SMi Group are thrilled to announce the launch of the Ophthalmic Drugs Conference, being held on the 28-29 November 2017 at the Copthorne Tara Hotel in London, UK. www.ophthalmicdrugs.com/slideshare
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Ophthalmic Drugs 2017
1. www.ophthalmicdrugs.com
Register online or fax 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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2. 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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3. Ophthalmic Drugs
www.ophthalmicdrugs.com Day Two | 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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4. LEADING MEDIA PARTNERS
OFFICIAL PUBLICATIONS
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: psolanki@smi-online.co.uk
P-259 Opthalmic Drugs.indd 4 7/7/17 12:50 PM
5. SMi PHARMACEUTICAL
EVENT PLANNER 2017
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:
amalick@smi-online.co.uk
P-259 Opthalmic Drugs.indd 5 7/7/17 12:50 PM
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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
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VENUE Copthorne Tara Hotel, Kensington, London, UK
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