Tuesday Night Around Atlanta

BIO hosted a Public Officials Reception last night at the Metro Atlanta Chamber of Commerce. Located across from Centennial Olympic Park, the Chamber's offices are fantastic, and our reception was on the rooftop with panoramic views of the Georgia World Congress Center, Philips Arena, The Georgia Dome, The Georgia Aquarium, The World of Coke Museum and the Atlanta skyline in the background.

CHI members Genentech and Allergan were present, and the governor's Secretary for the Life Sciences and Health Systems, Kathryn Lowell, mingled with the California attendees on behalf of Governor Arnold Schwarzenegger. Several state representatives from across the United States were on hand for the reception, but the keynote address was delivered by Georgia Governor Sonny Perdue (R-Georgia.) Atlanta is home to the Centers for Disease Control and Emory University, as well as a handful of life sciences research firms working on HIV/AIDS therapeutics and vaccines. He thanked the industry for selecting Atlanta for the event and expressed awe at the depth of the industry and the sheer size of the BIO convention.

After the Public Officials Reception, I worked my way back over to the Omni Hotel and stopped in to visit the Pillsbury Winthrop Shaw Pittman reception. Pillsbury is a CHI member, and their law firm specializes in biotechnology issues including patent law. After a brief discussion on Pillsbury's presence in San Diego with Richard Blaylock, partner, and Donna Perdue, patent attorney, we segued into an extensive conversation on the state of California's budget crisis in Sacramento. Mark Mlynarkczyk from MedImmune's Washington, D.C. office joined in our discussion, and soon we were dissecting the impact of yesterday's special election and pondering if California needs a more drastic fix to address the structural hurdles to financing the state. Other states such as Connecticut have a ballot question periodically that asks the electorate if they need to convene a constitutional convention. In California, that idea has been put forward by various reform groups as a means to wipe the slate clean and formulate a new budgeting system from the ground up.

Whether that is a viable option (or a wise one, even) remains to be seen. However, now that we know that five of the six propositions on yesterday's ballot have failed by wide margins, California now has a $23 billion dollar budget gap to cover -- and no ideas are off the table just yet (at least among the attendees at BIO!)

After the reception with the gracious folks from Pillsbury, I headed over to JCT Kitchen for the Council of State Bioscience Association's annual dinner. What an amazingly pleasant evening we had (and I have quite a few pictures that I promise I will get uploaded soon!) Several CHI members converged at this event, including Allergan, Astellas, Celgene, Genentech, and MedImmune (and if I have forgotten to mention anyone, I apologize!) The government relations folks from D.C. and Sacramento mingled to discuss patent reform, follow-on biologics, the California budget, the 32nd Congressional race -- among other topics.

At dinner, I sat with CHI members Ed Reno of Allergan and Barbara Morrow of Astellas. Also at our table were Terese Ghio of Arena; Elizabeth Bartz of State & Federal Communications; Shannon Sheehan of New Mexico BIO; Jayne Berkaw of Michigan BIO; and Leah Kientz and April Giles, both of the Colorado BioScience Association. In the small world that is our life sciences family, Elizabeth grew up in Warren, Ohio -- less than 15 minutes from where I grew up and graduated high school. She counts several CHI members among her clients, including Astellas Pharma, and completes lobbying reports at the federal and state level.

The other life sciences associations at the table discussed their activities in their respective states with me, and I am starting to notice that across the industry, people are spellbound by the depth of California's biomedical community and the organization of the trade associations in the state. No other trade association that I have had discussions with has a full-time presence in their state capitol and Washington, D.C., in addition to a home office operating in one of the largest biotech clusters in the world. CHI, more than anyone, is uniquely positioned in that respect, and I think our successes in advocating for the industry in Sacramento and D.C. result from that.

CHI-Advancing California biomedical research and innovation

CHI Makes New Connections in Atlanta

On Wednesday, I ran into Gregory Downs, Director of Business Development for Biovail based out of Toronto, Canada, on my way to the BIO Public Officials Reception at the Metro Atlanta Chamber of Commerce. Biovail is a contract research firm that manages clinical trials for pharmaceutical and biotech companies in the United States and Canada, including several clients in California’s major biotech clusters. While I discussed what CHI does for the life sciences industry in California, Downs recounted several recent successful clinical trials that his company has performed in California for various therapeutics.

For me, this has been the best aspect of being in Atlanta with all of the myriad life sciences firms at the 2009 International BIO Convention – casual conversations present opportunities for CHI and our members to partner with other organizations and to get the word out about the value and services we provide for biomedical research. I encourage CHI member companies that are considering using contract research firms for clinical trials to contact Greg to discuss Biovail, and CHI will be in touch with Greg to discuss our advocacy efforts in Sacramento to see if we can be a resource for Biovail to ensure that policies and regulations put forth in the California Legislature support the work that Biovail does in California.

For more information about Biovail, contact Gregory Downs, director of business development at (919) 876-4431 or greg.downs@biovail.com. For more information on CHI and services we provide in California, contact Molly Ingraham, vice president of operations at (858) 551-6677 or ingraham@chi.org.

CHI-Advancing California biomedical research and innovation

California Shines in the Exhibit Hall; BIO Convenes the State Government Relations Committee

The Exhibit Halls are open at the 2009 International BIO Convention, and today has been a fast-paced day. I started the morning visiting the California Pavillion, located in Exhibit Hall B-4 (Booth 4033.) I spoke briefly with Mary Ingersoll, who is the Executive Director of TeamCalifornia, as well as Tom Lease of California Business Investment Services, a division of the California Labor and Workforce Development Agency. Both were very interested in CHI and our member companies and want to continue the discussion when I arrive back in Sacramento as to how the life sciences industry can work with economic and business development organizations within the state government and in the private sector to attract more firms into the California marketplace.

