Friday, June 29, 2012

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

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Wednesday, June 13, 2012

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

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CODAN USA headquarters in Santa Ana, Calif.

Tuesday, June 12, 2012

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

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Friday, June 8, 2012

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

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