Marine Drug Development and Delivery Prof. Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D Department of Pharmaceutics KLE University College of Pharmacy BELGAUM-590010,

Marine Drug Development and Delivery

Prof. Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D

Department of PharmaceuticsKLE University College of PharmacyBELGAUM-590010, Karnataka, India

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Drug Drug Development

Substances produced by living organisms found in nature have played a critical role in the development of drugs for life-threatening conditions.

Number of recent breakthroughs have resulted in the development and approval of anticancer drugs derived from marine sources such as coral and sponges.

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Why Marine Drug Development

The marine environment provides a broad range of diverse habitats from which novel sources of natural products can be derived.

Studies from around the world have shown that marine organisms produce a diverse array of metabolites with novel chemical structures and potent biological activities as well as other desirable properties.

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Discovery and Development

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New Drug Development

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New Drug Development Stages

Natural/Marine product discoveryChemically modified drugDiscovery unknown structure of

compoundsSynthesis, recombinant DNASource of leads for product development

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New Drug Development Stages

Synthetic compounds based on existing compounds

Chemical improvement on drug moleculeDrug candidatesPre-clinical and clinical trialsApproval processMarketing new drug products

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Natural/Marine product discovery

Natural products, secondary metabolites, isolated Natural products, secondary metabolites, isolated from plants, animals and microbes are important from plants, animals and microbes are important sources for bioactive molecules that in many cases sources for bioactive molecules that in many cases have been developed into treatments for diseases. have been developed into treatments for diseases.

Marine natural products for inflammation, cancer, Marine natural products for inflammation, cancer, infections, and neurological disorders.infections, and neurological disorders.

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Chemically modified drug

Most therapeutic drugs distribute to the whole body, Most therapeutic drugs distribute to the whole body, which results in general toxicity and poor acceptance which results in general toxicity and poor acceptance of the treatments by patients. of the treatments by patients.

The targeted delivery of chemotherapeutics to defined The targeted delivery of chemotherapeutics to defined cells, either stromal or cancer cells in cancer lesions, cells, either stromal or cancer cells in cancer lesions, or defined inflammatory cells in immunological or defined inflammatory cells in immunological disorders, is one of disorders, is one of the main challenges and a very main challenges and a very active field of research in the development of active field of research in the development of treatment strategies to minimize side-effects of drugs.treatment strategies to minimize side-effects of drugs.

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Discovery unknown structure of compounds

Determining the structure of an unknown compound Determining the structure of an unknown compound is a time-consuming process which could take is a time-consuming process which could take months, therefore the ability to immediately ‘see’ the months, therefore the ability to immediately ‘see’ the structure of a chemical compound simply by looking structure of a chemical compound simply by looking through a microscope is a tremendous feat,” said through a microscope is a tremendous feat,” said Professor Jaspars. Professor Jaspars.

This new approach could lead to much faster This new approach could lead to much faster identification of unknown compounds and ultimately identification of unknown compounds and ultimately speed up the process of the development of new speed up the process of the development of new medicines.medicines.

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Synthesis, recombinant DNA

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Recombinant DNA

1. Transformation1. Transformation

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2. Non-bacterial Transformation2. Non-bacterial Transformation

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3. Phage3. Phage

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Source of leads for product development

The Lead User market research method is built The Lead User market research method is built around the idea that the richest understanding of new around the idea that the richest understanding of new product and service needs is held by just a few "Lead product and service needs is held by just a few "Lead Users”.Users”.

They can be identified and drawn into a process of They can be identified and drawn into a process of joint development of new product or service concepts joint development of new product or service concepts with manufacturer personnel.with manufacturer personnel.

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Synthetic compounds based on existing compounds

The more stable synthetic compounds, are based on the earlier natural and synthetic compounds, but differ so markedly from them in properties and activity as to constitutes a new class of compounds.

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Chemical improvement on drug molecule

Technology can be applied to chemically Technology can be applied to chemically improvement on the drug molecule/bioactive improvement on the drug molecule/bioactive molecule.molecule.

Drug molecule of protein, peptide or small Drug molecule of protein, peptide or small molecule drugs, either in development, or molecule drugs, either in development, or currently marketed, by other companies.currently marketed, by other companies.

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Drug candidates

Hits, leads and drug candidates constitute three Hits, leads and drug candidates constitute three millstones in the course of drug discovery and millstones in the course of drug discovery and development.development.

The definition of drug candidates is a critical point in The definition of drug candidates is a critical point in the value chain of drug innovation, which not only the value chain of drug innovation, which not only differentiates the research and development stages, differentiates the research and development stages, but more importantly, determines the perspective and but more importantly, determines the perspective and destiny of the pre-clinical and clinical studies. destiny of the pre-clinical and clinical studies.

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All outcomes from the development stage are All outcomes from the development stage are actually attributed to the chemical structure of actually attributed to the chemical structure of candidates. candidates.

The quality of candidates,The quality of candidates, however, is however, is restricted by the drug-likeness of lead restricted by the drug-likeness of lead compounds, which in turn is decided by the compounds, which in turn is decided by the characteristics of hitscharacteristics of hits

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Drug candidates

Pre-clinical Development In drug development, In drug development, pre-clinical developmentpre-clinical development is a stage is a stage

of research that begins before clinical trials (testing in of research that begins before clinical trials (testing in humans) can begin, and during which important humans) can begin, and during which important feasibility, iterative testing and drug safety data is feasibility, iterative testing and drug safety data is collected.collected.

The main goals of pre-clinical studies (also named The main goals of pre-clinical studies (also named preclinical studies and nonclinical studies) are to preclinical studies and nonclinical studies) are to determine a product's ultimate safety profile. determine a product's ultimate safety profile.

Products may include new or iterated or like-kind medical Products may include new or iterated or like-kind medical devices, drugs, gene therapy solutions, etc.devices, drugs, gene therapy solutions, etc.

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Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols).

These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place.

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Clinical trials

Approval Process

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Approval Process

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Approval Process

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Marketing new drug products

Test Procedures and Acceptance Criteria for Biotechnological/Biological Products addresses guideline specifications, tests and procedures for biotechnological/biological products.

Radiopharmaceuticals, products of fermentation, oligonucleotides, herbal products and crude products of animal or plant origin are similarly not covered.

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Marine Drug Delivery

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Marine Drug Delivery

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Thank youThank you

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E-mail: [email protected]. No: 00919742431000