The University of California and California State University systems have their booth set up adjacent to the main California Pavilion, and I discussed opportunities for the life sciences industry in need of laboratory and office space with Sandra Acton at Cal Poly Pomona. That University has various real estate opportunities for life sciences firms with the added benefit of being part of the vibrant research community at Cal Poly Pomona. For more information on opportunities to locate your company at Cal Poly Pomona, visit http://www.foundation.csupomona.edu/.

After checking in with the California exhibit, I ventured off to check out the competition -- visiting the state pavilions for other major biotech clusters in the United States, including Georgia, Maryland, Massachusetts and North Carolina, to name a few. There are representatives from all 50 states and various international countries all putting their best foot forward and presenting their arguments for why the life sciences industry should locate with them. What started in California in the 1970s with recombinant DNA technology has truly spread to every corner of the globe -- it really is something to see. Speaking of which, I will have pictures posted on the blog tonight or tomorrow as soon as I get a chance to upload some of the shots from the convention floor.

After checking out the geographical exhibits, I made my way over to visit various CHI member company exhibits, including Abbott Laboratories, Life Technologies, Merck, Novo Nordisk, Pfizer, Sanofi-Aventis, Vertex Pharmaceuticals, and Wyeth. This is just a small sampling of our member companies that are here in Atlanta, and I have a LOT more to see tomorrow and Thursday.

At 2:00 PM, it was time to head over to the Omni Hotel again for the BIO State Government Relations Committee meeting. While we are pretty focused right now on the budget situation in California (and again, if you're reading this before 8:00 PM on Tuesday, GO VOTE!) -- there are several issues coming to the forefront for state government relations personnel in the biosciences. Douglas Finan, Director of Environmental Health and Safety for GlaxoSmithKline provided a superb assessment of the recently emergent issue of pharmaceuticals in the environment (PIE.) In 2008, the Associated Press wrote a handful of stories about the existence of trace amounts of pharmaceutical compounds in surface and drinking water throughout the United States, which has lead to legislative action in several of the states around the country and federal action in the form of study bills being proposed in the 111th Congress.

Finan argues that phenomenon of PIE is nothing new, but that there are detection mechanisms available today that can pick up on the minute amounts of pharmaceutical waste in the environment. Unfortunately, the AP did not explicate how truly small the presence of pharmaceutical waste is in surface and drinking water. In a recent study in Erie, Pennsylvania, the United States Geological Survey was able to detect ibuprofen, one of the most commonly used medicines, at a level of three parts per trillion in the drinking water. At that level, one would need to consume two liters of water per day for more than 100 years in order to get a single dose of ibuprofen into their system!

Yet, Legislatures are paying close attention to PIE issues, and we as an industry need to be armed with solid data and arguments about proper disposal of pharmaceuticals. Many states, including California, have proposed take back programs for unused pharmaceuticals so that they can be incinerated. However, nearly all of the PIE comes from human excretion or flushing of unused pharmaceuticals -- not disposal in landfills. Landfills in the United States are well monitored for ground contamination, and pharmaceutical products can be safely disposed of through the trash. What the industry needs to impart to consumers is that flushing unused pharmaceuticals down the drain is not the most environmentally friendly means of disposing of unused products. Incineration is another safe way to dispose of pharmaceuticals, but it is also costly and has the negative consequence of air pollution. We all should be stressing that disposing of unused pharmaceuticals in the trash is a safe and environmentally sound disposal process, while incineration pollutes the air without any added benefit.

Most of us are familiar with the standard paradigm for product stewardship -- reduce, reuse, and recycle. For pharmaceuticals, however, reusing and recycling products prescribed as patient specific remedies that have expiration dates are not feasible. Our product stewardship should focus, then, on reducing the amount of pharmaceutical waste by encouraging patients to finish taking all medication as prescribed and properly disposing of unused medication in the trash.

Other discussion topics at the SGRC Meeting included activities at BIO, state level marketing legislation, and an update on biotech caucuses throughout the United States. Tonight, I am going to participate in numerous networking activities -- be sure to check back in with me in the morning for a full update on the evening (and hopefully some pictures from Atlanta, as well!)

CHI-Advancing California biomedical research and innovation

Monday marked the official start of BIO

Monday was the official first day of BIO here in Atlanta. Even though I had lived in Atlanta for four years before coming out to California, I had never been inside the Georgia World Congress Center. For those of you who have also not been inside the Congress Center, it is truly an amazing facility, encompassing more than 3.9 million square feet of meeting and exhibition space. And this week, that space is filled with everything biotech.

After registering for the convention and receiving my credentials, I walked around for a bit surveying the land. Most of the BIO activities are in the "B" Exhibit Hall, with the exhibits on the first floor, breakout sessions on the second floor, super sessions on the third floor, and the BIO store and career fair at the top level. The breakout sessions are shorter discussions on topical issues in the industry, while the super sessions are longer conversations on in depth issues. The folks at BIO are expecting between 16,000 and 18,000 attendees this week.The exhibit halls were not open Monday -- most of the exhibitors are putting the finishing touches on their displays and getting ready for the crush of attendees to flood the halls on Tuesday.

After lunch, I attended a super session sponsored by Eli Lilly called "Intellectual Property at the Crossroads." The panel assembled by Eli Lilly was fantastic, lead by Bob Armitage, their chief counsel who has worked for nearly two decades in the area of patent law. As you may have discerned from my last blog, the economy is coloring a lot of the discussions at BIO this week, and rightly so as the industry tries to find solid footing in today's market. Eli Lilly's discussion on intellectual property was mindful of today's unique circumstances and the elevated importance of strong patent protections for the life sciences industry.

