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JANUARY-FEBRUARY-MARCH 2009  
 
 IN THIS ISSUE  EDITORIAL
 
»
Retrospective Iris Pharma
   - History of logos
   - 20 years in 20 key dates
   - Testimonials
   - Iris Pharma around the world
   - Zoom on consulting services

» News
   - New dry eye animal model
   - Upcoming events

»
Extraordinary
   - A French visually impaired windsurfer broke 2 world records

Twenty years have passed since the founding of Iris Pharma and 20 years during which we have had the pleasure of accompanying you in your ocular drug and devices development projects. We have been collaborating with some of you since the beginning and almost 160 of you have joined us in the adventure and have shown your trust in us.

We invite in the next four newsletters to discover or rediscover through key dates and numbers, focus and news, testimonials and zooms on our services, the path travelled and the evolution of our company and we are certain to surprise you.

Happy reading and once again thank you for your confidence!Pierre-Paul Elena, Founder and CEO of Iris Pharma


Dr Pierre-Paul Elena,
Founder and CEO of Iris Pharma




 RETROSPECTIVE

A pioneer outsourcing services provider for ocular drug development

History of Iris Pharma and Clirophtha logos



The 20 years of Iris Pharma in 20 key dates

January 27, 1989:
Founding of Iris Pharma by Doctor Pierre-Paul Elena, a former research officer at Laboratoires Dulcis, a French firm specializing in ophthalmic prescription drugs, (now Allergan) in the medical school premises.

• 1989: First European client
• 1990: First in-house animal model. Iris Pharma proposes today close to 50 customizable models.
• 1991: Establishment of bioanalysis department
• 1991: New premises at La Gaude
• July 1994: Founding of Clirophtha, clinical research organization, specialized in ophthalmology, based at La Gaude. In the early 1990’s, the demand for clinical activities and full service drug development increased. The French ophthalmology market was among the largest in the world and the French legal environment was favorable to clinical research.
• 1994: First client on the North-American market
• 1995: Iris Pharma becomes a GLP site following inspection by the Drug Agency
• May 2002: Moved to new premises at La Gaude
• December 2002: First client outside Europe and North America
• 2003: Joint venture with Apple-Tree, clinical CRO based in Zurich, Switzerland
• 2004: Creation of Research department to offer even more new pathological models to our clients
• 2006: Creation of the Formulation department to develop and optimize new formulations and improve delivery of ocular drugs
• April 2007: Partnership with Promedica International in California
• October 2007: Inspection by COFRAC. Iris Pharma receives the certification to conduct toxicity studies in accordance with good laboratory practice (GLP) principles of the OECD.
• December 2007: Iris Pharma and Clirophtha merged under the name of Iris Pharma. This merger established the first global drug development service provider in the world totally dedicated to ophthalmology
• February 2008: Co-founder of Ophta Biotech, an association to promote ophthalmology in the Côte d’Azur, Corsica and Monaco.
• March 2008: Partnership with the Institut de la Vision
• July 2008: Partnership with CERB, an internationally renowned French CRO offering to the pharmaceutical, chemical and agrochemical industry research and development services in the fields of toxicology, pharmacology and analytical chemistry.
• November 2008: Enlargement of the animal housing
• December 2008: Iris Pharma opens its Paris premises for the inauguration of the Institut de la Vision

January 27, 2009:

Iris Pharma celebrates its 20th anniversary!

This specialist CRO is one of the world leaders and among the most respected global drug development service companies in ophthalmology.




Testimonials


Iris Pharma is our preferred partner for preclinical work in ophthalmology. Their stellar study conduct and expert advice have been crucial for advancing our AMD program. The staff at Iris Pharma is highly responsive to the challenges of drug development and excels at providing customized solutions quickly.
 
