Monday, November 19, 2012

Spotlight on Academic-Biomedical Industry Collaboration: UCSF Chancellor Susan Desmond-Hellmann

UCSF Chancellor Susan Desmond-Hellman
Susan Desmond-Hellmann, M.D., MPH became the ninth chancellor of the University of California, San Francisco on Aug. 3, 2009. An oncologist and renowned biotechnology leader, Desmond-Hellmann also holds the Arthur and Toni Rembe Rock Distinguished Professor appointment at UCSF. In her role as chancellor, she oversees all aspects of the university and medical center’s strategy and operations.

Prior to joining UCSF, Desmond-Hellmann spent 14 years at Genentech. From 2004-2009, she served as president of product development. In this role, she was responsible for Genentech’s pre-clinical and clinical development, process research and development, business development and product portfolio management. She also served as a member of Genentech’s executive committee, beginning in 1996. During her time at Genentech, several of the company’s therapeutics were approved by the U.S. Food and Drug Administration, and the company became the nation’s No. 1 producer of anti-cancer drug treatments.

Q: Industry and academia have traditionally operated at a different pace, with separate objectives. How have you addressed these challenges and what advice do you have for others who look to emulate your success?

A: The issue is more of having different goals, rather than a different pace, although quarterly earnings statements are definitely a driver that are foreign to most academics. We started by realizing that the old way of doing things – with pharmaceutical companies funding specific projects in a lab, then taking the results and never returning – doesn’t really work anymore. We need to start with an understanding of what academic researchers know and do well, which is advancing the core science on pathways and mechanisms of disease, and what industry partners know, which is how to take a discovery from a lab and turn it into a medicine.

We’ve had a number of partnerships, such as our agreement between Sanofi and our Diabetes Center, in which we’ve transformed that old model into a true collaboration, with the research starting here, then moving into the industry labs, then coming back for validation, and fostering communications throughout the process. Other partners have vast libraries of compounds or antibodies that are invaluable in our research. By working together, we can create a synergy that improves the science and also makes it more applicable for translation.

Q: How do you measure success of these academic/corporate partnerships?

A: We have many types of industry partnerships on campus, ranging from clinical trials to collaborations on very basic research that help us understand the mechanisms of disease. Success is measured differently for each of those. But my ultimate goal, which is shared throughout the UCSF campus, is to apply the most advanced science to improve the lives of people throughout the world. So for us, the real measure of these industry partnerships is whether they enable us to move faster and more effectively to translate the best science into real improvements for patients. That takes time, but that’s the ultimate success.

Q: What considerations do you make before deciding to partner with a pharmaceutical company?

A: There are many considerations, starting with how well our research is aligned in a specific field, and how well our strengths complement each other’s. As a public institution, it’s also very important to us that we establish some critical details up front, such as our faculty’s right to publish all results from their research – good and bad – and, where applicable, any intellectual property agreements. But, ultimately, we’re also looking for people who are aligned in our mission to translate great science into a real difference for patients worldwide.

Q: The Pfizer-UCSF partnership is unique in that it brought Pfizer labs to Mission Bay. How has the proximity helped advance key research?

A: Collaborations really are key to solving problems in science that we haven’t been able to solve, and it’s no secret that close proximity helps any relationship. Several industry neighbors have told us that being able to walk across the street, rather than calling someone from across country, is making a real difference in their collaborations with us.

Pfizer’s Center for Therapeutic Innovation, specifically, already has enabled UCSF and Pfizer to launch several key research collaborations at Mission Bay. Those include a project studying a treatment for a blood clotting disorder known as thrombosis, a therapy for a common and often deadly form of liver disease, known as non-alcoholic steatohepatitis, and new therapies for the devastating condition of pulmonary fibrosis, which scars the lungs and impairs normal breathing.

Q: At a time when federal support for basic research through the National Institutes of Health and National Science Foundation is declining, how might UCSF and academic institutes statewide continue to support groundbreaking research?

A: These are times when all of us are learning to be more creative. We’re doing our part by making sure we’re operating as efficiently as possible and supporting things like core research facilities on campus, so individual labs have access to top-of-the-line equipment, but can share that equipment with everyone else on campus.

