IDEA-to-IND Transforming Ideas to regulatory approval
IDEA-to-IND is an integrated service product for fostering scientific innovations through transforming an idea (IDEA) into IND and NDA/BLA (FDA). The key pre-clinical services offered through our IDEA-to-IND product are shown in the following flowchart.
IDEA-to-IND/NDA/BLA Workflow
Abbreviations: IND: Investigational drug application; NDA: New drug application; BLA: Biologics License Application; GMP: Good manufacturing practice; GLP: Good laboratory practice
MarinBio can do what other CROs will not or cannot do:
MarinBio’s IDEA-to-IND service product is a unique combination of discovery/R&D & pre-clinical research services, specifically designed to:
- Help entrepreneurs & startups to achieve their goals.
- Help translate scientific innovations from academic laboratories to regulatory approval.
Key features of MarinBio IDEA-to-IND:
- Test potential and actual clinical applications (not clinical studies) of ideas or innovations before even building your own laboratory set up. Furthermore, reducing investment costs, time and mitigating risks.
- Our scientists will test your ideas in our laboratory under your instructions and can also assist you in designing experiments or choosing assays.
- Ideal for startups and early-stage investors for validating new or licensed technologies.
- You own the IP rights of any technologies we developed specifically for your projects.
- Well-defined and bold strategies to reduce development time and cost.
Advantages of working with MarinBio:
- We have twenty-seven (27) years of experience in helping clients starting from testing ideas to validation and IND/NDA/BLA application.
- We have fully equipped non-GMP and GMP laboratories.
- Our scientists have an average 10-25 years of research experience in diverse areas.
How does MarinBio IDEA-to-IND work?
An outline of our IDEA-to-IND platform is shown in the following flowchart.
MarinBio areas of expertise
MarinBio service products
MarinBio accomplishments
- Proof-of-concept experiments on small molecules, proteins, antibodies, single chain/bispecific antibody constructs, gene therapy drugs ( plasmid, adenovirus associated virus (AAV), oligonucleotides, siRNA, & peptides).
- Pre-validation & Validation (experiments, protocols, and SOP) in support with FDA interactions.
- GMP assay (ELISA & cell-based) development for pharmacokinetic (PK) analysis.
- GMP/GLP potency assay development (cell-based).
- GMP/GLP purification of proteins (including antibodies)
- GMP drug stability assays.
- GMP lot release assays
What our clients say:
- “The feasibility of this custom assay format has been nicely demonstrated. You’ve met our goals of a faster, higher throughput, more easily quantitative assay than the previous method . . . and even exceeded our expectations by developing a homogenous format! Very well done.” Vision Clinical Research
- “Flexible, agile and creative when consulting on science. Work with integrity and high touch service.” Head of Clinical Development & Chief Medical Officer
“Parts of the figure were drawn by using pictures from Servier Medical Art. Servier Medical Art by Servier is licensed under a Creative Commons Attribution 3.0 Unported License (https://creativecommons.org/licenses/by/3.0/).”
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