Dr. Hendrik Gille, Team Leader Preclinical Research, Pieris AG, Freising, Germany




Logo NovagaliRecently Novagali Pharma has been awarded the 2009 North American Frost & Sullivan Award for Industry Innovation & Advancement of the Year for our two proprietary emulsion technology platforms, Novasorb and Eyeject. We are very proud of this award and our excellent, long-standing and fruitful collaboration with Iris Pharma has certainly played a critical role in this success. Working with Iris Pharma has significantly improved our ability to clarify issues and innovative design. The cutting-edge knowledge in ophthalmology of Iris Pharma staff, along with a forward-thinking state of mind have helped us lead our products intelligently through the preclinical and clinical stages all the way to the market."
 
Jean-Sébastien Garrigue, Director of Research and Development, Novagali Pharma SA, Evry, France




PMI logo"Promedica International, located in California, initiated its relationship with Iris Pharma almost four years ago.  Since then, our project teams have worked closely to coordinate systems and procedures for start-up and implementation of studies in the US and Europe, and we have collaborated on a variety of clinical research projects involving anterior and posterior segment ophthalmic conditions and therapies. 

Due to the tenure of both companies’ management teams, we have come to know each other quite well.  This facilitates efficient and effective ongoing communication between our organizations.

From PMI’s perspective, key benefits in working together with Iris Pharma are as follows:

1. Iris Pharma and PMI share a similar commitment to providing services of value to clients we appreciate.  
2. Iris Pharma’s extraordinary background in ophthalmology facilitates thoughtful consideration of factors that may impact development and/or implementation of clinical study protocols.  This provides significant value in project planning and risk analysis.
3. As PMI’s business focus is primarily in the area of clinical trials, our relationship with Iris Pharma complements our capabilities – we have a resource that can help clients needing preclinical or non-clinical services, as well.

We so value our relationship with Iris Pharma, and congratulate them on accomplishment of this important milestone – 20 years of business success!

Ginger Clasby, Executive VP, Business Development, Promedica International, Costa Mesa, CA, USA




Iris Pharma and its partners around the world



More information on our partnerships




Iris Pharma services

The development process of a drug is long, complex and expensive, and even though some stages are known and well defined, each project is unique and requires specific thinking. There is no straightforward path to the market.

Iris Pharma is specialized in the development of ocular drugs and ophthalmic medical devices. This has allowed us to acquire in over 20 years a unique experience and expertise to assist you in mastering the development process and save time and money. Our service range covers all the preclinical and clinical requirements and whether you are experts or novices in ophthalmology, a young biotech or big pharmaceutical company, we will always provide you the best solution and the best quality of service so that together we can make your product progress.

Our company offers individual services and solutions or as part of an integrated program (one-stop shop solution):



Focus on Iris Pharma strategic consulting services

Consulting services at Iris PharmaStrategic consulting at Iris Pharma is a service you can get on demand but it is also something that is provided when the studies are performed in our laboratories.

With about 1,600 preclinical studies and more than 80 clinical studies in ophthalmology performed over the last 20 years for more than 150 clients worldwide and almost 50 drugs marketed tested in our laboratories, Iris Pharma has built an extraordinary knowledge base concerning ocular drug and medical device development that allows us to advise and guide our clients in their drug development strategy and decision making.

Thanks to this unique and extensive experience in ophthalmology, Iris Pharma provides the necessary understanding and expertise to guarantee accurate consulting services at every stage of the drug development process from proof of concept studies to Phase IV clinical trials. As a partner, we help you to make the right decisions to develop successful ocular drugs and devices in a cost-effective and rapid manner.


"Step by step" consulting services
Working with Iris Pharma isn’t simply having highly qualified technicians or ophthalmologists acclaimed in their field perform preclinical or clinical studies. It is also the guarantee of a permanent and quality guidance by a specialist irrespective of the development level of your ophthalmic drug or ocular device.

Our expert team is capable, at each step, of advising you, proposing possible alternatives and guiding you towards the best solution with regard to your needs and objectives. We take the time to think through the results together and examine the following steps.


