Tag Archives: 21st Century Cures

AZ Brings Together Thought Leaders to Discuss 21st Century Cures Initiative

Last week AstraZeneca, in partnership with the National Journal, brought together thought leaders from key patient groups, payers, advocacy stakeholders and media for a thought leadership dinner in Washington, DC. Greg Keenan, Vice President, Medical Affairs and U.S. Head Medical Officer, AstraZeneca, Steve Mohr, Deputy General Counsel, North America and U.S. General Counsel, AstraZeneca and Rich Buckley, Vice President, North America Corporate Affairs, AstraZeneca participated in the first of five events to be hosted this year with the National Journal, with a specific focus on the 21st Century Cures initiative, which AstraZeneca proudly supports.

Earlier this year, the House Energy and Commerce (E&C) Committee released the first draft of its highly anticipated 21st Century Cures initiative. The proposed legislation – and its focus on accelerating the discovery, development, and delivery of new medical treatments and technologies – combined with the report released by the Senate HELP Committee’s “Innovation for Healthier Americans” and President Obama’s Precision Medicine Initiative, have reignited the debate about biomedical innovation and regulation in Washington.

Furthest along in this debate is the E&C Committee’s draft legislation, which has raised important questions about how drug manufacturers can expedite the development of effective, personalized treatments, while ensuring their safety and value for patients. What is the proper role of government in this process? And will legislation on these topics reach the President’s desk by the end of the year?

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As a company committed to listening and learning from all sides of the discussion, members of AstraZeneca’s North America leadership team were joined by 17 thought leaders and members of the media, representing companies such as Quintiles, Avalere, National Pharmaceutical Council, Aetna, AARP, National Center for Health Research and Manhattan Institute for Policy Research. Marilyn Werber Serafini, Vice President for Policy at the Alliance for Health Reform moderated the evening’s discussion, which brought forward four key themes attendees felt were fundamental to address in the House’s legislation:

  1. Importance of enhancing health care professional (HCP) engagement/participation in clinical trials
  1. Integrating patient-centered approaches into clinical trial design
  1. Continued funding of NIH and FDA through PDUFA, and holding the FDA accountable to measurable outputs
  1. Ensure a clear path for innovation that protects patient safety within the drug discovery, development and approval process

NJ_AstraZeneca_Dinner_051The candid discussion elevated a diversity of perspectives around the scope of the proposed legislation. One participant expressed concerns with patient safety coming at a sacrifice to innovation, which should not just mean “new” medicines, but those that meet a true unmet need and are both better and safer for patients.

As an alternative perspective, several attendees saw a clear effort being made by industry to deliver innovative medicines, but recognized there was a need to accelerate and modernize the FDA’s processes in order to bring those treatments to patients sooner.

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One guest in particular emphasized the importance of incentivizing physicians to participate in clinical research by removing barriers for this to happen and working within their hospitals and institutions to gain alignment on what this incentive framework looks like.

Despite differences of opinion and a diversity of voices at the table, there was alignment around a fundamental need for a healthy and innovative clinical research landscape that keeps HCPs, patients and patient safety at its core.

The dinner was part of a series of events coordinated by National Journal LIVE, a premier events business that convenes top leaders in the Washington, D.C. area to discuss possible solutions to the country’s biggest challenges.

“Innovation for Healthier Americans” U.S. Senate Initiative Aims to Advance R&D

On March 10, the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee held its first hearing on its “Innovation for Healthier Americans” initiative. Dr. Francis Collins, Executive Director of the National Institutes of Health (NIH) and Dr. Margaret Hamburg, Commissioner of the Food and Drug Administration (FDA) were the witnesses at the hearing. This Senate effort to accelerate the development of new cures and treatments for patients is a similar, parallel effort to the U.S. House Energy & Commerce Committee’s 21st Century Cures Initiative.  Both of these Congressional endeavors share a common goal with President Obama’s Precision Medicine Initiative, which involves increasing funding for multiple federal agencies in order to improve health information technology interoperability, while expanding and optimizing treatments for cancer in a variety of ways.

