Thursday, 16 May 2013
The Stevenage Bioscience Catalyst, United Kingdom
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. However, as these biosimilar markets are captured how we manage the life cycle of these products and target specific patient and commercial benefits to maximise our product development strategies becomes increasingly important.
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
Who should attend
Specialists in regulatory strategy and affairs, Biopharmaceutical developers/manufacturers including analytics/characterisation, marketing professionals, product enabling technology development companies
Meeting Chair: Dave Simpson PhD, Director, Virodigm Ltd
This event is part of the 2013 Euroscicon BioTherapeutics Week,
to find out more see www.biotherapeutics2013.com
9:00 – 9:45 Registration
9:45 – 10:00 Introduction by the Chairs: Dave Simpson PhD, Director, Virodigm Ltd
10:00 – 10:30 Novel Substituable Glycans in Biobetter Development
Jenny Thirlway, Glythera
With multiple products facing the prospect of market erosion as they approach their patent cliffs, efforts have increased to capture markets through development of biosimilars or through further improvement to the originator into next generation products. Half-life extension using PEGylation or cell lines / strains developed to modulate naturally occurring N-linked glycans have enjoyed notable success however, the latter can often be difficult to control during scaled up production. More recent strategies have included the direct substitution of the natural glycan with a modified version resulting in a similar product profile to the originator, characterisable by the same methods.
10:30 – 11:00 Critical steps in the development of Biosimilars
Dr Robert E. Zoubek, Formycon AG, Germany
The proof of safety and efficacy of a Biosimilar is demonstrated by its comparability to the reference medicinal product in extensive biochemical and specially designed non-clinical and clinical studies. Therefore, Biosimilar development differs from the development of Novel Biopharmaceuticals and its requirements on the Chemistry and Manufacturing Control (CMC) exceed those of Novel pharmaceuticals.
11:00 – 11:30 Speakers’ photo then mid-morning break and trade show
Please try to visit all the exhibition stands during your day at this event. Not only do our sponsors enable Euroscicon to keep the registration fees competitive, but they are also here specifically to talk to you
11:30 – 12:00 Biosimilars: The Race to Market and Cost Mitigation
Adam Bentley, Eden Biodesign, UK
12:00 – 12:30 Rational design of biobetters
Manuel Carballo-Amador, Faculty of Life Sciences, University of Manchester, UK.
Protein design is a potent approach for improving protein physicochemical properties with potential consequences for stability, activity, and solubility of proteins. Protein solubility plays an important role for recombinant therapeutic proteins during protein expression, purification, long-term storage and drug administration. Based on protein structure, Chan and Warwicker developed an algorithm to predict protein solubility, defining polar and non-polar patches on the protein surface. Using this algorithm, we predicted amino acid changes that would facilitate expression of forms of human erythropoietin (HuEPO) of directed solubility in E. coli. We found that a single point mutation (changing a single amino acid from positive to negative charge) verified the predicted effect on HuEPO solubility (the distribution between soluble and inclusion body fractions) in three different E. coli strains (Bl21 (DE3), CodonPlus and SHuffle). Further application of this algorithm will provide a powerful tool for the design of biobetters, with enhanced solubility and stability.
12:30 – 13:30 Lunch and trade show
Please try to visit all the exhibition stands during your day at this event. Not only do our sponsors enable Euroscicon to keep the registration fees competitive, but they are also here specifically to talk to you
13:30 – 15:30 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 plus Afternoon Tea/Coffee and trade show
15:00– 15:30 To be confirmed
Dr Ji-won Choi, Polytherics¸UK
15:30 - 16:00 Afternoon break and trade show
16: 00 - 16:30 Molecular Characterization of Biotherapeutics: Possibilities and Practicalities
Eric Chang,Faculty of Life Sciences, University of Manchester, Michael Smith Building, Oxford Road, M13 9PT, UK.
