Joseph Manna

Director, Head of Nonclinical Dmpk @Delphia Therapeutics

Cambridge, MA, US

Member of Drug Discovery Team Leadership o Help in target evaluation and engaged in robust scientific discussions about new and current therapeutic areas.• Lead all discovery, pre-clinical and clinical development DMPK efforts. This entails working collaboratively with chemistry, pharmacology, toxicology, and CMC to drive programs, ranging from lead discovery to IND enabling.o Work closely with pharmacology and toxicology to design experiments to understand preclinical pharmacokinetic/pharmacodynamic (PK/PD) and toxicity relationships.• CRO coordinator and manager. Evaluating and managing both foreign and domestic CRO activities. o Have built relationships across several CROs.o Managing all ADME/PK efforts to drive drug discovery utilizing international and domestic CRO facilities.• Experience with IND enabling activities.o Understand what data is necessary to help author a successful non-clinical ADME package for FDA submissions.o Authored appropriate sections for regulatory submission. • Experience in Human dose predictions, human PK modelling and PK/PD determinations.o Can model early human dose predictions and human PK to help drive discovery discussions and decisions.• Expert in bioanalytical assays and principles – including mass spectrometry-based techniques to evaluate small and large molecules in several different biological matrices.• DMPK financials monitoring and maintenance. Creating, tracking, and maintaining all DMPK budgets, reporting accruals to finance, working with finance during audits. • Mentored junior members to help them learn and understand ADME principles.

College of the Holy Cross

BS, Chemistry

Vanderbilt University

PhD, Chemical and Physical Biology