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Pre-Conference Workshop Day: Monday 26th September 2011     WORKSHOP A 10:00 – 11:3011:00 Registration and Welcome CoffeeP...
Conference Day One: Tuesday 27th September 2011        08:00 Coffee and Registration                                      ...
Conference Day Two: Wednesday 28th September 201108:00 Registration and Welcome Coffee                                    ...
Amorphous Pharmaceutical                                                                                                  ...
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Amorphous Pharmaceutical Materials Agenda

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Amorphous Pharmaceutical Materials Agenda

  1. 1. by and Bo t h J v e u “Excellent talks. All presentations were ok ul p 15 sa interesting, detailed and well explained. & y 2 to Presents the 5th Annual Pa 01 Extremely valuable – I’ve learned a lot about y 1Amorphous € amorphous characterisation, generation and 40 control” Caitriona, GlaxoSmithKline 0Pharmaceutical Main Conference: 27th - 28th September 2011Materials 2011 Workshop Day: 26th September 2011 with Co-Loc Pha atedEffectively, Preparing, Characterising and Stabilising r Co- C maceu tica r ys lthe Amorphous Form for Effective Drug Development 201 tals 1Amsterdam, The NetherlandsDevelop amorphous formulations into your R&Dstrategy with key insights on how to: Insights from Key Senior Speakers Including:• Assess the practicalities of patenting amorphous and co-crystal forms to secure your development designs, best practice advice given by Nico Niemeijer, Senior Director, Johnson Emmeline Marttin, European Patent Office and Johnson• Implement spray drying techniques to successfully form a solid David Elder, Externalisation Director, dispersion for improved drug development, learn how to utilise this GlaxoSmithKline techniqye with Nico Niemeijer, Johnson and Johnson Geert Verreck, Head of Solid State, • Consider and control dissolution behaviour and solubility of Janssen amoprhous forms to ensure they are thermodynamically effective, Jason Gray, Commercial Manager, topic led by Jason Gray, Merck Biopharmaceutical Formulation Group, University of Bradford• Understand the physical perspective of process induced phase and glass transitions to enhance favourable biopharmaceutical properties, Matthew Jamieson, Physical Properties and discussion led by Marc Decamps, University of Lille Developability Manager, GlaxoSmithKline Marc Descamps, Professor, University Lille Plus, Don’t Miss 2 Brand New Workshops: Clare Rawlinson-Malone, Senior Research A. Protecting Amorphous Formulation IP Investigator, Bristol-Myers Squibb Jason Gray, Commercial Manager, Biopharmaceutical Group, Tim Robbins, CPP Operations Manager, University of Bradford Abbott B. Development of Formulation Strategies for a Poorly Soluble Compound: Creating a Best Practice Strategy Approach Emmeline Marttin, Investigator, Pure and Setu Roday, Principal Scientist, Vertex Applied Organic Chemistry, EPO Setu Roday, Principal Scientist, VertexHighlights for 2011 Evgenyi Shalaev, Associate Research • New for 2011: agenda focus on rapid and scale-up manufacture of amorphous Fellow, Pfizer solid dispersions Duk Soon Choi, Research Leader, • More case studies than ever before! With insights from 9 leading pharma Hoffmann-La Roche companies • Brand new ice breaker session and interactive problem solving exercises to Navnit Shah, Distinguished Research Leader, really address your conference needs Hoffmann-La Roche www.pharmaamorphous.com +44 (0)20 7368 9300 +44 (0)20 7368 9301 enquire@iqpc.co.uk
  2. 2. Pre-Conference Workshop Day: Monday 26th September 2011 WORKSHOP A 10:00 – 11:3011:00 Registration and Welcome CoffeeProtecting Amorphous Formulation IPPatenting amorphous forms is a key consideration for anyone looking to formulate an amorphous material. The cost of filing a form that can be later disputed is a costly expense and one that can be avoided by taking into consideration the correct IP protocols in the design and production of amorphous materials.The widely known case of GSK v Ranbaxy Pharma is a prime example of the cost to industry over disputed amorphous designs. Ranbaxy, already having shipped over $12m worth of stock and booked over $27m worth of orders before being taken to court over IP infringements on amorphous forms, is a case not wanting to be repeated. This interactive workshop will cover