Research & Development

Global R&D System

To Meet Global Medical Needs with Our Networks Covering Japan, the United States, Europe, and Asia

Developing new pharmaceuticals entails a long period of over 10 years, as well as a diverse process ranging from basic research to marketing. To free patients from concerns over their illness as soon as possible, we must improve the efficiency of our R&D process. To this end, Santen conducts drug discovery and clinical development on a global basis, utilizing facilities of the Santen Group and related organizations worldwide. In this way, we are reinforcing our system to create new products that meet global medical needs in a timely manner.

In terms of research activities, within Santen we have concentrated our basic research, non-clinical studies, and drug formulation research at Nara Research and Development Center, so as to integrate the knowledge of our various sections and create better products. We are also working to speed up our decision-making. With external organizations, we have built a system to facilitate information exchange and collaborations through our own networks. In 2011, Santen purchased Santen S.A.S. (formally known as Novagali), a French ophthalmic pharmaceutical company that has excellent R&D capability and drug formulation technologies in the dry eye field. This purchase has reinforced Santen's development pipelines, enhancing its international competitiveness in the ophthalmic field.

To speed up clinical development, Santen has relocated its hub to the United States (Santen Inc.), where clinical trials can be conducted in a relatively short time. To improve the quality and efficiency of clinical development, we are building a system to conduct early-stage clinical development in the United States, while conducting the late-stage clinical development in Japan, the United States, Europe, China and other Asian countries, as well as in other emerging countries.

  • Nara Research and Development CenterNara Research and Development Center
  • Santen S.A.S.Santen S.A.S.
  • Santen OySanten Oy
  • Santen Inc.Santen Inc.

Santen's R&D Framework

R&D Strategy

Santen is pursuing development of products to satisfy unmet medical needs in ophthalmology worldwide.

As a pharmaceutical company specialized in ophthalmology, Santen wishes to preserve vision for patients by addressing unmet needs and by developing products that have significant positive impact on the QOL of patients. By focusing on the QOL of our patients we intend to address the needs of other important stakeholders such as, ophthalmologists, care givers and healthcare providers.

Therefore our Medium-Term Plan (MTP2020) is focused on enhancing our product pipeline and developing new treatment options. Alongside conventional drug development, we have started to tackle challenging new technologies to optimize treatment outcomes using a "Network Product Development(*1)" approach. Good examples of this include the creation of a new formulation in partnership with Singapore Eye Research Institute (SERI), DE-127 for myopia patients, and the development of DE-128 (MicroShunt) for glaucoma patients. We feel products like these will address unmet needs on a worldwide basis. In order to improve the outcomes of clinical research and improve patient care we are conducting translational research(*2) to identify biomarkers(*3) and eventually develop diagnostics. In addition, we are working to create preservative-free formulations of existing drugs while developing drug-delivery systems(*4) and better containers as a way of making these treatments more convenient and less burdensome for our patients.

R&D Strategy

*1
An approach of proactive use of compounds and technologies from outside the company in product development
*2
Multi-disciplinary research that links basic research, clinical research, and medical care and utilizes such findings for effective and efficient practical applications to contribute to healthcare advancement
*3
Indicators that objectively measure and evaluate biometric information to identify medical states including the onset or severity of disease
*4
Formulation technologies engineered to deliver the right amount of drug to the right target at the right time

The development pipeline

Merging Global Experience and Technology to Offer Patients a Brighter Future

To promote our network-based drug discovery and global R&D efforts, Santen is placing significant emphasis on strengthening our relationships with universities, research organizations and other pharmaceutical firms to conceive new treatments for patients around the world. We hope such relationships will lead to the discovery and launch of novel therapies for severe dry eye syndrome, glaucoma, diabetic macular edema and uveitis, a condition with limited treatment options.

Santen discloses the information on the ongoing clinical studies to confirm safety and efficacy of our drugs on the websites as below.

The development pipeline

Japan http://www.clinicaltrials.jpLink to external websites
Overseas http://www.clinicaltrials.govLink to external websites
The Ophthalmic Production Process Part I: R&D

Investigator-Sponsored Trials

Santen encourages and supports research to enhance the understanding of eye diseases and the development of innovative solutions for unmet needs in ophthalmology.

We invite you to explore our grant program below.

Investigator-Sponsored Trials (ISTs)

Santen offers grants to clinicians, scientists, and academic institutions (i.e., sponsor investigators) who are pursuing medically and scientifically sound research on our company's compounds, medical devices, products of interest.

We generally support research in the following therapeutic areas:

  • Retinal diseases and other posterior segment conditions
  • Glaucoma
  • Dry eye, corneal disorders, and other anterior segment conditions

Investigators from Japan, South Korea and China please contact your regional Santen representative for ALL IST submissions. For further questions, please email gma-ist@santeninc.com

EVALUATION PROCESS

  • To be considered for an IST grant, all applicants must provide comprehensive study details, such as scientific rationale, primary/secondary objectives, study endpoints, projected study design, and fair market study budget.
  • Study proposals will be reviewed for scientific merit, validity, and alignment with Santen's scientific research and business strategies.
  • Qualified applicants will be notified of decisions and given feedback as appropriate.
  • Accepted and approved proposals will begin the IST clinical research process in adherence

Santen Medical Education Grants

Santen offers grants to support medical education programs for healthcare professionals to help enhance their knowledge and skills, advance the quality of patient care, and align with our current areas of focus.

We support:

  • Continuing medical education programs
  • Independent medical education initiatives

RULES & REGULATIONS

You must submit all required grant application information at least 60 days before the educational program's start date, or we must automatically decline it.

  • Your application should not include the names of proposed or confirmed speakers or any direct or implied reference to products or compounds as this may compromise an impartial review of your request and force us to decline it.
  • All submitted proposals must be used to support education programs that comply with all applicable laws.
  • Santen does not control the content of activities funded under independent medical education grants.
  • All medical education grant requests must be reviewed by Santen's Medical Education Grants Committee. As such, Santen commercial personnel do not make commitments for grants.
  • The provision of medical education grants is not intended as an inducement to prescribe, refer, or recommend any of Santen's existing or future products and is not intended as a reward for any previous prescribing activity.
  • Santen does not promote the use of products that have not been approved by applicable regulatory agencies.
  • Grant application submission does not guarantee Santen support.