The document discusses the evolution of drug development through open innovation, emphasizing the need for transparency, crowdsourcing, and telemonitoring to enhance clinical trials. It highlights the inefficiencies of the current closed model and introduces the TLS model as a more cost-effective and participatory approach to drug development. The integration of modern technology aims to improve patient recruitment and data quality while reducing costs in the pharmaceutical industry.

1. July 2014
Open Innovation:
The Future of Drug Development
Tomasz Sablinski, MD
Co- Founder, CEO
“Toward a New, Open Source Pharmaceutical Industry”
July 16, 2014
Bellagio, Italy
#opensourcepharma

2. Does TLS Model Apply to Global Health ?
1. transparency
2. crowdsourcing
3. telemonitoring

3. Sixty Years of Declining Productivity

4. Dismal Success Rate in Late Development

5. The World of Computing Power vs. Pharma
The world of
Pharma:
CRF Books

6. Technology Today
most clinical studies are conducted
as if we were still in the 1980s
yet
technologies exist to move clinical
research into the 21st century

7. Technology Today
The first electronic medical record system was installed at
Akron Children Hospital in 1962
February 17, 2012

8. Drug Development – Current Model
Multiple Patient Visits
to Expensive Sites
High-Cost
Patient Recruitment
Insular Protocol Design
Driven by Market Access
+
20th
Century Data
Capture & Analyses
+ =
+
Pharma Company
Infrastructure
+
Exorbitant
Wasted Costs

9. Does This Look Familiar?
After: Henry Chesbrough, 2007
The closed innovation paradigm

10. The Open Innovation Paradigm

11. Open Innovation…
…Connecting Problems with Solutions

12. From Open Innovation to Crowdsourcing
one-on-one cooperations
crowdsourcing
consortia

13. Transparency Life Sciences
Transparency Life Sciences is
the world’s first drug development company
based on open innovation
We are revolutionizing drug development
by transforming clinical trials –
the most expensive & inefficient element

14. Drug Development – TLS Model
Get protocol input from
global community
of patients, MDs,
researchers; facilitates
patient recruitment
Minimize site visits,
Improve data quality,
Execute at fraction of
usual cost
+ =
Deliver more drugs
with optimal labels
1. Crowdsourcing 2. Telemonitoring/
eHealth
Impact
3. Transparency – Build trust & participation

15. Crowdsourcing – “10,000 Minds Are Better than 10”
Context
• Web-based approach solicits global
input from researchers, patients, MDs
• Applies proven open innovation
methodologies to clinical protocol design
• Opportunity to gain from expertise in
and outside drug development
• Tiered incentives to participate:
• Professional development (researchers)
• Impact / Belonging (patients)
• Community, financial (everyone)
Impact
• More relevant protocols, lower costs,
patient and researcher engagement

16. TLS Crowdsourcing Stats – As of July, 2014
Visits: over 34,000
Unique visitors: 21,8000
Registered users: 1,100 +
Contributors: 370 +

17. TLS Protocol Builder – Sample Feedback
Protocol Builder (MS)
“Real advances in one's ability
to walk, use hands, reduction
in stiffness are key endpoints
that I would like to see in
studies.”
- Patient X
Crowd Input - Patients
“Metabolic response from
Phase II would be required
and useful for Phase III
response ranges “
- Researcher Y
Crowd Input - Researchers

18. TLS Platform in Action – Metformin in Prostate Cancer

19. TLS Protocol Builder – Sample Researcher Feedback

20. The Long Tail Model, Chris Anderson - 2004
think of:
Amazon or Netflix
vs.
brick and mortar retailers

21. The Long Tail Model in Clinical Research
design: KOLs only
participation: few
easily accessible patients
I G N O R E D

22. The Long Tail Model – Transparency LS
design: patients and physicians involved;
head or long tail
execution of clinical trials:
making it possible for the long tail
patients to participate: telemedicine

23. Growth of Telemedicine
The Wireless Revolution Hits Medicine

24. Telemonitoring – Riding the Wave
Context
• Remote patient-monitoring device market
will reach $1.9 billion in 2014 (Juniper Research)
• By 2020, 160 million Americans will be monitored and
treated remotely for chronic conditions (Nerac)
Impact
• Goal: slash costs, improve quality
• Circumvent high fixed costs of hospitals, clinics (cost)
• Eliminate observer bias (quality)
• Baseline assumption is first/last visit in clinic,
balance of data collection via telemonitoring
• TLS leverages expanding ecosystem of
FDA-compliant telemonitoring service providers

25. Benefits of Telemonitoring in Clinical Research
Quantitative
Obvious – less expensive trials
Qualitative
Non-obvious – new endpoints, novel designs

26. Three Reasons to be Optimistic
1. social changes / culture
2. technology
3. crisis

27. TLS Model Does Apply to Global Health
1. transparency
- essential to do good
2. crowdsourcing
- motivated contributors
3. telemonitoring
- cost efficiency, operational
facility