SPECIAL ALERT: MassBioEd Launched their New Website this week! MassBioEd.org is the go-to STEM resource for Massachusetts educators, students, postdocs, and life sciences industry professionals. Check it out!
The head of the Food and Drug Administration today said the federal agency is working to expedite the approval of safe new drugs, but across-the-board federal budget cuts threaten to hamper its efforts. “Sequestration has added an unexpected (challenge),” Commissioner Margaret Hamburg told about 400 biotechnology leaders at the MassBio annual meeting in Cambridge. Hamburg added that she is hoping Congress will enable the FDA to access user fees the industry pays for the agency’s operating expenses. Link
2) MassBio panel tackles why rare disease treatments cost so much - Mass High Tech– 3/16/2013
One panel at the MassBio’s annual meeting on Thursday billed under the title, “Rare Disease Therapies: Is The Current Payer Model Sustainable?” probably could have more simply been called, “Why drugs for rare diseases cost so much.” The panel was moderated by Bruce Booth, a partner at Atlas Ventures, and was one of more than a dozen forums, seminars and keynote speeches over the course of the two-day annual meeting. Booth said that ever since the passage of the Orphan Drug Act – which turned 30 years old this year – about 350 orphan drugs have gone on the market. Link
3) AstraZeneca Shells Out $240M Upfront For Moderna mRNA Drugs - Xconomy– 3/21/2013
Nearly 400 biotechnology industry leaders gathered last week at the Royal Sonesta Hotel in Cambridge, right in the heart of the state’s biotech cluster, to participate in MassBio’s 2013 Annual Meeting.
The meeting took place across two days, and included discussions on healthcare reimbursement, what’s next in oncology research, the future of biosimilars and research resources sharing.
“These conversations go to the very heart of what we do and how we as an industry will operate into the future,” said Robert K. Coughlin. “We must understand our role in a shifting economic and regulatory environment and attempt to answer these big, complicated questions. Our only way forward is to address them together.”
FDA Commissioner Margaret Hamburg spoke Friday and addressed industry concerns on time to approval, the threat of sequestration and other budget cuts, and recent successes in the industry-FDA collaboration:
“I am committed to working with all of you—and many others—on the broad-based national strategy to advance biomedical product innovation that I believe is so very much needed at this critical time. I think I can say that at FDA we are striving to do our part. Success will require regulatory flexibility, advancing regulatory science, and true collaboration among health professionals, industry, government, academia, and our global health partners.”
Mass Bio’s Annual Meeting is only 2 days away! We have an exciting agenda including industry leader speakers with keynote speeches from FDA Commissioner Margaret Hamburg and John Crowley, Chairman & CEO of Amicus Therapeutics, Inc. Don’t miss out!
Join us as we honor our award recipients:
Josef von Rickenbach
Josef von Rickenbach, Chairman and CEO of PAREXEL International Corporation will be honored with the Henri A. Termeer Innovative Leadership Award for his commitment and contributions to the biotechnology industry. Read press release here.
Gloucester High School
Gloucester High School (GHS) has been named this year’s Joshua Boger Innovative School of the Year by the Massachusetts Biotechnology Education Foundation (MassBioEd) for inspiring students to explore life sciences careers through progressive biotechnology education and exemplary science career programming. Read press release here.
Massachusetts Biomedical Initiatives
Massachusetts Biomedical Initiatives (MBI) will be honored for its significant contribution and commitment to improving the competitiveness of Massachusetts as a destination for the life sciences industry with the MassBio Leading Impact Award. Read press release here.
Hope to see you there! Register Now!
MassBio Alert: FDA Commissioner Margaret Hamburg and John Crowley, Chairman and CEO of Amicus Therapeutics will deliver keynotes at the MassBio Annual Meeting being held March 14-15. Josef von Rickenbach, PAREXEL CEO will receive Henri A. Termeer Innovative Leadership Award. Register today!
1) Sequester goes into effect as President Obama and Republicans trade blame – Boston.com – 3/1/2013
Robert Coughlin, president and chief executive of the Massachusetts Biotechnology Council, said NIH cuts would disproportionately damage Massachusetts because it receives twice the funding per capita than other states. The result could be “catastrophic” for the state’s economic future because “it’s that research that is the pipeline for startups and new companies.” Link
2) Top 20 Best-Selling Drugs of 2012 - GENNews – 3/5/2013
GEN updates their list of the best-selling drugs of the 21st century with the top 20 best-selling prescription drugs worldwide of 2012, based on sales figures released by biopharma companies in press announcements, annual reports, and conference calls during 2012 and 2011. Drugs are ranked by 2012 sales. CER denotes “constant exchange rate.”Humira, Advair, Rituxan lead list of best-selling drugs in 2012. Link
3) State pumps Western Mass. schools with $9M to support life sciences – Mass High Tech– 3/1/2013
Now that the March 1st deadline to avoid sequestration has passed, national focus has shifted to how Congress can avoid government shutdown at the end of the month. In the fiscal year 2013 alone, $85 billion in reductions are set to go into effect, and its impact will be felt in the coming weeks. If the impending cuts are enacted, the biotech community can expect to be affected in a number of ways.
Some of the largest sequester cuts will be to the National Institute of Health (NIH), which is the biggest funder of medical research in the U.S. The budget of the NIH is scheduled to drop 7.6 percent in the next five years, forcing the NIH to delay or halt vital scientific projects and make hundreds fewer research awards. These NIH cuts will disproportionately harm Massachusetts, as the Commonwealth receives twice the NIH funding per capita than other states. These cuts not only have the potential to devastate our state economy, but will also delay progress on preventing debilitating chronic conditions, as well as the development of more effective treatment for common and rare diseases that affect millions of Americans. Additional information on how NIH funding cuts will harm Massachusetts can be found here.
According to the White House, in the year 2013 alone, Massachusetts can expect to see a reduction in funding for vaccinations of about $201,000, resulting in thousands of fewer children receiving immunizations. In addition, cuts to the AIDS Drug Assistance Program (ADAP) could result in thousands of patients across the nation losing access to life saving HIV medications. The Massachusetts State Department of Public Health will also lose funding, resulting in 9,200 fewer HIV tests in the Commonwealth. The White House’s report on the impact sequestration will have on Massachusetts can be accessed here.
The FDA will also lose a significant amount of its funding- more than 5 percent of its annual budget. These cuts pose a serious threat for the approval of new drugs. The sequester cuts would cause the FDA’s Center for Drug Evaluation and Research (CDER) to face delays in translating new science and technology into regulatory policy and decision-making, resulting in delays in potential life-saving drug approvals.
We look forward to hearing FDA Commissioner Margaret Hamburg’s perspective on this and other issues impacting the FDA at our Annual Meeting next week. The MassBio Annual Meeting is being held March 14-15, 2013 at the Royal Sonesta Hotel.