Expert Details

Expert in Pharmaceuticals, Biotechnology, Clinical Pharmacology, Pharmacokinetics, Clinical Trials

Expert ID: 727493 Australia

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Expert is an expert in drug discovery and development years of experience in clinical pharmacology, pharmacokinetics and clinical trials of pharmaceuticals.

Trained in medicinal chemistry, Expert undertook clinical pharmacology research in a University Hospital for 12 years before joining the international pharmaceutical industry. Expert worked in the USA industry for several years before returning as head of research and development at Biota Holdings, one of Australia’s leading biotechnology companies.

Expert has since held several senior roles in the Australian biotechnology industry including CEO of Boron Molecular, Chairman of Cryptopharma, and non-executive Director of EnGeneIC.

Expert is currently an independent expert witness in his areas of professional expertise. Expert acted as an expert to the lawyers engaged in one of Australia’s largest commercial litigation cases. This case ran for 4½ years in the Australian courts and involved a local biotechnology company and a major international pharmaceutical company. Expert performed a consultancy role between the biotechnology company plaintiff and the lawyers engaged on the litigation. Expert prepared extensive technical reports, chronologies and literature reviews for the case.

Expert’s consultancy is focussed on providing advice on drug discovery and development, pharmacokinetics, clinical trials and intellectual property matters to law firms, biotechnology companies and pharmaceutical companies.

Expert has 67 scientific publications including 3 book chapters and is an inventor on 3 published patents. His research has included early discovery and development of antivirals for respiratory diseases, human pharmacokinetic studies and clinical trials of various drugs.


Since Feb 2009 Expert has been an independent expert witness for a number of pharmaceutical intellectual property matters.Biota Holdings – Project Manager – Feb 04 to Aug 08 acted as a consultant expert to lawyers engaged in one of Australia’s largest commercial litigation cases.

Involved communicating complex scientific issues to the legal team, assisting in the preparation of questions f witnesses, and preparing technical reports, chronologies and literature reviews for the case.Biota Holdings - Since 2004, consultant on various R&D matters relating to new respiratory antivirals.Radpharm, Canberra, Australia - prepared business plan for the Company in 2003.

Education

Year Degree Subject Institution
Year: 1976 Degree: PhD Subject: Medicinal Chemistry Institution: The John Curtin School of Medical Research, Australian National University, Canberra, Australia
Year: 1973 Degree: BSc(Hons) Subject: Organic Chemistry Institution: The University of Adelaide, Adelaide, Australia

Work History

Years Employer Title Department Responsibilities
Years: 2004 to 2008 Employer: Biota Holdings, Melbourne, Australia Title: Consultant, Project Manager Department: Responsibilities: Project Manager providing expert advice to lawyers engaged in one of Australia’s largest commercial litigation cases.

Involved communicating complex scientific issues to the legal team, assisting in the preparation of questions f witnesses, and preparing technical reports, chronologies and literature reviews for the case.

Currently provide ad hoc advice to Biota R&D team.
Years: 2003 to 2008 Employer: Cryptopharma, Melbourne, Australia Title: Chairman Department: Responsibilities: Chaired Board meetings as founding, independent, non-executive Director. Participated in Scientific Advisory Board meetings during the initial years of the Company. (Intellectual property rights have since been returned to the University of Melbourne)
Years: 2002 to 2003 Employer: Boron Molecular, Melbourne, Australia Title: CEO Department: Responsibilities: Overall responsibility for the management of the Company. Stabilized the business & recruited management team. Raised $1.9M through a private placement. Wrote new business plan for redirection of corporate strategy. Prepared prospectus for a public offering (Boron Molecular is now a subsidiary of XCEED). Grew revenues in 1st three quarters of 2002/3 by >100% compared with same period in 2001/2. Attained near breakeven. Established systems and quality control procedures.
Years: 1993 to 2002 Employer: Biota Holdings, Melbourne, Australia Title: Director of Research and Development Department: Responsibilities: Responsible for all research and development activities of the Company. Initiated and completed development of the flu diagnostic, FLUOIA for international marketing. Built R&D team as inaugural R&D Director. Established laboratory facilities. Managed R&D relationship with GSK on Relenza. Screened opportunities for Biota’s US-based operations. Diversified Biota’s R&D portfolio.
Years: 1990 to 1993 Employer: Parke-Davis, Ann Arbor, MI, USA Title: Director, Clinical Pharmacology Department: Clinical Pharmacology Responsibilities: Managed transition of new pharmaceuticals for CNS diseases from pre-clinical to Phase I and Phase IIA clinical studies. Managed staff involved in Phase I and IIA CNS studies. Prepared clinical pharmacology reports for IND and NDA applications. Reviewed pre-clinical data for suitability for IND applications and Phase I studies in CNS. Attended all research and team meetings in the CNS preclinical and clinical area.
Years: 1988 to 1990 Employer: Parke-Davis, Sydney, Australia Title: Associate Regional Director Department: Clinical Research Responsibilities: Responsible for Phase I through Phase III clinical trials conducted in centres in Australia, New Zealand, and SE Asia. Reported directly to head office. Monitored clinical trials to FDA standards for gabapentin, quinapril and an anticancer drug developed in Auckland, New Zealand.
Years: 1987 to 1988 Employer: Astra Pharmaceuticals, Sydney, Australia Title: Clinical Trials Manager Department: Medical Responsibilities: Responsible for clinical trials in Australia. Managed group of 6 monitors.
Years: 1976 to 1987 Employer: The Queen Elizabeth Hospital, Adelaide, Australia Title: Chief Hospital Scientist Department: Clinical Pharmacology Responsibilities: Headed the Clinical Pharmacology laboratories at the Hospital. Responsible for therapeutic drug monitoring and a range of research projects and collabortaions both within and outside of the Hospital.

