Development of new drugs with high social values
DyDo Pharma, Inc.
To enter the orphan drug business, the DyDo Group established DyDo Pharma, Inc., which commenced activity in August 2019. Since so-called orphan diseases have few suitable treatment protocols, the field represents a challenge for society. Drug distribution was our founding business, and it is our firm desire to return to that business to help patients and customers. This will be a new challenge, but outsourcing is now advanced in every facet of the new drug field, including development and manufacturing. We will therefore build relationships with outsourced providers at each stage of the process, and work to solve the social challenges these diseases present.
Orphan drugs and DyDo’s target
There are approximately 7,000 orphan diseases. Only around 5% of drugs approved for use on a global basis are suitable to treat these diseases, many of which are serious. Several are progressive and life-threatening. Pharmaceutical companies and others around the world are working to create candidate drugs, including an increasing number of pharmaceutical companies in Japan. However, given the typically limited number of patients for these drugs, development efforts have so far been insufficient. DyDo Pharma’s goal is to identify new candidate drugs under development by biotechnology companies globally, continue their development in Japan, and obtain regulatory approval so they can reach patients as soon as possible.
Securing human resources for business operations
Although DyDo Pharma began operating in August 2019, we actually announced our entry into the field in March 2018. This enabled us to begin hiring external specialists, and we are currently securing personnel with extensive experience in every medical industry field, including business development, new drug development, pharmaceutical affairs, and reliability assurance.
Managing the business through external contractors
We are first of all aiming to invest in candidate drugs produced by pharmaceutical companies around the world, especially where we can obtain exclusive rights to develop, manufacture and market them in Japan. We will then develop them and obtain regulatory approval. Delivering a pharmaceutical to the market requires a wide range of expertise. We will utilize external organizations, such as Contract Research Organizations (CRO) for clinical development and Contract Manufacturing Organizations (CMO) for pharmaceutical manufacturing. We will structure our own sales organization, but in conformance with patient situations. We will also explore other arrangements, including joint sales structures with pharmaceutical manufacturing partners as well as sales outsourcing. Also, as required, we will consider collaborating with external experts, entities, and companies. This approach is aimed at facilitating possible lean management that does not require DyDo Pharma itself to bear considerable fixed expenses.
- Outsourced manufacturing
- Products Outsourcing
- Licenser/ venture capital
Permission for manufac
turing and sales
ProductsMedical supply wholesalers
A deliberative corporate governance system
While the DyDo Group’s business activities are closely related to pharmaceuticals, we are not specialists in this field. For this reason, we established an Advisory Board to advise the president in January 2019. Its functions are supplemented by lectures from external specialists that will, for example, assist the committee in issuing recommendations relating to specific issues.For details on the Advisory Board Click here to view DyDo Pharma, Inc.