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 Expert  727493

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


Available for your Consulting and Expert Witness Needs

Victoria
Australia
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

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.

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anti-infective agent

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antiviral agent

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biotechnology

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clinical pharmacology

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drug development

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drug dosage form development

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intellectual property

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pharmaceutical design

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pharmaceutical product development

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pharmaceutical research

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pharmacokinetic modeling

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pharmacokinetics

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research and development


Show Secondary and Basic Areas of Expertise

Education:
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  

Work History:
Years   Employer   Department   Title   Responsibilities

2004 to 2008

 

Biota Holdings, Melbourne, Australia

 


 

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

 

Biota Holdings, Melbourne, Australia

 


 

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.


Career Accomplishments:
Associations/Societies

RACI, ASCEPT

Licenses/Certifications

MRACI, CCP

Awards/Recognition

Churchill Fellow, 1983


Publications:
Publications and Patents Summary

Expert has 67 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

Consulting Services:
Selected Consulting Examples:
  • 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 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.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Expert Witness Experience Summary:
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 for expert witnesses, and preparing technical reports, chronologies and literature reviews for the case.

Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

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:
Foreign Language  
English  

Market Research:
Expert has extensive experience in the pharmaceutical and biotechnology industries in the area of drug discovery and development including intellectual property matters.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:
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.

Supplier and Vendor Location and Selection

Expert is very familiar with the Australian biotechnology industry and has introduced companies in the sector.

Other Skills and Services

Possess technical skills in pharmacokinetics and a knowledge of medicinal chemistry.


 

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