Processing. Please wait.

 

pic-1

Bryan Deane

New Medicines & Data Policy Director
Association of the British Pharmaceutical Industry (ABPI)

About Bryan

After graduating in Pharmacology and completing a PhD in Neuropathology, a variety of positions at SmithKline Beecham and GlaxoSmithKline were mostly focussed on commercial development, including regional input to early valuation of potential new medicines and to the design of the clinical development programmes to deliver them. These covered a variety of therapy areas including infectious diseases, respiratory diseases, gastroenterology, diabetes and oncology and experience of a wide range of countries and regions, from the UK to China and from Latin America to Asia-Pacific. This included a major role directing the implementation of a China joint-venture on a green field site, covering partner negotiation, factory build, and clinical development and registration. A period as a freelance consultant followed, leading a variety of projects such as new product launches, medical affairs programmes and restructuring healthcare agencies, as well as a joint project with the ABPI exploring clinical trial transparency. Bryan joined the ABPI’s Research, Medical & Innovation Team in May 2018, covering all aspects of New Medicines Development, including specific responsibility for Advanced Therapy Medicinal Products, Antimicrobial Resistance, and the Medicines Manufacturing Industry Partnership.
 

Speaker's Sessions:

1570805100
1570805100 - 1570807800
Elgar Concert Hall
English

Panel: Clinical Trials - Getting it Right First-Time

Clinical research is one of the most expensive areas of drug development and bringing a drug to market can take up to 13 years and involve a huge amount of capital investment.

Setting up to do a first in man trial places many demands on a small company, particularly those companies where many of the personnel are scaling a steep learning curve.  Not only do you have to think about your preclinical work, source appropriate quality materials for your trial but also design the trial, identify appropriate partners and receive the necessary approval from the regulators.  There’s plenty of scope for wasting money and time – something you or your investors will be keen to avoid.

To keep costs low, maximise competitive advantage, and deliver life-saving therapies to patients as quickly as possible, the life Sciences industry must leverage novel management models, new technologies and creative study approaches to accelerate clinical trials.

Our expert panel will discuss these and other relevant issues pertaining to successful Clinical Trials Including:
  • Top tips for successful clinical development
  • Adapting your work practices to comply with GLP and getting ready for GCP
  • Sourcing clinical grade materials – when is GMP appropriate and identifying credible suppliers
  • Designing your trial to maximise your asset’s value
  • Selecting clinical development partners - boutique, multinational behemoth, therapeutically focused - or even no CRO at all, and how best to work with them
  • Difficulties in recruiting volunteers and enrolling them in a study
  • Contract and budget negotiations with investigative sites
  • Country selection and initiation, regulatory compliance, and standardising procedures – the pros and cons of conducting studies in in emerging markets
Speakers