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European Pharmaceutical Contractor

Under the Microscope

An intrinsic feature of pharmaceutical drugs is their limited patent life and the loss of exclusivity and revenue that follows expiry. The explanation for this is that companies do not feel the need to invest vast sums of money into R&D and so generally produce less expensive ‘copies’.

As a consequence, pharma companies have to pursue alternative strategies: developing new medicines or shifting their investments to create biologics/ biosimilars. Efficient laboratories operating worldwide have to be actively involved in order to monitor the safety and efficacy of their agents.

EPC: Is there a difference between the analytical needs of a clinical study conducted today to 20 years ago?

Hermann Schulz: In the past, study protocols required safety panels – biochemistry and haematology, for instance – in order to allow an evaluation of the effect of the study drug on vital organ functions. Laboratory results were crucial to evaluate the drug’s safety, as opposed to its efficacy. Regulatory authorities and reimbursement agencies rarely used laboratory results as decision-making factors.

Today, the use of centralised laboratories in multinational studies is assumed in most study protocols. Although routine testing panels are required to monitor a drug’s safety, laboratory values are now essential to monitor the drug’s mode of action and prove its impact on biological processes in vivo. The analytical demands are definitely becoming more complex.

The tendency to use central laboratories instead of many local labs at the investigator sites is also driven by financial (cost-saving) and quality (good clinical practice and standard operating procedures) considerations. This has redirected the focus on the value to be gained in using a central lab, with enhancements made to operations in a range of areas: professional study coordination, efficient sample transportation, uniform database, global standards, broad testing portfolio, visit specific kits and sample storage with temperature monitoring.

Can you outline the variety of complex analytical demands facing pharma?

Biological markers are needed to prove the mode of action of the investigational drug. Tumour markers or microbiology tests, for example, enable the therapeutic effect to be monitored. Pharmacokinetic (PK) analysis offers insight into the drug’s concentration within different body compartments, as well as the bioavailability effects. Furthermore, metabolites generated in the body after drug intake can also be identified. Take a blood pressure lowering drug: three decades ago it was, in principal, sufficient to prove a pressure lowering effect to get a drug approved. Today, expensive mortality and morbidity studies are required, on top of complex analytical methods, to show how the drug works, which enzymes it may block, the hormones it can activate, and which receptors it may modulate.

Is there now an increased need within the industry for preclinical analytical work and drug stability testing?

Yes, indeed. Bolstering the testing options already available during the performance of a clinical trial itself is the great progress which has occurred in the preclinical phases. Significant advancements have been made in stability testing of the pharmaceutical agent, identifying small and large molecules, and toxicology testing. Regulatory authorities are increasingly expecting laboratories involved in drug research to work according to the highest established standards of good clinical laboratory practice, good manufacturing practice (GMP) or good laboratory practice (GLP).

It seems immunogenicity and biological activity testing is also gaining in importance – why is this, and what does it mean for labs?

Absolutely, it is important to evaluate if there is a reaction of the patient’s immune system to the new drug to assess the drug’s efficacy. As mentioned, laboratories dedicated to supporting clinical trials need to make substantial investments both in technology and specialist staff in order to transfer or develop new methods. An unfortunate repercussion of this growth, however, is that many smaller laboratories are unable to cope with the increase in complexity. As a result, consolidation is taking place.

You recently sold INTERLAB to synlab, partly to expand the range of services for Phase 2 and 3 studies – tell us more.

Some time ago, synlab had decided to invest in the pharma lab market, in addition to its strong position in human diagnostics, veterinary and environmental analysis.

With the synlab pharma institute – which I head – we have extended the range of services available at INTERLAB for larger Phase 2 and Phase 3 studies by adding clinical and preclinical analytical services: method development and validation, PK batch testing, drug stability and GLP/GMP testing. We believe that recent regulatory approaches will increase the need for analytical work for medical devices – biocompatibility testing included.

We are now able to deliver high-end analytical services not only to pharma, biotech and CRO companies worldwide, but also to manufacturers of medical devices, cosmetics, and novel foods. In fact, it is this expansive scope which persuaded me to accept the offer from synlab.

