic kits, for instance.

I think we’re at the beginning of that in multiple myeloma, and I can’t say that it’s an initiative that’s very far advanced right now. At Millennium, we recognize the importance of diagnostics within the realm of personalized medicine and continue to explore opportunities that might fit into our overall strategy.

Ms Giusti Yes, we even offer funding for diagnostic awards at our foundation to make sure that anybody interested in the diagnostic world can apply. There’s still a lot of work to be done. I think it comes back to having the data and really understanding what’s going on before you move to the diagnostic piece.

Dr Dunsire A good therapeutic will drive the need and the innovation behind the diagnostic as well. So, they kind of partner hand in hand.

PMO Multiple myeloma is a very diverse disease that not only affects plasma cells but also causes secondary effects. And of course, there are the adverse effects of therapy.

Are the efforts here with the CoMMpass trial and with other research going to be impacting some of these other issues, for example, the management of bone disease in multiple myeloma, anemia, infections, thrombotic events, and of course, the adverse events of therapy?

Ms Giusti Yes, in the CoMMpass trial we are collecting all of these clinical data that we can go back and look at and generate hypotheses. What are we seeing in terms of how patients are tolerating treatments? What are we seeing in their genetic makeup that makes them better able to tolerate certain drugs?

I think the beauty of CoMMpass is that it will generate a lot of hypotheses, and clinically what’s important to us is to work with companies like Millennium to determine which hypotheses we want to test. And then we can move to our clinical network, the MMRC, to build out clinical trials that will allow us to again have critical mass and have really good innovative clinical trials.

So I think that’s been the joy of developing collaborative models since 1998 – you keep generating hypotheses, and you have the systems and the models in which to test them.

Dr Dunsire When you think about the potential for reduction in side effects, it’s not only knowing who to treat, whose disease is most likely to be responsive, but the data might actually show who is at the highest risk of a given side effect for a given drug.

There is another thing we can do about that. When we bring together rational combinations of therapy, sometimes somewhat lower doses can be used, therefore exposing the patient to fewer side effects.

PMO Dr Dunsire, you mentioned earlier the interplay between pharmaceutical industry and diagnostics kits as being important. In fact, some of the great success stories in personalized medicine and oncology are examples of collaborative efforts between a diagnostics company and a pharmaceutical company, and the FDA seems to be receptive. Do you envision such a collaborative relationship in the agents that you’re researching and developing?

Dr Dunsire We certainly look for that. One that’s very early for colorectal cancer comes to mind in which we are in parallel developing the test right from the inception of the clinical trials. That’s the ideal circumstance when you have an agent that you know is targeting a specific receptor in a specific cancer.

Often, we have drugs like Velcade that are much broader in their action, so they’re not specifically targeted, but wherever we find efficacy, it’s still very important. So we would prefer to be targeted from the very beginning, but if an agent’s great, we will work post hoc to understand how to manage it better, how to target data, and how to better select the patients.

But Millennium has a very large investment in translational medicine. What that means is investing in finding the patient selection markers for a given therapy. We know the chemistry, we know the target, and we know how to assess whether the drug is interacting with the target, but figuring out how to select patients who are going to respond to that is next in the evolution of the science.

PMO It sounds like to really get personalized medicine in oncology to be a reality, there’s a lot of education that needs to happen – educating physicians, nurses, pharmacists, and patients. Are your organizations working together or individually to achieve that?

Ms Giusti I think the most important element is making sure that the patients are educated. I think one of the hardest parts about personalized medicine is that as a patient, you need to understand your genomics. But sometimes in myeloma, knowing your genomics puts you at high risk, and that can be challenging news to hear.

Just as an anecdote from myself as a myeloma patient – I was a translocation 4;14, high-risk patient, and that was really hard for me to know, but high-risk can sometimes be a good thing, because later on I was very lucky. I was on Velcade. Later, researchers retrospectively looked at the data and realized patients with that translocation do very well on proteasome inhibitors. And now you want to make sure all of the patients know this kind of information, but it’s hard because now patients are hearing that maybe they’re high-risk, but they may not know the whole story.