Strategic and global drug development consulting services
"One-stop shop solution". You have a development project for an ophthalmic drug or ocular device and you wish to have an accurate vision of the different middle and long term steps required to reach human experimentation or to market your drug? We can propose a complete design integrating timelines, regulatory requirements and costs to bring your compound or device to where you may want.


Experts meeting organization
Thanks to a vast international experts, researchers and specialists network, we can bring together for you the best current competences in ophthalmology to help you in the development of your project.

Training
You wish to further your knowledge in ophthalmology, improve your surgical technique (administration, injections, dissections, sampling, etc.), expand your knowledge on a specific subject such as the different methods of ocular drug delivery, how to reach effectively the target tissue, what model(s) to choose as a function of your product? Our experts can provide training on demand so that you can become familiar with the latest advances in ophthalmology.
Given that ophthalmology research advances quickly and things evolve, we can offer you the necessary resources to reinforce your knowledge and remain competitive.


Some of the "pluses" we can offer:

• Design, review and refinement of drug development programs (including reviewing the dossier for completeness, scientific content and technical competence, and giving advice on studies which may need to be completed or repeated)
• Preclinical development plan and timeline for successful clinical development and regulatory submissions
• Review and interpretation of preclinical studies
• Assessment of the existing preclinical package
• Preparation/review of preclinical sections of regulatory documents
• Clinical study design based on preclinical data
• Assistance in designing clinical protocols and in their scientific review
• Recommendation of clinical investigation sites and experts
• Preparation of CTAs
• Ophthalmic drug development training courses
• Put in contact partners for the co-development of products through our extensive industry network,

• Out-licensing assistance


For more information on how we can help you, please contact our team at info@iris-pharma.com


 NEWS

New dry eye model in albino rabbits

The Iris Pharma Research Team has developed a new dry eye model in albino rabbits to add to its catalog of animal models designed for preclinical testing in the field of ophthalmology.

This dry eye model in rabbits is induced by repeated daily instillations of 1.0% atropine sulfate. The model produces rapidly some typical dry eye symptoms such as a significant reduction in tear volume, Tear Break-Up Time (TBUT), corneal staining and histopathological signs of dryness and inflammation, and can be satisfactorily used for a preliminary assessment of the protective activity of some polymeric tear substitutes.

Today dry eye syndrome, or keratoconjunctivitis sicca (KCS), affects tens of millions of people worldwide, representing one of the most common ocular diseases.

Click here for more information on our ocular efficacy models.




Upcoming events

May 1-2, 2009: 12th Annual Vision Research Conference, Mechanisms of Macular Degeneration, Fort Lauderdale, FL, USA.

May 3-7, 2009: ARVO Annual Meeting, Fort Lauderdale, FL, USA. Come see us at booth #408-410.

May 7-13, 2009: 115th Annual Congress of the SFO (Société Française d'Ophtalmologie), Paris, France

 
May 18-21, 2009: Bio International Convention (BIO), Atlanta, GA, USA.


  EXTRAORDINARY

Olivier Brisse, French 35 years old visually impaired windsurfer, broke two windsurfing world records: pride and hope for the visually impaired!
 

Following the attempts and falls of the previous day, Olivier Brisse broke on Thursday 22 January 2009 two distance and speed windsurfing world records for the visually impaired: a distance measured with a GPS of 1.1 kilometers, on the same side, without falls in the morning and a run measured at 23.6 knots by the GPS, i.e. 43.7 km/h, in the afternoon with serious conditions and a wind blowing at 70 km/h.

Windsurfing with such a wind is difficult for the non-impaired, for the visually impaired it is a remarkable achievement. It is also the demonstration of a category of persons for whom we do not even suspect the capacity to carry out certain actions, which seem impossible for certain “non-handicapped”. Olivier Brisse has waved the flag of courage, hope and dignity in his category.


For more information on Iris Pharma activities, visit www.iris-pharma.com or contact us by email at info@iris-pharma.com

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