By Kristin Schneeman, Program Director, FasterCures
A panel of international financial innovators in health and nutrition agreed today that there is an urgent need to bridge a widening funding gap between early-stage research and product development, not just with more money but with “smart money.” In describing their models, they demonstrated that government and nonprofit intermediaries can be ideally positioned to play that role, if they take novel and thoughtful approaches.
Moderator Margaret Anderson, Executive Director of FasterCures and Glenn Yago, Executive Director of Financial Research at the Milken Institute laid out the challenges and the urgency in addressing them. The funding “valley of death” in medical research is real and widening; companies and venture capital are increasingly risk-averse, and information gaps between academia and industry are growing. The slow progress in addressing poverty and disease around the world is inhibiting global growth.
Noting that Germany suffers from a lack of entrepreneurialism, especially in life sciences, Stephan Gutzeit, Executive Director of Stiftung Charité, outlined his organization’s model. The foundation makes grants to academic labs, and then when the work is advanced enough to build a start-up company around, a for-profit venture arm invests in those companies, providing wrap-around support to move ideas along. Gutzeit echoed the words of Scott Johnson, founder of the Myelin Repair Foundation, from an earlier panel, when he said that nonprofits can play a unique role as “systems integrators” to bring together the players in the research and development system.
Ora Dar, Head of the Life Sciences Sector of Israel’s Office of the Chief Scientist briefed the group on a new program, the Life Sciences Fund, the Israeli government has embarked on to support its vibrant start-up community, which the government already supports with direct grants to young companies. Four management teams were selected and are in the process of raising funds. In addition to investing directly in all four funds, the government will provide upside sharing of its net profits and downside protection to other investors.
Craig Courtney, Special Advisor, Innovative Finance for the Global Alliance for Improved Nutrition infused the discussion with his learnings from nutrition. GAIN works to address constraints in the market and draw private capital in to improving global food markets. In all cases GAIN is creating partnerships, leveraging its global scale, and de-risking investment by private sources.
While experiences differ from country to country, and between organizations addressing developed world and developing world needs, many of the funding challenges are strikingly similar, and there is a need for more intermediaries to help bridge gaps and address market constraints. One panelist noted that in many cases the models being discussed weren’t terribly novel from a financial markets perspective. Several panelists appealed for a thoughtful role for government and not a knee-jerk reaction to merely inject more capital into the market.
Monday, April 26, 2010
Designing Innovative Medical Research Systems: Patients Are the Hidden Asset
by Gillian Parrish, Manager of Alliance Development and Communications, FasterCures
A panel of experts from across the medical research spectrum who convened today at the Milken Institute’s Global Conference said that while the capital for medical innovation is there, how those funds are allocated will dictate progress towards cures. The discussion—designing innovative medical research systems—explored new models emerging from the biotech and pharmaceutical industries that are clearing the way for faster medical progress.
Moderator Debra Lappin, President of the Council for American Medical Innovation, set the stage by outlining the tectonic shifts in medical research: from new and emerging interdependence of sectors, to flattening of federal funds through NIH, to a newly risk-averse environment in which high risk, high reward research is the first to be cut.
While concerns about gaps have opened up, overall, the medical research system has worked spectacularly well, said Chris Coburn, Executive Director, Cleveland Clinic Innovations. Coburn said “easy” achievements have already been accomplished, thus moving the needle becomes that much more complicated.
Technology, said Usama Malik, VP and Head of Worldwide Innovation, Pfizer, is the lynchpin that will decentralize industry and empower consumers. And technology is what’s needed to cultivate open innovation, which he said, is the model of the future, enabling a free flow of ideas allowing the system to pick the best/most impactful ones earlier on.
The group also discuss the growing disconnect between academia and industry, and the critical need to better bridge innovation from universities into commercial markets.
Scott Johnson, President and Founder, Myelin Repair Foundation, said that we need to reframe academic model to produce results more relevant to commercial industry—over 800,000 academic medical papers are published each year and industry has a hard time wading through them to find gems; we need apples-to-apples comparison.
“Top-down solutions won’t work,” Johnson added. “ You can’t force progress through policy, but you can incent collaboration.”
Despite wide agreement amongst insiders that public/private collaboration is essential, externally it is conflict of interest, rather than confluence of interest, that—unfortunately—makes headlines.
Among the factors that have led to an unclear regulatory pathway is a lack of understanding of the relevance of science in commercial marketplace, said Lesa Mitchell, VP, Advancing Innovation, Ewing Marion Kauffman Foundation.
A better understanding of the tradeoff and dynamic tension between risks and rewards, particularly from the patient’s perspective, is key to accelerating medical progress.
