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

© 2016 Stone Biostatistics

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