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PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS
Wednesday, 28th November, Copthorne Tara Hotel, London, United Kingdom
B: Are Eye Drops the Best Route for Ophthalmic Therapy?
13.30 - 16.50
Workshop Leaders:
Sunil Shah, Professor, Aston University
Afzal Mohammed, Professor, Aston University
A: Practical Applications of Artificial Intelligence
in Drug Discovery, Development and Clinical Trials
08.30 - 12.30
Workshop Leader:
Andrew Radin, CEO, twoXAR
www.ophthalmicdrugs.com
Register online or fax your registration to
+44 (0) 870 9090 712 or call +44 (0) 870 9090 711
SMi Pharma
@SMiPharm
#ophdrugs
CHAIRS FOR 2018:
Mitchell de Long, Vice President, Chemistry,
Aerie Pharmaceuticals
Naj Sharif, Executive Director and Head, Global
Alliances & External Research, Santen Inc.
KEY SPEAKERS INCLUDE:
Majid Anderesi, Associate Group Clinical Director,
Ophthalmology, Roche
Caroline Barelle, CEO,
Elasmogen Ltd.
Victor Chong, Global Head of Ophthalmology,
Boehringer Ingelheim
Daniel Chung, Clinical Ophthalmic Lead,
Spark Therapeutics
Aniz Girach, Chief Medical Officer,
Nightstar Therapeutics
Peter Morgan-Warren, Medical Assessor, Licensing
Division, MHRA
David Silverman, Clinical Director, Ophthalmology,
Roche
HIGHLIGHTS IN 2018:
• Discover recent advances in the treatment of glaucoma
• Gain insight into the first FDA-approved gene therapy,
developed for the treatment of inherited retinal
dystrophy
• Discuss case studies on novel non-invasive and site-
specific drug delivery strategies
• Examine the applications of artificial intelligence in drug
discovery
• Explore the use of biomarkers and surrogate end-points
from a regulatory perspective
Sponsored by
REGISTER BY JUNE 29TH TO SAVE £300
REGISTER BY SEPTEMBER 28TH TO SAVE £200
REGISTER BY OCTOBER 31ST TO SAVE £100
Ophthalmic Drugs
Exploring the future through ocular gene editing
and strategic drug delivery
COPTHORNE TARA HOTEL, LONDON, UK
CONFERENCE:
26TH - 27TH
WORKSHOPS:
28TH
NOV
2018
SMi Presents the 2nd Annual Conference...
08.30 Registration & Coffee
09.00 Chairman’s Opening Remarks
Naj Sharif, Executive Director in R&D, Head, Global Alliances
& External Research, Santen Inc, USA
ADVANCEMENTS IN TREATMENT OF OCULAR DISEASE
OPENING ADDRESS
09.10 New strategies for treating retinal vascular diseases
• Overview for pathogenesis of ischaemic retinopathies
• Cellular and molecular mechanisms of diseases
• Targeting new pathways
• Positioning preclinical evidence in the clinical setting to aid
translation
• Conclusions and future directions
Alan Stitt, Dean of Innovation and Impact,
Queen’s University Belfast
09.50 Gene delivery & gene editing in the retina
• Overview of methods for “in vivo” delivery to the retina
• Gene delivery to different cell types in the retina
• Crispr/Cas9 mediated gene editing in the retina
Abraham Scaria, Vice President and Head, Ophthalmology,
Casebia Therapeutics
10.30 New horizon for treatment of inherited retinal dystrophy
• Voretigene: The first gene therapy approved in
ophthalmology
• Other up-coming gene therapy trials in the pipeline
• Market access difficulties for gene therapy
Dr. Daniel Chung, Clinical Ophthalmic Lead,
Spark Therapeutics
11.10 Morning Coffee
KEYNOTE ADDRESS:
11.40 Current unmet needs for geographic atrophy; where are we
now and where should we go?
• Current unmet needs for Geographic Atrophy
• Is Complement pathway the right place to go?
• What about neuroprotection?
• Is choroidal more important than the RPE in GA?
