Insights On Drug Discovery
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"Relentless Transparency" Needed Between CDMO And Biotech Customer
5/15/2024
Vincent Kosewski, VP, Manufacturing & Supply Chain Management, Kala Pharmaceuticals, explains his phrase for how outsourcing communication needs to be handled.
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Speed To Clinic, Cost To Get There, And FDA Expectations
5/15/2024
GSK’s Ben Stevens provides an indepth analysis of the variables regulatory bodies and developers need to balance when considering fast track designations, and the overall rush to get to the clinic.
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When Outsourcing, Get The Right Professionals On Your Internal Team
5/15/2024
In our Outsourced Pharma Live titled “How Can CMC Keep Up With The Rush To The Clinic?”, our speakers all agree: Hire strategically internally for the best results.
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A New Acronym – CBMC? Put "Biology" In CMC? Our Panelists Think Not.
5/15/2024
Chief Editor Louis Garguilo asks our panel if CMC – chemistry, manufacturing, and controls – might be outdated, and whether biology should be added to the acronym.
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Consultants Know: Emerging Biotechs Have Outsourcing "Disconnects"
5/15/2024
Missing an analysis of all the pieces involved in development outsourcing, and a loose connection between the C-suite and reality, can slow down a biotech’s program.
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Speeding Up The Regulatory Side Of Outsourcing
5/15/2024
Benjamin Stevens, Director CMC Policy and Advocacy at GSK provides some initial thoughts on the regulatory aspects related to moving programs to and through the clinic as quickly as possible.
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You Need A Gap Analysis Before Outsourcing
5/15/2024
Vincent Kosewski, VP at Kala Pharmaceuticals, believes there’s a gap when it comes to biotechs performing the necessary gap analysis before initiating outsourcing activities.
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Outsourcing Not Plug-And-Play
5/15/2024
Joanne Beck, Chief Technology Officer, Aerium Therapeutics, starts our Outsourced Pharma Live with a caution: Working with CDMOs is less like a plug-and-play model, and more like a custom-fit set of activities.
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Cell And Virus Banking In OV Development And Manufacturing
5/14/2024
Delve into the exciting potential of OVs, including the critical role of cell and virus seed banks, and discover key considerations for establishing cell and virus banks for OV production.
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Potent Immune Response With Vernal's LNP-mRNAs
4/26/2024
As mRNA medicine continues to evolve, understand how trusted manufacturing partners will continue to play a pivotal role in translating innovative concepts into clinical reality.