SMi's 8th conference on Controlled Release builds upon the successes of the previous years in bringing together leading industry figures and tackling some of the most current and pressing issues faced by this important branch of drug development.

1. Controlled Release
Scientific Progress and Commercial Opportunities
SMi present their 8th conference on
Wednesday 30th and Thursday 31st March 2011
Copthorne Tara Hotel, London, UK
Book by 17th December to receive a £200 early bird discount off the conference
KEY SPEAKERS INCLUDE:
Dr. Didier Bazile
Global Head of Drug Delivery Technologies and Innovation
Sanofi-Aventis
Professor Lisbeth Illum
CEO
Critical Pharmaceuticals
Dr. Andrew Bryant
Program Manager – Novel Drug Delivery Systems
Pfizer
Dr. Frank Thielmann
Accompanying the growth of the
Senior Fellow - PDU Inhalation
Novartis
controlled release industry is an
increasing range of issues that
Dr. Joel Richard
require attention and further
Senior Director - Head of Drug Product Development
IPSEN
research. This conference will
display cutting edge
Dr. Stefan Bassarab
Director - Pharmaceutical Development
Boehringer-Ingelheim
developments in bioavailability,
drug delivery and formulation,
also addressing some of the
BY ATTENDING YOU WILL BE ABLE TO:
newest technologies available.
• Hear the latest developments in controlled release technology
• Discover successful approaches to various methods of drug delivery
• Learn how to increase formulation bioavailability and efficacy
www.controlledrelease.co.uk
Ocular Drug Delivery: Identifying Advances and
PLUS AN INTERACTIVE PRE–CONFERENCE WORKSHOP
• Take examples of success from the event
Opportunities
Tuesday 29th March 2011
Hosted by Dr Hong Guo, Vice President of Research, pSivida
Sponsored by
1.30pm - 5.00pm
Register online and receive full information on all of SMi’s conferences
Alternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711

2. www.controlled
Controlled Release
Day One Wednesday 30th March 2011
8.30 Registration & Coffee • Depot formulations based on biodegradable and/or natural
polymers and lipids for injectable sustained-release formulations
9.00 Chairman's Opening Remarks of proteins
Professor Howard Stevens, Professor of Drug Delivery, Strathclyde • High concentration formulations of mAbs for subcutaneous
University administration
• Alternative non-invasive routes and delivery systems
STRATEGIC OVERVIEW • Examples of successful and promising strategies and technologies
Dr. Joel Richard, Senior Director, Head of Drug Product
9.05 Physical Methods for Controlled Release of Drugs Development, IPSEN
• Reminder, why controlled release anyway?
• Challenges and obstacles 2.15 Injectable Sustained Release of Proteins
• Existing technologies • Why sustained release?
• Unmet needs and progress still required? • State of the art – successes and limitations
Dr. Andrew Bryant, Program Manager - Novel Drug Delivery • Technology choices
Systems, Pfizer
• Next generation of sustained release technologies
Dr. Andy Lewis, Operations Director, Critical Pharmaceuticals
9.40 Overcoming Poor Bioavailability through Amorphous
Limited
Solid Dispersions
• Current and foreseeable needs for solubilization platforms
• The role of solid dispersions in the pharmaceutical industry 2.50 Afternoon Tea
• Key technologies for manufacturing solid dispersions
• An illustrative case study BUSINESS STRATEGY
Dr. Filipe Gaspar, Director of Particle Design (R&D), Hovione
3.20 Partnering approaches in the controlled release industry
10.20 Increasing Bioavailability – Strategies for Overcoming • Role of partnerships/ alliances in drug delivery
Biological Barriers • What are the opportunities and challenges?