Victor Chong, Head of Ophthalmology, Boehringer Ingelheim
12.20 Genetically defined therapies in dry AMD
• Role of genetics in dry AMD
• Gyroscopes approach to the treatment of dry AMD
• Optimized drug delivery
Soraya Bekkali, CEO, Gyroscope Therapeutics
13.00 Networking Lunch
NOVEL APPROACHES TO DELIVERY OF OCULAR DRUGS
14.10 The future of ophthalmic delivery: preservative-free and
connected devices
• Understand the importance of patients’ adherence and
the cause of the poor adherence today
• Improve patients’ adherence by providing an easy to use,
convenient and ergonomic system
• Answer patients’ unmet needs by adding electronic
guidance and connectivity
Fanny Sellier, Global Category Manager for Ophthalmic
Devices, Nemera
KEYNOTE ADDRESS:
14.50 Drug delivery strategies for retinal diseases
• Drug delivery to the posterior ocular segment: Challenges
• Diseases affecting the posterior segment
• Conventional versus novel routes for the drug delivery to
the posterior segment
• Conclusion
Majid Anderesi, Associate Group Clinical Director,
Ophthalmology, Roche
15.30 Afternoon Tea
16.00 Non-invasive drug delivery technology (EvoluteTM) for
anterior segment ocular disease
• Overview of non-invasive drug delivery technology for
anterior segment ocular disease
• Results of a Phase II trial with nepafenac for post-surgical
pain and inflammation
Bob Butchofsky, CEO, Mati Therapeutics
16.40 soloMERs™ - site-specific biologics for ocular disease
• Advantages of soloMERs
• Isolation and characterisation of target specific soloMERs
• Efficacy in pre-clinical models of disease
• Elasmogen’s ocular portfolio
Caroline Barelle, CEO, Elasmogen Ltd
17.20 Chairman’s Closing Remarks and Close of Day One
Ophthalmic Drugs
Day One | Monday 26th November 2018 www.ophthalmicdrugs.com
Register online at www.ophthalmicdrugs.com
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, Director on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk
Sponsored by
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
Nemera is a world leader in the design, development and manufacturing of drug delivery
devices for the pharmaceutical, biotechnology and generics industries. Nemera’s services and
products cover several key delivery routes: Ophthalmic, Parenteral, Nasal, Buccal, Auricular,
Pulmonary, Dermal and Transdermal. Nemera always puts patients first, providing the most
comprehensive range of devices in the industry, including off-the-shelf innovative systems,
customized design development and contract manufacturing. In particular, we provide millions
of multidose eye droppers for preservative-free formulations. www.nemera.net
Leading Media Partners:
08.30 Registration & Coffee
09.00 Chairman’s Opening Remarks
Mitchell de Long, Vice President, Chemistry,
Aerie Pharmaceuticals
ADVANCEMENTS IN THE TREATMENT OF GLAUCOMA
OPENING ADDRESS
09.10 Glaucoma / retinoprotection treatments
• Recently approved & novel drugs in view
• Novel devices to lower & control IOP
• A case for & pathways to retinoprotection
Naj Sharif, Executive Director and Head, Global Alliances
& External Research, Santen Inc, USA
KEYNOTE ADDRESS:
09.50 The discovery and SAR of netarsudil, the first FDA-approved
ROCK inhibitor for the treatment of glaucoma
• Need for new glaucoma medications after a period of
focus on surgical treatment options
• First FDA-approved ROCK inhibitor for the treatment of
glaucoma
• Future of the glaucoma landscape and back-of-the-eye
disease
Mitchell de Long, Vice President, Chemistry,
Aerie Pharmaceuticals
10.30 Morning Coffee
11.00 Standardization and validation of functional read-outs in
preclinical ocular models
• Requirement for validated reference compounds for in vivo
studies
• Utility of imaging and electrophysiology modalities in ocular
models
• Challenges associated with implementing in vivo functional
readouts
Simon Kaja, Chief Scientific Officer, Experimentica Ltd
11.40 Application of artificial intelligence in drug discovery
• Specific applications of predictive algorithms in drug
research
• How “predictions” translate into testable hypotheses and
viable drug candidates
• The future of artificial intelligence-driven drug discovery in
ophthalmology
Andrew A. Radin, CEO & Co-Founder, twoXAR
12.20 Networking Lunch
REGULATORY CHALLENGES IN OPHTHALMIC DRUG DEVELOPMENT
13.30 Regulatory considerations for clinical aspects of ocular drug
development – established and surrogate end-points
• Overview of regulatory requirements for clinical approval of
ophthalmic drugs
• Trends in clinical trial efficacy end-points
• Regulatory view on use of biomarkers and surrogate end-
points in marketing authorisation submissions
• Considerations for rare diseases – conditional marketing
authorisations and exceptional circumstances
Dr Peter Morgan Warren, Medical Assessor, MHRA
KEYNOTE ADDRESS:
14.10 Global reimbursement strategies in ophthalmic clinical
development
• Introduction to global payer requirements
• HTA Core Model
• Use of patient reported outcomes in ophthalmic clinical
trials
• Structuring clinical development plans to meet payer
requirements
David Silverman, Senior Clinical Director,
Ophthalmology, Roche
14.50 Afternoon Tea
15.20 The challenge of replicating clinical trial performance of
intravitreal therapies in the ophthalmology clinic
• Review the development of practice in treatment of
diabetic macular oedema
• The challenges of accepting innovation into everyday
practice
• The emergence of “Real-World” data collection and lessons
learned
• A look into the future
Philip Ashman, Senior Vice President, Managing Director
Europe, Alimera Sciences
16.00 Natural history of disease studies in rare diseases
• The value of running Natural History of Disease studies,
especially in rare diseases
• Why run Natural History of Disease studies?