We have been fortunate to still maintain strong research funding from the National Institutes of Health, which surpassed $500 million this year, but we’re also looking at other innovative approaches. Those include industry collaborations, as well as programs like our Program for Breakthrough Biomedical Research, which provides seed funding to support highly innovative basic science – the blue sky projects that take big risks but have huge potential. And we’re constantly finding ways to support entrepreneurs on campus, to help make that leap into translating advances in the lab into commercial products.

Q: At Genentech, you supervised some of the biggest successes in drug development history. Are there parallels to be made between your business experience and the challenges you face as a chancellor?

A: As at Genentech, at UCSF I oversee a team of exceptionally talented, motivated people. As chancellor, my goal is to provide all of our faculty, whether they are basic or clinical researchers, educators, or clinicians with the support they need to succeed in their work. This means understanding the challenges and obstacles they face and identifying ways to help them address them. It also means identifying, from my more distant perspective, broad opportunities that individual faculty members may not see to advance their work.

Given my own background, I’m very interested in translational medicine, moving our research discoveries toward the clinic, and much of my effort focuses on facilitating this effort.

Q: If you could change policies at the state or federal level, what would your priorities be?

A: I’m very interested in ensuring that federal funding for research is sustained and at least keeps pace with inflation, in order to support our thriving research enterprise. Also, I would like to see the FDA continue to work on streamlining its approval process, which would help move drugs more quickly to market, while also making it more appealing for venture capital to continue to invest in this industry. I’d also like to see more collaboration between federal funding agencies, universities and regulatory agencies, and to see more investments in innovative science.

CHI-Advancing California biomedical research and innovation
Bookmark and Share

Thursday, November 15, 2012

A Conversation with Allergan CEO David Pyott

David Pyott

Allergan CEO, medical aesthetics pioneer and CHI Chairman-Elect David Pyott tells us what the business of beauty can teach the medical device industry about consumer-centric medicine. This article orginally appeared on It has been republished here, in part, with permission.

Hear from Pyott in person when he joins a panel of biomedical industry executives for the MassDevice Big 100 West. CHI President and CEO David L. Gollaher, Ph.D., will moderate the panel Dec. 11 in Newport Beach. CHI members receive a discount to attend. Click here for more information or to register with code CHI.

Allergan CEO David Pyott has described himself as a "mountaineer," a "born marketer," and a bit of a masochist, but there's one thing the man undoubtedly is: A pioneer of the medical technology world.

After taking the reigns of the Irvine, Calif.-based medical aesthetics giant in 1998, Pyott quickly set about transforming an eyecare company into a global juggernaut that pulls in north of $5 billion a year with a diverse line of specialty pharmaceuticals and medical devices. Pyott did so not by doubling down on conventional wisdom, but by changing the playbook. Much to the chagrin of some company executives at the time, he cut costs by 33 percent, shed Allergan's contact lens solution business and concentrated significant resources on a little-known product in the company's pipeline called Botox.

Today no one needs any introduction to Botox, which is as much a cultural phenomenon as it is a medical product. But the lessons of the drug and Allergan's medical aesthetics business, which makes up 40 percent of its sales (all paid for directly by consumers) could hold some significant lessons for the broader medical device world.

We sat down with Pyott recently to discuss how medical aesthetics could change the way medical devices are sold and marketed to patients.

MassDevice: When Allergan bought InaMed in 2006, you said, "Now Allergan is the global leader in medical aesthetics." I'm hoping you can define what the term "medical aesthetics" means to you and how it fits within your overall approach to the Allergan business.

David Pyott: I think I can be speaking accurately if I can say really I invented that term. I was literally sitting there, because I'm a recovering marketer, thinking "What on earth does one call the genre of Botox and its competitors?" Latisse was still a twinkle in my eye at that stage. Clearly it had something to do with improvement of appearance and so I liked the word aesthetics. But I wanted to make it very clear. This is aesthetics delivered through a physician, hence, why I chose the word medical. Breast implants were long way away from any form of cosmetics that you'd buy at the Macy's counter. But the further you got to that direction, such as physician-dispensed creams and lotions, that's probably the closest point to where the world of retail is just around the corner.

MassDevice: When you coined the term, how were these classifications of drugs and devices generally referred to in the medical community? Was it sort of ambiguous?

DP: I would say the markets were very small and I'm not sure that anybody had thought of the overarching market in such a holistic way. People were very much drilled in on the individual product segments. So, clearly by 2006 Botox had grown enormously, because we got the approval in 2001. By that stage it was probably roughly half a billion in sales. And dermal fillers, in my view, hadn't really happened in the United States.

