Regulation
Competence & continuity at CDER; plus BIO 3.0, AACR and 2Q preview: a BioCentury podcast
On the latest BioCentury This Week podcast, BioCentury editors discuss what Patrizia Cavazzoni’s appointment as permanent director of FDA’s Center for Drug Evaluation and Research means for the biopharma industry, as well as the reimagination of BIO, buzz over bispecifics at AACR, the latest on the biotech financing environment and this week’s Deal in Focus — a tie-up between a pair of Shanghai cancer companies.
Patrizia Cavazzoni’s ascension to permanent director of the Center for Drug Evaluation and Research brings “competence and continuity” to one of the most important positions in the life sciences ecosystem, says Washington Editor Steve Usdin. He said it was also met with a collective “sigh of relief” from biopharma executives.
Usdin believes one of the first things Cavazzoni will do as permanent director is to assess the COVID-19 experience at CDER to figure out “what went right, what went wrong, what needs to be retained, what needs to be thrown out,” and from there determine what changes in FDA policy she might pursue.
Staying with Washington, Usdin recounts his recent conversation with BIO’s leadership about how the trade group is reinventing itself for a changing political environment. In a video interview, Usdin discusses BIO’s engagement over the past year on racial equity, social justice, immigration, climate change and other social and political issues with President and CEO Michelle McMurry-Heath; Chairman Jeremy Levin, who is CEO of Ovid Therapeutics Inc. (NASDAQ:OVID); and Vice Chairman Paul Hastings, who is president and CEO of Nkarta Inc. (NASDAQ:NKTX).
Turning to the American Association for Cancer Research (AACR) virtual conference, Senior Editor Lauren Martz, Editor in Chief Simone Fishburn and Associate Editor Stephen Hansen examine how companies working on bispecifics are beginning to branch out into next-generation structures that offer new functions and potential improvements over first-generation compounds.
Martz also flags early clinical NK cell engager data from Affimed N.V. (NASDAQ:AFMD). On Friday, the company announced a 100% overall response rate among the first four patients treated with AFM13, a CD16A x CD30 innate cell engager delivered in complex with cord-blood derived NK cells.
Looking to the markets, Hansen breaks down the takeaways from his conversations with buysiders for BioCentury’s 2Q Financial Markets Preview. He points out that a record quarter for financings for biotechs contrasted with a slide in sector indexes. Driving that, he says, were worries over FTC’s increasing scrutiny of M&A and interest rates as well as a run of “bad performance” on clinical and regulatory milestones.
In BioCentury This Week’s Deal in Focus, Martz and Executive Editor Jeff Cranmer discuss what last week’s deal with I-Mab Biopharma (NASDAQ:IMAB) means for Shanghai Genechem Co. Ltd. The partnership with I-Mab is the first global deal by Genechem under its new initiative to leverage its platform to develop assets in-house or with partners in China as well as on a global scale. It also serves as an entry point to bispecifics for the company, which has been focusing on antibodies and cell therapies.
Martz adds that the novel targets in Genechem’s pipeline help the company to stand out from many of its fellow Chinese biotechs.
Look for more deals in the months ahead from Genechem whose BD is led by Tong Zhang. A veteran of the global BD team of Merck & Co. Inc. (NYSE:MRK) and WuXi AppTec Co. Ltd. (Shanghai:603259; HKEX:2359), Zhang also served as managing director at C-Bridge Capital (now CBC Group), where he helped incubate Everest Medicines Ltd. (HKEX:1952). BioCentury will publish its profile of Genechem this week.
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