AstraZeneca supports the Senate HELP Committee’s Innovation for Healthier Americans Initiative. We provided initial recommendations to the Committee, encouraging them to focus on exploring potential enhancements to the qualification pathway for certain drug development tools, such as biomarkers. We also encouraged the exploration of ways to get the FDA to more readily embrace modern clinical trial designs and methodologies. We are encouraged that the Senate HELP Committee and the House Energy & Commerce Committee are interested in tackling this important issue and we stand ready to work with both Committees in support of their efforts to advance medical innovation during this Congressional session.

As articulated by Sen. Lamar Alexander (R-TN,) the Chair of the Committee at the hearing, the goal of this bi-partisan effort is the identification of what the Congress, along with the President, can do to reduce the cost and the amount of time it takes to discover a medicine and deliver it to patients.

While much of the discussion at the hearing centered on the need for adequate and consistent funding for the NIH and the basic science it conducts, there was also discussion of the important role that biomarkers can play in advancing personalized therapies for patients. Both Dr. Collins and Dr. Hamburg indicated their appreciation for having the opportunity to discuss what more can be done to drive innovation in our nation, with Commissioner Hamburg stating that she “wants the FDA to be a gateway, not a barrier, to getting safe and effective medicines to patients.”

Learn more about the Innovation for Healthier Americans initiative here and follow the latest on 21st Century Cures with #Cures2015 on Twitter.

AZ Supports 21st Century Cures Initiative

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 Submits Recommendations to the Committee on Energy and Commerce to Better Serve Patients

With 3D printers that create human body parts to wearable technologies that transmit patients’ vitals in real-time to physicians, the paradigm of drug development is changing more rapidly than ever before. While the opportunities for innovation are boundless, recent figures from FasterCures, a center of the Milken Institute, suggest that there are still only 500 treatments available for an estimated 7,000 known diseases.

AZ1442_screenAt AstraZeneca, we’re committed to pushing the boundaries of drug development to get our medicines in the hands of those who need them most. This isn’t easy. For example, according to PhRMA, it takes drug companies 10-15 years to develop a new medicine, and costs $1 billion on average. For good reason, there are many laws and regulations that govern every step of the development process, but we need to ensure these laws do not unnecessarily hinder  innovation.

That’s why we’re excited to see the Committee on Energy and Commerce, part of the U.S. House of Representatives, taking a comprehensive look for the first time at how they can help pave the way for new cures and treatments for patients through the 21st Century Cures Initiative. The Committee on Energy and Commerce has  responsibility for a number of the nation’s key priorities, including food and drug safety, and oversight of multiple agencies like the Food and Drug Administration. Over the next several months, the Committee will continue to focus its efforts on finding ways to expedite the discovery, development and delivery of innovative treatments to patients. Representatives will examine how we conduct research, looking at newly available technologies and assessing the need to break down outdated administrative and procedural hurdles, to ensure the U.S. remains a leader in biomedical innovation. And they’re asking for input.

21st Century CuresMany key industry stakeholders have submitted recommendations to benefit the healthcare industry and patients around the world. On August 12, the President of AstraZeneca U.S., Paul Hudson, and Chief Medical Officer, Briggs Morrison, pledged our support for the initiative and submitted our recommendations, which:

  • ask the Committee to support translational research (research that turns basic discoveries into applicable outcomes);
  • encourage the modernization of the clinical trial ecosystem;
  • promote the regulatory acceptance of modern clinical trial designs, tools and methodologies; and
  • suggest that the Committee ensure that payers and formularly committees have relevant information about medicines from manufacturers to speed patient access to newly developed medicines.

It is our hope that these recommendations, taken together, can help to transform the healthcare industry, improve the lives of patients and dramatically enhance the current standard of care. We’ve already had several discussions with the Energy and Commerce Committee, and we applaud their efforts to look at how the Congress can play a role in accelerating progress in advancing medicine. We look forward to continuing this dialogue as part of our efforts to deliver on our ambition to achieve scientific leadership.