• Regulatory aspects of running Natural History of Disease
studies
• Natural History of Disease studies as part of running
Innovative trial designs
Aniz Girach, Chief Medical Officer, Nightstar Therapeutics
16.40 Chairman’s Closing Remarks and Close of Day Two
Ophthalmic Drugs
www.ophthalmicdrugs.com Day Two | Tuesday 27th November 2018
Official Media Partners:
Supporters:
Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
MARKETING PARTNERSHIP OPPORTUNITIES
SMi Group is offering companies the opportunity to partner on our dedicated events in order to help raise your company profile,
add value, create awareness of your products/services to our key audience within the pharmaceutical industry. Interested in partnering?
Contact Pav Solanki, Marketing Manager on +44 (0) 207 827 6048 or email: psolanki@smi-online.co.uk
We are proud to be partners with:
SEPTEMBER 2018
Immuno-Oncology
26th – 27th September 2018, London, UK
Biosimilars And Biobetters
26th - 27th September 2018, London, UK
OCTOBER 2018
Cell & Gene Therapy
10th - 11th October 2018, London, UK
Orphan Drugs
17th - 18th October 2018, London, UK
NOVEMBER 2018
Superbugs & Superdrugs USA
12th - 13th November 2018, New Jersey, USA
Biosimilars North America
14th - 15th November 2018, New Jersey, USA
Lyophilization USA
15th - 16th November 2018, New Jersey, USA
Ophthalmic Drugs
26th - 27th November 2018, London, UK
DECEMBER 2018
Cold Chain Distribution
10th - 11th December 2018, London, UK
SMi PHARMACEUTICAL EVENT PLANNER 2018
Practical Applications of Artificial
Intelligence in Drug Discovery, Development
and Clinical Trials
Workshop Leader:
Andrew Radin, CEO, twoXAR
Workshop Overview:
Considering the significant interest in artificial intelligence
(AI), this workshop will cover some of the basic underlying
concepts of what AI is, what it isn’t, and how it’s being
applied in drug development.
Why should you attend this workshop:	
•	Close the gap between the hype and practical
applications of AI
•	Understand the conceptual basics of AI to have
productive conversations internally and with partners
•	Consider an alternate approach to traditional
biopharmaceutical methods
Agenda:	
08.30	 Registration  Coffee
9.00	 Workshop leader introduction
9.10	What is artificial intelligence?
	 •	 Defining artificial intelligence
	 •	 The “black box”
	 •	 Basics and how artificial intelligence works
9.50	 Misconceptions surrounding artificial intelligence
	 •	 General vs narrow artificial intelligence
	 •	 What is the hype all about?
	 •	 Constant evolution of artificial intelligence
10.40 	 Morning Coffee and Networking Break
11.10	Examples of everyday application of artificial
intelligence
	 •	How are you applying artificial intelligence?
	 •	How are other companies applying artificial
intelligence?
	 •	Looking ahead: Future applications of artificial
intelligence
11.50	 Examples of application of AI in biopharma
	 •	Current applications of artificial intelligence in
the biopharmaceutical industry
	 •	Methods vs output
	 •	Potential future applications
12.30	 Close of workshop
About the Workshop Leader:	
Andrew Radin
Andrew A. Radin is Cofounder and Chief Executive Officer
of twoXAR, a company dedicated to transforming how
large biological datasets are harnessed to accelerate the
identification and validation of new medicines. Andrew
developed the company’s proprietary algorithm and
leads product development. Prior to co-founding twoXAR,
Andrew held Chief Technology Officer roles at several
early stage companies where he managed teams as
large as a hundred technologists distributed around the
world. Andrew studied biomedical informatics in Stanford
University’s SCPD graduate program and holds Master of
Science and Bachelor of Science degrees in computer
science from Rochester Institute of Technology.
About the Organisation:
twoXAR is an artificial intelligence-
driven biopharmaceutical company.
