Friday, November 27, 2015

Partnerships or Operating Models to Empower Delivery?

Chris Rull, Vice President, Service Provider Management Merck 

Over the past 5+ years, there has been a huge evolution in the strategic partnerships used to bring new therapies through clinical trials. I’ve witnessed this evolution from both sides of the partnership – working both within CROs and most recently within Merck..

One of the key challenges that sponsor companies face is in identifying the partnership characteristics the sponsor organisation needs most and being able to truly define their core and non-core competencies as desired.. Accomplishing this requires internal investment and analysis of organisational strengths and weaknesses. Through this process,  existing core competencies need to be identified along with opportunities to invest in maintaining and growing those competencies.

One of the most under-rated areas of partnership launch is Change Management, despite all the discussion around it.  Both parties need to be willing to invest, change and evolve with the partnership and make use of the expertise and experience that each bring. This of course requires the ability to really digest the cultural DNA and impact the organizational behaviours

Expectation alignment is also crucial - if internal strategy and external provision are not aligned, then no matter how strong the two partners are, challenges will arise.

And this draws back to the real goal of a true clinical development partnership – to bring new therapies to market and return efficiency to all parties. To do this, you have to achieve close alignment. All parties and players have to understand core strategy and the operating model in order to build a successful partnership.

Also essential is creating an environment within the partnership that empowers the functions accountable for the work. And you need a governance structure that is accountable and empowering and does not replace the functions that you are trying to optimize in the new structure.

In my opinion, one of the biggest red herrings is that many sponsors create or introduce strategic partnership as a result of external pressures that are misaligned to the above.  In these instances, regulatory reaction stands in the way of successful partnerships. Most of the regulations that relate to partnerships are self-imposed. Yet, if we spend the time with the regulations, they actually provide a great deal of flexibility to deliver your vision and purpose in a strategic partnership. 

In order to overcome these challenges, we have recently reorganized to deliver better service provider management. As head of this new function, my role is to provide clarity over who owns a relationship and ensure the relationship is managed effectively.

I’ve been a big believer in forums such as PCT-Europe for a long time; they are critically important as they bring people together from across the industry to discuss the issues in a very open and honest manner.

Friday, November 20, 2015

Data, transparency and the new EU regulatory environment

Thursday at the Partnerships in Clinical Trials meeting 2015 saw a panel of experts discussing questions posed by delegates on all manner of topics, such as the concept of "patient centricity" and industry's preparedness for the change, and a very interesting session on the implications of the EU Clinical Trials Regulation.

As I mentioned before, "patient centricity" is at the heart of this year's conference, and it certainly caught a lot of people's attention on Thursday morning. Panellists talked about technology, mobile devices, and new ways of capturing data, and suggested that we have only just begun to scratch the surface here. They painted a future where Google, Apple and the like will be the enablers of such technological advances, with patients monitoring their vital signs at home and conversing with their physicians by video and teleconference, rather than having to visit the clinic. After all, some patients may live a long way from the clinic and find it hard to come in as often as they would like.

But while being a homebird may suit some patients taking part in clinical trials, others will miss the chance to take some time out, the "human touch" of meeting their doctor face to face, the feeling of actually talking to someone properly rather than through an e-medium of some sort.  Probably the end result will be some combination of the two in differing proportions, with technology being seen as an adjunct - if a major one – to the current ways of doing things.

In any case, the patient will take a greater role in clinical trials, whether he or she likes it or not. Patients know best what is going on with themselves, declared Prof Brendan Buckley, CMO at ICON in Ireland. Patients, he said, would act as "data providers, with ownership of the process." "The idea of the patient as sub-investigator will be an important factor in the coming years, allowing us to better handle the very significant increase in data flow that we will have."

But he sounded a note of caution about moving too fast, suggesting that proper partnerships and joined up thinking were a prerequisite for true patient centricity, and this isn't happening now. For example, one CRO gets the data, another one gets the labs, and so on, and this makes it difficult to coordinate the various activities in order to achieve the sought-for patient centricity. What is needed is more partnership between CROs and pharma firms, so that the patient is prioritised. If outsourcing is done piecemeal it will be impossible to pursue this agenda, Buckley noted.

"Don’t get carried away with idealism," he cautioned. "There is a fundamental problem about how outsourcing happens – if the CRO gets the whole deal, and the full service process, there is some chance of advancing that agenda, but mostly outsourcing is technical and goes trial by trial."
It was noted that it's important to ensure that the protocol is well thought out, which apparently does not happen as often as it should. Some sponsors, it was suggested, put far too much into their protocols, and CROs need to make sure they are lean and uncomplicated.

And of course, again, don't forget the patient – or the regulator. The regulator's role is key here: companies are used to working to what regulators require in their guidelines. But in future, the regulators will increasingly want to know this: did you talk to the patients, did you ask them what they really need? And it's not only the regulators that have this in mind - the payers do too. If you have strong patient input, it will make your payer negotiations easier.

Which all goes to show that a joined-up approach to patient involvement, with continuous consultation, collaboration and co-ordination among all the key players, is the  way forward.

One of the afternoon sessions managed to throw some light on the less well-known aspects of the new EU Regulation that will take the European clinical trials scene by storm in a couple of years' time.

The session featured a very interesting presentation by Marine Dehlinger-Kremer of CRO SynteractHCR in Germany, who explained the many far-reaching changes that the Regulation will bring, not least the clinical trials portal and database, a single application to conduct a trial, and a great deal more transparency of trial data. As you may know, the application of the Regulation's provisions has been postponed from a notional mid-2016 to nearer the end of 2017, mainly because of the complexity of testing out the portal and database and undoubtedly a myriad other technical niceties.

Dehlinger-Kremer delved into some of the more technical and procedural changes brought posed by the Regulation, such as greater flexibility of monitoring (light or heavy depending on the nature and aim of trial), and the requirement for the sponsor to evaluate to the extent and nature of monitoring – which she said opens the way to risk based monitoring (RBM).

She also pointed out that failure to abide by the new transparency requirements would incur substantial penalties, although we don’t know yet what kind of sanctions the member states will be able to impose in case of non-compliance.

This was fertile hunting ground for Lawyer Peter Bogaert of Covington and Burling in Brussels, who keeps a very close eye on EU regulatory developments and has been known to represent the odd pharmaceutical company before the Court of Justice of the European Union.

He said that there would be a number of challenges with the implementation of the Regulation. For example, the new concept of a "low intervention trial", which he suggested could inadvertently lead to more off-label use.

