While historically dubbed slow to change, the pharma/biopharma industry has made strides during these past 20 years. Advanced IT and data solutions are addressing today’s increasingly complex drug research and development challenges, improving forecasting of high-value clinical trial materials, and enhancing patient-centricity through mobile platforms.
 
Over the years, pharma and biopharma companies have increasingly relied on contract service providers for skilled and flexible services in these areas.
 
Frank Lis, President, Sharp Clinical Services, and Ian Morgan, General Manager, Sharp Clinical Service UK discuss how the industry has evolved, advances in clinical trials, and where we can expect to see changes on the horizon. –KB
 
 
Contract Pharma: What were some of the major industry changes in the past 20 years that have greatly impacted clinical trials?       
                                                       
Frank Lis: The proliferation and adoption of technologies has had a huge impact on every party involved in clinical trials. 20 years ago, data gathering was done manually, using a lot of paper, spreadsheets and time. The introduction of things like interactive response technology (IRT) has changed that with the use computer-controlled supply systems to automate drug dispensing and manage site inventories. The practice is becoming more common because it allows for less waste within the supply chain and gives companies a tighter handle on the amount of drug used – making significant savings long the way.
 
At the other end of the supply chain, we see the rise of patient-centricity. Patients are now so connected through the internet and are drawing on the increasing influence of patient groups to become more involved in all aspects of their clinical trials. They’re forming support groups to discuss their disease and share available treatment options and these support groups will often continue long after the trial. There is a growing focus on having patients use their own devices – such as smartphones – to keep detailed diaries of their trial participation.
 
Pharma and Biotechs are similarly using mobile platforms and messaging to increase patient recruitment ahead of trials and then keep patients on track throughout. This can offer cost-savings and improves recruitment as well as patient adherence as mobile apps remind them about appointments, when to take drugs and even provide personalized guidance.
 
CP: What are some changes you anticipate for the future of the industry and outsourcing?
 
Ian Morgan: There are four core areas where the most change will be seen:
 
1. The rise of patient-centric practices
The concept of patient-centric clinical trials – where the participants are active collaborators in the trial and not merely the subject – is nothing new. However, genuine patient-centric trial practice is now really taking a step forward. The major pharmaceutical companies like GSK, Pfizer and Bayer have continued to promote patient centricity, finding new and innovative ways to engage and inform patients.
 
2. eHealth and data sharing across the EU
The increasing focus on transparency of clinical trials for patients has been matched by a commitment to the security of patient and trial information. Those in Europe engaged in clinical trials have most recently adjusted to the impacts of the General Data Protection Regulation last May and are now getting themselves ready for the introduction of the new EU Clinical Trials Regulation in 2019.
 
As well as the regulatory challenges, developments like the European Medicines Agency’s Clinical Data website are increasing the greater transparency of data across the research community.
 
3. mHealth and Wearable Tech
Wearable technologies are not widely accepted for clinical trials, but there have been significant steps taken as legislators focused on tackling the current lack of regulatory guidance for their use.
 
In July 2017, the FDA’s Centre for Devices and Radiologic Health released its Digital Health Innovation Action Plan committing it to develop and implement regulatory strategies and policies for digital health technologies. It follows from the European Commission’s Smart Wearables paper that discusses similar issues.  It’s only a matter of time before they start to be used.
 
More virtual clinical studies will be enabled by ever-improving technology.
 
4) Automated clinical trial supplies
The clinical trials consumables market is set to grow at 5% per-year between 2017-2021, and it’s going to change too. As trial managers seek to improve efficiencies in trial processes to save valuable resources, they are increasingly turning to the automation of clinical trial supplies.

The complexity of modern clinical trials increases exponentially when conducted across multiple-sites and across various countries. An increasingly pro-active approach to managing clinical trial ancillaries has become a key driver for cost-saving in trials, and continues the trend toward automation.
 
CP: What global market changes have had the greatest impact on the industry and the services sector?

Frank Lis: The notable shift in the drug development pipeline from searching for the next ‘blockbuster’ to a focus on high value therapies for rare and orphan diseases has arguably had the biggest impact on the industry. Trials are smaller, products are more expensive and manufactured in lower volumes and tend to have unique supply chain challenges. The FDA is also trying to be more flexible and reduce the amount of time it takes to get products to market specifically with rare and orphan disease. Contract services providers in turn have to be quicker in our response to study demands.
 
To give a rudimentary example, trial sponsors would traditionally overstock product by about 20% on overage to allow for flexibility in enrollment, retention and supply demand and just throw a lot of product in the bin when it wasn’t used. Now we’re talking about cell-based and biologic therapies with $10,000 plus vials so enrolment and forecasting has to be better and so does the supply chain. Things like Just in Time (JIT) labelling are key as well as they prevent overages.
 
We’re also seeing virtual pharma start-ups being used to supplement the R&D programs of large pharma. Virtual companies are propped up by private equity and venture capital in the early phases of discovery development and even phase I trial with large pharma stepping it when there’s positive early results.
 
Contract partners then have had to become more consultative to support these companies that often have no experience in developing and delivering clinical trials.
 
The downsizing of R&D departments in big pharma has also contributed to a proliferation of consultants in our industry. These independent consultants are highly sought after by smaller virtual start-ups, for their experience, connections and knowledge.
 
Finally, the push for patient-centricity is forcing change. ‘Virtual clinical trials’ where patients are managed remotely using digital platforms mandate for direct to patient (DTP) trials and this poses a challenge to logistics providers. Similarly, it’s becoming more prevalent for nurses to visit patient homes and for them to use tech (smartphones) to record diaries and perform check-ins (Skype). This will only grow and CROs, CDMOs and the like have had to start developing more partnerships with patient services providers to ensure they can offer the more comprehensive service required.