Speaker Spotlight: Tom Campbell, Ph.D., Dean of Chapman University School of Law

Tom Campbell

Campbell, Ph.D., a former U.S. congressman and state senator who serves as dean of the Chapman University School of Law, will give the keynote address for CHI 2012, the annual meeting of CHI. CHI 2012 focuses on the relationship between biomedical innovation and public policy. The goal of the meeting is to focus on the biomedical community’s work and needs, and how the industry can sustain California’s leadership in medical innovation.

Campbell served five terms in Congress, was also a California senator, and the director of finance for the state of California. He also served as the dean at the Haas School of Business at UC Berkeley and a Stanford University professor for almost two decades before that. He will provide CHI 2012 attendees with economic predictions based on the election, share insights on the future of healthcare legislation and address what is wrong with the political process. Campbell graduated with a doctorate degree in economics from the University of Chicago. He received his law degree from Harvard Law School.

Q: In your opinion, how likely are we to see the Affordable Care Act repealed?

A: The outcome of the presidential, Senate, and House elections will determine the future of our nation’s healthcare system. Bearing in mind that the president’s healthcare act passed under reconciliation, by which a Senate filibuster was avoided, it is also true that it can be repealed by a simple majority without the possibility of a filibuster. Thus, it is safe to assume that if the Republicans gain the presidency and have 50 senators, and hold the House majority, the president’s healthcare statute will be repealed. What will replace it is not certain, of course; but it is unlikely that the individual mandate will survive.

Q: What features of the ACA do you anticipate will survive if Obama is not re-elected?

A: Gov. Romney has recently announced he’ll keep the obligation for carriers to take all insurance applicants, even those with pre-existing conditions. Obviously, that will necessitate higher premiums in all insurance contracts than before the law was enacted, but no higher than what they are at present. As there will no longer be a minimum set of coverages that have to be present in all contracts, we can expect a wider choice of such options, offered by private insurers. Some, for instance, will not include contraceptive care.

Q: Do you anticipate Medicare will be turned to a voucher system?

A: A capitated federal grant to the states for Medicaid, and to seniors directly for Medicare, is likely, with increased numbers of eligibles, but reduced compensated services. If the president is re-elected, then we might still see some changes, as individual states take advantage of that part of the National Federation of Independent Business v. Sebelius decision that allows states to exempt themselves from federal compulsion.

Q: How are states currently dealing with this anticipated change?

A: The governor of Maine is attempting the argument that his state should be allowed to cover fewer people under Medicaid, with, admittedly, less money than coming from the federal government, rather than being compelled to cover with Maine’s own matching money the broader categories required by the federal government. Also, the president announced several months ago that he was going to propose a compromise with religious institutions; the details of that compromise will have to be worked out if he is re-elected.

Q: What will you draw on to give your keynote speech to CHI’s audience of legislators, biomedical entrepreneurs and executives, investors and academic researchers?

A: I will draw on my own experience in public life, having served as a member of Congress in what seemed a permanent Republican minority (1988-1992), then as part of the first Republican majority in 40 years (1995-2000), and in a legislative body with a very different set of procedures, the California Senate, just as term limits were being applied (1993-1995). I’ll have some iconoclastic recommendations regarding term limits, super-majority requirements for votes, and selection of committee chairs. I’ll touch on the effect of money in politics over the time the U.S. Supreme Court has redefined the relevant rules, my efforts as part of the bipartisan team to adopt McCain-Feingold (since struck down by the Supreme Court), and the rise of both self-funded candidates and super PACs.

It is not too late to register for CHI 2012, taking place Nov. 8 at Gilead Sciences Campus in Foster City, Calif. Click here to view the full agenda and speaker line-up for CHI 2012.

CHI-Advancing California biomedical research and innovation

The Good, The Bad, and The Ugly

A recent experience I had with a major healthcare provider here in San Diego reminded me of how very important it is, no matter the business, to keep in mind the basic principles of customer service. The way your customer feels about you, your product, or your brand, has a direct impact on your customer, and, ultimately, your bottom line.

This week, due to a billing error, a collections agency contacted me about an outstanding balance from an emergency room visit for my 2-year old son. I knew that this couldn’t be right, as I had never received a bill in the first place. After a number of calls and terrible customer service from a company it turns out was unaffiliated with the hospital, I took to social media in desperation.

The healthcare provider responded within a short time span -- as soon as the representative was able to investigate what had happened so she’d be able to provide a decisive, complete answer that would assuage my fears. That person contacted me -- several times, in fact -- to provide the explanation and definitive resolution to the billing error and resulting collections agency nightmare. A complete 180 from the deplorable experience with the billing service.

That representative went above and beyond, investigating and following up tirelessly, a problem it turned out was not hers to solve, all in the name of ensuring I had a positive experience with the brand. Mission accomplished!

It brought to mind some basic principles of customer service that CHI strives to provide its members  and that we should all keep in mind when interacting with our various audiences:

1)      To your customer, customer-facing employees ARE the company.

The impression a customer receives of your company is a direct result of the interactions he or she has with your customer-facing employees.  These customer touches occur anytime a person comes in contact with your company and uses that experience – good, bad or ugly -- to form an impression of your organization.  Making an investment in developing the skills and knowledge of these employees is as much an investment in improving the customer experience.

2)  Employee happiness matters.

There is a clear, strong link between an employee’s job satisfaction and the customer service that an employee provides. It doesn’t matter if you are selling healthcare services, medical devices, or shoes, for that matter. When an employee feels valued and that his or her work matters, he or she is motivated to provide excellent customer service. Conversely, if an employee isn’t satisfied with his or her work, he or she won’t be motivated to provide a high level of customer care.