At that point, the European market, particularly Central Europe, was probably two and a half times the consumption per capita of broader North America. And when we brought Juvederm into the Canadian and U.S. market, it probably took us three years to get up to European consumption levels. So, you can see that there is kind of a whole history in the background here of creating markets where really nothing had existed before.

MassDevice: Was there an a-ha moment for you in the medical aesthetics field, or is it directly tied to Botox? When you took over Allergan, it certainly wouldn't have been referred to as medical aesthetics company – it was more eyecare.

DP: I'm pretty sanguine about these things, because people often claim instant brilliance and I'm not sure I would ever subscribe to that theory. I think there are moments that are similar to hiking in the Sierras, a pass in the mountains as you get higher and higher

The way I would see it is if I look at that journey, when I came to Allergan, Botox was literally an orphan drug. And I think it was probably an orphan drug in the minds of a lot of the senior management as well. And this was before the heyday of orphan drugs.

I realized, listening to both people internally and then customers, that there was a huge opportunity for Botox, not only cosmetics but therapeutic, which is a different topic. That led to having investments and getting cosmetics through the FDA. So that really started in early 1998 and we got the approval three years later. And that was the beginning of the journey.

MassDevice: In one of your recent earnings calls you discussed the resiliency of the dermal filler and the Botox markets, the breast implants in markets like Southern Europe, which you seemed a little bit tickled by. Is there a broader lesson here?

DP: When we look back, the great recession year for us was 2009. When we entered 2009, of course, none of us knew how bad it was going to be. So we were pretty cautious and the first half of that year, the whole company declined about 10 percent.

But what was really interesting was that the recession, particularly in the U.S., around the world, some places you could argue maybe it never happened. Like China, Brazil, they felt they had a recession, but it was like hitting a little pothole, a very small one, and just bounced right through it. In the U.S., our market stopped declining five months after it started, and then it re-accelerated. So when we got to 2010 – in fact all of our product markets globally were already bigger than in 2008. Which, of course, I would never have dared to predict in early 2009. I was thinking, "Oh man, this is going to take years until we get back to the high-water mark."

Partly it was because of the segments of society that we probably addressed at that time, in terms of our penetration. So typically, this is kind of middle-top for income. It's not only women, probably 10 percent of the consumption's male – but women's repertoire of how they want to keep themselves looking a bit younger than their driver's license or passport, or birth certificate would say. Of course, the idea of going back to being the way you were before is not really a great option for most people.

During that phase, I literally heard about people postponing or canceling vacations or crimping on fine dining, basically to save up for Botox and Juvederm. We used to hear lots of that.

MassDevice: Well that's interesting too, because in the orthopedics business, we've heard tons of stories about people postponing all acute surgeries, and all other medical markets seemed to contract a bit there.

DP: I think we saw a bit of that with breast augmentation surgery. That was the one that was the most heavily hit, because of course there's somewhere a good correlation to what is the out-of-pocket spend.

I think another comment you made which I'd like to address was, "Why is Europe doing so well?" Well, my experience has been that, basically, innovation can trump a lot of economic headwinds. We have syndicated market research, so we have the very fix on the European market and of course we know our sales even better. We're growing somewhere between – depends on the country – two and three times the speed of the market in Europe.

MassDevice: You're a born marketer, I mean, when you're looking at these indications, and these products that you're going to place into there, when you look at the specialties, do you pick one that fit within that specialties where you can communicate directly to the patient? I saw some of the direct consumer advertisings you had for Botox for migraines, so you're going directly to the patient there and addressing their pain point.

DP: I think really where we start is where is the technology? Where do we have a solution that in some manner improves patient care? That's always the starting point and maybe because we've looked carefully and found, time and time again we found these solutions. If I cross over, to say, Botox for a chronic migraine, one of the reasons that we chose to go down that road was because so many migraine patients have just given up. They've tried treatment after treatment, on to doctor after doctor and they're basically at home miserable. We know from consumer research we've done that these people, when they're not in sort of maximum pain, because they're probably to some degree forced to be inward-looking. Because they don't go out so often because they're in terrible pain, so they're on the Internet a lot.

MassDevice: When we spoke to Align Technology CEO Tom Prescott, he said that the medical device industry used to look down on the private pay model. Do you think there's still that attitude?

