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Biopharmaceutical Research & Development

The Process Behind New MedicinesBiopharmaceutical Research & Development : OUR INDUSTRY IS POISED TO TRANSLATE OUR MOST PROMISING SCIENTIFIC BREAKTHROUGHS INTO MEANINGFUL TREATMENTS CAPABLE OF TACKLING THE MOST URGENT AND VEXING MEDICAL CHALLENGES OF OUR TIMES. WE STAND COMMITTED TO DRIVING PROGRESS FOR PATIENTS TODAY AND HOPE FOR TOMORROW. - KENNETH C. FRAZIER, CHAIRMAN & CEO, MERCKPHASE IPHASE IIPHASE IIIPHASE IVIND SUBMITTEDNDA/BLA SUBMITTEDFDA APPROVALTENSHUNDREDSTHOUSANDSNUMBER OF VOLUNTEERSTHE Biopharmaceutical Research AND Development PROCESSKey: IND: Investigational New Drug Application, NDA: New Drug Application, BLA: Biologics License ApplicationPOTENTIAL NEW MEDICINES1 FDA-APPROVEDMEDICINEBASICRESEARCHDRUGDIS COVERYCLINICAL TRIALSFDA REVIEWPOST-APPROVALRESEARCH &MONITORINGPRE-CLINICALFor patients, new medicines offer fewer side effects, fewer hospitalizations, improved quality of life, increased productivity, and importantly, extended lives.

sectors in the biopharmaceutical research ecosystem is among our greatest strength in ensuring a robust national biomedical research capacity, making the United States the worldwide leader in biopharmaceutical innovation. Drug discovery and development occurs as a result of many forms of collaboration, with learnings emerging from many

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