Navigating the University: Research and Resources Management Retreat August 19, 2014 Michael Jamieson DRSc Associate Director, International Center for Regulatory Sciences Assistant Professor, Clinical Pharmacy

 Why are laboratory notebooks and data management important to us as researchers!!!!!

 If a Job is Worth Going, it is Worth Doing Twice  Researchers and funding agencies need to put a premium on enduring that results are reproducible.  NIH Plans to Enhance Reproducibility  Frances S. Collins and Lawrence A. Tabak discuss initiatives that the US National Institutes of Health is exploring to restore the self- correcting nature of preclinical research.  Hedging Against Academic Risk  Investors in early stage companies must often take a leap of faith that the academic research behind a company’s strategy is well validated and can be reproduced by independent hands.

Amgen researchers tried to confirm the findings of published academic research, and could only do so in 6 of the 53 papers they considered: a result the commentary authors call "shocking." The authors don't claim fraud. Instead they blame increasingly lax standards in results reporting. Nature; (483) , 2012

A growing chorus of concern, from scientists and laypeople, contends that the complex system for ensuring the reproducibility of biomedical research is failing and is in need of restructuring. Nature; Francis S. Collins & Lawrence A.Tabak 27 January 2014

Preclinical research, especially work that uses animal models, seems to be the area that is currently most susceptible to reproducibility issues. Many of these failures have simple and practical explanations: different animal strains, different lab environments or subtle changes in protocol. Nature; Francis S. Collins & Lawrence A. Tabak 27 January 2014

As a funding agency, the NIH is deeply concerned about this problem. Because poor training is probably responsible for at least some of the challenges, the NIH is developing a training module on enhancing reproducibility and transparency of research findings, with an emphasis on good experimental design. Nature; Francis S. Collins & Lawrence A. Tabak 27 January 2014

 To ease the interpretation and improve the reliability of published results we will more systematically ensure that key methodological details are reported, and we will give more space to methods sections. We will examine statistics more closely and encourage authors to be transparent, for example by including their raw data.  April 25, 2013

 A guidance document, specifically written for academic researchers, that enables them to follow the principles of good documentation practices when doing non-regulated preclinical research.  Basically we are trying to create “Good Documentation Practices for Non Regulated Academic Research”

1.Insist on good laboratory notebook practices in your lab. 2.Develop a standardized format for all of your S.O.P’s. 3.Validate analytical methods where possible. 4.Ensure traceability for all batches/runs of your drug/device. 5.GLP like documentation practices for animal work. 6.Maintenance/calibration books for your equipment.

 Date: October 30, 2014  Time: 8:00 AM -3:30 PM  Location: Arresty Auditorium: Health Sciences Campus  Keynote Speakers: Shai Silberberg PhD, from National Institute of Neurological Disorders and Stroke, NIH Robert Pacifici, PhD Chief Scientific Officer of the CHDI Foundation. Supported by: The Provost’s Office as one of the CER mentoring symposium/workshops as well as the School of Pharmacy Research Office and The International Center for Regulatory Sciences  For more information please contact Daryl Davies PhD at

Michael W Jamieson DRSc Associate Director, International Center for Regulatory Sciences Assistant Professor, Clinical Pharmacy University of Southern California, School of Pharmacy 1540 Alcazar Street, CHP 140 Los Angeles, CA Tel: Fax: