Controlled Release  Scientific Progress and Commercial Opportunities                               SMi present their 8th c...
www.controlled  Controlled Release  Day One Wednesday 30th March 2011  8.30     Registration & Coffee                     ...                                                                                                            ...
Ocular Drug Delivery: IdentifyingHALF DAY PRE-CONFERENCE WORKSHOP   Advances and Opportunities       Tuesday 29th March 20...
PHARMACEUTICALFORWARD PLANNERDECEMBER 201001/02  Cold Chain DistributionJANUARY 201117/18  Pharmaceutical Microbiology19/2...
CONTROLLED RELEASE                                                                                               4 WAYS TO...
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Controlled Release conference, London, 30th-31st March


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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.

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Controlled Release conference, London, 30th-31st March

  1. 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, UKBook 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 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 - 5.00pmRegister online and receive full information on all of SMi’s conferencesAlternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
  2. 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 Chairmans 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• 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 Chairmans 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. 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.comSupported by
  3. 3. Controlled Release Day Two Thursday 31st March 2011 8.30 Re-Registration & Coffee ORAL, TOPICAL, INHALATORY AND OCULAR DRUG DELIVERY 9.00 Chairmans 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 Teax 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. 4. Ocular Drug Delivery: IdentifyingHALF 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, pSividaIn association with:Overview of workshopThis workshop shall thoroughly investigate the currentstate of ocular drug delivery in pharmaceuticals and willprovide invaluable advice on catering for unmet medicalneeds in the field.  By firstly providing a comprehensiveoverview of the current products and dosage forms thatare available and then addressing the specificadvantages of both topical and intravitreal methods ofdelivery, this session will use tangible examples ofsuccess to benchmark best practice in ocular drugdelivery. Finally it will focus on local drug deliveryapproaches in particular, including methods ofcontrolled release and its application in the treatment ofspecific clinical diseases.1.30 Registration & Coffee2.00 Welcome & Introductions2.10 Overview of Ocular Pharmaceutical Products • Common dosage forms in Ophthalmology • Unmet medical needs • Challenges of Ocular Drug Delivery2.50 The Ocular Drug Delivery Technologies • A fast growing industry • Success of a topic eye drop • Success of a intravitreal injection • Case study3.30 Afternoon Coffee3.50 Local Drug Delivery Approaches • Specific clinical diseases • Sustained local delivery • Implants • Biodegrable delivery systems4.30 Discussion Session5.00 Close of WorkshopAbout the workshop leader:Dr. Hong Guo has served as the Company’s Vice Presidentof Research since November 2009 having previously servedas Director of Research from January 2006 to November2009. Prior to joining pSivida, Hong served as the Director ofPreformulation and as a Senior Scientist for ControlDelivery Systems where she was one of the originalinventors of both the Medidur and Retisert sustainedrelease drug delivery systems. Prior to joining CDS, Hongwas a Post-Doctoral Research Scientist at New England EyeCentre and at the University of Kentucky. Hong receivedMasters of Science in Medicinal Chemistry and a Bachelorof Science degree in Pharmacy from China PharmaceuticalUniversity and Ph.D. in Medicinal Chemistry from theUniversity of Heidelberg, Germany.About pSividapSivida is a world leader in the development of tiny,sustained release, drug delivery products and technologiesthat are administered by implantation, insertion or injection.The company develops products to treat serious, unmet,medical needs alone or in partnership with othercompanies. pSivida has developed devices that are so smallthey are FDA approved to be administered into the eye andonce administered they release their drug for months andyears. pSivida is also developing a series of additionalminiaturized, bioerodible technologies designed to providelong term (months and years) release to virtually any site inthe body.
