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Lately it seems that drug developers and media alike are awakening to the profound impact of patients and patient organizations in driving the direction of medical research. Frustrated by the lack of options and armed with a unique understanding of the challenges, these foot-soldiers for cures are taking their fight from the bedside to the lab – funding high-risk, high-reward research projects, finding and fostering scientific expertise, and shifting the perception of patients as advocates to patients as participants. This panel will address lessons in patient participation – how to find and engage them before you need their help, what they're doing to speed medical progress in their diseases, and what you can learn from their pioneering efforts.
Election 2012: What does it mean for medical research?
This panel will focus on the implications of the outcomes of the November elections for biomedical research and innovation. What will happen to funding for science in an era of constrained federal and state budgets? How will efforts to reign in healthcare costs – with or without the Affordable Care Act – impact medical innovation? How will economic policy issues influence the direction of the biopharma industry? What initiatives should the new administration and Congress pursue in order to support biomedical innovation and leadership in the U.S.?
Translational research: Getting into humans faster
Our national investment in basic science is producing dividends as measured by the thousands of promising new discoveries that now need to move through the translational research process and into humans. Between the new National Center for Advancing Translational Sciences and the Cures Acceleration Network at NIH, and multiple novel financing and operational experiments taking place in academia and industry, the translational train has left the station. What are the next big innovations coming out of this effort that can help us get to human clinical trials faster? How can we better identify and fix failures in the process of moving compounds from animal models to humans? Can systems biology help? How can we accelerate development and regulatory pathways to proof of concept? What can be done to improve the reproducibility of results?
Beyond business as usual: Disrupting the biopharma business model
"Disruptive innovation" is all the rage in the business community, and the term is catching on in the biopharmaceutical industry, which may be the industry currently most in need of disrupting. But who is doing anything that might truly disrupt the biopharma business model, rather than just improving on how things are done now? Are we seeing the "dis-integration" of the pharmaceutical industry? Are there new players, new partnerships, new roles to be filled?
Tech transfer 2.0: Innovation in university commercialization
There is a growing realization that the traditional model of technology transfer at universities isn't entirely keeping up with the growing complexity and changing landscape of biomedical research and development. Though agreement structures are still evolving and funding sources are changing, a growing appetite for earlier information sharing and partnering have led to new and creative approaches to collaboration. What do these models look like? Can they be replicated? How can we incentivize a continued focus on advancing basic scientific discovery while at the same time supporting early-stage development?
What you probably don't know about innovation at the FDA
The Food & Drug Administration is frequently criticized for being a significant barrier to innovation, accused of being slow and unpredictable in its reviews and approvals. But most people, even within the pharmaceutical industry, are probably unaware of the many efforts in which FDA is engaged in trying to smooth and speed the drug development process. From qualification of new drug development tools to mining the mountains of data in its possession, FDA is working with partners in a variety of ways to improve the process from the earliest days of research. This session will review some of those efforts, evaluate their success thus far, and consider what further efforts are needed to improve FDA's ability to review the innovations coming through the development pipeline.
He who pays, eats: The evolving role of payers in the R&D ecosystem
Payers, including the federal Centers for Medicare and Medicaid Services, are taking an increasingly visible seat at the R&D table, long before they get asked to pick up the tab. They're mining their vast databases and partnering with pharmaceutical companies to help them develop more personalized medicines faster. What's coming next? Is it possible we'll see a future where payers reimburse only for drugs proven to work in certain populations? Will they co-sponsor clinical trials and share risk with developers? Could such collaboration revive waning investor confidence? How can we ensure the incentives of all the stakeholders are aligning to the greatest extent possible – and that the interests of patients remain the centerpiece?
Can clinical trials be better, faster, and cheaper?
It's impossible to talk about "faster cures" without talking about significantly reducing the time and cost of the clinical trials process. The challenges are well known, and many solutions have been proposed, but "transformation" has been elusive. This panel will discuss current innovations that could feed such systems change, including new trial models (such as adaptive trial designs, point-of-care studies, "clinical trials in a box"); better use of technologies for data collection and analysis as well as patient screening and recruitment (including mobile technology and electronic health records); and critical business process improvements such as reducing site monitoring and data validation costs and study start-up costs.
Optimists only: Why biopharma is still a great investment
The "VC retreat" from early-stage life sciences financing has created both a gap and an opportunity. While some firms have notably exited the field, new players have emerged, including biopharma VCs, public-private partnerships, and sovereigns. This panel will bring together investors that have recently become large players in life science investments to discuss why they decided to invest now and what makes life sciences an attractive field when compared to social media or IT companies. For those that recently exited, the panel will discuss what would be needed to bring them back, including risk management structures, regulatory issues, and exit strategies.
Social media changing research norms
As more scientists take their work to the Web and the cloud – publishing papers in open-access journals, recruiting trial participants through Facebook, and crowd-sourcing investigations – the availability and traction of social media tools to support medical research have grown. Facilitating everything from the establishment of "virtual lab space" to the crowd-funding of promising science/scientists, these networks are gaining traction in an increasingly collaborative research environment. Panelists will highlight popular networking sites/tools and preview what's next for patients and researchers.
License to drive (innovation): IP strategies to support, not slow, progress
We all agree that intellectual property should not be such a roadblock to medical progress, but what can be done to alleviate the strain it places on scientific collaboration, technology transfer, and commercialization? How can you identify overly restrictive IP protection activities and incentivize players to adhere to an agreed upon culture of responsibility? This panel will explore the IP implications of the movement toward precompetitive biology to enable more competitive chemistry, examples of responsible IP management practices, and how IP decisions can impact follow-on innovation and patient access. Special attention will be paid to relationship building, conflict avoidance, patient inclusion, and emerging tools to guide responsible IP negotiation and management.
Rules, tools, and data pools for catalyzing drug development
The semiconductor industry created the SEMATECH consortium in the 1980s in response to a perceived existential threat to the industry. Many would say the pharmaceutical industry is facing a similar crisis today. SEMATECH came together with government to solve common problems by leveraging resources and sharing risks. Today there are many efforts under way to create drug development tools – from therapeutic area data standards to preclinical safety biomarkers to patient-reported outcomes instruments – needed by the field, involving the pre-competitive sharing of data and expertise, and leading to the development of standards that are then qualified by FDA and other regulatory bodies. What are some of those efforts? Are they sufficient, and are they sufficiently unified? What are the barriers to accomplishing more? If appropriate infrastructures are in place, what questions do we want to ask of the data generated and gathered?
Molecular diagnostics: Turning on the lights
With the elucidation of the human genome and the revolution in molecular biology technologies, we are increasingly capable of monitoring human biology and disease in very sophisticated ways. Our ability to measure biological processes and indicators is now essentially "turning on the lights" on our ability to understand how life works. But tests using molecular methods, including molecular diagnostics, are the rate-limiting step for the full promise of personalized medicine to be realized. Challenges include the development of viable business models and the lack of reimbursement policies that recognize the value of companion diagnostics. In addition, laboratory-developed tests are being used extensively, but not always with proper validation, and FDA is struggling to provide regulatory guidelines that address this issue without stifling innovation. What are the components of a thoughtful strategy for incorporating high-quality, validated molecular testing into the development and delivery of targeted health interventions?
Basic science: The more we know, the more we know what we don't know
There is a growing sense not only in academia but also in industry that in many therapeutic areas of medical research we simply don't know enough about the basic biology of disease to effectively pursue treatments for them. Drug development in therapeutic areas such as HIV/AIDS and Alzheimer's have been brought up short by a sense that we may be shooting in the dark at unclear targets – that we're wasting ammunition, so to speak. What are some of the gaping holes in our understanding of basic biology that are preventing us from more effectively developing treatments? What is the appropriate balance between the pursuit of fundamental science and the pursuit of treatments? Can we do both at the same time more effectively?
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