Two issues came to the forefront of the intellectual property discussion. First, the efforts in Congress this year to pass meaningful patent reform. CHI supports S. 515, the patent reform bill by Patrick Leahy (D-Vermont.) But strong patent protection in the biotech industry is only half of the story. The data exclusivity protections in the competing follow-on biologics measures working their way through Congress are key to truly protecting the investments made by life sciences companies in research and development on their products. As follow-on biologics, or "biosimilars" are similar in composition to their pioneer products but not necessarily exact duplicates, protecting the data on the pioneer product is the only way to ensure that a follow-on product does not enter the market before the pioneer product's company has had a period of market exclusivity to recuperate their research and development costs. As such, the data exclusivity protections in the biosimilars legislation will determine the effective patent life of a product -- not the patent itself.

It appears that the legislation in the 111th Congress on patent reform and biosimilars will determine the continued ability of the life sciences community to attract venture capital for research and development. Now more than ever, the entire life sciences community needs to engage their elected representatives to educate them on the nature of the product pipeline, how our industry improves the quality of lives for millions of patients around the world, and economic contributions that we provide to state and local governments.

If you would like more information on how you can help CHI raise awareness on patent reform and biosimilars issues, please contact any of our staff that work directly in government relations: Todd Gillenwater, vice president of public policy (gillenwater@chi.org); Sandra Pizarro, vice president of state government affairs (pizarro@chi.org); or myself, Ritchard Engelhardt, associate director of government affairs (engelhardt@chi.org.)

After the informative session on intellectual property, I headed to dinner with Andrea Jackson who is the associate director of state government affairs with Genentech in Sacramento. We went off the beaten path and headed over to Decatur, about 15 minutes from the Congress Center, and home to the Centers for Disease Control and Emory University (the two jewels of the life sciences industry in Atlanta.)Andrea is one of the first people I had the privilege of meeting after joining CHI, and her experiences working for now President pro Tem of the Senate Darrell Steinberg (D-Sacramento) and with Genentech for several years make her a fascinating dinner date. We discussed many of the challenges the industry faces back in Sacramento with the ongoing budget crisis and the future of the single-sales factor in California. Andrea was one of the key players in securing passage of the single-sales factor in February's budget negotiations, and it really has made California a more competitive place for life sciences firms to locate and do business.

After dinner, we headed to the World of Coke Museum for the Midwest Jazz Reception, sponsored by a handful of state-level biotech and economic development associations from the Midwestern United States, including the Kansas Bioscience Authority, Illinois Department of Commerce and Economic Opportunity, Michigan Economic Development Corporation, and the Missouri Partnership. Aside from a lovely evening of music and festivities, we were able to have conversations with business leaders in the Midwest who are suffering, in my estimation, a great deal more from the economic downturn than many other parts of the country. While California may be facing a monumental budget deficit, places like Michigan have witnessed the collapse of its primary industry and are struggling to attract new industries to backfill the economic losses from the decline of the American auto industry.

In California, CHI discusses the importance of enacting state level policies that keep the Golden State competitive for thriving industries like the life sciences, and at events like the one sponsored at the World of Coke Museum, you can truly see the hunger in other parts of the country to attract our industries to other states. I hope I can relate their stories to the lawmakers back in Sacramento when I get home to communicate the importance of making our state a place where companies want to invest and grow.

Tuesday is the opening day of the exhibits at BIO. I have a full roster of exhibits to hit and the week is going by much faster than I imagined. Hopefully I will see you on the floors of the Georgia World Congress Center.And, if you're back in California, please remember to go vote! Polls are open in the Golden State from 7:00 AM to 8:00 PM.

CHI-Advancing California biomedical research and innovation

BIO Kicks Off with Sessions and Networking

Monday was the official first day of BIO here in Atlanta. Even though I had lived in Atlanta for 4 years before coming out to California, I had never been inside the Georgia World Congress Center. For those of you who have also not been inside the Congress Center, it is truly an amazing facility, encompassing more than 3.9 million square feet of meeting and exhibition space. And this week, that space is filled with everything biotech. After registering for the convention and receiving my credentials, I walked around for a bit surveying the land. Most of the BIO activities are in the "B" Exhibit Hall, with the exhibits on the first floor, breakout sessions on the second floor, super sessions on the third floor, and the BIO store and career fair at the top level. The breakout sessions are shorter discussions on topical issues in the industry, while the super sessions are longer conversations on in depth issues. The folks at BIO are expecting between 16,000 and 18,000 attendees this week.

The exhibit halls were not open Monday -- most of the exhibitors are putting the finishing touches on their displays and getting ready for the crush of attendees to flood the halls on Tuesday. After lunch, I attended a super session sponsored by Eli Lilly called "Intellectual Property at the Crossroads." The panel assembled by Eli Lilly was fantastic, lead by Bob Armitage, their Chief Counsel who has worked for nearly two decades in the area of patent law. As you may have discerned from my last blog, the economy is coloring a lot of the discussions at BIO this week, and rightly so as the industry tries to find solid footing in today's market. Eli Lilly's discussion on intellectual property was mindful of today's unique circumstances and the elevated importance of strong patent protections for the life sciences industry.

Two issues came to the forefront of the intellectual property discussion. First, the efforts in Congress this year to pass meaningful patent reform. CHI supports S. 515, the patent reform bill by Patrick Leahy (D-Vermont.) But strong patent protection in the biotech industry is only half of the story. The data exclusivity protections in the competing follow-on biologics measures working their way through Congress are key to truly protecting the investments made by life sciences companies in research and development on their products. As follow-on biologics, or "biosimilars" are similar in composition to their pioneer products but not necessarily exact duplicates, protecting the data on the pioneer product is the only way to ensure that a follow-on product does not enter the market before the pioneer product's company has had a period of market exclusivity to recuperate their research and development costs. As such, the data exclusivity protections in the biosimilars legislation will determine the effective patent life of a product -- not the patent itself.