A panel of experts from across the medical research spectrum who convened today at the Milken Institute’s Global Conference said that while the capital for medical innovation is there, how those funds are allocated will dictate progress towards cures. The discussion—designing innovative medical research systems—explored new models emerging from the biotech and pharmaceutical industries that are clearing the way for faster medical progress.
Moderator Debra Lappin, President of the Council for American Medical Innovation, set the stage by outlining the tectonic shifts in medical research: from new and emerging interdependence of sectors, to flattening of federal funds through NIH, to a newly risk-averse environment in which high risk, high reward research is the first to be cut.
While concerns about gaps have opened up, overall, the medical research system has worked spectacularly well, said Chris Coburn, Executive Director, Cleveland Clinic Innovations. Coburn said “easy” achievements have already been accomplished, thus moving the needle becomes that much more complicated.
Technology, said Usama Malik, VP and Head of Worldwide Innovation, Pfizer, is the lynchpin that will decentralize industry and empower consumers. And technology is what’s needed to cultivate open innovation, which he said, is the model of the future, enabling a free flow of ideas allowing the system to pick the best/most impactful ones earlier on.
The group also discuss the growing disconnect between academia and industry, and the critical need to better bridge innovation from universities into commercial markets.
Scott Johnson, President and Founder, Myelin Repair Foundation, said that we need to reframe academic model to produce results more relevant to commercial industry—over 800,000 academic medical papers are published each year and industry has a hard time wading through them to find gems; we need apples-to-apples comparison.
“Top-down solutions won’t work,” Johnson added. “ You can’t force progress through policy, but you can incent collaboration.”
Despite wide agreement amongst insiders that public/private collaboration is essential, externally it is conflict of interest, rather than confluence of interest, that—unfortunately—makes headlines.
Among the factors that have led to an unclear regulatory pathway is a lack of understanding of the relevance of science in commercial marketplace, said Lesa Mitchell, VP, Advancing Innovation, Ewing Marion Kauffman Foundation.
A better understanding of the tradeoff and dynamic tension between risks and rewards, particularly from the patient’s perspective, is key to accelerating medical progress.
Healthy Living Trends and Advances: Responding to Today’s Wellness Consumer
by Angelo Bouselli, Senior Communications Director, FasterCures
Among the early panels that kicked off the 2010 Milken Institute Global Conference was one focused, appropriately, on healthy living trends affecting aging baby boomers. Brian Wood, Managing Director at Imperial Capital moderated the discussion, on how clinical information and public education can influence a person’s behavior and their healthy living decisions.
“There is a need in this country to educate people on the food they eat, the diet supplements they take, and the overall need to increase physical activity in their daily life,” said Pierre Fitzgibbon, President and CEO, Atrium Innovations.”
The diet supplement industry is now a $25 billion industry in the U.S. and has seen an eight percent growth in the past year.
“There has been a healthy living shift in the way we look at diet supplements. This shift is being driven by the anti-aging movement, the rising cost of healthcare, and the overall focus on avoiding sickness,” said Guru Ramanathan, Chief Innovation Officer and Senior Vice President, GNC. “But diet supplements need to be coupled with changes in a person’s diet and daily exercise.”
“One of the biggest changes to nutrition in the U.S. happened between 1975 and 1985 with the introduction of high fructose corn syrup to the diets of millions of American’s. Corn syrup is used in many foods to soften texture and enhance flavor and corn syrup is one of the major causes of obesity in this country,” said David Heber.
Clinical research and public education are helping to advance the health living lifestyle movement forward. Product label claims and warnings, good manufacturing practices, and adverse effect reports are working to educate the public in decisions related to personalized nutrition.
According to Heber, “giving information to the public is not going to necessarily drive them to modify their unhealthy behavior, but personalizing the information for public consumption will have a greater effect on behavior changes.” Heber added, “99.9 percent of people are identical in genetic make-up, it’s a balanced nutrition and a healthy natural lifestyle that separate us apart.
There is an emerging trend and demand for healthier and more active lifestyles, including yoga. Trevor Tice, Founder and CEO of CorePower Yoga, a chain of over 30 yoga studios said “there are currently 15.8 million American’s that do yoga annually and spending on yoga fitness has doubled since 2004.”
Among the early panels that kicked off the 2010 Milken Institute Global Conference was one focused, appropriately, on healthy living trends affecting aging baby boomers. Brian Wood, Managing Director at Imperial Capital moderated the discussion, on how clinical information and public education can influence a person’s behavior and their healthy living decisions.
“There is a need in this country to educate people on the food they eat, the diet supplements they take, and the overall need to increase physical activity in their daily life,” said Pierre Fitzgibbon, President and CEO, Atrium Innovations.”
