Understanding the Pharmaceutical Industry

Course overview

Understanding the dynamics and drivers of the industry you work in is key to understanding how and why key decisions are made within your organisation.

In turn, this enables you to appreciate your potential impact on the overall success of the organisation. With this in mind, Falconbury have developed this concise distance learning course which delivers a complete insider’s guide to the pharmaceutical industry; it’s history and background, the process of discovery, clinical trials, taking the drug to market; the challenges and opportunities facing the industry now and in the future.

If you are new to the industry, or are in a support role or otherwise would like to broaden your understanding of the environment in which you work, then this 6 module course is essential for your development.

How does this distance learning programme work and what do you get?

• Six modules, each requiring between 3 to 4 hours study to be completed as you choose
• The course and its modules start at any time to suit you
• Modules may be downloaded to study on your PC or to print hard copies. (You may also opt to receive them printed-and-bound from us.)
• Each module has self-assessment progress questions and model answers
• The course has an optional on-line multiple choice assessment at the end, with a certificate of completion being awarded

Who should take this course?

Anyone working within the industry who is new to it or who would like to broaden their understanding of the pharmaceutical industry and who works in any of the following functions:

• R & D: all areas of drug discovery and development, including clinical, and regulatory affairs
• Production and quality assurance
• Marketing and sales
• Business development and licensing
• Finance
• Legal
• Human resources
• Administrative support

This course will:

• PROVIDE a review of the dynamics and drivers of the industry
• OUTLINE the drug development process, including pre-clinical activities
• DEFINE the key challenges faced in registering a drug
• FOCUS on the function and importance of alliances and deals
• ENABLE you to get-to-grips with the journey through each clinical trial phase
• EXPLAIN the particular marketing and selling strategies, tactics and techniques employed in the pharmaceutical industry
• EXAMINE the current and future trends and their implications across the sector

Course modules

MODULE 1 – INTRODUCTION TO THE PRESCRIPTION PHARMA INDUSTRY

• The structure of the pharmaceutical industry; international importance
• A brief history
• Medicines classification
• How the nature of disease and drug treatment relates to industry therapeutic areas
• Mission statements and therapeutic goals
• What is distinctive about the pharmaceutical industry?
• The importance of intellectual property rights

MODULE 2 – DRUG DISCOVERY AND PRE-CLINICAL ACTIVITIES

• The target product profile
• Key milestones in the development process
• Drug synthesis and selection; safety; animal pharmacology; ADMET
• Biotechnology/start-ups – differences between biotech and pharma companies
• Contract research organisations
• Enabling technologies

MODULE 3 – FROM CLINICAL TRIALS TO REGISTRATION

• GCP
• Data management and statistics
• Clinical trials by phase
• Attrition rates
• Pharmaceutical development
• Manufacturing (including GMP)
• Quality control/assurance
• Drug registration
• Orphan drugs

MODULE 4 – BUSINESS DEVELOPMENT

• The function of business development
• The importance of strategic alliances
• Mergers and acquisitions

MODULE 5 – HOW DRUGS ARE MARKETED AND SOLD

• Pharmaceutical market research
• Marketing strategies
• Promotional activities – the sales force and advertising
• Pricing
• Distribution
• Parallel trade
• Who’s who in the marketing department

MODULE 6 – CURRENT AND FUTURE TRENDS

• Emerging geographical markets
• US vs Europe
• Product life-cycle management (including Phase IV development)
• Strategy for new therapeutic markets
• Barriers to future entry
• Diversification away from pharmaceuticals

Course contributor

JOHN ANSELL
Since 1989 John Ansell has been a pharmaceutical industry consultant. He concentrates on international projects with a commercial and strategic emphasis, reflecting his previous industry experience in marketing and business development. He has worked with many major pharmaceutical companies but advises companies of all sizes including start-ups, as well as those providing services to the industry and those investing in it: some 110 clients in all.

A Biochemistry graduate with a Masters degree in Business Studies, John started his 20-year career in the pharmaceutical industry in Holland with Organon. He subsequently worked for Schering AG and Fisons in the UK, and again in Holland, with Solvay. Lastly, from 1985 to 1989 he worked in international marketing for Glaxo Holdings.

He is the author of over 40 articles and reports on pharmaceutical issues. His most recent article is Product Life Spans: Trends in the Quality and Staying Power of New Products(Spectrum, Decision Resources, June 2008).

He has advised numerous investment banks including six of the top seven; he is placed in the top 5% Leader category of the Gerson Lehrman Group’s consultants, based on quality of interaction with its financial and consultancy clients. He is also Honorary Consultant to the University of Manchester School of Pharmacy and Pharmaceutical Sciences.

John is a frequent speaker at industry conferences on various aspects of deals, marketing and R & D strategy. He has presented on US and European biotech deals, on deals involving genomics, generics and OTC, as well as widely on mergers and alliances. He has also acted as chairman at well over 30 pharmaceutical conferences, on a wide range of topics including biotechnology, R & D, business development and licensing, technology transfer, due diligence, marketing, promotion, pricing and corporate governance.

John was a long-standing member of the Editorial Advisory Board of the US journal Pharmaceutical Executive (1990-2002), served on the Editorial Board of the Journal of Biotechnology in Healthcare (1994-98), and has been Chairman of the Advisory Board of Decision Resources since its inception in 2005.

Past delegates’ comments

Some of the comments received by participants on this course:

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Sector	Course	Type
	Finance for Non-financial Managers in the Pharma Industry A 2-day guide to the essentials of effective financial and commercial skills for non financial managers working within the pharmaceutical and biotech sectors	Training course & In-house training
	Negotiating, Understanding & Drafting Contracts for the Pharmaceutical Industry A 3-day practical and interactive seminar focusing on current contract drafting, negotiating, best practice and related issues.	Training course & In-house training 11-13 Jun 2012 12-14 Nov 2012
	The ‘Mini-MBA’ for Pharma, Biotech & Life Sciences A 5-day ‘Mini-MBA’ programme developing the skills of key executives and managers in the pharma/bio-tech/life sciences sector.	Training course & In-house training 5-9 Mar 2012 8-12 Oct 2012

Client portfolio

Our client portfolio for this course includes the following companies:

More information

The following documents are available for this course:

• Sample module [327kb]

Falconbury’s distance learning programmes have been certified by the Academy of Distance Learning (ADLiB).. ADLiB supplies an unbiased authentication of, and quality assurance for, distance learning programme providers.

Upon course completion, distance learning participants are invited to undertake a final external assessment in the form of an online multiple-choice paper.

Participants are required to achieve a pass rate of 80% and above to ensure that a high level of competence has been achieved within the subject area and to receive the advanced ‘Certificate of Excellence’. The final external assessment can be taken up to three times, thereafter the ‘General Certificate of Course Completion’ will be issued.

NB: The final external assessment is an optional appraisal and those participants not wishing to undertake it will automatically receive the ‘General Certificate of Completion’ for their personal development/training profile.

Find out more about ADLIB here.

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