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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: [email protected]
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)