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PAASP news

Juni 2017

PAASP member was invited to a meeting organised by NIH 

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.

 

April 2017

March for Science

On April 22, 2017, in many cities around the world people will go on the street to create awareness for the importance of science. Find more information about this important event on the web page www.marchforscience.com. PAASP members will be marching in Heidelberg and Frankfurt, Germany, and Chicago, US. Feel free to join!

 

March 03, 2017 

Preclinical Data Forum Network Webinar Invitation

As part of "Rigor and Reproducibility" effort by the National Institutes of Health, OTIPI, jointly with the ECNP's Preclinical Data Forum Network, is proud to present a special webinar: "Trust but verify: developing (+)-opioids as medications to treat SUDs" by Phil Skolnick, PhD, DSc (hon.), Chief Scientific Officer, Opiant Pharmaceuticals.

Join us for an upcoming webinar presented by the Preclinical Data Forum Network on Tuesday, March 7th at 10 am ET.

 

About Phil Skolnick, PhD, DSc (hon.)

Chief Scientific Officer

Opiant Pharmaceuticals

Phil Skolnick has more than 45 years of pharmaceutical experience, with leadership positions in academia, government and industry. 

Prior to joining Opiant Pharmaceuticals as Chief Scientific Officer, he served as the Director, Division of Therapeutics and Medical Consequences at the National Institute on Drug Abuse, NIH (2010-2017). 

He was Chief Scientific Officer (2001-2009) and President (2007-2009) of DOV Pharmaceutical, Inc.  He was a Lilly Research Fellow (Neuroscience) at Lilly Research Laboratories (1997-2000).  Prior to this, he served as Senior Investigator and Chief, Laboratory of Neuroscience, at the NIH from 1986-1997.  He has also served as a Research Professor of Psychiatry at New York University-Langone Medical Center, Research Professor of Psychiatry at the Uniformed Services University of the Health Sciences, Adjunct Professor of Anesthesiology at Johns Hopkins University, and Adjunct Professor of Pharmacology and Toxicology at Indiana University School of Medicine.  

Throughout his career, he has been attached to more than 550 publications in the fields of molecular and clinical neuropsychopharmacology.  Dr. Skolnick received a BS from Long Island University (summa cum laude) and a PhD from the Department of Pharmacology, George Washington University School of Medicine.

 

February 06, 2017 

We are proud to announce that PAASP has partnered with Biowebspin, the leading online Life Sciences partnering platform between academia and industry with over 2 million researchers all over the world. Biowebspin’s mission is to help academic researchers and start-ups to find industrial partners for their research projects, technologies and licenses. Biowebspin detects new research and licensing opportunities matching the R&D and Business Development strategy of the industrial partner.

Under this partnership, PAASP and BWS have developed mechanisms and services to pre-evaluate academic projects based on the quality, integrity and robustness of the underlying research data. This will provide industrial partners or VC investors with valuable instruments to select specific projects and drug targets/candidates according to their needs and requirements.

 

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:

https://www.youtube.com/watch?v=9IMyHJKTR5U

 

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 [1]. 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’. 

Find out more in the original article on Retraction Watch.

 

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. 
Link: http://science.sciencemag.org/content/351/6273/548.full 

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.