This document discusses innovation in research quality governance and the Partnership for Assessment and Accreditation of Scientific Practice (PAASP). It introduces PAASP as a platform for research bias analysis based on quality standards developed by the pharmaceutical industry. PAASP aims to enhance the quality of investment in early-stage drug discovery by conducting audits to address all potential sources of bias in research. It provides a fast and cost-effective third-party evaluation of research quality separate from evaluating the underlying science.

1. Innovation in Research
Quality Governance
Partnership for Assessment and Accreditation of Scientific Practice
Heidelberg, Germany
www.paasp.net

2. Executive Summary
• Research data quality-based strategy becomes the cornerstone
of future success in drug R&D
• Pharma companies „invest“ in external innovation at earlier stages
• Externalization of preclinical research
• Increasing focus on innovative, high-risk assets
• PAASPort - a platform of research bias analysis
• Based on quality standards developed by pharma industry
• Designed by the field pioneers and key opinion leaders
• Audit procedure addressing all potential sources of bias
• PAASP offers a fast and cost-effective approach to enhance
quality of investment in early-stage drug discovery pipeline
17.07.2016 2

3. Reduce operational risks in areas of
applied biomedical science where
research results have direct or indirect
commercial value and have an impact
on competition (institutional or
personal)
PAASP Mission
17.07.2016 3

4. Data Quality: Due Diligence Plus
PAASP data on file
Quality can be secured during conventional due diligence if:
• Budget and timelines allow for in-depth research quality analysis
• Potential sources of bias are eliminated, e.g.
• impact of highly enthusiastic scientific opinion leaders
• data generated by teams that can „afford“ negative data
Post-licensing analysis of
„critical“ studies
• 12 drug discovery projects
• 3 drug companies
• 26 „critical“ studies
17.07.2016 4

5. All potential sources of bias are addressed
• Related to study design and analysis, personnel,
competition, financial and time pressure
• Beyond the conventional due diligence
• Third-party view
Competent and efficient workflow
• Experts with vast industry experience (Abbott /
AbbVie, Lundbeck, Merz, Boehringer-Ingelheim)
• Research quality separated from science
PAASPort: Build Confidence in Data
17.07.2016 5

6. We do not:
Judge on science itself
or help to find a good
project to invest into
We do:
Help to identify
questionable research
practice and protect
your investment
Our approach
Direct – evaluate the data where they are collected
Independent – we can afford unbiased judgment
Relative – compare current vs previous evaluations
Continuous – aim to trigger and guide improvement
17.07.2016 6

7. Diverse Businesses
Investors, CROs, Drug and Biotech companies
PAASP Customer Profile
Rely on data from non-regulated research
Make decisions at risk
Need confidence in external partners
Can afford a failure-tolerating culture
Our Customers
17.07.2016 7

8. The PAASP Core Team
17.07.16 8
Anton Bespalov, MD
Managing Partner
Responsible for:
Strategy & Networking
Björn Gerlach, PhD
Partner
Responsible for:
Operations
Christoph Emmerich, PhD
Partner
Responsible for:
Science
Dario Doller, PhD
Concert Pharma
Bruce Altevogt, PhD
Science Policy, Pfizer
Ulrich Dirnagl, MD
Charite Berlin
Magali Haas, MD
Cohen Veterans
Malcolm Macleod, MD
Edinburgh University
PAASP Management PAASP Advisory Board
Khusru Asadullah, MD
Charite BerlinMartin C. Michel, MD
Senior Partner
Responsible for:
Business Development