Marine Drug Development and Delivery Prof. Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D Department of Pharmaceutics KLE University College of Pharmacy BELGAUM , Karnataka, India 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 1

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. 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 2

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. 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 3

Discovery and Development 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 4

New Drug Development 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 5

New Drug Development Stages   Natural/Marine product discovery   Chemically modified drug   Discovery unknown structure of compounds   Synthesis, recombinant DNA   Source of leads for product development 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 6

New Drug Development Stages   Synthetic compounds based on existing compounds   Chemical improvement on drug molecule   Drug candidates   Pre-clinical and clinical trials   Approval process   Marketing new drug products 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 7

Natural/Marine product discovery  Natural products, secondary metabolites, isolated from plants, animals and microbes are important sources for bioactive molecules that in many cases have been developed into treatments for diseases.  Marine natural products for inflammation, cancer, infections, and neurological disorders. 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 8

Chemically modified drug  Most therapeutic drugs distribute to the whole body, which results in general toxicity and poor acceptance of the treatments by patients.  The targeted delivery of chemotherapeutics to defined cells, either stromal or cancer cells in cancer lesions, or defined inflammatory cells in immunological disorders, is one of main challenges and a very active field of research in the development of treatment strategies to minimize side-effects of drugs.  The targeted delivery of chemotherapeutics to defined cells, either stromal or cancer cells in cancer lesions, or defined inflammatory cells in immunological disorders, is one of the main challenges and a very active field of research in the development of treatment strategies to minimize side-effects of drugs. 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 9

Discovery unknown structure of compounds  Determining the structure of an unknown compound is a time-consuming process which could take months, therefore the ability to immediately ‘see’ the structure of a chemical compound simply by looking through a microscope is a tremendous feat,” said Professor Jaspars.  This new approach could lead to much faster identification of unknown compounds and ultimately speed up the process of the development of new medicines. 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 10

Synthesis, recombinant DNA 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 11 Recombinant DNA

1. Transformation 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 12

2. Non-bacterial Transformation 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 13

3. Phage 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 14

Source of leads for product development  The Lead User market research method is built around the idea that the richest understanding of new product and service needs is held by just a few "Lead Users”.  They can be identified and drawn into a process of joint development of new product or service concepts with manufacturer personnel. 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 15

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. 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 16

Chemical improvement on drug molecule  Technology can be applied to chemically improvement on the drug molecule/bioactive molecule.  Drug molecule of protein, peptide or small molecule drugs, either in development, or currently marketed, by other companies. 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 17

Drug candidates  Hits, leads and drug candidates constitute three millstones in the course of drug discovery and development.  The definition of drug candidates is a critical point in the value chain of drug innovation, which not only differentiates the research and development stages, but more importantly, determines the perspective and destiny of the pre-clinical and clinical studies. 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 18

 All outcomes from the development stage are actually attributed to the chemical structure of candidates.  The quality of candidates, however, is restricted by the drug-likeness of lead compounds, which in turn is decided by the characteristics of hits 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 19 Drug candidates

Pre-clinical Development  In drug development, pre-clinical development is a stage of research that begins before clinical trials (testing in humans) can begin, and during which important feasibility, iterative testing and drug safety data is collected.  The main goals of pre-clinical studies (also named preclinical studies and nonclinical studies) are to determine a product's ultimate safety profile.  Products may include new or iterated or like-kind medical devices, drugs, gene therapy solutions, etc. 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 20

  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. 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 21 Clinical trials

Approval Process 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 22

Approval Process 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 23

Approval Process 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 24

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. 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 25

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InhalationTransdermalTransmucosal Topical OralSponges Bioencapsulation 14/12/2011 Birla Institute of Technology, Mesra, Ranchi. 28

Thank you 14/12/2011 Birla Institute of Technology, Mesra, Ranchi Cont. No: