BS811 Tutorial Plan

3 hour session introductory to include get to know activities

Contact the students by email telephone to invite them to the session and investigate whether any students have additional requirements [e.g. visually impaired] or specific access requirements [e.g. disabled].

Resources :

Room for 16 – laid out as 4 tables of 4, name badges, lunch

Duration: 1*3 hour session (excluding coffee break?)

Specific outcomes: Introduction to some of the challenges in the life sciences, ‘get to know’ session on fellow students

Previous Knowledge Assumed: Familiarity with life science industry

Materials & Equipment: OHP/Powerpoint projection, flipchart

Assessment Method: Participation in the closing session

 

 

1Introduction

1.1Learning Objectives

I assume this day school segment forms the introduction to the course and the challenges in BS811. I would start by trying to position the industry, the record of achievement and the technological and market challenges. In particular I would focus on some of the strategic choices facing the industry today and, for new comers to the industry, the non-obvious free/oligopoly/state markets and the significance of the current decline in the image and standing of the industry [for example Merck has dropped from a record of being Fortune's most admired company 7 years in a row during the 80's]. I also assume that detail of the course and specifics follow lunch.

The aims and learning objectives are for students to:

• Understand the contribution of Pharma/Biotech to modern healthcare especially the progress in treating disease and non-institutional care

• Appreciate the 'topology' of the market (local/regional/global, big pharma, niche biotech, CSO, CRO) and the strategic role of each type of player. Use this topology as a 'team-building' exercise allowing each student to position their organisation on the 'map'.

• A brief synopsis of the challenge of harnessing science for health, the role of patents and the issues generated by high- tech and patent protection

• Build the case for Pharma/Technology marketing understanding the essential demographic drivers of the market (primarily ageing and lifestyle) and the regulated markets in which the transactions occur

• Positioning - understanding the public and government perception of the Life Sciences Industries and the often paranoid view arising from the government role as both industry champion and industry customer.

[I am unaware of the course syllabus or TMAs but would suggest} leading to TMAs on ...

• The advantages, and disadvantages, of global marketing in Life Sciences discussing the extent to which R&D requires a global approach compared with local/national requirements for the approval/reimbursement process

• The public policy issues for the Life Sciences Industries and the extent to which the 'Americanisation and Medicalisation' of the Industry is damaging its ability to innovate.

1.2Outline Programme

2A short history of progress

OH 1-6 - 15 minutes

10 minutes on a short history of the life sciences with a tableau from the early dyestuffs (Perkin) to Genomics to Nanotechnology

Phases of

Infectious diseases and now chronic diseases progress OH2

Important new classes of product OH3

Progress in morbidity and mortality against major disease classes OH4

Improvement in quality of life and non-institutional care OH5

Challenges ahead - particularly chronic, degenerative & lifestyle illnesses OH6

3Exercise on topology of healthcare supplier organisations

20 minutes OH7-10 [cumulative 35 minutes]

Introduction to the scale and variety of the market and the size/scope of the organisations within it.

Introduction to Pfizer’s Research alliance OH8 and their product strategies [including purchase of Pharmacia] and difficulties of R&D productivity including productivity from Groton

Introduction on the diversity and scale of the life sciences and the fact that there are multiple organisations and multiple niche markets - use data on the numbers of (even) pharma companies OH9

Group Exercise - based on the type of organisation each student works for and their linkages to other players in the industry chain. Introduction to the variety of the industry and an open discussion on the different topologies

Use the three (four) major dimensions of activity - as create (R&D), make (manufacturing), selling and consumer for technological products

Use the Y dimension of type of organisation from TIPCO to an alliance model (Cavalla, David Modern Strategy for Preclinical Pharmaceutical R&D Towards the Virtual Research Company ISBN 0-471-97117-0)

As an exercise position your own work and span within this matrix – this forms a good introduction as to a) what aspects of the industry you work in and b) the scale and scope of your organisation

Split into groups of 4. Introduce yourself and the type of organisation you work for. Enter the contour (oval) of your organisation on the sheet.

Then as a combined group integrate the 4 maps from 4 so that everyone has an idea of where the individual works and the type of organisation.

 

4Fundamentals

30 minutes [cumulative 65}

4.1Hi tech - leading edge science

Always so from the start the life sciences have been at the leading edge of innovation

Key Examples of which have been ..

• synthetic organic chemistry - quinine and aspirin

• antibiotics - penicillin

• molecular biology - e.g. Roche diagnostics

• genomics - herceptin  brac3

• nanotech - nanoparticle diagnostics

• robotics - surgery

Significance of the possibilities of chemical and biological space - and the need to integrate chemistry, biology and information OH12

Current key areas ...