A low-intervention trial according to the new legislation is a low-risk trial using an approved drug, for example, and with some administrative simplification with regard to informed consent, monitoring, damages, accountability, and so on. The criteria for such a trial are that you use the drug either in accordance with its approved labelling, or based on published scientific evidence on its safety and efficacy.

But if you apply for low-intervention status, the member state may have to confirm that there is indeed such scientific evidence or some existing treatment protocols that support this use. In this way, it becomes formalised, "which in some way is ratifying off-label use", Bogaert declared.

So, given that some member states are looking at greater off-label use, for example for economic reasons (as is happening in France and Italy with Roche's Avastin in wet AMD), "this will bring another dynamic because you could end up with more off label uses that are considered to be supported by scientific evidence," Bogaert noted. This is a completely separate question from clinical trials, but it could have wide ramifications, he added.

Something that is very germane to clinical trials is the amount of transparency the Regulation will bring to trial data, via the requirement for all studies to be registered and their results reported on the publicly accessible database.

The arguments about the benefits or otherwise of such openness have been well rehearsed. One is the assertion that miscreants might misappropriate the data for their own nefarious ends. The topic surfaced again at the discussion on Thursday, with suggestions that some companies in Latin America had used data released by the EMA to gain approval of their own drugs. Just how this would work is not clear (do you just cross out the originator product's name and insert your own?), but I'm willing to be convinced by some concrete examples.

Another argument leveled against the wider release of trial data is that it could defeat the wider objective of the new Regulation, which is to make the EU more attractive as a site to run clinical trials. Will fear of their data being released wholesale to all and sundry (it won't, or at least there will be safeguards in place to protect truly commercially confidential information) lead companies to flee Europe in droves? That remains to be seen.

What is more likely is that there will be knock-on transparency effects elsewhere. Noting that the EU is the first to ask for this level of transparency, Chiesi Farmaceutici's Antonio Ferrari thought the US and even the emerging markets might soon follow suit. "The US has started with its Sunshine Act, and its next steps will be transparency European style", he declared. Watch this space.

There was at least agreement that the new portal and database could do pharma firms a lot of good, given that it allows a single trial application for the whole of the EU and is also the conduit for inspection reports and trial results; moreover it will have a very nice dedicated workspace where the  member states and applicants can exchange information. 

Bogaert said the Regulation was, generally speaking, an efficient tool for ensuring the EU legislation on clinical trials was as strong as it could be, and that it would address many of the shortcomings of the clinical trials Directive it is replacing.

For those who are interested in the constantly changing EU clinical trial landscape, the hard work of getting the portal and database system up and running is now under way, and user acceptance testing is expected to begin in February 2016. Once that is done the system must be audited to ensure it is fit for purpose, a process that is expected to start around November and last until March 2017. Once the system has been given the all clear, the verdict will be published in the Official Journal, possibly in mid-year, and the whole thing will kick off six months later – ie, around the end of 2017.

It may be two years away, but that's not a long time where a project of this kind is concerned and you'll need to take time to ensure your IT systems and your thinking are up to speed. The advice to pharma companies and CROs? Start getting to know the system now. Many of your competitors already have. 

Thursday, November 19, 2015

This is what it means to be engaged with patients.

If the patients are senior citizens and travel to the trial centers using buses, don't book their appointments at 9.00 a.m. or after 3.00 p.m. Book them between 10.00 and 3.00 when the patients can use their free bus passes, and don’t have to compete with commuters, or put up with bloody, noisy, rude schoolkids.

Don't describe a protocol of monitoring for nasty drug side-effects in a cancer trial as a "wait-and-see" approach: patients with the disease will think that your approach is to “wait and see if they die”.
Don’t insist on a trial design that requires 22 hospital visits to take blood samples or assess lesion progress. Yes, its good to have data, but asking for 20 blood samples is going to give some patients the bleeding needle. Cut down the blood samples and have patients take photographs of their own lesions.

Don’t ask patients to fly across the country to the place where the trial-qualified staff are based: have visiting nurses – also trial-qualified – call in on the patients and do whatever is necessary.

Ask patients what they are really interested in as outcomes from a trial. The life-skills assessments that are routinely part of rheumatoid arthritis trials typically ask whether a particular treatment has helped a patient put on their socks and shoes, or cook a meal or undertake some task like walking across a room. But when you actually ask the patients what they want from an RA drug, they want to know if it will do something about fatigue: their fundamental problem is that they are so tired that they can't get out of bed - so putting on shoes and socks is just irrelevant.

These were just a few of the insights that came from the session "It all about the Patient – becoming more Patient-centric" at Informa's Partnerships in Clinical Trials meeting held in Hamburg. A panel of patient-engagers laid out some of the principles behind the new efforts from those who run and sponsor clinical studies to listen to the 'patient voice'.

It turns out that where it can be measured, patient-centricity can have some really positive effect of practical benefit to the pharma and clinical trial communities.

Replacing "wait-and-see" with the phrase "active monitoring" for a cancer trial approach increased recruitment almost overnight from 40% of target to 70% according to Sue Pavitt, a professor in applied health and translational research at the University of Leeds, UK.

Focusing rheumatoid arthritis trial assessments on fatigue, not dressing, gives patients the idea that the endpoint is relevant to them and aids recruitment, said Julie Hapeshi, a nurse-turned-trial-lead from the UK.

So far this new experiment of actively channelling patient input into clinical trial design is working out. Not only does it feel like it is the right thing to do, the results seem to be providing benefits not only for patients but for pharma, too.

In a lupus study run by AstraZeneca, patient consultation ahead of the trial not only reduced the number of hospital visits necessary for each patient by 25%, it also enabled investigators to get more out of the measurements they were taking on drug response and quality of life. So said Vincenzo Garzya, AZ's Patient-Centricity Excellence Director.

All of which excellent news really begs the question why this outbreak of common sense has only just happened in the in clinical trial community. Why haven't clinical trial organizations and pharmaceutical companies been listening to patients before? Why have companies only just begun to have Chief Patient Officers or Directors of Patient-Centricity Excellence? Why has it only just dawned on this industry that talking to its end-users might be good thing to do.

The answers that came back were revealing.  Panel chair David Wright, Clinical Trial Patient Engagement Technologies Lead at Amgen Global Development Operations (yes, he has a very large business card) said: "I guess we kind of thought we were [engaging with patients]. The fact that weren't only became clear when we started having problems in recruiting patients, and when the outcomes of trials were poor."

