Prof. Gayatri Saberwal

Prof. Gayatri Saberwal

Professor, Policy Research


Vidwan-ID : 562943

Research focus key words

Policy research, currently focused on clinical trial databases. Earlier work focused on rare diseases, entrepreneurship and patents.

Background

I obtained my MSc from the Jawaharlal Nehru University, New Delhi, and my PhD in the life sciences from the Centre for Cellular and Molecular Biology, Hyderabad. I then did post-doctoral work at the Weill Medical College of Cornell University, New York. I have been at IBAB since it was established in 2001. At IBAB I switched from being a biologist to being a policy researcher.

Education

  1. Msc: Jawaharlal Nehru University, Delhi
  2. PhD: Centre for Cellular and Molecular Biology, Hyderabad.
  3. Post-doctoral work: Weill Medical College of Cornell University, New York

Professional experience

Primarily at IBAB.

Research interest profile

We study the health-related industries and issues around them. We also write general articles and editorials about these issues.

Group members

  1. Albin Benny
  2. Blessy Sajeev

Collaborators

  1. Dr. Vina Vaswani, Professor, Yenepoya University
  2. Dr. Nithiyanandam Yogeswaran, Takshashila Institution

Funders

Our work has been supported by
1. The Wadhwani Foundation
2. Institut Merieux
3. Internal funds from IBAB

