What You Can Expect From BOS cmc 2014

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 Outsourcing Strategies cmc 201412th June, Copenhagen

Early and late stage CMC outsourcing for small molecules and biopharmaceuticals

12th June, Crowne Plaza Copenhagen Towers, Copenhagen, Denmark Including small molecule & biologics tracks (Pre-event Workshop 11th June)

Jesper ValbjornVP CMC, Genmab A/S

Dr Ulrich RuemenappContract Manufacturing Biotech, Head Biotech Projects, Bayer Pharma AG

Dr Rene HolmDivisional DirectorBiologics and Pharmaceutical Science, H.Lundbeck A/S

Dr Paul Little Director of CMC and Pre-clinical Development, Orphazyme

Alex Robertson Director, Sourcing, AstraZeneca

Dr Christoph Rosenbohm, Senior Director, Research Operations, Santaris Pharma A/S

Insight from expert speakers

including;

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

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

Small Molecule Drug Substance Outsourcing Chaired by Dr Signe Maria Christensen, R&D Outsourcing Manager, Leo Pharma A/S

10.00 Strategies for supplier selection and management through development Alex Robertson, Director, Sourcing, AstraZeneca

10.30 Enhancing value through smart CMC: A case study in building a robust package for acquisition, Maarten van Geffen, VP CMC, Operations & Quality, Amakem Therapeutics NV

11.00 API sourcing in emerging economies - managing the challenges, maximising benefits Dr Christoph Rosenbohm, Senior Director, Research Operations, Santaris Pharma A/S

11.30 Custom development and manufacturing capabilities at Cambrex, Sören Olsson, Director, New Products, Cambrex Karlskoga

11.40 Particle engineering: bridging between drug substance and formulation development Dr Marcel Hogerheide, Head of Business Development, Europe & Asia Pacific, Hovione

11.50 Chromatography vs crystallization – purifying your API, Dr Alexander Straetz, Sales Manager, CARBOGEN AMCIS Ren

12.00 Lunch and partnering

Small Molecule Drug Product Outsourcing Chaired by Dr Hasse Kromann, Head of Partnership Management, Research & Innovation, Leo Pharma A/S

13.30 Formulation Strategies for Low Soluble Drugs - an overview Dr René Holm, Divisional Director, , Biologics and Pharmaceutical Science, H.Lundbeck A/S

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

14.30 Application of QbD principles in formulation and process development and optimization of solids Dr Martin Schubert, Director and Head of Chemical Pharmaceutical Development, UCB Pharma SA

15.00 Life cycle management opportunities in softgel technologies; how could your product benefit from this versatile dosage form? Dr Kaspar van den Dries, R&D Director, Patheon

15.10 Processing highly potent small molecules Dr Jérôme Detreille, Senior Director New Business Development, Penn Pharma

15.20 Intelligent use of analytical tools – a CMC case study Andrew Maitland, Business Development Manager, Drug Development Services, LGC

15.30 Refreshments and partnering

08.00 Registration and Partnering

09.00 Masterclass/Workshop: Topic TBC

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. Located in Copenhagen, a key international pharmaceutical and biotech hub, attendee’s at BOS cmc Copenhagen 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 Copenhagen?

Pre-event Wokshop: Biotech Outsourcing Strategies Workshop: Developments in Solid State R&D (Workshop led by Gerry Steele, Founder, PharmaCryst Ltd)

11th June, 12 Noon to 6pm.

12.00 Registration & Buffet Lunch

13.00 What Physico-Chemical Data is Needed to Develop an API into a Drug Product? Basic physico-chemical such as pKa, solubility and stability data needed for salt/co-crystal screening. Solid-state issues, such as polymorphism/hydrates etc. Analytical techniques for their analysis, e.g. X-Ray, thermal, spectroscopic and moisture sorption methods Dr Kurt Voegtli, Scientific Specialist, CARBOGEN AMCIS

13.35 Advances in Salt/Co-Crystal and Solid Form Selection Studies: High throughput salt and polymorph screening techniques crystallisation conditions and equipment. Solid-state analysis, informatics and data visualisation.

14.10 Case Study 1 A detailed case study will be used to highlight key themes of this 1st session with the audience working in groups to propose a programme of work for a follow up compound.

15.00 Coffee Break

15.30 The importance of solid state data in the development of an appropriate early phase formulation Dr Noel Hamill, Investigator, Physical Sciences, Almac Sciences.

16.10 Applying QbD to the Complexities of Solid State R&D ICH Q11. Definition of critical quality attributes, linking material attributes and process parameters to drug substance CQAs, process design space, crystallisation, use of process analytical technologies (PAT), design of experiments etc.

16.50 Case Study 2: Groups will work on manufacturing strategies to overcome the challenges which this case study presented. Mock quality risk assessment (QRA) and proposals of experimentation to be undertaken.

17.30 Workshop Close & Drinks Reception (for workshop attendees)

BOS cmc 2014 Small Molecule Programme

BOS cmc 2014 Biologics Programme

“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)

“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)

Correct at date of print 20th October 2013

Here are some comments from past attendees...

Introduction to BOS cmc Copenhagen and to the BOS Events Formula

16.00 Exploring the secret to sustainable, productive outsourcing partnerships. Perspectives on what makes a partnership work.

Chairman: Eva Iden, Owner, Better and Beyond AB

Panel Member: Dr Paul Little, Director of CMC and Pre-clinical Development, Orphazyme

Panel Member: Dr Signe Maria Christensen, R&D Outsourcing Manager, Leo Pharma A/S

Panel Member: Dr Juergen Stichler, Director, Group Leader Drug Substance Operations, Actelion Pharmaceuticals

17.00 Conference Close – Drinks Reception

Biologics Drug Substance Outsourcing Chaired by Kim Hejnaes, CEO, Hejnaes Consult

10.00 Ensuring the right match for your company and your project - strategies to ensure a productive partnership in early scale up (due diligence/selection strategies/vendor management) Dr Amer Alghabban, Global Director Research & Development and Good Vigilance Practice Quality Assurance, Abbott Pharmaceuticals Operations

10.30 Antibody Drug Conjugates - challenges in establishing an effective drug supply chain Jesper Valbjorn, VP CMC, Genmab A/S

11.00 Minimising risk and ensuring IP protection when outsourcing Dr Ulrich Ruemenapp, Contract Manufacturing Biotech, Head Biotech Projects, Bayer Pharma AG

11.30 Gallus overview Cory Pigeon, Business Development Director, Gallus BioPharmaceuticals

11.45 Creating the building blocks for a state-of-the-art cell culture CDMO offering Dr Daniel Ozanne, Senior Commercial Development Manager, Fujifilm Diosynth Biotechnologies

12.00 Lunch and partnering

Biologics Drug Product Outsourcing Chair: Dr Stephan Christgau, Investment Director, Novo Seeds

13.30 Intellectual property protection in India: What has to be considered? Prof Rolf G Werner, Professorship for Industrial Biotechnology, Eberhard Karls University of Tuebingen, Germany

14.00 Regulatory challenges and support for SME companies Dr Mary Reilly, VP Pharma Development & Operations, Opsona Therapeutics

14.30 Managing QbD in Outsourced Products Dr Rikke Morkeberg, Director Drug Development, Alk Abello

15.00 Monoclonal antibody process development and manufacture Dr Gittan Gelius, Principal Scientist, Cobra Biologics

15.15 Making mammalian manufacturing flexible, faster and more cost efficient Dr Annika Shirleys, New Business Development Director, Patheon

15.30 Refreshments and partnering