2
Biotech Outsourcing Strategies 2012 Discovery, early development & clinical operations outsourcing Dr James Willson, Senior Clinical Scientist, Shire Pharmaceuticals (Clinical Track) James Willson joined Shire Pharmaceuticals in September 2011 as a Senior Clinical Scientist. He holds a PhD in Neuro- pharamacology obtained at the University of Southampton in 2003. After a brief postdoctoral position again at Southampton University he left to begin a career in clinical research. In 2004 James joined the Clinical Research Organisation ICON Clinical Research as a Clinical Research Associate. In 2010, James became a project manager at ICON. While at ICON he worked on a number of global trials (with sites in EU, Americas, Asia Pacific) in various indications. Currently at Shire Pharmaceuticals he is a study manager working on a large global programme of clinical trials. joining the senior leadership team in the Respiratory business Unit to manage their early portfolio in 2005. In 2009 he assumed responsibility for Outsourcing and Business Development for Molecular Discovery at GSK, a department providing early phase scientific support to targets in the preclinical phase of Drug Discovery. Mike left GSK in 2010 to join Innovative Medicines at AstraZeneca as Head of Discovery Research. With groups in Sweden, the UK and the US, his current group focuses on internal and collaborative research to provide a comprehensive range of technical and translational activities to preclinical project teams including, HTS and SAR screening, X-ray crystal/biophysics support, statistics, and bio-reagent generation and assay development capabilities. Gareth Lewis Functional Sourcing Manager, Pfizer (Clinical Track) Gareth is currently a Functional Sourcing Manager based at Pfizer UK, located in Walton Oaks, near Dorking in Surrey. Gareth has been involved in Clinical Research for over 20 years, working across a broad range of drug development programmes covering phases I-IV. Most of Gareth’s experience has been gained within the commercial arena of pharmaceutical companies, designing and implementing trials which have supported the development of some of the most well-known & commercially successful prescription medicines. As Director of the UK Clinical Research Group at Pfizer, Gareth has led that organisation through several significant organisational changes, including the integration with Wyeth. In his current role, Gareth has supported the implementation of an outsourced clinical operations partnership with Quintiles, involving the delivery of clinical trials across 30 countries globally. Over the past 2 years, Gareth has led the complex transition of ongoing clinical trials between CRO partners, in order to achieve strategic organisational goals. Pia Sauer Larsen R&D Outsourcing Manager, Clinical Outsourcing Management, LEO Pharma A/S Pia Sauer Larsen has15 years’ experience in various roles related to Clinical Development. She is currently working in the R&D Outsourcing Function at LEO Pharma A/S, a leading global pharma company specialising in dermatology and critical care. Previously Pia was working as Strategic Procurement management function at Genmab A/S, and in a DM role at Nycomed Denmark Aps mainly focusing on the relationship and outsourced DM services between DM CROs and the clinical teams and also spent more than 8 years in a Data Management Unit at a centralized imaging CRO and in the Danish Cancer Society. Dr Tamzin Blagbrough European Outsourcing Coordinator, Lilly UK Tamzin has worked for Lilly for 20 years in a variety of roles, starting in the analytical labs, progressing to be a project manager and most recently as part of the outsourcing group. In this role she is responsible for placing all phase I work outside of the US. In addition she is the relationship manager for the phase I strategic relationship with Covance. She has a degree and a PhD in Chemistry. Dr.Maribel Crespo Head of Discovery Alliances, Drug Discovery Division, Almirall Dr.Maribel Crespo has been with for Almirall for 20 years covering most aspects of the Drug Discovery process. With a degree and PhD in Chemistry, she started her career as Medicinal chemist, being appointed later as Discovery project leader and Therapeutic Area head. More recently she has joined the Discovery Alliances group. In this role, she is responsible of Discovery Outsourcing activities and Medicinal Chemistry and Hit Finding Partnerships. Dr Mike Snowden VP & Head Discovery Sciences, AstraZeneca Mike joined Glaxo Group Research in the UK in 1988 after completing a PhD and postdoctoral studies at Liverpool University. Recruited as a microbial biochemist and enzymologist, he worked initially on anti-infectives and then in the Cardiovascular and Respiratory areas where he led a number of early phase dyslipidemia and inflammation projects. In 2001 at the formation of GSK, Mike was appointed to head a cross therapy area group providing HTS and SAR screening support to the CNSP and Respiratory groups in the UK, A must attend one day event that: Analyses best practice in R&D outsourcing for virtual biotech and pharma Delivers a platform for virtual biotech and pharma to strengthen outsourcing relationships and forge new partnerships Creates the ideal environment to build networks in R&D and outsourcing Mike Snowden VP and Head Discovery Sciences, AstraZeneca Colin Green Principal Research Scientist, Tox/ADME, Chorus Europe Simon Cruwys Head of Inflammation Pharmacology, Grunenthal Gareth Lewis Functional Sourcing Manager, Pfizer James Willson Senior Clinical Scientist, Shire Pharmaveuticals Tamzin Blagbrough European Outsourcing Co-ordinator, Lilly UK Insight from expert speakers including; Featured Speakers BOS 2012 visit www.bio2business.com to view all our speaker biographies 2012– 25th September, Royal College of Physicians, London (including non-clinical & clinical tracks) www.bio2business.com The Biotech & Pharma Booking Rate is set at £215 + VAT – this rate is only available to non contract service provider attendees Group Booking Discount: BOS 2012 will be appropriate for non-clinical & clinical R&D professionals in your organisation. Bio2Business is happy to offer generous discounts to enable your team to attend. Call us on +44 (0)207 691 3568 or email: [email protected] for further details. Ways to Register: Online: www.bio2business.com or www.bio2business.com/registrations.php Telephone: +44 (0)207 691 3568 Email: [email protected] or [email protected] Post: Bio2Business Ltd. London BioScience Innovation Centre, 2 Royal College Street, London, NW1 0NH Enquiry Form (if you prefer to register your interest by post please complete the form below) Name Job Title Email Telephone Company Enquiry Type I would like to register Please contact me for to discuss further Promotional code Ref: Please send your completed form to Bio2Business Ltd, London BioScience Innovation Centre, 2 Royal College Street, London, NW1 0NH Booking Rates Registration & Contact Details Package Price Features Biotech & Pharma Delegate Rate £215 + VAT per delegate Single delegate pass(Available to non-service organisation only) CRO Delegate Pass £1550 + VAT per delegate Single delegate CRO Silver Package £1800 + VAT Single delegate plus Branding CRO Silver Package £2050 + VAT 2 Delegates plus Branding Banner Stand Exhibition Sponsor £2500 + VAT 2 Delegates + Stand + Branding Exhibition Package £2750 + VAT 2 Delegates + Stand + Branding Exhibition Package £3000 + VAT 3 Delegates + Stand + Branding Gold Package £4500 + VAT 3 Delegates + Speaker Slot + Stand + Branding Key Sponsor £7500 + VAT See media pack for details Additional Delegate Pricing for CROs (only in addition to one of the package outlined above) £390 + VAT Sole Trader Consultant Rate (applicable to Sole Trader or Limited Company where proprietor consultant is the sole employee) £390 + VAT