It appears that the legislation in the 111th Congress on patent reform and biosimilars will determine the continued ability of the life sciences community to attract venture capital for research and development. Now more than ever, the entire life sciences community needs to engage their elected representatives to educate them on the nature of product pipeline, how our industry improves the quality of life for millions of patients around the world, and economic contributions that we provide to state and local governments. If you would like more information on how you can help CHI raise awareness on patent reform and biosimilars issues, please contact any of our staff that work directly in government relations: Todd Gillenwater, Vice President of Public Policy (gillenwater@chi.org); Sandra Pizarro, Vice President of State Government Affairs (pizarro@chi.org); or myself, Ritchard Engelhardt, Associate Director of Government Affairs (engelhardt@chi.org.)

After the informative session on intellectual property, I headed to dinner with Andrea Jackson who is the Associate Director of State Government Affairs with Genentech in Sacramento. We went off the beaten path and headed over to Decatur, about 15 minutes from the Congress Center, and home to the Centers for Disease Control and Emory University (the two jewels of the life sciences industry in Atlanta.) Andrea is one of the first people I had the privilege of meeting after joining CHI, and her experiences working for now President Pro Tempore of the Senate Darrell Steinberg (D-Sacramento) and with Genentech for several years make her a fascinating dinner date. We discussed many of the challenges the industry faces back in Sacramento with the ongoing budget crisis and the future of the single-sales factor in California. Andrea was one of the key players in securing passage of the single-sales factor in February's budget negotiations, and it really has made California a more competitive place for life sciences firms to locate and do business.

After dinner, we headed to the World of Coke Museum for the Midwest Jazz Reception, sponsored by a handful of state-level biotech and economic development associations from the Midwestern United States, including the Kansas Bioscience Authority, Illinois Department of Commerce and Economic Opportunity, Michigan Economic Development Corporation, and the Missouri Partnership. Aside from a lovely evening of music and festivities, we were able to have conversations with business leaders in the Midwest who are suffering, in my estimation, a great deal more from the economic downturn than many other parts of the country. While California may be facing a monumental budget deficit, places like Michigan have witnessed the collapse of its primary industry and are struggling to attract new industries to backfill the economic losses from the decline of the American auto industry. In California, CHI discusses the importance of enacting state level policies that keep the Golden State competitive for thriving industries like the life sciences, and at events like the one sponsored at the World of Coke Museum, you can truly see the hunger in other parts of the country to attract our industries to other states. I hope I can relate their stories to the lawmakers back in Sacramento when I get home to relay the importance of making our state a place where companies want to invest and grow.

Tuesday is the opening day of the exhibits at BIO. I have a full roster of exhibits to hit and the week is going by much faster than I imagined. Hopefully I will see you on the floors of the Georgia World Congress Center.

And, if you're back in California, please remember to go vote! Polls are open in the Golden State from 7:00 AM to 8:00 PM.

CHI-Advancing California biomedical research and innovation

CHI Arrives in Atlanta for the 2009 BIO Convention!

Greetings! I am Ritchard Engelhardt, Associate Director of Government Affairs for the California Healthcare Institute. I am in Atlanta, Georgia this week for the 2009 International Biotechnology Industry Organization (BIO) Convention at the Georgia World Congress Center. I will be blogging updates from the convention for CHI members to keep you up to date on CHI's activities in Atlanta this week.

Last night was the first night of official activities for the BIO Convention, starting with the Council of State Bioscience Associations (CSBA) Meeting at the Omni Hotel at CNN Center. This is my first year with CHI, my first BIO Convention, and my first time attending the CSBA meeting on behalf of CHI. I have to say I am continually impressed with the organization of the life sciences industry across the country. There were representatives from over 30 state level associations at the CSBA meeting discussing the current landscape for policy, how today's difficult economic climate is affecting biomedical research, and sharing ideas on how to better represent life sciences companies in the Legislatures around the country and in the public sphere.

We discussed funding opportunities that arose out of the February American Recovery and Reinvestment Act (ARRA), commonly known as the stimulus plan. Andrew Kurtz from the National Cancer Institute briefed members on the differences between stimulus funding in general and the increased funding available through the National Institutes of Health (NIH) for research under ARRA. The main takeaway from the discussion is that ARRA funding outside of the NIH is very fast turnaround and needs to be allocated quickly, while NIH grants are better solutions for ongoing research within the industry.

The BIO State Government Relations staff presented a thorough discussion on the state of "Biotechnology Caucuses" in the states. The various state level organizations are working to establish a "Biotechnology Caucus" among members of their respective state legislatures. While California does not have an official Biotech Caucus, per se, we can be proud that we have two solid Select Committees on Biotechnology in each house of the California Legislature, with Senator Ellen Corbett (D-San Leandro) chairing the Senate Select Committee on Biotechnology and Assembly Member Jerry Hill (D-San Mateo) filling that role on the Assembly side. Both of these committees engage CHI and the industry on important policy decisions in California that affect the climate for biomedical research in the state.

We also had an engaging discussion on strategy for Follow-On Biologics (or "biosimilars") in the United States. As many of you know, CHI supports a pathway for biosimilars. Currently, there are two bills working their way through the 111th Congress -- one by Rep. Henry Waxman (D- Calif.) and the other by Rep. Anna Eshoo (D - Calif.) CHI supports the Eshoo bill, which provides a longer period of data exclusivity and protects investment in the biotechnology sector. The Eshoo bill has over 70 co-authors and BIO hopes to gain up to 100 before the bill makes it way through Congress. Looking to the European experience, where biosimilars have been a reality in the European Union for a few years now, BIO invited Ludovic Lacaine from EuropaBIO, a trade association for the biotech industry in the E.U. He discussed the coalition building experience that facilitated the passage of biosimilars legislation in the E.U., and was happy to report that 13 biosimilar products have made it to the market for patients in Europe. This news was two-fold for those of us in the room -- there is much hope that this will be the year for biosimilars legislation, but also a renewed sense of urgency that our lack of a biosimilars pathway in the United States is making us less competitive than our counterparts on the other side of the Atlantic.