3) Don’t assume customers know they are valued – show them.

The most important aspect of ensuring customers know they are valued is to take care of his or her need in a timely, efficient, and thorough manner. Every time an employee comes in contact with a customer, it is essential that that person comes with a mind to earn the business and trust of customers – something that cannot be taken for granted. Beyond fulfilling the stated request of the customer, it is critical to show appreciation and respect. Show that you care.

I hope that you feel CHI values you as a member and that your needs are being met. If you have questions about CHI’s offerings, or have input you’d like to share, please be sure to contact us!

Nicole Beckstrand is CHI’s vice president of marketing and communications. To reach her with your questions or input, email her at Beckstrand@chi.org. She is on LinkedIn and Twitter, as well.

CHI-Advancing California biomedical research and innovation

ResMed Hosts CHI Roundtable with Rep. Mary Bono Mack

(CHI roundtable participants pictured from left): Heather Turner (Orexigen), Terry McCune (K-Tube), Christen Chavez (ReMed), Mick Farrell (ResMed), Rep. Mary Bono Mack, David Gollaher (CHI) and Pedro Lichtinger (Optimer). 

Michael “Mick”Farrell, President of the Americas for CHI member ResMed, recently hosted a CHI roundtable with Rep.Mary Bono Mack (R-Palm Springs) led by CHI President & CEO David Gollaher at the company’s headquarters in San Diego. CHI members Heather Turner (Orexigen), Pedro Lichtinger (Optimer Pharmaceuticals), Terry McCune (K-Tube) and Christen Chavez (ResMed) participated. Bono Mack serves on the House Energy & Commerce Committee which has jurisdiction over FDA, so the regulatory environment for medical innovation was a key topic of discussion.  Participants gave examples of companies moving abroad, pushing jobs and revenues offshore because of inconsistency and unpredictability at the Agency. Investors cite the FDA regulatory environment as the greatest threat to the industry’s growth.  According to the July 20 MoneyTree Report by PwC and the National Venture Capital Association, life sciences investing declined for the fourth consecutive quarter, most notably in the biotechnology sector representing the lowest quarterly total for the industry since the first quarter of 2003. Bono Mack stated her commitment to working with CHI and its members to improve the regulatory environment for new technologies and therapies to get to market. CHI members also expressed concerns about government coverage and payment policies that do not reward innovation and limit patient access to new therapies. CHI has worked with legislators to prevent changes to coverage and reimbursement policies, such as Medicare Parts B and D, that would discourage future investment and innovation. CHI has addressed concerns with IPAB and continually monitors implementation of government-sponsored comparative effectiveness research. In closing, Bono Mack invited those who participated and any CHI member to come to her with concerns and to offer proposed solutions that she could consider. 

CHI-Advancing California biomedical research and innovation

CHI Event Spotlight: CHI Tackles Diabetes in U.S. Capitol

On July 24, CHI partnered with the Congressional Diabetes Caucus to bring together a panel of experts to discuss the key issues surrounding the diabetes epidemic. With diabetes affecting 25.8 million people, and ethnic minorities sharing a disproportionate burden, it is important now more than ever that we fund research and education efforts to understand and combat this disease for which there is no cure. During the event, Rep. Xavier Becerra (D-Los Angeles) acknowledged the prevalence of diabetes in his home district and reiterated the importance of combating the disease. In Los Angeles alone, the consequences of the diabetes pandemic are especially evident, where diabetes has been the 6th leading cause of death since 1997. Diabetes costs Los Angeles County an estimated $6.4 billion a year, according to the Los Angeles County Department of Public Health.

Panelists at the briefing included physicians, researchers, innovators and patient advocates. Speakers highlighted differences between diabetes types 1 and 2 and their variations in diagnosis, prevention and known causes. Type 1 diabetes, previously known as juvenile diabetes, is an autoimmune disease in which the body does not produce the hormone insulin. There is no known way to prevent type 1 diabetes. Type 2 diabetes, previously known as adult-onset diabetes, is a metabolic disease in which the body does not make enough insulin or use it effectively. Type 2 diabetes can be prevented or delayed by maintaining a healthy weight and exercising regularly.

Dr. Richard Bergman of Cedars Sinai noted that there are two categories of treatment: medical and behavioral. Type 2 diabetes is much less understood and, therefore, treatments are less developed. Researchers have discovered, however, that along with obesity, environmental factors including toxin exposure increase the risk of developing type 2 diabetes. Bergman also stressed the importance of NIH funding for diabetes research. Specifically, he noted the lack of incentives for intelligent, young researchers to enter the field where funding lags.

Panelists from the City of Hope and Medtronic spoke about their joint effort to create an automated insulin pump that assesses a patient’s blood-sugar levels systematically and releases or stops insulin injections accordingly. Essentially, this device would function as an artificial pancreas. For patients, this could dramatically improve the lives of those with type 1 diabetes by reducing their reliance on finger pricks and self-administered insulin injections.

Dr. Francine R. Kaufman, chief medical officer of Medtronic Diabetes, and author of "Diabesity: The Obesity-Diabetes Epidemic That Threatens America And What We Must Do to Stop It," presented Medtronic’s project, The Environmental Determinants of Diabetes in the Young, or TEDDY. The project aims to identify the triggers that cause children to get type 1 diabetes and to establish a central repository of data and biological samples. Highlights of Medtronic’s TEDDY diabetes program include:

• Discovery of new genes, potential targets for prevention and treatment
• Reprogramming adult pancreas cells to insulin-producing beta cells in mice
• Standardizing improved patient care for both type 1 and 2 diabetes
• Developing new glucose monitoring tools
• Developing and testing of novel drugs for treating diabetes complications 
•  Islet transplantation advances
• Promising therapies targeting immune cells to prevent and reverse type 1 diabetes
• Testing of novel type 1 diabetes prevention strategies

Michelle Mundt, a Juvenile Diabetes Research Foundation volunteer who has family members with type 1 diabetes, illustrated her daily life and the effects of diabetes. About 700,000 Americans suffer from type 1 diabetes, the most common chronic metabolic disorder to affect children. Mundt shared dramatic lifestyle changes post-diagnosis including the daily vigilance required to manage the disease. She and her husband have taught their children to check their insulin levels, count carbohydrates and account for exercise and sleep. Preparation, she said, is key to daily activities. She said her family always has juice boxes and snacks on hand in case blood-sugar levels drop too low.

CHI extends a warm thank you to the panelists for their participation as well as congressional staffers, and individuals from organizations like FasterCures, the American Diabetes Association, JDRF, the National Council on Aging, the American Podiatric Medical Association, and the California Hospital Association for attending.

For more information on what CHI member companies and other organizations are doing in the diabetes arena, click here.

CHI-Advancing California biomedical research and innovation

Speaker Spotlight: Dana Goldman, Ph.D., Director of the USC Leonard D. Schaeffer Center for Health Policy and Economics, UCLA Adjunct Professor

Goldman is a nationally-recognized health economist influential in both academic and policy circles. He is the author of more than 100 articles and book chapters, including articles in some of the most prestigious medical, economic, health policy, and statistics journals. He is a health policy advisor to the Congressional Budget Office, and is a frequent speaker on healthcare issues. He joins us July 12 at UCLA for “California: Uniting Science and Policy to Advance Cancer Care.” It’s not too late to register for the event – contact Marisa Reinoso at reinoso@chi.org.

Q: What policies have greatly impacted cancer care in your opinion?


A: I think what people don’t realize is just how important reimbursement and other health policies are in terms of changing the way treatment gets delivered. For example, if you look at the rules for Medicare reimbursement, most of the reimbursement has been generous, historically, for infused therapies. And the result is that we have many infused therapies for cancer. And the question is whether that generous reimbursement is going to continue. Even more important is the relationship between reimbursement and future innovation.

The idea is that we have the luxury in the United States because we have reimbursed, historically, at generous levels that, for our conditions, we’ve actually made progress. We’re actually winning the war on cancer and we’re doing it through treatment, as well as diagnosis. The issue is whether that type of progress will continue.

Q: You talk a lot about the importance, both from a health standpoint and an economic one, of prevention and preventive care. How much of this will rely on medical diagnostics and advanced technologies and how much is it reliant on an individual to change his or her behavior?

A: What we found is the change in behavior is notoriously difficult. If you roll the clock back 50 years and you think about hypertension, it has always been a serious health dilemma in this country. But we know there are behavioral modifications that will help people – they can change their diet, reduce their salt intake and exercise more. But what we found is that very few people comply.

Actually, the introduction of drugs, mainly beta blockers, diuretics, calcium channel blockers, and a whole host of therapies, have actually resulted in incredible improvements in cardiovascular-related mortality in the United States. These classes of drugs have been a huge success and they have been able to substitute where previously we had to rely on behavioral change. There is an important lesson here. Yes, we’d like to modify behavior. And, yes, behavior change has value. But it is also important that we continue to innovate to find ways where biomedicine can fill those gaps.

Q: How do you see California leading the way in terms of healthcare following the Affordable Care Act, with so many uninsured?

A: As in so many areas, California is one of those states that defines the way other states will react to policies. As you know, we face a severe fiscal and economic crisis in the state. It is easy to say one of the reasons for this is healthcare, so we should be working hard to reduce reimbursement in many areas. But it is important to realize that California is also the engine for biotechnology and biomedicine is one of the engines of growth in this state.

California has a reasonably competitive health insurance market. In the private sector, they have been initiating reforms that will drive reimbursement down where it needs to be driven down. And it will drive up where we need to reward value. We should be careful to make sure that we encourage those markets to work as efficiently as possible. And that may mean even raising reimbursement in some areas.

Q: What’s been consuming the majority of your time these days?

A: I have been spending my time trying to think about other ways that we can 1) reimburse high-value therapy and 2) come up with better models to try and understand the short- and long-implications of disease. For example, if you think about a country’s progress generally, and we tend to look at gross national product or gross domestic product, but we don’t take into account the health benefits that countries might get from various interventions. And that is an important part of progress. We need to find ways to promote not only longevity but also better quality of life when people get older.

There’s been a lot of focus on the ACA and its short-term implications. We are the only center that I know of that is actually thinking about how will this affect innovation in the long-term.

Q: What are you most looking forward to hearing about at “California: Uniting Science and Policy to Advance Cancer Care” on Thursday?

A: I’m looking forward to “The State of Cancer Research in the Golden State” and “Improving Access to Advanced Treatment” panels.

I think it is important we promote access to therapy and we do not end up with a world where we have large disparities in access because only the wealthy can get access to these therapies. At the same time, we have to make sure we can reimburse them appropriately.

Really, access to care is going to be a key issue going forward.




CHI-Advancing California biomedical research and innovation

Speaker Spotlight: Roy D. Baynes, M.D., Ph.D., Senior Vice President of Oncology Therapeutics, Gilead Sciences

Dr. Roy Baynes

Dr. Baynes serves as senior vice president of oncology therapeutics at Gilead Sciences Inc. of Foster City, Calif. There, he oversees a pipeline of products focused on treating chronic lymphocytic leukemia, indolent non-Hodgkin’s lymphoma, colorectal cancer, myelofibrosis and pancreatic cancer. “We stand at an incredibly exciting time in cancer research and drug discovery,” said Baynes, who came to Gilead from Amgen, where he served as vice president of global development and as therapeutic area head of hematology oncology. Baynes received his medical degree and doctorate from the University of the Witwatersrand, South Africa.