The company leverages its computa-
tional platform to identify promising drug candidates,
de-risks the opportunities through preclinical studies, and
progresses drug candidates to the clinic through industry
partnerships. Based in Palo Alto, California, the twoXAR
team includes experts in drug discovery and development,
biomedical informatics, computational biology, data
science and software development.
HALF-DAY POST-CONFERENCE WORKSHOP A
Wednesday 28th November 2018
Copthorne Tara Hotel, Central London, UK
08.30 – 12.30
HALF-DAY POST-CONFERENCE WORKSHOP B
Wednesday 28th November 2018
Copthorne Tara Hotel, Central London, UK
13.30 – 16.50
Are Eye Drops the Best Route
for Ophthalmic Therapy?
Workshop Leaders:
Sunil Shah, Professor, Aston University
Afzal Mohamed, Professor, Aston University
Workshop Overview:
Eye drops have long been the mainstay of ophthalmic drug
delivery. Yet they cause ocular surface problems and often
traverse the cornea poorly with little reaching the posterior
segment. Is there anything we can do about this? The aim
of any therapy would be to have good compliance and
effective and easy drug delivery.
This workshop allows an in-depth view in to the different
technologies that are available to either effect improved
results from topical therapy (be it drops, gels or ointments)
and also the limitations and uses of both externally and
internally implantable drug delivery devices.
Why should you attend this workshop:	
The workshop will allow you to gain a full understanding of
the technology available at present and its limitations.
Agenda:	
13.00 	 Registration  Coffee
13.30 	 Workshop leader introduction
13.40 	 Nanotechnology
14.20 	 Liposomes and other drop related delivery
devices e.g. iontophoresis
15.00 	 Afternoon Tea
15.30 	 Externally implantable devices
16.10 	 Internally implantable devices
16.50 	 Close of workshop
About the Workshop Leaders:	
Sunil Shah qualified from St. Georges Hospital Medical
School and completed his post-graduate training in
Torquay, Exeter, Manchester and Nottingham. He has
been a Consultant at the Birmingham and Midland Eye
Centre since 2000 where he runs a cornea and cataract
service. Professor Shah is a Section Editor for the British
Journal of Ophthalmology and a reviewer for Eye,
American Journal of Ophthalmology, Ophthalmology,
Investigative Ophthalmology and Visual Sciences, Contact
Lens and Anterior Eye, Journal of Cataract and Refractive
Surgery and Journal of Refractive Surgery. He is also an
honorary Professor at the University of Ulster, a Professor at
Aston University and an honorary Professor at UKM Medical
Centre, Malaysia. Professor Shah also provides specialist
advice to NICE and is a representative for the Royal College
of Ophthalmologists to the British Standards Institute. He is
the Principle Editor and E Tutor for the E-learning course in
Refractive surgery for the University of Ulster. He represents
the Royal College of Ophthalmologists on its refractive
sub-committee and its academic committee and he is a
past President of the British Society for Refractive Surgery
and a past council member for the British Contact Lens
Association.
Afzal Mohammed is Professor of Pharmaceutics and Head
of Pharmaceutics at Aston University. He is an internationally
leading scientist and a key opinion leader in paediatric
formulation development. The translational interface of his
research is funded by grants from various bodies including
MRC, EPSRC, BBSRC and NC3R as well as funding from
various international pharmaceutical companies and
INNOVATE UK. He has presented his research findings at
major national and international conferences and was
awarded Fellowship of the Academy of Pharmaceutical
Sciences in 2017. Research from his group has led to a
total of 102 publications which include research articles,
review papers, journal editorials, book chapters, PhD
theses, published conference proceedings and patent
applications as well as over 80 abstracts at various national
and international conferences. Afzal serves as an Associate
Editor for the Journal of Pharmaceutics as well as BMC
Journal of Pharmacology and Toxicology and is on the
editorial board for four other journals including Nature
Scientific Reports. Afzal Mohammed is the lead inventor
of a patented novel dry particle coating technology (WO
2016/066462 A1). He set up Aston Particle Technologies Ltd
(www.astonparticletechnologies.com) in July 2016 to unlock
the commercial potential for the technology.