Finally, we discussed business models for state level associations in a difficult economy. CHI has always been a leader in the trade association world and our finances are sound. We shared that we are able to remain successful in this difficult economy by funding our events throughout the year with sponsorship. This allows CHI's day to day operations and advocacy activities to be funded from our member dues, and gives us the leverage to reign in costs on other activities throughout the year depending on sponsorship levels. In doing so, it has allowed our base operations to remain strong during this economic downturn, and we have been fortunate to have member companies that realize the value of our events throughout the year and are willing to sponsor them -- various forums on specific life sciences issues, our Industry Report and launch (the premiere document on the state of the life sciences industry in California), our Life Sciences Day in March, and myriad other outreach activities.

After the meeting, we had a reception at the Omni and discussed CHI's success in utilizing new media with Jeremy Freking of the South Dakota Biotech Foundation. Jeremy was interested in how the SD Biotech Foundation could increase its presence on a limited budget. We discussed CHI's Web site, our activities and Facebook, LinkedIn, and Twitter, as well as our utilization of podcasting for our Patient Perspective Series and the upcoming use of webinars to conduct virtual meetings with our membership to discuss the advocacy and PAC processes. All of these solutions are low-cost, high visibility networking opportunities, and I invited Jeremy to take a look at what CHI is doing in all of these areas on http://www.chi.org/, as well as reaching out to our fantastic Director of Communications, Nicole Beckstrand, for her ideas. Jeremy is also on Facebook, and I told him that CHI established a Facebook page and a Blog that Legislators can follow to see what's going on in the life sciences industry, as well as to get a quick read on where CHI stands on important legislation moving through the California Legislature and the Congress.

All in all, it was a productive and fun first day -- and I even made a new Facebook friend from South Dakota, for good measure!

For more information about CHI's activities in Atlanta this week, contact Ritchard Engelhardt, associate director of government affairs at 916-273-2773 or engelhardt@chi.org.

CHI-Advancing California biomedical research and innovation

Premiere of CHI Patient Perspectives Series

CHI released its premiere podcast episode of its CHI Patient Perspective Series. The series examines patient experiences throughout the healthcare continuum, and touches on topics ranging from access to information and care, to breakthrough research improving quality of life, to solutions to the problems of rising healthcare costs and bureaucracy.

In this premiere episode Loring Leeds, clinical trial participant at City of Hope, discusses his journey to find a cure for HIV and AIDS-related lymphoma, the biases he faced as a patient and the miracle turnaround he experienced in a clinical trial of an experimental treatment at City of Hope.

To download the podcast, visit www.chi.org or download it on iTunes and other podcast directories. New installments of the podcast will be launched regularly and will be available on the CHI Web site for convenient listening. To subscribe to the series click on the RSS Feed .

If you have questions or issues downloading or subscribing to the series please contact Tiffany Taluban, CHI's public relations coordinator at taluban@chi.org or 858-551-6677.For sponsorship opportunities or if you have patients you would like to be featured in future episodes contact Nicole Beckstrand, CHI's director of communications, beckstrand@chi.org or 858-551-6677.

CHI-Advancing California biomedical research and innovation.

California Companies Urge Congress to Approach Patent Reform Cautiously

On Friday, CHI organized a letter with more than 100 California-based companies and organizations to Senator Dianne Feinstein, expressing important concerns about recently reintroduced patent reform legislation. CHI represents more than 250 life sciences companies and academic research organizations whose inventions are the basis of California’s global leadership in the life sciences industry, representing more than 270,000 jobs across our state and improving the lives of millions around the world.

California’s innovative high-tech industries lead the world in biotechnology, electronics, green technology, medical technology, information technology and telecommunications, and more. The biomedical industry’s advanced research and development is extremely risky and expensive in nature, with the average biotech drug, for example, taking almost 15 years and a billion dollars to reach the market. Strong patent protections enable companies to attract the risk capital they need in order to continue to innovate new technologies that save lives. The hundreds of smaller, venture capital-backed firms in the state, many spun out of California’s world-class research universities and private research institutes, could not attract funding without strong intellectual property protection.

CHI supports balanced and reasonable efforts to improve the U.S. patent system, particularly measures that would improve patent quality by adequately funding and modernizing operations at the U.S. Patent and Trademark Office. Unfortunately, the recently introduced Patent Reform Act of 2009 includes provisions that would undermine patent certainty, encourage infringement, and weaken the enforceability of patent rights and intellectual property protections upon which our industry depends. Reducing the value of patents will shrink investment, ultimately diminishing the flow of new medicines and treatments available to patients.

The letter submitted to Feinstein describes how these same provisions raised concerns and objections in the last Congress. In the current economic crisis, CHI believes the enactment of this legislation would cause even greater harm today—delaying promising research and development, reducing investment, diminishing innovation and slowing job growth.

CHI believes the proposed legislation fails to account for recent court decisions that have transformed the patent law landscape and corrected certain alleged failings of the current system in terms of excessive damages awards. While the full effects remain to be seen, decisions such as Ebay v. MercExchange (limiting the availability of injunctive relief), Seagate (limiting treble damages), KSR v. Teleflex (reinforcing the non-obviousness standard), and Microsoft v. AT&T (limiting offshore infringement liability) have clearly limited the legal options of patent holders. As for damage awards, the premier example of excessive damages raised in the past—the Alcatel-Lucent v. Microsoft decision—was overturned on the basis that the damages awarded were indeed excessive under the existing law. This suggests that the present system works and is not in need of fundamental overhaul in the form of mandatory apportionment.

