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: [email protected]
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