In light of the COVID-19 pandemic, the race is on to develop effective treatments. At the time of writing, there are two vaccines in Phase I clinical evaluation and 11 in pre-clinical, ^[1] as well as 95 clinical studies underway for potential drug therapies and many more in development. ^[2] Drugs presently undergoing clinical evaluation include antivirals, HIV combination drugs, antimalarials and immunosuppressants. ^[3] In response to the urgency of the situation, it is vital that these new treatments are made available as quickly as possible, without compromising the quality or thoroughness of safety evaluations. To achieve this, Contract Development and Manufacturing Organizations (CDMOs) must adapt their processes to safely accelerate the development of new COVID-19 therapies.

Expanded Access or Compassionate Use Programs

There are currently no EU-approved therapies for COVID-19. At this critical time, the availability of medicines through Expanded Access (otherwise known as Compassionate Use) is providing a way forward for patients severely afflicted with COVID-19. Expanded Access allows the use of investigational drugs, biologicals, and medical devices to diagnose, monitor or treat patients with serious diseases, including conditions for which there are no approved therapies. In the U.S., this is facilitated by the FDA, while in Europe the European Medicines Agency (EMA) provides recommendations through the Committee for Medicinal Products for Human Use (CHMP). Although, in Europe, Compassionate Use programs are implemented by member states, which individually set out their own rules and procedures.

Drugs considered for Expanded Access are usually in the development or registration phase, with scalable formulations already developed in preparation for commercial release. However, in some cases, new indications, a change in the target patient population or route of administration can mean that a suitable dosage form has not yet been developed. In these situations, an accelerated development programme is necessary.

Streamlining drug development with CDMOs

CDMOs are already widely used in the pharmaceutical industry due to the range of benefits they offer. By outsourcing drug development and manufacturing to CDMOs, the overall cost of drug development and the time taken to bring new drugs to market can be reduced, and manufacturing efficiencies can be improved.

For Expanded Access programs where new formulations or dosage forms are required, the improved efficiency and speed offered by CDMOs becomes even more important. As a result, in these situations the onus is on CDMOs already equipped with the expertise to streamline drug development to create fit-for-purpose formulations in a timely manner and with a reliable chemistry, manufacturing and control (CMC) package.

By providing integrated end-to-end CMC services across the drug development pipeline, CDMOs can significantly reduce the time taken to progress potential COVID-19 therapies to clinic. For instance, by supporting a full range of studies, from preformulation through to clinical trial GMP manufacturing, including the development of sterile injections, solutions for inhalation in vials, ADME studies, oral formulation and stability studies. By leveraging expertise in the development of capsule formulations in particular, the need for extended stability studies is removed, helping to accelerate drugs to clinical trial. Furthermore, modern CDMOs can support clinical studies by providing analytical data, formulation protocols and bioanalysis, supplemented by compilation of robust regulatory submission packages, which ultimately results in faster delivery of safe and effective medicines to patients.

Adapting CDMO working practices

While CDMOs are working to advance COVID-19 treatments through development quickly and effectively, it is crucial that they also adapt their working processes to protect their staff. To protect lab-based scientists, new safety procedures have been put in place. For example, in the UK this includes social distancing, ensuring that employees are never less than two metres apart. Regular handwashing is also essential. In light of these measures and the safety considerations that prevent visits to lab facilities, the use of virtual communication tools is on the rise, helping an inherently collaborative industry stay connected while working to develop safe and effective treatments for COVID-19 patients.

Rising to the challenge

In response to the global health crisis, pharmaceutical companies around the globe have risen to the challenge. Hundreds of drugs are currently under investigation for the treatment of COVID-19, but before they can reach the patients with life-threatening cases, they must be thoroughly tested to ensure safety. With mounting pressure to find an effective treatment, the race is on to deliver fit-for-purpose formulations in a timely manner – whether for repurposed drugs or new chemical entities. CDMOs represent an important component of the global response. As part of this important industry sector, CDMOs can provide the expertise to accelerate potential treatments through development without compromising safety evaluations.

Sources
1. www.raps.org
2. clinicaltrials.gov
3. https://arcinova.com/knowledge-centre/white-papers/543-the-development-of-medicines-for-expanded-access-or-compassionate-use-in-the-treatment-of-serious-diseases-with-no-approved-treatment-covid-19