Our Rare Disease
Drug Development Model

Our Rare Disease Drug Development Model Cydan is focused on accelerating meaningful therapies for people with rare monogenic, non-oncologic diseases. We start with a compelling scientific idea or promising drug candidate from collaborators in academia and/or industry, and then efficiently advance the therapy through pre-clinical research to enable the establishment of an independent company to progress drug candidates through clinical and regulatory development to commercialization.

Our Rare Disease Drug Development Model Cydan is focused on accelerating meaningful therapies for people with rare monogenic, non-oncologic diseases. We start with a compelling scientific idea or promising drug candidate from collaborators in academia and/or industry, and then efficiently advance the therapy through pre-clinical research to enable the establishment of an independent company to progress drug candidates through clinical and regulatory development to commercialization.

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Opportunities

Our funded, four-part model is unique and truly adaptable to multiple scenarios. With our collaborators, we work together to develop impactful therapies to improve  the lives of people living with rare diseases.

In the United States, an orphan rare disease is defined as a disease that affects fewer than 200,000 people.

Our collaborators and projects come from…

  • Academic laboratories
  • Non-profits
  • Government-funded labs
  • Small biotech/biopharma companies
  • Large pharma R&D
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Diligence and Screening

Once we identify a potential opportunity, Cydan conducts a rapid assessment to determine a path forward.

Cydan Screening

Our screening process answers these questions and more:

  • Is there a path to an asset?
  • What is the status of intellectual property protection?
  • Is this a disease with an unmet need for a new therapy? What is the pathophysiology?
  • Are there sufficient patients to support clinical development for the therapy?

We create and implement a scientific and clinical plan to demonstrate that the therapy will treat the pathology of the underlying disease and improve the quality of life for people living with these rare genetic disorders.

Cydan Dilligence

During diligence, Cydan employs extensive internal and external expertise to identify the development path. In addition to the Cydan team, we bring our experts in:

  • Biochemistry
  • Preclinical R&D
  • Medical affairs
  • Manufacturing and assay development
  • Toxicology
  • Clinical development and regulatory affairs
  • Chemistry
  • Intellectual property

During diligence, we seek to gain a full appreciation of the underlying mechanism of action behind potential therapies and determine if they will be transformative and fundamentally change the course of the disease. We work with the inventors/entrepreneurs to define what additional work needs to be done to identify the clinical candidate to support company formation. At this stage we may decide that the scientific idea is compelling but we must collaborate to create a new clinical candidate.

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De-risking

De-risking, the final stage of our collaborative model, is designed to yield a pre-investigational new drug (IND) or IND-enabled asset considered ready for funding and to launch a new company to bring this orphan drug candidate to patients.

We don’t just analyze your research, we conduct our own and share the data with you. We conduct a thorough analysis to:

  • Expand pharmacology with in vivo and in vitro studies
  • Work with leading contract manufacturing organizations to enable a good manufacturing practice (GMP) ready process, be it a biologic or a small molecule
  • Get answers to key toxicology questions
  • Potentially expand patent protection
  • Confirm that the disease epidemiology and competitive landscape will support the clinical development plan and the commercial opportunity
  • Map out a feasible clinical and regulatory development path
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NewCo Launch

Several elements are critical to create a company that can raise sufficient venture capital to enable the development of a therapy that has the potential to change the lives of people living with rare diseases. And we know how to do it.

Keys to successful company creation:

  • A cogent, investible corporate story with a clear objective and pitch
  • Answers to questions venture capitalists want answered
  • Company management with expertise and experience in business development, clinical development, science and medical affairs.