the key issues to consider and strategies to prevent IP complications and ways in which you can in tern protect you own formulation IPWhat will be covered: What you will learn:w Defining amorphous materials and the effect of this on IP claims w Strategies to protect amorphous formulations w Analysis techniques to formulate amorphous designs w How to avoid litigation against your amorphous IP w Case studies examples to successfully protect your amorphous formulation IP w Utilising the latest analytical techniques to formulate the best design strategyJason Gray, Commercial Manager, Biopharmaceutical Group, University of BradfordJason joined The University of Bradford in 2010 as Associate Lecturer and Commercial Manager. Jason gained his degree Biochemistry and chemistry in 2001. From this he completed his PhD at the University of Salford studying the formulation effects of proteins interactions on edible surfactants where he worked with Prof. Gordon Tiddy. After a Post Doctoral position at the University of Manchester Jason joined Zeneca in 1999 as a formulation scientist. In 2002 Jason joined the Merck Generics group of companies to head up their global Physical Properties Laboratories where Jason’s expertise within the field of physical properties led to several patent applications and he has been involved in many successful patent litigations worldwide. WORKSHOP B 12:00 – 14:30Development of Formulation Strategies for a Poorly Soluble Compound: Creating a Best PracticeStrategy ApproachUsing a combination of theoretical and practical knowledge application, participants will be able to formulate a best strategy approach to solve the key challenge of making a poorly soluble compound soluble; using amorphous solid dispersions. Utilising a combination of technology selection, manufacturing processes, form selection and excipient selection – this interactive workshop will give you a hands on look into formulating the most effective strategy to develop amorphous solid dispersions.What you will learn:w Enhance your knowledge of amorphous solid dispersions using the right technological profiling tools w Different formulation approaches to developing amorphous solid dispersionsw Taking a risk based approach to quantifying amorphous design strategiesSetu Roday, Principal Scientist, Vertex Media Partners Sponsorship and Exhibition Opportunities The Pharma IQ Amorphous Pharmaceutical Materials 2011 conference will be the perfect for leading service providers to meet senior-level decision makers in the pharmaceutical/biopharmaceutical industry implementing amorphous designs into R&D formulation strategies. Contact Pharma IQ to discuss how to position your company in front of our participants who are keen to learn more about today’s solutions to some of the common challenges faced by formulators. For more information on sponsorship and exhibition opportunities contact our Sponsorship team on +44 (0)20 7368 9300 or sponsorship@iqpc.co.uk About Pharma IQ Who should attend? Become a member of Pharma IQ and receive complimentary access Senior Vice President, Vice President, Executive Director, to resources that will keep you at the forefront of industry change. Director, Associate Director, Head and Principals of: You will receive access to our growing library of multi-media • Formulation presentations from industry leaders, an email newsletter updating • Preformulation you on new content that has been added, free aggregated news feed • Analytical from over 1000 global news sources tracking your industry and • Solid State special member only discounts on events. • CMC Become a member here: Web: www.pharma-iq.com • Drug Discovery • API Development www.pharmaamorphous.com +44 (0)20 7368 9300 +44 (0)20 7368 9301 enquire@iqpc.co.uk
  3. 3. Conference Day One: Tuesday 27th September 2011 08:00 Coffee and Registration Panelists: Nico Niemeijer, Senior Director, Johnson & Johnson Jason Gray, Lecturer, University of Bradford & Former Team Leader of 08:50 Pharma IQ’s Welcome and Chairperson’s Opening Address Physical Properties, Merck Optimising Amorphous Approaches to Qualify Design and Ensure Application 12:30 Networking Lunch Break 09:00 Successful Amorphous Formulation Strategies – Academic and Industrial Characterising Amorphous Materials to Optimise Your Formulation Strategy Perspectives Many APIs in the pharmaceutical drug delivery pipeline have a high 13:30 Application of a Solid Dispersion Made by Spray-drying in the