We have had many conversations about always having the patient at the middle. I really believe the patient is at the middle now because we are looking at the patient and saying, “It’s your tissue, it’s your data, it’s your doctor, it’s your life. You have to be educated on this and know that even if you’re high-risk today, it may not mean you’re high-risk tomorrow. So just know what has to happen in terms of new clinical trials.”

And that comes back to working with the community oncologists, who are seeing 70% of these patients, and making sure they’re educated on what we are seeing genomically. So we’re constantly partnering with Millennium in terms of investing in consumer- and patientbased programs as well as CME programs for our doctors.

Dr Dunsire I think one of the most concerning things is to encounter patients who just listen to their doctors, because doctors may be coming up the learning curve too. It’s so important for patients or their loved ones to engage in finding out about their disease, because nobody can advocate for them like they can. The patient really is the person whose life is at stake.

Getting accessible information to patients is so critical; that’s why we partner with organizations such as the Multiple Myeloma Research Foundation, because it enables us to get data to very learned third parties who can get it to patients in a way that’s distanced from the company, so the patient can trust that the source is not biased, but they can still get access to the information.

To me, that’s so critical, because the patients are the people who are going to sign up to have the biopsies, for instance, and to release their tissue to the tissue bank. The fact that they understand that this is not only important to them, but important for the understanding of the entire scope of the disease is so critical, and the faster we can build those databases with patients’ consent, the faster we get to outcomes.

PMO Our ability to accumulate data far outstrips the medical community’s ability to understand it and act on it appropriately. There has to be a parallel track for physicians as well to be able to understand this.

Dr Dunsire Yes, and I think we have seen that even with data that are absolutely clear and incontrovertible. For example, with the KRAS mutations and the use of EGFR inhibitors in colorectal cancer, it is a relatively simple message, but it still takes time for physicians to hear it, understand it, and act upon it across the spectrum. Academic centers act very quickly. Community doctors are faced with a much broader variety in everything they see, so it’s harder to accumulate all that new knowledge in every field at the same time. I think pharmaceutical sales reps can be an integral component of the education, bringing that information to doctors.

The partnerships that we engage in around major medical meetings, as well as the small community physician meetings throughout the year at different venues, help to get that message out, and then, of course, there are the various clinical milestones that are published in peer-reviewed journals and publications. So there are a number of different forums to get that information out, but what’s most important is having a really crystal clear message – when you see a particular constellation of symptoms, this is what it means, and here’s what you do about it. It’s my belief that we’re not there yet in multiple myeloma.

PMO So we’re not there yet in terms of the data, or we’re not there yet in terms of the educational initiatives, or both?

Ms Giusti As Deborah said, there’s not anything they can specifically act on right now, but that doesn’t mean that you don’t need to be learning in terms of what we’re seeing. Especially when you start to segment myeloma, they need to start understanding what might be high-risk, medium-risk, low-risk, and how we start to handle those things.

Dr Dunsire You have to really think about the explosion of knowledge in the biology of cancer. Cancer is a group in excess of 100 different diseases, for example, lung, colorectal, breast, or myeloma! Then when you start dividing each one up according to the genetic drivers, it’s an exponential function. And so oncologists today are having to take in so much more data faster than ever before, so we really have a responsibility to keep that information flowing, make it clear and understandable and actionable.

Ms Giusti It’s nice to have been a third party that’s been collecting the names of all the patients and the community oncologists who have joined our community since we started in 1998, because as new findings come out, it does make it easier for us that we have everybody in our database, and we can literally put together simple materials, do CME programs, and educate people very, very quickly.

One of the things that helps us is our expanded access program. We’re really starting to understand which community oncologists are seeing the bulk of patients, which community centers might be able to do good tissue banking, and which can be involved in phase 2 clinical trials. So we need to start keeping those data systems together so that we can reach out to them right away and get to the centers that are seeing the highest volume of patients.

