Attending Biotech and Pharma
BOS clinical Programme
The BOS clinical lecture programme sets out to share knowledge and experience in a wide area of topics associated with clinical R&D outsourcing. In addition we also look for perspective from organizations with different business models from fully virtual start up biotech to the large pharmaceutical company with dedicated resource for clinical outsourcing.
The day's programme will commence with a talk from Dr Nuala Brennan, Pangenetics B.V who will discuss the specific challenges of taking monoclonal antibodies into first in man. UK based Dr Karen Maubach from BTG will then talk about some of the key factors influencing supplier identification within a medium sized biotech with multiply clinical projects. Before the coffee break Dr Tasmin Blagbrough from Lilly UK will talk about the importance of real time, transparent data in multi-centre clinical trials and some of the tools available to achieve this.
The Technology showcase will feature six leading CROs and give food for thought before the lunch break.
After the lunch and partnering meetings we are very pleased to welcome back Dr Eric Hurden who will pick up where he left off after last years well received talk and give an update on the Biogen CRM affiliate programme. From Switzerland's specialty pharma Debiopharm we then welcome Marc Caron who will provide his insight into outsourcing central lab for late clinical phases. Bringing the session to close Lola Tome from Antisoma will share her experiences in managing regulatory interactions with the FDA from a European biotech perspective.
| Provisional Programme: Biotech Outsourcing Strategies 2010: BOS clinical |
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| 08.00 - 09.30 | Registration, partnering & breakfast |
| 09.30 - 11.00 | Clinical Outsourcing Module (part 1)
Chair: Dr Penelope Ward, President, Clinical Research + Development, Chief Medical Officer, Glenmark Pharmaceuticals Ltd |
| 09.30 - 10.00 | FIM studies post TGN from a biotech perspective
Dr Nuala Brennan, VP Clinical Trial, PanGenetics BV |
| 10.00 - 10.30 | Partnering strategies in early clinical development - identifying and selecting vendors best suited to your organisation
Dr Karen Maubach, Franchise Leader and Group Manager of Project Management, BTG |
| 10.30 - 11.00 | Building effective relationships between the sponsor and supplier for phase I clinical trials
Dr Tamzin Blagbrough, European Outsourcing Co-ordinator, Lilly UK |
| 11.00 - 11.30 | Coffee Break & Partnering |
| 11.30 - 12.30 | Technology Showcase
Chair: Dr Anthony Walker, CEO, Alacrita Consulting (formerly CEO Onyvax) |
| 11.40 - 11.50 | Early phase studies - bridging the volunteer/patient gap
Dr John Shilingford, Global Head, Clinical Operatons, Averion International |
| 12.30 - 14.00 | Lunch & Partnering |
| 14.00 - 15.30 | Clinical Outsourcing Module (part 2)
Chair: Dr Rob Williams, Head of Nonclinical Operations & Chief Development Scientist, Cancer Research UK |
| 14.00 - 14.30 | New strategies for placing global clinical studies - the first 18 months; Strategic drivers 2007-2008; Development of the affiliate-based Clinical Research Manager role; Lessons learned 2009-2010
Dr Eric Hurden, Associate Director, Clinical Operations, Oncology, Biogen Idec |
| 14.30 - 15.00 | Central lab selection for late clinical phase development - outsourcing strategies and considerations for the best working relationships.
Dr Marc Caron, Outsourcing and Project Manager, Debiopharm |
| 15.00 - 15.30 | Key regulatory challenges and approaches for biotech when interacting with the FDA - perspective from a European biotech
Dr Lola Tome, Regulatory Affairs Manager, Antisoma |
| 15.30 - 16.00 | Coffee Break & Partnering |
| 16.00 - 17.00 | Clinical Development Case Studies
Chair: Dr Andrew Wood, Director, Idfac Limited |
| 16.00 - 16.30 | Early drug development - failure is not an option; maximizing proof of concept
Dr Andrew Baxendale, Development Director, Fulcrum Pharma |
| 16.30 - 17.00 | The challenges of project management in the biotech environment – not only in cricket is an all rounder necessary
Dr Sheila Weir, Head, Project Management, Newron Pharmaceuticals SA |
| 17.00 Onwards | Drinks Reception: College Garden |
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