California is at the epicenter of this debate, so we are hopeful that Senator Feinstein's thoughtful views will be reflected in the legislation. We appreciated her efforts during last year’s debates on patent reform and we stand ready to work with her to ensure that reform of the patent system maintains and strengthens protections for innovations across all sectors of the economy.

CHI-Advancing California biomedical research and innovation.

Legislation for Follow-on Biologics Must Not Hinder Innovation

California Healthcare Institute supports the creation of a science-based pathway for the U.S. Food and Drug Administration (FDA) to review and approve follow-on biologic drugs. But we are concerned that the legislation introduced today by Chairman Waxman, Representatives Pallone, Deal and Emerson may actually hinder the development of new biotechnology therapies.

To serve the public interest, follow-on biologics legislation should incorporate three essential principles: employing the best science to make sure that products are safe for patients, encouraging price competition among manufacturers, and providing ample incentives to encourage continued private-sector investment in the next generation of breakthroughs.

While the FDA has an excellent track record ensuring the safety of generic drugs, scientists at the agency are far more cautious about follow-on biologics. Generic drugs are chemical compounds whose molecular structure can be copied precisely. The Waxman legislation would give the FDA wide discretion to determine what studies are necessary to determine the safety and efficacy of a follow-on biologic, and whether a follow-on product could be considered interchangeable with an innovator’s drug. In fact, the bill would empower the Secretary of Health and Human Services to make determinations of interchangeability before the FDA has completed its scientific and technical analyses. Yet biologics are genetically engineered living cells, which are vastly more complex than traditional pharmaceuticals. Indeed, FDA officials have suggested that biologics’ complexity is so great that even using the most advanced science, there is no way to know whether or not a follow-on biologic is an exact copy. Clearly there is a need for clinical studies, well beyond the requirements of the Waxman bill, to ascertain the safety of follow-on biologics.

The new legislation poses economic risks as well. It mirrors the Hatch-Waxman bill of 1984, which opened the door to generic drugs. Hatch-Waxman allowed innovators a protection known as the “data exclusivity period.” The innovator’s drug was permitted a minimum of five years post-approval on market before a generic competitor could use the original manufacturers’ clinical trial data to establish the generic’s safety and efficacy. The new legislation would extend this same approach to biologics. Yet today’s biotech industry, and the time and expense of developing a novel biotech drug—now more than 15 years and almost $1 billion—bear little resemblance to 1984’s pharmaceutical industry. Other legislative approaches, including one endorsed by Sen. Kennedy, have included substantially longer periods of data exclusivity. And we believe an extended period is necessary to encourage investors to continue to put up the risk capital on which the entire American biotechnology industry was founded.

Biologic drugs represent the cutting edge of medical research and biotechnology has developed advanced therapies and treatments for patients based on this technology. Continued research and development will lead to better, more personalized treatments, and perhaps cures, for these and other rare diseases.

Our industry supports more than 270,000 jobs in California—a number that balloons to more than one million when one considers indirect employment statistics—many of which are high-wage, high-value jobs. We are one of the few sectors of the economy creating jobs; a vital engine driving California’s future. As an industry dependent on large and risky investments to support research and development timelines that take more than 15 years, though, our firms are struggling like many others in the current economy. Promising research that could lead to cures and treatments for cancer, HIV/AIDS, Parkinson’s and other diseases are jeopardized by policies that do not reward innovation.

We urge Congress to move carefully on this issue and ensure that any pathway for approving follow-on biologics respects sound science, safeguards patient safety and provides incentives to continue research and development of breakthrough therapies and cures.

CHI-Advancing California biomedical research and innovation

CHI Applauds President Obama's Expansion of Federal Funding to Stem Cell Research

Saving and improving lives through medical innovation is the ultimate goal of the life sciences industry, and its greatest benefit to humankind. CHI enthusiastically supports President Obama’s decision to allow the National Institutes of Health (NIH) to fund stem cell research. CHI believes that stem cell research holds great promise for breakthrough, novel therapies and, one day, cures for millions of patients in the U.S. and around the world who suffer from dread diseases and conditions such as spinal cord injuries, blindness, diabetes, Parkinson’s and Alzheimer’s, and others.

California has been on the leading edge in stem cell research since the passage of Proposition 71 in 2004 and the development of the California Institute for Regenerative Medicine (CIRM). With the recent infusions in research dollars to the National Institutes of Health in President Obama’s stimulus package, and now the lifting of the research ban, California is uniquely positioned to capitalize on this opportunity to advance important, life-saving research.

Today’s action to expand NIH funding of stem cell research is a welcome and critical step—one that shows this administration’s willingness to base its decisions on sound science. But stem cell research has a long way to go before it can deliver on the promise of cures for critical unmet medical needs. To realize the promise of stem cell research and the intent of the millions of California voters who overwhelming passed Proposition 71, new medicines must be commercialized and used to treat patients. Policies need to reward medical innovation and minimize barriers to technology transfer to encourage the speedy delivery of new treatments derived from stem cell research. CHI will continue to work diligently with legislators to develop public policies that advance biomedical science, biotechnology, pharmaceutical and medical device innovation in California.

CHI-Advancing California biomedical research and innovation

Inaugural Reflections

Listening to President Obama speak this morning, I was struck by the tone of his inaugural address, more somber and subdued than the rhetorical tour de force many had expected. In fact, his speech was in keeping with the serious tone he adopted in Chicago, the evening he won the election. His over-arching theme was individual and collective responsibility, "the price and promise of citizenship," as he put it. And he emphasized both the need to make tough choices and to resist the impulse to serve narrow interests. This has implications for healthcare, an issue he numbered among the great challenges facing the United States, along with two wars and the economic crisis. For the central problems in our healthcare system—47 million uninsured, inconsistent quality, runaway spending—reflect failures of responsibility and lack of political will to make hard choices. As much as any issue, foreign or domestic, coming to grips with healthcare will test Obama's leadership and whether he can break with the past or merely reframe old problems in a new administration. Ultimately his success in governing may depend on his ability to inspire the levels of idealism that served him so well in his campaign for the presidency.

