Biotech Outsourcing Strategies 2013Discovery, Early Development and Clinical Operations Outsourcing

Hugh MarstonHead of Pharmacology, TPP Global Discovery

Insight from expert speakers

including;

17th September, Royal College of Physicians, London, UK Including Discovery/Early Development & Clinical Outsourcing Tracks (Pre-event Workshop 16th September)

Elizabeth MortimerDirector of Toxicology, Neusentis

Matt Gregory CEO, Isomerase Therapeutics Ltd

Eckhard Ottow Head of Global Innovation Sourcing, Bayer Pharma AG

Ian HayterDirector of Projects, Destiny Pharma Ltd

Diane ChisholmHead of Clinical Operations, Santhera Pharmaceuticals Ltd

What You Can Expect From BOS 2013Key CRO Sponsors

Gold Sponsors Exhibition Sponsors Silver Sponsors

Events Partners

Go to http://www.bio2bevents.com/bio2b-registration/registration to complete your registration enquiry online

Update Clinical and Non Clinical Tech Ops

Skills Sets

Build Specialist Outsourcing Knowledge

Refine Outsourcing

Business Process

Strengthen Existing CMO/CRO Supplier Relationships

Meet New CMO and CRO Partners

Network with Peers from

Biotech, Pharma and CMO/CRO

CommunityA Friendly,

Welcoming Event Which Fosters Networking &

Partnering

Make Efficient Use Of Limited Travel Budgets

By Meeting Your Suppliers All Under 1 Roof

Biotech & Pharma Package

£250 + VAT

Available to biotech and pharma delegates (non service providers only)

PackageCRO Sponsor Package

Silver Sponsor Package

Silver Sponsor Package

Banner Stand Exhibition Sponsor Package

Exhibition Sponsor Package

Exhibition Sponsor Package

Gold Sponsor Package

Key Sponsor

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

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

Price£1550 + VAT per delegate

£1800 + VAT

£2050 + VAT

£2500 + VAT

£2750+ VAT

£3000 + VAT

£4500 + VAT

Available on Request

£390 + VAT

£390 + VAT

FeaturesSingle delegate access to event and pre-event access to partnering software

Single delegate access to event and pre-event access to partnering software + Branding Package (see media pack for details)

X2 delegate access to event and pre-event access to partnering software + Branding Package (see media pack for details)

X2 delegate access to event and pre-event access to partnering software + Banner Stand + Branding Package (see media pack for full details)

X2 delegate access to event and pre-event access to partnering software + Stand (table top stand solution) + Branding Package (see media pack for details)

X3 delegate access to event and pre-event access to partnering software + Stand (table top stand solution) + Branding (see media pack for full details)

X3 delegate access to event and pre-event access to partnering software + 10 Minute Outsourcing Case Study Presentation + Stand (Table Top Stand Solution) + Branding (see media pack for full details)

Contact Bio2Business for a tailored package

Includes full access to event and full access to pre-event partnering software

Includes full access to event and full access to pre-event partnering software

Attend the new Pre-event workshop for a additional fee of £150 + VAT (price applies to all delegate types)

Book Now By:Registering Online: http://www.bio2bevents.com/bio2b-registration/registration

By Phone: +44 (0)207 691 3568 By Email: info@bio2business.com

Pre-event Wokshop: Biotech Outsourcing Strategies Workshop: Building Robust, Practical Contracts to Support Productive Outsourcing Partnerships16th September, 12 Noon to 6pm.

With support from Fasken Martineau LLP & 1to1to1 Ltd

PARTNER ING PRESENTAT ION EXHIB IT ION NETWORKING

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 2013 will feature Discovery/Early Development and Clinical Operations tracks creating more opportunities for interaction. As an attendee at BOS 2013 you can expect to develop your skills and build your outsourcing relationships all in a relaxed atmosphere.

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

Who should attend BOS 2013

BOS 2013 Discovery/Early Development

BOS 2013 Clinical Operations Outsourcing

10.00 Module 1 Chairman: Roger Joby, Managing Director, 1to1to1 Ltd.

10.00 A SMART approach: Innovations in early clinical development Dr Penelope Ward, Director, PWG Consulting (BioPharma) Ltd

10.30 How to get what you can’t afford? Obtaining therapeutic expertise through novel outsourcing Diane Chisholm, Director of

Clinical Operations , Fujifilm Kyowa Kirin Biologics Co. Ltd

11.00 Strengthening outsourcing partnerships through smart, robust, CRO auditing strategies Dr Amer Alghabban, Global

Director Research & Development and Good Vigilance Practice Quality

Assurance, Abbott Pharmaceuticals Operations

11.30 Gold Sponsor Outsourcing Case Studies

x3 Gold Sponsor Case Studies

11.30 Early phase clinical trials in patients – key success factors Dr Peter MacLennan, Director of Project Development and Scientific Affairs,

ORION Clinical Services

11.45 Meeting the challenges of the new USP regulatory guidance in elemental impurities testing Martin Westcott,

Business Development Manager, LGC

12.00 Lunch and partnering

13.30 Module 2 Chairman: Dr Stephen Greentree, Director Global Portfolio

Management, Biologics, Mylan GmbH

13.30 How is it possible to measure a productive outsourcing alliance? Sandra Johnson, Independent Outsourcing Specialist, Freelance

14.00 A perspective from Academia – Engaging with CROs for translational research grants Dr Jon Telfer, Translational Research

Manager, University College London

14.30 Effective project management strategies for remote site monitoring and vendor oversight - a specialty pharma perspective Sarah Deeley, Senior Clinical Scientist, Shire Pharmaceuticals

15.00 Gold Sponsor Outsourcing Case Studies

x3 Gold Sponsor Case Studies

15.00 Translational PharmaceuticsTM: a new platform to underpin early development Mark Egerton, Managing Director,

Quotient Clinical

15.15 Project Management in Clinical Research Roger Joby, Managing

Director, 1to1to1 Ltd

15.30 Refreshments and partnering

16.00 CMO & CRO Selection - Vendor selection strategies to maximise win/win outsourcing partnerships

Chairman: Keith Rodgers, Managing Director, Inspirexe Limited

Panel Member: Dr Lan Bandara, Director, Global Head of Clinical Outsourcing, EISAI Ltd

Panel Member: Dr Simon Cruwys, Senior Director, Head of Inflammation Pharmacology, Grunenthal GmbH

Panel Member: Dr Mary Vinson, Development Project Leader, Heptares

Panel Member: John MacDonald, VP Global Strategic Sales , ICON Clinical Research

17.00 Conference Close – Drinks Reception

“Good Opportunity to meet people and get an update, nice

and relaxed format”

Dr Hans Lindner,Head of Global Pharma Development, Bayer Schering Pharma AG (BOS cmc 16th June 2011)

“The meeting allows you to connect to people in an efficient

and open manner”

Prof Hans-Jurgen Federsel, Senior Principal Scientist, AstraZeneca (BOS cmc, 16th June, 2011)

“BOS cmc is a rare example of an event focused on partnering in outsourcing and

thereby attracts those function in Pharma & Biotech companies that we as a CMO

need to meet: a focused partnering event with excellent participation”

Dr Marcel Hogerheide,Senior Business Development Manager, Hovione (BOS cmc, 16th June, 2011)

Correct at date of print 31st July 2013

From CROs and CMO – business development, sales, marketing and corporate management functions

10.00 Discovery Module Chairman: Dr Phil Jones, Director, European Screening

Centre

10.00 European lead factory - a new, innovative model in collaborative drug discovery. Prof Echhard Ottow, Head Global

Innovation Sourcing, Global Drug Discovery, Bayer Pharma AG

10.30 Exploring the outsourced drug discovery model – what does “Virtual” R&D truly mean to biotech? Dr Matt Gregory, CEO,

