Marine drug development and delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.

1. Marine Drug Development and Delivery
Prof. Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D
Department of Pharmaceutics
KLE University College of Pharmacy
BELGAUM-590010, Karnataka, India
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 11

2. DrugDrug 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.
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 22

3. 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.
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 33

4. Discovery and Development
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 44

5. New Drug Development
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 55

6. 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
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 66

7. 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
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 77

8. Natural/Marine product discovery
 Natural products, secondary metabolites, isolatedNatural products, secondary metabolites, isolated
from plants, animals and microbes are importantfrom plants, animals and microbes are important
sources for bioactive molecules that in many casessources 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.
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 88

9. 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 acceptancewhich results in general toxicity and poor acceptance
of the treatments by patients.of the treatments by patients.
 The targeted delivery of chemotherapeutics to definedThe 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 immunologicalor defined inflammatory cells in immunological
disorders, is one ofdisorders, is one of the main challenges and a verymain challenges and a very
active field of research in the development ofactive field of research in the development of
treatment strategies to minimize side-effects of drugs.treatment strategies to minimize side-effects of drugs.
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 99

10. Discovery unknown structure of compounds
 Determining the structure of an unknown compoundDetermining the structure of an unknown compound
is a time-consuming process which could takeis a time-consuming process which could take
months, therefore the ability to immediately ‘see’ themonths, therefore the ability to immediately ‘see’ the
structure of a chemical compound simply by lookingstructure of a chemical compound simply by looking
through a microscope is a tremendous feat,” saidthrough a microscope is a tremendous feat,” said
Professor Jaspars.Professor Jaspars.
 This new approach could lead to much fasterThis new approach could lead to much faster
identification of unknown compounds and ultimatelyidentification of unknown compounds and ultimately
speed up the process of the development of newspeed up the process of the development of new
medicines.medicines.
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 1010

11. Synthesis, recombinant DNA
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 1111
Recombinant DNA

12. 1. Transformation1. Transformation
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 1212

13. 2. Non-bacterial Transformation2. Non-bacterial Transformation
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 1313

14. 3. Phage3. Phage
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 1414

15. Source of leads for product development
 The Lead User market research method is builtThe Lead User market research method is built
around the idea that the richest understanding of newaround the idea that the richest understanding of new
product and service needs is held by just a few "Leadproduct and service needs is held by just a few "Lead
Users”.Users”.
 They can be identified and drawn into a process ofThey can be identified and drawn into a process of
joint development of new product or service conceptsjoint development of new product or service concepts
with manufacturer personnel.with manufacturer personnel.
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 1515

16. 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.
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 1616

17. Chemical improvement on drug molecule
 Technology can be applied to chemicallyTechnology can be applied to chemically
improvement on the drug molecule/bioactiveimprovement on the drug molecule/bioactive
molecule.molecule.
 Drug molecule of protein, peptide or smallDrug molecule of protein, peptide or small
molecule drugs, either in development, ormolecule drugs, either in development, or
currently marketed, by other companies.currently marketed, by other companies.
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 1717

18. Drug candidates
 Hits, leads and drug candidates constitute threeHits, leads and drug candidates constitute three
millstones in the course of drug discovery andmillstones in the course of drug discovery and
development.development.
 The definition of drug candidates is a critical point inThe definition of drug candidates is a critical point in
the value chain of drug innovation, which not onlythe 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 andbut more importantly, determines the perspective and
destiny of the pre-clinical and clinical studies.destiny of the pre-clinical and clinical studies.
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 1818

19.  All outcomes from the development stage areAll outcomes from the development stage are
actually attributed to the chemical structure ofactually attributed to the chemical structure of
candidates.candidates.
 The quality of candidates,The quality of candidates, however, ishowever, is
restricted by the drug-likeness of leadrestricted by the drug-likeness of lead
compounds, which in turn is decided by thecompounds, which in turn is decided by the
characteristics of hitscharacteristics of hits
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 1919
Drug candidates

20. Pre-clinical Development
 In drug development,In drug development, pre-clinical developmentpre-clinical development is a stageis a stage
of research that begins before clinical trials (testing inof research that begins before clinical trials (testing in
humans) can begin, and during which importanthumans) can begin, and during which important
feasibility, iterative testing and drug safety data isfeasibility, iterative testing and drug safety data is
collected.collected.
 The main goals of pre-clinical studies (also namedThe main goals of pre-clinical studies (also named
preclinical studies and nonclinical studies) are topreclinical 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 medicalProducts may include new or iterated or like-kind medical
devices, drugs, gene therapy solutions, etc.devices, drugs, gene therapy solutions, etc.
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 2020

21.  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.
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 2121
Clinical trials

22. Approval Process
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 2222

23. Approval Process
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 2323

24. Approval Process
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 2424

25. 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.
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 2525

26. 14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 2626
Marine Drug Delivery

27. 14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 2727
Marine Drug Delivery

28. 14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 2828

29. Thank youThank you
14/12/201114/12/2011
Birla Institute of Technology,Birla Institute of Technology,
Mesra, Ranchi.Mesra, Ranchi. 2929
E-mail: bknanjwade@yahoo.co.in
Cont. No: 00919742431000