The diet supplement industry is now a $25 billion industry in the U.S. and has seen an eight percent growth in the past year.
“There has been a healthy living shift in the way we look at diet supplements. This shift is being driven by the anti-aging movement, the rising cost of healthcare, and the overall focus on avoiding sickness,” said Guru Ramanathan, Chief Innovation Officer and Senior Vice President, GNC. “But diet supplements need to be coupled with changes in a person’s diet and daily exercise.”
“One of the biggest changes to nutrition in the U.S. happened between 1975 and 1985 with the introduction of high fructose corn syrup to the diets of millions of American’s. Corn syrup is used in many foods to soften texture and enhance flavor and corn syrup is one of the major causes of obesity in this country,” said David Heber.
Clinical research and public education are helping to advance the health living lifestyle movement forward. Product label claims and warnings, good manufacturing practices, and adverse effect reports are working to educate the public in decisions related to personalized nutrition.
According to Heber, “giving information to the public is not going to necessarily drive them to modify their unhealthy behavior, but personalizing the information for public consumption will have a greater effect on behavior changes.” Heber added, “99.9 percent of people are identical in genetic make-up, it’s a balanced nutrition and a healthy natural lifestyle that separate us apart.
There is an emerging trend and demand for healthier and more active lifestyles, including yoga. Trevor Tice, Founder and CEO of CorePower Yoga, a chain of over 30 yoga studios said “there are currently 15.8 million American’s that do yoga annually and spending on yoga fitness has doubled since 2004.”
Thursday, April 8, 2010
Infusing Life into the Valley of Death
Medical research leaders and patient advocates yesterday participated in a forum that spotlighted the Cures Acceleration Network (CAN) provision of the Patient Protection and Affordable Care Act signed into law by President Obama on March 23, 2010. Speakers and participants were eager to discuss CAN and its potential to transform the medical research enterprise by supporting efforts specifically designed to bridge a gap in the therapeutic development pipeline between basic and clinical research.
Senator Arlen Specter (D-PA) introduced CAN to bridge this gap, often referred to as the “Valley of Death,” where research lies dormant and ideas come to a halt because the necessary next steps to take basic research discoveries and turn it into a safe and effective therapy are not taken. The forum was convened by Parkinson’s Action Network and FasterCures.
According to Amy Rick, CEO of PAN, “the business of taking a discovery and pursuing it for its full therapeutic potential is dramatically different than the business of basic research.” It includes considerations like FDA, legal issues, intellectual property, and the timing structure and milestones are different, as well. Appropriate incentives need to be in place to fill the valley of death.
CAN, as authorized, will be established within the Office of the Director of National Institutes of Health (NIH) and would award grants through NIH to biotech companies, universities, and patient advocacy groups. John Schall, deputy CEO of PAN, provided details of this provision, including:
John Myers, Senior Health and Science Policy Adviser to Sen. Arlen Specter (D-PA), encouraged patient advocacy groups to stay involved throughout the appropriations process already underway and build on the momentum of the health reform law, to ensure the potential of the CAN provision can be realized. Learn about how you can support this effort.
The forum, moderated by Margaret Anderson, Executive Director of FasterCures, elevated questions and discussion items that will likely continue as the process to implement the new health reform law unfolds.
This conversation will continue online at FasterCures TRAIN Central Station. Join the discussion.
Senator Arlen Specter (D-PA) introduced CAN to bridge this gap, often referred to as the “Valley of Death,” where research lies dormant and ideas come to a halt because the necessary next steps to take basic research discoveries and turn it into a safe and effective therapy are not taken. The forum was convened by Parkinson’s Action Network and FasterCures.
According to Amy Rick, CEO of PAN, “the business of taking a discovery and pursuing it for its full therapeutic potential is dramatically different than the business of basic research.” It includes considerations like FDA, legal issues, intellectual property, and the timing structure and milestones are different, as well. Appropriate incentives need to be in place to fill the valley of death.
CAN, as authorized, will be established within the Office of the Director of National Institutes of Health (NIH) and would award grants through NIH to biotech companies, universities, and patient advocacy groups. John Schall, deputy CEO of PAN, provided details of this provision, including:
- CAN is designed to accelerate the development of high need cures, including through the development of medical products and behavioral therapies. “Medical product” in this context means a drug, device, biological product, or any combination of the three.
- A diverse, 24-person board will be convened to advise the Director of the NIH on the conduct of the activities of the CAN. This board will represent multiple sectors including at least four individuals from the venture capital community and at least eight patient advocates.
- CAN is subject to the appropriation of funds.
John Myers, Senior Health and Science Policy Adviser to Sen. Arlen Specter (D-PA), encouraged patient advocacy groups to stay involved throughout the appropriations process already underway and build on the momentum of the health reform law, to ensure the potential of the CAN provision can be realized. Learn about how you can support this effort.
The forum, moderated by Margaret Anderson, Executive Director of FasterCures, elevated questions and discussion items that will likely continue as the process to implement the new health reform law unfolds.
This conversation will continue online at FasterCures TRAIN Central Station. Join the discussion.
Thursday, April 1, 2010
Health Reform Act Creates Cures Acceleration Network to Speed Researchers along the Path to New and Better Treatments for Disease
The Patient Protection and Affordable Care Act which President Obama signed into law on March 23rd included a little-discussed, but important provision creating a Cures Acceleration Network (CAN) at the National Institutes of Health (NIH), which will work to reduce the time it takes to move new drugs and therapies from the microscope to the marketplace.
This provision, introduced by Senator Arlen Specter (D-PA) as an amendment to the original Senate bill in 2009, creates new funding mechanisms at the NIH through which contracts will be awarded to accelerate the development of “high need cures” – defined as drugs, biological products, or devices:
• That are a priority to diagnose, mitigate, prevent, or treat harm from any disease or condition
• For which the incentives of the commercial market are unlikely to result in its adequate or timely development.
It will establish CAN within the Office of the Director of NIH and authorize grants expected to more quickly move discoveries from the lab through the development, testing and regulatory review process, into the hands of the patients that need them. This is an important step forward in bridging the ever-widening gap between basic and clinical research, known as the “valley of death” – where promising ideas for new treatments for deadly and debilitating diseases are often slowed and sometimes dropped before they can be fully explored.
FasterCures is committed to helping move basic science down the path towards treatments, and looks forward to supporting NIH in this effort. As we noted in our report “Entrepreneurs For Cures: The Critical Need for Innovative Approaches to Disease Research,” the true measure of success will be in lives saved and suffering diminished.
To learn more, participate in the forum:
Infusing Life into the Valley of Death
Wednesday, April 7, 2010, 8:30-10am
1101 New York Ave. NW Suite 620
Washington, DC 20005
Click here for additional information and to register.
Parkinson's Action Network and FasterCures invite you to participate in a forum about the Cure Acceleration Network, a provision in the health reform law, to learn how it can bridge the chasm between a basic scientific discovery and its application as a medical solution, known as the "Valley of Death." Speakers include John Myers, Office of Sen. Arlen Specter (D-PA); Amy Rick, CEO, Parkinson’s Action Network; John Schall, Deputy CEO, Parkinson’s Action Network; and Margaret Anderson, Executive Director, FasterCures. RSVP by Monday, April 5 to Angelo Bouselli abouselli@fastercures.org or 202.336.8900.
This provision, introduced by Senator Arlen Specter (D-PA) as an amendment to the original Senate bill in 2009, creates new funding mechanisms at the NIH through which contracts will be awarded to accelerate the development of “high need cures” – defined as drugs, biological products, or devices:
• That are a priority to diagnose, mitigate, prevent, or treat harm from any disease or condition
• For which the incentives of the commercial market are unlikely to result in its adequate or timely development.
It will establish CAN within the Office of the Director of NIH and authorize grants expected to more quickly move discoveries from the lab through the development, testing and regulatory review process, into the hands of the patients that need them. This is an important step forward in bridging the ever-widening gap between basic and clinical research, known as the “valley of death” – where promising ideas for new treatments for deadly and debilitating diseases are often slowed and sometimes dropped before they can be fully explored.
FasterCures is committed to helping move basic science down the path towards treatments, and looks forward to supporting NIH in this effort. As we noted in our report “Entrepreneurs For Cures: The Critical Need for Innovative Approaches to Disease Research,” the true measure of success will be in lives saved and suffering diminished.
To learn more, participate in the forum:
Infusing Life into the Valley of Death
Wednesday, April 7, 2010, 8:30-10am
1101 New York Ave. NW Suite 620
Washington, DC 20005
Click here for additional information and to register.
Parkinson's Action Network and FasterCures invite you to participate in a forum about the Cure Acceleration Network, a provision in the health reform law, to learn how it can bridge the chasm between a basic scientific discovery and its application as a medical solution, known as the "Valley of Death." Speakers include John Myers, Office of Sen. Arlen Specter (D-PA); Amy Rick, CEO, Parkinson’s Action Network; John Schall, Deputy CEO, Parkinson’s Action Network; and Margaret Anderson, Executive Director, FasterCures. RSVP by Monday, April 5 to Angelo Bouselli abouselli@fastercures.org or 202.336.8900.
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