Melissa Jean Mottolo, a Roche Patient Recruitment Strategist said that it wasn't clear that regulators would give permission for this sort of contact. "We thought we weren't allowed to do it. Everyone told us that there was no point in going to the FDA because they are going to say 'no'. In fact we went, and they said 'yes'.

She also added that the internet has meant that patients have found it easier to get information on their conditions. "Dr Google has been very useful", as David Wright put it
Lesley Robson, who is Clinical Operations Manager at Cancer Research UK's Centre for Drug Development, thought the explanation lay in a changed attitude among patients: "Patients are getting a voice. What used to happen was they got ill, came in for treatment and took whatever they got and never challenged it. Now they are more confident that they should have a say."

There may be other explanations, too. I have often heard it said at pharma conference that the prescriber or the health insurance or the healthcare system is its customer, not the patient.
And when it comes to clinical trials, clinicians have served as gatekeepers to patients. “Gatekeeper” a polite term: “nanny” or “minder” or “pimp” might serve sometimes.

Those basic truths about the commercial and clinical realities may have penetrated too far in to the culture of the pharmaceutical industry and its suppliers/partners.

Its good to know that that may be changing, even if those waiting for the change have had to be – well – patient.

John Hodgson

John is Data Editor, Pharma at Scrip Intelligence @scripjohn

Trudie Lang on the African Ebola trial

Trudie Lang, Professor of Global Health Research at the University of Oxford, UK, was involved in running the clinical trial of the treatment  used in the Ebola outbreak in West Africa. Ian Schofield spoke to Prof Lang after her presentation at the PCT conference, and asked her about the ground-breaking trial, what the experience taught her about our preparedness for future outbreaks, and what more the industry could do.

How did you first get involved in the Ebola  trial?

I was working on the drug trial – we ran a trial platform from Oxford funded by the Wellcome Trust. I have worked in tropical medicine for the last 20 years, mainly working on malaria, worms, leishmaniasis and so on, so we are used to setting up clinical trials in vulnerable populations in resource limited settings with low capacity on the ground. Previously I worked in Africa and Asia, 
and for this we worked in Liberia and Sierra Leone.

So what happened when you first went over there to get involved on the ground?

We worked with local investigators, with Médecins sans Frontières, with their treatment centres and with local clinicians, and we had a small clinical operations team that went into the tents to work with local healthcare providers and local researchers on the ground, so there was a lot of partnership. We were the sponsor, we wrote the protocol, planned the research, and gave as much support as we could, but what we really need to think about in the future is helping countries like Sierra Leone and Liberia to be able to lead these themselves. The research capacity gap is really the key, and it's important that they have more local capacity to allow them to operate their own trials. The only way they will do that is by working on other trials and having research as a normal part of operations in those countries, where now it really isn’t happening.

You mentioned the time taken to sort trial contracts out for the Ebola trial – what lessons does that hold?

Yes, we all know it takes far too long to set up any clinical trial and there are things you could do differently, contracts are always a problem, and then we were in this Ebola situation. But the same things come up – IP, time to publication, future pricing of drugs – so we should get ourselves sorted out and try to make sure we are prepared for the next time. We can have meetings with the WHO, have cross-stakeholder meetings, drop-down boxes and template contracts that we could pull off the shelf, but you know this takes work and time and resource and it is very, very difficult to get funding for this kind of research preparedness and capacity development, which is a massive gap.

Was it difficult to draw up a protocol in an on-site situation where there was a disease outbreak?

We are quite experienced in designing clinical trials to work in those settings and do quite a lot of work on being lean and agile, so I think actually the science was the easy bit. We were quite bold in our trial design and we had to work within the situation we were faced with: we couldn't do randomisation, for example – that would have been completely unethical – but we used a design that oncologists use, in that we were looking for big difference in drug effect so we could use historical controls and this was a perfectly legitimate scientific approach. But although there were big scientific challenges in terms of design of protocol, they weren’t necessarily logistical or organisational system challenges.

You mentioned it would have been easier to have access to commercial back up from industry.

I think it's more a question of commercial involvement rather than back up – they have an awful lot of expertise in running trials. I do a lot of research skills training, and I always say to people that a clinical trial is a clinical trial – most of us had never worked on an Ebola trial before and yet we were able to walk in and write a protocol and set up a trial because the skills you need to set up an Ebola trial are not really any different from oncology trials in Washington or Paris. But you need to be a trialist, and we need to be working much more in partnerships – industry has a lot to bring.

Have you been engaging with industry since this happened? Is there a forum where you can talk about this?

The WHO is writing a blueprint on what to do next time, and on the question of research readiness. I think it would be great to involve pharma more in some of this capacity development effort if there was interest, and of course these are emerging markets, so why not? Perhaps there is not the immediate commercial incentive to do so because it is not about a particular product, but it is about preparing the ground for clinical trials for a product. So should there be another outbreak and we want to test a vaccine, then it would be good to get some of this groundwork under way. So it would be interesting to work with pharma if anyone was wanting to get involved, but that might be a tall order because there is no in immediate commercial viability. But maybe some corporate social responsibility activities would be attractive to groups.

Have you learned enough from these experiences to really make a difference next time?

I think we made an enormous amount of progress, we ran trials within this outbreak and that has never been done before. We need to keep that corporate knowledge, if you like, between all the organisations and hope that we do better next time in having international leadership and so on.

Where might future outbreaks happen? 

Who knows, this is the thing isn’t it? We may well have another Ebola, a haemorrhagic fever type viral infection, a respiratory disease outbreak. There will be other outbreaks, and there will be other therapies and vaccines that will need to be evaluated, so we need to work at the global level to make sure we deal with some of these issues.

Wednesday, November 18, 2015

Partnerships, patients and what to do with data

It's the end of day one of the PCT meeting here in Hamburg. The sessions are over, company execs (well, some of them) have danced to the Beatles tribute band, and now it's time for a quick overview of the tastiest topics of the day.

The big theme of this year's event is "patient centricity" – getting patients more closely involved in clinical trials – which means finding out what they want from trials, taking their views into account in trial design, and how to work out where the patients are that will make your trial worthwhile running.

For me one of the most interesting presentations on this theme came from Vincenzo Garzya of Astrazeneca, who summed up "patient centricity" as "open and sustained engagement of the patient" to get the best outcome for them and their family.  

Patient centricity is now the focus across the healthcare landscape, Garzya said, noting the various initiatives under way such as the US Patient Focused Drug Development (PFDD), PCORNet – a large, national network for conducting clinical effectiveness research with a $250m investment, the European Medicines Agency's move to incorporate patients into its benefit-risk decision-making, and the UK NHS "No decision about me, without me" campaign.

