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5th Annual Stability Testing (2011) Pp


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5th Annual Stability Testing (2011) Pp

  1. 1. 5th Annual Stability TestingBringing together the multiple facets of stability testing for improved efficacy and end product quality3rd – 4th November 2011, Visiongain Conference Centre, London, UK BOOK NOW! Key Speakers Dr Garry Scrivens, Senior Principal Scientist, Pfizer Dr Glen Hodge, Senior Principal Scientist, Pfizer Dr Simon Hicks, Senior Scientific Investigator, GlaxoSmithKline Dr Bernhard Helk, Section Head, Technology department, Novartis Dr Abigaill Moran, Deputy Manager and Pharmaceutical Asessor, Licencing Division, MHRA Dr Leonardo Allain, Research Fellow, Merck Dr Brett Cooper, Research Fellow, Merck Dr Alexander Pontius, Laboratory Head, Bayer Schering Pharma Sarah Hayter, Analytical Scientist, AstraZeneca Professor Pauline Rudd, Principal Investigator, National Institute for Bioprocessing Research and Training Dr Paul Matejtschuk, Principal Scientist, National Institute of Biological Standards and Control Dr Simon Gaisford, Senior Lecturer in Pharmaceutics, The School of Pharmacy, University of London Dr Paul Royall, Lecturer in Pharmaceutics, Kings College LondonAssociate Sponsor Organised By Driving the Industry Forward | www.futurepharmaus.comMedia Partners To Book Call: +44 (0) 20 7336 6100 |
  2. 2. Conference Introduction 5th Annual Stability Testing 3rd - 4th November 2011, London, UKDear Colleague, Associate Sponsor: harmaceutical companies are under intense pressure to provide safe, effective P Epichem offers a range of impurity and degradant standards for medicines for patient consumption while also maintaining adherence to stringent APIs and excipients, particularly for OTC and generic drugs. Many of regulatory and quality requirements. Stability testing is a highly integral part of these standards are hard to find or exclusive to Epichem and can be pharmaceutical product development which constitutes one of the fastest growing markets in the pharmaceutical and biotechnology sectors. supplied in multi-gram quantities to enable you to rapidly and cost effectively undertake stability testing for product development. Epichem’s laboratory n a state of affairs where the outcome of stability testing can have substantial I medical and financial implications it is important to consider the most comprehensive and systems have passed audits by four of the world’s top pharmaceutical companies and cost-effective approach to successful stability testing. and all standards are supplied with CoA and MSDS. Epichem also has considerable isiongain’s 5th Annual Stability Testing Conference will look at the stability of the V experience in the identification and synthesis of new impurities and degradants, and ingredients and overall product during different phases of the product lifecycle. can advise on methods to minimise their formation. By attending this event you will gain insight into the various aspects of stability testing ranging from updates on current guidelines, effective planning, methods For further information please visit: and regulatory requirements to evaluation of results, the case of biologics and the Media Partners: industry-hospital interface. Our conference will provide you with current essential information on the key issues surrounding stability testing via our expert speakers. is the leading industry-sponsored portal for the pharmaceutical sector. Supported by most of the leading Reasons to register today: pharmaceutical corporations, provides dynamic real-time news, • Receive an update on the WHO and ICH stability guidelines features, events listings and international jobs to industry professionals across Europe • earn strategies for effective planned stability testing at different stages of the L and the US. product life cycle For further information please email: • dapt your forced degradation studies: predicting stability rate data A BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY • xamine Quality by Design in the context of stability testing E WORLD. It is based and located in Warsaw, Poland. • onsider compliance of pharmaceutical product with regulatory requirements C Biotechnology World was founded in 2007 to provide the world’s biotech and pharma • ssess challenges in the stability testing of biologics: aggregation, denaturation, A information and market to make it universally accessible and useful for scientific oxidation and de-amination and business processes. Its first step to fulfilling that mission was building the • xplore analytical testing methods and specifications: focus on HPLC E BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in • iscuss how to effectively evaluate stability results D different channels. BIOTECHNOLOGY EUROPE offers companies completed internet • ain further insights in to outsourcing: the pros and cons G public relations, publication and marketing solutions. One of the mains goals of • nvestigate the pharma industry-hospital interface: what are the stability issues? I BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe to • tilise networking opportunities with diverse leaders U global biotechnology, pharmaceutical and life science activities. I look forward to meeting you at the conference For further information please visit: Future Pharmaceuticals has forged powerful relationships Driving the Industry Forward | Best