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Amorphous Pharmaceutical Materials 2010

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Reasons to register today: …

Reasons to register today:
• Understand the use of isothermal calorimetry to characterise stability of amorphous pharmaceuticals
• Implement the latest technological developments
• Discuss the best approaches to control and stabilise amorphous drug forms
• Examine the quantification of amorphous content
• Gain a clearer insight on amorphous food materials
• Seize this opportunity to network with leaders from pharma-biotech, healthcare and regulatory agencies


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  • 1. Amorphous Pharmaceutical Materials Assessing emerging applications, methodologies, techniques and challenges 14th - 15th June 2010, BSG Conference Centre, London, UK BOOK NOW! Key Speakers Ljiljana Harding, Inhalation & Devices Centre of Emphasis, Pfizer Franco Sartor, Principal scientist , GlaxoSmithKline Sigrid Stokbroekx, Research Fellow, Johnson & Johnson Pharmaceutical R&D Dr. Rolf Hilfiker, Vice President Head of Department Solid-State Development, Solvias Roger Parker, Senior Scientist, Food Structure and Health Programme, Institute of Food Research Dr. Simon Gaisford, Senior Lecturer in Pharmaceutics, The School of Pharmacy, University of London Mark Saunders, Owner, co-founder and Development Director, Kuecept Robert Whittock, IP/IT Practice Group, Freshfields Bruckhaus Deringer LLP Wouter Pors, Attorney, Bird & Bird Michael Gamlen, Managing Director, Pharmaceutical Development Services Prof. Graham Buckton, Chief Executive Officer, Pharmaterials Driving the Industry Forward | www.futurepharmaus.com Media Partners Organised To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/amorphouspharma
  • 2. Conference Introduction Amorphous Pharmaceutical Materials 14th – 15th June 2010, London, UK Dear Colleague, Media Partners: With the continuous increase in the number of insoluble developmental drug PharmiWeb.com is the leading industry-sponsored portal for molecules and growing regulatory scrutiny over pharmaceutical solids, the use of the pharmaceutical sector. Supported by most of the leading amorphous solids is steadily rising in the pharmaceutical companies. pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, This conference combines presentations on the approaches to amorphous events listings and international jobs to industry professionals across Europe and the US. detection and quantitation within GSK, and clinical advice and practical tips For further information please email: corporate@pharmiweb.com from Pfizer and Johnson & Johnson. The biopharmaceutical implications for BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. development of amorphous solid solution intermediates will be discussed and It is based and located in Warsaw, Poland. Biotechnology World was strategies to protect and commercialise innovations in amorphous materials will founded in 2007 to provide the world’s biotech and pharma information and market to be presented. make it universally accessible and useful for scientific and business processes. Its first step During the two days you will be exposed to several analytical strategies to protect to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will and commercialise innovations in amorphous materials. Visiongain’s Amorphous allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers Pharmaceutical conference will provide an enlightening and thought-provoking companies completed internet public relations, publication and marketing solutions. One of forum with a series of case studies ranging from amorphous formulation to novel the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector amorphous microparticle technology. in Europe to global biotechnology, pharmaceutical and life science activities. For further information please visit www.biotechnology-europe.com Reasons to register today: Future Pharmaceuticals has forged powerful relationships with Driving the Industry Forward | www.futurepharmaus.com • Understand the use of isothermal calorimetry to characterise stability of key industry leaders to provide a platform for successful brand amorphous pharmaceuticals recognition, and for senior decision-makers to have the means to procure and plan • Implement the latest technological developments implementation strategies based on the topics covered. Positioned to be an authoritative resource within top pharma companies as well as small, specialty, and biotech, Future • Discuss the best approaches to control and stabilise amorphous drug forms Pharmaceuticals magazine is geared to create a deep penetration into a highly targeted • Examine the quantification of amorphous content and responsive audience, bridging the gap between the industries’ top issues and the • Gain a clearer insight on amorphous food materials solutions top-tier vendors can