Biotech Outsourcing Strategies cmc 2013 Early and late stage CMC outsourcing for small molecules and biopharmaceuticals Ulrich Ruemenapp Contract Manufacturing Biotech, Head Biotech Projects, Bayer Pharma AG Insight from expert speakers including; 13th June, Crowne Plaza Copenhagen Towers, Copenhagen, Denmark Including small molecule & biologics tracks (Pre-event Workshop 12th June) Hans Lindner Head of External Technology & Innovation, Bayer Pharma AG Henrik Naested Head of Manufacturing, Symphogen A/S Amer Alghabban Director of Global Quality Assurance Auditing, Merck Serono S.A Maarten van Geffen Head of CMC and Operations, Amakem Therapeutics NV Frederik Beck CMC Outsourcing Manager, Zealand Pharma A/S What You Can Expect From BOS cmc 2013 Key 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 CMC Technical Operations 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 Community A 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) Package CRO 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 Features Single 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]
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Biotech Outsourcing Strategies cmc 2013 · PARTNERING PRESENTATION EXHIBITION NETWORKING Launched in 2006 BOS Events are niche, outsourcing focused partnering events for the biotech,
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Biotech Outsourcing Strategies cmc 2013Early and late stage CMC outsourcing for small molecules and biopharmaceuticals
Ulrich RuemenappContract Manufacturing Biotech, Head Biotech Projects, Bayer Pharma AG
Insight from expert speakers
including;
13th June, Crowne Plaza Copenhagen Towers, Copenhagen, Denmark Including small molecule & biologics tracks (Pre-event Workshop 12th June)
Hans LindnerHead of External Technology & Innovation, Bayer Pharma AG
Henrik NaestedHead of Manufacturing, Symphogen A/S
Amer AlghabbanDirector of Global Quality Assurance Auditing, Merck Serono S.A
Maarten van GeffenHead of CMC and Operations, Amakem Therapeutics NV
Frederik BeckCMC Outsourcing Manager, Zealand Pharma A/S
What You Can Expect From BOS cmc 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
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
Pre-event Wokshop: Biotech Outsourcing Strategies Workshop: Building Robust, Practical Contracts to Support Productive Outsourcing Partnerships12th June, 12 Noon to 6pm.
12.00 Registration Lunch and Networking
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 Fasken Martineau
14.20 IP and the Outsourcing Contract: identifying and protecting intellectual property and know-how, Fasken Martineau
3.00 to 3.30 Coffee & Networking
15.30 Other Risks and Pitfalls to Avoid in the Outsourcing Contract: data protection , liability, security of supply and other general outsourcing issues, Fasken Martineau
16.10 The contract as a force for good! KPI’s, 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, looking at some model contracts and working through problem contracts All
5.30 Drinks Reception
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 cmc 2013 will feature small molecule and biologics speaker tracks creating more opportunities for interaction. As an attendee at BOS cmc 2013 you can expect to develop your skills and build your outsourcing relationships all in a relaxed atmosphere.
From Biotech & Pharma: Executives involved in the following disciplines: lead optimisation, early scale up, scale up, pre-clinical development, pre-formulation, formulation, CMC, regulatory affairs, clinical CMC development, drug product, drug substance, drug
From CROs and CMO – business development, sales, marketing and corporate management functions.
Who should attend BOS cmc 2013 ?