The molecular characterization of protein therapeutics is very difficult due to the presence of a wide variety of post-translational modifications. Two of the main tools available for biopharmaceutical analytics are chromatography and mass spectrometry. In this presentation, we describe our work applying these approaches, especially with a view to the investigation of modifications such as phosphorylation, methylation, methionine oxidation, glycosylation and other charge variants.
16: 00 - 16:30 Regulatory & Clinical Development Considerations for Biosimilars
The idea is to provide background to the legislation and guidance, followed by discussion of some of the typical development challenges and decisions.
16:30 Chairman’s summing up
The Deadline for abstract submissions for oral presentation is July 10th 2013
Abstracts for poster presentation only can be submitted up to two weeks before the event
There will be a best poster prize.
You can download the instructions for authors at
www.euroscicon.com/AbstractsForOralAndPosterPresentation.pdf
Keywords: biopharmaceutical, drug delivery, Biosimilar, Regulatory, CMC,EU, Product registration, Biosimilars, Biologicals, Regulatory, Monoclonal antibodies, process development, automation, cell line, bioreactor, Characterisation, Biosimilarity, Comparability,biobetters, next generation biologics, technologies,CMC, Biosimilar, Comparability, Similarity, CTD,Biobetter, enabling, technologies, glycan, characterization, chromatography, mass spectrometry, post-translational modifications, variants
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
Gerry McGettigan, a molecular biologist, has twenty years’ experience in the biotechnology and pharmaceutical industries, in regulatory affairs, clinical development and business development. He has worked with large and medium pharma companies (Almirall and Glaxo) and was Regulatory & Scientific Affairs Director of The Liposome Company, a US biotechnology firm.
He founded the European regulatory affairs and product development consultancy company, GMG BioBusiness Ltd, which was sold to a top 5 CRO in 2005. He also set up and was CEO of the Catalan biotechnology development agency, Biocat. Gerry has worked directly with many clients on projects ranging from early stage regulatory strategy and complex biotechnology products, to MAAs for novel healthcare products.
Gerry has excellent relationships with top level business, science and governmental executives. Gerry is a member of TRI Cap, a group of independent investors, through which he invests in biotech / pharma and other companies. Gerry is Non-Executive Director of two biotech companies, Syntropharma and Biopta.
Robert Zoubek is Director for Scientific Affairs at Formycon, a company which offers and performs Biosimilar development since 2003 (formerly as Scil Biopharma Services). As a passionate biochemist with more than 10 years of experience in protein chemistry, he squired numerous development projects thus knowing the needs in biosimilar development. Robert studied biology at the LMU Munich and business administration at the University of Manchester. He attained his PhD from the Medical School of Erlangen for his studies on therapeutic peptides. After the following postdoc fellowship he joined GlycoForm in Abingdon/ UK, where he developed platform technologies for Biobetters. Robert joined Formycon (former Scil Technology) in 2009. He supervised the analytical laboratories and implemented new sensitive methods for protein characterisation and comparability exercises.
Eric Chang is a PhD student in Biotechnology at the University of Manchester working with Prof Alan Dickson, Dr David Knight and Dr Kenneth Cook. He is sponsored by Dionex of Thermo Scientific. His work involves the characterisation of therapeutic proteins.
Having completed a biochemistry PhD at the University of Nottingham, Jenny Thirlway began a Post Doc at the University of Manchester studying Calcium Dependent Antibiotics from S. coelicolor. Jenny then joined Eden Biodesign where she was responsible for the cell line / strain and fermentation development teams. Post-acquisition by Watson Pharmaceutical (now Actavis) she was involved in development, scale up and manufacture of an FSH biosimilar product. Jenny joined Glythera immediately after an investment of £2M to spin the company out from Bath University and now oversees the development of Glythera’s core technologies centred on stable linker and glycan chemistries.
Event Web Site: www.regonline.co.uk/biosimilar2013
Post expires at 11:13am on Thursday May 16th, 2013
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