The Henry Stewart Annual Briefing
An Introduction
to the
Pharmaceutical Industry Today

What you need to know about the Pharmaceutical Industry – all in just one day!

Chair:
Julian Blagg
Senior Director, Sexual Health Chemistry
Pfizer Global Research and Development

The Pharmaceutical Industry Today
The pharmaceutical industry is one of the largest and most exciting sectors to be working in today. It is a rapidly changing environment where many advances have taken place over the past 20 years. Furthermore, it will continue to develop and evolve at an ever-increasing pace over the next decade. New drugs, new technologies and exciting new discoveries have driven this evolution. Dr Allan Jordan, Senior Medicinal Chemist at Vernalis will present a clear picture of today's pharmaceutical industry.

Allan Jordan
Senior Medicinal Chemist
Vernalis

 

Regulatory Control of Medicines
As a result of the Thalidomide disaster of the late 1950s and early 1960s, medicines have become one of the most highly regulated products in the world. Data demonstrating their safety and efficacy must be filed with government agencies in order to move through clinical development, to obtain approval to sell a new drug and at regular intervals thereafter.
Each country has its own regulatory authority and laws governing the development and sale of medicines. In addition, in Europe, there is a regulatory agency at the European level (EMEA). Internationally, there is regulatory co-operation between Europe, the USA and Japan (ICH). As a result, the regulatory control of medicines is a complicated business. The speaker will discuss the current regulatory framework for medicines including:

Leigh Shaw
Pharmaceutical Regulatory Affairs

 

Drug Discovery and Development
Why is drug discovery so important and what are the key stages in drug development? Dr Allan Jordan, Senior Medicinal Chemist at Vernalis will take you through the whole lifecycle of drug discovery - a process that normally takes the Pharmaceutical Industry 10 years. He will explain how new technologies are shaping the future of the industry and discuss the strengths and benefits of conducting pharmaceutical research in the UK.

Allan Jordan
Senior Medicinal Chemist
Vernalis

 

Preclinical Studies
Before first administration to man, the safety of a new drug has to be evaluated in animals. In this highly regulated environment, a programme of studies, designed to be relevant to the proposed therapeutic use of the drug, must be undertaken. Additional studies will also be required as the compound passes through the different phases of clinical development. The speaker will address the following points:

Christine Robinson
Drug Development Scientist

 

Clinical Trials Phases I-IV
Clinical trials are one of the most important areas of research simply because human patients are involved. In this presentation, Dr Jörg Täubel, Managing Director of Richmond Pharmacology, will describe the stages of the clinical trial process, explaining the importance of each stage.

Jörg Täubel
Managing Director
Richmond Pharmacology Ltd.

 

Medical Marketing
Medical marketing involves planning and analysis in order to help promote and sell pharmaceutical products to both clinical and medical professionals. Brian Smith, Marketing Consultant for PragMedic, will explain the strategies involved and how medical marketing differs from marketing in other industries.

Brian Smith
Marketing Consultant
PragMedic UK

 

Key Legal Issues for the Pharmaceutical Industry
In order to protect the huge investment in time and money necessary to bring a product to market, knowledge must be protected as an asset. Consequently, workers in the Pharmaceutical Industry need an understanding of the relevant intellectual property rights. This talk examines some of the basics, with particular emphasis on patents. It will assist pharmaceutical personnel to spot issues where further advice may be needed. Topics covered will include:

Nigel Stoate
Associate
Taylor Wessing

 

Anatomy of a Licensing Deal
This session will look at the key features of a pharmaceutical licensing deal. Topics that will be covered include:

Daniel Pavin
Partner
Taylor Wessing

 

Understanding the Dynamics of the Generics Industry
An innovator pharmaceutical product is protected throughout the effective life of its patent, enabling the patent owner to reap the benefits of monopoly pricing. When the innovator patent expires, generic manufacturers can enter the market and sell their products at a cheaper price.
The speaker will discuss what hurdles the generic company has to overcome to launch a generic pharmaceutical, how the entry of generics onto the market affects the innovator product and how the healthcare authorities are focusing on generic drugs as a way of reducing the prescribing within our healthcare system.
Topics covered include:

Tony Toks Akiwumi
Business Development Director
Rosemont Pharmaceuticals Limited

 

How the Price of a Product is Set – An Introduction to Global Pharmaceutical Pricing and Reimbursement
Establishing prices for pharmaceutical products is a complex process involving integrated approaches to strategy development, as well as an appreciation of the very different pricing and funding systems and requirements adopted by governments. In this introduction to pharmaceutical pricing and reimbursement, Adam Barak, Director of ABPPC and former Head of European Pricing at GlaxoWellcome, will review the main issues facing pharmaceutical manufacturers when developing optimal pricing strategies including:

Adam Barak
Director
ABPPC Ltd.