Thursday, 19 April 2012
The Penridge Suite, 470 Bowes Road, London N11 1NL
Whilst biopharmaceuticals remain a major component of the global therapeutics market, the ever expanding portfolio of products losing patent protection and with increasing healthcare costs remaining a poignant issue, the opportunity for development of competing, follow on biologics remains an attractive proposition for both Biotech and Pharma companies alike. This Euroscicon biosimilars conference will focus on multiple aspects of biosimilar product development to successfully deliver safe, biosimilar products to the market place.
This event has CPD accreditation and will have a discussion panel session.
On registration you will be able to submit your questions to the panel that will be asked by the chair on the day of the event
Meeting Chair: Dave Simpson PhD, Director, Virodigm Ltd
9:00 – 9:45 Registration
9:45 – 10:00 Introduction by the Chair: Dave Simpson PhD, Director, Virodigm Ltd
10:00 – 10:30 Biosimilar Development: How do all the pieces fit together for registration in the EU.
Dr Anita Bate, Chief Scientific Officer, Eden Biodesign, UK
Development of any biological product through to registration is a multi-disciplinary excercise. Careful planning with all teams involved is required to ensure that the required elements for product registration are addressed. This presentation will provide a top level overview of how all the pieces fit together and some of the pitfalls to avoid along the way.
10:30 – 11:00 Process Development
Dr Gittan Gelius, Cobra Biologics, Germany
11:00 – 11:30 Speakers’ photo then mid-morning break and trade show
11:30 – 12:00 Device development for biosimilars
Andrew Pocock, Team Consulting Ltd, Cambridge, UK
12:00 – 13:00 Lunch and trade show
13:00 – 14:00 Question and Answer Session
Delegates will be asked to submit questions to a panel of experts. Questions can be submitted before the event or on the day
14:00 – 14:30 Analytical strategies
Dr Gerrard Powell, Senior Analytical Scientist Eden Biodesign
14:30 – 15:00 Afternoon Tea/Coffee and trade show
15:00 – 15:30 Biosimilars: Development Challenges and Considerations
Dr Raymond Donninger, Covance Inc, UK
Biosimilars are the next evolution in biopharmaceutical development and present unique challenges as well as opportunities. This talk focuses on the main considerations both in nonclinical and early clinical development of these compounds. The regulatory environment will also be discussed as this is a fundamental consideration in the development of any therapeutic product but in the field of biosimilars regulatory uncertainty drives a number of key challenges.
15:30– 16:00 Talk to be confirmed
16:00 – 16:30 Chairman’s summing up
Media partners
Dont forget to sign up to Euroscicons’ e-newsletter at www.euroscicon.com/signup.htm to keep up to date with European Life Science news and events and to be notified of the follow up to this event
This meeting was organised by Euroscicon (www.euroscicon.com), a team of dedicated professionals working for the continuous improvement of technical knowledge transfer to all scientists. Euroscicon believe that they can make a positive difference to the quality of science by providing cutting edge information on new technological advancements to the scientific community. This is provided via our exceptional services to individual scientists, research institutions and industry.
About the Chair
David’s background is in cell line, process and analytical development, Tech Transfer and manufacturing of clinical products. Formerly of Eden Biodesign, David led the process development capabilities and post-acquisition by Watson Pharmaceuticals led the development and manufacturing of a recombinant FSH biosimilar product. David now owns an independent consultancy supporting all aspects of biopharmaceutical product and commercial development needs.
About the Speakers
Anita Bate is a co-founder of Eden Biodesign and is responsible for ensuring that the company maintains its technical skills for product development. In addition she has overall responsibility for CMC technical regulatory and technical diligence activities. Anita has a very broad skill base having held senior positions in the pharmaceutical industry managing both process and analytical development groups. She has worked on over 60 wide ranging client projects for Eden Biodesign as both consultant and project manager and has particular expertise in development genetics, due diligence for in licensing, viral safety strategy and CMC technical regulatory affairs.
Andrew Pocock’s background is in industrial design and engineering having a 1st Class degree from Teesside Polytechnic, and a Master of Design from the Royal College of Art, London. With over 20 years’ experience in product development consulting, Andy has encountered a range of technical and user based design challenges across a range of industries. He was Director of the Design Research Centre before coming to Team as Senior Consultant in 2000. He has since managed major medical device projects for international clients, with a particular focus in drug delivery.
Raymond Donninger joined Covance in January 2008 as an Early Development Program Manager with a particular focus on large molecule programmes. He has been involved in drug development in various forms for 16 years and specifically biotechnology product development for the past 9 years.
His experience ranges from manufacturing through to marketing of biotechnology products. Raymond has spent 9 years working in the field of biosimilar therapeutic proteins and has development, clinical use and commercial experience with these compounds in developing and developed markets. He is currently managing 6 biosimilar early development programmes that include fully integrated programme design, CMC, toxicology and clinical aspects.
He has experience in the fields of therapeutic proteins, nucleic acid therapeutics, small peptides, immunotherapies, cell therapies, vaccines and biosimilars. He has been responsible for the design, monitoring and reporting of GCP clinical studies as well as providing input on early biotechnology product development strategies. Raymond holds a B.Sc. Honours degree in Medical Biochemistry, a Medical degree and a Masters degree in Business Administration.
Keywords: biopharmaceutical, drug delivery, Biosimilar, Regulatory, CMC,EU, Product registration, Biosimilars, Biologicals, Regulatory, Monoclonal antibodies
Registration Web Site: www.regonline.co.uk/biosimilars2012
Post expires at 4:06pm on Thursday April 19th, 2012
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