John F. Kokai-Kun, PhD, Director of External Scientific Collaboration at US Pharmacopeia, explains the supply chain and logistical issues limiting the scale of monoclonal antibody treatment.
Dr. Kokai-Kun has shepherded several drug candidates through various phases of development, from pre-IND and IND-enabling studies, to process development, through IND submission and into early and late phase clinical studies.
The various programs which he has managed include biologic drugs; monoclonal antibodies, enzymes, peptides and vaccines; several of which have reached late stage clinical studies.
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