• Understanding biological barriers • Reaching a successful partnering in drug delivery
• Strategies to increase transport across biological barriers Mr. Olivier Drap, R&D Business Development, Pfizer
• Nanosystems engineering and mechanism of action
Dr. Andreas Schatzlein, Reader in Cancer Pharmacology, School of SiRNA, PROTEIN AND CHRONO THERAPUTICS
Pharmacy, University of London
3.55 sd-rxRNA: The novel class of the RNAi compounds with potential
10.55 Morning Coffee therapeutic applications
• Delivery is a major challenge for the development of RNAi
11.25 Data-driven Strategies in the development of controlled release therapeutics
formulations • RXi has developed a novel class of RNAi compounds termed “self
• Limitations of the current development paradigm for controlled delivering rxRNA” or sd-rxRNA™, that combines beneficial
release products properties of the RNAi and conventional antisense technologies
• The role of human regional absorption studies to direct the • The combination enables robust cellular uptake of the molecules
development of controlled release formulations and silencing of the target genes
• In vivo efficacy has been achieved using local administration of the
Register online at www.controlledrelease.co.uk• Alternatively fax
• Investigating factors affecting regional drug absorption
• The application of rapid formulation development concepts to new compounds
optimise controlled release products in humans Dr. Dmitry Samarsky, Vice President- Technology Development,
Dr. Alyson Connor, Senior Research Fellow, Quotient Bioresearch, RXI Pharmaceuticals
Clinical Sciences
4.30 Requirements for manufacturing PLGA based sustained release
NASAL AND PARENTERAL DRUG DELIVERY
forms of therapeutic proteins
• Adjustment and control of particle size
12.05 Nasal delivery of macromolecules – are we there yet?
• Recent developments and success stories • Optimization and control of protein load
• Issues still to tackle • Analytical tools relevant to characterize micro particles
• Novel applications Dr. Stefan Bassarab, Director, Pharmaceutical Development,
Professor Lisbeth Illum, CEO, Critical Pharmaceuticals Limited Boehringer-Ingelheim
12.40 Networking Lunch 5.05 Time for a new look at drug delivery: the Chronopharmaceutical
opportunity
1.40 Parenteral Biologics Delivery: Key Challenges and Perspectives • Chronobiology of the GI tract
• Lifecycle management of biologics: context and expectations for • Chronotherapeutics and the disease state
new delivery systems and routes of administration • Chronopharmaceutical drug delivery opportunities
• Strategies developed for production of long acting protein Professor Howard Stevens, Chairman, Drug Delivery International
therapeutics Ltd
• Protein engineering and post-translational modifications to
prolong half life 5.40 Chairman's Closing Remarks and Close of Day One
Sponsored by
Hovione is an international company dedicated to the cGMP development and manufacture of APIs and Intermediate Drug
Products via particle design, serving exclusively the pharmaceutical industry. With FDA inspected sites in US, Portugal,
Ireland and China, the company also offers integrated API, particle design and formulation development and
manufacturing. www.hovione.com
Quotient Clinical, a strategic business unit of Quotient Bioresearch, combines the experience and capabilities of
Pharmaceutical Profiles and the former Inveresk clinical unit in the UK. Our expertise in early clinical development ranges
from First-in-Human through to Proof-of-Concept, augmented by our unique capabilities in drug product optimisation and
14C enabled drug development. www.quotientbioresearch.com
Supported by

3. drelease.co.uk
Controlled Release
Day Two Thursday 31st March 2011
8.30 Re-Registration & Coffee ORAL, TOPICAL, INHALATORY AND OCULAR DRUG DELIVERY
9.00 Chairman's Opening Remarks 12.00 Approaches and gaps in establishing hypromellose matrix
Professor Howard Stevens, Professor of Drug Delivery, robustness
Strathclyde University • Polymer grade selection
• Release mechanism understanding
NANOTECHNOLOGY • Review of in vitro test methods and models
• Review of in vivo study types
Mr. Richard Elkes, Formulation R&D, Merck Sharp & Dohme
9.05 Nanotechnology: state-of-the-art in pharmaceutical applications
• Opportunities for drug delivery
12.35 Networking Lunch
• Clinical research and Market situation
• Regulatory status
1.35 Gastroretention for oral controlled release of drugs
• Examples of successful implementations
• Is it a worthwhile mechanism to explore?
