Trends Driving Healthcare Technology The Healthcare system needs - PDF document

Agenda Hur bedrivs framgångsrikt forskningssamarbete mellan industri och akademi inom medicinsk teknik? •The European Healthcare landscape in the future � •Defining the challenges Linköping •The large company strategy •Open Innovation – is it a sustainable model? 2012-09-05 •Examples of successful collaborations between academia, SME’s and large industry Bengt Nielsen, Ph.D • We need a new model for R&D and innovations Chairman NovaMedTech e-mail: nielseninnovation@gmail.com •Conclusions Trends Driving Healthcare Technology The Healthcare system needs Information & Imaging Technology Advances solutions to the critical healthcare questions Supercomputers 1978 Medical images on an iPhone, 2008 + Molecular Medicine & …more than additional Biology Advances technical “gadgets” The Structure of DNA, The HUMAN GENOME. Distribution of Nature 1953 the molecular functions of 26,000 genes, (fragmented approach) Science 2001 Convergence Driving Rapid Innovation / GE /

Societal health challenges in Europe • An ageing population • Growing prevalence of What are the challenges ahead? chronic diseases • A declining labour force • Rising health care costs Courtesy: COCIR R&I Task Force Outcome of the present model Chronic Diseases Focus: chronic diseases - there are some 150 million patients with chronic conditions in the EU Vision : high quality, patient-centred affordable healthcare across the EU Areas of work : • Health Research • Health Technology Assessment • eHealth, TeleHealth and mHealth • Patient Safety & Quality of Care The fundamental driver of high costs & quality issues is the inconsistency of healthcare delivery & outcomes from region to region, state to state, & even hospital to hospital. Such variance is bad for your health & the healthcare system as a whole Courtesy: Courtesy: COCIR COCIR Personalized Healthcare Needed! R&I Task Force R&I Task Force / GE /

The healthcare landscape in Europe toward 2020 The healthcare landscape in Europe toward 2020 Objectives The vision Critical factors Possible positives • Technology marches forward on all • Technology has improved, and fronts: from Imaging technologies to • Incentives for improving • The society-wide financial can now cure (Diag & Treat) nanotechnology supported by ICT/e- benefits of patients being able to return more efficiently the chronic technologies Health, from material sciences to to work, or live independently, has diseases more than paid back innovation costs molecular medicine • Regulators and payers work • Leverage the Healthcare in harmoniously together to ensure that • Healthcare is not viewed as a cost, but • Healthcare companies are seen as Europe, with a better Access & innovation meets the needs of the as a major investment Quality and decreased the cost population, and that all individuals the chief drivers of innovation have access to the latest, most • Create the Molecular Medicine • e-health has ensured that • Significant cost savings as a result effective medical interventions Market supported by technologies of innovative technologies healthcare is well managed • Industry forms partnerships to • 20% of GDP is spent on healthcare, a • Create European Jobs and innovate large chunk of which goes towards • The system promotes greater equality Growth of care. technological improvements • Create the IT infrastructure as an • Reinforce thanks to innovative enabler for new medical practice • The political economies of Europe technologies the development (e-Health, Molecular Medicine, …) Possible negatives focus on entrepreneurism of Personalized medicine • Chronic disease continues to rise (future medical practice) • Health systems are able to reform Courtesy: Courtesy: Today 2020 COCI R their business models to promote COCI R R&I Task Force R&I Task Force cost-effective innovation. The Healthcare challenges: The education/ competence perspective Innovation occurs at the intersection of disciplines Animal Research Care Areas: The key stakeholders landscape: Chemists Biologists Research Centers • Cancer plan Physicians: NM, oncology, • Cardio plan Biotechnology IP cardiology, neurology Societies • Other plans Patient centric Academia (Maternal & Infant Innovation Care, Prevention, Computer Mechanical Mental Health, SME’s Scientists Engs Patients Infectious diseases, Development IP Large companies Ambulatory, Emergency, etc) Physicists Mathematicians Regulatory bodies PRACTICAL REALITY… Governments “Hardware + Wetware + Software” / GE /

The different priorities of key stakeholders Point of Academia SME Large focus Company Publications Less important Very Less in early stage important important Research Patent Less Very Very The large company view important important important Time scale Years Months/ Quarter and weeks Clinical Very Less Less important until the late important important research stage Technology Important Critical Critical model & process Marketing/ Less Critical Critical Products important Regulatory Less Critical Critical approvals important Risks taking Yes Yes No All 3 parties needs to collaborate together well tuned in order to find new solutions Critical things that needs to be From Academic Research to business: considered before decisions on investment: Large Company or R &D funnel Many large companies, has a huge freedom and many challenges: 1. Purchase/ license, create JV’s Enabling productification Clinical Research or develope internally. & clinical validation ”Seed Funding” being persued Academic for the Healthcare to selected partners to develop new BD market introduction technology & SME to kick off specific 2. Decision is depending upon: & research projects & Pharma applications (upscaling, manufacturing, - subject/ area Enabling fast results from marketing, sales, regulatory, launch) Collaboration In vitro to - speed to market & PoC in man. external - core competence within the company research funding - maturness of the idea/ technology - health economics assessment 5 years 3. ...but the shareholders want dividend 3-5 years and minimize risk Building a Business Developent, BD Funnel With courtesy from GE Healthcare / GE /

Drug Development : Very high risk Compound Success Compound Success Years Years Rates by Stage Rates by Stage 0 5,000–10,000 2 Discovery Screened (2–10 Years) Preclinical Testing 4 Regulatory Process is becoming Laboratory and Animal Testing 250 6 Enter Preclinical more challenging Phase I Phase II Testing 20–80 Healthy Volunteers Used to 8 Determine Safety and Dosage 100–300 Patient Volunteers Used to Look for Efficacy and Side Effects 10 Phase III 5 1,000–5,000 Patient Volunteers Enter Used to Monitor Adverse 12 Clinical Reactions to Long-Term Use Testing FDA Review Approval 14 Additional Post- 1 Marketing Testing 16 Approved by Approved by the FDA the FDA Net Cost: $802 Million Net Cost: $802 Million Invested Over 15 Years Source: Tufts Center for the Study of Drug Development Invested Over 15 Years With courtesy from Pfizer Research and Development The large company focus: in Molecular Imaging •The large company is focusing on development R & D (late stage projects) Clinical Function •Minimizing risk Clinical Pre- Definitive patient Feasibility Research Life studies clinical studies cycle ….but Entry • Large companies are needed for market introd Product into man Launch within Healthcare 10 -15 years The Medical Device Directory is becoming a very similar process to the drug regulations / GE /

The journey from idea to reality........ Innovation ”no man’s land” or t he ”valley of death” The critical gap ”valley” The marketing, product and business challenges Product phase Research and solution design 10 15 Years Many different types of competence needed to bridge the gap... But also new models for bringing product to market! Examples of successful research projects Relative Relative & Cost Cost commercialization Seen from a large company horizon / GE /