That's all very well, but what is pharma doing about it? Companies apparently are becoming more interested in working with patients – and some would say that's none too soon – but as Garzya noted, it is a cultural change that "needs to come from the top." AZ, for example, had taken the initiative through forging a collaboration with PatientsLikeMe, which has access to data from around 300,000 patients and more than 2,500 conditions across a range of diseases.

David Wright of Amgen said there were pockets of patient engagement activity, but this was still really fragmented, and "not stitched together well." Companies don’t share information well internally among the different parts of the organization, he observed. "What does patient centricity actually mean?" 

The point was made that in practice it is quite challenging to get the right people round table to talk about what patients really want. In any case, there are two types of patient – those who are experts, for example because they are working actively in the charitable sector, and they have real value in terms of disseminating information to patient groups; and those who have to trek into hospitals to give blood samples or have biopsies taken, who feel tired or sick on chemo, and so on. These are the people you really need to talk to in order to get an idea of what is really on patients' minds, and the factors that will determine whether they are willing to enter a trial or not.

One session examined the concept of "social listening". Now, while this might sound suspiciously like something the intelligence services are doing behind your back, it is apparently a good way of finding out what your potential trial subjects might need before they do. It could involve scanning the social media communications of patients in a network, such as that for lupus, for example, to find out what their worries and priorities are and then addressing these issues when designing recruitment programs.

Also on the menu today was the future of clinical trial partnerships, in a session chaired in typically witty and provocative style by Dr Phil Hammond, UK GP and media personality rolled into one.
It seemed that partnerships weren't all they should be. Some speakers suggested there were no truly strategic partnerships that had stood the test of time, and that a new partnership model was needed. Sponsors needed to consider what they wanted the future landscape to look like, it was suggested. 

One issue that cropped up several times during the session was the fact that while new tools and technology are allowing us to gather more and more patient data, we don't know exactly what to do with it when we've got it. "The challenge is to transform that data so that we can read and interpret it," said Christian Tucat of CRO INC Research. "This will be the biggest challenge over the next five years." Others pointed out that the data is likely to be in many different places, and that ways would need to be found to bring it all together in one place.

The interesting question was asked: how far are the regulators enablers or limiters when it comes to clinical trials? Opinion differed, but the general agreement seemed to be that they should be involved in some way, as should all other stakeholders – indeed the Transcelerate initiative is trying to do just that in an effort to forge more meaningful partnerships. But what scope is there for greater collaboration among pharma firms? Could we see the day when several major companies come together to work on big trials for, say, combinations of their own drugs? One day perhaps, but not quite yet, it seemed.

At the end of the day, the impression I came away with was that there is a great deal of potential for collaboration among sponsors, CROs, patients, regulators and other stakeholders when it comes to efficient and practical clinical trial design, but that there is still some way to go before this becomes a reality. Where the roadblocks are depends on where you stand, but there seemed to be a strong feeling that sponsors need to be less cautious, more open to collaboration and more prepared to bring the patient much more nearer to the core of the clinical trial process. 

An early summary of PCT's first day

Some very interesting presentations on PCT's first day. A a quick summary of the hot issues so far, with more detail to follow in a subsequent bulletin.

We may be getting more and more patient data through new technological tools, but how do we analyse and interpret all that data? Where is it all stored and how do you access it?

Do regulators help or hinder the trial process? They don't help us, but neither do we help ourselves, said one speaker; for others this is the perfect time to partner more closely with the regulators.

The folk from Transcelerate explained their approach to getting stakeholders together to reduce  the cost and risk of running clinical trials. They also suggested that getting big companies to collaborate to run bigger trials is a key goal - but will it ever happen?

What about the patient perspective? "Patient centricity" is the new buzzword: a whole afternoon here was devoted to the importance of getting the patient's view all the way along the development pathway, so the idea must be making waves (and not before time, some might say).

Another engrossing presentation: Trudie Lang of Oxford University on the difficulties of testing the Ebola vaccine in Africa and the lessons learnt. We'll be bringing you an exclusive interview with Trudie, so watch this space.

Ian Schofield
Scrip Intelligence

Tuesday, November 10, 2015

Experts gather to address key clinical challenges at PCT-Europe

Informa Life Sciences is predicting record attendances at its Partnerships in Clinical Trials(PCT) Europe Conference in Hamburg, 17th to 19th November 2015. Experts from all over the world are preparing to gather in Hamburg to address the issues facing the complex partnerships involved in delivering patient-centric clinical trials and bringing new therapies to market.

This year, PCT-Europe 2015 will focus on delivering fresh and inspirational stories and speakers discussing solutions to the challenges faced by all those involved in delivering patient-centric clinical trials.
With outsourcing of clinical trials efforts increasing at a rate of over 40% a year, making partnerships work for everyone involved is of critical importance to the industry and those relying on the development of new therapeutics.

Ensuring alignment between the multiple parties and stakeholders involved in recruiting and caring for patients, collecting data and delivering meaningful submissions to regulators is a significant and multi-faceted challenge.

These challenges will be addressed in detail at this year’s conference that will be held at the CCH Congress Center. With more than 120 speakers from leading biotech, pharmaceutical and contract research organisations (CROs) attending, PCT Europe is a must for any industry professional.

Tuesday, November 3, 2015

Biomarkers in Life Sciences/Healthcare Convergence Lead to Better, More Personalized Healthcare

By MaryAnne Rizk, PhD., Vice President, Global CRO Partnerships, Oracle Health Sciences

One of the great challenges for the effective use of pertinent data from multiple sources is to be able to integrate, standardize and normalize those data, which include clinical, outcomes, financial, administrative and genomic data into a single repository upon which one can query and analyze to create actionable information. What’s needed to advance personalized or individualized medicine is the effective utilization of all available data to develop the optimal treatment plan for an individual patient for improved outcomes. Genomic biomarkers are becoming the Holy Grail for Pharma and Biotech companies to find these right treatments and for clinical care providers to improve patient care.

In many diseases, there is a direct link between certain genes and the disease itself.  These genes, as well as the proteins that are derived from them, are collectively referred to as “biomarkers” and often are indicative of the presence of a disease, the potential to develop a disease or indicators for targeted drug treatments. The costs for whole genome analysis, targeted DNA sequencing and other molecular diagnostic tests are dropping, the sophistication of the tests is increasing and more tests are being developed, all of which are having a positive effect on R&D and clinical care. With biomarkers being the first step in personalized medicine, Pharma and Biotech companies are aggressively incorporating biomarkers into their R&D efforts and clinical research programs. 

