Dr Kulasiri Gunawardena
PHARMACEUTICAL PHYSICIAN
Trained in respiratory/general medicine to specialist level with over 20 years’ experience in clinical research and drug development within CROs and big pharma environments. Kulasiri’s experience spans translational stages through to late development, including leading the design and execution of early studies (PoM/PoC) to validate drug targets creating novel segmentation of common respiratory diseases. He has contributed to numerous Health Authority documents, including a recent PhII/III biotherapeutic project.
Dr Charles Owen
ALLERGY & BIOTHERAPEUTIC DISCOVERY
Significant experience working in pharmaceutical and biotechnology industries, leading the consultancy. At Novartis, he was responsible for scientific support of omalizumab (Xolair), a therapeutic monoclonal antibody, which remains the only significant new therapeutic for the treatment of asthma launched in the last 40 years. Charles has amassed significant experience of drug discovery, development and post-launch marketing support. He is a molecular biologist & protein biochemist by training.
Jo Sanni
CLINICAL PROJECT MANAGER
During her time in pharma, Jo has been responsible for planning & delivering early phase clinical studies (biologics and small molecules) across many therapeutic areas. As Operational Head she was responsible for delivery of a large portfolio of early phase respiratory-based projects. She expanded her global management experience through mentorship of managers in the Asia region, leading teams in process improvement, change management & communication.
Liz Campbell
PROJECT MANAGEMENT
Liz has over 20 years’ experience within pharma culminating in a position as Head of Project Management at Celltech. She has worked as a freelance consultant for the last 14 years. Liz has managed cross-functional teams (biological and small molecule) spanning pre-clinical discovery through to clinical proof of concept. She has extensive experience leading small companies through partnering strategies and in establishing appropriate Quality and document management systems.
Sarah Polley
REGULATORY AFFAIRS PROFESSIONAL
Sarah has over twenty years of international experience within the pharmaceutical and biopharmaceutical industry.
She has held senior positions in QC, QA, Validation and, for over ten years, has held increasingly responsible positions in Regulatory Affairs.
Sarah has experience of Regulatory CMC, Phase I - III clinical trials, pre-submissions, agency interactions, post approval variations and due diligence.
Dr Jennifer Sims
TOX/REG DRUG DEVELOPMENT
More than 25 years’ experience in the specialist biotech and global Pharma, and UK/European regulatory agencies. Prior to becoming an independent consultant in 2012, Jenny was Head of Translational Sciences & Safety for Novartis Biologics. She specializes in integrated non-clinical development, including safety assessment, translational PK-PD, immunogenicity risk assessments and regulatory strategies for biopharmaceuticals and advanced therapeutic products.