Q: Cancer is an incredibly challenging field, full of discovery and of setbacks. What first drew you to this kind of research?


A: Firstly, it was about the science. The molecular and biological understanding of disease has always been an integral part of cancer research. In part, this relates to accessibility to tissue from biopsies or, in the case of hematological malignancies, from blood.


The second driver was really an intensely personal one. Most people are touched directly or indirectly by this dreadful disease, cancer. I have had too many close friends and family members who have either done battle with cancer or are doing battle with cancer. I’ve always taken the view that cancer patients just simply cannot wait, which has given a great sense of urgency to cancer research.


And, thirdly, there was the opportunity. Most people who come through academic programs are reasonably multi-talented and can go in any direction. So, oftentimes, it’s a combination of scientific interest, personal motivation and the opportunity. At the time I was ready to start my clinical and research career, the biggest opportunity was in the oncology and hematology arena. I fell in love immediately with the discipline and have been there ever since.


Q: Knowledge about cancer genotypes has led to greater, more targeted treatment for women with breast cancer, especially, and other cancers. What is on the horizon for molecularly targeted therapies?


A: We stand at an incredibly exciting time in cancer research and drug discovery. The biological underpinnings and basis of disease are becoming more clearly understood. Our ability to segment and select patients who will ultimately benefit from specific approaches is being enhanced on a daily basis.


The unmet medical need remains huge. You pull together the rapidly advancing science and biology and the unmet needs related to this grievous condition, cancer, and it’s a very compelling area to be working in.


Gilead has a tremendous history of medicinal chemistry and antiviral drug development. About two years ago, Gilead made a decision to get back into the cancer arena, driven largely by the notion that the molecular understanding had reached a level of sophistication where indeed it lent itself to meaningful drug development.


The company is working quickly to advance the cancer arena and, more specifically, the targeted therapeutics arena. And a lot of this has been built on licensing and acquiring assets. It’s been a thoughtful, deliberate process.


Q: Are there policies at the local, state or federal level that have a significant impact on your work?


A: When it comes to drug discovery, it’s important to begin with the end in mind. I think our goal is to come forward with innovative medicines that can address serious unmet medical needs and transform the lives of patients. So, that’s our guiding principle and, I think, if one stays true to that mission, the policy considerations have to fall in line.


Q: What are you most looking forward to in terms of our July program, “California: Uniting Science & Policy to Advance Cancer Care?”


A: CHI has developed an energizing program with a diverse range of speakers and very topical discussion points relating to oncology. I’m particularly looking forward to the session I’ll be moderating, “The State of Cancer Research in the Golden State,” because I think the Golden State has a tremendous amount to be proud of. As the birthplace of biotechnology, and as home to several prominent academic research centers and a strong biotech industry presence, California has played a key role in the personalized medicine innovation we are seeing in oncology today.

CHI-Advancing California biomedical research and innovation

Executive Spotlight: Bernd J. Larsen, President & CEO, CODAN USA

Bernd J. Larsen

CODAN in the U.S. is a part of the privately-held, European-based CODAN group of companies, which for more than 50 years has been a market leader in the area of I.V. drug delivery systems. CODAN’s core business is the manufacturing and sales of I.V. sets and accessories for both infusion and transfusion therapy. Larsen has been president of CODAN in the U.S. for 11 years and previously held senior-level executive positions with Maersk Medical in Denmark, Germany and the U.S.

Q: Share with us a brief history of the company and describe your products.

A: CODAN was founded in 1959 in Denmark. Our first U.S. facility opened in 1971 in Burbank, Calif., primarily focused on product assembly and sales. In 1997, the company was moved to new more spacious facilities in Santa Ana, Calif. where we are today. I should perhaps mention that, as of a few years ago, we also operate an assembly facility across the border in Tijuana, Mexico. We manufacture both private-label OEM products built to customer specifications as well as CODAN branded products, including CODAN for Kids for the neonatal/pediatric arena, specialty anesthesia sets and blood sets sold under the name Walrus by CODAN, CODAN Rx for the hospital pharmacy, CODAN CYTO for the delivery of cytotoxic drugs, and a catalogue of other miscellaneous I.V. products.

Q: What are your biggest goals for the year ahead and beyond?

A: Our management team recently completed our “Road to 2017” strategy plan and this plan outlines how we will transition the company emphasis to CODAN labeled products while continuing to offer private label products. The CODAN labeled products will be spearheaded by our anesthesia product line where we have established an excellent reputation with anesthesiologists and where we can leverage our leadership position in raw material, manufacturing, inspection and sterilization processes, and in packaging and distribution networks.

Q: If you could change a public policy at the federal or state level, what would it be?

A:  There is some uncertainty at FDA around the 510(k) regulatory process and an opportunity to improve the predictability of these processes to speed the delivery of I.V. drug delivery systems to patients.  

Q: What is the most rewarding part of your job?

A: Working with good people inside and outside of the company is very rewarding to me. It has also been rewarding to see our company’s impressive growth in new products and revenue over the past four years, despite a tough economy.

Q. Describe your leadership style.

A. I try to follow an old management philosophy: “He who informs inspires! He who ignores injures!” I strive to give our employees as much information as possible about the company and where we are going vis-à-vis our targets so they feel trusted and an important part of what we are working to achieve as a company. I also believe in letting people do their jobs and not micromanaging them. I believe that most people will rise to the challenge if they feel empowered to do so.  