The Center for Drug Evaluation and Research (CDER) at the FDA recently boasted of the Department’s strides in precision medicine, demonstrating that since 2012, CDER has approved thirty targeted (biomarker –related) therapies, eight of which were approved in 2014. Personalized medicine is rapidly coming of age, with 42% of all compounds and 73% of oncology compounds in the Pharma development pipeline have the potential to be personalized medicines. In addition, Pharma has nearly doubled their R&D investment in personalized medicines over the past five years, and expect to increase their investment by an additional one-third in the next five years. Also, Biopharmaceutical researchers are predicting a 69% increase in the number of personalized medicines in development over the next five years.

The importance of biomarkers in personalized medicine is to define which patients would benefit most from which therapies, at the right dose with the lowest risk. During clinical development, Pharma and Biotech companies are now using the presence or absence of biomarkers as key inclusion/exclusion criteria for their clinical trials. Taking this approach, along with greater use of adaptive study designs, are being employed to improve the chances of including the right patients that have the best chance of demonstrating a beneficial effect of the experimental drug being tested, thereby reducing the time, cost and risk of development and accelerating the availability of effective treatments sooner. 

As clinical development proceeds, Pharma, Biotech and CRO’s are expanding their data needs to include clinical outcomes, comparative efficacy and cost effectiveness. Historically, these needs could only be partially met, since the technology to effectively integrate these data from multiple disparate sources didn’t exist, or was too cumbersome.

Personalized drug safety, the practice of determining which patients are more likely to experience a serious adverse event, is another area of focus for Pharma, Biotech and CRO’s. Patients who experienced a serious adverse reaction to an experimental drug in a clinical trial are evaluated in an attempt to identify biomarkers that may be correlated to that event/reaction. Once a biomarker has been shown to be correlated with an untoward event, that biomarker can be used to exclude patients from being treated with a given drug or prevented from being enrolled in a clinical trial. The effective use of biomarkers as a risk/safety mitigation tool can be extremely beneficial by excluding patients that may be at risk for an untoward event from being exposed to the drug, thereby avoiding adverse events that could be very costly. 

In any clinical research project for any Pharma or Biotech company, mitigating risk, reducing time, minimizing cost and improving the probability that the right patients will be enrolled to optimize beneficial effects are critical to the overall success of the project.  For the scientific and healthcare community, it’s exciting to see precision medicine and the use of biomarkers “going mainstream” since improving patient care, optimizing outcomes and reducing costs are common goals.  Cracking the code on personalized medicine takes a true collaboration between Pharma/Biotech and Healthcare organizations.  Creating a technology platform that fosters the collaboration of all key stakeholders, Pharma/Biotech, Healthcare and CROs provides the basis for the growth of personalized medicine.  

Friday, October 16, 2015

Partnerships, collaboration and innovation

By Barbara Tardiff, Pfizer

Bringing new therapies to patients is a complex, multi-faceted effort that intrinsically requires collaboration, innovation and partnership. There are many challenges that need to be overcome during the therapy development process, and while many pharmaceutical companies are comfortable creating innovative scientific solutions, they are not all so comfortable innovating in the clinical trials process and operations. And historically, service companies have not seen innovation as part of their scope.

Successful partnerships are needed to develop and maintain a stable pattern of continuous innovation.  Clinical trial leadership and governance need to be engaged and open to innovation and intent on building trusting relationships with partners. Building and managing complex collaborations involving three or more partners is a pivotal challenge that requires particularly strong and effective leadership.

Without substantive and regular innovation of processes and operations, the number of new therapies and the speed with which they are made available will be greatly limited. In general, the challenges associated with innovation must be solved through creative engagement, and not through regulation. However, regulators can encourage innovation by incorporating appropriate levels of nuance into the application of regulations and being open to varying approaches to ensuring that marketed therapeutics are safe and efficacious.

PCT-Europe plays a pivotal role in bringing partners and potential partners together in a forum that encourages the sharing of ideas and approaching challenges from fresh perspectives. These issues will feature prominently in the very popular Outsourcing and Partnership Forum workshops that will be hosted at this year’s PCT Europe in Hamburg.

Monday, September 28, 2015

Partnering to prevent cancer

Stephen Nabarro, PhD

Partnerships are vital to bringing novel, more effective medicines to patients affected by cancer.

A key challenge in forging new partnerships from a business perspective, is that both parties need to recognise what each is bringing to the table. I think partners that appreciate the added value that the other party brings to the table, are far more successful than those who are more restricted in their outlook.

A fundamental point that we try to bring out about CDD is the way that we work entirely through partnership and collaboration – partnerships with Industry and Academia, to source new drugs and science; the ECMC clinicians and research nurses for expertise and the operational staff at clinical trial sites for delivery; I should mention patients too – they are crucial! CDD spans the spectrum of drug development. We can deliver all the preclinical work, drive the program strategy and deliver science driven- Phase I clinical trials that will enable onward development, or will open up a new field of research etc.

Elaborating on the comment above, to deliver pioneering early phase oncology trials, we work closely with clinicians and scientists from the Experimental Cancer Medicine Centre (ECMC) network, which is an initiative jointly funded by CRUK and the health departments of England, Scotland, Wales and Northern Ireland.

One challenge for our industry is the reluctance of companies to partner with their competitors in order to test a novel – novel drug combination in clinical trials where there is a strong scientific rationale. A unique role of the ECMC Combinations Alliance (part of CDD) is that as a neutral party we can broker that relationship and can therefore drive forward new treatment option for patients.

Partnering for patient-centricity

Ultimately, of course, the key partner in all drug development collaborations is the patient, which is something CRUK keeps in mind when designing studies – all of which we aim to make as patient-centric as possible.

All CDD sponsored clinical trials are early phase often first in class or first in human trials and conducted for the benefit or future benefit of patients, we do not treat health volunteers due to the nature of our investigatory agents.  This is also the case in Pharma at least in the oncology setting and the industry have to  generate the data needed to support  efforts to gain regulatory approval for new or better medicines.

But the difference with a truly patient–centric trial is that the protocol places a greater emphasis on the patients’ best interests, which is particularly important for early phase oncology trials were recruitment is a challenge.

As we all know, Phase I trials are used to determine the tolerability and effective dosage of a candidate drug as the basis for further examination in larger clinical studies conducted in subsequent years.  This time needed to carry out late-phase research means very few of the cancer patients who take part in Phase I trials are likely to benefit from drugs developed as a result - many choose to participate for altruistic reasons.

