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What does the Net Present Value have to do with preclinical drug discovery research?

When looking for Investors in the Life Science sector, entrepreneurial scientists and start-up companies have to deal with an unavoidable questions: ‘What is actually the appropriate valuation of my

idea or business?’ Venture capitalists may hesitate investing in biotechnology if bioentrepreneurs fail to provide or accept realistic estimates of the value of their technologies. One of the underlying reasons is that there is often little intuition into what biotech companies are worth and numbers sometimes can seem very arbitrary. Furthermore, owing to the complexity and specificity of scientific knowledge, it can be challenging and time-consuming to evaluate the technological and scientific risks associated with an early-stage Biotech company.  ...read on!

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Blinding - does it really have an impact?

Zubin Mehta, conductor of the Los Angeles Symphony from 1964 to 1978 and of the New York Philharmonic from 1978 to 1990, is credited with saying, “I just don’t think women should be in an orchestra.” In 1970, the top five orchestras in the U.S. had fewer than 5% female musicians and this number gradually increased over years reaching on average 25-30%. So, what was the source of this change?

Well, blinding seems to be one of the factors!  ...read on!

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Case Study: Scientists believed a whiff of the bonding hormone Oxytocin could increase trust between humans. Then they went back and checked their work…

Over the last two decades, the neuropeptide Oxytocin (OT) has been studied extensively and many articles have been published about its role in humans’ emotional and social lives, e.g. increasing trust and sensitivity to others’ feelings. Even a TED talk has been recorded (Trust, morality - and oxytocin?) with over 1.4 million viewers. (LINK)

The human trials conducted were based on early animal studies, where a critical manipulation of the OT system was translated into behavioral phenotypes affecting social cognition, bonding and individual recognition.

However, some recent publications question the sometimes bewildering evidence...  - read on

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Accurate design of in vitro experiments – why does it matter?

Good statistical design is a key aspect of meaningful research. Elements such as data robustness, randomization and blinding are widely recognized as being essential to producing valid results and reducing biased assessment. Although commonly used in in vivo animal studies and clinical trials, why is it that these practices seem to be so often overlooked in in vitro experiments?

In this thread we would like to stimulate a discussion about the importance of this issue, the various designs available for typical in vitro studies, and the need to carefully consider what is ‘n’ in cell culture experiments.

Let’s consider pseudoreplication,as it is a relatively serious error of experimental planning and analysis that hasn’t received much attention in the context of in vitro research.

The term pseudoreplication was defined by Hurlbert more than 30 years ago ... read on

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A Call for GLP in Drug Discovery

GLP and GMP are inevitably linked to the pharmaceutical industry. Well, not to the complete industry. The exception is the discovery part of the business, balking at the very idea of GLP in research and painting dark pictures of pointless regulations smothering creativity.

True, the GxPs do not apply. Nevertheless, the significance of quality is hardly debatable which raises an important question: If the GxPs do not define the quality requirements of drug discovery, WHO DOES?

QUALITY DEFINITIONS 

The exclusion approach – “GxPs do not apply to drug discovery” – is of course some kind of definition but obviously a bit limited in terms of what should be done. Even worse, it is easily interpreted as “rules do not apply at all”. This is a dangerous attitude, since no rules and no commitment quickly lead to quality anarchy.

Relevance of quality accepted, ... read on 

 

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Decision-enabling studies: Robust enough to support critical decisions?

Decision-making is an essential function of any company and determines long-term success. However, what are the key factors that influence decision-enabling in the pharmaceutical industry leading to new products and approved drugs?

To analyze the importance of Good Research Practice (GRP) standards as well as the quality and validity of data for this decision process we have conducted an analysis of 12 drug discovery projects (preclinical up to clinical candidate selection) that were licensed over the past two years by three EU pharma companies. There were a total of 26 studies that were identified as ‘critical’ (consensus decision based on discussions with representatives of the licensee companies).

Post-licensing analysis of these ‘critical’ studies indicated that not every study was designed in a way ...

...read on...