regards with key industry leaders to provide a platform for successful brand recognition, and for senior decision-makers to have the means to procure and plan implementation strategies based on the topics covered. Positioned to be an authoritative resource within top pharma companies as well as small, specialty, and Nima Farah biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into a highly targeted and responsive audience, bridging the gap between the industries’ Conference Producer top issues and the solutions top-tier vendors can provide. For further information please visit: InPharm is the online platform for exclusive pharmaceutical news, comment, contracts, services, jobs and events and is Who should attend this conference? home to, Pharmafile and Pharmafocus. Presidents, Vice Presidents, Directors, Chief Executive Officers, Chief Scientific For further information please visit: Officers, Heads, Managers, Team Leaders, Researchers and Consultants of: • Stability Testing • Quality Assurance • Quality Control • Regulatory affairs • Research and Development Sponsorship and exhibition opportunities • Analytical Chemistry • Analytical Development This event offers a unique opportunity to meet and do business with some • Analytical Laboratory of the key players in the pharmaceutical and biotech industries. If you have • Contract Laboratory • Forced Degradation Studies a service or product to promote, you can do so at this event by: • Formulation Studies • Formulation Development • Hosting a networking drinks reception • Product Submission • Validation • Taking an exhibition space at the conference • Documentation and Technical writing • Advertising in the delegate documentation pack • Business Development • Project Management • Providing branded bags, pens, gifts, etc. • Product Development • Pharmaceutical & Biopharmaceutical Production If you would like more information on the range of sponsorship or • Product Lifecycle Management • Biologics exhibition possibilities for visiongains 5th Annual Stability Testing • Biosimilars Conference, please contact us: • Technical Operations Branded and Generic Pharmaceutical Companies,Contract Research Damian Gorman, +44 (0)20 7549 9934 Organisations/ Contract Manufacturing Organisations Drug Regulators, Academics & Government Bodies
  3. 3. Day 1 5th Annual Stability Testing Thursday 3rd November 2011 09:00 Registration and refreshments 12:40 Networking lunch 09:30 Opening address from the chair Dr Garry Scrivens Senior Principal Scientist 13:40 Quality by design applied to a stability Pfizer sensitive compound • Quality by design within pharmaceutical sciences 09:40 Forced degradation to develop stability • Target product profiles CASE STUDY indicating methods • Risk analysis at various stages of development • Overview of regulatory guidance • Formulation variables and effect on quality attributes • What are the appropriate conditions • Case study demonstration on a stability sensitive compound • Pitfalls of using excessive conditions Dr Brett Cooper • Making the link between forced degradation studies and stability data Research Fellow, Pharmaceutical Sciences Dr Simon Hicks Merck Senior Scientific Investigator GlaxoSmithKline 10:20 Increasing the reliability of shelf-life predictions 14:20 Prediction of aggregation propensities of from accelerated stability studies therapeutic proteins • hort (e.g. 2 week) accelerated stability studies can be used to predict S • Review of methods for in silico prediction of aggregation propensities shelf life much more than conventional approaches • ntroduction to the SAP (spatial aggregation propensity) technology, a I • Focuses on solid-state degradation – e.g. API, tablets and capsules (etc.) new technology developed at Novartis and MIT • rovides quantitative information on the temperature and humidity P • dentification hot-spots for aggregation based on the dynamic exposure I dependence of chemical degradation reactions of spatially-adjacent hydrophobic amino acids • an predict degradation rates in packaging such as blisters and bottles C • anking of monoclonal antibodies by SAP scoring and comparison of the R with and without dessicant as well as unpackaged products results with characterisation and long-term stability data • his approach has proven useful in a number of applications, e.g. setting T shelf-life, selecting packaging, assessing new formulations, excipient • emonstration of the utility of the SAP technology in protein engineering D compatibility studies, assessing stability impact of changes to API synthetic and in the design of antibody drug conjugates route, demonstrating equivalence between batches of API and drug product, Dr Bernhard Helk understanding impact of processing changes as part of QbD studies, Section Head, Technology Department inclusion in registration documentation as supportive data to minimalize Novartis stability commitment and as a post-approval change stability protocol • This approach is convenient, inexpensive and rapidly carried out 15:00 Afternoon refreshments Dr Garry Scrivens Senior Principal Scientist Pfizer 15:20 Sponsor Spotlight Session 11:00 Morning refreshments T ake this unique opportunity to be a part of the conference theme, network, share ideas and provide an overview of your 11:20 Novel thermal methods for stability testing of product/services to the audience. For more information please contact amorphous drugs and drug products • Relaxation rates of amorphous glasses • Crystallisation kinetics of glasses • tability testing of amorphous drug products (solid dispersions and oral films) S 16:00 Stability testing in early phase clinical studies • Amorphous content quantification • Considerations when assessing pre-clinical solution stability data • ach section with a focus on instrument selection and experimental best practice E • Assessing stability for simple, early phase clinical formulations Dr Simon Gaisford • reas for future improvement: predictive science and/or high A Senior Lecturer in Pharmaceutics throughput testing The School of Pharmacy, University of London Sarah Hayter 12:00 Stability studies: physical stability and extreme Senior Scientist Astrazeneca storage temperatures • Overview of physical stability: 16:40 Closing remarks from the chair - Physical process - Factors affecting stability across the product lifecycle • Extreme storage temperature-impact on stability testing • Summary 16:50 Networking drinks Dr Paul Royalll Take your discussions further and build new Lecturer in Pharmaceutics relationships in a relaxed and informal setting Kings College London Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2011
  4. 4. Day 2 5th Annual Stability Testing Friday 4th November 201109:00 Registration and refreshments 12:00 Assessing and assuring stability of biological reference materials09:30 Opening address from the chair • Role of biological reference materials • Freeze drying reference standards Dr Paul Matejtschuk • Impact of formulation & manufacture on stability Principal Scientist, Standardisation Science • Accelerated degradation testing & stability National Institute of Biological Standards and Control Dr Paul Matejtschuk Principal Scientist, Standardisation Science 09:40 Impact of contaminants on the stability of National Institute of Biological Standards and Control pharmaceutical products • Leachables: definition 12:40 Networking lunch • Overview of major leachables • Quality Problems 13:40 Relevance of in vitro dissolution testing for • Toxicological risk evaluating stability effects on new formulations Dr Leonardo Allain • Prerequisites for dissolution testing Research Fellow • Selection of dissolution method parameters Merck • Automated dissolution testing • Evaluating manufacturing process10:20 Potentially Genotoxic degradation products- • Evaluating effects during stability studies strategies for control in clinical drug products • Monitoring modification changes during storage • ey considerations for developing stability indicating methods for K Alexander Pontius potentially genotoxic degradation products Laboratory Head • helf life predictions in drug substances and drug products using S Bayer Schering Pharma accelerated stability assessments • Specification strategies for maximizing drug product shelf lives 14:20 A Regulator’s Perspective on Stability • Relevant case study examples • Clarifying ICH and CHMP guidelines for stability • dentifying common reasons for failure and for questions from I Dr Glen Hodge competent authorities Senior Principal Scientist • Outlining how to avoid problems with regulatory submissions Pfizer Dr Abigail Moran Deputy Manager and Pharmaceutical Assessor, Licensing Division 11:00 Morning refreshments MHRA11:20 A systematic approach to protein glycosylation 15:00 Afternoon refreshments analysis: a path through the maze • Basics of glycobiology • oles for glycosylation in determining the efficacy, pharmacokinetics, R 15:40 Sponsor Spotlight Session stability and safety of biological drugs T ake this unique opportunity to be a part of the conference • Factors that control glycosylation processing pathways theme, network, share ideas and provide an overview of your product/ • Rapid, detailed, quantitative glycan analysis at all stages of bioprocessing services to the audience. For more information please contact • pproaches to glycan analysis include mass spectrometry, capillary A electrophoresis and various HPLC techniques. The appropriate strategy depends on the information that is required • generic robotics HPLC platform has been designed to be rugged in terms of A 16:00 The pharma industry-hospital interface: what are cost, reliability, data interpretation and operator training. Data can be coupled the stability issues? with software and data bases for computer assisted data interpretation • Overview of challenges • he system can be used as a front end to many separations technologies to T • Prominent issues determine the factors that control glycosylation and glycoprotein integrity • Clinicans perspective Professor Pauline Rudd • Future: problem solving for patient benefit Principal Investigator National Institute for Bioprocessing, 16:40 Closing remarks from the chair Research and Training 16:50 End of conference
