HYSERICAL CHAOTIC 60 Chaotic Meetings and still going

HYSERICAL CHAOTIC 60 Chaotic Meetings …and still going. . April 1982 to April 2013 CONFIDENTIAL

Longest serving member First meeting attended in 1987 Age 22 In the same year… broke lab record for highest number of pipette bulbs stuck on face APPLAUSE! 3 CONFIDENTIAL

60 Chaotic Meetings • Introduction • In the beginning • The early years • The middle years • Up to date • The Benefits • The future ? 4 CONFIDENTIAL

Introduction • What is Chaotic ? – Chemical Aspects of Toxicology – Meet bi-annually to Discuss technical, scientific and regulatory issues surrounding Formulation and Analysis – Members include formulators, analysts, test material controllers, managers and QA from all major UK Pharmaceutical companies and Contract Research Organisations – Hosted by member companies on a voluntary/rotation basis – Company annual membership fee • Industry Standards – Networking – Publication – Questionnaires + Help Sessions 5 CONFIDENTIAL

In the beginning… 1982 • Can you remember these ? • Shout the answers ? 6 CONFIDENTIAL

In the beginning… 1982 7 CONFIDENTIAL

In the beginning • 1982 - In this year – – – – 8 Falklands War Margaret was our leader (RIP) Blade runner was released at the cinema First Artificial Heart transplant Thriller released Commodore 64 MRI introduced in hospitals Madness and (just) Men at Work CONFIDENTIAL

In the beginning • Aftermath of GLP Introduction • A list of ‘formulators’ and relevant people compiled in Oct 1982 at Labsure Symposium • ‘Chemistry in Toxicology’ meeting held November 1982 at HRC (Huntingdon) • Chaired by Richard Halliday of HRC • Agenda Items – Formulation Sampling / Tolerances / Inventory Systems / Dealing with QA / Safety / Desire to meet again • Participants – HRC / Shell / FBC / ICI / SKF / Beechams / Boots • Chaotic 1 was therefore spring 1983 at Shell, name by Mike Crofts, FBC 9 CONFIDENTIAL

Companies past and present Beecham Smith Kline 10 CONFIDENTIAL

The Early Years Shell Chaired / Minuted the early meetings. Chris Wood attend his first meeting 11 CONFIDENTIAL

The Early Years • • • • • 12 Chemistry in Toxicology – HRC, Huntingdon Chaotic 1 -2 – Shell Centre, London – First discussion of regulatory inspections Chaotic 3 – ICI, Alderley Edge – SOPs were still optional at this time Chaotic 4 - Shell Centre, London Chaotic 5 – Glaxo, Ware Chaotic 6 -8 – Shell Centre, London – First help session. First mention of International Meeting. Chaotic 9 – Hazelton, Harrogate - Chris Wood attends ! Chaotic 10 – Glaxo, Ware – First use of Capsules. Chaotic 11 – Boots, Beston Chaotic 12 - Shell Centre, London Chaotic 13 – ICI, Alderley Park Chaotic 14 – HRC, Huntingdon Chaotic 15 – Schering, Chesterford Park Chaotic 16 – Welcome, London. Publication of Paper on GLP reqs of Manufacturers/Suppliers Chaotic 17 – Hazelton, Harrogate Chaotic 18 – Roche, Welwyn Chaotic 19 – Shell, Sittingbourne. Dispense first demo. Chaotic 20 – HLS + Officers Mess, Duxford. 1/2 day meeting followed by joint meeting with RSC (to celebrate 10 years). Agreed to write a guide on Formulating. CONFIDENTIAL

The Middle Years • Peter Banham and then Richard Halliday as Chair, John Rider as Secretary • Focus shifted to GLP with more QA/less formulation/analysis people • Published the veritable formulation bible ‘GLP Applications for Test Material Control, Formulation and Analysis’ • Dean, Rowena, Ian, Rodney, Mike, Christine all ‘enjoying’ our first Chaotics 13 CONFIDENTIAL

