|
|
Expert in Pharmaceuticals, Biotechnology, Clinical Pharmacology, Pharmacokinetics, Clinical Trials
Available for your Consulting and Expert Witness Needs
|
|
|
 |
| Summary of Expertise: |
 |
Primary Expertise Areas:
(links show more experts in each area)
|
Expertise Description: |
|
anti-infective agent expert
antiviral agent expert
biotechnology expert
clinical pharmacology expert
drug development expert
drug dosage form development expert
intellectual property expert
pharmaceutical design expert
pharmaceutical product development expert
pharmaceutical research expert
pharmacokinetic modeling expert
pharmacokinetics expert
research and development expert |
Expert is an expert in drug development with over 30 years experience in 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 recently 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 development, pharmacokinetics, clinical trials and intellectual property matters to law firms, biotechnology companies and pharmaceutical companies. Expert has 65 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.
|
| Show Secondary and Basic Areas of Expertise |
| Year |
|
Degree |
|
Subject |
|
Institution |
|
|
1976
|
|
PhD
|
|
Medicinal Chemistry
|
|
The John Curtin School of Medical Research, Australian National University, Canberra, Australia
|
|
|
1973
|
|
BSc(Hons)
|
|
Organic Chemistry
|
|
The University of Adelaide, Adelaide, Australia
|
|
| Years |
|
Employer |
|
Department |
|
Title |
|
Responsibilities |
|
2004 to
|
|
(Undisclosed)
|
|
|
|
Consultant, Project Manager
|
|
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 for expert witnesses, and preparing technical reports, chronologies and literature reviews for the case. Currently provide ad hoc advice to Biota R&D team.
|
|
2003 to 2008
|
|
Cryptopharma, Melbourne, Australia
|
|
|
|
Chairman
|
|
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)
|
|
2002 to 2003
|
|
Boron Molecular, Melbourne, Australia
|
|
|
|
CEO
|
|
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.
|
|
1993 to 2002
|
|
(Undisclosed)
|
|
|
|
Director of Research and Development
|
|
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.
|
|
1990 to 1993
|
|
Parke-Davis, Ann Arbor, MI, USA
|
|
Clinical Pharmacology
|
|
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.
|
|
1988 to 1990
|
|
Parke-Davis, Sydney, Australia
|
|
Clinical Research
|
|
Associate Regional Director
|
|
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.
|
|
1987 to 1988
|
|
Astra Pharmaceuticals, Sydney, Australia
|
|
Medical
|
|
Clinical Trials Manager
|
|
Responsible for clinical trials in Australia. Managed group of 6 monitors.
|
|
1976 to 1987
|
|
The Queen Elizabeth Hospital, Adelaide, Australia
|
|
Clinical Pharmacology
|
|
Chief Hospital Scientist
|
|
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.
|
Associations/Societies
RACI, ASCEPT, Ausbiotech
|
Licenses/Certifications
MRACI, CCP
|
Awards/Recognition
Churchill Fellow, 1983
|
| Publications: |
|
Publications and Patents Summary
Expert has 64 scientific publications including 3 book chapters and is an inventor on 3 published patents.
|
|
Selected Publications and Publishers
|
|
|
- Expert Reviews Ltd
|
|
|
- Journal of Medical Virology
|
|
|
- Antimicrob Agents Chemother
|
|
|
- Angew Chem Int Ed Engl
|
|
| Government Experience: |
|
| Years |
|
Agency |
|
Role |
|
Description |
|
1986 to 1987
|
|
TGA, Australia
|
|
External Drug Evaluator
|
|
Evaluated phamacokinetic component of drug applications to the Therapeutic Goods Administration, Department of Health, Australia for new chemical entities and generic pharmaceuticals
|
| Selected Consulting Examples: |
-
Since Feb 2009 providing expert witness services to two major law firms in Australia on 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 for expert 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.
|
As a member of the Intota consultant network,
Expert is a specialist who provides technical consulting to corporate, legal and government clients. Expert provides professional consulting as a Pharmaceuticals Consultant, Biotechnology Consultant, Clinical Pharmacology Consultant, Pharmacokinetics Consultant, Clinical Trials Consultant. Expert may consult as an independent consultant or as a member of a consultancy, consulting company,
or consulting firm. Consultants service will be covered by a consulting contract.
Ask an expert initial screening questions and ask the experts services particulars, by simply submitting
an expert request.
|
|
Expert Witness Experience Summary:
|
|
Currently acting as an expert to two major law firms in Australia on pharmaceutical intellectual property litigation. From 2004 to 2008 acted as a consultant expert to lawyers representing Biota Holdings in litigation against GSK on Relenza. Involved communicating complex scientific issues to the legal team, assisting in the preparation of questions for expert witnesses, and preparing technical reports, chronologies and literature reviews for the case.
|
Intota experts can serve as expert witnesses or litigation consultants offering expert testimony, expert advice, litigation support,
forensic services, and related expert witness services. Expert can serve as an expert witness or litigation consultant in intellectual property (patent, trademark, trade secret, copyright),
product liability, and insurance matters. Expert may provide forensic expert witness testimony, litigation consulting services, forensic investigation,
and forensic testing if appropriate in litigation areas as a Pharmaceuticals Expert Witness, Biotechnology Expert Witness, Clinical Pharmacology Expert Witness, Pharmacokinetics Expert Witness, Clinical Trials Expert Witness.
Intota provides attorneys and legal professionals the opportunity to ask an expert initial screening questions and
ask the experts services particulars by submitting an expert request.
|
| International Experience: |
|
| Years |
|
Country / Region |
|
Summary |
|
1990 to 1993
|
|
USA
|
|
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.
|
|
1988 to 1990
|
|
South East Asia
|
|
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.
|
|
1985 to 1985
|
|
UK
|
|
International Cancer Research Technology Transfer, Institute of Cancer Research, Belmont, Sutton, Surrey, UK for research on platinum based anticancer drugs.
|
|
1983 to 1983
|
|
USA
|
|
Churchill Fellowship, Oncology Department, Mayo Clinic, Rochester, MN, USA on the pharmacokinetics of anticancer drugs in obesity and the pharmacokinetics of cisplatin.
|
|
1978 to 1978
|
|
USA
|
|
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.
|
| Language Skills: |
|
Have extensive experience in the pharmaceutical and biotechnology industries in the area of drug discovery and development including intellectual property matters.
Expert serves as a resource to
Intota Market Research Services
for customized marketing research in industries or areas related to
Pharmaceuticals, Biotechnology, Clinical Pharmacology, Pharmacokinetics, Clinical Trials.
Experts are an invaluable source of overall industry insight as well as insight into specific companies and firms for
custom business to business (b2b) and industrial market research. Intota uses analyst and
consultant resources from Guideline whose Research Directors manage the research and analysis of the qualitative
and quantitative data as well as report writing for the custom studies. The methods and tools
used by Intota market research combine the insights of technical experts and industry insiders with secondary
research to provide the custom b2b and industrial market research you need.
|
| Additional Skills and Services: |
|
Training/Seminars
Most recent presentation was entitled "Zanamivir PK/PD: implications for the treatment of avian influenza (H5N1) infections in humans" presented at EACPT, Edinburgh, July 15, 2009.
|
|
Supplier and Vendor Location and Selection Very familiar with the Australian biotechnology industry and have introduced companies in the sector.
|
Other Skills and Services
Possess technical skills in pharmacokinetics and a knowledge of medicinal chemistry.
|
|
Expertise