Publications and Patents:
Research publications

  1. Borah R, Dhal, AD, Mendiratta, J, Mishra, M and Saberwal G
    Identifying trials run in India that are registered in other clinical trial registries: A cross-sectional study.
    BMC Medical Research Methodology, 24:201 doi: 10.1186/s12874-024-02336-w (2024). 
  2. Borah R, Samanta AD, Rajueni K, Vaswani V and Saberwal G 
    In India, most principal investigators have run very few trials over the years.
    Front. Med., 11:1424570. doi: 10.3389/fmed.2024.1424570 (2024)
  3. Samanta A D, Borah R and Saberwal G
    Three levels of discrepancies in the records of trial sites in India, registered with the European Union Clinical Trials Register
    Front. Med. 11:1357930 doi: 10.3389/fmed.2024.1357930 (2024)
  4. Bhalla IS, Ravindranath AG, Vaswani R , Saberwal G
    Data from the Indian drug regulator and from Clinical Trials Registry-India does not always match
    Front. Med., 11:1346208. doi: 10.3389/fmed.2024.1346208 (2024)
  5. Mendiratta J, Pillamarapu M, Saberwal G.
    In Clinical Trials Registry-India, the classification of sponsors needs to be standardised.
    Indian J. Med. Ethics, doi: 10.20529/IJME.2023.071 (2023)
  6. Mendiratta J, Pillamarapu M, Chakraborty I, Vaswani R, Kapoor M, Vadlamani S, Saberwal G.
    Ethnic representation in interventional clinical trials run in India
    The Lancet Regional Health – Southeast Asia, 15: 100230 (2023)
  7. Mendiratta J, Vaswani R N, Saberwal G
    Representation from India in multinational, interventional, Phase 2 or 3 trials registered in Clinical Trials Registry-India: A cross-sectional study
    PLOS ONE , 18(9): e0284434. doi: 10.1371/journal.pone.0284434 (2023)
  8. Saberwal, G., Choudhury MC, and Chakraborty I
    Facilitating audits of clinical trial data in documents of the Food and Drug Administration.
    The Journal of Scientific Practice and Integrity, doi: 10.35122/001c.57582 (2022)
  9. Kapoor M, Ravi S and Saberwal G
    Conducting clinical trials only in India’s large cities is unlikely to sample the country’s ethnicity well enough.
    Current Science, 123 (12), 1514-1517 doi: 10.18520/cs/v123/i12/1514-1517 (2022)
  10. Chakraborty, I, Shreya, A, Mendiratta, J, Bhan, A. and Saberwal, G.
    An analysis of deficiencies in the Ethics Committee data of interventional trials registered with the Clinical Trials Registry – India.
    PLOS Global Public Health, 2(10): e0000617 doi:10.1371/journal.pgph.0000617 (2022)
  11. Chakraborty M, Choudhury MC, Chakraborty I and Saberwal, G.
    Rare disease patients in India are rarely involved in international orphan drug trials.
    PLOS Global Public Health, 2(8): e0000890 doi:10.1371/journal.pgph.0000890 (2022)
  12. Choudhury M. C., Chakraborty I and Saberwal, G.
    Discrepancies between FDA documents and ClinicalTrials.gov for Orphan Drug-related clinical trial data.
    PLOS Global Public Health, 2(4): e0000261. https://doi.org/10.1371/journal.pgph.0000261 (2022).
  13. Mahanta U, Saberwal G and Sharma G
    Are countries becoming better at SARS-CoV-2 genomic surveillance?
    Frontiers in Public Health, 10:887955. doi: 10.3389/fpubh.2022.887955 (2022)
  14. Kalia, K, Saberwal, G. and Sharma, G.
    The lag in SARS-CoV-2 genome submissions to GISAID.
    Nature Biotechnology, 39: 1058–1060 doi.org/10.1038/s41587-021-01040-0 (2021)
  15. Venugopal, N. and Saberwal, G.
    A comparative analysis of important public trial registries, and a proposal for an interim ideal one.
    PLoS ONE, 16(5): e0251191. https://doi.org/10.1371/journal.pone.0251191 (2021)
  16. Kumari, S. Mohan, A. and Saberwal, G
    Hidden duplicates: 10s or 100s of Indian trials, registered with ClinicalTrials.gov, have not been registered in India, as required by law.
    PLoS One 15(6): e0234925 (2020).
  17. Pillamarapu M, Mohan A and  Saberwal G
    Response to the Letter on: “An analysis of deficiencies in the data of interventional drug trials registered with Clinical Trials Registry – India”.
    Trials 21: 39 (2020).
  18. Pillamarapu, M., Mohan, A. and Saberwal, G.
    An analysis of deficiencies in the data of interventional drug trials registered with Clinical Trials Registry – India.
    Trials 20: 535 (2019).
  19. Choudhury M. C. and Saberwal, G.
    The origins, achievements, and challenges of orphan medicinal product organizations in India: An interview-based study.
    Orphanet J Rare Dis. 14, 241 (2019).
  20. Choudhury M. C. and Saberwal, G.
    The role of patient organizations in the rare disease ecosystem in India: An interview-based study.
    Orphanet J Rare Dis. 14:117 (2019)
  21. Chaturvedi, N, Mehrotra, B, Kumari, S, Gupta, S, Subramanya, H S and Saberwal, G.
    Some data quality issues at ClinicalTrials.gov.
    Trials 20:378 (2019)
  22. Dash, S. P. and Saberwal, G.
    The bio-­incubation boom in India.
