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The bioanalytical recession continues “Many of us feel a heavy weight from a lack of funds, burdensome regulations and even anxiety over whether our positions will continue. All three discourage long-term thinking.” Keywords: contract research n economics n global recession n MS

Four years ago Richard Abbott opined on these pages about the impact of the recession on bioana­lysis in a wide ranging report, drilling down from the various pressures on Pharma at that time [1]. At least in the USA, the recession officially, but imperceptibly, ended in June of 2009 and thus 4 years later we would expect to be back to a more positive frame of mind. However, we are not! Several things have continued to go badly wrong on a global basis. Austerity in Europe has not worked and neither has stimulus in the USA. The best that can be said is that it could have been worse. In both cases the private economy yawned. The self-evident problem is that when a government needs money, it must tax the private economy. There must be an economy to tax. Pharmaceutical R&D facilities continue to be closed and headcount reductions are ongoing. AstraZeneca, for example, is again refocusing and realigning its research sites. Lilly recently announced a further three log unit cutback. Merck is rumored to now be looking for R&D efficiencies, an activity that should be continuous, not sporadic or lumpy. Acquisitions and licensing deals continue at a good pace and that is positive for bioanalytical research. Over 80% of prescriptions are now written for generics. While 2012 was a bounce-back year for innovative medicine approvals in the USA, these were at a high cost per treatment, which reflects a combination of complicated biology, a high regulatory hurdle and a focus on unmet needs for orphan diseases and cancer, where premium pricing is feasible. The industry remains heavily burdened by its successes 20–30 years ago, which now make pricing pressure in many common therapeutic areas so high that further research is discouraged. Besides the usual safety and efficacy concerns, there is a large risk that new medicines will not pass muster in comparative effectiveness contests with the now generic products. Our Pharma (and thus bioanalytical) recession continues unabated. Yet we still have a

US$600 billion industry and that is not too bad. The large problems of cost versus safety versus efficacy versus speed-to-market are unresolvable. Opinions will always differ. Economic enough, safe enough, efficacious enough and fast enough are indeterminate variables. There are encouraging signs that companion diagnostics (some genotype, some phenotype; some singular tests and some as panels) exhibit promise for personalized clinical trials and therapy, but we must be patient. In addition, more therapeutic drug monitoring may assure that the bioavailability anticipated from trial averages is proper in individuals. The challenge remains to accomplish these tasks conveniently and economically. If only we could advance chemical measurement performance at the pace of semiconductor innovation. During my career we have reduced the volume required and the concentration required by a million fold (in a few cases both together), but unlike for semi­conductors, only rarely has the cost come down in proportion for the tools or the labor. The last major bioanalytical disruption was two decades ago, when quantitative LC–MS/MS made UV, fluorescence and electrochemical detectors historical curiosities for most work with biological samples. I have recently commented in this journal on the ontogeny of analytical instruments [2]. Where will the next major disruption come from and when? I want methods that are not faster per sample in a large batch with QCs, but are random access methods allowing much faster turnaround time to clinical decisions. This is conceivable with an LCectomy on LC–MS/MS, leaving ambient ionization MS/MS. My academic colleagues Cooks and Ouyang see this as feasible and their laboratories at Purdue University (IN, USA) are very determined [101]. So too are our laboratories at Prosolia (IN, USA) with my business colleague Wiseman and his team [102]. Bioana­lysis no doubt remains an ambiguous term. In this journal we tend to consider it as

10.4155/BIO.13.206 © 2013 Future Science Ltd

Bioanalysis (2013) 5(20), 2445–2447

Peter T Kissinger

Purdue University, 560 Oval Drive, West Lafayette, IN 47907, USA E-mail: [email protected]

ISSN 1757-6180

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Kissinger determination of drugs and metabolites in preclinical and clinical phases of biological samples research. The broader context includes in vitro work, all forms of omics, ex vivo tissue imaging of endogenous substances and xenobiotics, flow cytometry, in vivo imaging, biomarkers and the related companion diagnostics. The term has also been applied to ana­lysis of anything biological, even an isolated protein. Recession is also an ambiguous term and we have a financial recession, a spiritual recession, a leadership recession, and an innovation recession. Many of us feel a heavy weight from a lack of funds, burdensome regulations and even anxiety over whether our positions will continue. All three discourage long-term thinking. As headcounts have come down, R&D is more D than R and there is little time to explore new technologies (research tools) on speculation. Since the mid-1990s, bioanalytical work has been increasingly outsourced, especially the regulated work supporting clinical trials. That was a fun time, but by 2005 the stress on many independent laboratories grew as there was overcapacity. Prices for method development, validation and sample processing got very tough. A demographic change also occurred with large BioPharma firms entering long-term contracts with major CROs. Small boutiques needed to broaden their reach to small discovery companies with few new molecular entities and fewer samples. Now with a full blown recession in life science venture funding, many of the small firms are hanging on by their toenails making it even harder. We can all gripe with each other over the very well-funded social networks. Life sciences may be idling while we wait for the next dot.com crisis. Not to wish trouble on anyone, but we need some capital too! Today!