PMO I’m going to ask both of you to look into the future. What do you foresee as the future of personalized medicine in oncology when sequencing the entire human genome will cost less than $1000?

Dr Dunsire Everything will move faster when we can get more data. Of course, as Kathy pointed out, the informatics to manage all of that and make sense of it all is critical, and we certainly are building that kind of infrastructure.

So our job is to help patients understand why it could be extremely valuable to not only have the data but also be able to share the data, anonymized, but within a much broader database, because that’s the only place that we can truly get power in the data.

Ms Giusti I think there are 2 elements that are changing healthcare dramatically. One is that it’s becoming much more efficient to acquire genomics from these patients. The second is the social networking phenomenon. I have patients who literally go on Facebook and say: “Hi, I’m a fellow t(4;14)” or “I’m a fellow syngeneic transplant,” not a fellow myeloma patient.

I think the greatest roadblock is going to be how quickly we can build the IT systems, and how many people are going to be able to understand all of these data and really be able to help us do something with them quickly. It takes a certain skillset to be able to look at all of that and understand where we go clinically from that information, and how we design new and innovative trials that will show that there’s an unmet medical need in a certain area where we need to move the trial and get FDA support faster. The whole world is changing overnight.

PMO So what do you say to patients who sort of fall into a gray area, who don’t carry a molecular marker that’s been associated with a specific therapy? What do you offer those patients?

Dr Dunsire I’d say they don’t carry a molecular marker…yet. Eventually, they will. Cancer is a disease of cells growing and dividing abnormally. We might not yet know how to recognize that, but through the acquisition of more and more data, we’ll start to say, “That very unusual myeloma patient who doesn’t have any of the known abnormalities shares this mutation with 20 other people.” Maybe that’s a new target that’s worth looking at.

So I would say that just because we’ve only categorized a few doesn’t mean we’re at the end; it means we’re at the beginning, and they should still seek deep sequencing information and contribute to the databases, because that’s the only way we’ll find the rest of those markers.

Ms Giusti Absolutely. We didn’t expect to see patients with BRAF mutations when we started our genomic initiative. That’s why you have to keep building on that database; you want to be sure that what you saw is true, and you want to see new things as you have more and more tissue and more access to patients.

PMO So let’s talk a minute about the economics of personalized medicine for oncology, because many people have questioned whether we can afford personalized medicine in oncology, whether this is the answer to the American health system. Would it make sense, for example, not for Millennium necessarily, but would it make sense for a pharmaceutical company to develop a drug that diagnostics show is going to be effective for only 5% of the patients?

Dr Dunsire I think a lot depends on the tumor type – how many people does 5% represent? It also depends on the magnitude of benefit. Nonetheless, I think about personalized medicine as the only way forward because of the current paradigm – treating 100 people to get a response in 30 or 35. A company may have to question the economics of that course of action. In addition to that, the impact of 65 of the 100 patients not gaining benefit but experiencing side effects may also impose a negative economic impact.

To really treat these diseases, personalized medicine, I think, is actually what makes the economics viable.

Ms Giusti It’s frustrating. When patients call us now and they’ve relapsed, many times the first question we’re asking them is what they have already been on and what trial might we be able to get them into. And that’s just somewhat serendipity, because the questions we really want to ask are: what does your disease look like from a molecular standpoint, what have other patients who have a disease that looks like yours done, and what do we think has worked for them so we don’t subject you to things that are going to have high side effects or things that just don’t work? It’s hugely challenging for patients, and expensive.

PMO When erlotinib was developed – and although it was only going to affect 3% to 5% of the patients with non–small cell lung cancer – everyone applauded that effort. In multiple myeloma specifically, if you found there was an agent that only affected 5% of myeloma patients, would that make sense from a resource allocation perspective?

Dr Dunsire I think it could. Again, it comes down to the potential benefits seen.