OPHTHALMIC DRUGS
Conference: Monday 26th  Tuesday 27th November 2018, Copthorne Tara Hotel, London, UK
Workshops: Wednesday 28th November 2018, Copthorne Tara Hotel, London, UK
4 WAYS TO REGISTER
ONLINE at www.ophthalmicdrugs.com
FAX your booking form to +44 (0) 870 9090 712
PHONE on +44 (0) 870 9090 711
POST your booking form to: Events Team, SMi Group Ltd,
Ground  First Floor, 1 Westminster Bridge Road London, SE1 7XW, UK
If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email events@smi-online.co.uk
EARLY BIRD
DISCOUNT
□ Book by 29th June to receive £300 off the conference price
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Payment must be made to SMi Group Ltd, and received before the event, by one of
the following methods quoting reference P-270 and the delegate’s name. Bookings
made within 7 days of the event require payment on booking, methods of payment:
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PAYMENT
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
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______________________________________________________________________________________
VAT
I cannot attend but would like to purchase access to the following
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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.
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VENUE Copthorne Tara Hotel, Scarsdale Place, Kensington, London W8 5SY

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SMi Group's Ophthalmic Drugs 2018

  • 1. PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS Wednesday, 28th November, Copthorne Tara Hotel, London, United Kingdom B: Are Eye Drops the Best Route for Ophthalmic Therapy? 13.30 - 16.50 Workshop Leaders: Sunil Shah, Professor, Aston University Afzal Mohammed, Professor, Aston University A: Practical Applications of Artificial Intelligence in Drug Discovery, Development and Clinical Trials 08.30 - 12.30 Workshop Leader: Andrew Radin, CEO, twoXAR www.ophthalmicdrugs.com Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 SMi Pharma @SMiPharm #ophdrugs CHAIRS FOR 2018: Mitchell de Long, Vice President, Chemistry, Aerie Pharmaceuticals Naj Sharif, Executive Director and Head, Global Alliances & External Research, Santen Inc. KEY SPEAKERS INCLUDE: Majid Anderesi, Associate Group Clinical Director, Ophthalmology, Roche Caroline Barelle, CEO, Elasmogen Ltd. Victor Chong, Global Head of Ophthalmology, Boehringer Ingelheim Daniel Chung, Clinical Ophthalmic Lead, Spark Therapeutics Aniz Girach, Chief Medical Officer, Nightstar Therapeutics Peter Morgan-Warren, Medical Assessor, Licensing Division, MHRA David Silverman, Clinical Director, Ophthalmology, Roche HIGHLIGHTS IN 2018: • Discover recent advances in the treatment of glaucoma • Gain insight into the first FDA-approved gene therapy, developed for the treatment of inherited retinal dystrophy • Discuss case studies on novel non-invasive and site- specific drug delivery strategies • Examine the applications of artificial intelligence in drug discovery • Explore the use of biomarkers and surrogate end-points from a regulatory perspective Sponsored by REGISTER BY JUNE 29TH TO SAVE £300 REGISTER BY SEPTEMBER 28TH TO SAVE £200 REGISTER BY OCTOBER 31ST TO SAVE £100 Ophthalmic Drugs Exploring the future through ocular gene editing and strategic drug delivery COPTHORNE TARA HOTEL, LONDON, UK CONFERENCE: 26TH - 27TH WORKSHOPS: 28TH NOV 2018 SMi Presents the 2nd Annual Conference...
  • 2. 08.30 Registration & Coffee 09.00 Chairman’s Opening Remarks Naj Sharif, Executive Director in R&D, Head, Global Alliances & External Research, Santen Inc, USA ADVANCEMENTS IN TREATMENT OF OCULAR DISEASE OPENING ADDRESS 09.10 New strategies for treating retinal vascular diseases • Overview for pathogenesis of ischaemic retinopathies • Cellular and molecular mechanisms of diseases • Targeting new pathways • Positioning preclinical evidence in the clinical setting to aid translation • Conclusions and future directions Alan Stitt, Dean of Innovation and Impact, Queen’s University Belfast 09.50 Gene delivery & gene editing in the retina • Overview of methods for “in vivo” delivery to the retina • Gene delivery to different cell types in the retina • Crispr/Cas9 mediated gene editing in the retina Abraham Scaria, Vice President and Head, Ophthalmology, Casebia Therapeutics 10.30 New horizon for treatment of inherited retinal dystrophy • Voretigene: The first gene therapy approved in ophthalmology • Other up-coming gene therapy trials in the pipeline • Market access difficulties for gene therapy Dr. Daniel Chung, Clinical Ophthalmic Lead, Spark Therapeutics 11.10 Morning Coffee KEYNOTE ADDRESS: 11.40 Current unmet needs for geographic atrophy; where are we now and where should we go? • Current unmet needs for Geographic Atrophy • Is Complement pathway the right place to go? • What about neuroprotection? • Is choroidal more important than the RPE in GA? Victor Chong, Head of Ophthalmology, Boehringer