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Ep 12 Roy Baynes - Reflections on Cancer Therapy in Celebration of the 10-Year Anniversary of Keytruda
103 Plays6 months ago
Roy Baynes M.D., Ph.D, has been instrumental in developing some of the most impactful drugs, including Keytruda. Listen in as he shares his learnings from decades of innovation in cancer treatment across pharma, biopharma and biotech.
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Transcript
Introduction to Mighty Spark Communications
00:00:00
Speaker
Hi, everyone, and welcome to Spark Time. I'm Dani Stoltzfus. And I'm Will Riddle. Of Mighty Spark Communications. Our mission is to use scientific innovation to drive transformative change. We believe that compelling storytelling is the most effective tool we have in our arsenal to motivate and inspire audiences to invest themselves in audacious goals. We are scientists by training, storytellers by experience, and entrepreneurs by nature. Let's get started.
Insights into Drug Development and Patient Care
00:00:30
Speaker
Roy Baines joined us today for a wonderful conversation about his career and the guiding principles he's carried with him throughout his time building and turning around programs at Amgen, Gilead, Merck and now ICON. Such extraordinary experiences in worldwide drug development programs as well as private biotech. And it was truly a treat to hear his perspective on how to bring the best care for patients forward in these environments.
00:00:55
Speaker
definitely. Roy, as you said, was speaking from incredible experience, having helped launch the largest drug product ever globally. And I enjoyed Roy's review of the cancer therapy landscape from his time at ASCO this year. It sounds like he's convinced the next wave of targeted therapies will continue to bring good news for patients with better and more specific precision therapies. I really liked Roy's perspective on that medicines are for patients and that should be the guiding principle when thinking about how to talk about what a company is doing in terms of drug development. I think that resonates really well with all audiences, but especially you know investors and potential patients that may receive therapies in the future. Anyway, let's dive in.
00:01:39
Speaker
Dr. Roy Banes currently serves as Executive Vice President and Chief Medical Officer of ICON Therapeutics, a privately held biotechnology company. Prior to ICON, Dr. Banes served as Chief Medical Officer as well as Senior Vice President and Head of Global Clinical Development at Merck, where he helped Merck become a leading oncology and global healthcare care company. Roy also previously served as SVP of Oncology, Inflammation and Respiratory Therapeutics at Gilead, which was preceded by a service at Amgen as a Vice President of Global Clinical Development and Therapeutic Area Head for Hematology and Oncology.
00:02:15
Speaker
Before Amgen, Roy was the Charles Martin Professor of Cancer Research at the Barbara Ann Karmainos Cancer Institute, a national cancer institute designated comprehensive cancer center at Wayne State University. He received his medical degree and doctorate in philosophy from the University of Witwatersrand in South Africa and completed his medical training in the Department of Hematology and Oncology at Johannesburg Hospital. He's received innumerable awards for his activities as a physician scientist and currently serves on the board of directors at Natera, Travier Therapeutics, Katalim, and is a paid advisor to Duchang Capital and Nurex Therapeutics. Hi, Roy. It's really such a pleasure to have you here today. So how are you doing? Doing great. Thank you very much.
00:02:57
Speaker
Wonderful. So Roy, it's really a pleasure to have you here. And i I really want to begin by rewinding back to the time when you were a professor and understand why you made the transition from academia to industry.
From Academia to Biotech: Roy Baines' Journey
00:03:10
Speaker
Because I made this transition myself and I mean, I know my reasons for doing it. And there's such a feeling of shock that goes with that change in environment. So I'd love to hear from you what motivated you to leave academia. And what was driving you at that point in time? Well, great. Thank you for the question. And I'll start off by giving a little background just so that the transition becomes clearer. I had experienced a wonderful academic career moving through the ranks initially in Southern Africa and then in the United States. And this spanned almost a quarter of a century.
00:03:45
Speaker
My final academic position before joining industry was a very exciting one as head of the Hematologic Malignancies Program, head of the bone marrow transplant program, and head of the JP McCarthy Umbilical Cord Stem Cell Bank at the Comannus Cancer Institute in Detroit, Michigan. It was an NCI designated comprehensive cancer center. It was part of the Detroit Medical Center in Wayne State University. There I had an endowed chair. I was professor of medicine and professor of oncology. We had built a well-funded substantial clinical and research program and a transplant program that was ranked number one nationally a couple of years in a row.
00:04:30
Speaker
Our funding at the time was a blend of federal funding, state funding, industry funding, professional society funding, and organizational funding. We had also created a self-therapy collaboration with Aspen Biosciences in Ann Arbor, Michigan. um And I had been asked to create an academic research organization for the university and was asked to take on the assistant dean role for research. During my academic career, I had extensive collaborations with the biopharmaceutical industry and was always most impressed with the energy, the focus, and the resources that could be brought to bear on advancing key scientific questions and programs. It certainly was a truism at the time, and I think it still is, that a majority of the major scientific advances that affected the lives of patients were coming from industry.
00:05:25
Speaker
always has been a healthy symbiotic relationship between
Industry vs Academia: Resources and Team Dynamics
00:05:30
Speaker
the academic scientific discovery engine and the industrial focus and execution. um And eventually it became clear to me that to bring the most value to advancing innovative medicines for the benefit of patients that we serve, I would be optimally configured in an industrial environment. So therefore, in 2002, I made the shift and enthusiastically transitioned over to Amgen. It is certainly true, as you suggest, that the industrial environment is very different from the academic environment environment in ways that are really quite numerous. and I won't try and delineate them all, but I think key differences include those relating to the harnessing of resources,
00:06:15
Speaker
individualism versus teamwork, function versus cross-function, alignment of incentives, the target audiences, and then the scientific and quantitative rigor that is brought to the commercialization process. In addition, there's the distinct difference between stewardship of development as we have in industry versus ownership, which is often the case in the academic environment. industry um in many ways is as academic as the academic environments. um And industry provides a very steep learning curve. um And I can tell you after a quarter of a century in it, it's that learning curve has never plateaued.
00:07:01
Speaker
Yeah, yeah, yeah. It's so interesting those, the contrast that you draw there, because so many of those are so familiar to me. And I was really, really impressed specifically around the rigor with which science was done in industry and and to to get something that you could take to the point of putting into a human, you know, it's a whole different level. And yeah, it's really nice to hear that you had a similar experience, Roy.
Keytruda and Advances in Cancer Therapy
00:07:30
Speaker
so Roy, I read recently that we are approaching the 10-year anniversary of the Keytruda launch. and I saw an estimate that by the end of year 2024, it will have been administered to over 2 million patients. It's clearly changed the landscape of cancer therapies. I'm curious, so what is your perspective on oncology treatments in 2024 versus 10 years ago when Keytruda launched? and What's exciting you right now?
00:07:59
Speaker
Yeah, it's a great question. And, you know, as we think about the treatment of the cancer patient, innovation has really exhibited numerous waves of advance. Going way back, you know, we started off with surgery, then there was radiation, then chemotherapy, then combined modality therapies. Then importantly, there was supportive care, which allowed the movement of cancer treatment really into the community setting from the academic centers. Next came targeted therapies 1.0, which was really the first um foray into targeted therapies. Then we had the immunotherapy era, of which Keytruda is obviously a tremendous example. And now we're in the next wave, which arguably I think is being dominated by the antibody drug conjugates.
00:08:50
Speaker
So, the prediction at least that I have, and again who knows what the future really holds, is the next wave will be again targeted therapies, but I call this targeted therapy 2.0 because I think there have been so many remarkable advances in technology and artificial intelligence that we're on the cusp now of really even better and more specific um ah precision medicine therapies. So that that's sort of where I am excited about it. I have had the unique privilege and frankly ecstatic pleasure of having participated meaningfully in a number of these different waves. I i certainly see my most important work in relation to Keytruda.
00:09:35
Speaker
And there I had um really a wonderful time building the team, enabling that team, helping architect what I think is arguably one of the most comprehensive oncology drug development programs ever. To date, Keytruda in the United States, I believe, has had more than 50 different approvals, some 40 indications. It's covered 17 major cancer types. and has had two groundbreaking histology agnostic biomarker driven indication approvals.
00:10:07
Speaker
The molecule, as you note, has achieved enormous um success. It certainly had enormous commercial success, and I think indeed today it's the largest product globally. um Generally, such success is a really good proxy, though, for the benefit it brings to patients. So I am extremely excited, however, at the prospect that these recent technological advances that I mentioned to you have afforded us to further accelerate innovative um therapeutic development. Yeah, wow. I mean, it's just phenomenal when you you put it in those terms, the the the impact and the reach that Keytreator has had. in I mean, I just can't even imagine to have been part of something so special.
Roy Baines' Move to ICON and Early-Stage Biotech
00:10:50
Speaker
It's really a joy to hear you talk about it, Roy, and the fact that you took such pleasure in the process, that's really special.
00:10:57
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I want to talk about you know what you did after that because I know that you transitioned from Merck to ICON where you're at right now. and Personally, I'm really drawn to you know the nimbleness and the adaptability and the flexibility and the focus on the ultimate vision that you find in those really early biotech companies. but I'm curious, what drew you to the early stage biotech arena and out of you know Merck and such a large biopharma company? Because they're very different environments.