The Middle Years • • Chaotic 21 – Glaxo, Ware Chaotic 22 – Shell, Donington Chaotic 23 – Zeneca CTL - Alderley Park Chaotic 24 – Smith. Kline. Beecham, The Frythe Chaotic 25 – Glaxo. Welcome, Dartford Chaotic 26 – Agr. Evo, Chesterford Park – David Moore, Director of Do. H answers questions Chaotic 27 – Inveresk, Edinburgh Chaotic 28 – Bi. BRA, Surrey Chaotic 29 – Roche, Welwyn Chaotic 30 – Glaxo. Welcome, Ware Chaotic 31 – Knoll, Nottingham Chaotic 32 – Covance, Harrogate Chaotic 33 – Sequani, Ledbury – Chris Wood – Chairman / Corporate Culture talk by Zoe Wakerly Chaotic 34 – CTL – Alderley Park 14 CONFIDENTIAL • •

The Later Years • • • 15 Chris Wood took over as Chairman General shift back to Formulation/Analysis Move towards central hosting. Chaotic Organising Committee Sub Groups – CPD / Cleaning Validation CONFIDENTIAL

The Later Years • • • • 16 Chaotic 35 – GSK, The Frythe Chaotic 36 – Safe. Pharm, Derby Chaotic 37 – GSK, Ware – Deans presentation on ‘Infamous QA Comments’ Chaotic 38 – HLS, Huntingdon Chaotic 39 – Astra. Zeneca, Alderley Edge Chaotic 40 – Covance, Harrogate Chaotic 41 – Inveresk, Edinburgh Chaotic 42 – GSK, Ware Chaotic 43 – Chaotic, Anglessey Chaotic 44 – Safe. Pharm, Derby Chaotic 45 – Sequani, Ledbury – first Cleaning Validation sub committee Chaotic 46 – Sanofi Aventis, Alnwick – ‘Who wants to be a millionaire’ QA quiz Chaotic 47 - Astra. Zeneca – Alderley Park – Steve Monk was our mystery guest speaker Chaotic 48 – HLS, Northampton Chaotic 49 – Aptuit Edinburgh – ‘Unbundling training and competence’ talk by Andrew Waddle. Ian leaves a 50 pence tip! Chaotic 50 - Chaotic, Anglessey CONFIDENTIAL

Recent Times • Chaotic 51 – GSK, Hatfield, “Where’s the ****** veg ? ” • Chaotic 52 – Covance, Harrogate, Rudding the Posh Hotel ! • Chaotic 53 – Sanofi, Alnwick, Karaoke and the “Rocking Horse incident” • Chaotic 54 – Pfizer, Sandwich, “can we see France from here ? ” • Chaotic 55 – Harlan, Nottingham • Chaotic 56 – AZ Alderley • Chaotic 57 – Joint Hosts, Anglesey • Chaotic 58 – Sanofi, Lumbley Castle, Alnwick • Chaotic 59 – GSK, Fanham Hall, Ware “Tour of Dean’s Dispensary” • Chaotic 60 – York 17 CONFIDENTIAL

Food for thought In 1982…… • Litre of Petrol - 36. 4 p • Pint of Beer – 62 p • Packet of 20 Cigarettes - £ 1. 07 • Golf GTI - £ 6, 500 • Typical drug takes 14 years to develop to Market and cost £ 200 Million) – the time peaked around 1980 …and In 2013 • Litre of Petrol - £ 1. 36 (+274%) • Pint of Beer – £ 2. 50 (+303%) • Packet of 20 Cigarettes - £ 7. 60 (+610%) • Golf GTI - £ 28, 000 (+330 %) • Typical drug takes 12 years to develop to Market and cost £ 800 Million (+300%) 18 CONFIDENTIAL

The Benefits • Gain the latest Regulatory/GLP advice – Experiences are shared – enable Proactive preparation • Gain the latest technology and advancements • Gain Formulation/Analysis tips and issues – Best Industry standards • Gives CPD (Continual Professional Development) • Gives Answers to our Questions • Give Training and Presentation experience in a non-threatening environment. • Web site – information repository • Working parties and Collaborations • Networking (outside of meeting) – A lot of good friends – A lot of contacts to ask Questions when the answer is needed yesterday – A good forum for brainstorming ideas – Fun, a few beers, a nice meal and a day or 2 out of the office 19 CONFIDENTIAL

The Future • The Challenges – – • The Opportunities - 20 Economic environment Mergers and Acquisitions Attendance Commitment Chaotic 60, 75, 100……… Web Site development European / International ? More CPD / Sub Groups 1 or 2 Days ? Subject Areas Presenters We need your involvement and continued support CONFIDENTIAL

Acknowledgements Thanks to the Organising committee And thanks to the group for your continued support. Special Thanks to – We wish her well for the future 21 CONFIDENTIAL