permeability but poor intrinsic solubility, i.e. dissolution is the rate limiting Development, Production and Regulatory Filing of a Solid Dosage Form stage for bioavailability. An increasingly valuable tool for improving API Using spray Drying techniques to successfully form a solid dispersion performance is therefore dispersing them in an amorphous polymeric matrix; represents one of the key methods of developing an amorphous form. Other this provides improved stability for the high-energy amorphous state. This considerations that have to be taken into account to take development from presentation will cover the following: concept to production include the regulatory aspects of a solid dosage form q Importance of interactions between API and polymeric excipients made from the solid dispersion. This talk will include: q Impact of APU: polymer ratio q Development and characterisation of a solid dispersion q Development of novel polymeric material q Forming a control strategy to ensure successful production of a solid dosage form q Demonstrating advantages in bioavailability of novel amorphous formulations q Large scale production of amorphous solid dispersions q Further challenges surrounding amorphous stability and commercialization q Regulatory aspects to consider when filing a solid dosage form Clare Rawlinson-Malone, Research Investigator II, Portfolio Enabling Nico Niemeijer, Senior Director, Johnson and Johnson Technologies, Bristol Myers Squibb 14:15 Identifying, Characterising and Mitigating Undesired Disordered Phases in 09:45 Technology Spotlight Session Pharmaceutical Materials If you have the latest innovative technology or service in the market and would This talk will cover Information about quantification of amorphous content by like showcase your solution in front of senior industry figures and heads of various analytical techniques, primarily of amorphous content induced by micronisation labs, then Pharma IQ’s Amorphous Pharmaceutical Materials 2011 can provide q Introduction to the methods used to identify amorphous and disordered you with the perfect opportunity. In a saturated market the pressure is on materials within crystalline API, with a specific focus on inhaled formulations for everyone to push compounds into the next stages of development ahead of q Assessing various methods to overcome the challenge of producing suitable the competition. The longest running amorphous conference in Europe offers standards and reference amorphous materials you the unique chance to demonstrate your solution meets the challenge. q Evaluation of the various risk mitigation approaches used in tackling the For more information on sponsorship and exhibition opportunities issue of unwanted amorphous material to ensure optimal product performance contact Sponsorship on +44 (0) 20 7368 9300 or enquire@iqpc.co.uk Dr Matthew Jamieson, Physical Properties Particle Generation Control & Engineering Manager, GlaxoSmithKline 10:30 Ice Breaker Session Conferences bring about the perfect opportunity to network with peers and 15.00 Networking Coffee Break benchmark on solutions to key challenges. q What are the take-home messages you hope to gain over the course of the 15:30 A Physical Perspective of Process Induced Phase and Glass Transitions of conference? Pharmaceuticals q What key challenges do you hope to overcome? Most drugs are formulated in the solid state which may be either crystalline q Formulate an outline of all the key issues you wish to be addressed during or amorphous (i.e. glassy). Disordered solids and amorphous materials the conference, discuss as a group and feedback to the conference chair are of interest in pharmaceutical formulations because they may have q At the end of day 2 results and concluding strategies will be assessed favourable biopharmaceutical properties e.g. enhanced solubility and Facilitated by Conference Chair dissolution capabilities. The drawback is their intrinsic physical and chemical instabilities since glassy materials are in a non-equilibrium state. 