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April 13, 2021updated 26 Jan 2022 12:34pm

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Overcoming sourcing challenges for EU clinical trials supplies

When a large pharmaceutical company required a unique solution for the sourcing of its comparator medicines, Abacus Medicine Pharma Services was well-placed to step in with its new-generation pharma services. The client’s clinical development strategy demanded a significant supply of reference products with maximum diversity of batch, expiry, and origin conditions – no problem for a service provider with Abacus Medicine Pharma Services’s expertise and resources. This whitepaper explores the comparator sourcing challenges faced by Abacus Medicine Pharma Services’s client and how the European medicine market, accessed via Abacus Medicine Pharma Services’s valued clinical trial solutions, is able to keep their busy clinical pipeline progressing as planned. To read the full story and find out more about Abacus Medicine Pharma Services, download below.
by Abacus Medicine Pharma Services
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25 years spent in an industry is time well spent, especially when it is in the pharmaceutical industry.  For Simon Estcourt, MD of healthcare and pharma services company Aposave, his years of experience come with a responsibility: helping under-served patients access life-saving medications they’d previously have no hope of receiving.

“I’ve worked for both the largest service providers and the smaller niche players in the industry,” he explains. “But what led me to where I am now in my career is working for a company that was a pioneer in providing unlicensed medicines to patients and physicians around the world. We became experts and my team created a new category of unlicensed medicines called ‘managed access programs.’ This became the accepted industry term used to describe the service that providers like Aposave provide, who help bridge the gap between patients, doctors, therapy developers and unlicensed products.”

Creating a new generation healthcare and pharma services company that supports the pharma industry’s next generation of pharmaceutical products, provides Estcourt with a great opportunity to bridge this gap. The British native spoke to Pharmaceutical Technology about how Aposave is doing just that.

Managed access programs (MAP) are not only part of the pharma industry’s ethical responsibility, they are also a sound business model. How is Aposave bringing therapies to under-served patients while helping pharma companies?

Many people don’t realise that access to medicine is not equal. Not only is it not equal across the globe, but also within Europe, or even within an individual country. One of the reasons is that increasingly, for companies to be able to bring a medicine to market, they need to demonstrate that it has value to that local healthcare economy. This is because those economies aren’t going to pay for all new medicines that come along if they are no better than the existing standard of care.

That has resulted in regulatory authorities putting in higher and higher market access hurdles. So, pharma companies not only have to demonstrate that their drugs are safe and efficacious, they also have to prove that they have added economic value to that healthcare economy and that it’s worthwhile prescribing it for the extra quality of life, or survival that you get for those patients. And of course, not all countries will take the same view on what the utility of that drug is for their country, and not all countries have the same level of health care budget available.

So, this is where a MAP comes in?

Exactly. MAPs provide a solution for patients, health care professionals and the pharma industry. It can take up to four years for a drug to be fully launched, and most so-called “global launches” only launch in fewer than 40 countries around the world. So, that leaves a huge number of patients waiting for a drug that may be delayed or never launched. MAPs provide a mechanism to provide access to these drugs in a controlled, safe and compliant way. The team at Aposave created this approach and has now brought this experience and knowhow to Aposave where we continue to work with pharma companies to help them provide access to these products around the world.

Aposave is also active in the clinical trials services sector – how do these activities intersect with your passion for MAP?

The main reason for pharma companies to want to run a MAP is an ethical one, as it may be the only way to provide a treatment option to a patient. That is what motivates me and my team, with that enthusiasm we’ve had great success in providing access to medicines. Where there is common ground between clinical trials and MAPs is that the best way to provide the broadest access to medicine is for it to be commercially launched. To achieve this requires a successful clinical development program. Our services help companies run efficient and cost-effective clinical trials.

And how exactly does Aposave do that?

The role we play as a pharma services company in supporting clinical trials is primarily by providing comparator drugs for use in phase three clinical trials. During this phase, what regulators want to see is how the drug that’s in development compares to the current standard of care.

Because we are part of the Abacus Medicine Group, we have extensive supply networks, not only throughout Europe, but throughout the world.  We have unrivalled access to products, which means we can provide fantastic solutions for companies that need access to all different types of comparator drugs for use in their clinical trials. For example, they might need drugs that have a specific country of origin, be from a particular batch or have a specific expiry date.

The other thing that really sets us apart from the rest of the industry is that because our parent company is a business that trades in medicines around Europe, we can help others ensure that any excess products that they buy for clinical trials don’t get wasted.

It is not uncommon for anything between 20 and 40 per cent of the products purchased to be used as comparators in clinical trials get thrown away or wasted, and that’s because clinical trials are notoriously inefficient in the way that they’re run. So, you end up with delays, with not being able to recruit patients at the right pace, which can result in expired and therefore, wasted products.

Aposave can work with pharma companies to design a solution that means they never have a product that gets wasted or thrown away.  We have a methodology that helps us recycle those products through our parent business and this ensures that our clients have always got just the right amount of product that they need at the right time. So, it’s a just-in-time procurement and distribution service that is a very innovative and new approach that we are taking to the market. This is a tangible example of why we say we’re a new generation healthcare and pharma services company, because we’re not doing the same old things and reinforcing the status quo, we’re constantly looking to innovate and move the industry along to support the next generation of pharma products.

To see where Aposave can help save your company money and provide unique clinical trial solutions, download the white paper below.

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Overcoming sourcing challenges for EU clinical trials supplies

When a large pharmaceutical company required a unique solution for the sourcing of its comparator medicines, Abacus Medicine Pharma Services was well-placed to step in with its new-generation pharma services. The client’s clinical development strategy demanded a significant supply of reference products with maximum diversity of batch, expiry, and origin conditions – no problem for a service provider with Abacus Medicine Pharma Services’s expertise and resources. This whitepaper explores the comparator sourcing challenges faced by Abacus Medicine Pharma Services’s client and how the European medicine market, accessed via Abacus Medicine Pharma Services’s valued clinical trial solutions, is able to keep their busy clinical pipeline progressing as planned. To read the full story and find out more about Abacus Medicine Pharma Services, download below.
by Abacus Medicine Pharma Services
Enter your details here to receive your free Case Study.

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