Q. What are you doing when you are not at work?

A. My main hobbies are reading for pleasure and writing, and I hope to publish a book about my experiences in America in the near future. I used to be an avid hiker, but while I still enjoy it, I do not get out there as much as I used to. I also enjoy spending time with my family, my wife Marianne, my five children and 11 grandchildren.


CHI-Advancing California biomedical research and innovation

CODAN USA headquarters in Santa Ana, Calif.

Community Spotlight: CHI Supports Volunteer Reading Program



CHI Communications Specialist Heather Chambers with OB Elementary students.

























While the end of the school year is typically a time for celebration, for me, it was bittersweet to say goodbye to a group of students in Ocean Beach Elementary School’s classroom 7.

For the second year in a row, I had the opportunity to share my love of reading with a classroom full of first and second graders. I am grateful that CHI values its employees and their personal pursuits and has allowed me the time to read to the children each Wednesday morning.

The Rolling Readers program is designed to reach underprivileged children and encourage lifelong learning that starts with reading at the grade-school level. It pairs adult volunteers with schools that offer the free lunch program.

Research shows that children who aren't reading proficiently by the end of third grade are four times less likely to finish high school on time. If they are poor and not reading proficiently, they are 13 times less likely to finish high school. And for children who live in areas of concentrated poverty, the prospects are even grimmer.

In order to encourage leaning in this fun, “free time,” we explored the world of fantasy, adventure, mystery and even foreign language.

The highlight of the Rolling Readers program is its annual book drive. This year, each student took home a copy of “City Dog, Country Frog” by author Mo Willems. It is satisfying to know that they will have a book to call their own, to share with friends and encourage reading among family members.

As these students move forward with their education, hopefully they will find comfort and joy in reading. I certainly found joy in reading to them.

CHI-Advancing California biomedical research and innovation

Executive Spotlight: Ralf Otto, Ph.D., VP Operations and Fremont Site Head, Boehringer Ingelheim

Ralf Otto

Otto joined Boehringer Ingelheim (BI) in 2001. At BI, he has served as executive director of a large-scale cell culture manufacturing facility and also played a key role in a technology and capacity upgrade project of the facility. Beginning in 2010, Otto worked in BI’s Pharma production network as head of network competitiveness, holding global responsibility for improving sites’ competitiveness with a focus on Brazil and China. In 2011, he joined BI Fremont as site head.

Otto previously worked for Henkel in Duesseldorf, Germany, where he spent three years in various biotechnology-related positions. Since 2002, he has routinely taught commercial biotechnology courses at the University of St. Gallen (Switzerland), University of Stuttgart, and the University of Karlsruhe (both in Germany). He graduated with a degree in biotechnology and carried out his doctorate at the German Cancer Research Center/University of Stuttgart. His scientific writing has appeared in numerous international journals and books, and he holds more than 20 patents.

Q: Share a brief history of BI and its Fremont facility, acquired from Amgen.

A: Boehringer Ingelheim (BI) was founded in 1885 by Albert Boehringer in Ingelheim am Rhein, Germany. More than 125 years later, the company is still family-owned and is one of the world’s 20 leading pharmaceutical companies. The Boehringer Ingelheim Corporation currently has more than 42,000 employees and 145 affiliated companies spread across the globe. BI has six facilities in the United States: our U.S. headquarters and R&D including Biologics Skill Center in Ridgefield, Conn.; our generic company, Roxane, in Columbus, Ohio; a manufacturing facility in Bedford, Ohio; our animal medical facilities in St. Joseph, Mo. and Fort Dodge, Iowa; our chemical facility in Petersburg, Va.; and lastly, our biotechnology facility in Fremont, Calif.

BI acquired the Fremont facility in March 2011 from Amgen, making it BI’s first biotechnology facility in the U.S. This facility encompasses more than 300,000 square feet of state-of-the-art development and manufacturing space. BI’s vision was to transform the site into a development, clinical manufacturing, and innovation site that can develop and produce multiple drugs for different contract manufacturing clients and our own biologics.

Q: How many employees does the site have today? What kind of manufacturing capabilities?

A: BI Fremont has approximately 300 employees. The site is capable of developing and manufacturing non-clinical, clinical, and commercial biopharmaceuticals and includes a non-GMP pilot plant and process development labs. The facility boasts two trains that enable us to manufacture multiple products simultaneously, up to the 12,000-liter level from cell harvesting, cultivation, and purification, ending with fill and finish. Additionally, we are currently extending our services into disposable technology that would complement the usual bioreactors.

Q: Tell me some of your biggest goals for the year.

A: I want us to make BI Fremont the first choice for clients on the West Coast, especially in the Bay Area. While Fremont is BI's first biotech facility in the U.S., BI has been a successful contract manufacturer in other countries for decades. We are excited to expand our innovation to California. I want us to continue building a high-performing team in Fremont, ensuring that every employee can deliver his or her best. As for productivity, we have set the goal to beat our benchmark and to cultivate a culture of innovation that drives superior solutions for BI patients and clients. Our culture is based on values that make this a great place to work, and together we are focused on ways to build a sustainable future for the site.

Q: What are the biggest challenges to achieving these goals?

A: With the acquisition we inherited systems that need to be significantly transformed to support our multi-faceted business direction. We also need to ensure that employees have the right skills through training and by hiring new talent so that we can fulfill our objectives. Change is always a challenge, but we already have accomplished great achievements at high speed—for example, a four-fold increase in productivity, multi-product operations, and new product introduction—so we are sure that we can deliver even more on our ambitious targets.