BOS cmc 2013 Small Molecule Programme
BOS cmc 2013 Biologics Programme
10.00 Small Molecule Drug Substance Outsourcing Chaired by Christoph Rosenbohm, Senior Director, Research Operations, Santaris Pharma A/S
10.00 Defining your API sourcing strategy in early stage development Dr Paul Deutsch, Head of Chemical Process Development, UCB Pharma SA
10.30 Successful development in a virtual pharma environment Maarten van Geffen, Head of CMC and Operations, Amakem Therapeutics NV
11.00 Building sustainable outsourcing partnerships through effective relationship management Gordon Ewart, Senior Director, Head of Global Relationship Management, Shire Pharmaceuticals
11.30 Special services at CARBOGEN AMCIS Dr Alexander Strätz, Sales Manager, CARBOGEN AMCIS
11.40 High potency development and manufacturing at Cambrex Sören Olsson, Director, New Products|Cambrex Karlskoga, Cambrex Karlskoga
11.50 TBC Dr Spoorthi Dharmayat, Principal Scientist, LGC
12.00 Lunch, partnering and stand visits
13.30 Small Molecule Drug Product Outsourcing Chaired by Giles Breault, Ex-Global Head of Productivity and Business Services,
Novartis
13.30 Phase I formulation strategies - selecting the appropriate oral dosage forms in early stage clinical trials Dr Rudolf Hausmann, Director Technical Development & Operations, Santhera Pharmaceuticals Ltd
14.00 Creating a development path for peptide drugs: a biotech case study outlining the development and outsourcing approaches for a clinical development candidate Dr Frederic Beck, CMC Outsourcing Manager, Zealand Pharma
14.30 Ensuring Quality in Drug Product outsourcing Katrine Thor Andersen, Owner and Sr. Consultant,. PharmaAcross Consulting ApS
15.00 Selecting CDMO for development with commercial manufacturing in mind David Lindholm, Nordic Business Manager, Recipharm AB
15.10 Synthesis, Solubilisation and Formulation from a Single Source Dr Marcel Hogerheide, Business Development Exclusives and Particle Design, Hovione
15.20 TBC Dr Jean Paul Hermet, Business Development Manager, Bachem
15.30 Coffee, Partnering and Stand Visits
10.00 Biologics Drug Substance Outsourcing Chair, Dr Amer
Alghabban, Director, Global Quality Assurance Auditing, Merck Serono
10.00 Defining your sourcing strategy: When to outsource and when to keep in house Ulrich Ruemenapp, Contract Manufacturing Biotech,
Head Biotech Projects, Bayer Pharma AG
10.30 Tech Transfer - Effectively managing the transition from in-house discovery to outsourced early scale up in a biotech setting Peter Horrocks, Group Leader BioProcess Development, Syntaxin Ltd
11.00 Innovative models in biologics outsourcing Edward van Wezel,
Managing Partner, BioGeneration Ventures
11.30 Gold Sponsor Outsourcing Case Studies
12.00 Lunch, partnering and stand visits
13.30 Biologics Drug Product Outsourcing Chaired by Jesper Valbjorn,
VP CMC Operations, Genmab A/S
13.30 Strengthening outsourcing partnerships through smart, robust CMO auditing strategies Dr Amer Alghabban, Director, Global Quality
Assurance Auditing, Merck Serono
14.00 Working in partnership with CMOs to overcome complex analytical challenges - specific and unique challenges presented by recombinant antibody mixtures Dr Henrik Naested,
Team Manager, Manufacturing, Symphogen A/S
14.30 Outsourcing Biologics Drug Product Development – selecting the right fit for your project Dr Rikke Bolding Jensen, CMC Team
Leader / Dr Allan Hey, Senior CMC Project Manager, Takeda Nycomed
15.00 Gold Sponsor Outsourcing Case Studies
Confirmed Gold Sponsors: Cobra Biologics
15.00 TBC Ola Tuvesson, Head of Operations, Cobra Biologics AB
15.30 Coffee, Partnering and Stand Visits
Chair: Maarten van Geffen, Head of CMC and Operations, Amakem Therapeutics NV
Panel Including: Hans Lindner, Head of External Technology & Innovation, Bayer Pharma AG Karsten Lindhardt, VP R&D, Site Head, Egalet Ltd Ulrich Ruemenapp, Contract Manufacturing Biotech, Head Biotech Projects, Bayer Pharma AG Dr Marcel Hogerheide, Business Development Exclusives and Particle Design, Hovione
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