    Current Science 115, 228–233 (2018)
  23. Mehrotra, B. and Saberwal, G.
    Patents protecting biologics or small molecule drugs are litigated, not others awarded to drug discovery companies.
    Journal of IP Rights, 21, 149-156 (2016).
  24. Keezhupalat, S.M., Naik, A., Gupta, S., Raghunathan, S. and Saberwal,G.
    An analysis of sponsors/collaborators of 69,160 drug trials registered with ClinicalTrials.gov
    PLOS ONE 11(2): e0149416. doi:10.1371/journal.pone.0149416 (2016)
  25. Saberwal, G.
    India’s intellectual property-based biomedical start-ups.
    Current Science, 110, 167-171 (2016)
  26. Jaroslawski, S. and Saberwal, G.
    In eHealth in India today, the nature of work, the challenges and the finances: an interview based study.BMC Medical Informatics and Decision Making, 14, 1-12 (2014) 
  27. Kumari, S. and Saberwal, G.
    Patent maintenance by Indian pharma and bio-pharma companies.
    Asian Biotechnology Development Review, 15, 69-77 (2013)
  28. Jaroslawski, S. and Saberwal, G.
    Case studies of innovative medical device companies from India: Barriers and enablers to development.BMC Health Services Research, 13, 199-207 (2013)  
  29. Saberwal, G. Giving voice to India’s entrepreneurs.
    Nature Biotechnology 31, 104-107 (2013)
  30. Marimuthu, G., Kumari, S., Kandasamy, M., Raghunathan, S. and Saberwal, G.
    Patents protecting biologics or small molecule drugs are usually maintained.
    Nature Biotechnology, 30, 50-53 (2012)
  31. Soby, S, Sebastian, T.E. and Saberwal, G.
    US patent holdings of Indian non-corporate entities.
    Asian Biotechnology Development Review, 14, 21-33 (2012)
  32. Soby, S., Kandasamy, M. and Saberwal, G
    Work outsourced to Indian biotech and pharma companies is not yet significantly innovative.
    Current Science, 102, 401-404 (2012)
  33. Sebastian, T.E., Pattnayak, J.P., Soby, S and Saberwal, G.
    Patent holdings of Indian pharmaceutical and biotechnology companies in international markets of different sizes.
    Asian Biotechnology Development Review, 13, 17-37 (2011)
  34. Saberwal, G.
    Seeding a skilled workforce.
    Nature Biotechnology, 27, 773-775 (2009)
  35. Sebastian, T.E., Chandra Bindu, Y. and Saberwal, G.
    Patent holdings of US biotherapeutic companies in major markets.
    Drug Discovery Today, 14, 442-445 (2009)
  36. Sundaramoorthy, S., Chandra Bindu, Y. , Mehdiratta, R. and Saberwal, G.
    The US patent holdings of homegrown Indian biotech and pharma companies.Current Science, 96, 252-259 (2009)
  37. Parida, D.K, Mehdiratta, R. and Saberwal, G.
    How many patents does a bio-therapeutics company need?
    Nature Biotechnology, 26, 763-766 (2008)
  38. Saberwal, G
    New pharma-biotech company formation in India
    Nature  Biotechnology, 24, 499-501 (2006)
  39. Andersen, O.S., Saberwal, G., Greathouse, D.V. and Koeppe, R.E., II.
    Gramicidin channels – a solvable membrane “protein” folding problem. Indian Journal of Biochemistry and Biophysics 33, 331–342 (1996)
  40. Saberwal, G., Thennarasu, S., Dhople, V.M., Jagannadham, M.V. and Nagaraj, R.
    Studies on the synthesis of the toxins pardaxin, δ-toxin and their analogues by solid-phase synthesis.Proceedings of the Indian Academy of Sciences (Chemical Sciences) 106, 1109–1121 (1994)
  41. Koeppe, R.E., II, Greathouse, D.V., Jude, A., Saberwal, G.,Providence, L.L. and Andersen, O.S. Helix
    sense of gramicidin channels as a “nonlocal” function of the primary sequence. The Journal of Biological Chemistry 269, 12567–12576 (1994)
  42. Saberwal, G. and Nagaraj. R.
    Cell-lytic and antibacterial peptides that act by perturbing the barrier function of membranes: facets of their conformational features, structure-function correlations and membrane-perturbing abilities.
    Biochimica et Biophysica Acta 1197, 109–131 (1994)
  43. Saberwal, G. and Nagaraj, R.
    Conformations of peptide fragments comprising the amino-terminal, central, and carboxyl-terminal regions of a membrane-active polypeptide. Build up of secondry structure in Pardaxin.
    The Journal of Biological Chemistry 268, 14081–14089 (1993)
  44. Saberwal, G. and Nagaraj, R.
    Interaction of hydrophobic peptides with model membranes: slow binding to membranes and not subtle variations in pore structure is responsible for the gradual release of entrapped solutes.
    Biochimica et Biophysica Acta 1151, 43–50, (1993)
  45. Vairamani, M., Srinivas, R., Viswanadha Rao, G.K., Nagaraj, R., Laxma Reddy, G. and Saberwal, G.
    Mass spectra of t-butlyoxycarbonyl (BOC)-protected peptides.
    Organic Mass Spectrometry 25, 97–100 (1990)
  46. Saberwal, G. and Nagaraj, R.
    A synthetic peptide corresponding to the hydrophobic amino terminal region of pardaxin can perturb model membranes of phosphatidyl choline and serine.
    Biochimica et Biophysica Acta 984, 360–364 (1989)

