REBUCK CONSULTING : REBUCK CONSULTING Navigating the Asian Pharmaceutical and Academic Labyrinths in
Clinical Trials & Drug Development
Who Am I? : Who Am I? Tony Rebuck
Born: England
Educated: Australia
Academic career: Canada
Pharmaceutical industry: Toronto, Philadelphia and Singapore
Private consulting
Background : Background Medical Degree: Sydney University
Research Thesis: Pulmonary Physiology
Clinical Practice: Respiratory Medicine
Academic Practice: Professor of Medicine THE BIG MERGER
“Opportunity Knocks”The Headhunters : “Opportunity Knocks”The Headhunters Searle ? Monsanto ? Pharmacia ? Pfizer
ICI ? Zeneca ? Astra Zeneca
SmithKlineBeecham ? GSK
Avandia : Avandia Phase 2 and 3
Monotherapy, SUs, Metformin, Insulin
BID, OD
FDA
EMEA
ASIA/PACIFIC R&D
Regulatory & Government Experience : Regulatory & Government Experience Australia
New Zealand
India
Pakistan
China
Korea
Japan
Malaysia
Singapore
Thailand
Philippines
Pfizer Singapore (2005-2008) : Pfizer Singapore (2005-2008) Medical Director Pfizer Clinical Research Unit
Singapore General Hospital
Successful FDA inspection with no findings
Executive Director Pfizer Phase I Unit
Raffles Hospital, Singapore
Managed expansion of Research Unit to 48 beds focusing on “First in Human” studies.
Consulting : Consulting Clinical Trials: Australia
Phase 1: Singapore/ Hong Kong
Drug Development Programs: Japan/USA
Biotech: Singapore/Melbourne
Expertise In : Expertise In Evaluating Clinical Research Programs
Review of documents
Second opinion
Analysis of Safety Data from Pre-clinical and Phase 1
Evaluation of surrogate end-points and proof-of-concept from Phase 2
Assessment of efficacy from Phase 3
Assessing Clinical Data & Gap Analysis : Assessing Clinical Data & Gap Analysis Are we missing anything?
Is there a safety “signal”?
Is this the best efficacy end-point?
Do we need more pre-clinical tox studies?
The golden rule: Are we going into phase 3 with the correct dose?
Evaluation of Emerging Safety & Efficacy : Evaluation of Emerging Safety & Efficacy Have we the best design for the ISS?
Does the ISE present our data in the best light?
Can we make a provisional risk/benefit analysis in light of our competitors?
Is there a commercial and/or medical unmet need for our compound?
Leveraging Therapeutic Areas of Expertise : Leveraging Therapeutic Areas of Expertise Oncology
Lung specialist in diagnosis and management of lung cancer
Clinical drug development supervision for Casodex, Zoladex, Arimidex, and Tamoxifen
Diabetes
Clinical Development, Regulatory Affairs, Safety and Efficacy of drugs for type II Diabetes
Pulmonary
Academic research in Asthma, COPD, Pulmonary Fibrosis, HIV, Sarcoidosis, Transplantation
CNS
Supervisory manager of clinical development teams for Seroquel and Paxil
Spokesman For Media : Spokesman For Media Media trained
Presentation of data
Multi-national Regulatory experience
Opinion leader development
Contact Me : Contact Me tammy@rebuckconsulting.com
+65-9800-8606
THANK YOU!