Arnold S. Monto, MD
Clinical Advisor
Arnold S. Monto, MD
Clinical Advisor
Arnold S. Monto, MD, is the Thomas Francis Collegiate Professor Emeritus of Public Health and Epidemiology at the University of Michigan. His work focuses on the epidemiology, prevention, and treatment of acute respiratory infections, particularly influenza. Dr. Monto led the landmark Tecumseh study of community infections and initiated the ongoing HIVE study, examining influenza vaccine impacts on transmission and seasonality of respiratory viruses like RSV and common cold coronaviruses. He has significantly contributed to research on SARS-CoV-2 vaccines, antiviral resistance, andcorrelates of protection of influenza and COVID-19 vaccines.
A former president of the American Epidemiological Society, he received prestigious awards like of the Infectious Diseases Society of America for lifetime achievement and of the Charles Merieux award of the National Foundation for Infectious Diseases. Dr. Monto also was on the emergency committee advising the WHO during the 2009 influenza pandemic and now chairs the FDA's Vaccine and Related Biological Products Advisory Committee, when conducting COVID-19 vaccine reviews. The CDC annually awards the "Arnold S. Monto Award" for epidemiology and vaccinology innovation.
Bruce Miller, PhD
Clinical Advisor
Bruce Miller, PhD
Clinical Advisor
Bruce has 30 years’ experience in drug development and led multiple drug development programs in COPD and other inflammatory diseases having held senior scientific roles with GSK, Johnson & Johnson, Rhone-Poulenc Rorer, and Sterling-Winthrop Pharmaceuticals.
Bruce was a key participant in numerous public-private collaborations that furthered disease understanding in COPD. He was co-chair for the COPD Foundation’s Biomarker Qualification Consortium’s Fibrinogen Working Group, producing work that resulted in the first regulatory qualification with FDA and EMA for a biomarker to support COPD clinical trials.
Bruce is now a consultant to industry and other organisations providing expert input into drug development programs and disease understanding efforts. He has authored/co-authored over 200 peer-reviewed publications in respiratory research and inflammation/immunology and is a co-inventor on three issued international patents.
Bruce received his Ph.D. from in Toxicology and Pharmacology from The University of North Carolina at Chapel Hill.
Jacob Harker
Drug Product Consultant
Jacob Harker
Drug Product Consultant
Jacob is an independent consultant and formulator with some 20 years of experience in developing drug-device combination products. He is passionate about novel formulation technologies and developing dry powder oral and nasal inhalers. During his career as a formulation chemist and product development specialist, Jacob worked at Pfizer, AstraZeneca and Circassia, before starting his consultancy in 2018. He now works with a variety of companies to help develop their respiratory assets. Jacob has significant experience in developing formulations and drug-device combination products, specifically in the field of respiratory and nasal delivery, having worked extensively with both conventional ordered mixtures and spray-dried formulations.
Eddie French, PhD
Drug Product Advisor
Eddie French, PhD
Drug Product Advisor
Eddie is an independent pharmaceutical consultant who specialises in therapeutic product design and development; working with biotechs, SME pharma and medtech companies and charitable organisations. He has been involved with taking over 40 compounds into early clinical studies. Eddie is the formulation team leader on ENA Respiratory’s INNA-15 project.
He has over 35 years’ experience in the pharmaceutical industry. The majority of this time was spent with Pfizer as a director within Pharmaceutical Sciences, focusing on drug delivery and drug product development. Eddie is a previous chair of the Academy of Pharmaceutical Sciences of Great Britain and of the inhalation focus group. He has been an honorary professor at the Universities of Bath and Nottingham in the UK and holds an adjunct position at the Monash School of Pharmacy in Australia.
Prior to his industrial career, he was a lecturer in pharmaceutics at the University of Bath.
Eddie has a Ph.D. in drug delivery.
Tim Hammond, PhD
Toxicology Consultant
Tim Hammond, PhD
Toxicology Consultant
Tim has 35 years’ experience in pharmaceutical Drug Discovery and Development and was a former Vice President of Safety Assessment in the UK for AstraZeneca.
He has wide experience in toxicology required to take candidate drugs through each phase of clinical development up to and including marketing authorisation. Since 2012 he has been an independent consultant. Tim has experience in supporting a wide range of therapeutic areas including respiratory. Tim is a past President of the British Toxicology Society, is a Fellow of the Royal College of Pathologists, is a member of the American Society of Toxicology and was a founding member of the International Safety Pharmacology Society who awarded him the Distinguished Scientist Award in 2007.