Ingelheim 12.20 Genetically defined therapies in dry AMD • Role of genetics in dry AMD • Gyroscopes approach to the treatment of dry AMD • Optimized drug delivery Soraya Bekkali, CEO, Gyroscope Therapeutics 13.00 Networking Lunch NOVEL APPROACHES TO DELIVERY OF OCULAR DRUGS 14.10 The future of ophthalmic delivery: preservative-free and connected devices • Understand the importance of patients’ adherence and the cause of the poor adherence today • Improve patients’ adherence by providing an easy to use, convenient and ergonomic system • Answer patients’ unmet needs by adding electronic guidance and connectivity Fanny Sellier, Global Category Manager for Ophthalmic Devices, Nemera KEYNOTE ADDRESS: 14.50 Drug delivery strategies for retinal diseases • Drug delivery to the posterior ocular segment: Challenges • Diseases affecting the posterior segment • Conventional versus novel routes for the drug delivery to the posterior segment • Conclusion Majid Anderesi, Associate Group Clinical Director, Ophthalmology, Roche 15.30 Afternoon Tea 16.00 Non-invasive drug delivery technology (EvoluteTM) for anterior segment ocular disease • Overview of non-invasive drug delivery technology for anterior segment ocular disease • Results of a Phase II trial with nepafenac for post-surgical pain and inflammation Bob Butchofsky, CEO, Mati Therapeutics 16.40 soloMERs™ - site-specific biologics for ocular disease • Advantages of soloMERs • Isolation and characterisation of target specific soloMERs • Efficacy in pre-clinical models of disease • Elasmogen’s ocular portfolio Caroline Barelle, CEO, Elasmogen Ltd 17.20 Chairman’s Closing Remarks and Close of Day One Ophthalmic Drugs Day One | Monday 26th November 2018 www.ophthalmicdrugs.com Register online at www.ophthalmicdrugs.com 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, Director on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk Sponsored by 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 Nemera is a world leader in the design, development and manufacturing of drug delivery devices for the pharmaceutical, biotechnology and generics industries. Nemera’s services and products cover several key delivery routes: Ophthalmic, Parenteral, Nasal, Buccal, Auricular, Pulmonary, Dermal and Transdermal. Nemera always puts patients first, providing the most comprehensive range of devices in the industry, including off-the-shelf innovative systems, customized design development and contract manufacturing. In particular, we provide millions of multidose eye droppers for preservative-free formulations. www.nemera.net Leading Media Partners:
  • 3. 08.30 Registration & Coffee 09.00 Chairman’s Opening Remarks Mitchell de Long, Vice President, Chemistry, Aerie Pharmaceuticals ADVANCEMENTS IN THE TREATMENT OF GLAUCOMA OPENING ADDRESS 09.10 Glaucoma / retinoprotection treatments • Recently approved & novel drugs in view • Novel devices to lower & control IOP • A case for & pathways to retinoprotection Naj Sharif, Executive Director and Head, Global Alliances & External Research, Santen Inc, USA KEYNOTE ADDRESS: 09.50 The discovery and SAR of netarsudil, the first FDA-approved ROCK inhibitor for the treatment of glaucoma • Need for new glaucoma medications after a period of focus on surgical treatment options • First FDA-approved ROCK inhibitor for the treatment of glaucoma • Future of the glaucoma landscape and back-of-the-eye disease Mitchell de Long, Vice President, Chemistry, Aerie Pharmaceuticals 10.30 Morning Coffee 11.00 Standardization and validation of functional read-outs in preclinical ocular models • Requirement for validated reference compounds for in vivo studies • Utility of imaging and electrophysiology modalities in ocular models • Challenges associated with implementing in vivo functional readouts Simon Kaja, Chief Scientific Officer, Experimentica Ltd 11.40 Application of artificial intelligence in drug discovery • Specific applications of predictive algorithms in drug research • How “predictions” translate into testable hypotheses and viable drug candidates • The future of artificial intelligence-driven drug discovery in ophthalmology Andrew A. Radin, CEO & Co-Founder, twoXAR 12.20 Networking Lunch REGULATORY CHALLENGES IN OPHTHALMIC DRUG DEVELOPMENT 13.30 Regulatory considerations for clinical aspects of ocular drug development – established and surrogate end-points • Overview of regulatory requirements for clinical approval of ophthalmic drugs • Trends in clinical trial efficacy end-points • Regulatory view on use of biomarkers and surrogate end- points in marketing authorisation submissions • Considerations for rare diseases – conditional marketing authorisations and exceptional circumstances Dr Peter Morgan Warren, Medical Assessor, MHRA KEYNOTE ADDRESS: 14.10 Global reimbursement strategies in ophthalmic clinical development • Introduction to global payer requirements • HTA Core Model • Use of patient reported outcomes in ophthalmic clinical trials • Structuring clinical