Tuesday, March 13, 2012

Executive Profile: Rob Perez, Executive Vice President and Chief Operating Officer, Cubist Pharmaceuticals

Rob Perez
Perez has served as executive vice president and chief operating officer of Cubist since August 2007.

He grew up in the Los Angeles area and received his undergraduate degree from California State University at Los Angeles and his MBA from the Anderson School at UCLA. He began his career as a sales representative in South Central Los Angeles working for Zeneca Pharmaceuticals. Ultimately, he became a regional business director, responsible for sales, marketing and national accounts for the western regional business unit.

After Zeneca, he joined Biogen, in 1995, where he worked with the team that developed a commercial model for Biogen’s first product, Avonex for multiple sclerosis. He eventually led the U.S. neurology business before leaving to join Cubist. At Cubist, he says, they saw a potential in Cubicin that no one else saw.

“I have always worked at companies that have had to compete against larger firms with more resources, so the hallmark of all the businesses that we’ve built has been our ability to learn quickly,” Perez said. “I try to find people and develop processes that allow our team to gain a competitive advantage by listening to those closest to the customer, and by then making incremental changes to the business based on this feedback.”

Q: Share with me a brief history of Cubist Pharmaceuticals and some of the important milestones of the company.

A: The company was founded in 1992, and, in the fall of 1996, Cubist completed its initial public offering. To date, Cubicin (daptomycin for injection) has been used to treat more than a million patients and Cubist is well on its way to surpassing $1 billion in U.S. annual net revenues.

The history of Cubist is a great story that is really about the people who have collectively advanced the science and the business to where we are today, a successful pharmaceutical company. At Cubist we don’t fear failure and that is a large part of what has made us successful. Our culture is one that rewards success, but, at the same time, we view failure as an opportunity to learn. The best example of this at Cubist was the “rescuing” of daptomycin after the Phase 3 results from community-acquired pneumonia were known. Daptomycin failed to meet statistical noninferiority criteria in a clinical trial for severe community-acquired pneumonia. We needed to understand why it did not work in the lungs and we launched an effort to isolate the effect. We discovered the reason and published the results. We ended up with a drug approved in the U.S. for complicated skin and skin structure infections in 2003, and, three years later, received an expanded U.S. label for Cubicin for the treatment of S. aureus bloodstream infections (bacteremia), including right-sided infective endocarditis caused by MRSA and MSSA.

More recently, 2011 was a transformational year for Cubist with positive Phase 2 results for two of our antibiotic candidates, propelling them into Phase 3 — one program already enrolling patients and the other expected to start this year. Also in 2011, we partnered with Optimer Pharmaceuticals to co-promote their therapy, Dificid, for the treatment of clostridium-dificile associated diarrhea (CDAD). We capped off the year with a business development deal to acquire Adolor Corporation, adding a new U.S. commercial product in Entereg and a promising pipeline candidate in CB-5945, also on a path to begin Phase 3 trials in 2012.

Q: What are some of your biggest goals for the upcoming year?

A: The transformational year I just mentioned has put a lot on our plate for 2012. We are going to be focused on executing our business plan aimed at continued momentum in Cubicin sales and putting more marketing muscle behind our newly acquired drug Entereg toward our goal of achieving peak annual sales of $100 million. Also, our sales force will continue to co-promote Dificid as part of our strategic partnership with Optimer.

In the clinic, we expect to have three Phase 3 programs up and running this year. There is a great and growing unmet medical need for antibiotics to treat serious infections, and two of the three programs are focused on antibiotics. The third program we acquired through the Adolor acquisition focuses on a therapy to treat a gastrointestinal side effect of opioid pain management.

Q: What are the biggest challenges facing developers of novel antibiotics today?

