SMi Group's inaugural Ophthalmic Drugs 2017 conference

SMi Group's inaugural Ophthalmic Drugs 2017 conference

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  www.ophthalmicdrugs.com Register online orfax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 @SMIPHARM #ophdrugs CHAIRS FOR 2017: Naj Sharif, Executive Director in R&D, Head, Global Alliances & External Research, Santen Inc Mitchell de Long, Vice President, Chemistry, Aerie Pharmaceuticals KEYNOTE SPEAKERS INCLUDE: Michael Lai, Global Program Medical Director, Novartis Sérgio Leal, Ophthalmologist Director, Global Clinical Leader, Bayer Victor Chong, Global Head of Ophthalmology, Boehringer Ingelheim Amir Shojaei, Vice President Therapeutic Area Head, Ophthalmology, Shire Tomas Navratil, Senior Vice President, Development, Envisia Therapeutics Aniz Girach, Chief Medical Officer, NightstaRx FEATURED HIGHLIGHTS: • Case studies and developments in pre-clinical and clinical trial design and application • New approaches to drug delivery to the back of the eye and nanotechnology • Discover innovation in diagnostic technology • Regulatory keynote on medical devices and human factors • Tackle challenges in clinical trial recruitment and retention • Explore various combination products improving health outcomes • Exciting insight into stem cell and gene therapy CONFERENCE: 28TH-29TH NOV 2017 COPTHORNE TARA HOTEL, LONDON, UK SMi Presents the Launch of… Ophthalmic Drugs Strengthening the ocular drug pipeline through advancements in pre-clinical and clinical research BOOK BY AUGUST 31ST TO SAVE £300 BOOK BY SEPTEMBER 29TH TO SAVE £200 BOOK BY OCTOBER 31ST TO SAVE £100 Sponsored by
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  Ophthalmic Drugs Day One| Tuesday 28th November 2017 www.ophthalmicdrugs.com 8.30 Registration & Coffee 9.00 Chair’s Opening Remarks Naj Sharif, Executive Director in R&D, Head, Global Alliances & External Research, Santen Inc NOVEL APPROACHES TO THE TREATMENT OF OCULAR DISEASES OPENING ADDRESS 9.10 Novel LFA-1 Antagonist for treatment of Dry Eye Disease – Results from 5 adequate and well controlled trials of Lifitegrast • Challenges in drug development for Dry Eye disease • Development Rationale behind lifitegrast • Clinical results from four 12-week efficacy and safety studies and one long term (1-year) safety study Amir Shojaei, Vice President Therapeutic Area Head, Ophthalmology, Shire 9.50 Novel pharmaceutical approaches in the treatment of presbyopia • Current management of presbyopia and unmet needs • Potential therapeutic targets in presbyopia • Overview of investigational drugs for the treatment of presbyopia Michael Lai, Global Program Medical Director, Novartis 10.30 Morning Coffee 11.00 Innovative medical devices: Revolutionising the treatment of dry eyes • Receiving FDA approval for medical devices and the hurdles to overcome • Using electrical stimulation to increase natural tear production in adults • Patient reception to the device in clinical trials and how this compares to other drugs on the market • What does the future hold for medical devices in the treatment of various ocular diseases? Speaker TBC 11.40 Development of a lentiviral vector platform for the treatment of chronic ocular disease • Introduction to the LentiVector® platform • Experience in translating from preclinical studies to First-in- Man clinical trials • Demonstration of long-term clinical gene expression in patients with advanced wet age-related macular degeneration • Current challenges and future goals Scott Ellis, Head of Early Development, Oxford BioMedica 12.20 Networking Lunch ADVANCEMENTS IN OPHTHALMIC CLINICAL TRIALS 13.30 Preclinical ophthalmic drug discovery: challenges and advances • Preclinical models • Advances in imaging modalities • Functional read-outs • Reference compounds Giedrius Kalesnykas, Chief Executive Officer, Experimentica Ltd PANEL DISCUSSION: 14.10 Applications of emerging computer technologies to drug development • Application of emerging technologies to change the traditional trial designs: Almira Chabi, Senior Director, Santen Inc • Applications of blockchain in pharma and drug development: Francis Kendall, Technology Evaluation and Integration Leader Strategic Innovation, Roche • The changing regulatory landscape in the context of emerging technologies: Malcolm Barratt-Johnson, Managing Director, PharmaMedic Consultancy Ltd Panel Chair: Almira Chabi, Senior Director, Santen Inc Panellists: Almira Chabi, Senior Director, Santen Inc Francis Kendall, Technology Evaluation and Integration Leader Strategic Innovation, Roche Malcolm Barratt-Johnson, Managing Director, PharmaMedic Consultancy Ltd 14.50 Afternoon Tea OPTIMISING CLINICAL STUDIES IN OPHTHALMOLOGY 15.20 Novel endpoints in ophthalmic clinical trials • What are the key endpoints being explored now and in the future? • What are the advantages and disadvantages of each key endpoint? • Regulators’ feedback is relating to these endpoints • What endpoints are realistically measurable in the timescale? Aniz Girach, Chief Medical Officer, NightstaRx CLOSING KEYNOTE 16.00 Delivering breakthrough results in ophthalmology • The virtue of only doing one new thing at a time • Building value through your IP portfolio • Set and enforce success criteria • Take reasonable risks as fast as possible Mitchell de Long, Vice President, Chemistry, Aerie Pharmaceuticals 16.40 Chair’s Closing Remarks and Close of Day One Register online at www.ophthalmicdrugs.com Experimentica Ltd. is a Finland-based contract research organisation (CRO) dedicated to developing and offering preclinical ocular models and services to clients in the pharmaceutical, biotech and academic sectors. Founded in 2013 Experimentica Ltd. offers exclusively in-house expertise and an industry-leading portfolio of functional assays and in vivo imaging for preclinical ocular models. The mission of Experimentica Ltd. is to bridge a gap between the development of novel ocular models and their use in developing clinical applications. www.experimentica.com Sponsored by