“The challenge is in deciding if great things come from funding more scientists more of the time or fewer chosen scientists all of the time.” Science demands facts, which we also describe as data or evidence. Facts require unambiguous measurements that arise from validated pro­ cedures and calibrated instruments on appropriate samples. In bioana­lysis the samples are of critical importance. In many cases, the data vary with how the sample is obtained, processed, stored and even transported [3]. We are truthseekers, but finding truth is very difficult given all the variables, many of which are not shared 2446

Bioanalysis (2013) 5(20)

with our bioanalytical laboratories. We are often book ended between experimental design upfront and data interpretation after our work is done. Opportunities are thus missed. This problem is made worse by outsourcing and the procurement people at sponsors talking to business development people at CROs. The scientists from both sides do not engage nearly as much as we did in the mid-1990s. Of course I generalize. There are fine exceptions. One of my students this past spring reported on the history of the microscope, thermometer and stethoscope and their impact on medicine. We can now see atoms, determine temperature in seconds, and view the beating heart with ultrasound. The instrumentation evolved slowly over centuries. This is physics and we are quite good at that. Determining temperature, distance, pressure, acceleration, frequency, light intensity, magnetic flux, current and voltage are mature and the transducers have advanced in recent decades to take full advantage of digital electronics. While these tools are useful to us as bioanalytical chemists, we are far more challenged to get chemical information we can rely on for good decisions. For one thing, there is so much more to look for given the 68 million charac­terized chemicals in the Chemical Abstracts Service databases, and increasing daily. My physics friends have so little to do. My biology friends tell me chemistry is so simple. My engineering friends just make things work. While not a phenomenon derived from the recession, science has been doing more and more about less and less for a couple of centuries. A recession is a strain on continuing along these lines. Are we spending on the right things? Perhaps governments will force bending the cost curve downward just as has happened in business (think reduced R&D headcount). Should grants to academia be fewer, larger and more selective? Are too many institutions granting the PhD degree? Is basic research the cause or result of a vigorous economy? I see it as the result. Curiosity-driven research is quite rare and always has been. We are overwhelmed perhaps with the derivative applications in efforts that often seem very repetitive and fashionable. The use of the citation index to judge a scientist is as absurd as endorsements on Linked-In®. Please hit me again with an endorsement to make my mother proud! Let us face reality, new insights about nature and true process innovation are both very rare. The challenge is in deciding if great things come from funding more scientists more of the time future science group

The bioanalytical recession continues or fewer chosen scientists all of the time. As resources tighten, the latter will appear to be more efficient, but are we equipped to decide? Spreading the wealth when there is little to spread inevitably reduces the trajectory of progress. If it carries on too long, progress will be reversed. Today the grant giving process is very inefficient, with time increasingly going to the paperwork of proposing and peer reviewing, and less to doing the science itself. The pain in academia is very real. There is no recovery in sight, but it will come. It must. The purpose of editorials is to stimulate debate. I was asked to comment on the recession and its impact on bioanalytical chemistry. The global spiritual and economic recession continues unabated while we wait for the much

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larger economic forces of energy, food, transportation, population and squabbles over political power to calm. We bioanalytical chemists are well equipped to deliver evidence in response to requests when funded to do so. Getting good numbers is what we do. How can we help you? Financial & competing interests disclosure The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert t­estimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.

References 1

Abbott RW. Impact of the recession on bioana­lysis. Bioana­lysis 1(6), 1033–1035 (2009).

2

Kissinger PT. Ontogenic stages for chemical instrumentation. Bioana­lysis 4(24), 2867–2868 (2012).

3

Kissinger CB, Kissinger PT. Your bioanalytical data are only as good as your samples. Bioana­lysis 4(12), 1411–1415 (2012).

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„„Websites 101 R Graham Cooks, Department of Chemistry,

102 Prosolia.

www.prosolia.com

Purdue University. www.chem.purdue.edu/people/faculty/ faculty.asp?itemID=1

www.future-science.com

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The bioanalytical recession continues.

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