Antonopoulos christos medical director roche hellas

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Κλινική Έρευνα … στην πράξη! Χρήστος Αντωνόπουλος MD, Ph.D. Ιατρικός ∆ιευθυντής Ιατρικό Τµήµα Roche Hellas

Transcript of Antonopoulos christos medical director roche hellas

Κλινική Έρευνα … στην πράξη!

Χρήστος Αντωνόπουλος MD, Ph.D.Ιατρικός ∆ιευθυντήςΙατρικό ΤµήµαRoche Hellas

“Clinical trials are crucial for developing new

medicines, improving existing treatments,

boost research and

contribute to economic growth”

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John Dalli, former EU Health Commissioner

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Advances in science

Scientific Knowledge

Advances in Technology

Integrated Development

Drugs + Biomarkers & Diagnostics

MET IHCCancer genomics

Bi-specific antibody

Antibody-drug conjugate

Dual acting fragment antibody

Glyco-engineered antibody

Proprietary and confidential. For internal use only.

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Proprietary and confidential. For internal use only.

Baseline

aPDL1 Phase I Study23% Response Rate in NSCLC

Post C2 (Week 6)

Herbst et al ASCO 2013

Proprietary and confidential. For internal use only.

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Advances in science

Scientific Knowledge

Advances in Technology

Integrated Development

Drugs + Biomarkers & Diagnostics

MET IHCCancer genomics

Bi-specific antibody

Antibody-drug conjugate

Dual acting fragment antibody

Glyco-engineered antibodyHow can society leverage this progress?

“Partnerships benefit both industry

and academia by providing

opportunities for the sectors to work

together to explore promising new

technologies and address scientific

problems that may lead to

breakthroughs in treatments for the

most challenging diseases and

conditions”.

Tufts Center for the Study of Drug Development

Government and industry roles in R&DShould complement each other in partnership

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National Health System

Pharmaceutical Industry

Clinical trial activity in Greece Significantly less vs. similar size EU countries

8Source: *Malone, J, “Greek science: hope in crisis; Lancet 2012 **Clinical trials submitted in marketing-authorization applications

to the European Medicines Agency 2005-2011

� Even before crisis, Greece spend

little on R&D in terms of % of GDP

– 0.6% in 2007 vs. 1.8% UK or

3.7% in Finland*

� Since crisis, significant reduction of

government funding of ~50%*

� Pharmaceutical industry maintained

investment in R&D despite difficult

environment

Clinical trials submitted in MAAs to EMA**

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x2

x

Good quality infrastructure….

� Sufficiently large patient pool

(11m population)

� ~130 public public hospitals

� 7 medical schools

� Highest number of physicians

per capita

...limited by inadequate processes

and lack of support for CTs

� Regulatory framework

� Administrative procedures

� Complexity of approval processes

� Lack of acknowledgment of clinical

trials as investment priority

Clinical trial enironment in Greece

9Source: Athanasakis et al., National School of Public Health, Archives of Hellenic Medicines, 2012

Cautious optimism, outlook improving

How to improve environment for CTs in Greece

Rapid access to

innovative

medicines

Sustainable,

balanced

Budget

Revised

Claw Back

Mechanism

Respect for

Intellectual

Property

Rights

Predictability

and

Transparency

Payment of

outstanding

Debts

Create more favorable environment for R&D investment

Roche investing in Greece

Significant investment, increased in 2014

Investment in

Clinical Trials

Bringing

Innovative

Medicines to

Greece

Collaborations

with local

partners

Management

Trainee Program

Uninsured

Patients

Support

Program

CSR initiatives

Roche investing in Greece

Continue to heavily invest in clinical trials

Clinical Trials

Growth is closely

linked with clinical

research

investments.

31 clinical trials

in 170 centres

including > 1200

patients

Bringing

Innovative

Medicines to

Greece

Novel treatments

for Cancer

combining

medicines with

diagnostics =

Personalized

Healthcare

CLEOPATRA Study Design

13* < 6 cycles allowed for unacceptable toxicity or PD; > 6 cycles allowed at investigator discretion. HER2, human epidermal growth factor receptor 2; MBC, metastatic breast cancer; PD, progressive disease.

HER2-positive MBCcentrally confirmed

(N = 808)

Placebo + trastuzumab

1:1

Docetaxel*≥ 6 cycles

n = 406

n = 402

Pertuzumab + trastuzumab

Docetaxel*≥ 6 cycles

PD

PD

Baselga J, et al. N Engl J Med 2012; 366:109–119.

• Randomization stratified by geographic region and

neo/adjuvant chemotherapy

• Study dosing q3w:

– Pertuzumab/placebo: 840 mg loading → 420 mg maintenance

– Trastuzumab: 8 mg/kg loading → 6 mg/kg maintenance

– Docetaxel: 75 mg/m2 → 100 mg/m2 escalation if tolerated

Final OS AnalysisMedian follow-up 50 months (range 0–70 months)

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ITT population. Stratified by geographic region and neo/adjuvant chemotherapy.

CI, confidence interval; Pla, placebo; Ptz, pertuzumab.

S. Swain et al. Final overall survival (OS) analysis from the CLEOPATRA study of first-line (1L) pertuzumab (Ptz), trastuzumab (T), and docetaxel (D) in patients (pts)

with HER2-positive metastatic breast cancer (MBC). Presidential Symposium 1.ESMO 2014.Abstract number 350O_PR14

OS

(%

)

0

10

20

30

40

50

60

70

80

90

100

0 10 20 30 40 50 7060

Time (months)

HR 0.68 95% CI = 0.56, 0.84

p = 0.0002

Ptz + T + D

Pla + T + D

128104226268318371

02391179230289350

n at risk

Ptz + T + D

Pla + T + D

402

406

40.8 months

56.5months

∆ 15.7 months

ESMO 2014

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Multiple SclerosisOver 2.3M people affected worldwide

• Chronic autoimmune disease; damages

the brain & spinal cord

• Demyelination, axonal (nerve fiber)

injury and scarring

• Variable clinical course: 4 main patterns

• Treatment: interferon, disease modifying

agents

• Median age 23 years; ~2:1 female

• Second leading cause of acquired

neurologic disability in young adults:

• Visual loss

• Sensory and motor symptoms

• Loss of coordination

• Bladder/bowel dysfunction

1MSIF, Atlas of MS 2013, http://www.msif.org/includes/documents/ cm_docs/2013/m/msif-atlas-of-ms-2013-report.pdf?f=1

Proprietary and confidential. For internal use only.

Geographic Atrophy (GA)Advanced form of dry Age-related Macular Degeneration

Advanced form of dry Age-related Macular Degeneration● Progressive, degenerative disease

of the central retina (macula)● Interferes with driving, reading,

watching TV, daily living

● Accounts for ~10% legal blindness● Affects 8M people WW, ~1.2M in

US

● Genetic predisposition: complement factor H● Supports role of inflammation in etiology

No Currently Approved Standard Of Care

PROGRESSION of GEOGRAPHIC ATROPHY

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Clinical investigation of the amyloid hypothesis in Alzheimer’s Disease

Brain Amyloid Beta expression

Amyloid expression may

precede Alzheimer

symptoms by 20 years

Clinical symptoms

HYPOTHESIS:

Accumulation of amyloid

in brain drives Alzheimer

pathogenesis and leads

to neuronal dysfunction

and cognitive decline

Doing now what patients need next