Upgraded Life Festival Dr. Amy Leval| Janssen| May 31, 2016

Transforming therapeutic advancements with big data- Research and Development

Cliff Enright, SunburstArtwork from The Creative Center at University Settlement, a non-profit organization dedicated

to bringing creative arts to people living with and beyond cancer and other chronic illnesses.

2 Edwin Levick, Courtesy The New York Public Library

Medical science reformation

1906 FDA False labeling- not false claims!

1938 Drug safety

1948 1st RCT

1953 DNA Watson and Crick

1966 Drug efficacy

1980s Computer capacity to describe molecular structure

Rational drug development

1990 Human Genom Project

1991 www

2000 clincialtrials.gov

2008 Next generation sequencing

4

Clinical Trials.gov

5

6

DBHD epidemic

7

8

9

Open data movements

Expanding use of real world evidence to inform trial design – entire lifecycle

Innovative Medicines Initiative (IMI) - OMOP

Targeted therapies gaining early regulatory approval

Present

Why is this region unique?

Link, link, linkGenotype with phenotypeLongitudinal cohorts

Put into global context!

11

By analyzing a broader range of parameters, real world evidence research can uncover outcomes, unmet needs and clues to future medical breakthroughs.

Janssen is partnering with top institutions world wide to accelerate this new line of research.

Our network aims to: Apply scientific best practices Advance methodologies Generate evidence about disease pathways,

healthcare delivery, and the effects of medical interventions

Support medical decisions and identify new medical breakthroughs

Janssen’s global real world evidence network

Sweden

HungaryKoreaUSA

Taiwan

Canada

12

Real world evidence will impact all phases of medical research and therapeutic development.

Thanks to its data infrastructure, the Nordic region can become a hot-spot for advanced medical research by enabling uniquely comprehensive and long term studies.

Janssen is partnering with Karolinska Institutet in a major collaborative research initiative that focuses on: Treatment resistant depression Prostate cancer Psoriasis B-Cell malignancies Methodology development

Janssen’s real world evidence network also facilitates collaboration in other disease areas, across Nordic institutions.

Unique opportunity for Nordic life science

Of all global real world evidence research originates from Sweden. Other Nordic countries are also generating an extensive proportion.

10%

13

Future

14

15

Zika, pre-prints and #ASAPBio

16

Cure for DBHD?

Crispr Cas9

Immunotherapy and microbiome

2017 EU Open Data

Preprints

Registry trials

Disease Interception Acceleration

Collaborative analytics

Future pieces

Wearables

17

Kiitos!