David McDougall, PhD

David possesses extensive expertise in drug development, utilizing pharmacokinetic, pharmacodynamic, and exposure-response modeling to inform strategic decision-making. He has successfully managed pharmacometric analyses for multiple NDA/BLA submissions and has extensive experience collaborating with regulatory agencies, including the FDA, EMA, and UK MHRA.

Highly proficient in pharmacometrics and statistical software, David is skilled in using tools

such as NONMEM, PsN, R, RMarkdown, and Berkeley Madonna. He excels at producing

submission-quality, reproducible pharmacometric reports using LaTeX.

With over 10 years of clinical experience as a pharmacist across various therapeutic areas in major teaching hospitals in Australia and the UK, he has a strong ability to contextualize modeling and simulation solutions within clinical frameworks. He effectively communicates technical analyses to decision-makers in clear, accessible language.

Bruce Green was most recently a VP at Parexel in the Clinical Pharmacology / Modelling Simulation group (CPMS). Formerly the the Founder and CEO of Model Answers, the CPMS group is a global team with hubs in NC, USA, Brisbane Australia and various locations across the EU. He is passionate about delivering the highest quality pharmacometric tools to the drug industry in an efficient and practical manner, thereby facilitating optimal critical decision-making during the drug development process. He has developed numerous pharmacometric models and delivered many reports to regulatory authorities around the globe to assist drug approvals across many continents. He has first-hand experience of the FDA, having worked as a ‘Guest Reviewer’ in the Office of Clinical Pharmacology and Biopharmaceutics during sabbatical in 2005. He works with a team of highly talented individuals whose work and private attributes reflect his own ideologies. They are entrepreneurial, innovative, and excel across multiple disciplines. 

Bruce has received extensive training in clinical practice and pharmacometrics. He has specific research interests in developing appropriate drug dosing strategies for the obese, and continues to encourage drug developers and clinicians to consider dosing drugs using body composition, rather than body weight. He completed his Doctorate degree with a dissertation titled ‘Dosing of Enoxaparin in Obese Patients’, which included development of an appropriate dosing strategy and clinical trial designs, to ensure obese subjects can enjoy the same expected clinical outcomes as non-obese subjects when given enoxaparin.

Bruce remains committed to education and supports higher degrees via Kings College London, and at the School of Pharmacy, UQ. 

Winn is a formally trained clinical pharmacist with more than 10 years of experience in pharmacokinetics and pharmacodynamics modeling. He received his PhD from the University of Strathclyde in Glasgow, UK. He continued his post-doctoral training with the Pharmacometrics Research Group at Uppsala University focusing on novel in vitro methodologies utilizing various pharmacometrics approaches to predict optimal drug dosing combinations. 

In 2018, Winn joined a private consulting firm, Model Answers, specializing in using model-based analysis to support all phases of preclinical and clinical drug development. Winn recently served as Associate Director at Parexel where he worked with numerous biotech and pharmaceutical companies encompassing various clinical indications and therapeutic areas such as infectious disease, oncology, immunology, and rare diseases.  

His expertise includes clinical population pharmacokinetics (POPPK)/ pharmacodynamic modeling (PD), first-in-human (FIH) dose selection, and mechanistic modeling using a variety of pharmacokinetic applications including NONMEM, R, WinNonlin, and others.  

Aniruddha Amrite is a strategic leader in drug development with over 17 years of industry experience. Dr. Amrite has contributed to the development and approval of five commercially available drugs across diverse therapeutic areas, including oncology, rare diseases, and CNS. 

He has extensive expertise in clinical pharmacology, DMPK, and the application of modeling and simulation in drug development. His leadership roles include heading clinical pharmacology teams, developing strategies for small molecules, mAbs, ADCs and RNA-based therapies, and engaging with global regulatory agencies to drive successful IND/CTA filings and drug approvals.