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Explaining The Unexplainable: How To Win US FDA’s Trust In Artificially Intelligent Drug Manufacturing
One issue that has surfaced as the pharmaceutical industry responds to the US FDA’s recent discussion paper on manufacturing with AI machine learning models is the question of how to explain what the models are doing.
In the aftermath of announcing a major collaboration with Sandoz on biosimilars, Evotec’s chief business officer Matthias Evers speaks about how the deal provides “validation” of Just-Evotec’s technology platform, while also outlining the firm’s wider ambitions to enable more efficient development of and broader access to biologics.
A partnership approach is required to reduce greenhouse gas emissions generated by pharma clinical studies. That is the advice in this guest contribution by the Sustainable Healthcare Coalition and Johnson & Johnson’s Janssen company to In Vivo’s rolling series on issues in sustainability for healthcare product manufacturers and providers.
Healthcare product innovation and design evolves continually, and COVID-19 times were no exception. But patient-centred design has always been the platform on which medtech businesses build success, says Mike Phillips of outsourcing industrial design company Renfrew Group International.
Bavarian Nordic managed to change its financial story in 2022 when its smallpox vaccine, Jynneos, became a critical tool in the global response to the mpox pandemic. CEO Paul Chaplin speaks to In Vivo about what this year holds in store.
Belgian mRNA technologies firm Etherna, which is backed by high profile investors including former Bayer CEO Marijn Dekkers and Moderna co-founder Kenneth Chien, has reoriented its business model. Interim CEO Bernard Sagaert tells In Vivo how the firm hopes to deliver superior products for partners in the rapidly expanding RNA space.
Pharmaceutical cold chain products are growing in number, complexity and reach. While life sciences organizations and their partners have been steadily investing in capabilities to effectively manufacture and distribute them, scaling them at the speed of innovation in an era of increasing regulatory and environmental requirements is more and more challenging.
Ongoing debate emanates from industry players around the most efficient design of the manufacturing process for cell and gene therapies. The arguments surrounding outsourcing, centralizing, and standardizing processes will no doubt continue through into the near future.
While not immune to the impact of a storm of macroeconomic pressures, pharma companies have pulled through before, and they’ll do it again. However, this time around, the economic, geopolitical and internal cost and revenue pressures are unique and weathering the near-term turbulence will call for smart investment strategies that not only focus on quality assets, but that update companies to take advantage of new digital opportunities.
The issue of counterfeit medicines continues to be a huge issue of the pharmaceutical industry, with 10% of the world’s drug thought to be fake. Industry 4.0 provides an opportunity to overhaul current systems and create an efficient industry operating dynamic.
Syngene’s COO, Mahesh Bhalgat, said the firm is better placed than some peers to serve clients for biologics-based advanced therapies and address the cost element for new modalities like mRNA. He also outlines the research, development and manufacturing services company's capabilities in oligonucleotide-based therapeutics, an area that's seeing growing interest.
Pharmaceutical supply chains may grow less efficient and less risk prone as US government gets more involved to ensure availability of pandemic and essential medicines. But what about pediatric oncology medicines and other treatments that save lives even though they may not be considered essential?
Benoit Opsomer, vice-president and head of bioprocessing, Asia Pacific, Merck Life Science, explains how recent targeted CDMO buyouts put the German group in pole position with services across the mRNA value chain, even as it supports global players such as BioNTech. Striking multi-country expansion of manufacturing footprint, including in China, is also underway amid rising demand for biopharma single-use assemblies.
Indian firms are getting their act together in areas like cell and gene therapy, with Dr Reddy’s aiming big and readying a facility alongside an alliance with a Chinese firm for a CAR-T therapy. The company is also doubling down in contract development and manufacturing, with an eye on opportunities in biologics.
Sweden is a European leader in the life sciences and now has its sights set on becoming a global force in digital and e-health. A rich academic tradition, strong manufacturing infrastructure and health care as a pillar of its unique Mixed Economy make Sweden an attractive home for pharma, biotech and medtech companies and a target for investors.
Hype around the metaverse has made it a sexy topic, but a recent Accenture report grounds the concept in a sober, yet still exciting, reality. The consulting firm looked at how the metaverse is being applied in the life sciences sector and concluded that while it is early days and the concept remains nebulous, executives would be remiss if they ignored the growing possibilities the metaverse has to offer.
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