January 01, 2017
The PAASP team wishes you a Happy New Year and is again dedicated to deliver insights into the quality of research. This includes informing you about current developments and publications about this topic but also providing information and background to specific topics interesting to you.
2016 was a successful year and progress on different levels could be achieved to advance research quality, however, there is still a lot to do. So, let’s get started!
November 16, 2016
Prof. Dr. Martin Michel presented the November Cohen Veterans Bioscience Webinar on November 16th from 12 pm noon – 1 pm ET. Martin shared several interesting but also funny insights to the current crisis in the scientific community. He created awareness about the scope of the problem and informed about current activities taking on the challenge to make a difference.
Watch the webinar on YouTube:
September 02, 2016
Together with Rainer Spanagel (Central Institute of Mental Health, Mannheim) and Henry Kranzler (University of Pennsylvania Perelman School of Medicine), Anton Bespalov took part in the „publish or perish“ debate during the World Congress on Alcohol and Alcoholism (Berlin, Sep 2-5, 2016). There were a range of issues discussed – from the efforts undertaken by journals to keep the IF high to predatory journal phenomenon. There is no doubt that publishing is important and not publishing means putting scientific career in danger and slowing down the scientific process. A much more critical question is what should be published and when. First, there is a clear bias today towards publishing positive data and keeping negative data mostly in the drawers. However, it is the negative data that are essential for the self-correcting nature of science and for the scientific progress. Second, selective publishing and limited efforts to repeat study results before attempting to publish is another major issue. These unfortunately rather common practices start to take their toll on several areas of biomedical sciences. These problems seem to be understood (at least, by those who were presented during the debate) but so far have had only limited impact on the publication practices (as indicated by the presentations at this Congress that we have attended before and after the debate). Self-correcting nature of science may indeed require some external facilitating influence to enable the urgently needed changes.
September 02, 2016 – Statement by Prof. Martin C. Michel
“In God we trust” is minted on each US coin. The evidence-based medicine movement has adapted this to “In God we trust, all others must bring data”, and this credo has considerably improved the quality of medical care over past decades. But for the non-clinical sciences it has become clear that we cannot necessarily trust data at face value; a scaringly high percentage of data turn out not to be reproducible. This adversely affects many young scientists who build their starting projects on data reported by others. It also has a major impact on commercial drug development, globally accounting for more than 200 billion $ in annual expenditure. You can argue as long as you wish whether it is more worthwhile to do research in oncology, depression or urinary incontinence. What you cannot argue with is the fact that research efforts in none of these areas are largely wasted resources if the resulting data are insufficiently robust to allow confirmation by others.
The first good news is that factors increasing the risk for poor reproducibility have been identified in recent years. Two years ago I took a look at my last ten original published papers to see whether they adhered to the quality standards I now consider necessary; the scary result was that none of them did, albeit each of the underlying studies had been done with utmost care . The second good news is that these risk factors are actionable. Their knowledge can be used to assess the quality of existing data, for instance when deciding whether to put a compound into development or to acquire an asset, and to design future studies including the associated data analysis and reporting. While the shift to evidence-based medicine has been a paradigm shift for clinical medicine and for drug approvals by regulatory authorities, I believe that the shift to quality-based evidence will be the next big paradigm shift in the way we gather, evaluate and use information in the biomedical sciences general and in drug development in particular. Because I see the strive for better data quality to be as important as the shift from anecdotal to evidence-based medicine, I have decided to join PAASP, which is a frontrunner in assisting scientists in industry and academia in improving the quality of their non-clinical studies and providing services to investors to evaluate the value of assets under consideration for acquisition.
1. Michel MC. How significant are your data? The need for a culture shift. Naunyn-Schmiedeberg’s Archives of Pharmacology 2014; 387: 1015-6.
August 17, 2016
The owners of the PAASP GmbH increased with the joining of Prof. Martin C. Michel the capital stock from the minimal required value of 25.000€ to 37.500€. This increase shows our trust in the future of this project and our commitment to PAASP.
July 11, 2016
We are delighted to announce that Prof. Martin C. Michel will join PAASP management team as a Senior Partner from August 1st. Martin is a physician trained in experimental and clinical pharmacology in Essen (Germany) and San Diego (California). He headed the Nephrology and Hypertension Research Laboratory in Essen (1993-2002), the Department of Pharmacology & Pharmacotherapy at the University of Amsterdam (The Netherlands, 2003-2011) and was Global Head of Product and Pipeline Scientific Support at Boehringer Ingelheim (2011-2016). Since 2012 he is Professor of Pharmacology at the Johannes Gutenberg University in Mainz (Germany). He has published more than 500 scientific articles, has been Editor-in-Chief of Naunyn-Schmiedeberg’s Archives of Pharmacology and also serves on the board of many pharmacological, physiological and urological journals. He is serving as chair of IUPHAR committees on β3-adrenoceptors and on data reproducibility. His research focusses on urogenital and cardiovascular pharmacology.
June 17, 2016
Co-authored by PAASP’s managing partner, Anton Bespalov, the correspondence article ‘Failed trials for central nervous system disorders do not necessarily invalidate preclinical models and drug targets’ was published last week in Nature Reviews Drug Discovery. Here, the authors discuss the great importance of 1. Data robustness, 2. Data generalizability and 3. Target engagement when designing preclinical studies: The decline of drug development over the last decade in the fields of neurology and psychiatry has largely been attributed to a high failure rate in the translation of preclinical efficacy findings, caused by multiple factors, including limited training and poor protocol design, inadequate animal models, insufficiently validated therapeutic targets and problems with data handling and reporting.