00:11:30
Speaker
Well, let me give you, it's going to be a bit of a long-winded answer, but interestingly, I must say having worked you know in a large publicly traded traded biotech, namely Amgen, yeah a large publicly traded biopharma company, namely Gilead, a very large publicly traded pharma company, Merck, and then a small privately held biotech company called Icon Therapeutics, I've experienced, in fact, all of them to exhibit numbleness, adaptability, and focus.
00:12:04
Speaker
and that's not That's not often you know what you'd hear, but I think in part this reflects that you know each one of these organizations has had outstanding, experienced, and practical CEOs who are fiercely committed to the science and to patience. It should also be noted that in three of these four, um I have worked for my very dear friend and mentor, Roger Perlmutter. He was head of R&D at Amgen, head of R&D at Merck, and is currently the CEO at Icon Therapeutics. So um all of these roles that I've held over the years, spanning, as I said, about a quarter of a century, have either been turnarounds or builds. So at Amgen and Merck, it was really turning around
00:12:54
Speaker
ah development organizations, and then at Gelliard and ICON, it's building new organizations. And I think to be successful in these efforts, one really has to issue distraction and exhibit a high degree of nimbleness, adaptability, and focus. At the same time, one has to articulate organizational clarity, messaging has to be consistent, and there can be no white space between you and your boss. So in terms of my move from Merck to ICON, there were a few points to make. At Merck, I think I had probably the greatest job in the world.
00:13:30
Speaker
I was brought in by Roger and Ken Fraser to turn around a development organization that had somewhat lost its way. After having been arguably the leading science driven biopharmaceutical company, we all recognize the phenomenal potential of contributor to benefit patients. And I had enormous support to build the best teams, help chart the course, execute and deliver results all within a highly compliant framework. I was head of clinical development and CMO and led the development organization there for almost a decade. um Not only did we get Keytruda really a long way down the road, but we had some 26 other new molecular entities approved. So while we can never say that mission was accomplished, I believe we did restore Merck to the premier research-intensive biopharmaceutical entity and its iconic position it had previously held.
00:14:29
Speaker
I was quite far along in my career when I joined Merck, and so a high priority was also placed on building a robust succession plan. I retired from Merck about two years ago and handed the reins over to my successor, Eliyev Bahr, just as Roger Perlmutter had handed his reins over to his successor, Dean Lee. Both of these gentlemen were hand-picked and mentored and groomed for success. And while my decade-long tenure at Merck was amazing to experience, it was also intense. And I can say that for my from my quarter of a century in leadership positions in industry, I had been on duty essentially 24-7, 365 for that entire duration.
00:15:15
Speaker
And all of these companies have global footprints so that, you know, it's actually a 24-hour day. So on a personal basis, my wife and family were eager for me to decelerate a little and spend a little more time with them. So they encouraged retirement. Second, I think as a matter of really good business hygiene, it also makes great sense, you know, after protracted leadership tenure to have fresh eyes and hands to take an organization to the next level. And I do believe that you know Roger, myself, and frankly Ken Fraser for that matter, handed over a business in excellent shape to people who were hand-pecked and who are well-configured to take the company to the next level. When it came to retirement, I really didn't know what I wanted to do. I was doing some board work and um I was doing a number of advisory roles. and Roger called me up and we discussed this new company, Icon Therapeutics, that he was building.
00:16:14
Speaker
And I was completely mesmerized by the platform, ah which purposefully integrates science, engineering, artificial intelligence to really open up new vistas for drug discovery. And in a pretty short period of time, ah this platform has begun to deliver meaningful new drug candidates to address difficult to drug targets and comp complex biology. This is moving very quickly and it was clear that we needed to develop the organization so that we could develop our own drugs. As I enthusiastically signed up for my third tour of Judy with Roger and my fourth industry build or turnaround,
00:16:55
Speaker
We've also been able to prime the pump with a few assets in licensed under very favorable terms, and a number of former colleagues and drug developers with long industry tenure after hearing and seeing what we are doing have elected to join us on this six exciting new journey. So at this time, I'm busy enough to keep me interested. I'm scar i'm still learning, um but I do have a little bit more work-life balance. I will also add um that you know in this quarter of a century in industry, there is not a day that goes by without me learning something really new and really important as we sort of try and develop important medicines for patients.
