Novartis Pharma GmbH (NovP)
Workpackage (WP) participation
The Pharmaceuticals Division of Novartis is recognised worldwide for the innovative medicines it provides to patients, physicians and healthcare organisations. Novartis Pharma GmbH develops and markets patent protected prescription drugs for a great variety of therapeutic areas including ophthalmology. Additionally to the current product portfolio, there exists a product development pipeline with products in various stages of clinical development.
Novartis Pharma GmbH offers the widest spectrum of eye care products in surgical, ophthalmic pharmaceuticals and vision care on the market, with greatest number of molecular entities approved by the FDA and EMA for clinical use in the United States and EU, respectively. Novartis conducts more clinical trials than any other pharmaceutical company.
Main tasks attributed to the project
Novartis Pharma GmbH will provide its expertise in the field of clinical study design as well as development of innovative drugs- both in pre- and post-approval stages. Partner Novartis will support the TargetAMD consortium with its expertise in editing and reviewing the most relevant documents for the clinical trial. For example the investigator brochure (IB), the investigational medicinal product dossier (IMPD) and the clinical trial protocols (CTP). Partner Novartis will participate in data management and biostatistics, too (WP 8). Novartis will also provide the know-how of which components of the clinical trials, such as devices, and reagents, can become incorporated into an “AMD Gene Therapy” kit and whether patent protection can be obtained (WP10).
Dr. Stefan Scheidlstefan.firstname.lastname@example.org
Dr. Stefan Scheidl, head of Therapeutic area Ophthalmics. Dr. Scheidl is responsible for ophthalmic research and development projects conducted by Novartis in Germany. He has more than 10 years experience in clinical trials and drug development.