John D. Carroll of FierceBiotech to Keynote the 2012 AZBio Awards GalaContinue reading
360 Vantage CEO Named to 2012 PharmaVOICE 100 List for Leadership, Innovation and Commitment to the Life Sciences Industry
Mario Martinez II selected as one of PharmaVOICE’s 100 most inspiring people in Life Sciences.Continue reading
On October 23rd Arizonans will be gathering from throughout the state at the Phoenix Convention Center for the 7th Annual AZBio Awards. In addition to shining a spotlight on the achievements of our industry’s leaders, we will be using this opportunity to show our appreciation to the community that has supported the biosciences over the years. The distance we have travelled isn’t merely measured in industry achievements. Every Arizonan has contributed to our progress; either directly, as an innovator, researcher, leader, or investor, or indirectly as Arizona voters and taxpayers.Continue reading
A 4th of July Message from AZBioContinue reading
On May 17th, we wrapped another successful AZBio Expo. Our community came together to share ideas, spotlight technologies, make connections and more. Over the last two weeks, I have been looking back as I edited hours of great videos that are full of insights shared by leaders from across our community.
The last of the videos is below. It begins as it should with a note of thanks to everyone who helped us make the AZBio Expo 2012 a great day. It ends with a look at what comes next as we move forward. We can learn from hindsight but our forward facing activities require focus on the road ahead and the a driving force to take us there.
In case you missed it, here are the closing remarks from the 2012 AZBio Expo…
Looking back, the lesson is that we need to reach more people both here at home and outside of Arizona. When we get the word out; when we stand out and get noticed, great things can happen. So going forward, how can we best spread the word?
We have a lot going on and a lot coming up at AZBio as we move forward faster.
This is about more that just getting nominated or winning. The AZBio Awards create the opportunity for these companies to tell their story, get noticed and most importantly, get connected to the media and others as the big day approaches. It’s our way of making sure Arizona Bioscience Innovation is where it deserves to be…in the spotlight. Learn more at www.AZBioAwards.com. Please help us aim that spotlight. Nominate someone!
Thanks to a significant investment made on behalf of our industry by the Arizona Commerce Authority, the Arizona Pavilion at the BIO International Convention is something we can all be proud of. This gives us the ability to showcase what is happening here in our community to the world from June 18th to June 21st. Here in Arizona we are changing things up and we are making the most of our opportunities in the pavillion. Our leaders are stepping up to tell our story, including Mara G. Aspinall, President, Ventana Medical Systems, Inc. and Head of Roche Tissue Diagnostics, representatives from the International Genomics Consortium and others. If you will be at BIO 2012 in Boston, reach out to us so that we can get YOU on the schedule too. If you can’t be with us LIVE in Boston, we will have a way for you to tell your story…virtually.
The AZBio Expo Online is being built to showcase the amazing work being done here in Arizona. It will officially launch at the BIO International Convention and be accessible 365 days a year. The system includes: Video, Data Sheets, White Papers, Webinar Sessions and more. This virtual experience brings together a cross section of our AZ Bio Industry from universities and institutes to medical device companies and diagnostic companies, as well as drug developers and industrial biotech firms. Our incubators show how they can help new companies grow. Our law firms, risk management experts and suppliers share information key to growing businesses, and every panel and presentation from the May 17th AZBio Expo 2012 is just a click away for instant replay.
Our AZBio Expo 2012 Exhibitors already have logins to the new system and are adding in their content now. You can join them in showcasing what YOU are doing here in Arizona also. Contact AdvancingBio@AZBio.org for more information and take your place on this virtual stage.
Doing great research and discovering new breakthroughs is not the end of the road, it is the beginning of the journey. Moving forward faster means getting the word out, finding new partners to work with, and sharing what you have developed with the world so that it can make a difference. Creating impact starts with making connections and AZBio and the AZBio Expo Online can help you do just that.
So are you ready to connect with the world? The doors open June 18th, but this is your invitation to come inside and to help us build the virtual experience now. Won’t you join us?
As I shared in the video above, none of this is possible without the support of our community. The video below is in appreciation to the organizations who support AZBio so that we can support you. Get to know them, they are investing in our success.
Wondering who are the companies that together are AZBio? Click here to visit the AZBio Member Directory.
Over the last few weeks the important reauthorization of the Prescription Drug User Fee Agreement or PDUFA has been top of mind for industry leaders and legislative leaders alike.
PDUFA (and its sister MDUFA) provide for the both the resources the FDA needs to fulfill its role of ensuring that products are safe and effective in a way while including performance metrics for the agency to ensure that it is efficient and does not hamper innovation. Few pieces of legislation will have a greater effect on our industry in the coming years as we shared in the letter on the importance of reauthorizing MDUFA and PDUFA last April.
Word from D.C. as of today is that the Senate has reached an agreement to limit discussion and vote to 17 amendments to S.3187, the FDA bill. Voting on these amendments will commence tomorrow, May 24 at 2:00pm Eastern time.
Overall, the proposed legislation is good for the FDA, industry and the patients that will ultimately benefit from new innovations. Of the 17 amendments, four may be problematic. Interestingly each of these 4 will require 60 votes to pass.
Importation Amendment #2107 – Sen. McCain
At face value this sounds like a good idea. Lifting the ban on importing drugs from Canada woould make less these expensive drugs available in the U.S. Free trade is good right? Usually so. But, don’t confuse this amendment with free trade. Legitimate drugs coming our of Canada at the prices established on the government schedule (similar to our medicate schedules) would in fact be cheaper in the short term, but over time the normal economic factors would come into play and the pricing pendulum would swing back as the market equalized. At best this would be a short term benefit.