How are recent regulatory approaches impacting the business, particularly in terms of analytical work for medical devices and cosmetics?

In recent years, significant expansion of regulatory requirements has occurred, and the evaluation of medical devices is being adapted to confront the challenges faced by pharma. A number of medical devices with therapeutic effects are entering the pipeline and, by my reckoning, these devices should be treated as a ‘drug’, rather than a ‘device’. Consequently, extra analytical needs will emerge and specialised laboratories will become more involved in the evaluation of medical devices. A similar development is being observed with respect to cosmetics.

What’s the key to helping sponsors and CROs reduce the costs and inefficiencies within the clinical trial process?

Sponsors and CROs should involve their laboratory partner(s) as soon as possible during the planning of a trial. We are always committed to sharing our knowledge and expertise with clients to help them find a cost-efficient solution – analysing special lab parameters like specific biomarkers, for example.

Finding a cost-saving solution involves reviewing new technologies in terms of cost-efficient batch or multiplex testing – where various biomarkers are present – or stability studies, where such data is limited, in order to verify shipment solutions to keep expensive dry-ice shipments to a minimum.

You also work in bioanalysis. With strong competition in this area, how do you provide added value to clients?

Bioanalysis is a difficult market because some competing laboratories are taking advantage of special tax redemptions in their regions. In Europe and especially in Germany – a region with high cost for rental space and staff – we are principally motivated to be competitive and deliver a great cost-benefit ratio.

As stated above, bioanalysis is only one of multiple lab services that may be needed when developing a new drug. Many bioanalysis labs are specialists in this area, but do not cover other analytical areas needed for studies in later phases. My philosophy is to create trust and convince our customers of our ‘one-stop-shop’ solution so that they are able to exploit our cooperative platform.

You have a history of export success – how are lab services utilised in emerging markets changing?

All cross-border services are complex and expensive when compared and contrasted with a harmonised EU. Again, size and volume is key to achieving best pricing. Due to the importance of setting up more complex technologies and obtaining the participation of highly trained technicians, there is a preference for running routine methods locally in emerging countries – shipping all other samples in temperature-controlled conditions to specialised labs located in Western Europe. Due to the cost of complex testing and the large number of samples shipped, the cost of transportation can be considered marginal.

Pharma says they select investigators in such emerging countries because of a significantly lower ‘cost per patient’. What is your view?

We are supporting clinical trials in emerging countries and observe the great deal of effort consumed training investigators, nurses and clinical monitors in those countries. Also, quality assurance awareness needs to be more focused and there is a strong fluctuation of staff. This specific background sums up why so many cases do not support the initial assumption that emerging countries per se are ‘cheaper’.

Of course, treatment-naïve patients are harder to come by in Europe or North America, but not all studies need naïve patients; this may be a reason why a larger proportion of sites are again being recruited in industrialised nations. I cannot say a lot more on how sponsors could reduce their costs. What I do know is that efficient centralised laboratories provide the most complex technologies at a pricing inconceivable a decade or so ago.

State-of-the-art technology is clearly vital in your line of business – how do you go about having the right equipment?

Interesting question: due to the size of synlab (we operate over 275 laboratories in almost 30 countries, and staff over 7,000 employees), we are being approached by manufacturers that reveal their new devices during development. This gives us the possibility to identify areas in which we would like to invest.

Over the next decade, what do you think the big changes will be for analytical services?

Firstly, I am expecting a further consolidation of laboratories – especially in Europe. Secondly, laboratory technologies will allow us to identify smaller molecules at a fraction of today’s cost. And finally, I am afraid that regulatory requirements will continue to increase and cause a further rise in the R&D cost.

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In 1994, Dr Hermann Schulz founded INTERLAB central lab services – worldwide GmbH in Munich and he has since been the Chief Executive Officer. Before this, he held senior R&D positions within the industry in the cardiovascular area for over a decade. He was a member of the Board of the German Society of Pharmaceutical Medicine for six years and is a founding member of the International Association of Central Laboratories. In 2014, Hermann decided to sell INTERLAB to the synlab group and became the Executive Vice President of synlab pharma institute, a division of synlab Umweltinstitut GmbH.
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