Q: If you could change a public policy at the state or federal level, what would it be?

A: California is one of only three states where manufacturers are required to pay both a sales and property tax for equipment. We support current state legislation that would credit manufacturers for sales tax purchases.

Q: Some may be surprised to hear that BI is a family-owned company. Describe your corporate culture and how it may differ from others.

A: We provide value to the customer by being innovative and entrepreneurial in everything we do. We call this approach “value through innovation.” Value through innovation means coming up with new and better ways of improving health, which reflect and anticipate the needs of our customers and patients. We also emphasize both personal and professional development and encourage employees to never stop learning. Based on our values, we can guarantee sustainability as BI’s 125 years record shows.

Q: What is the most rewarding part of your job?

A: In a short period of time, I have seen great results from our staff in Fremont. Fremont has a diverse workforce that is extremely flexible, responsive, and experienced, which has achieved great success in just our first year. I am excited about our prospects for this year and beyond.

Q: What are you doing when you are not at work?

A: I spend time over the weekends traveling around California with my family. I am very much impressed by the country, people, and culture.

CHI-Advancing California biomedical research and innovation

Executive Spotlight: Dr. Alain Baron, President and CEO, Elcelyx Therapeutics

Dr. Alain Baron

Elcelyx Therapeutics is a privately held biotechnology company focused on creating a wide range of products based on the science of nutrient sensing. The company’s novel product candidates are directed at the prevention and treatment of obesity and diabetes. Since joining Elcelyx Therapeutics in 2010, Baron has been focused on advancing the company’s new products to treat metabolic diseases based on a completely novel platform, called “gut sensory modulation.” He brought his expertise as an entrepreneur-in-residence and a member of the life science team at Morgenthaler Ventures, a position he has held since 2008, along with prior experience as senior vice president of research at Amylin Pharmaceuticals. He has held faculty positions at Indiana University School of Medicine in Indianapolis and UCSD, along with the Veterans Administration Medical Center in San Diego. Baron graduated from McGill University in Canada with a bachelor’s degree in biology and a medical degree from the Medical College of Georgia Augusta. He completed postdoctoral studies at UCSD.



Q: Share with us a brief history of the company. How did your leaders come together? How was the company originally funded?


A: Elcelyx was founded by two former Amylin Pharmaceuticals employees, myself and Martin Brown. Elcelyx was first funded by Morgenthaler Ventures in a Series A round in March of 2010. Currently, the company is funded by Morgenthaler Ventures, Kleiner Perkins Caufield & Byers, and Technology Partners.


Q: Tell me some of your biggest goals for the year.


A: Elcelyx is developing new products to treat metabolic diseases based on a completely novel platform, named “gut sensory modulation,” that shows promise to produce very safe and effective oral therapies.


Q: What are the biggest challenges to achieving these goals?


A: Recognizing the importance of safety of therapeutics for metabolic diseases in the current regulatory environment, Elcelyx has focused its efforts at maximizing safety in its development of novel therapeutics.


Q: If you could change a public policy at the state or federal level, what would it be?


A: Given the time and risks involved with drug development, there is a great need to improve dialogue with the U.S. Food and Drug Administration to make their decisions more predictable.


Q: What is the most rewarding part of your job?


A: The collaborative environment created and nurtured at Elcelyx makes for a very productive and enjoyable workplace. Knowing we are working to address large, unmet medical needs is all the more rewarding.


Q: What are you doing when you’re not at work?


A: I love to spend time with my family and friends, read, play tennis and travel.

CHI-Advancing California biomedical research and innovation

Event Spotlight: CHI Hosts Annual Reception and Hill Meetings in Washington, D.C.



House Energy & Commerce Committee Chairman Fred Upton accepts CHI Chairman's Award from CHI President and CEO David Gollaher, Ph.D., and CHI Chairman and Gen-Probe CEO Carl Hull.

CHI honored House Energy and Commerce Committee Chairman Fred Upton (R-MI) with the CHI Chairman’s Award during a reception May 9 in Washington, D.C., at the Folger Shakespeare Library. Guests at the reception and private dinner enjoyed an evening with the California delegation and leaders driving biomedical innovation at the event, called “Invest. Innovate. Compete.” During the dinner, Rep. Brian Bilbray (R-San Diego) expressed his support for the biomedical community and stressed the importance of bringing life-saving cures to patients in need.

Prior to the event, CHI board members participated in meetings on Capitol Hill to discuss the impact of the U.S. Food and Drug Administration and user fee reauthorizations, the importance of National Institutes of Health funding, and the significance of the California life sciences community to continued innovation and job creation. Meetings were held with Energy and Commerce Committee members including: Rep. Brian Bilbray (R-Carlsbad), Rep. Lois Capps (D-Santa Barbara), Rep. Anna Eshoo (D-Atherton), Rep. Phil Gingrey (R-GA), and Rep. Mike Rogers (R-MI). Other member meetings included Sen. Barbara Boxer (D-CA), Rep. David Dreier (R-San Dimas), Rep. Jackie Speier (D-Hillsborough), House Majority Whip Kevin McCarthy (R-Bakersfield) and key legislative staff at the Senate Health, Labor, Education and Pensions (HELP) Committee. Over the course of the day, one message was repeatedly conveyed: the important and successful role of CHI in communicating and contextualizing the importance of consistent, predictable and efficient FDA regulatory processes to continued biomedical research, investment and innovation in our state.