A: The challenges we face today started appearing on the horizon several years ago. Despite the remarkable public health success of anti-infective agents, there is a trend toward increasing numbers of bacterial infections that exhibit resistance to new and standard antimicrobials, with 70 percent of hospital-acquired infections caused by bacteria that are resistant to at least one antimicrobial. At the same time, many pharmaceutical companies have backed away from research and development of new antimicrobials because of increased incentives to develop drugs in other therapeutic areas and because of contradicting market forces within the antimicrobial marketplace. As a consequence, anti-infective research has virtually dried up, leaving very few new anti-infective agents in the near term. Cubist is one of the few companies with a promising pipeline in this area. Some public health leaders have identified the challenge and are prompting government action. Now is the time to identify and implement appropriate incentives that will drive antimicrobial research and development.

Recommended incentives have recently been manifested in the Generating Antibiotic Incentives Now (GAIN) Act, which has now been introduced in both the Senate and the House. Dr. Barry Eisenstein, senior vice president of scientific affairs for Cubist, was invited to testify at a congressional subcommittee hearing on the topic. The bi-partisan legislation calls for the enactment of specific economic and market incentives to entice pharmaceutical companies to develop new antibiotics to treat the growing number of serious infections caused by multi drug-resistant (MDR) bacteria. For example, the legislation’s provision for extending the exclusivity granted to some badly needed antibiotics is designed to have the same impact on antibiotic R&D as the Orphan Drug Act had on drugs to treat rare diseases, which now enjoy a healthy pipeline. CHI recently released a report on the subject, available here.

Another challenge that we are working through with others in industry is clear guidance from FDA in defining new regulatory approaches to facilitate antimicrobial development and approval. Recent meetings on this front have been promising, and we look forward to working closely with FDA to ensure more therapies are approved for patients battling sometimes life-threatening infectious diseases. More on this topic can be found at a website sponsored by Cubist: http://www.battlingsuperbugs.com/

Q: What is the most rewarding part of developing products that address unmet medical needs in the acute care environment?

A: We know that Cubicin has been used to treat more than a million patients and we know that if our pipeline of much needed therapies is someday approved, millions more could benefit from much needed therapies. We use the term patients, but these are people who are moms and dads, children, friends, colleagues, and neighbors. Everyone at Cubist comes to work each and every day with the goal of contributing to the advancement of therapies and leaves at the end of the day knowing that somewhere that day Cubist made a difference in someone’s life.

Q: When you’re not working, where do you like to spend your time?

A: I have three great passions outside of work. First and foremost is my family. My wife and I take such great pleasure in watching our kids’ many interests/activities. Second, I enjoy spending time trying to make a difference in the lives of kids who don’t have the educational opportunities that my kids have been blessed with. Finally, my one vice is basketball. I am admittedly a “hoop junkie.” I play with friends whenever I can (although at my age it is not really basketball, but something closely resembling the sport that I love) and also avidly follow the Lakers, and UCLA basketball. There are a lot of demands on my time, but setting priorities helps me maintain a healthy balance in life. For our corporate intranet I publish a blog sharing musings about the business/industry and observations from a personal perspective — I repurpose part of my blog posts on my twitter account @robperez32.

CHI-Advancing California biomedical research and innovation

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Monday, March 12, 2012

Executive Spotlight: Jeff Dunn, President and CEO, SI-Bone

Jeff Dunn
SI-BONE Inc. of San Jose, Calif. is the leading sacroiliac (SI) joint medical device company dedicated to the development of tools and products for diagnosing and treating patients with low back issues related to SI joint pathology. The company has developed, and is manufacturing and marketing, less invasive approaches using implants for the treatment of SI joint disorders.

Dunn has more than 30 years of executive experience, including serving as the CEO of six other companies. He has taken one company public, sold all the others to larger public companies, served on numerous boards of directors and is an advisor to other CEOs. Prior to SI-BONE Inc., Dunn was CEO of INBONE Technologies, which he built into a leading ankle replacement and small bone fusion medical device company. Dunn led the sale of INBONE to Wright Medical in April 2008. He holds a bachelor’s degree from Colgate University and a master’s of business administration from Babson College.

Q: How did SI-BONE form?