Biotech Outsourcing Strategies 2012 Featured Speakers BOS 2012 · Sourcing case study - vendor perspective Drug discovery outsourcing John Ellingboe, Senior VP of Discovery Chemistry,

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Page 1: Biotech Outsourcing Strategies 2012 Featured Speakers BOS 2012 · Sourcing case study - vendor perspective Drug discovery outsourcing John Ellingboe, Senior VP of Discovery Chemistry,

Biotech Outsourcing Strategies 2012Discovery, early development & clinical operations outsourcing

Dr James Willson, Senior Clinical Scientist, Shire Pharmaceuticals (Clinical Track)

James Willson joined Shire Pharmaceuticals in September 2011 as a Senior Clinical Scientist.

He holds a PhD in Neuro-pharamacology obtained at the University of Southampton in 2003. After a brief postdoctoral position again at Southampton University he left to begin a career in clinical research.

In 2004 James joined the Clinical Research Organisation ICON Clinical Research as a Clinical Research Associate. In 2010, James became a project manager at ICON. While at ICON he worked on a number of global trials (with sites in EU, Americas, Asia Pacific) in various indications.

Currently at Shire Pharmaceuticals he is a study manager working on a large global programme of clinical trials.

joining the senior leadership team in the Respiratory business Unit to manage their early portfolio in 2005. In 2009 he assumed responsibility for Outsourcing and Business Development for Molecular Discovery at GSK, a department providing early phase scientific support to targets in the preclinical phase of Drug Discovery. Mike left GSK in 2010 to join Innovative Medicines at AstraZeneca as Head of Discovery Research. With groups in Sweden, the UK and the US, his current group focuses on internal and collaborative research to provide a comprehensive range of technical and translational activities to preclinical project teams including, HTS and SAR screening, X-ray crystal/biophysics support, statistics, and bio-reagent generation and assay development capabilities.