DP: I don't think so. I mean if you look at the pressures that are facing our industry, whether it's device or pharma, I think there are huge pressures. I think a lot of both; well, industry executives realize that private pay could be an escape valve. How do you get out of some of these pressures? And we've seen that in Europe in a different field, another example of how we go to and fro between cash pay and reimbursed.

In this country, artificial tears are paid for out-of-pocket. You just go down to Walgreens and you can find it on the shelf. Now, you probably as a consumer have in the back of your head that the optometrist or the ophthalmologist recommended you brand A or B, hopefully ours. We happen to be the world's No. 1 producer of artificial tears. But then in Europe, it's very interesting. There there is a bifurcated model where historically the government has paid for tears.

But, more recently, certain governments have either completely de-reimbursed tears or made it possible in parallel to introduce, I'll call it non-price regulated tears, I mean you still have the approval, right? But then you have the ability to price-relate. There's another example of where you can kind of go down two streets.

It shows there are ways to segment markets and of course you've got to do it within the regulatory process of that individual country.

You can see there are many different angles to this question about how medical aesthetics can translate. You can come in through, "What is the regulatory framework?" You can come in through, "How do you drive the consumer element?" if you like delivering consumer or consumerized medicine. Then I suppose this is just the whole backdrop of how do you innovate, right?

MassDevice: I like the idea of how you pioneer delivery to a consumer market because there's a great desire in all the companies that we cover for growth. And it feels like they are just throwing products against the wall, seeing if they can keep the same model or expand to a different country.

DP: Yeah, well, I mean to end on a high note, I would say, hard times often are great times to get creative, right? Because you sit there and go, "This isn't enough, we've got to find something new."

CHI-Advancing California biomedical research and innovation

Bookmark and Share

Tuesday, November 13, 2012

Legislator Spotlight: Rep. Jackie Speier (D-Hillsborough)

Rep. Jackie Speier

Rep. Jackie Speier, D-Hillsborough, has championed numerous issues of importance to California's biomedical community, including reforms to the U.S. Food and Drug Administration and funding increases for the National Institutes of Health. Speier, who serves as co-chair of the Biomedical Research Caucus in the House of Representatives, represents a congressional district that includes some of the biggest names in biotech and academia, from Genentech to UCSF. In 2012, Newsweek named Congresswoman Speier as one of the 150 fearless women in the world. During her more than 30 years of public service, she has passionately advocated for women's issues and health access.

Q: You are aware of the numbers regarding this industry: 270,000 jobs, 2,300 California biomedical companies, $2.7 billion in VC funding, $7 billion in NIH funding. But when you think about the California life sciences sector, what does it mean to you?

A: It means the difference between life and death, in many respects, because the drugs and medical devices that are being created are saving people’s lives and fundamentally transforming our ability to tackle the most serious and deadly diseases of our time. The life sciences sector is one of the strongest examples of the innovative spirit that is a trademark of our state. Every day, the brightest minds in our universities are unlocking scientific discoveries that will lead to companies of tomorrow and cures that were unimaginable only decades ago. This industry has become a shining example of all that is possible when we pair bright minds with a commitment to improving people’s lives. But this industry is not without its challenges. There is much we still need to do to ensure that American patients have access to these life-saving discoveries. I don’t want to say to my constituents, “You are going to get better care in Europe.” We have to be diligent and thorough, but we also have to be willing to provide compassionate care, too.

Q: How do you plan to reinstate science as a government priority at a time when Congress is proposing cuts across the board?

A: It is a priority. And it’s a priority for a vast number of Americans. You ask American voters whether or not they want to see science as a No. 1 priority and it would be overwhelmingly yes, particularly when someone is diagnosed with a very serious medical condition. So, how do you convey that to the majority right now in the House that believes that we should slash funding to the NIH, FDA & CDC? I think we all have to do a better job of conveying the link not only between federal funding for medical research and scientific progress, but also, economic growth. The statistics really speak for themselves. In 2010 alone, the $26.6 billion invested by taxpayers in NIH research grants generated $68 billion in new economic activity and supported nearly 490,000 public and private sector jobs, representing a 150 percent single-year return on public investment. This isn’t just about science and saving lives, this is about supporting our economic growth and recovery. Cutting funding for these agencies isn’t just bad for our health as a nation, it’s bad economics.

