Outsourcing
The rise of CRDMOs offers a seamless, one-stop solution for drug development, as the industry shifts from fragmented outsourcing to integrated services.
project delays. That’s not to mention the possibility of intellectual property leakage – something that becomes less likely when only one vendor is involved.
Changing client demands
Of course, while CRDMOs do offer some broad-brush advantages over their more disjointed rivals, the specifics will depend on their precise business model. And as Li points out, different CRDMOs will define their purpose in different ways. BioDuro-Sundia, for instance, offers a full spectrum of drug discovery services, including medicinal chemistry, biology, pharmacology and drug metabolism and pharmacokinetics (DMPK). Within the manufacturing space, it covers everything from pre-formulation to commercial manufacturing. “In terms of molecular modalities, we do everything from small molecules to biologics,” says Li. “On the formulation side, we mainly do oral formulations, along with solid, and we are aiming to develop new capabilities in injectables.” Thermo Fisher Scientific, boasts a comprehensive service model, with expertise spanning complex formulation, solubility enhancement, cold chain manufacturing, clinical research services and patient recruiting, among others. It can handle drug formats ranging from small-molecule APIs to cell therapies, along with everything in between. “The services we offer are crucial in today’s globalised and highly regulated environment,” says Cannon. “Uniting these services under one partner helps customers achieve a seamless flow from development to commercialisation and beyond.” As ever, it comes down to what the customer is looking for. Li notes that BioDuro-Sundia’s services are especially popular with smaller biotechs. “Big pharmaceutical companies, on the other hand, have enormous resources internally, and they tend to outsource specific services,” he says.
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In a more general sense, though, he thinks two trends are emerging, which could shape the outsourcing landscape for years to come. The first is the movement towards more complex therapies – away from the ‘low hanging fruit’ of small molecule drugs, to more complex modalities such as oligonucleotides and peptides. As pharma gravitates towards these molecules, they’ll need partners with deep and highly specialised expertise. Secondly, with geopolitical risks looming large, pharma companies are trying to find ways to alleviate their concerns. “This is beyond our industry – there are a lot of politics involved,” says Li. “During Covid, we noted the supply chain became a huge challenge. Many customers are also concerned about the BIOSECURE Act, so they’re looking for companies free of geopolitical risk, just like us. We’re a US company with operations in China, so we can bring down the cost and bring up the speed while maintaining the US brand and global quality standard.”
Cannon says clients are increasingly concerned with flexibility, real-time data insights, end-to-end reliability, and savings. And while they need drug development, clinical research and manufacturing expertise, that’s only part of the equation. “They also want clinical supply chain support, consulting and regulatory guidance services, comprehensive lab services, market access, and post-commercialisation expertise that ensures the integrity and compliance of their products worldwide,” she says. “Our investment speaks directly to these evolving needs.” In short, the days of multiple, disconnected vendors may be numbered, with the industry moving towards more of a ‘one-stop-shop’. There may be a place for providers with highly specific competencies, but for many pharma companies and biotechs the thought of handing over a project to a single CRDMO partner may prompt a sigh of relief. ●
Clinical Trials Insight /
www.worldpharmaceuticals.net
Corona Borealis Studio/
Shutterstock.com
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