How robust are preclinical data and how biased is research?

Recent publications showed some worrying results about the quality in research and point towards a major issue in the scientific field: The lack of being able to reproduce research data. This issue seems to be so prominent that the phrase “Reproducibility Crisis” came up because 50 -90% of data could not be reproduced. Interestingly, according to a survey published in Nature shows that researchers are aware!

In summary, it looks like there is a huge problem of biased research in different scientific areas. Various solutions are discussed to improve data quality and integrity, but unlike in many other professions and private life, a comprehensive evaluation of bias in research is missing.

PAASPort: It is possible to judge bias in research!

Scientists at PAASP US can apply a unique evaluation protocol which was named PAASPort to identify potential bias in research.

This tool allows the identification of many -if not all- risk factors leading to biased research data. However, also protection mechanisms are identified which are used by the researchers to prevent such bias. Like this it is possible to create a comprehensive picture about the quality of research data by a particular lab.

Therefore,  The PAASPort consists of a three step process which is shown in the image below: 1. Planning, 2. On-site Visit and 3. Feedback. During all these phases the PAASPort requires to maintain close discussions with researchers about the processes

Who profits when using the PAASPort?

The PAASPort is optimised for preclinical research and many institutions can profit by using the PAASPort.

Besides the PAASPort, PAASP US offers also other services, several of them in collaboration with specialists in their respective fields.

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Global PAASP network

The PAASP US, LLC is part of the global PAASP network with several partners in Europe. 

For more information regarding data quality, good research practices and other resources, visit the central web page:

The Team

Patricia Kabitzke

I obtained my PhD from the City University of New York in Neuroscience, followed by a Postdoctoral fellowship at the Columbia university in New York. During the latter, I completed two projects: 1.) I investigated the neural mechanisms underlying the innate fear response early in life, examining the function of components of the fear circuit by blocking the actions of the primary inhibitory neurotransmitter (GABA) in three different regions of the medial prefrontal cortex (mPFC). 2.) I developed novel assays of sociality in rodents and investigating the congenital overexpression of the D2 receptor on social interaction. Following my postdoctoral training, I joined PsychoGenics, a contract research organization, where I managed multiple, simultaneous, custom pharmacological and phenotyping projects for disorders of the central nervous system. I served as the PI on 3 major IACUCs, working with the IACUC chair and safety committee in an AAALAC-accredited, barrier facility and with supervisors and staff to create and maintain animal use protocols, standard operating procedures, records, and training records. Subsequently, I joined Cohen Veteran Bioscience as a program manager. 

Andre Der-Avakian

Andre Der-Avakian is Assistant Professor of Psychiatry at the University of California San Diego (UCSD) and Associate Member of the American College of Neuropsychopharmacology (ACNP). He is Principal Investigator on research projects funded by grants from the National Institute of Mental Health (NIMH) and National Institute on Alcohol Abuse and Alcoholism (NIAAA) and has managed research contracts and collaborations with industry and non-profit organizations. His lab is focused on developing novel cross-species behavioral and neurophysiological assessments of reward, cognition, and other behaviors in rodents relevant to psychiatric disorders, and using those translational measures to facilitate drug discovery efforts for depression, schizophrenia, and substance use disorders. Andre received his Ph.D. in Neuroscience from the University of Colorado Boulder and he completed a NIMH-sponsored postdoctoral fellowship in the Department of Psychiatry at UCSD.

Rob Miller

Rob Miller has 17 years of biopharma commercial experience with Lilly, Abbott and AbbVie that provides the PAASP US team with an in-depth understanding of how future PAASP biopharma customers develop risk-adjusted valuations for both internal and external innovation:

    •New product commercial development and for over 40 neuroscience programs

    •Commercial forecasts and valuations for over 25 licensing/acquisition assessments

    •Market research projects with over 1,500 HCPs, 300 patients and 250 payers

Rob’s commercial experience also includes seven years of medical product sales and account management with Baxter Healthcare plus account-based consulting and sales with health information firm Sachs Group / Solucient. As a Regional Director Rob managed licensing agreements with large US health systems and academic medical centers. Account based sales and licensing agreements will be directly relevant for building the US PAASP customer base and generating revenue.Rob is currently Vice President, Strategic Initiatives, with Thresholds, which is a behavioral health service provider based in Chicago.  Thresholds generates over $90 million in annual revenue and Rob is responsible for leading initiatives to diversify and grow revenue beyond state Medicaid including Substance Use Disorders and programs for early psychosis and young adults with an SMI diagnosis. 

Dan Deaver

During my academic career I fostered important research collaborations both within and outside the university related to drug development. These efforts required the generation of robust data packages. In the late 1980s, I worked closely with the Upjohn Company during their development of recombinant bovine somatotropin. During the early 1990s I developed an extensive research collaboration with Zetachron, Inc. to study transport of drugs across mucosal membranes using their proprietary drug delivery systems. While this effort ended when Zetachron was acquired by Watson Pharmaceuticals, it provided the foundation for me to collaborate with Dr. David Edwards in the Department of Chemical Engineering at Penn State. Edwards and I co-developed a gel-based drug technology that was out-licensed by Penn State, and eventually developed and approved by the FDA as a veterinary product (OvuGelTM). In addition, I played a key role in assisting Edwards in the development of large porous particle technology for delivery of steroids and proteins by inhalation. Advanced Inhalation Research (AIR) was spun-out of Penn State in late 1997. I joined AIR as a consultant in 1998, while closing down my academic laboratory for a permanent move to AIR in early 1999. Alkermes, Inc acquired AIR for approximately $120,000,000 shortly before I started, and AIR continued to operate as a largely independent subsidiary for about the next 18 months. As AIR was fully integrated into Alkermes my roles evolved overtime. In 2007, I was promoted to Vice-President of Nonclinical R&D. In this capacity I provided leadership and scientific oversight for all biological aspects of nonclinical R&D. I was directly involved with three programs that lead to marketed drugs – Vivitrol®, Bydureon®and Aristada®. Also, I was actively involved in the oversight of medicinal chemistry, pharmacology and toxicology efforts directed towards expanding Alkermes internal drug portfolio. Underscoring all of these activities was the critical importance of generating robust nonclinical research packages to increase the likelihood of a drug reaching market. My demonstrated success in this regard highlights the skillset that I bring to this project.

PAASP US – Latest News

PAASP US has won the 6th NIH/NIDA Challenge Award

In December 2018, the National Institute on Drug Abuse (NIDA) initiated its sixth annual Challenge competition with the aim to solicit and support entrepreneurial ideas that could eventually result in marketed products advancing knowledge and providing healthcare solutions in the field of Substance Use Disorders.

On January 23, NIDA has announced the results of this competition and PAASP US was amongst the ten winners. Our award-winning proposal was called ‘Analytics Platform for risk management in drug discovery’ with the aim to establish a platform that will serve to assess the robustness of research data, evaluate the industrial maturity of the therapeutic efficacy claims, and support the corrective measures, should the gaps or missing information be identified. The most important part of the Award is the coaching that PAASP US will now receive and that will support a development of a comprehensive proposal covering various aspects of the PAASPort application in the US – from market research to developing a digital platform supporting its administration.

PAASP US, LLC is found

We are very glad and proud to announce that Andre Der-AvakianPatricia Kabitzke and Rob Miller registered a new venture called ‘PAASP US LLC’ on January 15th, 2019.

Dan Deaver joined the team as the Chief Scientific Officer.

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