There is also much we can do to streamline the FDA approval process, while still being thorough, and creating the pathways for companies to succeed. I make a point of visiting life science companies in my district, easily three or four a month. These companies are doing such remarkable work. Their work will potentially reduce the cost of healthcare because they are creating a smarter, more efficient healthcare system through their innovative advances. For example, we know that chemotherapy does not work on 80 percent of tumors, and, therefore, most patients would either be just as well off without that treatment altogether or benefit more from an alternative medical option. But even though we have this information, we still spend $80 billion each year on cancer therapies. This isn’t just about money, this is about sparing patients a horrific experience to try and stay alive. Part of our job is to convey that personalized medicine is not an add-on to healthcare. It is a refinement of providing healthcare to patients so that we are not administering certain therapies to people that are not going to work.

Further, I envision a system where this wasted money is redirected to research that will result in additional treatment options tomorrow so chemotherapy isn’t their only recourse.

Q: You have championed many bills to support biomedical research funding, including SBIR and STTR grants that promote entrepreneurship. Talk about the importance of these to you.

A: I think these grants give fledging companies an opportunity to survive, and, oftentimes, to thrive. It advances our knowledge base and the science that allows us to then build the next generation of life sciences companies with new discoveries that are going to improve the quality of life.

I oftentimes tell people about the meeting of a venture capitalist, Bob Swanson, and Herb Boyer, a UCSF professor. It was a quintessential San Francisco story – two guys drinking beers at Perry’s. At the end of a three-hour meeting, they didn’t just shake hands and found a company; they founded an industry with hundreds of thousands of employees in this region. So, why wouldn’t we want to promote more relationships like that which might just create the newest industry that’s going to improve our health?

Q: San Mateo County received $75 million in stimulus funds from HHS. Much of the money went to organizations including SRI International, Applied Biosystems, Epitomics and others. Have these projects lived up to their potential?

A: Actually, San Mateo County probably received a great deal more because stimulus funds also supported our public health system and UCSF collaborations with businesses in this county. To be honest, I’m not familiar with the outcome of the grants that are mentioned in the question but I can say this about grants for science in general: It’s almost always money put to good use. The returns on the investment almost always reverberate across many years, if not decades. For example, there are people at UCSF whose surgeries are going to be much more precise because the PET machine now exists. As I visit life science companies throughout my district, I am frequently told that SBIR grants were the source of a lot of development funding for new tests and treatments that have moved forward in this county, and from here to the four corners of the world. SBIR got a big boost through the stimulus bill. In sum, if you give a genius a dollar, it’s likely she’ll turn it into at least two dollars of value for taxpayers. The challenge is to recognize that the lead times are long, the path to commercialization too arduous in many instances, and the commitment of Congress to predictable funding weak. Rather than asking if the projects live up to their potential, perhaps we should ask if we do ourselves any favors by shortchanging human genius.

Q: You heard a lot over the past couple years about the issues of consistency and unpredictability at the FDA. You communicated with the FDA and helped convey dialogue with the industry’s thought leaders to discuss how we can address those issues while also maintaining the high standards of safety that the public expects and deserves. How do we ensure that that dialogue continues and that those improvements are implemented?

A: We need to set high expectations of our members of Congress to keep engaged with the FDA and create opportunities for the FDA and the life sciences industry to interact. Safety and efficacy are essential, but the process required to receive those results should also be predictable. The last thing we want is for the industry to come to a screeching halt. PDUFA and MDUFA were great bipartisan efforts this year. Vigilance is absolutely key to making sure that improvements at the FDA continue, we cannot afford to take our eye off the ball. I can guarantee you that Congresswoman Anna Eshoo and I will be monitoring the relationship between FDA and the life science companies for years to come.

Q: What are you most proud of as a Bay Area native and graduate of two UC campuses?

A: I am so grateful that I was the beneficiary of advanced education at two UC campuses that were affordable. Unfortunately, we can’t say that today. My education at UC Hastings College of Law cost me $700 a year. If you account for cost of living, it should cost about $2,700 a year. The average Hastings student right now is paying $47,000 a year. We have made it unaffordable to get the kind of education I got 40 years ago. Likewise, if advanced degrees in scientific fields become prohibitively expensive at our state universities we are going to have a serious problem producing the brain trust that has historically created the life science companies that call our state home. I think we have a huge responsibility to turn this trend around.

CHI-Advancing California biomedical research and innovation

Bookmark and Share