Also that day, CHI released a report on FDA with respect to the agency’s approval of drugs and biologics, building on our earlier study, Competitiveness and Regulation: The FDA and the Future of America’s Biomedical Industry (2011). The report, Managing Priorities: Therapeutic Area Variation in FDA Drug Regulation, presents new data that illustrate important differences in FDA performance from one therapeutic area to another and examines misalignment between regulation and public health needs. It comes as Congress considers critical legislation that would renew and expand fees paid by drug and medical-device companies to help fund the FDA. Current legislation allowing the FDA to collect fees from drug and medical-device companies expires Sept. 30.

Genetic Engineering and Biotechnology News highlighted the report’s findings in a recent article and The Burrill Report featured a one-on-one interview between CHI CEO David L. Gollaher, Ph.D., and Burrill’s Daniel Levine.

CHI-Advancing California biomedical research and innovation

Executive Spotlight: Kleanthis Xanthopoulos, Ph.D., CEO of Regulus Therapeutics Inc.



Kleanthis Xanthopoulos

Xanthopoulos understands the biotech business from the inside out. Xanthopoulos is president and CEO of Regulus Therapeutics Inc., which was formed in late 2007 by Alnylam Pharmaceuticals of Cambridge, Mass. and Carlsbad, Calif.-based Isis Pharmaceuticals. It is testing drugs that use microRNA technology, a gene “silencing” technique used for treating various diseases. Regulus has created leading strategic alliances with GlaxoSmithKline and Sanofi-Aventis to develop microRNA therapeutics. Regulus moved to La Jolla in mid-2010 in the proximity of leading academic institutions including The Scripps Research Institute, Salk Institute, Sanford-Burnham Medical Research Institute and UC San Diego.

Before joining Regulus, Xanthopoulos spent time as managing director of Enterprise Partners Venture Capital, where he analyzed the best deals in the biomedical space. Prior to that, he co-founded and served as president and CEO of Anadys Pharmaceuticals, Inc., and served as a member of the board until its acquisition by Roche in late 2011. And before Aurora Biosciences became Vertex Pharmaceuticals, he was vice president from 1997 to 2000. Xanthopoulos participated in The Human Genome Project as a section head of the National Human Genome Research Institute from 1995 to 1997. Previously, he was an associate professor at the Karolinska Institute in Stockholm, Sweden after completing a postdoctoral research fellowship at The Rockefeller University, New York.

An Onassis Foundation scholar, Xanthopoulos received his bachelor’s degree in biology with honors from Aristotle University of Thessaloniki, Greece, and received both his master’s and doctorate degrees in microbiology from the University of Stockholm, Sweden.


Q: You went from being head of a biotech to the investor world, and, now, as head of this company spun out of Alnylam and Isis. What has the transition back been like?


A: Entering biotech life again was a perfectly natural transition, like coming home. I fell in love with the groundbreaking biology and was enamored with the opportunity to translate this big idea into innovative medicines. I like to say that my time spent at the VC firm was as a biotech sabbatical — taking time off from my true passion of building companies.


Q: What led Regulus to locate on the Torrey Pines Mesa as opposed to, say, Carlsbad where Isis is located?


A: It made terrific sense to be incubated within Isis. There is a lot of educational knowledge that we extracted from Isis, and the best way to do this is by osmosis. So, being there was very important for the first years of Regulus’ life. But, ultimately, we wanted our own culture and identity, and we felt that, based on some local collaborations and activities that we have, it would be much better served if we were in the Torrey Mesa as opposed to North County.


Q: Regulus has made some major industry collaborations, big names such as GlaxoSmithKline. What can we expect from the Regulus partnerships in the years to come?


A: Regulus has a dominant locked-in position in the world of microRNAs, which are remarkable and elaborate. They manage control of transcription and post-transcription mechanisms by dictating the half-life of messenger RNA. More than 700 microRNAs have so far been identified in humans, so that means 700 targets. And that, for a small company like us, means collaboration. We have 40 active academic institutions that work with Regulus and many of them are in very close proximity, including one with UCSD. It is part of the strategy and one that we pursued and have benefitted from exceptionally well.


Within six months of formally announcing Regulus, we had the partnership with Glaxo. It is encompassed around four microRNAs. Only one had been identified before the collaboration. So what you should expect is steady stream of news over the period of the collaboration.


Q: Talk about the environment for startups in California. What would be your advice to start-ups looking to grow within the state, such as Regulus has?


A: The good news is that any good, solid idea that is addressing significant needs in the pharmaceutical drug development stage is going to get funded. The bad news is the other ideas, or maybe product ideas alone, have a much more difficult time. Re-licensed or repurposed drug stories, I think, are going to have a harder time moving forward. In the early part of this year, we have seen a resurgence of platform technology stories emerge successful on the biotech scene. These platform stories are getting attention from not only VC firms, but institutional investors looking to take additional risks in their portfolio. This is a departure from the past several years in which companies with later-stage assets were the only investment opportunities for institutional investors. The tide seems to have turned and the early platform companies are now vying for the same Wall Street monies as the later-stage companies. A truly innovative breakthrough idea, such as the one Regulus is pursuing, will get funded.

Q: When Regulus first began, the CEO of Alnylam told investors that he expected Regulus to "dominate the microRNA space.” How do you think Regulus has stood up to that test?


A: Unfortunately, we did better than expected. And by unfortunately, I mean, we have scared away a lot of competition. Many people think that is good. I, personally, think that a little bit of competition is very healthy. So, unfortunately, we don’t have that, so the case of microRNA almost exclusively relies on how good Regulus is going to do.


Q: That has also brought you some healthy collaborations and financial backing. Talk about your growth as a company and where you see yourselves going in the next five to 10 years.


A: The biggest risk for Regulus five years ago was, “Can you target microRNAs and have a sort of peak effect without having a lot of side effects?” That was the big biological risk. Today, we have been able to show in 25 different models of human studies and animal studies that you can do that with a good therapeutic model. So, now you can say that the proof of concept has been established.


