Marine Drug Development and Delivery

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

2
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.

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.

4
Discovery and Development
5
New Drug Development
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

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

8
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.

9
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 the main
  challenges and a very active field of research in
  the development of treatment strategies to
  minimize side-effects of drugs.

10
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.

11
Synthesis, recombinant DNA
Recombinant DNA
12
1. Transformation
13
2. Non-bacterial Transformation
14
3. Phage
15
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.

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.

17
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.

18
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.

19
Drug candidates

• 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

20
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.

21
Clinical trials

• 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.

22
Approval Process
23
Approval Process
24
Approval Process
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.

26
Marine Drug Delivery
27
Marine Drug Delivery
28
(No Transcript)
29
Thank you
E-mail bknanjwade_at_yahoo.co.in Cont. No
00919742431000