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