10:50 Networking Coffee Break Manufacturing processes (milling, drying, extrusion…) may lead to a variety of physical state conversions of materials. They can induce, either intentionally Ensure Compliance with Regulatory Updates and Recent Case Law in the or unintentionally, the slipping of crystalline substances into the amorphous Solid State Arena glassy state. Sometimes processing acts in opposite direction promoting recrystallisation of the amorphous state or inducing polymorphic conversion 11:20 Assessing the Practicalities of Patenting Amorphous & Co-Crystal Forms between crystalline phases. During processing materials are maintains in to Secure Your Development Designs nonequilibrium conditions (driven materials). ined Securing a patenting request is vital to ensuring progression of formulation Comb with We will explore: n designs when forming both co-crystal and amorphous forms to enhance sessio eutical q Several aspects of molecular materials transformed via milling and drying acPharm ys lsta necessary drug properties or reformulate exisitng drugs to file new patent Co -Cr operations. forum requests. This interactive talk will expose you to the patenting application q The first point concerns the nature of the end product as a function of the process giving you the opportunity to raise questions, assess latest case dynamic forcing parameters. studies and ensure your IP applications when filing amorphous or q The second point concerns the modifications induced by applying forcing to co-crystal patent claims. Including how to: an amorphous solid which can either hyperstabilize the glass or rejuvenate it. q Preparing and presenting an amorphous patent claim This can be used to manipulate the amorphous state. q Exploring the definition of amorphous and utilising this to form the right q We will discuss the possibility of rationalization with the help of an effective patent claim, avoiding complications temperature concept. q Overcoming typical approval objections to patent applications and taking Marc Descamps, Professor, University of Lille steps to avoid complications q Useful hints and tips for drafting a patent application claims form 16:15 Panel Session: Overcoming the Risks of Taking Amorphous Systems From Emmeline Marttin, Investigator, Pure and Applied Organic Chemistry, EPO Discovery to Clinical Stage q Assessing the potential implementation of amorphous designs into drug 12:05 Discussion Panel Ensuring Patenting Designs: Worst Case Scenarios & Best Practice development as common industry practice bined Strategies q Discussing the best characteristics of amorphous designs with evidence Com with ses sion cal Discuss the importance of regulatory compliance when filing IP requests from based data to support design proposals aceuti q Forward thinking of the necessary data required for progression to clinical Pharm ys lsta Industry and regulatory perspectives Co-Cr stages fo rum q Discuss the factors involved with ensuring a successful patenting request q Learn best practice strategies q Analysing the risk and benefits associated with amorphous development q Defining amorphous forms, what makes something amorphous and in Facilitated by Day 1 and 2 Speakers patenting terms r Is a solid solution amorphous? 17:00 Chairperson’s Closing Remarks and Close of Day One r IWhat about nano crystalline? q Address the latest issues looking to the future of using amorphous or co- crystal forms to reformulate existing drugs for new patenting claims Facillitated by: Emmeline Marttin, Investigator, Pure and Applied Organic Chemistry, EPO +44 (0)20 7368 9300 +44 (0)20 7368 9301 enquire@iqpc.co.uk
  4. 4. Conference Day Two: Wednesday 28th September 201108:00 Registration and Welcome Coffee 14:15 Controlling Solid State Transformations Using XRPD Screens q Assessing the benefits of using X-ray Powder Diffraction to investigate solid 08:50 Pharma IQ Welcome and Chairperson’s Opening Address change state transformations and control amorphous stability throughout solid state and later development phasesAchieving Stabilised Amorphous Forms Throughout Development Phases q Developing a novel, high-throughput automated polymorph screening approach usign XRPD and hot-stage polarising microscopy to determine 09:00 Advancing the Pipeline: Rapid Manufacture of Amorphous Solid transformation and stability Dispersions – What is the Rush? q Identifying best practice measures to predict, control and stabilise The rapid movement of the pharmaceutical industry has meant that in recent transformations using a range of techniques years heavy emphasis has been placed on rapid manufacture and producing Setu Roday, Principal Scientist, Vertex to scale. The key challenge for successful and rapid scale up of amorphous solid dispersions q Understanding the dynamic environment in which the pharmaceutical 15:00 Networking Coffee Break industry exists q A simple but