Isomerase Therapeutics Ltd and Prof Hugh Marston, Head of Pharmacology, TPP

Global Development

11.00 Outsourcing discovery chemistry in emerging markets - managing the challenges Dr Joachim Demnitz, Former VP/Co-founder &

Head of External Chemistry, Aniona ApS (currently VP at Syngene)

11.30 Gold Sponsor Outsourcing Case Studies

x3 Gold Sponsor Case Studies

11.30 The European Lead Factory, the role of Syncom BV, one of the chemistry partners Dr Ton Vries, CEO, Syncom BV

11.45 Bachem’s products for research Dr Jean-Paul Hermet , Business

Development Manager , Bachem

12.00 Lunch and partnering

13.30 Early Development Module Chair: Sharon Grimster, Interim Operations

Director, DSM

13.30 Utilizing intelligent preclinical design to shape clinical studies to POC Dr Elizabeth Mortimer, Director, Toxicology, Neusentis

14.00 Leaner, faster, contract development and manufacturing? Opportunities and challenges of the small, virtual business model Ian Walker, Head of Project Leadership, Acacia Pharma

14.30 Formulating successful outsourcing partnership in early development - Case studies in drug product outsourcing Ian

Hayter, Director of Projects, Destiny Pharma Ltd.

15.00 Gold Sponsor Outsourcing Case Studies

x3 Gold Sponsor Case Studies

15.00 Special services at CARBOGEN AMCIS Jocelyn Saget, Sales

Manager, CARBOGEN AMCIS

15.10 Synthesis, solubilisation and formulation from a single source Dr Marcel Hogerheide, Business Development , Hovione

15.20 Bachem: specialties and technological expertises Dr Jean-Paul

Hermet, Business Development Manager, Bachem

15.30 Refreshments and partnering

12.00 Registration & Buffet Lunch

13.00 Set the scene: the role of the outsourcing contract in successful outsourcing partnerships, pitfalls to avoid and lessons to learn from other industries. Roger Joby, Managing Director, 1to1to1 Ltd

13.40 Preparing for the outsourcing contract, key considerations: pre-contract documentation, preferred supplier lists, RFPs, master agreements, SLAs, KPIs. Francesca Boateng-Muhammad, Senior Associate, Fasken Martineau LLP & 1to1to1 Ltd and Sharmela Thevarajaha, Associate, Fasken Martineau LLP & 1to1to1 Ltd

14.20 IP and the outsourcing contract: identifying and protecting intellectual property and know-how. Francesca Boateng-Muhammad, Senior Associate, Fasken Martineau LLP & 1to1to1 Ltdand Sharmela Thevarajaha, Associate, Fasken Martineau LLP & 1to1to1 Ltd

15.00 Coffee Break

15.30 Other risks and pitfalls to avoid in the outsourcing contract: data protection and other general outsourcing issues. Francesca Boateng-Muhammad, Senior Associate, Fasken Martineau LLP and Sharmela Thevarajaha, Associate, Fasken Martineau LLP & 1to1to1 Ltd

16.10 Understanding the impact of the Scope of Work (SoW): KPIs, performance management, and the outsourcing contract. Roger Joby, Managing Director, 1to1to1 Ltd

16.50 Case studies: interactive session pulling together salient points of the day. Roger Joby, Managing Director, 1to1to1 Ltd, Francesca Boateng-Muhammad, Senior Associate, Fasken Martineau LLP & 1to1to1 Ltd and Sharmela Thevarajaha, Associate, Fasken Martineau LLP & 1to1to1 Ltd

17.30 Workshop Attendee Closing Drinks Reception

08.00 Registration and Partnering

09.00 Masterclass/Workshop: PCMG support for preclinical/non clinical development Dr Lan Bandara, Director, Global Head of Clinical Outsourcing, EISAI Ltd

(taking place in the Council Chamber)