So, how do we look five years from now? We are very likely going to be a public company. We are still going to be less than 100 people. We are religiously defending our turf when we can, maintaining that the best brain trust one can possibly have in-house, but also utilizing a lot of extra hands outside. We going to have at least three programs in the clinic and maintain four to six preclinical programs at any given time.

Q: What are some of your proudest accomplishments since Regulus was formed in September 2007?


A: For me, it is all about people, strategy and finance. I think we have been, so far, good on all three fronts, and that’s something I am proud about. We have brilliant people, who are all tremendously seasoned drug hunters or hugely experienced people in finance and operations. We are now at about 55 employees. We are one of the few companies that has been growing at significant rates over the past four years. We have raised over $110 million. The vast majority of this is from the alliances, so it is non-dilutive financing. And I think we have a very good strategy of how to methodically move the pipeline from a big idea to a meaningful set of preclinical and clinical progress.




CHI-Advancing California biomedical research and innovation

Executive Profile: Brian O'Callaghan, President and CEO, Sangart



Brian O'Callaghan

O'Callaghan joined Sangart as president and CEO in June 2008. He brings a breadth of experience to Sangart, having held senior positions with a number of pharmaceutical and biotechnology companies in both Europe and the U.S. These include senior positions with Pfizer in the U.K. and Merck Serono in Germany, before becoming president and CEO of BioPartners, a Swiss-based biotechnology company. Since relocating to the U.S., O'Callaghan has held senior management positions at Novartis, Covance, and, most recently, NPS Pharmaceuticals, where he served as chief commercial officer. O'Callaghan brings his extensive experience to lead Sangart through regulatory submission and commercial launch of the MP4 platform.

Q: In looking at the history of Sangart in San Diego, it was interesting to me that you have both these civilian and military applications. Tell me more about Sangart's connection with the Letterman Army Institute of Research.

A: The company was founded by a guy named Dr. Bob Winslow. Bob started this journey when he was with the Letterman Army Institute of Research about 20-30 years ago. His experience there culminated in him founding Sangart about 14 years ago.

What is great is that some of the people still with Sangart today were with Bob at the Letterman Army Institute of Research. Literally decades of research has gone into developing what became MP4, which is Sangart’s platform product.


What Bob discovered was that you could replicate a low-volume setting for some of the properties of blood. As a result, Bob developed the MP4 molecule as an agent that could very effectively transmit gases into the body.


There are the two gases that Sangart is currently focusing on with MP4: oxygen and carbon monoxide.


The oxygenated compound (MP4OX) is designed to deliver oxygen in the capillaries, where red blood cells may not naturally reach, when the body is suffering from hemorrhagic shock. The carbon monoxide formulation (MP4CO) is designed to deliver therapeutic levels of carbon monoxide to patients with sickle cell anemia.


Q: How does this compare to standard care available today?


A: There is no real treatment right now for trauma-related ischemia. When patients suffer blood loss due to a traumatic event, they eventually get to a critical care setting. They get all sorts of fluids, including blood, as well as surgery, of course. If the lactic acid levels, which are routinely measured, show lactic acidosis, an indicator of a lack of oxygen, then they receive MP4OX, in a blind setting, as an addition to standard of care. We measure the resolution of lactic acidosis, which indicates the delivery of oxygen to the ischemic tissue. We also look at other endpoints, such as the ICU setting to see if they are spending less time in the hospital on ventilators, etc.


Our Phase IIb study is evaluating MP4OX plus standard of care in trauma patients, with lactic acidosis due to hemorrhagic shock. It’s running in about 50 sites in about 15 countries throughout the world.


Q: How do you balance the need to raise capital with everyday activities?


A: We have been insulated more than most from all that is going on in the last two to three years because our investors are very patient.


We are funded through to our next major milestone events. Those being the generation of the next rounds of clinical data from the PhIIb study for MP4OX and the PhIb study for MP4CO.


With positive data from our two clinical trials, we are confident of raising additional funding from existing or alternative investors.


Q: Where do the biggest opportunities lie?

A: The biggest opportunity, by far, is in trauma. You can take oncology and cardiology and the other major killers, and you can combine all the deaths that come from those and they don't compare to trauma. Trauma is, by far, the biggest killer in our society.

The good news is that if you do get into a critical care setting, your chances of survival are actually very high. This product will be serving a critical unmet medical need where there are not any products like it out there. The market is estimated to be about $6 billion in the developed worlds at least.

When you look at the pharmacoeconomic aspects of keeping people out of ICU and off ventilators, while also getting them out of the hospital faster, you are potentially saving thousands of dollars per day by using MP4OX. We are estimating savings of anywhere between $5,000 to $10,000 a day, while also contributing to patients being discharged, on average, a week earlier.

Q: What does the future of traumatic brain injury and other types of severe blood loss treatment look like 20 years from now?

A: Traumatic brain injury is one of the things the Army wants us to look at. Traumatic brain injury might have more of a relevance to the military in the battlefield than the civilian setting. What they are looking for are newer formulations that are more robust to be used in the battlefields. So they are looking for formulations that can basically be used in the soldiers' backpacks or in forward positioned surgical units.

Q: What differentiates Sangart from others in the field?

A: Studies show that our MP4 products can potentially be safer and more effective as therapies for trauma and sickle cell disease. We have investors who are very patient and willing to continue investing in us given our strong clinical data. Finally, and very importantly, we are willing to do our development overseas rather than the U.S. should it serve MP4’s needs.



CHI-Advancing California biomedical research and innovation