This reliance on patients generously giving their time needs to be reflected in the protocols and to do this you have to really listen and act on patient advice. You have to find out what schedule might be tolerable for patients, or indeed, what might put them off participating.  In the end, if you can make the trials more palatable and less onerous recruitment is faster and retention can be dramatically improved.  This in turn leads to better data generation which will inform on future development.

Working with the regulatory authorities

CDD historically did 100% source document verification (SDV) like all other sponsors, but by adopting and really driving forward the use of risk-based monitoring, involving liaising with the MHRA for their feedback and input, we have shown that it is possible to conduct early phase oncology studies just as effectively and as safely but more efficiently. This increase in pace is enabling new treatments to be developed faster for patients.

The CRUK ECMC Secretariat have partnered with the HealthResearch Authority (HRA) to streamline and pilot several R&D processes across the ECMC network. The unique set up of the UK-wide ECMC network has the opportunity to undertake innovative ways of working that allows processes to be tested at a national scale and impact measured in a controlled manner. Working in partnership with the HRA, pharmacy and medical exposure reviews have been identified by the research community as being key bottlenecks during trial set up. These pilots have been a huge success in dramatically reducing the number of duplicate reviews, and as a result both of these R&D processes will form part of the technical assurance component of HRA Approval when it is rolled out across England in all Phases and all therapeutic areas at the start of 2016.

In summary, the hurdles and opportunities we have discussed emphasise the importance of bringing together all the key players at PCT-Europe to discuss key challenges and how to overcome them.

Monday, September 7, 2015

A broken design? Why we need to improve trial recruitment

Designing for better trial recruitment

Despite some improvement, many organisations still have difficulty committing to recruitment targets and we need to find out why.

Research by organisations like Tufts University shows nearly half of all sites fail to enrol a single patient and that, on average, recruitment takes twice as long to achieve as expected.

But while these findings illustrate the scale of the patient recruitment problem, they don’t explain why we as an industry face this challenge and it is important that sponsors and CROs consider what factors may impact recruitment.


Obviously, trial design is important. You can’t control doctors’ decisions to recruit patients or guarantee patients will say yes, all you can do is establish the correct entry and eligibility criteria.

Just getting doctors excited and motivated to enrol patients in studies can be hard, especially if there are items such as complicated blood sampling protocols that could deter them from recommending participation.

Indeed, this may be why bigger sites with study coordinators tend to recruit patients more effectively. They have more staff skilled in handling a wider variety of study protocols.


Another key factor sponsors and CROs need to consider when thinking about patient recruitment is the disease they are studying.

Cancer is an area where clinical trials rely heavily on patient altruism. People who decide to take part don't always  benefit and indeed are normally unable to receive established treatments while involved in the trial.

Finding cancer patients for clinical trials is therefore a major challenge, which sponsors and CROs need to plan for appropriately.

Similarly, for conditions like diabetes for which reasonably effective treatments are already available, convincing patients to opt instead for an untested therapy can be a challenge.

Clinical change

But while design, disease and patient desire are obvious factors that impact recruitment, other less intuitive considerations also play a part.
Take for example public perception, which can impact trial timelines in a variety of ways. Sometimes negative press about Phase I trials can actually make it easier to find patients as people learn about the payments involved.

However, stories about trial participants being exposed to risk can have the opposite effect, which is particularly important in early phase cancer studies reliant on patient altruism.

Trends in trials

Another often unconsidered factor that impact both recruitment and the trial process as a whole is how a sponsor interacts with its CRO or CROs.

A few years ago it was very fashionable to have full service CROs, but the current trend is for more functional outsourcing where only activities like patient monitoring and data management are conducted by contractors.

This change between approaches can cause real problems as organisations may lose the expertise they had in a specific area when they outsource it, and once it is gone it can be very difficult to replace.

These issues are why PCT-Europe is so important. Allowing senior people to network and discuss the latest challenges in an environment free of the sales pitches you find at other conferences is extremely valuable.

Tuesday, August 25, 2015

Pharma needs to be bolder to be truly patient-centric

By Jack Whelan

I became interested in clinical trials and how study participants interact with the drug industry after I was diagnosed with a rare and incurable blood cancer called Waldenstrom's Macroglobulinemia.

At the time of diagnosis, all the literature and on-line information indicated about a 5 year outlook after treatment began.  I was told the only treatment options available to me were chemotherapies borrowed from other blood cancers.

But I felt exploring what was available in forward-looking science, specifically clinical trials of molecular targeting agents might be safer and more effective than conventional chemotherapy. 

Seven years on I am still here and I attribute this to clinical trials - I’m currently taking part in my seventh – and my focus on communicating with drug developers as an engaged, educated partner, more commonly known as an e-Patient.

As an experienced trial participant it is my opinion that the biggest challenge facing drug firms today is data collection.

Figuring out how to gather the information needed to prove a new therapy is safe and effective in a way that is timely and complies with the rules that govern clinical trials, particularly those relating to the patient, is difficult because of the out-dated systems, procedures and assumptions about novel targeted therapies.

Many newer targeted therapies generate an immediate response, yet because clinical trial data is reported in “batch mode” rather than in real time we often fail to identify benefits or anticipate emerging adverse events until it is too late.

Although there have been advances, like the use of mobile devices to report trial data in real-time, there remain various out-of-date regulatory requirements that slow the flow of information from patient to drug developer.

As an engaged outsider, I’ve seen far too many examples where privacy and data protection regulations, such as EU Data Protection laws and the US Health Insurance Portability and Accountability Act (HIPAA) regulations, restrict information flow between patients and biopharmaceutical companies. 

Thus I believe the opportunities for more meaningful, more in-depth epidemiological studies have been hampered by too much regulation.

To solve these problems, the industry needs to become much bolder. Rather than being risk averse and trying to satisfy the perceived needs of regulators, drug developers need to instead focus on the patient’s needs.

This most regulated of industries must educate regulators to eliminate many of the out-of-date assumptions and systems that no longer apply to modern medicines.   

Many of the shortcomings of current clinical research methodologies are directly attributable to out-of-date, policies and procedures that the industry follows to achieve compliance and to earn checkmarks on a myriad of now unnecessary check-lists. 

But the underlying goal of all clinical trials remains the same; to determine the safety and efficacy of a drug based on indicators collected from patients.

We urgently need more direct contact and information flow between patients and all those who bring us new therapeutics.

I’m honoured to speak at PCT-Europe on behalf of patients from around the world whose voices might not otherwise have been heard.