Gareth LewisFunctional Sourcing Manager, Pfizer (Clinical Track)

Gareth is currently a Functional Sourcing Manager based at Pfizer UK, located in Walton Oaks, near Dorking in Surrey. Gareth has been involved in Clinical Research for over 20 years, working across a broad range of drug development programmes covering phases I-IV. Most of Gareth’s experience has been gained within the commercial arena of pharmaceutical companies, designing and implementing trials which have supported the development of some of the most well-known & commercially successful prescription medicines. As Director of the UK Clinical Research Group at Pfizer, Gareth has led that organisation through several significant organisational changes, including the integration with Wyeth. In his current role, Gareth has supported the implementation of an outsourced clinical operations partnership with Quintiles, involving the delivery of clinical trials across 30 countries globally. Over the past 2 years, Gareth has led the complex transition of ongoing clinical trials between CRO partners, in order to achieve strategic organisational goals.

Pia Sauer LarsenR&D Outsourcing Manager, Clinical Outsourcing Management, LEO Pharma A/S

Pia Sauer Larsen has15 years’ experience in various roles related to Clinical Development. She is currently working in the R&D Outsourcing Function at LEO Pharma A/S, a leading global pharma company specialising in dermatology and critical care.

Previously Pia was working as Strategic Procurement management function at Genmab A/S, and in a DM role at Nycomed Denmark Aps mainly focusing on the relationship and outsourced DM services between DM CROs and the clinical teams and also spent more than 8 years in a Data Management Unit at a centralized imaging CRO and in the Danish Cancer Society.

Dr Tamzin BlagbroughEuropean Outsourcing Coordinator, Lilly UK

Tamzin has worked for Lilly for 20 years in a variety of roles, starting in the analytical labs, progressing to be a project manager and most recently as part of the outsourcing group. In this role she is responsible for placing all phase I work outside of the US. In addition she is the relationship manager for the phase I strategic relationship with Covance. She has a degree and a PhD in Chemistry.

Dr.Maribel CrespoHead of Discovery Alliances, Drug Discovery Division, Almirall

Dr.Maribel Crespo has been with for Almirall for 20 years covering most aspects of the Drug Discovery process. With a degree and PhD in Chemistry, she started her career as Medicinal chemist, being appointed later as Discovery project leader and Therapeutic Area head. More recently she has joined the Discovery Alliances group. In this role, she is responsible of Discovery Outsourcing activities and Medicinal Chemistry and Hit Finding Partnerships.

Dr Mike SnowdenVP & Head Discovery Sciences, AstraZeneca

Mike joined Glaxo Group Research in the UK in 1988 after completing a PhD and postdoctoral studies at Liverpool University. Recruited as a microbial biochemist and enzymologist, he worked initially on anti-infectives and then in the Cardiovascular and Respiratory areas where he led a number of early phase dyslipidemia and inflammation projects. In 2001 at the formation of GSK, Mike was appointed to head a cross therapy area group providing HTS and SAR screening support to the CNSP and Respiratory groups in the UK,

A must attend one day event that:

Analyses best practice in R&D outsourcing for virtual biotech and pharma

Delivers a platform for virtual biotech and pharma to strengthen outsourcing relationships and forge new partnerships

Creates the ideal environment to build networks in R&D and outsourcing

Mike SnowdenVP and Head Discovery Sciences, AstraZeneca

Colin GreenPrincipal Research Scientist, Tox/ADME, Chorus Europe

Simon CruwysHead of Inflammation Pharmacology, Grunenthal

Gareth LewisFunctional Sourcing Manager, Pfizer

James WillsonSenior Clinical Scientist, Shire Pharmaveuticals

Tamzin BlagbroughEuropean Outsourcing Co-ordinator, Lilly UK

Insight from expert speakers including;

Featured Speakers BOS 2012

visit www.bio2business.com to view all our speaker biographies

2012– 25th September, Royal College of Physicians, London (including non-clinical & clinical tracks)

www.bio2business.com

The Biotech & Pharma Booking Rate is set at £215 + VAT – this rate is only available to non contract service provider attendees

Group Booking Discount: BOS 2012 will be appropriate for non-clinical & clinical R&D professionals in your organisation. Bio2Business is happy to offer generous discounts to enable your team to attend. Call us on +44 (0)207 691 3568 or email: [email protected] for further details.

