Tag Archives: R&D

AZ Supports 21st Century Cures Initiative

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By Jacqueline Kirby, Vice President, US Government Affairs

Jacqui KirbyCongress recently moved biomedical innovation in the United States forward in a significant way, as the House Energy and Commerce Committee unveiled its draft 21st Century Cures Initiative legislation and the Senate HELP Committee released its “Innovation for Healthier Americans” report.

We at AstraZeneca support the 21st Century Cures Initiative as we noted last August. We believe it is an important step toward encouraging the discovery of cures and treatments for some of the most debilitating diseases and conditions while helping to ensure that the United States remains at the forefront of biomedical research.

The 21st Century Cures Initiative is designed to “take a comprehensive look at what steps we can take to accelerate the pace of cures in America.” The House E&C Committee examined “the full arc of this process – from the discovery of clues in basic science, to streamlining the drug and device development process, to unleashing the power of digital medicine and social media at the treatment delivery phase,” as noted in the mission statement.

Upon initial review, we are pleased to see that the draft of legislation addresses many of the topics we included in our written recommendations to the Committee, including biomarkers, antibiotic drug development and reimbursement, utilizing real world evidence for regulatory decision-making, modernizing clinical trials (through encouraging broader use of Bayesian statistics and adaptive trial designs), and FDA review and evaluation of combination products.

AstraZeneca likewise applauds the Senate HELP Committee’s release of the “Innovation for Healthier Americans” report. “’Innovation for Healthier Americans’ is an important call to action, soliciting input and participation from the full universe of stakeholders interested and/or involved in medical innovation in America,” former FDA Commissioner Dr. Andrew von Eschenbach wrote in introducing the report. The report aims to examine the current drug development process, identifying inefficiencies in this process that stand in the way of bringing new medicines to patients and soliciting stakeholder feedback.

AstraZeneca is committed to working closely with members of Congress on the 21st Century Cures Initiative and on the related Senate FDA reform effort in the months ahead to ensure the United States remains a leader in biomedical research.

21st Century Cures Twitter 2.2.15

AZ R&D Boston Hosts U.S. Congresswoman Clark

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(Left to Right) Alice Pomponio, Head of North America Science Affairs, AstraZeneca; Carl Barrett, VP Translational Sciences, Oncology Innovative Medicines, AstraZeneca; Ambar Ahmed, Research Scientist, Oncology Innovative Medicines, AstraZeneca; Rep. Katherine Clark, U.S. House of Representatives; Jeff Brown, Director Translational Science Lead, Oncology Innovative Medicines, AstraZeneca; Melanie Frigault, Translational Science Strategist, Oncology Innovative Medicines, AstraZeneca; Jacqueline Kirby, VP US Government Affairs, AstraZeneca

On March 10, AstraZeneca leaders hosted U.S. Representative Katherine Clark at the company’s Boston Research and Development (R&D) site in Waltham, Mass. for an overview of the company’s discovery research and a tour of its laboratories.  The Waltham location – which employs hundreds of talented AstraZeneca researchers, scientists and support staff representing more than 30 nationalities – serves as the company’s headquarters for small-molecule discovery research in North America and global infectious disease research, with an additional significant focus on oncology drug research.

The tour featured opportunities for Rep. Clark to learn about AstraZeneca’s scientific discovery center, conduct of pharmacologic safety assessments, and the company’s research in oncology.

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(Left to Right) Prasad Nadella, Acting Head of Pathology, Global Safety Assessment, AstraZeneca; Rep. Katherine Clark, U.S. House of Representatives; Geoff Gallo, Director, U.S. State Government Affairs, AstraZeneca

“It was a pleasure to visit with senior leaders and scientists at AstraZeneca’s Waltham R&D facility to learn about the cutting-edge research and strategic partnerships that are helping to advance science and further the discovery of new medicines.”

As part of the burgeoning Boston R&D community which boasts more than 450,000 healthcare and medical research employees, more than 400 biopharmaceutical companies and more than 53,000 biotech employees, AstraZeneca has forged a number of innovation collaborations with area organizations.  These include the Broad Institute, Massachusetts General Hospital, Harvard University, Massachusetts Institute of Technology (MIT), Tufts University, Moderna, X-Chem, Enlight Biosciences, Foundation Medicine, Cubist Pharmaceuticals and more.

Opened in 2000, AstraZeneca’s Waltham R&D complex has since expanded to more than 500,000 square feet, including 285,000 square feet of laboratory space.  In addition to this site, AstraZeneca has a manufacturing facility located in Westborough, Mass. and a neuroscience research team based in Cambridge, Mass.

