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JULY-AUGUST-SEPTEMBER 2009

To mark this year of celebration for the 20 years of Iris Pharma, we have, as you know, decided to issue 4 special retrospective newsletters. In this issue, the third of the serie, we will continue to help you discover or rediscover our company and our services from an original and almost certainly novel perspective. Importantly, we will be presenting with unconcealed pride the results of our latest perception survey conducted in 2009 with clients and prospects.

 
The service provided by Iris Pharma seems completely controlled, both on the pre-sales phase, service quality, human resources and general performance. 

•    84% of clients and prospects are satisfied overall
•    96% of clients would recommend Iris Pharma.
•    92% of clients plan to work with Iris Pharma again

Image profile:
Overall, 90% of the prospects that responded are willing to become clients of Iris Pharma.
The Iris Pharma image benefit is mainly centered on 4 axes:
The credibility of the service provider/trust granted for 100% of the persons who responded.
The expertise in terms of preclinical (95%) and clinical (73%) development.
The understanding of needs in 90% of cases.
The good quality/price of solution proposed ratio also for 90% of the responders.


Your expectations:
You asked us for more communication on our know-how, expertise and range of solutions that we can propose. We therefore commit ourselves to providing you more regularly with information on all the possibilities we offer to accelerate the development of your ocular drugs and devices and the novelties and innovations developed by our departments and laboratories.


An excellent evaluation from the investigators both with respect to their satisfaction and human resources
Satisfaction survey performed in 2005 by Clirophtha on its investigators (Iris Pharma and Clirophtha had not yet merged).

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Analytical methods in all ocular matrices
 
That it is in R&D or in production, many decisions are based on the results of quantitative chemical analysis. Each time a decision is taken according to a result of analysis, it is fundamental to have a good evaluation of the reliability of this result. As part of our service offering for the development of drugs and ophthalmologic devices, Iris Pharma offers in-house its bioanalytical laboratory services for your drug candidates and metabolites. However advanced your development program may be (early development, clinical phase…), our experienced teams can offer a number of validated methods for the determination of pharmaceutical compounds in biological samples, from small molecules to larger peptides.

Our ophthalmologic specialization is a real advantage, because we do routine bioanalytical testing in the majority of ocular matrices and are able to determinate very small quantities. 



Customized service tailored to your needs

We also develop and validate customized trials from human or animal matrices, depending on your needs.
A few examples of the methods we have validated:

Compounds	Analytical techniques	Analytical samples
Diclofenac	RRLC-MS/MS	Plasma (rabbit)
Dexamethasone	RRLC-MS/MS	Aqueous Humor (rabbit) Choroid (rabbit) Retina (rabbit) Vitreous (rabbit)
Timolol	RRLC-MS/MS	Aqueous Humor (rabbit) Iris-ciliary body (rabbit) Choroid (rabbit) Plasma (human)
Acyclovir	HPLC Fluorescence detection	Aqueous Humor (rabbit) Cornea (rabbit) Vitreous (rabbit)
Carteolol	HPLC UV detection	Aqueous Humor (rabbit) Iris (rabbit)
Azithromycin	LCMS	Tears  (rabbit) Bulbar Conjunctiva (rabbit) Aqueous Humor (rabbit) Cornea (rabbit) Plasma (human)

Respect for GLP and high-technology equipment for top quality work

All our work is carried out with full respect for Good Laboratory Practices (GLP). But we may, of course, develop and validate non-GLP trials, according to your requirements. We offer bioanalytical method validation to support international submissions of investigative and new drug substances and products:

Iris Pharma also conducts method validations in accordance with recognized international recommendations and guidelines, including those issued by the United States Food and Drug Administration (FDA).

Because it is essential to provide you with clearly superior results in bioanalysis, our laboratories have invested in advanced technologies that deliver the highest standard of performance and reliability. For each analytical methodology offered, Iris Pharma can process samples using state-of-the-art apparatus and annually qualified analytical software.

Analytical methodologies:


For further details, please consult our website on www.iris-pharma.com or contact  us on info@iris-pharma.com.

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Formulation is a key, but equally delicate, stage in ophthalmology

Formulation in the ophthalmology field is a particularly difficult subject that requires know-how and great experience to allow ophthalmic medications to be used effectively and provide maximum benefit.

The eye’s natural elimination systems, tears and the elimination of lachrymal fluid through the naso-lachrymal canal which very significantly reduces time of contact with active ingredients, the organ’s complexity, the difficulty in reaching certain tissue or segments and overall sensitivity, are all challenges that have to be met to improve drug delivery. “Drug delivery is no less vital than drug discovery”, Herbert E. Kaufman, M.D., Ophthalmic drug delivery systems, 2nd edition.


Iris Pharma offers innovative technology and techniques to help you move from discovery to development.

Our dedicated team specializes in non-GLP pre-clinical ocular formulation, critical stages that influence drug availability and thereby its pharmacokinetic properties and future development. 


Our aim is to help you in developing appropriate formulation of drugs for ophthalmology used in preclinical studies, depending on the chemical properties of your compounds and the dosage form desired. 
We have already developed several formulations, particularly ophthalmic gels, which feature amongst the most recent and most promising techniques for topical application. These gels help to improve product availability and extend the time during which the active ingredient is in contact with ocular tissue. We can also evaluate and improve the solubility of your compounds and their stability, with or without preservative.

We also have extensive experience in formulations and the most widely used forms of administration in ophthalmology:
 
If you wish to be sure of having the most appropriate drug formulation to attain the effective drug concentration at the intended site of action for a desired length of time, do not hesitate to contact our specialists through info@iris-pharma.com.


Other services:
» Pre-clinical development
» Ocular histopathology
» Clinical services
» Strategic consulting in the drug development process

In a preclinical study context, Iris Pharma has acquired a new corneal measurement tool.

Although rather widespread in clinical studies or for example for measurement with patients prior to a laser operation on the cornea, measurement of corneal thickness is a rather rare occurrence in preclinical studies and with animals.

Yet corneal pachymetry is a highly attractive and invaluable proposition, making it possible to measure corneal thickness with extreme precision – down to one thousandth of a millimeter – over the whole surface and with no contact. This is why Iris Pharma has gotten equipped with a new ultra-sonic pachymeter – AccuPach VI by Accutome – which complements HRA in corneal examinations with animals. The apparatus will be used most notably in studies of corneal neovascularization, corneal wound healing, corneal infection and of course tolerability studies. It will then be put to the test, given the 300 and more tolerability studies already conducted by Iris Pharma for customers.

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Given the results of the inspection made by the French Committee of Accreditation (COFRAC) earlier this year, the inter-ministerial group of chemical products (GIPC) has taken the decision to renew the accreditation of Iris Pharma’s facility for compliance with Good Laboratory Practices (GLP) for toxicity studies.

Iris Pharma has a non-clinical laboratory totally dedicated to ophthalmology. We offer partial or global outsourcing of animal studies to determine the safety of test articles under laboratory conditions. We not only perform highly controlled studies to obtain regulatory authorization (registration studies, GLP safety testing), but also propose pilot studies (proof of concept) that correspond to simplified prospective studies.

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