Crowdsourcing Clinical Drug Development

in a transparent model

Tomasz Sablinski M.D., Ph.D.

Founder, Transparency Life SciencesHead of Development, Celtic Therapeutics

Open Science SummitMountain View, CA

Oct 23, 2011

Perspectives

- clinical investigator

- basic researcher

- biotech consultant

- CRO

- big pharma

- investor

- entrepreneur

the drug development industry is facing extinction

psychotherapy is not an answer

intensive care is the only hope

“open innovation”

the abuse of terminology

Obvious fields:

- pre-competitive space- sharing data on:

placebo responsefailed clinical studies

Obstacles to crowdsourcing and transparency in pharma

- legal

- IP

- arrogance of experts

- fear for loosing jobs

- secretive culture

- antiquated computer sciences

- development / marketing confluence

Drug Development - Sources of Waste

partial list………

8

Pharma CompanyInfrastructure

+

Multiple Patient Visitsto Expensive Sites

High-Cost Patient Recruitment

Insular Approach toProtocol Design

+

20th Century Data Capture & Analyses

+ =+

Attacking the sources of waste

New model:

a platform for collecting key information, analyzing it, and building knowledge in a

transparent, complete, easy to understand format to enable multiple parties to move a project ahead

in a virtual global environment

secrecy = legacy

transparency = currency

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Transparency Life Sciencesis a Drug Development

Company

We acquire IP and pharmaceutical assets from academia, biotech, and pharma, and add significant value by conducting clinical studies via open-source methods, and by executing with unmatched productivity.

FoundersTomasz Sablinski, MD, Ph.D. – Harvard, Novartis, Celtic RxMarc Foster – FoldRx, Schrodinger, multiple exits in high

techGareth Hicks, Ph.D. – Cambridge, GSK, Novartis, TiogaLawrence Steinman, MD – Professor - Stanford, multiple

biotechs

AdvisorsKarim Lakhani – Harvard Business SchoolBernard Munos – Former strategist, Eli LillyJohn L. Brown – Former President, Health Properties, Time-

WarnerScott Becker – Co-Founder, Invite Media (acquired by Google)

Passionate About Changing the World of Drug

Development

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Three major enablers:

technologysocial changes / culture

crisis

TLS Approach

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1. Crowd-Sourcing – an approach to protocol design and data analysis, allowing for input from all available stakeholders “10,000 minds are better than 10”

2. Data & Technology Platform – web-based platform integrating multiple real-time data inputs via telemedicine Enhance trial cost-efficiency, safety, data

3. Transparency – Plans, data, analyses are shared openly, in real timeBuilds trust in TLS, provides best analyses

How Will it Work in Practice?High-Level View

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ProtocolDesign

Patient Recruit-ment

StudyExecution

DataCollection

Analysis

Crowd-Sourcing

OnlineGroups

Tele-medicine

Secure,Open

Vendors

MoreCrowdInput

Trial Step

Key Leverage Point

Why do people “go to” work?

because of the context

($$ is the major incentive)

Why do people contribute?

because of their passion for the content

($$ is NOT the major incentive!)

For TLS partnerships are essential

Patients web groups

Disease foundations

Telemedicine companies

Genetic testing enterprises

Bioinformatics companies

Focus: Clinical studies

Welcome to our project collaborative space !