Government Experience

Years Agency Role Description
Years: 1986 to 1987 Agency: TGA, Australia Role: External Drug Evaluator Description: Evaluated phamacokinetic component of drug applications to the Therapeutic Goods Administration, Department of Health, Australia for new chemical entities and generic pharmaceuticals

International Experience

Years Country / Region Summary
Years: 1990 to 1993 Country / Region: USA Summary: Parke-Davis (Anne Arbor, MI, USA) – Director, Clinical Pharmacology
Managed transition of new pharmaceuticals for CNS diseases from pre-clinical to Phase I and Phase IIA clinical studies.
Managed staff involved in Phase I and IIA CNS studies.
Prepared clinical pharmacology reports for IND and NDA applications.
Reviewed pre-clinical data for suitability for IND applications and Phase I studies in CNS.
Attended all research and team meetings in the CNS preclinical and clinical area.
Years: 1988 to 1990 Country / Region: South East Asia Summary: Parke-Davis (Sydney, Australia) – Associate Regional Director, Clinical Research
Responsible for Phase I through Phase III clinical trials conducted in centres in Australia, New Zealand, and SE Asia
Reported directly to head office in the USA
Monitored clinical trials to FDA standards for gabapentin, quinapril and an anticancer drug developed in Auckland, New Zealand.
Years: 1985 to 1985 Country / Region: UK Summary: International Cancer Research Technology Transfer, Institute of Cancer Research, Belmont, Sutton, Surrey, UK for research on platinum based anticancer drugs.
Years: 1983 to 1983 Country / Region: USA Summary: Churchill Fellowship, Oncology Department, Mayo Clinic, Rochester, MN, USA on the pharmacokinetics of anticancer drugs in obesity and the pharmacokinetics of cisplatin.
Years: 1978 to 1978 Country / Region: USA Summary: Study leave with Professor Sidney Riegelman, Department of Pharmacy, UCSF, San Francisco, CA to conduct a research project on propranolol optical isomers and complete the advanced course in pharmacokinetics.

Career Accomplishments

Associations / Societies
RACI, ASCEPT
Licenses / Certifications
MRACI, CCP
Awards / Recognition
Churchill Fellow, 1983
Publications and Patents Summary
Expert has 67 scientific publications including 3 book chapters and is an inventor on 3 published patents.

Additional Experience

Expert Witness Experience
Since 2009 Expert has acted as an independent expert witness on a number of intellectural propertry matters relating to pharmaceuticals.

From 2004 to 2008 Expert acted as a consultant expert on a major commercial litigation matter between two pharmaceutical companies. This involved communicating complex scientific issues to the legal team, assisting in the preparation of questions f witnesses, and preparing technical reports, chronologies and literature reviews for the case.
Training / Seminars
As Honorary Senior Felllow, Department of Pharmacology, Iniversity of Melbourne, Expert presents approximately five lectures per year to medical and science students at the University of Melbourne on pharmaceutical discovery and development.
Vendor Selection
Expert is very familiar with the Australian biotechnology industry and has introduced companies in the sector.
Marketing Experience
Expert has extensive experience in the pharmaceutical and biotechnology industries in the area of drug discovery and development including intellectual property matters.
Other Relevant Experience
Possess technical skills in pharmacokinetics and a knowledge of medicinal chemistry.

Language Skills

Language Proficiency
English

Fields of Expertise

anti-infective agent, antiviral agent, biotechnology, clinical pharmacology, drug development, drug dosage form development, intellectual property, pharmaceutical design, pharmaceutical product development, pharmaceutical research, pharmacokinetic modeling, pharmacokinetics, research and development, evidence based medicine, combination drug therapy, central nervous system agent, chemical intellectual property, product invention, patent searching, adverse drug reaction, drug interaction, pharmaceutical analytical chemistry, pharmaceutical science, active pharmaceutical ingredient, investigational drug procedures, abbreviated new drug application, protocol development, Good Clinical Practice, drug discovery, molecular diversity, pharmacodynamics, royalty rate, nasal spray, antidepressant drug, animal disease model, drug product approval, prescription drug, drug formulation, rational drug design, agreement, clinical study, pharmaceutical research and development, therapeutic drug monitoring, generic drug, prodrug, drug metabolite, animal drug testing, drug monitoring, clinical trial design, medicinal chemistry, cytotoxic drug, drug clinical trial, antitumor drug, controlled-release oral drug delivery, drug toxicology, pharmaceutical product formulation, chemotherapeutic drug, licensable technology, drug labeling requirement, drug safety testing, software modeling, copyright, clinical research management, clinical research, clinical virology, inventions, clinical protocol, foreign patent, pharmaceutical industry, pharmaceutical analysis, drug-drug interaction, pharmaceutics, antihypertensive drug, new product development, drug delivery, drug blood level determination, development process, simulation, license, trademark, new drug, technology licensing, licensing, controlled-release drug delivery, patent, drug regulation, pharmaceutical drug, enzyme kinetics, computer modeling, virology, toxicology, therapy, pharmacology, pharmaceutical chemistry, nonparametric statistics, modeling, metabolism, mathematical model, investigational drug, formulation, drug metabolism, drug bioavailability, dosage form, clinical trial, bioequivalence

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