Before you apply

↓ Eligibility
↓ The review process
↓ The assessment criteria
↓ The budget
↓ The review panel
↓ Reporting and monitoring
↓ Dissemination of results and promotional materials
↓ Rights and ownership

The Open Innovation Program is open to clinical researchers worldwide who meet the eligibility criteria. Applicants must submit their application through the Submittable platform, accessed through this website.

Applications are initially open for fifteen projects across infectious and vector-borne diseases, as well as in the detection of drug-resistant pathogens. Each applicant may submit a proposal for up to three projects with the exception of applications that include the ‘Respiratory Panel 1/2/3/4’, in which applicants may submit up to four projects in their proposal.

⟶ See list of available projects

Targets last updated on September 27, 2023.
Please carefully review the updated targets for each panel when you submit your application.

Eligibility

Applicants must meet the following criteria:

  1. Have access to a laboratory with BSL-2 (biosafety level-2) or higher, capable of performing the proposed clinical trial
  2. Are a part of or have a research team consisting of two or more qualified researchers 
  3. Have experience in PCR molecular diagnostics 
  4. Possess or have access to both positive and negative clinical specimens 
  5. Employed by or affiliated with a university, research institution, and clinical laboratory, or other similar organization 
  6. Eligible to conduct the proposed clinical studies appropriate for regulatory approval
  7. Hold a doctorate or medical degree (e.g., PhD, MD, PharmD)
  8. Applicants can be of any nationality and projects can be hosted at eligible organizations in any country apart from Cuba, Iran, North Korea, Sudan, Syria, Burma/Myanmar, Niger, Russia, Belarus, or the Crimea, Donetsk or Luhansk regions of Ukraine, or other sanction-sensitive countries or regions as updated from time to time.

The review process

Applications will be reviewed in two rounds. In the first round, all eligible submitted applications will be assessed by Seegene’s review panel consisting of molecular diagnostics experts from both R&D and non-R&D departments. For each of the fifteen projects, a shortlist of applications will be initially compiled and announced. In the second round, the research sites of shortlist candidates will be assessed with a site qualification visit by a Seegene representative, and the final decision will be made by the review panel. Each member of the review panel will individually review the shortlisted applications. Finally, the review panel will convene to discuss the merits of each application in detail and select the applications to be granted.

1st assessment (Shortlist selection)

  1. Basic qualifications 
  2. Research environment and clinical study potential (including laboratory certification, equipment possession, research expertise and staff) 
  3. Availability of clinical specimens
  4. Understanding of the project (clinical study design)
  5. Budget (involving staff, participation rate, duration)

2nd assessment (Awardee selection)

  1. Site qualification visit report:
    The most critical assessment criteria will be the consistency between what is written in the application form and the actual observations from the on-site visit. (ex. laboratory facilities, clinical specimens etc.)

The assessment criteria

1. Understanding of molecular diagnostic product development process and product design for the proposed project.

In each project, Seegene performs the product design, product development planning, and feasibility studies without clinical specimens, while the awardee conducts preclinical and clinical studies with clinical specimens. The applicant’s ability to plan and conduct the preclinical and clinical studies, including the acquisition of appropriate clinical specimens, should be demonstrated.

Role of Seegene and Awardee

Preclinical study
Awardee
Secure sufficient samples for the proposed preclinical study that uses clinical specimens

1. Perform the feasibility study using clinical specimens with the Seegene assay of the project.
2. Analyze the preclinical study results
3. Share and report preclinical study results in the format provided by Seegene
4. Provide occasional consulting services upon request by Seegene on the design and development of the Seegene product of the project (ex. identification of potential targets, cut-off values).

Seegene
1. Seegene will provide the materials and equipment listed in the “Budget” section of this document.
2. Seegene will provide the report format for pre-clinical and clinical studies.

Clinical study
Awardee
1. Secure clinical specimens for clinical study
2. Develop protocols for the studies
3. Execute the studies with the Seegene assay of the project, in accordance with applicable regulatory guidance or requirements
4. Analyze the study results
5. Share and report the study results in the format provided by Seegene

Seegene
1. Seegene will provide the materials and equipment listed in the “Budget” section of this document.
2. Seegene will provide the report format for pre-clinical and clinical studies.

