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

 

Ready to Start Your Project?

Our Scientists can help you

Celebrating 27 Years of Our Clients' Trust
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