CHI-Advancing California biomedical research and innovation

Healthcare Reform: Lessons from Abroad

In a remarkably thoughtful and lucid essay, Atul Gwande, a Boston cancer surgeon, surveys national health systems in other industrialized democracies and examines how they came into being. Outside the United States, from Britain to Australia, national systems guarantee medical coverage for all citizens. And while far from perfect, each is popular and successful in providing care. From country to country, however, the circumstances that led to universal coverage were quite different. In Britain, for example, government assumed an increasing role in managing physicians and hospitals as a result of German bombing and massive relocation of citizens to the countryside. Gwande explains that the NHS was not the result of ideology or social architecture. The National Health Service (NHS), formally established in 1948, essentially institutionalized a government-managed system already put in place by the war.

Borrowing from economics, Gwande suggests that our healthcare system, like so many other industries and institutions, is “path-dependent.” That is, choices made in the past – e.g. to subsidize private health insurance purchased by employers – strongly influence today’s alternatives. In designing a program to cover the uninsured, control costs and improve quality, “we’ll inevitably want to build on the institutions we already have,” Gwande writes. “That precept sounds as if it would severely limit our choices. But our health-care system has been a hodgepodge for so long that we actually have experience with all kinds of systems. The truth is that American health care has been more flotilla than ship.” Beyond employer-sponsored private insurance, there is Medicare, Medicaid, the Veterans Administration as well as the Federal Employees Health Benefits Program. Each could be modified to expand coverage to new groups.

Gwande concludes by describing how his home state of Massachusetts has achieved nearly universal coverage (97.4 percent) by building on its existing system, mandating coverage and providing subsidies for low-income people. And while his patients sometimes used to forgo needed care in the past, “for the past year, I haven’t had a single Massachusetts patient who has had to ask how much the necessary tests will cost; not one who has told me he needed to put off his cancer operation until he found a job that provided insurance coverage. And that’s a remarkable change: a glimpse of American health care without the routine cruelty.”

To read Gwande’s essay in The New Yorker, click here.

CHI-Advancing California biomedical research and innovation

Obama and the Trial Lawyers -- What to Expect

At first glance, the election of Barack Obama, an attorney who was president of the Harvard Law Review and who taught constitutional law at the University of Chicago, would seem promising for the trial bar. Plus, Vice President-elect Joe Biden has a long record in the Senate as a friend of plaintiffs' attorneys. With solid Democratic majorities in both houses of congress, some fear, America's inclination to litigate could quickly worsen.

Even so, there are some encouraging signs. In Obama's book, The Audacity of Hope, he suggests that the benefits of regulation must be weighed against its costs. Moreover, the transition team has announced that Obama plans to appoint Cass Sunstein, his former Chicago colleague who recently moved to Harvard as the Felix Frankfurter professor of law, to head the Office of Information and Regulatory Affairs in the new administration. This is a key job in determining the president's approach to regulatory policy, and Sunstein's appointment sends a positive signal. Sunstein's most recent book is Nudge: Improving Decisions about Health, Wealth, and Happiness (2008), co-authored by economist William Thaler. The book elaborates the theory of libertarian paternalism and applies the field of behavioral economics to law. The central concept is that institutions can maintain people's freedom of choice while also guiding their decisions in directions that improve their lives. The classic example is that when employers offer employees a 401(K) plan, most people will participate if the default option is opt-in rather than opt-out. Sunstein and Thaler argue that "people often make poor choices - and look back at them with bafflement! We do this because as human beings, we all are susceptible to a wide array of routine biases that can lead to an equally wide array of embarrassing blunders in education, personal finance, health care, mortgages and credit cards, happiness, and even the planet itself." Though he is often classified as a liberal, Sunstein supported the nomination of Chief Justice John Roberts to the Supreme Court, and during his years at University of Chicago occasionally found himself allied with conservatives. Like Obama, he may prove to be a centrist and pragmatist.

To read about Sunstein's views of Obama, whom he calls "A Visionary Minimalist," click here.

CHI-Advancing California biomedical research and innovation

Patents and Drugs: Is the Present System Working?

The pharmaceutical industry is frequently singled out as the prime example of a successful U.S. patent system. But Benjamin Roin, a junior faculty member at Harvard Law School, argues a different view. To his way of thinking, the most basic standards of patent law -- that inventions can only be patented if the are novel and non-obvious -- undermine the development of new drugs. This is because much or most of the cost of producing a new pharmaceutical product derives from a long and costly regulatory process: series of clinical trials demanded by the U.S. Food and Drug Administration (FDA). Without FDA approval, a new drug is not eligible for marketing. So, unlike other industries in which novelty and non-obviousness make sense, in drug development such requirements "bear little relationship to the social value of those drugs or the need for a patent to motivate their development."

If, for example, academic scientists publish their research findings about a compound, it may be considered no longer novel, whether or not the scientists had any idea how it could be used as a drug. Without a strong patent, manufacturers are reluctant to invest hundreds of millions in clinical studies, knowing that a generic company could duplicate their product as soon as it was proven successful. "Congress can easily avoid this problem," writes Roin, "by ensuring that the successful completion of the FDA's rigorous clinical trial process is rewarded with a lengthy exclusivity period enforced by the FDA."