00:17:39
Speaker
Well, that's a true gift. I mean, Will and I talk about the new things we learn every day, but it's so inspiring to hear that you still do that after 25 years in the industry. that That makes me really happy, Roy. Yes. And and Roy, I'd like to to thank you for sharing these perspectives. They're a real pleasure to listen to and
Strategies for Effective Healthcare Communication
00:18:00
Speaker
and to understand what you've been thinking along the way. And on the on that note, continuing to hear you're continuing to hear your perspective, um on communications. It's clear that you're such a ah deeply thoughtful communicator. I'd like to hear your perspective on communicating with healthcare providers and patients and advocacy groups. These are such different audiences than the ones that Danny and I typically think about with respect to communication, which are investors and and pharma partners.
00:18:30
Speaker
So, can you tell us about the communication techniques that um you have found especially effective in engaging these audiences, the healthcare providers, patients, and advocacy groups? Yeah. Well, there's remarkable commonality, you know, with respect to communication with these different audiences. One of the early CEOs at Mercken Company, a gentleman by the name of George Merck, said it best, where he encouraged all of the company to have as a guiding principle the notion that medicines are developed for patients. And if you keep that as the central idea, pretty much all the rest falls into place.
00:19:12
Speaker
So while the level of technical detail may vary, telling the story generally involves the same pathway. And that is, it involves a statement of the unmet medical need, some clarity as to how science and technology allows us to explore innovative solutions, defining an actionable development strategy, outlining the execution of the program and hopefully culminating in the realization of an innovative breakthrough medicine that addresses Grievous Medical Disease. So it is key that communications be consistent, that they be truthful, that they be concise.
00:19:57
Speaker
They should be memorable. They should address the overwhelming communication objectives, which I'd outlined just previously. But fundamentally, they must always be science based and they should never go beyond the data. Yeah, that that's a really good point. And I love that, I mean, we talk about truth so often on this podcast, and I love that that you you use the word truth as well because we're we're very rooted in truth and data and letting it speak for itself. So it's really it's really nice to hear, Roy, that you you share that perspective with us because we talk about it just about every time we do a podcast at this point. So it's really, really special.
00:20:41
Speaker
ah I wanted to ask you about spring. so we We've just come out of spring and spring's a
Innovations Showcased at Biotech Conferences
00:20:50
Speaker
traditionally very busy conference season in the biotech industry. and We know that the ICON team was at both ASCO and AACR. I'd love to hear how you know the work that you you briefly described to us that's happening at ICON right now was received in those meetings. and Other innovations that you you you heard about in those conferences that really excite you in the oncology space? Sure. So, indeed for a small startup company, we at ICON had quite a busy spring. Yeah. We had a poster presentation at the American Association for Cancer Research summarizing our phase one experience.
00:21:30
Speaker
ah with an agent that we in-licensed, namely a systemically administered toll-like receptor 7 and 8 co-agonist. It now has the name of IKE 1001. That's EIK 1001. And this presentation outlined really favorable molecular attributes as well as encouraging monotherapy activity. um At the American Society of Clinical Oncology, we had four presentations. These included an oral presentation of our phase one experience of IKE 100, one in combination with not surprisingly Keytruda. And again, very encouraging efficacy and managing manageable safety profile were outlined.
00:22:15
Speaker
We then had a poster summarizing similar combination experience with a Tezilizumab, and again, showing evidence of efficacy and manageable toxicity. ah We had two posters outlining clinical trials in progress. One of those relates to um the TLR7 and 8 co-agonist, where we are combining this with histology-appropriate chemotherapy and Keytruda in patients with non-small cell lung cancer. And we outlined our Phase 1 study of our Part 1 Selective Inhibitor, known as Mike 103, in patients with defined histologies and patients selected upon genotypic characteristics. um I must say at ASCO, we were also very busy with other stuff. We had we hosted an investigative meeting for our Part 1 study. We had a small booth on the trade floor.
00:23:10
Speaker
which as a small company we all had to staff and we had more than 40 different um professional interactions with thought leaders and investigators and all in all a very successful outing for a small company. In general terms, um as I look at ASCO, you know it was probably not the most um intensive ASCO that one had ever been to. I will say that you know the oncology community over the past decade has been remarkably spoiled by prodigious um outputs, both in the immuno-oncology space and major advances in other therapeutic classes.
00:23:52
Speaker
Nevertheless, there were some meaningful progress reported, particularly for certain additional immuno-oncology combinations. ah Interesting novel a little target called GDF-15. This is a monoclonal antibody targeted approach, which full disclosure, I'm involved in that little company. And we also had um quite a lot of exciting data on certain antibody drug conjugates. There was really exciting data on a couple of targeted therapies. One of these was a tyrosine kinase inhibitor targeting the elk mutation in non-small cell lung cancer, where remarkably patients have, you know, been on drug for many years and five-year survival rate more than 50%, which is, you know, somewhat unheard of.
