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



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




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




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




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)




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




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.




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




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




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




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.

Promote Medical Innovation Aug 2010

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