2. Clinical study design and plan

Clinical study proposals should include a study protocol synopsis, including the proposed intended use, number of samples, site information, study duration, study objective, study procedure, reference method, and statistical methods. 

3. Potential scientific and societal impact

Research proposals should clearly explain the significance of the contribution they intend to make. The ultimate purpose of this program is to benefit society and patients through improved techniques, syndromic PCR technology, technology sharing, and Seegene OneSystemTM solution to enable early diagnosis of diseases. 

4. Applicant/team qualifications and project budget feasibility

The applicant (and other team members) should have the requisite skills and experience to conduct the clinical study. The research team members should hold post-graduate degrees and research experience in related fields. Evaluation will be based on the track record of the applicant(s) and the suitability of the host universities and institutions. Additionally, the project budget must be clearly explained and will be assessed for its feasibility in delivering the proposed study plan. 

5. Access to clinical samples and specimens for the proposed development study plan

Applicants should be able to secure the clinical specimens for the development studies proposed in the application. The number of positive and negative clinical specimens should meet the guidance or requirements for market approval by the target region/country’s regulatory body.

The budget

The budget is up to 600,000 USD per project. The award can be used to cover the following eligible costs, but it is subject to change according to the labor costs by country and prices: 

1. Direct costs

Project specimen costs, personnel expenses, and clinical study costs are direct costs.

Below is an example case study with estimated direct costs

Note: Rates, costs and taxes incurred will vary according to your region, this example is intended for illustrative purposes only.

Example
Project: Tick-borne disease

  • Project specimen costs*: 454,740 USD (including 10% VAT)
    a. Total sample number for preclinical study: (9 targets x 4 specimen types x 20 preclinical specimens) + 50 negative specimens = 770
    b. Total sample number for clinical study: (9 targets x 4 specimen types x 65 clinical specimens) + 70 negative specimens = 2,410
    c. Total cost: {(a+b) x 130 USD} x 1.1 (10% VAT) = 454,740 USD

    * Project specimen costs are calculated based on the number of specimens needed for a clinical study with 130 USD per specimen, but the cost is subject to change according to the country and specimen type.
  • Personnel expenses: 22,000 USD (including 10% VAT) but it is subject to change according to the labor costs by country and prices.
  • Clinical study management cost*: 47,850 USD (including 10% VAT)
    * Clinical study management cost can be used for purchasing necessary materials not provided by Seegene.
  • Salaries of the principal investigator and research team members. It is expected that the awards will cover a percentage of the investigators’ salary. Consulting fees for the principal investigator are included in the personnel expenses. 
  • Travel and subsistence expenses for team members will be covered for carrying out the project and related dissemination activities. However, this does not cover normal living expenses.
  • Publication costs.
  • Ethical approval fee.

2. Indirect costs or institutional overheads

Indirect costs are generally 10% of the requested direct costs (if required by the associated institution). Because indirect costs can vary depending on the institution, applicants should allocate and verify appropriate indirect costs in the budget.

Example

  • Indirect costs: 52,459 USD (including 10% VAT)
  • The following costs are not eligible:
    - Education costs.
    - Accommodation and normal living costs.
  • Reagents and equipment-related consumables below are not included in the eligible costs but are provided free of charge. We provide free rental of necessary equipment for the duration of the study: 
    - Reagents: extraction reagents, Seegene PCR reagent kits for only the clinical study.
    - Equipment: NIMBUS/STARlet, CFX96
    Equipment rental from Seegene is available during the contractual period if needed.
    - Equipment-related consumables: tips, tubes, waste bags, PCR tubes, caps etc.

    * Materials other than the provided consumables, such as comparators, are to be procured using the research award.