Genetics - Important but need to understand the impact and consequences OH13

Informatics - Significance of medical records OH14

Therapy Gap - the move to individual diagnosis and the practicality of building markets / ethics issues OH15

Partnerships & exploring new technologies / areas - need for partnerships OH16

Current R&D and taxonomy of disease areas, explore the myth of large pharma companies [few compete in multiple franchises] OH17 & 18

4.2Patent protection - to re-coup the R&D

Sense of scale of Life Science R&D

Outline of patent law

Tension - for example AIDs drugs for South Africa [have you seen The Constant Gardener]

5Markets

5.1Market dynamics

20 minutes - [cumulative 85}

Fundamentals of our reliance on pharma and life science products

- ageing & growing dependence on pharma products OH20

- escalating costs of the service elements of health care (NHS funding 05 and rise = PFI, doctors salaries & new drugs)

- Global requirements (greying of the major economies - Japan, EU, US)

- Tensions in the world markets - increased demand vs price pressure OH21

- Different characteristics of markets and product launch / age discussion [e.g. early access to new drugs in USA] OH22

- Global industry / local markets - the wide variation in national access policies and reimbursement and the growing significance of HTA and the 4th hurdle OH23

5.2Market access

30 minutes - [cumulative 115]

5.2.1Role of governments

Increasing role of governments

- To underwrite the cost of health support OH24

- To regulate the markets

- To protect against unscrupulous selling (e.g. history of FDA)

- To be customer of pharma companies

- determining HTA measures and the 4th hurdle

5.2.2Why are life sciences any different?

Introduce issues of ..

- Safety - physiologically active -

- Introduction - restricted advertising and 'indirect selling' - question which industry is most like Life sciences with 35000 GPs and no direct sell

- Regulation - extreme focus on efficacy and use - for example

5.2.3Market drivers

Strategic drivers - so I've got a good idea ... build it and they will come - and the reality of trading in the life sciences. OH25

TEAM EXERCISE [15 minutes within 30 minutes on market access]

Discuss the statement for the life sciences so I've got a good idea ... build it and they will come

Divide into groups of 4 and develop an influence map on the market forces around life science products.

I need to explain what an influence map is and provide an example

 

• patient lobby - herceptin

• off label prescribing - professional latitude - typically 35% of product written off-label

• role of indications (related to proof) - suppose lucozade could only be sold to athletes

5.2.4Globalisation

Issues of globalisation & size - OH26

- To recoup R&D

- Differential pricing

- Parallel exports

- Different licensing arrangements

- selling under licence

- Trade agreements and patents (e.g. HIV)

5.2.5Marketing

Elements of the marketing mix OH27

- Size of market - big and small (orphan) - exercise on profitability of Forest

- Generic prescribing - impact

- Pricing and parallel imports

- Novelty and me-toos - evidence for fast followers and price reductions of competition - nature and Lichtenberg

- Advertising and OTC

- Advertising and disease awareness - e.g. Viagra and ADHD

6Positioning

6.1The public image

15 minutes [cumulative 130]

OH 29

6.1.1part 1

The patient view

- The pharmacist is the #1 trusted profession in the aged

- prepared to risk treatments e.g. Lorenzo’s oil

- Pressure to make things available e.g. herceptin

6.1.2part 2

Big fat profits OH30

- OFT investigations

- medicalisation - e.g. restless leg syndrome

- pill pushers - e.g. vioxx

- Generic price fixing

6.2The government view

15 minutes [cumulative 145]

Schizophrenic

- Chicken and the fox - Sir Richard Sykes Parliamentary review of pharma OH31

- should life sciences be seen as a DTI or DoH favourite OH32

- Risk and return attitudes - for example should aspirin be banned

- Evidence based medicine - e.g. keyhole surgery and the absence of clinical trials

- Contribution to the UK Knowledge Society & R&D OH33

6.3Exercise - explain the public image issue of pharma

30 minutes - [cumulative 175}

OH34

GROUP EXERCISE [20 of the 30 minutes]

As a Whole Group – Introduce an open discussion based on the 'public trust' data on the industry and data on Merck to ask “what should/could the Life Science industry be doing to readdress the current PR problem”

Work as a group of 16

Use a 2 column – smiley, frowny board to identify the possible measures +ve or –ve to change the perceptions

- Possible answers...

+ reduce patent life

- Get away from the NHS - free at the point of care

+ Better profile - more advertising

+ get R&D working

- become more engaged in the health industry

- stop the own goals - e.g. Morgan Sperlock/Michael Moore film, Pfizer whistle blower

- Less opulence

7Close

5 minutes [cumulative 180]