Kenny Simmen
Strategic Advisor
Kenny Simmen
Strategic Advisor
Dr Simmen has 30 years of global pharmaceuticals experience across drug discovery and early clinical development, and innovation collaboration and dealmaking. He currently serves as an independent advisor and Board member for several biotech companies worldwide. This follows a distinguished career at Johnson & Johnson, where he led global external innovation efforts and collaborations in therapeutics and vaccine development for infectious diseases through J&J Innovation.
He previously led global early-stage R&D strategy against many pathogens in a team that progressed multiple candidates into clinical development, including the approved HCV antiviral (Simeprevir), co-developed with Medivir AB. In his external innovation role, he led the establishment of collaborations and license agreements with companies and academics worldwide and worked closely with the BLUE KNIGHT™ joint initiative between J&J Innovation and US BARDA. He began his career in pharma at Roche having completed postdoctoral work at the Netherlands Cancer Institute. He obtained his PhD in molecular biology and gene transcriptional regulation from the EMBL in Heidelberg.
Arnold S. Monto, MD
Clinical Advisor
Alison Humbles, PhD
Strategic Advisor
Dr Humbles has over 20 years’ experience in the pharmaceutical and biotech industry supporting projects from early target identification and validation to drug candidates within the clinic. These projects have been across multiple therapeutic areas, including respiratory, autoimmunity, inflammatory and infectious disease, and included many drug modalities. Currently an independent Research & Development consultant, she was previously Disease Area Lead for Respiratory at Roche where she led a respiratory research group.
Prior to this Dr Humbles held senior scientific roles at MedImmune LLC, (now part of Astra Zeneca) after spending significant time in academic research at the Children’s Hospital, Harvard Medical School, Boston. Her work to date has led to over 70 authored/co-authored peer-reviewed publications in respiratory, inflammatory and immunology research. She gained her PhD in Pharmacology from the University of London.
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.
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.
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.
Exploristics
Exploristics
Exploristics is an Irish-based, global provider of specialized software and data-driven consultancy for the pharmaceutical, biotechnology, medical diagnostics, and devices sectors. We offer expert statistical consultancy, biostatistics, and data science services to streamline clinical development. Exploristics has developed KerusCloud, a unique, cutting-edge, cloud-based study simulation platform for designing smarter clinical studies helping to identify the key drivers of study success and so improve outcomes. With uniquely realistic simulation capabilities, KerusCloud offers a powerful, practical and cost-effective solution to selecting the best design and analysis options for a clinical study. It allows prospective optimisation of multiple study uncertainties in a virtual environment, ensuring that real trials are suitably designed to answer the challenges facing current clinical research. This approach has been shown to substantially de-risk studies, reducing development timelines, costs and patient burden.
At Exploristics, we transform clinical development, accelerating the delivery of new therapeutics to address unmet medical needs efficiently and effectively.