AstraZeneca’s roots in Massachusetts extend much farther than the research community.  For decades, the company has provided qualified patients in the state with free medicine through its patient assistance programs, which include AZ&Me and the MedImmune Assistance Program.  In 2013 alone, these programs provided more than $1.3 million in savings to more than 760 patients in Massachusetts.

AstraZeneca’s commitment to Massachusetts is also reflected in its community partnerships and investments.  The AstraZeneca Hope Lodge, for example, arose from the company’s collaboration with the American Cancer Society and allows cancer patients and their family members to reside free of charge while they receive treatment for their illnesses in some of the world’s premier hospitals.

AstraZeneca hosts R&D and VC Days in Boston

AstraZeneca uses these 5 R’s to pursue competitive opportunities.

AstraZeneca leaders traveled to the company’s research facility in Boston this week to meet with representatives of venture capital firms and academic institutions who are interested in learning more about the company’s partnering goals.

Our business model is driven by investment in innovative, prescription-based biopharmaceutical R&D. But the pace of scientific and technological advance means that companies like ours can no longer always go it alone.

More than ever before, we are looking beyond our own laboratories to find partners with complementary skills and common goals. In fact, we are aiming for as much as              40 percent of our pipeline to be sourced from partnerships by 2014.

Shaun Grady, VP Strategic Planning and Business Development, AstraZeneca describes:

“The R&D and VC Days have both been a fantastic opportunity to demonstrate our credentials as a partner of choice in our drive to widen our portfolio through external R&D partnerships or acquisitions. It has been incredibly valuable to discuss face to face our mutual areas of interest with some of our key target audiences in order to gain a better understanding of our common goals and cement future relationships.”

AstraZeneca has nine innovative medicine units responsible for sourcing innovation from both inside and outside our own labs. Members of these teams are constantly scouting for new partnerships and collaborations that could benefit both parties, and ultimately the patients who rely on medical research and our industry for new medicines.

“We are looking for scientific excellence and  early and late-stage products, and have established  an evaluation framework known as the ‘5 R’s’  to ensure that we are pursuing the most competitive opportunities,” said Mene Pangalos, Executive VP, Innovative Medicines, AstraZeneca.

More detail on these evaluation criteria can be found here.

AstraZeneca has more than 1,200 alliances with academia and industry partners. AstraZeneca is also actively investing in emerging and innovative biotech companies through MedImmune Ventures, our corporate venture capital fund, helping them translate valuable scientific discoveries into exciting and marketable new medicines.

Visit our partnering website for more information or to take an interactive journey through our world of collaborations.

GAINing ground against Superbugs

Nearly 100,000 Americans lose their lives every year to infections, according to the CDC.

Infectious diseases are spreading across country borders, and the antibiotics that doctors previously relied on are becoming less effective.

Why?

Infection-causing bacteria, or Superbugs, are fighting back.

They are constantly evolving and mutating in a bid to survive, which means our aged arsenal of antibiotic medicines is simply not enough.

The Generating Antibiotic Incentives Now (GAIN) Act of 2011 will be an important step forward in providing balanced incentives for antibiotic research and development, which has languished during the past 10-20 years.

Today, only a handful of companies, including AstraZeneca, are investing in infection research. AstraZeneca scientists in Boston are collaborating with colleagues across the globe for novel antibacterial and antiviral medicines. In fact, our $100 million expansion of new laboratories in Boston was driven by the strategic business decision to expand our discovery research in infection.

A combination of factors has led to the industry’s diminishing antibiotic pipeline, including a limited market for these short-term therapies (especially as compared to drugs that treat chronic diseases) and the need for clear guidance from FDA on viable clinical trial design. 

Discovery of new antibiotics is painstaking because the Superbugs we battle are so smart. These bacteria have multiple mechanisms of resistance, and it is difficult to find drug candidates to fight them.  When a new treatment is found, resistance can develop before the new drug even reaches the market. 

The GAIN Act addresses these challenges by proposing an extended term of exclusivity for infectious disease products, combined with priority review and fast track provisions.

The additional extended exclusivity provided for companion diagnostic tests will further support innovation.  Requiring FDA to provide much-needed guidance on the conduct of clinical trials for antibiotic drugs generally as well as, upon request, specific advice on nonclinical and clinical investigations for individual qualifying pathogens is critically important to the development and approval of new antibiotics. 

Without effective antibiotics, modern medical care would not be possible. Even routine procedures – hip replacements or chemotherapy for cancer patients – can’t happen safely without effective guards against infection. 

AstraZeneca is asking Congress to support the GAIN Act and help our industry stop the Superbugs.

-by Laura Woodin

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