PCT-Europe represents one of the best learning experiences for me personally to strive to be a more effective, knowledgeable advocate. I also see the incredible networking opportunities and the vibrant exchange of knowledge and information between collaborators and sometime competitors for the benefit of patients. 

Finally, and again on a personal note, it’s fun to be able to remind life sciences professionals about the nobility of their work and offer a sincere thank you from patients everywhere.

Jack was diagnosed with a rare, incurable blood cancer which research then indicated a five-year outlook for symptomatic patients requiring treatment. Travel with Jack on an intensely personal and oft-humorous bumpy ride on the road to Personalized Medicine still under construction. Encounter some relapsed/refractory detours, conflicting signals and biomarkers, inhibiting regulatory roadblocks and potholes in the healthcare system.  Learn why Jack, not much of beer drinker himself hangs a bottle of Guinness on his chemo infusion rack and speaker’s podium. Using business communications and research skills from his career as a Wall Street Research Analyst in Information Technology (IT) and career Sales VP in IT, he now helps bridge the communications gap between life sciences, medical professionals and patients as a Patient Advocate, Research Advocate and Legislative Advocate.

If you are eager to hear more from Jack, then make sure to register for our upcoming event here

Friday, August 21, 2015

Clinical research: Part art, part science, all communication

By Michael A. Martorelli, Fairmount Partners

I’ve followed contract research for twenty years as an investment analyst and banker. I’ve seen the industry fragment and consolidate, shrink and expand and I’ve used these observations to advise CROs and other service providers of the opportunities and pitfalls.

The most important lesson I’ve learned is that having a clear aim from the outset is the key to success in any drug development project.

The goal of clinical research is to provide regulators with the information they need to make informed decisions about the marketability of new therapeutic products as quickly and efficiently as possible.

To conduct such research in the most effective way requires that sponsors understand the tasks they want their outsourcing providers to conduct empower them to carry them out.

For their part, contractors need to understand and complete their assigned tasks as quickly and efficiently as possible, hopefully on time and on budget.


To achieve these aims, sponsors and contractors need to be led by skilled and adaptable management teams that are capable of establishing the correct clinical programme for each investigative compound.

Clinical research is both an art and a science and its effective management requires leaders who strive for optimal success while being able to adjust to unforeseen difficulties.


The other key party in all effective clinical research is the regulator. It is important that regulators are on top of the scientific and medical advances on which new therapies are based.

In addition, regulators must demand that clinical trials are conducted to high standards while keeping in mind the need to assess the potential marketability of drug candidates as rapidly as possible.

It is also vital that regulators provide sponsors and their contractors with consistent guidance that makes clear their expectations.

Equally, drug developers and their outsourcing providers need to communicate effectively with regulators, remembering at all times that failure to so could result in poorly conceived, poorly executed trials that yield unpersuasive results.


Patients are the ultimate beneficiaries of effective clinical research and it is vital that sponsors, outsourcing providers and regulators share information.

PCT-Europe is an excellent forum for such interaction because it offers workers at all levels of all companies the chance to share experiences and find ways of dealing with common challenges.


By Michael A. Martorelli, Fairmount Partners
Mr. Martorelli came to Fairmount after serving as managing director of research and senior health care analyst at Investec Inc. and its predecessor, PMG Capital. Prior to PMG Capital, Mr. Martorelli spent more than ten years at Janney Montgomery Scott as a research analyst covering companies in various segments of the health care industry.


Tuesday, August 4, 2015

Challenging Industry to Create True Strategic Partnerships

By: Julianne Hull, CEO of WenStar

With outsourcing of clinical trials increasing at a rate of over 40 percent a year, it is critical that partnerships between pharmaceutical and contract research organisation (CRO) partners deliver real value and achieve the desired purpose. This trend has caused an increasing amount of clinical and operational expertise to be developed by CROs, but is this expertise being used to its fullest capability?

It is clear that at the highest levels in partnerships there is usually alignment, but it is questionable whether that alignment permeates through to the Quality Assurance, Operations, Purchasing and Data teams abound.

All to often, strategic partnerships are announced with a great fanfare, but after a few years most of them go quiet – the key question is “why, did they not achieve their original purpose?” Was too much time spent focussing on the partnership – and not on the outcomes they are designed to deliver that will ultimately lead to bringing new medicines safely to market?

There is almost no discussion about those partnerships that end prematurely, or those that are not renewed once they reach their original end date leading to a lack of knowledge sharing and ability to review the full extent of experience gathered.

These issues will feature prominently in the very popular Leadership and Change Management workshops as well as the Outsourcing and Partnership Forum workshops that will be hosted at this year’s PCT Europe in Hamburg.

About the Author: Julianne has worked in the pharmaceutical industry for 20+ years working for Marion Merrell Dow, Wyeth, Pfizer, Biogen Idec and now Ipsen. She holds a BSc in Biochemistry and an MSc in Molecular Virology (Queens University). Julianne has experience in leading clinical operations, clinical data management and vendor management/outsourcing groups globally. Julianne was instrumental in implementing the groundbreaking Wyeth/Accenture strategic alliance in Clinical Data Management. She has been working in varying facets of outsourcing since 1998 including tactical, preferred provider, functional and strategic alliances with responsibilities for governance, vendor outsourcing and operational delivery.

Tuesday, July 28, 2015

Free Webinar: Pharmacoeconomic Assessment through Market Approval and Beyond

Pharmacoeconomic assessment of a drug, medical device, or other healthcare product can take on many forms and occur at multiple points in the development cycle.  Cost-effectiveness analysis, a major component of pharmacoeconomic assessment, has traditionally occurred in the later phases of product development—either as a piggy-back to a phase III or pivotal clinical trial, or peri-authorization.

Join Medpace experts as they explore the application of pharmacoeconomic assessment throughout all phases of clinical trials as well as in observational studies, including registries and other post-marketing data collection.  Save your seat:

This discussion will cover topics including:

 ·         How pharmacoeconomic assessment can be envisioned in the context of early phase product development, implemented, maintained to support product marketing, and used to inform future decision-making.
·         Cost-effectiveness analysis at different phases in the product development cycle.
·         Pharmacoeconomic assessment in the post-marketing context.
·         Comparing and contrasting approaches for small/medium product developers relative to larger companies. 
·         Case studies on “real world” implementation.


Lee Walke, Vice President e-Clinical at Medpace, has nearly 25 years of progressive clinical development experience with expertise in collecting real-world outcomes and clinical data, data integration, endpoint derivation, electronic submissions, Electronic Health Records (EHR), and electronic Patient Reported Outcomes (ePRO).