development plans to meet payer requirements David Silverman, Senior Clinical Director, Ophthalmology, Roche 14.50 Afternoon Tea 15.20 The challenge of replicating clinical trial performance of intravitreal therapies in the ophthalmology clinic • Review the development of practice in treatment of diabetic macular oedema • The challenges of accepting innovation into everyday practice • The emergence of “Real-World” data collection and lessons learned • A look into the future Philip Ashman, Senior Vice President, Managing Director Europe, Alimera Sciences 16.00 Natural history of disease studies in rare diseases • The value of running Natural History of Disease studies, especially in rare diseases • Why run Natural History of Disease studies? • Regulatory aspects of running Natural History of Disease studies • Natural History of Disease studies as part of running Innovative trial designs Aniz Girach, Chief Medical Officer, Nightstar Therapeutics 16.40 Chairman’s Closing Remarks and Close of Day Two Ophthalmic Drugs www.ophthalmicdrugs.com Day Two | Tuesday 27th November 2018 Official Media Partners: Supporters: Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 MARKETING PARTNERSHIP OPPORTUNITIES SMi Group is offering companies the opportunity to partner on our dedicated events in order to help raise your company profile, add value, create awareness of your products/services to our key audience within the pharmaceutical industry. Interested in partnering? Contact Pav Solanki, Marketing Manager on +44 (0) 207 827 6048 or email: psolanki@smi-online.co.uk We are proud to be partners with: SEPTEMBER 2018 Immuno-Oncology 26th – 27th September 2018, London, UK Biosimilars And Biobetters 26th - 27th September 2018, London, UK OCTOBER 2018 Cell & Gene Therapy 10th - 11th October 2018, London, UK Orphan Drugs 17th - 18th October 2018, London, UK NOVEMBER 2018 Superbugs & Superdrugs USA 12th - 13th November 2018, New Jersey, USA Biosimilars North America 14th - 15th November 2018, New Jersey, USA Lyophilization USA 15th - 16th November 2018, New Jersey, USA Ophthalmic Drugs 26th - 27th November 2018, London, UK DECEMBER 2018 Cold Chain Distribution 10th - 11th December 2018, London, UK SMi PHARMACEUTICAL EVENT PLANNER 2018
  • 4. Practical Applications of Artificial Intelligence in Drug Discovery, Development and Clinical Trials Workshop Leader: Andrew Radin, CEO, twoXAR Workshop Overview: Considering the significant interest in artificial intelligence (AI), this workshop will cover some of the basic underlying concepts of what AI is, what it isn’t, and how it’s being applied in drug development. Why should you attend this workshop: • Close the gap between the hype and practical applications of AI • Understand the conceptual basics of AI to have productive conversations internally and with partners • Consider an alternate approach to traditional biopharmaceutical methods Agenda: 08.30 Registration Coffee 9.00 Workshop leader introduction 9.10 What is artificial intelligence? • Defining artificial intelligence • The “black box” • Basics and how artificial intelligence works 9.50 Misconceptions surrounding artificial intelligence • General vs narrow artificial intelligence • What is the hype all about? • Constant evolution of artificial intelligence 10.40 Morning Coffee and Networking Break 11.10 Examples of everyday application of artificial intelligence • How are you applying artificial intelligence? • How are other companies applying artificial intelligence? • Looking ahead: Future applications of artificial intelligence 11.50 Examples of application of AI in biopharma • Current applications of artificial intelligence in the biopharmaceutical industry • Methods vs output • Potential future applications 12.30 Close of workshop About the Workshop Leader: Andrew Radin Andrew A. Radin is Cofounder and Chief Executive Officer of twoXAR, a company dedicated to transforming how large biological datasets are harnessed to accelerate the identification and validation of new medicines. Andrew developed the company’s proprietary algorithm and leads product development. Prior to co-founding twoXAR, Andrew held Chief Technology Officer roles at several early stage companies where he managed teams as large as a hundred technologists distributed around the world. Andrew studied biomedical informatics in Stanford University’s SCPD graduate program and holds Master of Science and Bachelor of Science degrees in computer science from Rochester Institute of Technology. About the Organisation: twoXAR is an artificial intelligence- driven biopharmaceutical company. The company leverages its computa- tional platform to identify promising drug candidates, de-risks the opportunities through preclinical studies, and progresses drug candidates to the clinic through industry partnerships. Based in Palo Alto, California, the twoXAR team includes experts in drug discovery and development, biomedical informatics, computational biology, data science and software development. HALF-DAY POST-CONFERENCE WORKSHOP A Wednesday 28th November 2018 Copthorne Tara Hotel, Central London, UK 08.30 – 12.30