provide. • Seize this opportunity to network with leaders from pharma-biotech, For further information please visit: www.futurepharmaus.com healthcare and regulatory agencies InPharm is the online platform for exclusive pharmaceutical news, I look forward to meeting you at the conference comment, contracts, services, jobs and events and is home to InPharmjobs.com, Pharmafile and Pharmafocus. Best regards For further information please visit: www.In-Pharm.com ‘Pharma Connections Worldwide® is the leading professional business networking website focused in the Pharmaceutical, Pranita Nangia Biotechnology and Life Sciences research industry. Our goal is to provide a conduit for Conference Producer delivery of premiere content coupled with the right clientele in order to facilitate business development opportunities among industry professionals responsible for making key decisions in a global marketplace. ‘ For further information please visit: www.pharmaconnections.com Who should attend? VPs, Directors, Heads and Managers of: About Visiongain: Visiongain is a specialist business information company focused on providing cutting edge • Stability / Stability testing products and services across the Pharmaceutical/Biotech, Telecommunications, Defence • Pre-formulation and Finance sectors, which include reports, conferences, online daily news and offline • Solid State Chemistry news analysis and bespoke consultancy. With a commitment to innovation and excellence, visiongain offers flexible solutions to meet our clients’ business intelligence needs, providing • Formulation the right information at the right time to facilitate the commercial decision-making process. Our • Crystallisation pharmaceutical products include Pharma Business Daily, the leading daily email newsletter for the pharmaceutical, biotech and healthcare industries, and a range of independent, high-quality, • Drug Discovery in-depth reports covering focused and topical areas of concern. Our pharmaceutical conferences • Drug Delivery address the hottest commercial, regulatory and technical topics and provide an ideal forum for • Analytical methods / development debate and networking for pharmaceutical professionals from around the world. For further information, please visit: www.visiongain.com • API Development • Validation • Pharmacokinetics Sponsorship and exhibition opportunities: • Quality Control This event offers a unique opportunity to meet and do business with some • R&D of the key players in the pharmaceutical and biotech industries. If you have a service or product to promote, you can do so at this event by: • Product Submission • Hosting a networking drinks reception • Research and Development • Taking an exhibition space at the conference • Materials Science • Advertising in the delegate documentation pack • Technical Operations • Providing branded bags, pens, gifts, etc. If you would like more information on the range of sponsorship or exhibition • Statistical Sciences possibilities for visiongain's Amorphous Pharmaceutical Materials, please • Manufacturing Science contact us: • Regulatory affairs Ronald Magali, +44 (0)20 7549 9934 • Particle Engineering ronald.magali@visiongainglobal.com • Product Design Emma Thomas, +44 (0) 20 7549 1943 • Business Development emma.thomas@visiongainglobal.com
  • 3. Day 1 Amorphous Pharmaceutical Materials Monday 14th June 2010, London, UK 09:30 Registration and refreshments 13:10 Networking lunch 10:00 Opening address from the chair 14:30 Stable amorphous dispersions – science, formulation and manufacturing method 10:10 Amorphous content: Quantification in drug • Methods of manufacture and the importance for stability substance and drug product • Relaxation of bulk and surface • Ways to trace amorphous content in crystalline solids • Intentional and accidental amorphous materials • Ways to trace amorphous content in formulated products • Use of NIR, IGC, and thermal methods • Micronisation and amorphisation • The value of Raman mapping • Impact on drug substance properties Prof. Graham Buckton Dr Rolf Hilfiker Chief Executive Officer Vice President, Head of Department Solid-State Development Pharmaterials Solvias 15:10 Strategies to protect and commercialise innovations 10:50 Biopharmaceutical implications for development in amorphous materials of amorphous solid solution intermediates • How to draft for existing active ingredients • Why amorphous solid dispersions / solutions • Create a return on investments and maintain market position • Current in vitro testing strategies • Effective enforcement • Physiology of the gastrointestinal tract and its relevance to oral delivery of poorly soluble compounds Wouter Pors  • Case Study: novel amorphous microparticle technology for targeted Attorney at law drug delivery Bird & Bird Mark Saunders Owner, co-founder and Development Director 15:50 Afternoon refreshments Kuecept 16:10 Patents - amorphous materials & formulations 11:30 Morning refreshments • Satisfying patentability requirements • Practical advice to drafting strong claims 11:50 Approach to amorphous detection and  • Assessing infringement quantitation within GSK • Reviewing recent case law examples  • Internal strategy, methods and techniques Robert Whittock  • Case study A: detection and quantitation of amorphous for IP/IT Practice Group micronised material Freshfields Bruckhaus Deringer  • Case study B: dealing with amorphous formation in a Liquid Deposited Formulation 16:50 Solid state method development Franco Sartor Principal scientist • Understand the importance of validation and development GlaxoSmithKline • Discuss the stability issues in solid state • Characterisation of solid forms 12:30 Amorphous food materials – Some lessons from food research 17:30 Closing remarks from the chair • Hot melt extruded flavour encapsulation systems, a vitrified emulsion. • Small molecules: solvent, plasticiser, both or neither? • Protein stability in the glass state: physical, chemical and biological 17:40 Networking drinks • Brian Arthur’s “The Nature of Technology”: so what’s new? Take your discussions further and build new Dr Roger Parker relationships in a relaxed and informal setting. Senior Scientist, Food Structure and Health Programme BBSRC Institute of Food Research Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2010
  • 4. Day 2 Amorphous Pharmaceutical Materials Tuesday 15th June 2010, London, UK 09:30 Registration and refreshments 12:30 Presentation to be announced Bertrand Gellie Director of Organic Chemistry 10:00 Opening address from the chair European Patent Office 10:10 Partially amorphous materials: In-situ monitoring of 13:10 Networking lunch the recrystallisation process at the nanoscale using heated tip AFM • Process-induced disorder and its importance in pharmaceutical industry 14:30 Formulating materials to retain amorphous character –ensuring you get what you pay for • The use of Atomic Force Microscopy (AFM) and related techniques for detection and characterisation of process-induced changes in • Amorphous materials are highly active in their nature and need careful pharmaceutical materials, incl. several examples from the literature processing to ensure they retain their amorphous character • Novel Nano-thermal analysis approach to characterisation of partially • Many amorphous materials also have low bulk density and present amorphous materials at the nanoscale, incl. examples of in-situ handling problems monitoring of the recrystallisation process • Formulation development to ensure the products retain their amorphous Ljiljana Harding character, otherwise the desirable properties will be lost Inhalation & Devices Centre of Emphasis • Enabling the small scale manufacture of products containing amorphous Pfizer materials for use in preclinical and Phase 1 testing while retaining their amorphous character and overcoming bulk density problems • Reviewing the possible impact of common pharmaceutical processes on 10:50 Automated solid dispersion screening: A useful amorphous character tool to design amorphous systems Michael Gamlen • The approach to automate and miniaturize the search for Managing Director precipitation inhibitors Pharmaceutical Development Services • Preparation of amorphous films • Evaluation of amorphous systems 15:10 Assessing the amorphous drug stability in drug Sigrid Stokbroekx formulations Research Fellow Johnson & Johnson Pharmaceutical R&D • Discus different methods for preparing amorphous formulation • Comparison of different techniques • Analyse formulation designs 11:30 Morning refreshments 15:50 Afternoon refreshments 11:50 Stability assessment of amorphous pharmaceuticals with calorimetry • Instrument considerations and experimental design 16:10 Examining methods for formulation, development, - Scanning calorimetry and isothermal calorimetry stability of amorphous materials • Determination of relaxation rates • Analysing the use of freeze-drying and spray drying • Examples of applications • Assessing key challenges - Measurement of glass transitions with DSC • Examining improved bioavailability and stability - Stability of glassy pharmaceuticals - Oral fast-dissolving films 16:50 Chair’s closing remarks Dr Simon Gaisford Senior Lecturer in Pharmaceutics The School of Pharmacy, University of London 17:00 End of Conference