A: It was Dr. Mark Reiley, who founded Kyphon and invented kyphoplasty (a procedure that attempts to stop the pain caused by spinal bone fractures) with whom I got together about six years ago when I became the CEO of two of Mark’s companies. One was an ankle replacement company and one was a small bone fusion company. One company was in Colorado; one was in Berkeley, Calif., and I was the CEO of both of those at the same time. We merged those companies into a company called INBONE Technologies, which was acquired by Wright Medical Group in April 2008. Wright Medical is not in the spine business, so, as part of the deal, we took all the assets related to SI-BONE — the patents, the 510(k)s, etc. — and we spun that company out into an independent company.

For the next seven or eight months, we had no employees; it was just Mark and I. On Nov. 26, 2008, we received 510(k) clearance from the FDA. We then raised private money, about $4.5 million from friends and family. We hired our first employee in April 2009 and basically spent that year setting up manufacturing, quality systems, setting up the training programs for the surgeons, doing work around the diagnosis and finding the diagnostic algorithms to teach surgeons how to diagnose SI joint pain.

We have trained more than 700 surgeons to date. We did our very first surgery in June of 2009. We have grown as a company approximately 50 percent every single quarter, quarter over quarter, since June 2009.

Q: I also saw that you recently raised some venture funding.

A: We raised $16 million from Montreux Equity Partners and also Skyline Ventures. Our very first venture money came in last summer from Skyline, and then we had a bunch of private investors also participate who were friends of Mark’s and mine that have made money with us before.

Q: Talk a little bit about this type of surgery and the market SI-Bone is addressing.

A: There is $50 billion a year spent on lower back pain in the United States. Clinical studies show that 22 percent of that is related to the SI joint. The only surgery to treat the SI joint over the last number of decades is an open surgery where the patient endures a 12-inch incision. It is very bad for the patient, obviously. Ours is a minimally invasive surgery. It takes about an hour. So, we are treating something that almost has never been treated, but accounts for 22 percent of all lower back pain. As you probably know, the No. 1 reason that people visit their physician is for the flu. The second most important reason is back pain. So, it is a huge problem, and we are addressing an underserved, unmet need that afflicts millions of patients.

Q: How does the company stand out in the competitive landscape for minimally invasive surgery and surgery like yours?

A: Well, in the United States, there is only one very small company and one medium sized private company which have introduced products to compete with us. Let’s just say we have 95-plus percent market share. In Europe, there is one other competitor. We believe in our product. It is significantly better, easier to use for surgeons, better for the patient.

The key, though, is to educate the surgeons on how to diagnose this thing. We believe that everything is about patient selection because many people with lower back pain have an under-diagnoses. We spend a tremendous amount of money on educating surgeons, physician assistants, physical therapists, etc. about how to effectively diagnose these patients.

Q: Are you seeing patients that have gone through fusions or other surgeries come to you afterward? Are these new patients?

A: We have plenty of patients that are both de novo, who have been
diagnosed with sacroiliac joint issues or dysfunction, and previous spine fusion patients.

In the United States, there are hundreds of thousands of lumbar fusions each year. Literature shows that about 75 percent of all patients that have lumbar fusions develop adjacent segment disorder within five years. So, if you fuse a part of the lumbar spine, typically it affects other pieces of the orthopedic anatomy. The majority of people who have those kinds of surgeries within five years will have some kind of SI joint issues.

Q: You touched on this a little bit, but what does the reimbursement landscape look like for your device?

A: Our reimbursement rates are typically running about 94 percent. So, the reimbursement is actually quite reasonable. But, of course, as we get bigger as a company, the payers, i.e. the insurance companies and Medicare and the key medical societies including NASS, AAOS, CNS, AANS, ISAAS, ISIS and the AMA, are going to want to see efficacy, economic justification and safety data, so that is why we are investing so much in clinical studies. We are launching multiple studies.

Q: What else is good to know about SI-BONE?