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  Ophthalmic Drugs www.ophthalmicdrugs.com DayTwo | Wednesday 29th November 2017 8.30 Registration & Coffee 9.00 Chair’s Opening Remarks Mitchell de Long, Vice President, Chemistry, Aerie Pharmaceuticals COMBATING CHALLENGES IN DRUG RELEASE AND DELIVERY OPENING ADDRESS 9.10 Utilising nanotechnology technology to formulate and develop extended release therapies for glaucoma, cataract, AMD, and DME indications • Extended release drug delivery approaches in ophthalmology will be discussed together with their implementation via particle engineering towards future extended release medicines • The covered extended release therapies will include IOP lowering therapies for glaucoma, anti-inflammatory therapies for post-operative inflammation and pain following cataract surgery, anti-inflammatory therapies for the DME, and anti-VEGF therapies for AMD and DME • The stages of development will span from in vitro/in vivo proof of concept, clinical proof of concept, and Phase 3 study designs and approaches Tomas Navratil, Senior Vice President, Development, Envisia Therapeutics 9.50 36 month intra-vitreal steroid implant for chronic diabetic macular oedema • The evolution of treatment options for patients with DMO • Product design and development • Trials and tribulations - The challenges encountered in clinical development and market access • The importance of Real World Data Steve Morris, VP, Medical Director, UK and Head of Medical Affairs EU, Alimera Sciences 10.30 Morning Coffee 11.00 Non-invasive therapies for diabetic macular oedema and non-proliferative diabetic retinopathy • Current gold standard – anti-VEGF / steroids /conventional laser • Oral therapy for DME • Oral therapy for NPDR • Light and laser therapy for DME Victor Chong, Global Head of Ophthalmology, Boehringer Ingelheim COMBINATION PRODUCTS FOR OCULAR DISEASES AND COLLABORATION 11.40 Novel prostaglandins, conjugate products and MIGS for glaucoma treatment • Omidenepag Isopropyl: a novel agonist of prostaglandin EP2 receptors to lower IOP • The use of conjugate drugs and combination products • InnFocus Microshunt MIGS Device for robust IOP reduction Naj Sharif, Executive Director in R&D, Head, Global Alliances & External Research, Santen Inc 12.20 Networking Lunch COMMERCIAL POTENTIAL OF OCULAR DRUGS AND IMPROVED PATIENT CARE 13.30 Current challenges for clinical development in ophthalmology • Currently accepted regulatory endpoints for clinical trials in ophthalmology • Defining unmet needs • Resetting the bar for relevant efficacy gains • Bridging the gap between patient complaints and outcome measures Sérgio Leal, Ophthalmologist Director, Global Clinical Leader, Bayer 14.10 The quality of life and patient reported outcomes’ impact on gaining access for dry eye disease • PRO (patient reported outcome) measures in Dry Eye Disease • Quality of life impact for patients with Dry Eye Disease. • End points in clinical trials, and their link to both clinical relevance and QoL for patients with dry eye disease • Creating utility values from general PRO measures (EQ5d, SF36...etc) • Filling in the gap to achieve reimbursement Amer Omar, Head of Health Technology Assessment/ Health Economics, Ophthalmology 14.50 Afternoon Tea REGULATORY CONSIDERATIONS 15.20 New technologies in ophthalmic drug delivery • Poor patient compliance is a major impediment to effective treatments in eye care • Preservatives are often associated with negative side effects and consequently do affect patient adherence • Novel drug delivery systems can contribute to patient adherence and have even been approved by the FDA • Monitoring systems for clinical trials are a revolutionary method to ease work of clinicians and make clinical data more reliable Matthias Birkhoff, Vice President Business Development, Aptar Pharma 16.00 Adhering to regulations while establishing effective clinical development strategies • Detailing key early decision points in the clinical development of ocular therapeutics • How can early decisions shape the course of entire clinical programs and what can we learn from past failures in this critical early stage progression? • Novel approaches and the impact they will have on the current clinical model Speaker TBC 16.40 Chair’s Closing Remarks and Close of Day Two Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 Leica Microsystems develops and manufactures microscopes and scientific instruments for the analysis of microstructures and nanostructures. It is one of the market leaders in compound and stereo microscopy, digital microscopy, confocal laser scanning microscopy with related imaging systems, electron microscopy sample preparation, and surgical microscopes. www.leica-microsystems.com/home/ Sponsored by
