Discovery Research From The Editor

31. One Percent Of A Hundred People's Efforts 12/5/2024

    Persephoni BioPartners CEO Hilary Shultz, and newly hired Chief Scientific Officer William Heath – a 34-year veteran of Eli Lilly – explain their biotech-forming business model, dubbed a venture studio, and provide sound advice on working with CDMOs.

32. Go Ahead, Outsource Your Entire Biotech 12/2/2024

    Persephoni BioPartners CEO Hilary Schultz has created a business model that may propel “externalization” to an ultimate implementation: The formation of a biotech by outsourcing the entire organization, which then outsources to advance an asset. Schultz describes Persephoni as a venture studio. Chief Editor Louis Garguilo investigates further ...

33. Fabled Route-Scouters Riding AI Applications 11/18/2024

    Route scouting professionals – self-effacing hunters of small-molecule simplicity, searching for efficient pathways to commercial success, fearless in pointing out risks, and at times, dead ends. Today they face mounting challenges. Can artificial intelligence (AI) bring more clairvoyance to these battered scientists? “Absolutely,” says Dr. Jürgen Swienty-Busch of Elsevier.

34. Is Executive Leadership At Today's CDMOs Up To The Job? 11/11/2024

    A report from WittKieffer's Global Life Sciences provides a macro analysis of the executives that helm today’s CDMOs. Competent executive leadership should be a main driver of business-to-business confidence. So as a component of your CDMO due diligence, are you adequately assessing the senior executives at that organization? If so, do they inspire confidence that theirs is a well-governed and operated entity?

35. Global CDMOs: What's The Right Price And Location? 11/5/2024

    Jin-an Jiao of Synthekine, a developer of CAR T therapies and biologics, says despite the specifics of his pipeline, plenty of CDMOs are interested in working with him. “However,” he says, “what’s most interesting is there's a huge difference in price estimates for the same work.” Here's his advice on how to handle that.

36. I Outsource, Reluctantly 11/1/2024

    “I’ve worked with CROs and CDMOs since 2000,” says an outwardly jovial Jin-an Jiao, VP, Process and Analytical Development, Synthekine, a developer of CAR T therapies and biologics. His apparent mirth, though, masks a complication: Generally speaking, Jiao is a reluctant outsourcer. Here's how he handles that.

37. Were We (Are We) Correct About Oligonucleotides? 10/25/2024

    In 2023, Chief Editor Louis Garguilo proclaimed it was "the year of oligonucleotides," and 2024 would be an incredible growth year for oligos. How are those proclamations panning out? He takes a detailed look, including the important role in the expected growth played by CDMOs.

38. BIOSECURE Act Starts Dismantling WuXi 10/16/2024

    Components of the WuXi global organization are for sale. It’s a forced divestiture. WuXi AppTec is marketing some of its U.S. and European operations. The ill-advised BIOSECURE Act targeting several China-based biopharma companies is having its intended effects, even before the legislation is fully passed by the U.S. government. Where do you stand?

39. BIOSECURE Act Passes House. How Will It Impact Your Outsourcing? 9/10/2024

    The U.S. House of Representatives was hell-bent on sending a message to China – and all of us in the biopharma industry. Congress hopes that message – and real-life consequences – will be accomplished via its successfully passing the BIOSECURE Act in a House vote. Breaking analysis from Chief Editor Louis Garguilo. 

40. The High Life And Times Of A Qualified Person (QP) In Europe 8/26/2024

    You must be appropriately qualified, trained, accepted by the relevant competent authority in the European Union, and named on a site’s authorization. According to Nolliag Buckley, a Qualified Person (QP) also needs more. “Honest to God, you must be creative. That sort of individual skill is helpful. I'm a troubleshooter. That's what I love.”