And I go back to the example of Gleevec for chronic myelogenous leukemia, where it was felt that this was a very small patient population, but it’s a transforming agent that is potentially curative and has totally changed the face of that disease, so that made perfect sense in hindsight.

Prospectively, it was done because the company believed in taking forward an agent with that type of efficacy, even if it was for a small population. At Millennium, we are about curing cancer, and if we find an agent that has the potential to do that, even if it’s in a very small patient population, if we know who they are, it could make very good economic sense for them and for us, for regulators, and for payers.

PMO We talked about all of the shareholders in treating myeloma patients. We haven’t talked about payers yet. They need to be educated too. What are we doing for them?

Dr Dunsire We have a field force that reaches out specifically to educate payers. Obviously, the biggest payer and the hardest to reach is Medicare. But in the private payer market, the insurance companies, we find a very receptive audience wanting to understand the data and the impact on patients.

I’ve personally found that the payers are very much part of the constellation of people who are caring for patients and that they’re very receptive and thirsty to hear the data. They’re also very critical thinkers about the data, so you can’t pass something by them that’s modest or not better than another therapy, because they’re extremely well educated.

Ms Giusti What we have found is that myeloma is not necessarily big on their radar right now because it’s not one of the most expensive cancers that they’re dealing with, but they are watching our model and what we’re doing because they like the way that we educate our patients. So, for example, if a patient goes to our Web site and joins the MMRF, they immediately get a welcome, they get a PDF of information on the disease and information on the treatments, and we’re in touch with them all the way through their journey. Payer groups look at that and see that is a very economical and a great way to work with patients.

We’re seeing the same thing with a lot of the community oncologist networks who are saying: “You already have CME materials; can we just co-market with you and provide those materials to all of our doctors?” And that’s a great idea, to be honest with you. As long as we’re developing these materials, why not make sure the dissemination of the information is as broad as it possibly can be.

PMO One of the other critical parties that need to be on board for personalized medicine in oncology to work is the regulators. What has been your experience with the FDA and the regulatory bodies?

Dr Dunsire We have had outstanding interactions with the FDA on this score. Dr Hamburg has been very clear that she is most excited about finding transforming therapies across all diseases. They also want to be sure that any biomarkers are robustly validated so that they predict overall outcomes. So there is a dialogue, and it’s a very open, robust, and engaged dialogue.

Ms Giusti We have a great relationship with the FDA. I have to say they’ve been phenomenal. We go down at least once, often twice a year, and just give them a full update on what’s happening in the field of myeloma. And I have to say, they have been incredibly welcoming.

We remind them all the time that even though we’ve made tremendous progress, there still is a certain element of unmet medical need. We did talk with them about the CoMMpass trial. They were ecstatic that we were doing it, because I think they too want to know that the data are coming in, and we’re all going to start looking at them together.

I think what people are applauding is the fact that we now have this whole collaboration where you’re looking at a group like ours reaching out, getting to 1000 patients. We’re doing it with the community centers and academic centers looking at the data, and then we have companies like Millennium coming in, helping to fund the trial and looking at the data that will eventually go out into the public domain. And the FDA is listening to this and saying hooray, thank goodness. May you find great information and may you find biomarkers, and please come back and talk to us about it and design the right kind of clinical trial that we can help you.

I think we both feel very fortunate in our relationships with the FDA.

PMO Twenty years ago FDA was willing to fast-track in the HIV/AIDS arena.

Dr Dunsire And that made a huge difference to patients.

PMO Are they willing to do that now for personalized medicine?

Ms Giusti Yes.

Dr Dunsire They certainly have demonstrated that a couple of times in the past year. I think of the Pfizer compound for ALK-positive lung cancer, which came together with a diagnostic. Here a pharmaceutical company and a diagnostic company collaborated. The FDA was a great partner all the way through that, and the drug was brought to market incredibly quickly, with very fast passage through the regulators.

So I think like any relationship, when it’s open, transparent, factual, and collaborative, great things can result.

PMO Thank you both for being with us today and for this very insightful discussion and your perspectives.


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