Research to Commercialization

Research: Often drug discovery starts with new entity drugs, rather than improvements of existing drugs. If this is the case, the MarinBio scientists can creatively help your efforts to develop, screen and elucidate the mechanism of action of new entities. We can suggest efficient methods to achieve the results you need, and with a lower cost than later stage drug requirements. We will work with you collaboratively to identify the progression of your project that will provide the stepping stones for the next phase of your drug discovery. Briefly, the MarinBio scientist will aid you by:

• Exploring an discussing methods
• Verifying a published paper that may aid your project plans
• Testing a tecnnique that will move your project forward

Drug Screening, Mechanism of Action: Screening your drug candidates allows you to discern which candidate drugs are more potent, enabling you to rank the order and decide which candidates to move forward, and help to elucidate the specificity of action.  More difficult is to identify the mechanism of action of your lead compounds. Your drug may work via receptors, or through a totally different pathway. You lead drug may have “off target” activities, that are revealed through our “research”. Our scientists are here to help you through this difficult path to further the development of your lead compounds.

PRECLINICAL – CLINICAL REGULATORY 

Preclinical Studies: From the research phase of drug development and screening candidate drugs, the preclinical portion of the project starts with a clinical indication and an idea of how to target it therapeutically. The pre-clinical testing involves the in vitro assay development, of which MarinBio scientsts are expert. Preclinical in vivo models leads to studying the half-life of the drug using various dosages and administration route. PK studies, will allow the safety to be assessed, and hopefully the efficacy of the drug through animals studies. MarinBio scientists will help you through this phase by developing Good Laboratory Practices (GLP)  assays to test the serum/plasma or other fluids. The lead compound is selected and the regulatory process to IND and commercialization starts. MarinBio will assist your staff in reporting the data for your Investigational New  Drug (IND)  application submission to the US Federal Drug Admnistratin (FDA). Incorporated into the IND submission are the following:

• Toxicity testing
• Pharmacology, method of administration, body concentrations, immune response, etc
• Efficacy

Clinical Trials: There are several phase of trials for testing human responses. Each phase has an increasing number of patients that allows for the assessment of the candidate drug.

Assays on patient samples, for example, serum, are governed by Good Clinical Practices (GCP).  These are similar to  GLP, reproducible, robust, accurate, and suitably documented with Quality Department oversight.

PHASE I looks for dose limiting toxicities, and obtains initial information on pharmacology and hopefully some efficacy. These trials are often performed with normal subjects. The subject number is limited, typically from 20 to 100 subjects.

PHASE II investigates drug dose and efficacy parameters, may include several trials in different indications and with different subset of subjects. More individuals are enrolled for these studies, typically few hundred patients.

PHASE III is usually a single trial with enough patients to achieve evidence of cost benefit, the ratio of desired result (efficacy) and the type and likelihood of adverse effects. The number of enrolled patients can be 300 to over 10,000. 

Manufactured lots of drug for preclinical and clinical trials must be made under under current Good Manufacturig Practices (cGMP).  

Commercialization:  At the conclusion of a successful Phase III clniical trial, a New Drug Application (NDA) for small molecules or Biological License Application (BLA) for large biological molecules, is filed with the FDA to obtain approval for commercialization.  The processs from preclinical studies to  successful monetization can take over 10 years and hundreds of millions of dollars. Also for this phase the GLP assay requirements are similar to the Phase III. A very robust, accurate assay is necessary.

LEGAL 

Our legal efforts have supported clients that range from the largest 5 international pharmaceutical corporations, biotech and agricultural corporations to virtual companies. MarinBio scientists have performed multiple assays using methods that were employed during the initial patent application. Some of these methods ranged from the 1980 or earlier to current methods. Our clients, the litigators and their associates, communicate with our scientists indicating what methods need to be repeated, the type of data they would hope to have, the time frame, and the route of communication. Our scientists typically talk with our legal clients about the data and conclusions before any conclusions are written and are discoverable. We will discuss the pros and cons of the experimental approaches and the resulting data. All written and electronic files are transmitted to our clients in the format they require. The MarinBio scientists have supported our clients through depositions, expert witness testimony at trial and supporting reports.