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  LEADING MEDIA PARTNERS OFFICIALPUBLICATIONS SUPPORTING MEDIA PARTNERS MEDIA PARTNERS Want to know how you can get involved? Interested in promoting your services to this market? Contact Pavan Solanki, SMi Marketing on +44 (0) 20 7827 6048 or email: [email protected]
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  SMi PHARMACEUTICAL EVENT PLANNER2017 SEPTEMBER Cancer Vaccines 27th - 28th September 2017, London, UK Biosimilars and Biobetters 27th - 28th September 2017, London, UK OCTOBER European Pharmaceutical Pricing & Reimbursement 11th - 12th October 2017, London, UK Orphan Drugs and Rare Diseases 18th - 19th October 2017, London, UK NOVEMBER Superbugs & Superdrugs USA 13th - 14th November 2017, New Jersey, USA Pharmaceutical Microbiology East Coast 13th - 14th November 2017, New Jersey, USA Lyophilization USA 16th - 17th November 2017, New Jersey, USA Biosimilars North America 15th - 16th November 2017, New Jersey, USA Ophthalmic Drugs 28th - 29th November 2017, London, UK DECEMBER Cold Chain Distribution 13th - 14th December 2017, London, UK SPONSORSHIP AND EXHIBITION OPPORTUNITIES 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: [email protected]
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  Please complete fullyand clearly in capital letters. Please photocopy for additional delegates. Title: Forename: Surname: Job Title: Department/Division: Company/Organisation: Email: Company VAT Number: Address: Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: Mobile: Switchboard: Signature: Date: I agree to be bound by SMi’s Terms and Conditions of Booking. ACCOUNTS DEPT Title: Forename: Surname: Email: Address (if different from above): Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: OPHTHALMIC DRUGS Conference: 28th - 29th November 2017, Copthorne Tara Hotel, London, UK 4 WAYS TO REGISTER FAX your booking form to +44 (0) 870 9090 712 PHONE on +44 (0) 870 9090 711 ONLINE at www.ophthalmicdrugs.com POST your booking form to: Events Team, SMi Group Ltd, Ground & First Floor, 1 Westminster Bridge Road London, SE1 7XW If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at [email protected] 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. Access to the Document Portal will not be given 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 conferences documentation via the Document Portal 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 the Document Portal 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. Unique Reference Number Our Reference P-259 Terms and Conditions of Booking DELEGATE DETAILS Payment must be made to SMi Group Ltd, and received before the event, by one of the following methods quoting reference P-259 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: □ UK BACS Sort Code 300009, Account 00936418 □ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU Swift (BIC): LOYDGB21013, Account 00936418 IBAN GB48 LOYD 3000 0900 9364 18 □ Cheque We can only accept Sterling cheques drawn on a UK bank. □ Credit Card □ Visa □ MasterCard □ American Express All credit card payments will be subject to standard credit card charges. Card No: □□□□ □□□□ □□□□ □□□□ Valid From □□/□□ Expiry Date □□/□□ CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card Cardholder’s Name: Signature: Date: I agree to be bound by SMi’s Terms and Conditions of Booking. Card Billing Address (If different from above): DOCUMENTATION I cannot attend but would like to Purchase access to the following Document Portal/Paper Copy documentation. Price Total □ Access to the conference documentation on the Document Portal £499.00 + VAT £598.80 □ The Conference Presentations – paper copy £499.00 - £499.00 (or only £300 if ordered with the Document Portal) PAYMENT VAT VAT at 20% is charged on the attendance fees for all delegates. VAT is also charged on Document portal and literature distribution for all UK customers and for those EU Customers not supplying a registration number for their own country here CONFERENCE PRICES GROUP DISCOUNTS AVAILABLE I would like to attend: (Please tick as appropriate) Fee TOTAL □ Conference only £1499.00 + VAT £1798.80 PROMOTIONAL LITERATURE DISTRIBUTION □ Distribution of your company’s promotional literature to all conference attendees £999.00 + VAT £1198.80 The conference fee includes refreshments, lunch, conference papers, and access to the Document Portal. Presentations that are available for download will be subject to distribution rights by speakers. Please note that some presentations may not be available for download. Access information for the document portal will be sent to the e-mail address provided during registration. Details are sent within 24 hours post conference. VENUE Copthorne Tara Hotel, Kensington, London, UK □ Please contact me to book my hotel Alternatively call us on +44 (0) 870 9090 711, email: [email protected] or fax +44 (0) 870 9090 712 □ Book by August 31st to receive £300 off the conference price □ Book by September 29th to receive £200 off the conference price □ Book by October 31st to receive £100 off the conference price EARLY BIRD DISCOUNT