efficient manufacturing process for amorphous solid 15:30 Interactive Roundtable Discussion; ‘Two Heads are Better Than One’ dispersions This is your chance to discuss key topics and challenges in smaller groups. q Critical parameters to consider for consistent performance of ASD batches Attendees will be able to share their own experiences and hear those of others, prepared by roto-evaporation exchange ideas and get clear answers to specific questions. So, in order to Tim Robbins, CPP Operations Manager, Abbott make the most of these interactive sessions, participants should come armed and ready to share their own experiences and have clear questions they need 09:45 Realising the Practical Development Potential of Amorphous Solid answers to. Either bring your questions with you on the day, or submit in Dispersions as Successful Drug Candidates advance to: enquire@iqpc.co.uk Ensuring amorphous solid dispersions are successful drug candidates Choose from the following: involves taking into consideration a number of factors. This talk will take into A) Best Practice Methods and Technologies to Develop an Amorphous Form account bioenhancement strategies, chemical and physical stabilisation, Attendees will share their experiences and best practice strategies in a guided correlation activity using cast study examples to realise the practical discussion on the most effective methods to produce an amorphous form. This development potential of amorphous solid dispersions. roundtable will focus on the scientific application of methods and technologies used q Assessing the bio-enhancement strategies for poorly soluble drugs; the role Facilitated by: Evgenyi Shalaev, Associate Research Fellow, Pfizer of amorphisation q Chemical and physical stabilisation of amorphous products; the role of: B) Implementing Amorphous Forms into Your R&D Strategy water, excipients, moisture and processing in de-stabilisation Half the challenge with amorphous implementation is convincing the powers q Correlations between molecular mobility and chemical stability above that amorphous materials are a viable option form for enhancing r Learnings from Ritonavir necessary drug properties. This roundtable will focus on strategies utilised to q Approaches to stabilise amorphous drugs, some case examples highlight the benefits of using amorphous and how the risk factors can be David Elder, Externalisation Director, GlaxoSmithKline overcome with effective strategising Facilitated by: David Elder, Externalisation Director, GlaxoSmithKline10:30 Networking Coffee Break C) Protecting Amorphous IP Formulations11:00 Influence of Amorphous Content on Dissolution Behaviour and Solubility The legal implications associated with developing an amorphous form can With the increasing development of new pharmaceuticals which are poorly sometimes seem off putting to those looking into amorphous as a viable option soluble in nature many different strategies have been developed to improve form. This roundtable will focus on the strategies that can be taken during the the solubility of materials to make them therapeutically effective. Strategies concept and design stages to prevent future complications including the development of amorphous forms, salts and co-crystals are all Facilitated by: Jason Gray, Commercial Manager, Biopharmaceutical used to promote enhanced solubility/bioavailability. Therefore, the dissolution/ Formulation Group, University of Bradford solubility of these forms is a vital criterion when deciding which approach to develop. With the high cost of APIs any new method developed needs to be beneficial D) Ensuring Amorphous Stability Throughout the Development Process in reducing both timescales and costs of bringing a product to market. We Amorphous materials are considered to be one of the favourable drug present our data on using a UV area imaging flow through dissolution data that, enhancement forms however stability issues can hinder formulation projects by using only 3mg-19mg of sample fast discriminatory dissolution and and have detrimental effects in later stages. This roundtable will focus on solubility data can be obtained for materials processed with varying amorphous fundamental stability issues and the methods of overcoming them content. Additionally comparisons between amorphous forms produced by Facilitated by: Setu Roday, Principal Scientist, Vertex differing techniques can also be compared. Including: q Intrinsic dissolution of