- Clinical Pharmacology
- Translational Medicine
- Clinical Science and late phase development
- Clinical Safety
- Regulatory Affairs
- PK, disease modelling and PK-PD analyses
- Multi-scale epidemiological system analyses
- Health economic analyses
- DMPK and non-clinical safety
- CMC and Formulation Science
- Business development
- Financing strategies
- Business and Market Access
- Intellectual Property
Craig Rayner PharmD MBA
(Chief Executive Officer and Board Member)
Dr. Rayner has more than 15 years of drug development experience. His past appointments include leadership roles in Clinical Pharmacology and Early development (Roche), Clinical development (CSL-Behring), in Business Development/Licensing as Global Due Diligence Director (Roche) and as an academic researcher in clinical pharmacology and infectious disease research (Monash University).
Dr. Rayner has extensive experience in early and late development of therapeutics, regulatory interaction experience with all major global health authorities, multiple filings and accountability for numerous due diligences, active support of negotiations, deal making and integration activities.
He holds an Adjunct Associate Professorship in Pharmaceutical Science (Monash University), and is broadly published in clinical pharmacology and also infectious diseases. Dr. Rayner is Chair of Development Committee of Medical Countermeasures Products Australia (MCPA).
Patrick Smith, PharmD
(Chief Scientific Officer and Board Member)
Dr. Smith has more than 15 years of global drug development experience and is considered an authority in anti-infective and antiviral clinical pharmacology.
Dr. Smith has broad appreciation for all aspects of drug development, with particular emphasis on innovative translational and quantitative approaches in early phase development to optimize speed and efficient proof of concept delivery.
His past appointments include Head of U.S. Clinical Pharmacology for Roche, member of key infectious diseases corporate governance committees defining disease area and portfolio strategy.
He holds a Research Professor appointment at the State University of New York at Buffalo and has more than 100 peer reviewed publications in top tier journals.
Regina Dutkowski, PhD
(Chief Development Officer and Board Member)
Dr. Dutkowski has had more than 25 years of hands-on development experience including accountability for Global Clinical Development Strategy in infectious diseases and inflammation, multiple successful NDAs including industry benchmarks for efficiency, lead regulatory interface with all major Health Authorities on clinical strategy, as well as fulfilling advisory responsibilities across the infectious diseases and inflammation therapeutic areas.
Dr. Dutkowski’s past appointments include Global Development Team Leader, Clinical Science Leader, infectious diseases and Inflammation Franchise Leadership team (Roche).
Leigh Farrell PhD FAICD
(Chairman and Chief Operating Officer)
Dr. Farrell has over 20 years of experience in the biotechnology and pharmaceutical industry. His past appointments include eight years at Vice President Business Development Biota Pharmaceuticals, Associate Director GBS Venture Partners (one of Australia’s largest venture firms), Research Manager Johnson & Johnson Research and CEO of Gene Shears Pty Ltd.
Dr. Farrell has extensive international networks including pharmaceutical and biotechnology companies, venture capital, and investment banks, and is Chair of the Steering Committee of Medical Countermeasures Products Australia (MCPA).
Dr. Vis Niranjan, MD
(Chief Medical Officer)
Dr. Niranjan is an internationally (India, Australia and USA) trained pediatrician, critical care physician (certified, licensed in the USA) and scientist (molecular biologist). After a clinical career spanning more than a decade, Dr. Niranjan has been a highly sought after consultant to the biopharma sector for close to two decades.
His drug development expertise straddles both high-level strategic inputs (simplifying study designs, selecting approvable, marketable, differentiated end-points) and drilling down into operational minutiae (medical monitoring, data review, CRO oversight), culminating in several successful NDAs/BLAs.
Dr. Niranjan has assessed causality for complex drug safety issues both during development and life-cycle of the drug. Notwithstanding his varied expertise, Dr. Niranjan’s passion remains pediatric drug development.
(Virtual CFO & Company Secretary)
Mr. Murphy is d3 Medicine’s virtual CFO and company secretary and Director of MPR Accountants & Advisors.
The MPR Group is sought after advisor to innovative and biotech small and medium enterprises, and specialises in delivering Virtual CFO, board advisory services, as well as outsourced accounting, grants and funding solutions.
Keith Nieforth PharmD
Dr. Nieforth has more than 20 years of global drug development experience and held a variety of positions within Clinical Pharmacology at Roche, from direct project support roles supporting successful NDAs, to membership on the global Clinical Pharmacology Leadership Team as systems expert for the department.
In addition to his expertise in quantitative and systems aspects of drug development, Dr. Nieforth has a passion for understanding and optimising the human aspects of successful systems implementation.
Dr. Julie Bullock PharmD
Dr. Bullock has over 10 years of drug development experience within the FDA. Dr Bullock's past appointments include Clinical Pharmacology Team Leader and Senior Clinical Pharmacology Reviewer (FDA).
Her regulatory experience was focused in the therapeutic areas of hematology/oncology and coagulation. She has unique insight in pediatric development, PK/PD approaches for biosimilar products, oncology dose finding strategy and streamlining development for breakthrough therapies and accelerated approval.
Dr. Bullock has contributed to over 14 new molecular entity approvals during her 10 year FDA career.