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Ucm074980  Form

Ucm074980 Form

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>> Female Speaker: It is my distinct pleasure tointroduce Dr. Zahra Shahrokh.Zahra has 25 years of experience in developingbiotechnology products, and has a track record ofregulatory approval of five recombinant proteins, aswell as additional clinical development activities.She's currently the chief development officer at STTbiologics, and a CMC consultant.Prior to that, she was the head of pharmaceutical andanalytical development and also the head of CMC programmanagement at Shire.Zahra also had leadership roles in Genentechpharmaceutical R&D development for 10 years.Zahra has a PhD in biophysics from UC-Berkeley,and other very impressive credentials.So welcome Dr. Shahrokh.>> Zahra Shahrokh: So in this outline I will bespeaking to different modalities of physicians andI rEvally want to give you a good sense of what are thedifferent product development phases, and how-- what kind of regulatory interactions you want to have?What kind of packa

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