T: +44 (0) 7919 211836
Providing innovative
solutions in optimising drug
development programmes
About us
Headed by a consultant biostatistician with over 23 years of experience
in the pharmaceutical industry, Stone Biostatistics provides innovative solutions
in optimising drug development programmes specialising in oncology.
•
Andrew Stone is a former head of the Biometrics oncology TA at AstraZeneca and has significant regulatory experience, leading biostatistics team to the submission or approval of six oncology products.
Andrew Stone, Director
*Pharmaceutical Statistics 2014 13: 229-237
You can benefit from the following experience and expertise
PIII trial design
Approved the design of >50 PIII oncology trials as part of cross functional TA teams
Early Phase design
Member of TA team accountable for all PI and PII products in oncology
Adaptive Design
Designed and obtained regulatory acceptance for one of the first adaptive designs in oncology in 2006*
Innovation
Implemented use of tumour size as an endpoint to make reliable and more rapid early Go/No Go decisions
Product approval and submission
Led biostatistics teams to approval or submission of six products
Health Authority Meetings
Represented AZ at multiple meetings in the US, Europe and Japan
Advisory Committees
Represented AZ at 2 ad-coms (ODAC)
for olaparib (BRCA ovarian) and vandetanib (medullary thyroid)
Recognised expert
Lead or contributed to multiple industry
wide working groups to shape regulatory policy: including co-lead of PhRMA PFS expert working group
*Pharmaceutical Statistics 2014 13: 229-237