amorphous forms 16:15 Developing a Best Practice Formulation Strategy for Unstable Amorphous q Ensuring solubility of amorphous forms Compounds q Fast analysis of amorphous forms using UV area imaging q Maximising the potential of physical and chemical properties of Jason Gray, Commercial Manager, University of Bradford & Former Team pharmaceutical compounds using amorphous solid dispersion technologies Leader of Physical Properties, Merck q Selecting the appropriate solid form and functional excipient to enhance stability and dissolution, selection of manufacturing processes and selection 11:45 Session Reserved for Sponsor of technologies This session is reserved for a sponsor, the perfect platform for you to showcase q Balancing benefits and risks of amorphous solid dispersion systems your company’s services and solutions. This is your chance to profile Duk Soon Choi, Research Leader, F Hoffmann La Roche yourselves as thought leaders within the industry in front of senior Directors and Heads of Lab from the Pharma/Bio-Pharma industry. 17:00 Chairperson’s Closing Remarks and Close of Day Two For more information please contact sponsorship on +44 (0) 207 368 9300 or email sponsorship@iqpc.co.uk12:30 Networking Lunch Break “Excellent talks. All presentations were interesting, detailed & wellImplementing the Latest Technologies to Stabilise Amorphous Compounds explained Extremely valuable - I’ve learned a lot about amorphousduring Design and Solid State Formulation characterisation, generation & control”13:30 Measuring Solid State Transformations Using Raman Spectroscopy and Caitriona Cashell, GlaxoSmithKline Characterisation Screens q Utilising Raman Spectroscopy to characterise amorphous materials and quantify relative amounts “Very good, very high level in every direction, skills of presentation, q Assessing the polarisability of molecules with the non-destructive nature of content of presentation, slides. Highly valuable on the learning about Raman spectroscopy to detect small amounts of amorphous state q Determine structure and composition of amorphous forms to predict stability amorphous practical cases & theoretical approach.” in later stages Dr Daniele Schott, Solvias AG Geert Verreck, Head of Solid State, Janssen +44 (0)20 7368 9300 +44 (0)20 7368 9301 enquire@iqpc.co.uk
  5. 5. Amorphous Pharmaceutical 5 WAYS TO REGISTER Materials 2011 Freephone: 0800 652 2363 or +44 (0)20 7368 9300 Main conference: Workshop Day: Location: Fax: +44 (0)20 7368 9301 27th - 28th September 2011 26th September 2011 Amsterdam, The Netherlands Post: your booking form to To speed registration, please provide the priority code located on the mailing label or in the box below. IQPC Ltd. 129 Wilton Road, My registration code is PDFW London SW1V 1JZ Please contact our database manager on +44(0) 207 368 9300 or at database@iqpc.co.uk quoting the registration code above to inform us of any changes or to remove your details. Online: www.pharmaamorphous.com Email: enquire@iqpc.co.uk Join our LinkedIn group Team Discounts* IQPC recognises the value of learning in teams. Groups of 3 or more booking at the same time from the same company receive a 10% Amorphous Pharmaceutical discount. 5 or more receive a 15% discount. 7 receive a 20% discount. Materials 2011 Only one discount available per person. PACKAGES Tick Book and pay by 15th July*** Book and pay by 12th August*** Standard Price Venue & Accommodation Conference + 2 Workshops + Audio Recordings* €3,347+VAT €3,447+VAT €3,747+VAT Save €400 Save €300 VENUE: TBC, Amsterdam, The Netherlands Conference + 1 Workshop + Audio Recordings** €2,798+VAT €2,898+VAT €3,098+VAT Save €300 Save €200 ACCOMMODATION: Overnight accommodation is not included in the registration fee. For updates on the venue and accommodation options, Conference + Audio Recordings* €2,249+VAT €2,449+VAT €2,449+VAT Save €200 please visit www.pharmaamorphous.com Roaming Pass (to Pharma Co-Crystals) €199+VAT * Tick this box to opt out of full conference recordings (reducing price by €550) Free Online Resources ** Please select choice of workshop(s) A 6 B 6 To claim a variety of articles, podcasts and other free resources please *** To qualify for discounts, payments must be received by the early bird registration deadline. Early booking discounts are not valid inconjunction with any visit www.pharmaamorphous.com other offer. All above price are subject to Dutch VAT 19%. 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