The review panel

  1. Jin-Su Choi, B.S. (Review Panel Chair)
    President / Chief Operation Officer (COO)
  2. Dae-Hoon Lee, Ph.D.
    Executive Vice President / Chief R&D Officer
  3. In-Taek Hwang, Ph.D.
    Senior Vice President / Head of Fundamental Science
  4. Bernard Kim, Ph.D.
    Senior Vice President / Head of Extraction Science
  5. Yun-Jee Kim, Ph.D.
    Vice President / Head of Molecular Diagnostics 
  6. Jun Yong Ha, Ph.D.
    Vice President / Head of Clinical Affairs
  7. Jik-Young Park, Ph.D.
    Vice President / Head of Development Automation
  8. Daeho Shin, MBA
    Executive Vice President / Chief Global Sales & Marketing Officer 
  9. Dong Ju Seo, MBA
    Senior Vice President / Head of Global Business (Asia, Middle East, Africa)
  10. Eunsin Bae, M.D.
    Vice President / Head of Global Business (Europe)
  11. Seong-Youl Kim, Ph.D.
    Senior Vice President / Head of Global Marketing Center
  12. Jeung-Gu Kim, M.S.
    Vice President / Head of Sales Management
  13. Ki Sun Lee, MBA (2nd round review only)
    Executive Vice President / Head of Manufacturing & Procurement
  14. Boo Hyun Yang, M.S. (2nd round review only)
    Executive Vice President / Head of Patent Center
  15. Seung-Goo Kang, M.S.
    Senior Vice President / Head of Quality Management
  16. Harry Cho, B.S.
    Senior Vice President / Head of Planning and Coordination
  17. Jeng-Yong Kim, B.S. (2nd round review only)
    Senior Vice President / Head of Financial Management
  18. Young Seag Baeg, MBA
    Vice President / Head of Corporate Strategic Planning
  19. Eui Chong Kim, M.D., Ph.D.
    Advisor / Emeritus Professor at Seoul National University
  20. Richard S. Creager, Ph.D.
    Chief Executive Officer (CEO) of Seegene USA, Inc
  21. Glen Hansen, Ph.D.
    Chief Medical Officer of Seegene USA, Inc
  22. Lothar Kruska, Ph.D.
    Chief Executive Officer (CEO) of Seegene Germany GmbH
  23. Charlotte Sager, Ph.D.
    Head of Product Development of Seegene Germany GmbH
  24. Franco Maccheroni, M.S.
    Chief Executive Officer (CEO) of Arrow Diagnostics S.R.L (A Seegene affiliate in Italy)
  25. Lara Boatti, Ph.D.
    Head of R&D of Arrow Diagnostics S.R.L (A Seegene affiliate in Italy)

The Review Panel is subject to change. 

Reporting and monitoring

Awardees must submit a report within one month (30 days) from the completion of the preclinical and clinical studies. Report template and a completed example will be provided at the time of the contract.

  • The award is provided in three phases. Initial payment is 30% of the total payment and given on the effective date* of the contract. The second payment is 30% of the total payment and given after the submission of the feasibility study reports with clinical samples. The last payment is 40% of the total payment and given after the submission of the clinical study report. 
    * The effective date will differ depending on the individual contract date.
  • The award can be rescinded if false information is discovered in the clinical study proposal or attached materials.
  • Applicants may propose minor modifications (adding or removing) of analytes if there is a valid reason.

Dissemination of results and promotional materials

The Awardee and lead institution should endeavor to make the results generated through the Open Innovation Program available to the broader scientific community, in consultation with Seegene, through publication in journals, reports, at scientific meetings and through other appropriate routes.

The Awardee and lead institution must acknowledge support received from Seegene in publications and other forms of communication including media appearances and press releases.

Awardees must seek Seegene’s written consent prior to publishing any results arising from the research associated directly from the award. There is no expectation or requirement that research will be published in journals owned or managed by Springer Nature. Where manuscripts are submitted to Springer Nature journals, they will be subjected to the same editorial and review processes and standards as any other submission.

Applicants can request Article Processing Charges for open access publications as part of the direct costs on their research proposal.

The Awardee should follow good publication practice as set out by, for example, the Committee on Publication Ethics and the Council of Science Editors.

Awardees will be interviewed by Seegene or Springer Nature as part of a series of Q&A articles about funded projects which would appear on Seegene’s website or other promotional materials.

Rights and ownership

The full rights to any and all inventions originating from projects shall be the exclusive property of Seegene. 

Before you apply for the Open Innovation Program, please review the sample Services Agreement.

Sample Services Agreement (pdf)
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