Phase 1, phase 2 and phase 3 – the three key stages in a drug’s journey to market – and each stage is marked by its own complex processes, strict regulations and logistical challenges, hence the need to issue a license an average of ten years to new products. , which means that companies providing pharmaceutical services need to improve their game. In addition, over the past 10 to 20 years, a fourth stage has emerged: profitability. Additionally, the industry’s extremely low approval rates show that the majority of drugs are unlicensed. Meanwhile, those who reach the end of the process can only become available in a small number of countries. The results of all this leave many people around the world struggling to access the pharmaceuticals they need, from healthcare providers looking for patient treatments to clinical researchers in need of benchmarks.
Should patients with unmet medical needs just accept that a drug is not an option until it is approved in their country, then? The response from next-generation pharmacy services company Aposave is an emphatic “no”. As part of a single company service, pharmacies and private hospitals can request access to a range of unlicensed drugs (ULMs) from the vast European network of Aposave’s parent organization, Abacus Medicine. Group. By combining Aposave’s in-depth knowledge of the ULM market with the resources of Abacus Medicine, healthcare providers can receive drug deliveries that they were previously unable to make at fast speeds and prices. competitive.
Connected pharmaceutical services
The company’s innovative services, as varied as they are, all revolve around this principle of access. Simon Estcourt, CEO of Aposave, defines the objective as “helping people to access medicines at different stages of the life cycle”.
He adds that Aposave works with a range of different stakeholders, getting involved in the life cycle of the pharmaceutical product from phase two with managed access programs and a comparator and sourcing of reference drugs.
“The first step in which we help companies gain access to drugs is through our clinical trial solutions, where we provide access to drugs that can be used as comparators,” says Estcourt. “These are used to help researchers show that their product has the same safety or better efficacy than those already on the market. Aposave has access to a wide range of products, mainly from Europe but also from many countries around the world, to help companies develop medicines effectively and efficiently. We also distribute the products to trial sites. ”
After clinical trials, successful treatment options will have demonstrated their safety and effectiveness, but will still have to wait a few more years to go through the New Drug Request (NDA) stage. Due to the lengthy approval process, many products awaiting approval have the potential to treat a patient or significantly improve their quality of life. For underserved therapeutic areas in particular, the ability to provide patients who desperately need treatment options with an investigational drug could save lives.
“Often, patients will learn that an interesting new product is in development and contact the pharmaceutical company to ask if they can access that product because they may not have other treatment options. available to them, ”explains Estcourt. “What Aposave can do in this scenario is run a managed access program, which is a controlled means by which the pharmaceutical company can make its products available to patients before obtaining a formal license. It’s a fully outsourced service, the company will basically provide us with the product, and then we’ll take care of everything from the doctor’s request to all the settlements, and make sure the drug gets to the patient. It is mainly about providing treatment options for patients who cannot afford to wait for the product to be available in the market in which they live. ”
Expanding Reach Through Business Partnerships
Aposave’s distribution services and in-depth knowledge of European specialty medicine markets are invaluable to companies looking to bring licensed products to life that may be overlooked in some smaller countries. The goal is once again to provide patients with better access to treatment options, in the meantime helping small pharmaceutical companies expand the reach of a product. Ancillary services such as labeling and packaging can also be provided.
“Not all companies have big footprints and lots of employees across Europe,” says Estcourt. “Many companies that do not have a physical presence in Europe can look for a partner who can promote and distribute their products for them. Aposave approaches this as a business partner. Because our parent company, Abacus Medicine, has such an extensive distribution network across Europe, we can use this existing infrastructure to make our customers’ products available in different countries. This saves them from having to put in place an infrastructure and employees in those communities. ”
Companies that use Aposave’s unique pharmaceutical service offering from phase two onwards are able to address various gaps in their supply chains with customized and cost-effective company solutions. Aposave also offers ways to mitigate product waste by “ recycling ” leftover test products through different parts of the supply chain, helping companies increase profits, reduce waste and save money. serve patients.
It is clear that Aposave’s services have tremendous benefits for everyone involved, says Escourt: “Our different solutions help pharmaceutical companies not only to bring their products to market, but also to extend their reach into markets in which they might not otherwise have been able to penetrate. We understand where the gaps and needs are, and then tailor a solution for that business. This is great not only for the pharmaceutical company, but also for the patients and doctors in these countries who are benefiting from the opportunity to access these products. ”