However, a failed clinical trial does not necessarily invalidate the potential of a drug target or animal model. It rather indicates the need for improved experimental designs and robust translational strategies to better inform compound and dose selection for clinical trials. Therefore, an increase in robustness, generalizability and evidence of target engagement could significantly increase the probability of successful translation of innovation to novel treatments for patients.
June 14, 2016
The Winnower is an open platform to share and discuss different ideas. PAASP has contributed an assay on this web page to summarise the problem in biomedical research, to provide potential solutions and to identify the role of PAASP in the process of establishing a quality assurance system. Feel free to give any feedback. (link to the assay)
June 11, 2016
Anton will give the Plenary Lecture 5 at the 2nd Central European Biomedical Congress which is held in Krakow from 15-18 June (link to program). He is talking on Friday 14:30 in the Medium Hall about an Industry perspective on how novel new drug targets need to be. Please do not hesitate to sent a short email to make an appointment in advance for to meet and discuss novel drug targets but also the topics we work on at PAASP: How to improve drug discovery by using effective quality concepts.
May 23, 2016
PAASP will be present at two meetings this week (CW 21), in Dublin and Berlin.
Anton is going to hold one of the three keynote lectures at the conference “Measuring Behaviour 2016” in Dublin. He will be talking about data quality in preclinical research and challenge the status quo of experimental designs in pharmacological experiments. Please find here the abstract for his presentation with the title: “Lacking quality in research: Is behavioral science affected more than other areas of biomedical science?“.
Björn will be joining the Charité Entrepreneur Summit 2016 which is held in Berlin.
Mar 29, 2016
Y47 and PAASP GmbH joined forces to improve your working environments and research quality combined.
Y47 brings the Lean philosophy to your research department to improve the innovative power of your research teams. Thereby, an environment will be created in which people can flourish and the empowerment of people will develop a culture of true and continuous improvement. The charismatic Arnoud Herremans from Y47 and the PAASP team collaborate now to bring Innovation Excellence and High Quality Research to your group and company. For more information about Y47 please click here.
Feb 24, 2016
PAASP is member of the DGGF (Deutsche Gesellschaft für Gute Forschungspraxis; German Society for Good Research Practice).
The DGGF is the largest association within Germany focusing on quality management in the chemical and pharmaceutical industry. It was founded in 1995 with the aim to promote exchange of scientific information and opinion, specific education and training, and to promote contact for national or international professional associations with similar objectives. Find out more about the DGGF.
Feb 06, 2016
Scientific discoveries require scientists having significant freedom and excessive policing in science will have negative impact on creativity and the advancement of science.
However, we, at PAASP, focus on pharmaceutical research and development where poor robustness of preclinical data is one of the underlying causes of the overall poor productivity. By working directly with scientists of all levels we are developing quality check point controls as well as structured on-site interviews to establish quality assurance systems with the ultimate goal to improve data integrity and reproducibility.
This approach is in line with a recent proposal by Viraj Mane and Amy Lossie aiming at the implementation of independent audit of research manuscripts, which provides ‘an unbiased verification that experiments are conducted ethically, results are calculated appropriately, and conclusions are based on the dataset rather than potential newsworthiness’.
Feb 04, 2016
F1000 Research launched a new publishing channel that is expected to facilitate open and transparent publication and discussion of confirmatory and non-confirmatory studies in the biomedical research sector.
Championed by Amgen’s Senior Vice President for Research, Sasha Kamb, and former Editor-in-Chief of Science and F1000Research International Advisory Board member Bruce Alberts (UCSF), the Preclinical Reproducibility and Robustness channels open for everyone to publish and discuss confirmatory or non-confirmatory scientific research results.
This channel appears to be an excellent venue for disclosing results of information and data sharing that is in focus of ECNP Network “Preclinical Data Forum”. PAASP is a member of this Network that comprises a variety of members representing industry, academia, publishers, funding agencies, non-profits. One of the main aims of this Network is to develop a mechanism that would allow peers to identify valuable unpublished information, share it and, if appropriate, publish.
Dec 24, 2015
PAASP GmbH is registered at the Chamber of Commerce in Mannheim with the registration number “HRB 723704” and the mission to increased reproducibility in science can officially begin.
Dec 07, 2015
Anton Bespalov took part in the study group “Reproducibility and robustness of experimental data in the neurosciences – opportunities for improvements” at the annual ACNP meeting in Hollywood, FL. Session was chaired by Raquel E. Gur (University of Pennsylvania) and Magali Haas (Cohen Veterans Bioscience) and was aimed to identify recommendations to improve current research practice from industrial, academic and publishers’ perspective. Recommendations will be summarized and submitted to ACNP for further discussion and possible action.
Dec 07-08, 2015
Björn Gerlach attended the “Jubiläumstagung des Instituts für Forschungsinformation und Qualitätssicherung (iFQ)” in Berlin.
Dec 01, 2015
Anton Bespalov and Björn Gerlach gave a presentation on “Research data robustness and its impact on modern drug discovery and development” to students of The Graduate School for “Translational Research Innovation – Pharma” at Göthe-University Frankfurt. This discussion was hosted by the Fraunhofer Project Group for Translational Medicine and Pharmacology (TMP).
Nov 30, 2015
PAASP GmbH is in course of formation in Germany.