promote medical innovation aug 2010
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8/7/2019 Promote Medical Innovation Aug 2010
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Gone Tomorrow?
A Call to Promote MedicalInnovation, Create Jobs andFind Cures in America
Walter H. Plosila, Ph.D.Senior Advisor Battelle Technology Partnership Practice
August 19, 2010
8/7/2019 Promote Medical Innovation Aug 2010
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BUSINESS SENSITIVE 2
CAMI Efforts to Advance a Policy Agendafor Medical Innovation
� Starting point to inform the CAMI national policy agendawas the input of experts drawn from across the diversestakeholders involved in advancing medical innovation.
� 72 expert interviews completed over the past three months:- 25 with industry executives
- 14 with research institution leaders- 8 with patient advocacy groups
- 5 with private foundations and non-profit organizations
- 16 with state and regional biomedical organizationsand state agencies
- 4 with investment/venture capital executives
� In the challenge areas identified by the experts, Battelleconducted further research on key facts and studies as wellas identified international models
� A Roundtable of CAMI stakeholders further informed andrefined the proposed policies and actions
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BUSINESS SENSITIVE 3
Broad Conse nsus That U.S. Leade r ship in Medical Innovation is ´Our s to Loseµ
� Over the past 30 years,the U.S. has become theglobal leader in biomedicaldevelopment because of its world-class medical
innovation eco-system.� But there are significant
concerns for the future:
± Our ecosystem for medical innovation is under challenge
± Still time for proactive policy changes to make a difference
± Imperative for public-private partnerships since no sector can do it alone
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BUSINESS SENSITIVE 4
Wh y Medical Innovation Matters: A Proven Economic Driver
S trong Job Growth: High Quality Jobs:
� Average wages in biomedical industry stood at $66,716 in 2008,
well higher than the national average for all industries of $42,270.
Occupation Average Wages
Biomedical Industry Other Industries
Management $134,000 $100,310
Scientists &Technicians
$73,478 $64,280
Production $35,094 $32,320
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BUSINESS SENSITIVE 5
Wh y Medical Innovation Matters: Critical for Addressing Health Needs
� New medical technology advances leadto improved quality of healthcare andbetter health outcomes.
± 29% reduction in death rate fromcardiovascular diseases between 1999 and2006 (Lloyd-Jones, AHA, 2009)
±Childhood cancer 5 year survival rate gainsfrom less than 50% to now more than 80%(American Cancer Society, 2009)
± 68% reduction in HIV mortality (Duggan & Evans,2007)
� And medical innovations can reducehealth care costs and generate positive
benefits over costs. ± For instance, in heart attack care, every $1
spent on medical innovation has generated$7 in benefits (Cutler and McClellan, 2001)
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BUSINESS SENSITIVE 6
Four Leading Challe nges f or Advancing U.S. Medical Innovation
� Lack of consistency and predictability inFDA regulatory review
� Shortfalls in private investment
for company formation, R&Dand related job growth
� Gaps between research andtranslation of medical innovationinto new treatments
� Limitations in U.S. biosciences talent pool
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BUSINESS SENSITIVE 7
Close r Look at Regulator y Challe nges
� Concern that FDA¶s ability to address both patient safetyalong with patient access to new treatments has beencompromised.
� Key issues include:
± Lack of predictability and consistency
± Lack of resources unable to keep pace with science
± Ongoing workforce crisis at FDA
� Also, need to allow for continuing medical innovation innew reimbursement and standards and measurementsdeveloped as part of healthcare reform implementation.
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BUSINESS SENSITIVE 8
Close r Look at Pr ivate Investme ntChalle nges
� U.S. is falling behind in its R&D taxcredit as well as other tax incentivesand policies impacting medicalinnovation and related manufacturing
� Sharp fall-off in investment in highgrowth potential biomedical start-ups and emerging companies
� This is not simply a result of therecent financial crisis.
± Formal venture capital hasincreasingly sought later stageinvestments in medical innovation
± Decline in the initial public offering(IPO) market only complicates thesituation; financial crisis + structuralchanges
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BUSINESS SENSITIVE 9
Close r Look at T r anslationalResear ch Challe nges
� With the rising challenge of the ³valley of death´ there is asignificant need to focus more on translational/ applied R&Dand industry partnerships
� Concerns about having federal R&D funding for medicalinnovation grow in a predictable manner
� Strong support for Bayh-Dole Act, but concern thatuniversity technology transfer not properly supported
� See U.S. as losing its competitiveness in clinical trials
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BUSINESS SENSITIVE 10
Close r Look at the Tale nt Challe nges
� Perhaps the mostserious long term threatto medical innovation isthe well documented,looming crisis in
accessing scientific andengineering talent thatrequires serious andsustained attention.
� Major concerns about theK-12 system
� Need to grow our own,while remaining a magnetfor high-skilled foreigntalent
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BUSINESS SENSITIVE 11
Comprehensive Action Plan Proposed
REGULATORYPOLICIES ANDACTIONS PROPOSED:
� Launch a public-privatepartnership to establisha comprehensive andmeaningfully fundedFDA-wide RegulatorySciences Roadmap
� Fund FDA sufficientlybased on increasingwork demands andmandates
� Expand the extensiveand highly successfulharmonization efforts of the InternationalConference on
Harmonization inregulatory sciences
� Adopt policies thataccount for andencourage the diffusionof new medicaltechnologies as a partof healthcare reformimplementation
PRIVATEINVESTMENT POLICIES ANDACTIONSPROPOSED:
� Strengthen the R&Dtax credit
� Adopt tax andeconomic incentivesto boostmanufacturing andexport-related jobgrowth resulting frommedical innovation
� Encourage venturefinancing for emergingbiomedical venturesfrom formation
through IPO� Provide federal
financing support for bioscience R&Dinfrastructure atuniversity-relatedresearch parks
TRANSLATIONALRESEARCH POLICIES
AND ACTIONSPROPOSED:
� Advance public-privatecollaboration approachesat NIH
� Commit to a 10-year ³growth´ budget for NIHwith a renewed focus on
bridging the ³valley of death´
� Appropriate funding for theCures AccelerationNetwork
� Protect and enhancesupport for universitytechnology transfer set out
in Bayh-Dole Act� Reform the SBIR/STTR
programs to better address³valley of death´ challenges
� Advance national policiesand demonstration projectsto encourage participationand retention in clinical
trials in the U.S.
TALENT POLICIES
AND ACTIONSPROPOSED:
� Provide federalsupport for K-12bioscience teacher preparation andprofessionaldevelopment
� Provide funding tovocational andtechnical schoolsand communitycolleges to establish.programs to retrainexisting workforce for biomedical careers
� Increase the number
of U.S. and foreignstudents pursuinggraduate degreesand careers in thebiosciences in theU.S.
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