00:24:40
Speaker
um And then we also heard of a new interesting novel agent targeting the BCR-ABL rearrangement in patients with chronic myeloid leukemia who were resistant to, you know, the first and second and third generation drugs. So again, speaking to the importance of the targeted therapy approaches. A couple of ADCs or antibody drug conjugates were presented, which actually disappointed. They didn't really do as well as expected. So again, not everything's going to be a home run, but overall, you know there was there was some meaningful progress in a few areas.
00:25:15
Speaker
Well, unfortunately, everything is not a home run, but it is great to hear what what has been successful and and hopefully things that aren't successful yet will show some success in the future. So thanks for that very nice recap of what the ICON team has been presenting as as well as some of the exciting advancements that you saw at those conferences. So I want to bring the question back to ICON. We know that it's grown very rapidly since its inception, um no doubt driven by the fact that the science is compelling and it's delivering on the process or the promise of single molecule tracking as a tool to drive new discoveries in biology.
00:25:52
Speaker
So, ICON has also gained significant investment from significant investors, which is a testament to you, Roy, as well as
The Art of Storytelling in Biotech Communication
00:26:00
Speaker
the rest of the leadership team in your ability to clearly articulate the value of the science, the data, and the meaning it has for patients. So, what do you think is important in delivering a compelling corporate story? Yeah, I've thought about this quite a lot you know of over the years, and I will say that I think there are a couple of things that, at least for me, have been important. Firstly, try and understand your audience. Absolutely.
00:26:29
Speaker
then have real clarity of message. And the clarity of message, at least for a science and development person, really, um I think is quite consistent. And that is that you need to be able to highlight an exceptional leadership team. You have to be able to articulate unique capabilities. And in this case, I think we can talk to the purposeful integration of science and engineering. um a very powerful and highly innovative research platform with supporting research, generating novel composition of matter against difficult to drug targets, and an extremely experienced and capable clinical research and development organization.
00:27:15
Speaker
I generally feel that it's important to always um highlight proof points that the platform you're talking of is working and delivering exciting new molecules. And also articulate the proof points of clinical research and development is priming the pump, if you will, to be ready to um move our own organic molecules forward quickly, but really priming that pump with exciting assets that have been in licensed at very reasonable terms. Generally in these communications, I think one should really try to simplify complex elements. um And then I think ultimately you have to paint the picture for how this translates to the promise of meaningful commercial and funding opportunities.
00:28:02
Speaker
What great advice and really you spoke so clearly to so many of the things that we also believe are important about a compelling story and thank you for clarifying your perspective, especially with as it relates to icon and I wanted to kind of wrap up the podcast now with you, Roy. And one thing we do with every guest that we have, and I mean, I think you're especially well poised to answer this question, given your wonderful history and achievement in the industry, is if you were to give some advice to an early stage biotech company, you know, especially in this case, a clinical team, given
Prioritizing High-Potential Assets in Biotech
00:28:40
Speaker
that's, you know, your world of expertise, what would it be? What would you tell them based on all your years of experience?
00:28:48
Speaker
Yeah, it's actually pretty short answer to that. And that is always follow the science and focus on high potential assets. who And I think if you do that in the context of remember the medicines are for patients, everything else falls into place. Yeah, that's so simple. I love it. I love it. Fantastic. Yeah. Thank you so much, Roy. Roy, it's been a real pleasure. Thank you for joining the podcast. Thank you.
00:29:23
Speaker
Well, I thoroughly enjoyed our conversation with Roy today. He's so eloquent and thoughtful and a real fountain of wisdom. On that note, I really loved hearing how he still learns something new and important every day and recognizes that even though he thinks there's a steep learning curve that doesn't ever plateau in drug development. Yes, and I really resonated with that guiding principle that Roy shared that he attributed to George Merck, that medicines are developed for patients and everything else falls into place. And whether we talk to investors or patient advocates, this is an incentive that drives all of us. Yes, I completely agree. And I really like Roy's advice about how to deliver a compelling corporate story. So know your audience, which we always talk about, have clarity in your messaging that's consistent, and then also
00:30:12
Speaker
thinking about how to articulate that you are successful in terms of your platform or your clinical development plan, and really to simplify complex elements and paint the big picture for your audience about how what you're doing in the early days will translate to meaningful commercial outcomes. So join us next time as we continue to power scientific innovation, storytelling to drive transformative change and solve our most demanding challenges.