Matthew J. Page, Ph.D., M.P.P., Epidemiologist at Medpace, has a diverse background in academia and research including teaching college courses in epidemiology and biostatistics and working with pharmaceutical and medical device companies to implement numerous pharmacoeconomic methodologies, including cost-effectiveness analysis and budget impact modeling.

Space is limited. Save your seat here:

Wednesday, June 10, 2015

Patient-Centered Trial Design: A Real-Life Example

By: Kristina Lopienski, Product Marketing Manager, Forte Research Systems, Inc.

The increasing complexity of protocols can cause several inefficiencies in the clinical trials process, such as longer study cycle times, inadequate recruitment and retention rates, and more protocol amendments. Many see the need to simplify such costly and time-consuming trials, but how do sponsors actually achieve this?

At the 2015 Partnerships in Clinical Trials conference, Pablo Lapuerta, Executive Vice President, Clinical Development and Chief Medical Office of Lexicon Pharmaceuticals, presented a session titled, “How Lexicon Achieved Efficiency in Phase 3 with a Patient-Centric Study Design.” In this session, Lapuerta discussed how his company successfully implemented a patient-centric study design for its Phase 3 trial. This oncology study was for a serotonin synthesis inhibitor developed for the treatment of Carcinoid Syndrome, a rare tumor that secretes chemicals into the bloodstream, most often in the gastrointestinal tract or lungs.

Like most rare diseases studies, enrollment was a challenge. In the past, it has taken more than five years to enroll 400 patients with metastatic carcinoid tumors for Phase 3 trials (even with more than 500 sites participating). Lexicon decided to do something different for this study. Patients with carcinoid syndrome who screen failed the Phase 2 protocol would have a new opportunity to be eligible for the Phase 3 study that was designed to focus on the patient. It included the following features to support recruitment and retention:

·         Less frequent visits
·         Home health option
·         Support for travel
·         Short placebo-control period
·         Long open-label phase
·         Less procedures
·         Flexibility on treatment during open-label extension patient focus

In addition to a protocol design that reduced inconveniences for the patient, Lexicon also had an effective CRO partnership. Representatives from both companies visited sites repeatedly in a coordinated fashion, attended scientific congresses together, updated sites on study progress, obtained feedback from investigators on the protocol and patients, and shared best practices in study conduct and patient management.

By maintaining a focus on the patient throughout the trial, this unique Phase 3 study was a success. Lexicon saw both positive site feedback and significant patient interest. Though it still took two years to complete enrollment, there were over 200 total patients in the Phase 3 program. Taking a patient-centric approach means committing to making the patient the priority in choices related to clinical trial design. This includes keeping things simple, holding back on the “wish list” of procedures and measures, and appreciating the value of safety data collected in a setting that reflects actual practice.

Have you been part of a study that incorporated a patient-centric trial design (from protocol design to study conduct)? How did it go?

About the Author: Kristina Lopienski is the Product Marketing Manager for Overture EDC at Forte Research Systems. In her role, she works to bring educational resources to clinical research professionals. She writes on a variety of topics affecting clinical trials on the Forte Clinical Research Blog. Kristina served as the guest blogger covering Partnerships in Clinical Trials 2015. 

Tuesday, June 2, 2015

Life Sciences Shifting Quickly: Is Your Talent Supply Chain Ready?

By Kevin Duffy

When it comes to the emerging trends in human capital management within the Life Sciences sector, senior business leaders are anxious over the competitive landscape and the shrinking supply of skilled talent to help drive their R&D pipelines. What is less understood is that having a strong workforce plan that includes external talent (temporary workers, independent contractors/freelancers, service providers, retirees, etc.) can make or break a company’s ability to achieve its strategic goals. Though the full-time labor force still accounts for the majority of the world’s workers, those numbers are shifting quickly.  Comprehensive plans must re-balance the talent portfolio to account for the opportunity, risk, and cost factors that come with the external workforce.

A contributing factor to this dynamic is that Biopharmaceutical and Medical Device organizations are primarily clustered geographically in the Northeast, mid-Atlantic and northern California regions.  This environment creates incredible competition for talent and places additional pressure on organizations to find the right talent to fit key roles.  Qualified talent is fully aware of the position this creates which can result in movement from role to role, based upon their economic drivers.  To that end, meaningful retention then becomes the issue as talent is being traded back and forth.  To add to the complexity, the capital influences within this industry also have a strong impact on the availability of talent within your supply chain.  It becomes both disruptive and polarizing as we see more mergers, acquisitions, and divestitures on the near horizon as companies position their financial strategies going forward. 

It’s a complex and high-stakes undertaking within this industry therefore forecasting and understanding the need for all talent types is imperative. It’s likely that you already have a higher percentage of external talent then you realize conducting important work on your company’s behalf.  Whether it be in R&D, working in the lab, or positioning you in the marketplace, these individuals can often times form the backbone of your operations.  They are in your talent supply chain, but they’re independent contractors, consultants, and small firms whose people don’t work for you directly. Instead, they essentially act as “companies of one” working for themselves and lending their talents on a series of short-term engagements.

That’s the reality of the new labor dynamic: Modern companies have to adapt to a more flexible, far less permanent definition of work. In doing so, they also have to completely rethink how they acquire, deploy, and engage their workforce—both external and full-time—for maximum business impact.  Companies are now evaluating their legacy policies around how to incorporate external workers into core company processes, such as learning and development, strategic workforce planning, and the like.  This growing reliance on harnessing the power of the entire workforce prompted KellyOCG to sponsor the latest research from Harvard Business Review Analytic Services.

Not surprisingly, more than 70 percent of those surveyed said their organizations are already using the external workforce to meet market demands and maintain efficiency. But more than half also said that using external workers allows them to bring in expertise that their full-time staff lacks, and that non-FTE workers will become increasingly valuable to their organization over the next two to three years.

While this approach may have been a nice to have in the past, it is becoming even more relevant and vital to the health and stability of leading Life Sciences organizations.  By understanding and engaging multiple channels for talent within your supply chain and having a strong grasp on your long term talent agenda, you will move to the front of the competitive landscape to lead the industry’s growth.

To read the full research paper sponsored by KellyOCG on this topic, click here. 

Kevin Duffy is vice president of Global Solutions and Industry Vertical Leader for Life Sciences at KellyOCG.  He has over 30 years of experience in the Healthcare, Clinical Research & Drug Development industries.