Ways to Register:

Online: www.bio2business.com or www.bio2business.com/registrations.php

Telephone: +44 (0)207 691 3568

Email: [email protected] or [email protected]

Post: Bio2Business Ltd. London BioScience Innovation Centre, 2 Royal College Street, London, NW1 0NH

Enquiry Form (if you prefer to register your interest by post please complete the form below)

Name Job Title

Email Telephone

Company Enquiry Type

I would like to register Please contact me for to discuss further Promotional code Ref:

Please send your completed form to Bio2Business Ltd, London BioScience Innovation Centre, 2 Royal College Street, London, NW1 0NH

Booking Rates

Registration & Contact Details

Package Price Features

Biotech & Pharma Delegate Rate £215 + VAT per delegate Single delegate pass(Available to non-service organisation only)

CRO Delegate Pass £1550 + VAT per delegate Single delegate

CRO Silver Package £1800 + VAT Single delegate plus Branding

CRO Silver Package £2050 + VAT 2 Delegates plus Branding

Banner Stand Exhibition Sponsor £2500 + VAT 2 Delegates + Stand + Branding

Exhibition Package £2750 + VAT 2 Delegates + Stand + Branding

Exhibition Package £3000 + VAT 3 Delegates + Stand + Branding

Gold Package £4500 + VAT 3 Delegates + Speaker Slot + Stand + Branding

Key Sponsor £7500 + VAT See media pack for details

Additional Delegate Pricing for CROs (only in addition to one of the package outlined above) £390 + VAT

Sole Trader Consultant Rate (applicable to Sole Trader or Limited Company where proprietor consultant is the sole employee) £390 + VAT

Page 2: Biotech Outsourcing Strategies 2012 Featured Speakers BOS 2012 · Sourcing case study - vendor perspective Drug discovery outsourcing John Ellingboe, Senior VP of Discovery Chemistry,

Registration breakfast and partnering

Discovery ModuleChair: Prof Hugh Marston, Head of Pharmacology, TPP Global Development

Harnessing advances in translational research to approach attrition at discovery and how external R&D can effectively partner with PharmaDr Mike Snowden, VP and Head of Discovery Sciences, AstraZeneca

Building a pharmacological platform of evidence to support out-licensingDr Simon Cruwys, Head of Inflammation Pharmacology, Grunenthal

Managing discovery chemistry partnerships Dr Maribel Isabel Crespo, Head of Discovery Alliances, Almirall

Coffee break and partnering

Technology ShowcaseChair: Alan Harris, Owner, Alacrity Pharma Associates

Services beyond drug substance manufactureSonal Naik, Sales Representative, CARBOGEN AMCIS

Some considerations in the development of synthetic peptides destined for first-in-human activity Dr Gareth Maguire, Business Development Manager, Almac

Key expertises in process development and API manufacturing Dr Jean-Paul Hermet, Business Development Manager, Bachem

Registration breakfast and partnering

Strategic Clinical Outsourcing Module Chair:Dr Keith Borkett, Director of Clinical Operations, Paion UK Ltd

Managing change when evolving to a strategic partner outsourcing modelMr Gareth Lewis, Functional Sourcing Manager, Pfizer UK

Functional vs. full outsourcing: evaluating the best approach for your companyDr Pia Sauer Larsen, R&D Outsourcing Manager, Clinical Outsourcing Management, LEO Pharma A/S

Outsourcing partnership models at Phase I: case studies in phase I contractingDr Tamzin Blagbrough, European Outsourcing Coordinator, Lilly UK

Coffee break and partnering

Technology ShowcaseChair: Anthony Walker, Partner, Alacrita Consulting

Early phase clinical trials: key success factors Dr Peter MacLennan, Director of Project Development and Scientific Affairs, ORION Clinical Services Ltd.

High priority on high potents Dr Michael Quirmbach, Sr. Manager Business Development and Technology Manager HPAIs, Dr Reddy’s

William Harvey Research Limited - A preclinical CRO in an academic environment Professor Chris Thiemermann, Chairman and Chief Executive, William Harvey Research Ltd

Saving cost through the application of High Performance Capillary Electrophoresis for analytical outsourcing Dr Stuart Hassard, Chief Scientific Officer, deltaDOT

Lunch and partnering

Early Development & Outsourcing Case Study ModuleChair: Dr Sarah Nesfield, Director, CRO Management, Scinovo, GlaxoSmithKline

Communication in outsourcing: avoiding common pitfalls, managing cultural divides, maximising vendor attentionDr Colin Green, Toxicology Project Leader, Lilly UK

Anatomy of a typical API projectDr Paul Madeley, Managing Director, Synth-Isis Ltd

Sourcing case study - vendor perspectiveDrug discovery outsourcingJohn Ellingboe, Senior VP of Discovery Chemistry, GVK Biosciences Pvt Ltd

Coffee break and partnering

Translational Pharmaceutics: Innovation in the early development processMr Kieron Hall, Vice President Business Development, Quotient Bioresearch

Harnessing the value of adaptive clinical trialsDr Laurent Spiess, Vice President, Business Development, Adaptive Clinical Trials, Aptiv Solutions

Lunch and partnering

Clinical Operations Outsourcing ModuleChair: Dr Stephen Greentree, Director Global Portfolio Management, Mylan

Understanding regulatory hurdles In early clinical DevelopmentTacye Connolly, Director & Owner, Regulatory Resources Group

Is clinical procurement putting the cart before the horse? Mr Roger Joby, Managing Director, 1to1to1.

Challenges of monitoring international trials sites Dr James Willson, Senior Clinical Scientist, Shire Pharmaceuticals

Coffee break and partnering

08.00

09.30

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10.00

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11.00

11.30

11.30

11.40

11.50

08.00

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09.30

10.00

10.30

11.00

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12.00

12.10

12.20

12.30

14.00

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15.00

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11.40

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15.30

Non-clinical trackIntroduction to BOS 2012 and to the BOS Events Formula Clinical Track

Who should attend BOS Events?From Biotech & Pharma: Executives involved with the following disciplines: discovery biology, discovery chemistry, pharmacology, DMPK, lead validation, lead optimisation, in vitro ADME, early scale up, scale up, pre-formulation, formulation, CMC, regulatory affairs, clinical development, clinical operations, project managers, programme managers, clinical research, outsourcing managers, contracts managers from CROs and CMO – business development, sales, marketing and corporate management functions

Very beneficial. I could meet with many existing partners in a short space of time and discover lots of new ones - some of which I hadn’t known existed before the meeting. Dr Chris Hobbs, Group Director of Chemistry,

Proximagen Neuroscience

Very useful, a good mix of lecture topics and time to meet new contacts Dr Paul Briner, Director Chemical Development,

Prosidion Ltd

Bio2Business have an extraordinary track record in bringing together key people in non-clinical pharmaceutical research. Their events are vital to our commercial activities Patrick Falvey,

Sales Executive, Celtic Catalysts

Launched in 2006 BOS Events are niche, outsourcing focused partnering events for the biotech, pharma and contract services

community. The 1 day event formula includes high quality presentations from thought

leaders in the industry, 1 to 1 partnering, exhibition and informal networking.

BOS 2012 will feature non-clinical and clinical tracks creating more opportunities

for interaction between clinical and non-clinical teams. As an attendee at BOS 2012

you can expect to develop your skills and build your outsourcing relationships all

in a relaxed atmosphere. Here are some comments from past attendees.....

Drinks Reception in the College Gardens – At the end of the day’s proceedings all delegates, speakers and sponsors are invited to an evening drinks reception in the gardens of the Royal College of Physicians

Exhibition NetworkingPartnering Presentation

Plenary Module - Outsourcing Strategy Strategy Chair: Sharon Grimster, VP Development, F Star

Developing an integrated outsourcing strategy - the Bayer approachDr Jens Gysler, External Cooperations, Bayer Pharma AG

Q&A session

Drinks Reception

16:00

16:00

16.50

17.00

Correct at date of print 14th September 2012

Key CRO Sponsors

Gold Sponsors

Exhibition Sponsors

Silver Sponsors

Banner Sponsors

Sponsoring “Biotech Outsourcing Strategies 2012” presents a highly effective opportunity for contract service providers to position expertise and capabilities to industry decision makers. Sponsorship opportunities include speaker participation, stand space, events media branding and more.

Contact Bio2Business Ltd on +44 (0)207 691 3568 or email: [email protected] or [email protected] to discuss further