Dr. Mario Maio, Head of Formulation & Process Development
• Gastrointestinal diseases and controlled release
Department, Merck
• Approaches – successes and failures
Professor Clive Wilson, Professor of Pharmaceutics, Strathclyde
9.40 Development and clinical production of microsphere University
formulations
• The added value of controlled release drug delivery technologies 2.10 Topical delivery by multifunctional lipid liquid crystalline
• Success factors in the process development, scale-up and systems
manufacturing of microsphere-based formulations • Phase change triggered adhesion to mucosal and dermal
• Case study: Phase II clinical proof of concept with a controlled surfaces
release formulation of interferon alpha • Local delivery and sustained release from lipid liquid crystalline
Mr. Gerben Moolhuizen, Chief Business Officer, OctoPlus surface films
• Permeation enhancement through interactions between liquid
10.20 Nanotechnologies tools in candidate selection for the crystal nanoparticle carriers and biological surfaces
intravenous route Dr. Fredrik Tiberg, President & CEO, Camurus
• Tackling solubility issues in early development,
• Added value of nanotechnologies for the intravenous route, 2.45 Afternoon Tea
x your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
• Points to consider in nano-objects development,
3.15 Review of controlled release strategies for inhaled therapies
• Drug Delivery based candidate design.
• The need for controlled release formulations in inhaled products
Dr. Didier Bazile, Global Head of Drug Delivery Technologies and
• Formulation strategies
Innovation, Sanofi-Aventis
• In-vitro testing approaches
Dr. Frank Thielmann, Senior Fellow PDU Inhalation, Novartis
10.55 Morning coffee
3.50 Drug delivery to the eye: From ocular barriers to the approaches
HOT MELT EXTRUSION
to enhance drug bioavailability
• Structure and physiology of the eye in relation to drug
11.25 Hot Melt Extrusion Concept and Application bioavailability
• Definition and Hot Melt Extrusion History • Approaches used to improve precorneal retention
• Advantages and different equipment • Approaches used to facilitate corneal drug permeability
• Parameters Affecting Extrusion
Who should attend:
Dr. Vitaliy Khutoryanskiy, Lecturer in Pharmaceutics, University
• Micro-pelletization of Reading
Dr. Hassan Mohammad, Principal Scientist, Mundipharma
Research LTD 4.25 Chairman’s Closing Remarks and Close of Day Two
SMi Controlled
Release past
delegate
breakdown
Chief Executives, Chief Scientific Officers, Vice Presidents, Heads,
Directors, Principal Scientists and Managers in the following areas:
• Controlled Release • R&D
• Drug Delivery • Inhalation
• Drug Development • Operations
• Nanotechnology • Global Alliances
• Formulation • Product Development
• Business Development • Technology Development
• Regulatory and Technical Affairs • Technical Sciences
• Product Development • Particle Design

4. Ocular Drug Delivery: Identifying
HALF DAY PRE-CONFERENCE WORKSHOP
Advances and Opportunities
Tuesday 29th March 2011
1.30pm - 5pm
Copthorne Tara Hotel, Central London
Hosted by
Dr. Hong Guo, Vice President of Research, pSivida
In association with:
Overview of workshop
This workshop shall thoroughly investigate the current
state of ocular drug delivery in pharmaceuticals and will
provide invaluable advice on catering for unmet medical
needs in the field. By firstly providing a comprehensive
overview of the current products and dosage forms that
are available and then addressing the specific
advantages of both topical and intravitreal methods of
delivery, this session will use tangible examples of
success to benchmark best practice in ocular drug
delivery. Finally it will focus on local drug delivery
approaches in particular, including methods of
controlled release and its application in the treatment of
specific clinical diseases.
1.30 Registration & Coffee
2.00 Welcome & Introductions
2.10 Overview of Ocular Pharmaceutical Products
• Common dosage forms in Ophthalmology
• Unmet medical needs
• Challenges of Ocular Drug Delivery
2.50 The Ocular Drug Delivery Technologies
• A fast growing industry
• Success of a topic eye drop
• Success of a intravitreal injection
• Case study
3.30 Afternoon Coffee
3.50 Local Drug Delivery Approaches
• Specific clinical diseases
• Sustained local delivery
• Implants
• Biodegrable delivery systems
4.30 Discussion Session
5.00 Close of Workshop
About the workshop leader:
Dr. Hong Guo has served as the Company’s Vice President
of Research since November 2009 having previously served
as Director of Research from January 2006 to November
2009. Prior to joining pSivida, Hong served as the Director of
Preformulation and as a Senior Scientist for Control
Delivery Systems where she was one of the original
inventors of both the Medidur and Retisert sustained
release drug delivery systems. Prior to joining CDS, Hong
was a Post-Doctoral Research Scientist at New England Eye
Centre and at the University of Kentucky. Hong received
Masters of Science in Medicinal Chemistry and a Bachelor
of Science degree in Pharmacy from China Pharmaceutical
University and Ph.D. in Medicinal Chemistry from the
University of Heidelberg, Germany.
About pSivida
pSivida is a world leader in the development of tiny,
sustained release, drug delivery products and technologies
that are administered by implantation, insertion or injection.
The company develops products to treat serious, unmet,
medical needs alone or in partnership with other
companies. pSivida has developed devices that are so small
they are FDA approved to be administered into the eye and
once administered they release their drug for months and
years. pSivida is also developing a series of additional
miniaturized, bioerodible technologies designed to provide
long term (months and years) release to virtually any site in
the body.

5. PHARMACEUTICAL
FORWARD PLANNER
DECEMBER 2010
01/02 Cold Chain Distribution
JANUARY 2011
17/18 Pharmaceutical Microbiology
19/20 Pre-Filled Syringes
24/25 Paediatric Clinical Trials
26/27 Social Media in the Pharmaceutical
Industry
31/1 Biomarkers Summit
FEBRUARY 2011
02/03 Adaptive Designs in Clinical Drug
Development
07/08 Parallel Trade
21/22 Advances & Progress in Drug Design
23/24 Stem Cells
MARCH 2011
07/08 Imaging in Cancer Drug Development
14/15 Pharmacovigilance
16/17 Superbugs & Superdrugs
23/24 Accelerating Patient Recruitment &
Retention in Clinical Trials
30/31 Controlled Release
APRIL 2011
13/14 Asthma & COPD
MAY 2011
11/12 Generics, Supergenerics and Patent
Strategies
16/17 Clinical Trial Logistics
JUNE 2011
01/02 Pain Therapeutics
27/28 Nanotechnology
27/28 RNAi
29/30 Pharmaceutical Portfolio & Product
Lifecycle Management
29/30 KOL Europe (Munich, Germany)
JULY 2011
06/07 BioBanking
06/07 ADMET
11/12 Freeze Drying
18/19 Clinical Trial Logistics Asia (Singapore)
20/21 Pre-Filled Syringes Asia (Singapore)
SPONSORSHIP AND EXHIBITION OPPORTUNITIES
All conferences take place in central London, UK – unless
indicated otherwise in brackets
SMi offer sponsorship, exhibition, advertising and
branding packages, uniquely tailored to complement
your company's marketing strategy. Prime
networking opportunities exist to entertain, enhance
and expand your client base within the context of an
independent discussion specific to your industry.
Should you wish to join the increasing number of
companies benefiting from sponsoring our
conferences please call:
Alia Malick on
+44 (0) 20 7827 6168 or
email: amalick@smi-online.co.uk
Want to know how you can get involved?
Interested in promoting your pharmaceutical
services to this market?
Contact Kiran Sharma SMi Marketing on
+44 (0)20 7827 6050 or
email: ksharma@smi-online.co.uk

6. CONTROLLED RELEASE
4 WAYS TO REGISTER
www.controlledrelease.co.uk
FAX your booking form to +44 (0) 870 9090 712 POST your booking form to: Events Team, SMi Group Ltd, Great Guildford
PHONE on +44 (0) 870 9090 711
CONFERENCE PRICES
Conference: Wednesday 30th and Thursday 31st March 2011, Copthorne Tara Hotel, London, UK Workshop: Tuesday 29th March 2011, London
EARLY BIRD
Business Square, 30 Great Guildford Street London, SE1 0HS, UK
DISCOUNT
DELEGATE DETAILS
□ Book by 17th December to receive a £200 off the conference
I would like to attend: (Please tick as appropriate) Fee Total
□ Conference & Half Day Workshop £1998.00 + VAT £2347.65
□ Conference only £1399.00 + VAT £1643.83
□ Half Day Workshop only £599.00 + VAT £703.83
VENUE
PROMOTIONAL LITERATURE DISTRIBUTION
Unique Reference Number
□ Distribution of your company’s promotional
Our Reference LVY13
GROUP DISCOUNTS AVAILABLE
literature to all conference attendees £999.00 + VAT £1173.83
CD ROMS/DOCUMENTATION
Title: Forename:
Surname:
The Conference fee includes refreshments, lunch, conference papers and
Job Title:
CD ROM containing all of the presentations.
