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Radha Krishnan, PhD

Radha Krishnan, Ph.D.

Radha Krishnan, Ph.D. has fifteen years experience in product development of small molecule and peptide/protein based drugs from innovation through pivotal clinical phases especially in the therapeutic areas of diabetes & endocrinology, gastroenterology and cardiology. Expert skills pharmaceutical development of peptide based drugs and innovation of new technologies for oral delivery of peptides.

Experience include, rapid product development form discovery to IND pivotal clinical phase, pre-clinical development strategy, pharmaceutical development (solid and liquid dosages development of peptides/small molecules), CMC regulatory, manufacturing (recombinant proteins/ synthetic peptides/ small molecules), regulatory strategies & IND preparations, novel technologies for oral deliveries of peptides, medicinal chemistry development, IP strategies & creation, out-sourcing management, out-licensing and corporate development.

Proven Records

A. IND and product development of peptides and small molecules for oral delivery

1. Oral insulin: Diabetes

a. Oral insulin products: technology innovation of oral insulin, innovation of novel recombinant process for insulin conjugate manufacturing, CMC development, solid dosage pharmaceutical development to IND PhII

2. Oral calcitonin: Osteoprosis

a. Oral calcitonin products: technology research through development to IND phase II proof of concept, novel manufacturing process development for clacitonin conjugate and CMC regulatory development.

3. Oral natriuretic peptide (oral BNP): Cardiovascular

a. Oral natriuretic peptide product: drug substance manufacturing, pharmaceutical development to solid dosage, development through IND ready stage

4. Small molecule prodrug: IBD

a. 5-ASA prodrug: product development through IND PhII proof of concept, CMC regulatory, solid dosage development, bulk manufacturing process development through phase III ready stage.

B. IND and product development of peptide for parenteral delivery

1. Insulin neogenesis peptide: Diabetes

a. Short peptide drug: pharmaceutical development, bulk manufacturing strategies, re-formulation for late phase II studies.

C. Thirteen years experience in planning, strategizing, out-sourcing, supply management and executing manufacturing and pharmaceutical development activities in the following projects from discovery stage to IND or Phase III ready stage.

1. Insulin conjugates

2. Calcitonin conjugates

3. B type natriuretic peptide

4. Solid and liquid dosages for peptides (Insulin, Calcitonin and BNP)

5. Parenteral formulation for peptides (Insulin neogenesis peptide)

6. Multi Kg synthetic process for IBD prodrug

7. Enteric coated tablets process for IBD prodrug

8. Alkyl PEGs (single molecular weight alkylated polyethylene glycol derivatives)

9. Pegylation chemistry

10. Oral delivery systems for conjugation

11. Recombinant process for peptides and proteins (insulin, GI peptide)

12. Synthetic process for peptides (Calcitonin, BNP, GI peptides)

13. Medicinal chemistry discovery

14. In vivo screening of formulation and discovery candidates

D. Established relationships with contract research organizations (CROs) world wide

1. Calvert Labs (USA)

2. Cardinal Health (USA)

3. Patheon (Canada)

4. MDS Pharma (USA)

5. Metrics (USA)

6. Fulcrum Pharma (USA)

7. Kinexum Metabolics (USA)

8. Skinner Associates (USA)

9. Pharma Consultants (USA)

10. Bioprocess Consultants (USA)

11. Clinigne and Syngene (India)

12. Devos (USA)

13. Effret Associates (USA)

14. RTI (USA)

15. Arizona VA Hospital (USA)

16. AAI (USA)

17. Diabetes and Glandular disease Research Associates (USA)

18. Gastroenterology Division, Duke Medical Hospital (USA)

19. Baker Heart Research Institute (Australia)

E. Established relationships with contract manufacturing organizations (CMOs) world wide.

1. American Peptide (USA)

2. Ambiopharm (USA, China)

3. Avecia (biopharm products) (UK)

4. Avecia- custom chemical division (now Nicolas-Piramal) (UK)

5. Biocon (India)

6. Biomm (Brazil)

7. Brasagen (Australia)

8. Becton Jackson (USA, Europe)

9. Bachem (USA)

10. Chinese Peptide Company (China)

11. CKD (Korea)

12. Cardinal Health (USA)

13. Dow Pharma (both custom chemical and biopharm products) (USA)

14. Girindus (USA and Germany)

15. Lonza (Switzerland)

16. MDS Pharma (USA)

17. Rhodia (UK)

18. Roche�Colorado (USA)

19. Shantha Biotech (India)

20. Polypeptide (USA, Denmark)

21. Itoham Life Sciences (Japan)

22. Wallace (India)

23. Wockheart (India)