We are delighted to announce that Malgorzata Pietraszek has joined our PAASP Team.
Malgorzata has over 20 years of experience in CNS pharmacology acquired in both pharmaceutical industry and academic environments. Malgorzata holds a PhD from the Institute of Pharmacology Polish Academy of Sciences (PAS) in Cracow and a MSc from the Jagiellonian University (Cracow).
Between 1993 and 2007, Malgorzata conducted research in the therapeutic areas of schizophrenia and Parkinson’s disease at the Institute of Pharmacology PAS in Cracow. During this time, she maintained active collaborations with partners from academia and pharmaceutical industry that resulted in numerous publications.
In 2007, Malgorzata joined Merz Pharmaceuticals (Germany). She was involved in preclinical drug R&D program in different CNS indications. Malgorzata implemented many in vivo models, trained postdocs and technicians and organized internal workshops to accelerate drug R&D in the therapeutic areas of schizophrenia and neurodegenerative disorders. In addition, Malgorzata supported clinical development in the therapeutic areas of CNS disorders. She established and managed collaborations with key opinion experts from academia as well as with many CROs. Additionally, she was involved in in vivo preclinical data quality assessments. Since 2014, Malgorzata serves as a CNS drug R&D consultant on a freelance basis.
PAASPort is our tool to evaluate bias in preclincical drug discovery research. Application of PAASPort is based on the analysis of a balance between potential sources of biases (related to various types of pressure to obtain or deliver data) and the protective measures that exist at various levels – from the organization level to individual scientists and experiments.
We now proudly announce that our PAASPort became a registered trademark just like Coca-Cola® in 1888. Time will tell whether PAASPort®will also be as broadly known in the scientific community as Coca-Cola, one of the world’s most recognizable brands.
After founding PAASP almost two years ago and with the important upcoming projects, it was time to give the web interface a new appearance and include more functionality.
Despite providing clearer access to PAASPs products, a new information database was included in the style of in internet blog. This gives you the possibility to search for articles and guidelines we have commented on. We are also constantly expanding this database to provide easy access to the information available in the area of good research practice.
June 5, 2017 – Anton Bespalov took part in a meeting in Washington, DC (USA) hosted by Francis Collins, Director of National Institutes of Health, and Nora Volkow, Director of National Institute on Drug Abuse. This meeting was aimed to address the role of science in addressing the opioid crisis (link to the NEJM paper – http://www.nejm.org/doi/pdf/10.1056/NEJMsr1706626) and was attended by representatives from pharma and biotech, SMEs, academic scientists, consultants in the related fields of drug discovery research, as well as officials from FDA / CDER. The goal was to identify efforts that need be prioritized in order to facilitate development of medications for opioid use disorders and overdose prevention/reversal. It was emphasized that the goal is to come up with an action plan (i.e. not a conventional academic / scientific meeting). NIH Opioid Research Initiative suggested three main directions for developing actionable plan: i) pain management, ii) opioid addiction treatment, and iii) overdose reversal. PAASP’s position is that this field of drug development is not much different from others where failures to develop novel and effective medications have complex reasons including poor quality of preclinical data and inappropriate use and interpretation of preclinical data. In support of this opinion, it was confirmed by several meeting attendees (in private conversations) that there are too many novel drugs and mechanisms that are reported at every scientific conference to have miraculous anti-addictive and / or analgesic efficacy in preclinical settings. This high rate of positive results can only be explained by either false positive results due to insufficient research rigor or inappropriateness of the models used.
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.
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:
“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.