Home » Life sciences » Putting patient safety front and centre for the pharma and biotech industry

Dr Carmen Sweeney

Scientific Director, Charles River Laboratories Ireland Limited

Vaccines and therapeutics must be subjected to rigorous safety testing before they are used by patients. That’s where the work of outsourced contract service providers plays a critical role.

Before a vaccine or therapeutic reaches the market, it must undergo a barrage of validated tests to make sure that it is safe and efficacious for patients to use. Take the COVID-19 vaccines, which — despite their speedy roll-out — underwent the same strict processes as any other vaccine before they could be approved by the regulators. “That rigorous regimen is essential and for very obvious reasons,” says Dr Carmen Sweeney, Scientific Director at Charles River Laboratories Ireland Limited. “Ultimately, patient safety is always paramount.”

The staff at Charles River know all about the importance of patient safety. As a contract research organisation (CRO), its products and services help pharma and biotech companies develop novel drugs and therapeutics from early phase discovery through to market.

The value of outsourcing to a third party

Charles River has been helping pharma companies with COVID-19 research from the start of the pandemic. “In Ireland alone we’re involved in the batch release and safety testing of one of the main COVID vaccines, and we’re about to embark on work for another. The pandemic has been an unprecedented event that has had such a terrible impact around the world, so it’s exciting to know that our services can help put a product onto the market that is going to save lives” says Dr Sweeney.

However, anyone outside the biotech industry might be surprised to learn that contract research organisations are necessary. Because don’t pharma companies have their own in-house experts and facilities to run vital biologics tests themselves? Why do they need to outsource them to a third party?

It’s also imperative for a CRO to have good communication across all of its divisions to manage client expectations. There’s no point in us promising something we can’t deliver.

“It depends on the company,” explains Dr Sweeney. “Our clients are varied and include big pharma, mid pharma, virtual biotech start-ups, universities and government agencies. Not everyone is the same and not everyone has their own in-house capabilities. And the fact is that CROs are experts in their field who do this kind of work, day in, day out.”

Much of the work carried out by the company involves cell and gene therapy products — a promising and evolving area of medicine. “The great thing is that cell and gene therapy products are able to target serious, life-limiting diseases, and can give people more hope and more time,” says Dr Sweeney. “If successful, they can make profound, dramatic and very evident changes.”

Adhering to timelines while following strict procedures

The best CROs will always be mindful of clients’ timelines — but never at the expense of patient safety. Even in the middle of global pandemic, corners are never cut, and steps are never missed. “Quality always come first,” says Dr Sweeney. “It’s also imperative for a CRO to have good communication across all of its divisions to manage client expectations. There’s no point in us promising something we can’t deliver. But it is important to do things right first time, on time.”

Being flexible and adaptable is key, too. “In Ireland, our site is very different to how it was three years ago because we’ve extended our capabilities and broadened our service offerings,” says Dr Sweeney. “We’ve had to adapt in order to meet growing client needs and demands, and as a consequence of Brexit. And most recently we developed the capability to support biosafety level 3 (BSL3) pathogens like SARS-CoV-2 to meet the needs of our customers in the fight against COVID-19.”

Of course, CROs are service providers — they don’t develop their own products. Isn’t that ever a source of frustration for Dr Sweeney and her team? “Not really,” she says. “That’s because we get to work with all kinds of different products. We don’t forget the importance of our work and never lose sight of the bigger picture, which is getting medicines to market that can help patients. COVID has brought that into sharp focus. It really is an honour to do what we do.”

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