His argument, that the way to address inadequacies in the patent system with respect to drugs is not to rewrite intellectual property law, but rather for Congress to change FDA regulation to provide longer periods of data exclusivity, commensurate with the cost of complying with the regulatory process, is suggestive for the issue of follow-on biologics.

To read Roin's paper, click here.

CHI-Advancing California biomedical research and innovation

Life Sciences in the Obama Administration: A Perspective on Harold Varmus

On December 26, President-elect Obama announced his team of science and technology advisors, including MIT geneticist Eric Lander and Harold Varmus, president of Memorial Sloan Kettering, former Director of the National Institutes of Health (NIH) and a co-recipient (along with J. Michael Bishop) of the 1989 Nobel Prize in Physiology or Medicine for discovery of the cellular origin of retroviral oncogenes. These appointments signal a fresh political perspective on scientific advice. Announcing his selections, Obama said that promoting science goes beyond providing resources, that it is also about promoting free inquiry and listening to what scientists have to say, “especially when it is inconvenient." Varmus is out with a new book in February, The Art and Politics of Science, which chronicles his experiences at NIH. Of particular interest is his discussion of how research priorities are set and the ongoing tension between political and scientific interests. "One of my first exposures to this problem occurred soon after I arrived at the NIH," Varmus writes, "when I received a call from my own former congresswoman, Nancy Pelosi, asking me to add $50 million to the budget for AIDS research." He declined "as politely as I could," but knew that Rep. Pelosi's position on the House Appropriations Committee made her a power to contend with. To read an excerpt in The New Scientist, click here.

CHI-Advancing California biomedical research and innovation

CBO’s Magnum Opus: Healthcare and Insurance Reform

Just before Christmas, the Congressional Budget Office (CBO) issued two volumes that focus on healthcare: Key Issues in Analyzing Major Health Insurance Proposals and Budget Options, Volume 1: Health Care. These documents expand CBO’s previous work on health insurance and healthcare financing and, as CBO Director Peter Orszag writes in his blog, “are intended to assist the Congress as it contemplates possible changes– both large and small– to federal health programs and the nation’s health insurance and health care systems.” While these new volumes make no recommendations, Orszag has been named by President-elect Obama to lead the Office of Management and Budget, so the substance of his work at CBO will gain momentum in the new administration.

The two documents do not make for light reading. The volume on health insurance http://www.cbo.gov/doc.cfm?index=9924 covers the public and private insurance markets as well as funding, benefit design and financial incentives for patients and providers. If there is an implicit argument, it is that the present fee-for-service system of paying physicians is incapable of reining in costs. What should replace it to align providers’ incentives with efficiency and better cost management remains unclear.

The volume on budget options http://www.cbo.gov/doc.cfm?index=9925 contains 115 specific items. Its chapter headings provide an overview:

• The private health insurance market
• The tax treatment of insurance
• Changing the availability of health insurance through existing federal programs
• The quality and efficiency of healthcare
• Geographic variation in spending for Medicare
• Paying for Medicare services
• Financing and paying for services in Medicaid and SCHIP
• Premiums and cost sharing in federal health programs
• Long-term care
• Health behavior and health promotion
• Closing the gap between Medicare’s spending and receipts.

To read Peter Orszag’s blog, click here.

CHI-Advancing California biomedical research and innovation

Big Question 2009: What Will Change Everything

Beginning several years ago, John Brockman, the digital impresario and creator of the website www.edge.org, has started off each New Year by posing what he calls “the World Question.” Respondents run the gamut from physicist Freeman Dyson to novelist Ian McEwan. This year’s question is, “What will change everything? What game-changing scientific ideas and developments do you expect to live to see?”

Many responses focus on breakthroughs in the life sciences. Psychologist Steven Pinker, for example, after saying that predicting the future is impossible, suggests that personal genomics will transform medicine, as it expands beyond physiology to explain “temperament and cognition.” Neuroscientists talk about developments from direct, brain-to-brain communication of feelings and thoughts, to electrical brain stimulation to manage mood disorders, to cryonic suspension of brains.

Not surprisingly, one of the grandest ideas comes from J. Craig Venter, who writes: “We can start with digitised genetic information and four bottles of chemicals and write new software of life to direct organisms to do processes that are desperately needed, like create renewable biofuels and recycle carbon dioxide. As we learn from 3.5 billion years of evolution we will convert billions of years into decades and change not only conceptually how we view life but life itself.”

The contributors are alphabetized. To browse through them, or find a particular person, click here.

CHI-Advancing California biomedical research and innovation

Marcia Angell Zeros in on Conflicts of Interest

Marcia Angell, author of The Truth About the Drug Companies: How They Deceive Us and What to Do About It (2004), has just published her latest polemic in the January 12 issue of the New York Review of Books. The influence of pharmaceutical manufacturers has become so profound and pervasive, she writes, that “it is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines.” This is a conclusion she reached “slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.”

While Angell is hard on drug companies for over-promoting their products, and inventing new disorders to stimulate demand for their treatments, she is even harder on the medical profession. In a capitalist economy, after all, companies are responsible for increasing shareholder value. But “physicians, medical schools, and professional organizations have no such excuse, since their only fiduciary responsibility is to patients.” To her way of thinking, doctors and academic medical centers should never take money from industry, beyond the direct cost of research projects. Nuance and ambiguity do not figure into her view of the world. Money corrupts; there are no benign conflicts of interest.

She maintains that the present controversies surrounding relationships among industry, physicians and medical schools – stirred by Sen. Charles Grassley and others in Congress – are creating a crisis of confidence in the integrity of American medicine. Unless the medical profession endeavors to “put and end to this corruption . . . the government will step in and impose regulation.” Still, most of us would agree with her conclusion: “No one in medicine wants that.”

http://www.nybooks.com/articles/22237

CHI-Advancing California biomedical research and innovation