William Salminen, PhD, DABT, PMP is board certified in Toxicology and Project Management and has over 20 years of drug development experience for an array of drug products and indications. He leads the Nonclinical/Toxicology and Clinical Pharmacology/Pharmacokinetic groups within Premier Consulting, which provide clients with nonclinical and clinical pharmacology strategies, study requirements and designs, pharmacokinetic modeling, input on regulatory submissions, and addressing nonclinical and clinical issues (e.g., Clinical Holds) with regulatory authorities (e.g., US FDA). William’s key experience includes but is not limited to regulatory strategy and advice, nonclinical safety and toxicology strategy and advice, US FDA pre-IND meetings, IND applications and maintenance and NDA and BLA submissions. He has significant experience with 505(b)(2) NDAs and the unique regulatory, nonclinical, and clinical strategies involved with developing drugs under the 505(b)(2) pathway.