  5. 5. PHARMACEUTICALFORWARD PLANNERDECEMBER 201001/02 Cold Chain DistributionJANUARY 201117/18 Pharmaceutical Microbiology19/20 Pre-Filled Syringes24/25 Paediatric Clinical Trials26/27 Social Media in the Pharmaceutical Industry31/1 Biomarkers SummitFEBRUARY 201102/03 Adaptive Designs in Clinical Drug Development07/08 Parallel Trade21/22 Advances & Progress in Drug Design23/24 Stem CellsMARCH 201107/08 Imaging in Cancer Drug Development14/15 Pharmacovigilance16/17 Superbugs & Superdrugs23/24 Accelerating Patient Recruitment & Retention in Clinical Trials30/31 Controlled ReleaseAPRIL 201113/14 Asthma & COPDMAY 201111/12 Generics, Supergenerics and Patent Strategies16/17 Clinical Trial LogisticsJUNE 201101/02 Pain Therapeutics27/28 Nanotechnology27/28 RNAi29/30 Pharmaceutical Portfolio & Product Lifecycle Management29/30 KOL Europe (Munich, Germany)JULY 201106/07 BioBanking06/07 ADMET11/12 Freeze Drying18/19 Clinical Trial Logistics Asia (Singapore)20/21 Pre-Filled Syringes Asia (Singapore) SPONSORSHIP AND EXHIBITION OPPORTUNITIESAll conferences take place in central London, UK – unlessindicated otherwise in brackets SMi offer sponsorship, exhibition, advertising andbranding packages, uniquely tailored to complement your companys marketing strategy. Primenetworking opportunities exist to entertain, enhanceand 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: 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:
  6. 6. CONTROLLED RELEASE 4 WAYS TO REGISTER your booking form to +44 (0) 870 9090 712 POST your booking form to: Events Team, SMi Group Ltd, Great GuildfordPHONE 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 DISCOUNTDELEGATE 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 DISTRIBUTIONUnique Reference Number □ Distribution of your company’s promotionalOur Reference LVY13 GROUP DISCOUNTS AVAILABLE literature to all conference attendees £999.00 + VAT £1173.83 CD ROMS/DOCUMENTATIONTitle: Forename:Surname: The Conference fee includes refreshments, lunch, conference papers andJob Title: CD ROM containing all of the presentations.Department/Division: □ Please contact me to book my hotelCompany/Organisation:Please complete fully and clearly in capital letters. Please photocopy for additional delegates. Copthorne Tara Hotel, Scarsdale Place, Kensington, London, W8 5SREmail: PAYMENTAddress: Alternatively call us on +44 (0) 870 9090 711, email: or fax +44 (0) 870 9090 712Town/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 TotalMobile: □ The Conference Presentations on CD ROM £499.00 + VAT £586.33Switchboard: □ The Conference Presentations - paper copy £499.00 - £499.00Terms and Conditions of Booking (or only £300 if ordered with a CD ROM)Signature: Date:ACCOUNTS DEPTTitle: Forename:Surname:Email: Payment must be made to SMi Group Ltd, and received before the event, by one of theI agree to be bound by SMis 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 00936418Post/Zip Code: Country: □ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU Swift (BIC): LOYDGB21013, Account 00936418Direct 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 SMis 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 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 bepaid immediately and prior to the start of the event. If payment has not been received then credit carddetails 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, anotherdelegate to take your place at any time prior to the start of the event. Two or more delegates maynot ‘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 asubstitute, then we will refund/credit 50% of the due fee less a £50 administration charge, providingthat 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 Conferencedocumentation on CD ROM to any delegate who has paid but is unable to attend for any reason. Dueto the interactive nature of the Briefings we are not normally able to provide documentation in thesecircumstances. We cannot accept cancellations of orders placed for Documentation or CD ROM asthese are reproduced specifically to order. If we have to cancel the event for any reason, then we willmake 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 Act1998 and we may use this to contact you by telephone, fax, post or email to tell you about otherproducts and services. Unless you tick here □ we may also share your data with third parties offeringcomplementary products or services. If you have any queries or want to update any of the data thatwe hold then please contact our Database Manager or visit ourwebsite quoting the URN as detailed above your address on theattached letter.