Department/Division:
□ Please contact me to book my hotel
Company/Organisation:
Please complete fully and clearly in capital letters. Please photocopy for additional delegates.
Copthorne Tara Hotel, Scarsdale Place, Kensington, London, W8 5SR
Email:
PAYMENT
Address:
Alternatively call us on +44 (0) 870 9090 711,
email: hotels@smi-online.co.uk or fax +44 (0) 870 9090 712
Town/City:
Post/Zip Code: Country:
Direct Tel: Direct Fax:
I cannot attend but would like to purchase the following CD ROMs/paper copy
documentation: (Shipped 10-14 days after the event) Price Total
Mobile:
□ The Conference Presentations on CD ROM £499.00 + VAT £586.33
Switchboard:
□ The Conference Presentations - paper copy £499.00 - £499.00
Terms and Conditions of Booking
(or only £300 if ordered with a CD ROM)
Signature: Date:
ACCOUNTS DEPT
Title: Forename:
Surname:
Email:
Payment must be made to SMi Group Ltd, and received before the event, by one of the
I agree to be bound by SMi's Terms and Conditions of Booking.
Address (if different from above): following methods quoting reference Y13 and the delegate’s name. Bookings made within 7
days of the event require payment on booking, methods of payment are below. Please
indicate method of payment:
Valid From □□/□□ Expiry Date □□/□□
Town/City: □ UK BACS Sort Code 300009, Account 00936418
Post/Zip Code: Country: □ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU
Swift (BIC): LOYDGB21013, Account 00936418
Direct Tel: Direct Fax:
IBAN GB48 LOYD 3000 0900 9364 18
VAT
□ Cheque We can only accept Sterling cheques drawn on a UK bank.
□ Credit Card □ Visa □ MasterCard □ American Express
Card No:
All credit card payments will be subject to standard credit card charges.
CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card
Cardholder’s Name:
Signature: Date:
Card Billing Address (If different from above):
I agree to be bound by SMi's Terms and Conditions of Booking.
VAT at 17.5% is charged on the attendance fees for all delegates. VAT is also charged on CD
If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at events@smi-online.co.uk
ROMs and Literature Distribution for all UK customers and for those EU customers not
supplying a registration number for their own country here: _______________________
Payment: If payment is not made at the time of booking, then an invoice will be issued and must be
paid immediately and prior to the start of the event. If payment has not been received then credit card
details will be requested and payment taken before entry to the event. Bookings within 7 days of
□□□□ □□□□ □□□□ □□□□
event require payment on booking. CD Roms will not be dispatched until payment has been received.
Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another
delegate to take your place at any time prior to the start of the event. Two or more delegates may
not ‘share’ a place at an event. Please make separate bookings for each delegate.
Cancellation: If you wish to cancel your attendance at an event and you are unable to send a
substitute, then we will refund/credit 50% of the due fee less a £50 administration charge, providing
that cancellation is made in writing and received at least 28 days prior to the start of the event.
Regretfully cancellation after this time cannot be accepted. We will however provide the Conference
documentation on CD ROM to any delegate who has paid but is unable to attend for any reason. Due
to the interactive nature of the Briefings we are not normally able to provide documentation in these
circumstances. We cannot accept cancellations of orders placed for Documentation or CD ROM as
these are reproduced specifically to order. If we have to cancel the event for any reason, then we will
make a full refund immediately, but disclaim any further liability.
Alterations: It may become necessary for us to make alterations to the content, speakers, timing,
venue or date of the event compared to the advertised programme.
Data Protection: The SMi Group gathers personal data in accordance with the UK Data Protection Act
1998 and we may use this to contact you by telephone, fax, post or email to tell you about other
products and services. Unless you tick here □ we may also share your data with third parties offering
complementary products or services. If you have any queries or want to update any of the data that
we hold then please contact our Database Manager databasemanager@smi-online.co.uk or visit our
website www.smi-online.co.uk/updates quoting the URN as detailed above your address on the
attached letter.