  • 5. Registration Form Amorphous Pharmaceutical Materials 14th – 15th June 2010, London, UK Angel For multiple bookings Pentonville Road Photocopy this form Conf. code VG Amorphous Ci Pharmaceutical Materials ty Ro ad Standard Prices Conference only Fee: £1299 VAT: £227.33 Total: £1526.33 14th – 15th June 2010 Old Street Location: BSG House Old Street Address: 226-236 City Road City Road Promotional Literature Distribution London EC1V 2TT Distribution of your company’s promotional literature to all conference attendees UK Fee: £999 VAT: £174.83 Total: £1173.83 Details How to book Forename: Surname: Email: conferences@visiongainglobal.com Web: http://www.visiongain.com/amorphouspharma Job Title: Company: UK Office: Tel: +44(0) 20 7336 6100 Main Switchboard Number: Fax: +44(0) 20 7549 9932 Visiongain Ltd Address: BSG House 226-236 City Road London EC1V 2QY UK Country: Postcode: General information Venue: Directions: BSG Conference Centre 226 – 236 City Road, London, EC1V 2TT. United Phone: Fax: Kingdom. Closest tube station is Old Street (Northern Line). Accommodation: Travelodge London City Road Hotel, 7-12 City Road, London, EC1Y 1AE, Tel: 0871 984 6333, Fax: 0207 628 2503, Email: http://www.travelodge.co.uk/search_and_book/hotel_overview.php?hotel_id=340. Payment terms: Visiongain require the full amount to be paid before the conference. Visiongain Signature: Ltd may refuse entry to delegates who have not paid their invoice in full. A credit card guarantee may be requested if payment has not been received in full before the event. Visiongain Ltd reserves the I confirm that I have read and agree to the terms and conditions of booking right to charge interest on unpaid invoices. Substitutions/name changes or cancellations: There is a 50% liability on all bookings once made, whether by post, fax, email or web. There is a no refund policy for cancellations received on Methods of payment or 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 Payment must be made in sterling to transfer places between conferences and executive briefings. However, if you cannot attend the By Mail: Complete and return your signed registration form together with your cheque payable 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 substitutions must be from the same company or to Visiongain Ltd and send to: visiongain Ltd, BSG House, 226-236 City Road, London, EC1V 2QY, UK organisation and are not transferable between countries. By Fax: Complete and fax your signed registration form with your credit card details Invoice alterations: There will be an administration charge of £50 for any changes to an invoice, excluding substitutions/name changes, requested by the customer. This will be charged to the to +44 (0) 20 7549 9932 customer by credit card prior to the changes being made. By Phone: Call us on +44 (0) 20 7336 6100 with your credit card details Indemnity: Visiongain Ltd reserves the right to make alterations to the conference/executive briefing content, timing, speakers or venue without notice. The event may be postponed or cancelled By Credit Card: Fill in your card details below and fax back to +44 (0) 20 7549 9932 due to unforeseen events beyond the control of visiongain Ltd. If such a situation arises, we will try to reschedule the event. However, visiongain Ltd cannot be held responsible for any cost, damage or By Bank Transfer: expenses, which may be incurred by the customer as a consequence of the event being postponed or Visiongain Ltd A/C: visiongain Ltd cancelled. We therefore strongly advise all our conference clients to take out insurance to cover the cost of the registration, travel and expenses. Barclays Bank Sort Code: 20-71-64 Data Protection: Visiongain Ltd gathers and manages data in accordance with the Data Piccadilly Branch Account No: 6038 7118 Protection Act 1988. Your personal information contained in this form may be used to update you on 48 Regent Street Swift Code: BARC GB22 visiongain Ltd products and services via post, telephone, fax or email, unless you state otherwise. We may also share your data with external companies offering complementary products or services. If you London, W1B 5RA IBAN: GB80 BARC 20716460387118 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, Please debit my credit card: EC1V 2QY. Alternatively, you can visit our website at www.visiongain.com and amend your details. Access MasterCard Visa American Express 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. Fee: The conference fee includes lunch, refreshments and conference papers provided on the day. Card number: This fee does not include travel, hotel accommodation, transfers or insurance, (which we strongly recommend you obtain). VAT: VAT will be charged at the local rate on each conference. Delegates may be able to recover VAT Expiry Date: incurred by contacting Eurocash Corporation plc +44 (0) 1273 325000, eurocash@eurocashvat.com. Eurocash specialise in recovering cross-border VAT. Security number (last 3 digits on back of credit card): How we will contact you: Visiongain Ltd’s preferred method of communication is by email and phone. Please ensure that you complete the registration form in full so that we can contact you. Signature: Unable to attend Cardholder’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 your copy of the event CD Rom two weeks after the event. Yes, please send me a copy of the CD for Price£550 VAT:£96.25 Total:£646.25 News updates Office use only Please tick if you do not want to receive email news updates in the future www.visiongain.com/amorphouspharma