  5. 5. Registration Form 5th Annual Stability Testing 3rd - 4th November 2011, London, UK Angel Conf. code PP Pentonville Road 5th Annual Stability CiStandard Prices ty Testing Ro adConference only Fee: £1299 VAT: £259.80 Total: £1558.80 3rd - 4th November 2011 Old Street Location: Visiongain Conference Centre Old StreetNumber of bookings: Total cost: Address: 230 City Road City RoadPromotional Literature Distribution LondonDistribution of your company’s promotional literature to all conference attendees EC1V 2TT UK Fee: £999 VAT: £199.80 Total: £1198.80Details How to book Email: Forename: Surname: Web: UK Office:Job Title: Company: Tel: +44(0) 20 7549 9961 Fax: +44(0) 20 7549 9932 Main Switchboard Number: Visiongain Ltd 230 City Road Address: London EC1V 2QY UK General informationCountry: Postcode: Venue: Venue: Directions: Visiongain Conference Centre 230 City Road, London, EC1V 2TT. United Kingdom. Closest tube station is Old Street (Northern Line). Accommodation: Thistle City Barbican, Central Street, Clerkenwell, London, EC1V 8DS, Phone: 0871 376 Phone: Fax: 9004 / +44 845 305 8304, Fax: 0871 376 9104 / +44 845 305 8343 Travelodge London City Road Hotel, 7-12 City Road, London, EC1Y 1AE, Tel: 0871 984 6333, Fax: 0207 628 2503, Signature: Payment terms: Visiongain require the full amount to be paid before the conference. Visiongain Ltd may refuse entry to delegates who have not paid their invoice in full. A credit card guarantee may I confirm that I have read and agree to the terms and conditions of booking be requested if payment has not been received in full before the event. Visiongain Ltd reserves the right to charge interest on unpaid invoices. Substitutions/name changes or cancellations: There is a 50% liability on all bookings once Methods of payment made, whether by post, fax, email or web. There is a no refund policy for cancellations received on or Payment must be made in sterling after one month before the start of the event. Should you decide to cancel after this date, the full invoice must be paid. Conference notes will then be sent to you. Unfortunately, we are unable to transfer places By Mail: Complete and return your signed registration form together with your cheque payable between conferences. However, if you cannot attend the conference, you may make a substitution/name change at any time, as long as we are informed in writing by email, fax or post. Name changes and to Visiongain Ltd and send to: visiongain Ltd, BSG House, 226-236 City Road, London, EC1V 2QY, UK substitutions must be from the same company or organisation and are not transferable between By Fax: Complete and fax your signed registration form with your credit card details countries. Please note that discounted delegates places at a visiongain event are non refundable. Invoice alterations: There will be an administration charge of £50 for any changes to an invoice, to +44 (0) 20 7549 9932 excluding substitutions/name changes, requested by the customer. This will be charged to the By Phone: Call us on +44 (0) 20 7336 6100 with your credit card details customer by credit card prior to the changes being made. Indemnity: Visiongain Ltd reserves the right to make alterations to the conference/executive By Credit Card: Fill in your card details below and fax back to +44 (0) 20 7549 9932 briefing content, timing, speakers or venue without notice. The event may be postponed or cancelled due to unforeseen events beyond the control of visiongain Ltd. If such a situation arises, we will try By Bank Transfer: to reschedule the event. However, visiongain Ltd cannot be held responsible for any cost, damage or Visiongain Ltd A/C: visiongain Ltd expenses, which may be incurred by the customer as a consequence of the event being postponed or cancelled. We therefore strongly advise all our conference clients to take out insurance to cover the Barclays Bank Sort Code: 20-71-64 cost of the registration, travel and expenses.Piccadilly Branch Account No: 6038 7118 Data Protection: Visiongain Ltd gathers and manages data in accordance with the Data 48 Regent Street Swift Code: BARC GB22 Protection Act 1988. Your personal information contained in this form may be used to update you on visiongain Ltd products and services via post, telephone, fax or email, unless you state otherwise. We London, W1B 5RA IBAN: GB80 BARC 20716460387118 may also share your data with external companies offering complementary products or services. If you Please debit my credit card: wish for your details to be amended, suppressed or not passed on to any external third party, please send your request to the Database Manager, visiongain Ltd, BSG House, 226-236 City Road, London, Access MasterCard Visa American Express EC1V 2QY. Alternatively, you can visit our website at and amend your details. Please allow approximately 30 days for your removal or update request to be applied to our database. Following your removal or update request, you may receive additional pieces of communication from visiongain Ltd during the transitional period, whilst the changes are coming into effect.Card number: Fee: The conference fee includes lunch, refreshments and conference papers provided on the day. This fee does not include travel, hotel accommodation, transfers or insurance, (which we strongly recommend you obtain).Expiry Date: VAT: VAT will be charged at the local rate on each conference. Delegates may be able to recover VAT incurred by contacting Eurocash Corporation plc +44 (0) 1273 325000, Security number (last 3 digits on back of credit card): Eurocash specialise in recovering cross-border VAT. How we will contact you: Visiongain Ltd’s preferred method of communication is by email and Signature: phone. Please ensure that you complete the registration form in full so that we can contact you. Unable to attendCardholder’s name: Obviously nothing compares to being there but you need not miss out. Simply tick the box and send with your payment. You will receive speaker talks in PDFs two weeks after the event.News updates Yes, please send me speaker talks Price£550 VAT:£110 Total:£660Please tick if you do not want to receive email news updates in the future