Rob Crombie, PhD
Dr Rob Crombie, Chief Executive Officer of Que Oncology, has over 20 years of background in private and public markets in the UK and Australia with a strong business development and transactional focus.
Rob has founded and transitioned several start-up companies most recently as the inaugural CEO of ASX-listed cancer drug company Prescient Therapeutics (ASX:PTX). As former Head of Melbourne Operations for Arana Therapeutics (ASX:AAH), Rob played a key role in Arana's successful A$318M acquisition by Cephalon Incorporated (now Teva Pharmaceuticals). Rob has an academic background in Genetics from Trinity College Dublin, Ireland, a PhD in cancer research from The University of Glasgow, and a Howard Hughes post-doctoral fellowship from Baylor College of Medicine, Houston, Texas.
David Moskovic, MBA
David Moskovic, Director of Clinical Operations at Que Oncology has over 20 years of clinical research experience in project management, clinical operations, business/ strategic development, and drug development. Dave has extensive experience in oncology studies including supportive care studies as well as various complex disease indications and orphan drug indications. Prior to joining QUE Oncology, he worked in various clinical project management roles in the CRO industry and was the Director of Clinical Operations for a biotechnology company where he oversaw clinical development programs in CNS (Alzheimer’s disease) and oncology from Phase I to Phase III global pivotal studies. Dave graduated from Cornell University with a Bachelors of Science degree in Genetics and from Boston University with an MBA.
Ardian Latifi, PhD
Dr Ardian Latifi, Clinical Development Manager at Que Oncology, has over 9 years of preclinical and clinical research experience. His PhD thesis focused on drug resistance in ovarian cancer publishing several scientific articles in various journals. Following his graduation from the University of Melbourne, he embarked on conducting Clinical Research programs at Nucleus Network - a specialist phase 1 clinical unit. During his employment with Nucleus Network, Ardian has held various position in conducting clinical studies. In addition, he has played a significant role as a Business Development Associate in acquiring new studies and repeat work. As a result, Ardian has obtained extensive experience in clinical trials and has established good working relationships with several local and international sponsors, CROs, and other related health institutions.
Nicole Kruger, Clinical Operations Manager at Que Oncology, has over 25 years’ experience in the biotechnology and pharmaceutical industry, with over 20 years in the clinical research field. Starting as a Clinical Trial Assistant and progressing through Clinical Research Associate, Project Manager and Operations Manager roles, she has worked with major pharmaceutical companies, Contract Research Organisations and small to medium biotechnology companies to implement and manage their clinical research programs and projects. Nicole is responsible for ensuring delivery of high quality clinical trials at QUE Oncology.
Alan Parr, Pharm.D, PhD
Dr Alan Parr, Head of CMC at Que Oncology, has worked in the field of Pharmaceutical Sciences for 33 years including with Glaxo, GlaxoWellcome and GlaxoSmithKline. As formulation scientist, formulation manager, and eventually as Director of Biopharmaceutics with GSK. Responsibilities ranged from development of formulations from early development phase all the way through to the scale up of commercial size batches for the marketplace. Specific activities during this time have included physical property characterization, formulation screening, formulation development, manufacture of clinical supplies, transfer of product to production and overall project management. He has been intimately involved with the creation, review and submission of regulatory documents to the US Food and Drug Administration, including Investigational New Drug (IND) applications, New Drug Applications (NDA) as well as foreign filings (Marketing Authorization Applications (MAA)).
Michael J. Dalton, Pharm.D
Michael (Mike) Dalton, Head of Regulatory Affairs at Que Oncology, has more than 30 years of experience in the pharmaceutical industry working with large companies, small start-ups, and contract research organisations. Mike started his career at Burroughs Wellcome Co. in the clinical research department in 1982. Following the merger of Glaxo and Burroughs Wellcome in 1995, Mike joined Wilmington based CRO Pharma Research as Vice President of Regulatory Affairs. Mike then moved to Triangle Pharmaceuticals in Durham NC, where he was Senior Director of Regulatory Affairs and was named acting Director of Drug Safety. Mike left Triangle following its buyout by Gilead Pharmaceuticals. During his career in the pharmaceutical industry, Mike has been involved with at least 15 NDA approvals for NCEs and many other important supplemental NDAs. Mike has also helped file more than 75 INDs and has been the FDA contact person for many of these applications.
Michael Walker, PhD
Michael Walker, Biostatistics Consultant at Que Oncology, received his Ph.D. from Stanford University, and has taught statistics and clinical trial design at Stanford and UC San Diego for 25 years. He provides statistics and clinical trial consulting for diverse pharmaceutical and biotechnology companies. His FDA experience includes IND, NDA, IDE, 510k, PMA, SPA and other submissions. He has published in the New England Journal of Medicine and in Lancet and has developed products with over one billion dollars in revenues.