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

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

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 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

analytics, project managers, programme managers, outsourcing managers, contracts managers.

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

Gold Sponsor Outsourcing Case Studies

Confirmed Gold Sponsors: Carbogen AMCIS, Cambrex, Quotient Bioresearch

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

Gold Sponsor Outsourcing Case Studies

Confirmed Gold Sponsors: Recipharm, Hovione, Bachem

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

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

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

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)

08.00 Registration, Partnering & Stand Visits 09.00 Optional Masterclass’s

Correct at date of print 12th February 2013