  • 5. HALF-DAY POST-CONFERENCE WORKSHOP B Wednesday 28th November 2018 Copthorne Tara Hotel, Central London, UK 13.30 – 16.50 Are Eye Drops the Best Route for Ophthalmic Therapy? Workshop Leaders: Sunil Shah, Professor, Aston University Afzal Mohamed, Professor, Aston University Workshop Overview: Eye drops have long been the mainstay of ophthalmic drug delivery. Yet they cause ocular surface problems and often traverse the cornea poorly with little reaching the posterior segment. Is there anything we can do about this? The aim of any therapy would be to have good compliance and effective and easy drug delivery. This workshop allows an in-depth view in to the different technologies that are available to either effect improved results from topical therapy (be it drops, gels or ointments) and also the limitations and uses of both externally and internally implantable drug delivery devices. Why should you attend this workshop: The workshop will allow you to gain a full understanding of the technology available at present and its limitations. Agenda: 13.00 Registration Coffee 13.30 Workshop leader introduction 13.40 Nanotechnology 14.20 Liposomes and other drop related delivery devices e.g. iontophoresis 15.00 Afternoon Tea 15.30 Externally implantable devices 16.10 Internally implantable devices 16.50 Close of workshop About the Workshop Leaders: Sunil Shah qualified from St. Georges Hospital Medical School and completed his post-graduate training in Torquay, Exeter, Manchester and Nottingham. He has been a Consultant at the Birmingham and Midland Eye Centre since 2000 where he runs a cornea and cataract service. Professor Shah is a Section Editor for the British Journal of Ophthalmology and a reviewer for Eye, American Journal of Ophthalmology, Ophthalmology, Investigative Ophthalmology and Visual Sciences, Contact Lens and Anterior Eye, Journal of Cataract and Refractive Surgery and Journal of Refractive Surgery. He is also an honorary Professor at the University of Ulster, a Professor at Aston University and an honorary Professor at UKM Medical Centre, Malaysia. Professor Shah also provides specialist advice to NICE and is a representative for the Royal College of Ophthalmologists to the British Standards Institute. He is the Principle Editor and E Tutor for the E-learning course in Refractive surgery for the University of Ulster. He represents the Royal College of Ophthalmologists on its refractive sub-committee and its academic committee and he is a past President of the British Society for Refractive Surgery and a past council member for the British Contact Lens Association. Afzal Mohammed is Professor of Pharmaceutics and Head of Pharmaceutics at Aston University. He is an internationally leading scientist and a key opinion leader in paediatric formulation development. The translational interface of his research is funded by grants from various bodies including MRC, EPSRC, BBSRC and NC3R as well as funding from various international pharmaceutical companies and INNOVATE UK. He has presented his research findings at major national and international conferences and was awarded Fellowship of the Academy of Pharmaceutical Sciences in 2017. Research from his group has led to a total of 102 publications which include research articles, review papers, journal editorials, book chapters, PhD theses, published conference proceedings and patent applications as well as over 80 abstracts at various national and international conferences. Afzal serves as an Associate Editor for the Journal of Pharmaceutics as well as BMC Journal of Pharmacology and Toxicology and is on the editorial board for four other journals including Nature Scientific Reports. Afzal Mohammed is the lead inventor of a patented novel dry particle coating technology (WO 2016/066462 A1). He set up Aston Particle Technologies Ltd (www.astonparticletechnologies.com) in July 2016 to unlock the commercial potential for the technology.
  • 6. OPHTHALMIC DRUGS Conference: Monday 26th Tuesday 27th November 2018, Copthorne Tara Hotel, London, UK Workshops: Wednesday 28th November 2018, Copthorne Tara Hotel, London, UK 4 WAYS TO REGISTER ONLINE at www.ophthalmicdrugs.com FAX your booking form to +44 (0) 870 9090 712 PHONE on +44 (0) 870 9090 711 POST your booking form to: Events Team, SMi Group Ltd, Ground First Floor, 1 Westminster Bridge Road London, SE1 7XW, UK If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email events@smi-online.co.uk EARLY BIRD DISCOUNT □ Book by 29th June to receive £300 off the conference price □ Book by 28th September to receive £200 off the conference price □ Book by 31st October to receive £100 off the conference price Payment must be made to SMi Group Ltd, and received before the event, by one of the following methods quoting reference P-270 and the delegate’s name. 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