03.02.21 Biotech Founders Share Insights On FDA, CMC, And GMP
As you gear up for your first-in-human studies, your chemistry, manufacturing, and controls (CMC) and medical affairs leaders will come together to play principle and interdependent roles in the success of those initiatives. On a recent episode of the
Business of Biotech podcast, Dr. Perez, chief medical officer, and Dr. Ihle, VP of CMC and quality, at Bolt Biotherapeutics, Inc., shared their collective advice for emerging biotech leaders who are new to first-in-human studies.
While GMP adherence might seem like a prescriptive series of boxes that biopharmaceutical producers are responsible for checking off, there’s a bit more strategy involved as it relates to a company’s overarching chemistry, manufacturing, and controls (CMC) strategy. Dr. Shabbir Anik, chief technical operations officer at Sutro Bio, discusses his company’s holistic view of CMC and how it d
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Suárez gets a grandmaster norm
There were big rating favourites both in the IM and the WGM tournaments, while the strongest, the GM event, did not have a player clearly above the rest rating-wise. Noël Studer from Switzerland was the top seed, but losses in rounds 1, 5 and 6 left him out of the podium with a 5/9 score.
It was second seed Alexandr Fier, from Brazil, who ended up atop the standings tied with IM Julio Suárez Gómez the latter obtained a grandmaster norm. The young player from Galicia won four games and only lost against Vladislav Nevednichy to get as many points as Fier he also had a better second tiebreaker (the first one, direct confrontation, was tied as they drew their game).