Add to this the quality concerns, and this amendment is probably not making a good law better. One quality concern is that there is no exemption for biologics. Biologic products are especially susceptible to contamination and have particular and highly sensitive requirements for production, cold storage, and shipment that, if not observed, can render the product ineffective or unsafe. Here in the U.S. the FDA, working with industry ensures that the proper safeguards are in place. It is unclear how this will be accomplished with imported products. Secondly, and of even greater concern, is that there is no guarantee that drugs from Canadian pharmacies actually originate from the legitimate supply chain. Products of suspect origin or counterfeit products trans-shipped through other nations already do enter the Canadian market. These products would then be eligible for import into the United States. This concern has on the rise in Canada and should this amendment pass, the FDA simply does not have the resources to accomplish this just as the Canadians have not had the resources to fully monitor and control the supply chain there.
Patent Settlements Amendment #2111 – Sen. Bingaman/Sen. Vitter
Patent protection is the reward for the risk and huge investments made by industry in bringing innovative and life saving pharmaceuticals to market. The are the foundation these investment decisions are built on. The amendment would effectively make it commercially impossible for generic litigants to enter into settlement agreements at any stage, so every such lawsuit would have to be fought to the end – at great expense for both parties and needlessly consuming scarce taxpayer-provided judicial resources. It seems that they only party truly benefiting from this will be the lawyers. We know empirically that patent lawsuits over generic drugs are lost as often as they are won. There is no basis to believe that forcing a lawsuit on every patent and then forcing such lawsuit to be fought to the bitter end will in any way increase the “win rate” of generic litigants or benefit consumers.
Additionally, for small business this is especially concerning. Small businesses do not have massive legal resources or the funding to take an issue like this to a fully litigated conclusion. Having the ability to meet and agree to a reasonable settlement that satisfies both parties is often the small business owners only option. This amendment would remove that option and should it become law would most likely become problematic during the rule-making stage when the SBA Office of Advocacy reviews it under the Regulatory Flexibility Act. Thus, a well intended amendment is probably not a good idea. We have a legal process that already works. By entering into commercially reasonable, lawful settlement agreements, innovator and generic drug-makers today routinely settle litigation on terms that are favorable to consumers by permitting generic launch prior to the expiration of innovator patents.
Genetically Engineered Salmon Amendment #2108 – Sen. Murkowski
Earlier this month, we shared how possible amendments regarding genetically modified salmon negatively effect Arizona and the industry as a whole by setting a very dangerous precedent. This amendment would have the Congress second-guess the FDA by seeking redundant and costly studies from other federal agencies based on political and market considerations. Congress should not substitute its judgment for that of the scientists at FDA by attempting to alter FDA’s scientific review of in this case, not to mention the consultative efforts of the Commerce Department and the Interior Department, specifically National Marine Fisheries and the Fish and Wildlife Service.
Fraud Amendment #2109 – Sen. Sanders
This amendment would terminate statutory exclusivity for a drug or biologic granted under Hatch-Waxman, the Orphan Drug Act, BPCA, the BPCIA, or any other Federal Food Drug and Cosmetic Act (FFDCA) provision if there is a criminal conviction of a Sponsor, a finding of civil liability, or a settlement agreement in which the Sponsor admits to fault—not just to the violations of the Federal Food Drug and Cosmetic Act, but to other laws beyond the scope and authority of the FDA. While misdeed need to be appropriately addressed in all industries, and are, these exclusivity provisions are a critical part of the FDA statutory framework that provide a pathway for approval of generic drugs, a new pathway for approval of biosimilars, and provide the incentives deemed necessary by Congress to incentivize the development of drugs for rare diseases and research into pediatric uses of biopharmaceuticals.
Corporate and private equity investment, as well as federal grants and research contracts are the fuel for the engine of innovation in this sector. In what is often perceived as a high risk investment category, statutory exclusivity, like patents, helps to sweeten the reward if, after a very long haul, these companies are successful.
Violation of the False Claims Act, Anti-Kickback laws, Foreign Corrupt Practices Act, Social Security Act and state laws referenced in the Amendment are serious issues and already carry severe criminal and civil penalties, including fines of millions and billions of dollars, imprisonment, and exclusion from participation in federal programs. But to single out one industry with additional far reaching and economically crippling sanctions is neither fair or reasonable. The first time it is applied, it is likely to be challenged in the courts, but until then it creates yet one more reason for wary investors to shy away from all companies in the sector. Ultimately, weakening incentives for biomedical innovation only serves to hurt patients awaiting new therapies for devastating diseases; not punish bad actors who are a rare exception to the rule.
Wrapping it up
Reauthorization of PDUFA is critical to the health of the bioscience industry, the efficiency and effectiveness of the FDA, and to the patients who desperately need these future life saving innovations. That is why the FDA and industry worked long and hard to present an agreement that meets the needs of the FDA, the industry and most importantly the American people. Members in both Houses of Congress have worked tirelessly to bring a very good law to the floor but it is always good to remember that not all changes are necessarily improvements.
Tomorrow will be an interesting day on Capitol Hill.
A key requriement for our bioscience community to keep movng forward faster is the approval of the 2012 PDUFA agreements. Something fishy could hold things up and AZBio shares the G2 on why this is not a good idea. Continue reading
Governor Brewer Signs Legislation to Aid Small Businesses, Spur Investment and Create JobsContinue reading
The AZBio begins tomorrow at 7:30 AM . See who will be showing up…Continue reading