A: What I am most proud of is we have hired 100 people in the last two years and we just have a tremendously talented group of people that are working together to help these patients. They are thriving as I am on the patients. What’s more fun than helping patients? Additionally, we have an advisory board made up of brilliant medical professionals like Dr. Steve Garfin, Dr. Frank Phillips, Dr. Paul Anderson and others. I would go out on a limb and say that our advisory board is among the most talented and respected spine advisory board in the United States.

So, we have a very good group of people that are trying to solve this problem and help educate people here and in Europe about how to help these patients.

CHI-Advancing California biomedical research and innovation

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Friday, March 2, 2012

CHI Spotlight: Opening a New Door for Unfunded Research Projects

Marc Boutin
The National Health Council (NHC) is the only organization of its kind that brings together all segments of the health community to provide a united voice for the more than 133 million people with chronic diseases and disabilities and their family caregivers. Made up of more than 100 national health-related organizations and businesses, its core membership includes approximately 50 of the nation’s leading patient advocacy groups, which control its governance.

Marc Boutin serves as the organization’s executive vice president and chief operating officer. Throughout his career, he has been actively involved in health advocacy, policy, and both federal and state legislation. He has designed and directed advocacy strategies for legislative initiatives, which have included issues ranging from access to healthcare to cancer prevention. Before joining the Council, Boutin served as the vice president of government relations and advocacy at the American Cancer Society for New England. In addition, he was a faculty member at Tufts University Medical School, where he lectured on healthcare policy.

Q: I understand the National Health Council has started a new program that connects promising biomedical research with funding sources. Talk a little about the impetus for your newest endeavor, HealthResearchFunding.org?

A: HealthResearchFunding.Org was conceived several years ago by a group of chief medical officers and research directors from NHC member patient advocacy organizations. They recognized the need to make the best use of the significant expertise and funds spent on the rigorous scoring of research proposals. With the help of the National Institutes of Health (NIH), the NHC set out to develop an innovative solution to make the most out of the nation's investment in biomedical research.

Q: How might someone who is interested participate?

A: Researchers whose proposals have been peer reviewed, deemed meritorious, but unfunded by either the NIH or by an NHC member organization, are invited to register with HealthResearchFunding.org. Once registered, researchers can upload requests for proposals and search for funding sources. There is no charge for use of the site by investigators or their institutions.

By using this online resource, potential research supporters can avoid duplication of effort and more efficiently identify and evaluate peer-reviewed research proposals. On the other hand, researchers gain another opportunity to showcase their worthy proposals and possibly find a funding source.

The database will be expanded later this year to include NHC business and industry members and funding sources outside NHC membership.

Q: Who may search the database?

A: Registered investigators have the ability to search for funding sources through the database, but cannot view or search for proposals from other researchers. Funding sources are able to search for research proposals, individual researchers and information from other funding organizations.

Q: How does HealthResearchFunding.org help researchers?

A: HealthResearchFunding.org helps researchers obtain a broad audience of potential funding sources from the nonprofit sector for their proposed research.

By offering investigators the opportunity to promote their peer-reviewed research proposals through the database, we hope to increase the likelihood of potential funding for worthy health research. By utilizing the database, researchers gain an organized and unvarying environment in which to exhibit their proposals alongside their peers. As the system grows, their respective research institutions could spend less time, effort, and resources looking for financial support and more time conducting research to aid in the development of new treatments for patients.

Q: How does this database help funding sources?

A: HealthResearchFunding.org helps participating funding organizations avoid duplication of effort as they seek to fund research by making use of the significant public investment of intellectual capital, time, and funds in the NIH and NHC member peer review process. When on the database, funding organizations are able to upload requests for proposals and have the ability to post ideas for collaboration with other funding sources.

Q: What is the ultimate goal for this program?

Our goal is to help researchers and funding sources in their development of new treatments and cures for people with chronic conditions.

To do so, we hope to expedite the process by which participating non-government funding organizations underwrite biomedical research by linking them with researchers whose proposals to NIH and NHC member organizations have been deemed meritorious and worthwhile.

To learn more, visit http://www.healthresearchfunding.org/ or write to healthresearchfunding@nhcouncil.org.

CHI-Advancing California biomedical research and innovation

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