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Caitriona, GlaxoSmithKline
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Pharmaceutical
Main Conference:
27th - 28th September 2011
Materials 2011
Workshop Day:
26th September 2011
with Co-Loc
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Effectively, Preparing, Characterising and Stabilising r
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the Amorphous Form for Effective Drug Development 201 tals
1
Amsterdam, The Netherlands
Develop amorphous formulations into your R&D
strategy 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, Vertex
Highlights 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. Pre-Conference Workshop Day: Monday 26th September 2011
WORKSHOP A 10:00 – 11:30
11:00 Registration and Welcome Coffee
Protecting Amorphous Formulation IP
Patenting 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 IP
What 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 strategy
Jason Gray, Commercial Manager, Biopharmaceutical Group, University of Bradford
Jason 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 – 14:30
Development of Formulation Strategies for a Poorly Soluble Compound: Creating a Best Practice
Strategy Approach
Using 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 dispersions
w Taking a risk based approach to quantifying amorphous design strategies
Setu 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. 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
ac
Pharm 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. Conference Day Two: Wednesday 28th September 2011
08:00 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 phases
Achieving 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, GlaxoSmithKline
10:30 Networking Coffee Break
C) Protecting Amorphous IP Formulations
11:00 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.uk
12:30 Networking Lunch Break
“Excellent talks. All presentations were interesting, detailed & well
Implementing the Latest Technologies to Stabilise Amorphous Compounds explained Extremely valuable - I’ve learned a lot about amorphous
during 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. 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
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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
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** Please select choice of workshop(s) A 6 B 6 To claim a variety of articles, podcasts and other free resources please
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