Series of blog posts at Nature Biotechnology

  1. Reviewing a mythbreaker
  2. Clinical trials and beyond
  3. Australia’s government and biotech
  4. Building biotech in Australia
  5. Fueling Australian biotechs

Series of articles in Current Science

  1. Saberwal, G. 
    Drug Prices (Editorial) 
    Current Science 127 (2), 131–132 (2024)
  2. Saberwal, G.
    Anti-vaxxers (Editorial)
    Current Science, 126 (12), 1411–1412 (2024)
  3. Saberwal, G. 
    Institution building (Editorial) 
    Current Science, 126 (9), 987–988 (2024)
  4. Kataria A and Saberwal G.
    FAIR principles, Data transparency and Drug approvals. (Editorial)
    Current Science, 125 (12), 1287–1288 (2023)
  5. Saberwal G.
    Clinical trial transparency – Status and Prospects (Editorial)
    Current Science, 124 (11) 1239-1240 (2023)
  6. Saberwal G.
    How to make Clinical Trials Registry-India world-class.
    Current Science, 124 (7), 785–789 (2023)
  7. Saberwal, G.
    The many uses of data in public clinical trial registries.
    Curr. Sci. 120, 1686–1691 (2021)
  8. Saberwal, G.
    Breaking all the rules, at lightning speed (Editorial)
    Curr. Sci. 119, 7- 8 (2020)
  9. Saberwal, G.
    India to power the more widespread use of biosimilars? (Guest Editorial)
    Curr. Sci. 116, 1451–1453 (2019)
  10. Subramanya, H. S. and Saberwal, G.
    India needs more policy research. (Guest Editorial)
    Curr. Sci. 116, 1279–1280 (2019)
  11. Choudhury, M. C., and Saberwal, G.
    Patient advocacy. (Guest Editorial)
    Curr. Sci. 116, 345–346 (2019)
  12. Saberwal G
    Our educational system is unlikely to enable super-power status for India any time soon (Guest Editorial)
    Curr. Sci., 116, 509–510 (2019)
  13. Saberwal, G.
    Cuba: A different kind of role model for biotechnology
    Current Science 115, 1835–1836 (2018)
  14. Saberwal, G.
    Bio-business in brief: What ails clinical trials?
    Current Science 115, 1648–1652 (2018)
  15. Mukherjee, S. and Saberwal, G.
    Managing India’s AIDS crisis in the 2000s: Quantitative modeling had impact.
    Current Science 114, 2005–2006 (2018) (Guest Editorial)
  16. Saberwal, G.
    Regulatory harmonization: a view from India. (Guest Editorial)
    Current Science. 114, 423–424 (2018).
  17. VijayRaghavan, K. and Saberwal, G.
    Bio-business in brief: The case for ambitious action in the public sector
    Current Science 113, 1841–1845 (2017).
  18. Saberwal, G.
    Supporting start-ups (Guest Editorial)
    Current Science 113, 195–196 (2017).
  19. Venkatachalam, S. and Saberwal, G
    Bio-business in brief: A case for new drugs at generic prices from India
    Current Science, 102, 13751-1381 (2012)
  20. Saberwal, G
    Translating academic discoveries
    Current Science 103, 767-769 (2012)
  21. Saberwal, G
    Bio-business in brief: A bit about technology transfer
    Current Science, 99, 177-180 (2010)
  22. Saberwal, G
    Bio-business in brief: The debate over biosimilars
    Current Science, 98, 1575-1578 (2010)
  23. Saberwal, G
    Bio-business in brief: The paradox of being a drug company
    Current Science, 97, 623-625 (2009)
  24. Devaguptapu, S, Mehdiratta, R and Saberwal, G
    Bio-business in brief: The case of Cytokinetics Inc.
    Current Science, 94, 1576-1581 (2008)
  25. Mehdiratta, R,  Parida, D K and Saberwal, G
    Bio-business in brief: The challenges of clinical trials
    Current Science, 93, 1367-1375 (2007)
  26. Mehdiratta, R and Saberwal, G
    Bio-business in brief: Many a monoclonal.
    Current Science, 93, 789-796 (2007)
  27. Mehdiratta, R and Saberwal, G
    Bio-business in brief: The case of conotoxins.
    Current Science, 92, 39-45 (2007)

Perspectives and other articles/books and participation in online events

  1. Saberwal, G.
    Clinical trial registries: The good, and the not so good
    Journal of Biosciences, 49: 90 doi: 10.1007/s12038-024-00477-0 (2024)
  2. Saberwal G and Kaushik K. (Eds)
    IRIWI. I Realised I Wasn’t Interested … Inspirational stories of science career transitions.
    IndiaBioScience, https://indiabioscience.org/indiabioreads/iriwi-i-realized-i-wasnt-interested (2023)
  3. Saberwal, G.
    The need for a new keyword – ‘Trial registry-metaresearch’ – to track certain uses of clinical trial registry records.
    Trials, 24, 190 doi: 10.1186/s13063-023-07231-1 (2023)
  4. Chakraborty, I and Saberwal, G.
    CTRI requirement of prospective trial registration: Not always consistent.
    Indian J Med Ethics, 7(4) NS: 312-314 doi: 10.20529/IJME.2022.033 (2022)
  5. Served as a panelist on an online discussion
    ‘Clinical Trial Registries: Current Challenges and Future Potential on 08 Sept 2022, Organized by Till Bruckner, TranspariMED
  6. Saberwal, G.
    On being a professional mutant.
    Nature Biotechnology, 32, 106-107 (2014)
  7. Saberwal, G
    Caring for a severely disabled person.
    Available here.
  8. Kapoor, M. and Saberwal, G
    The new crossroads
    Biotech News, 5, 143-145 (2010).
  9. Saberwal, G.
    Drug development in India: What does the future look like?
    Contemporary Perspectives: History and Sociology of South Asia, Ed. N Tyabji, 3, 293-309 (2009)
  10. Saberwal, G
    A long march
    Biotech News, IV, 68-69 & 75 (2009)Saberwal, G.  Biotechnology Incubation in India.
    In Business incubation: Initiatives in India Ed. R. K. Lagu, brought out by NSTEDB, DST (2004)

A talk on my unusual career

  1. My career path: An irreproducible experiment

Media coverage of our work

Our research has been covered in the popular press, or by other sites. Our opinion may also have been cited on an area related to our research.

  1. Trials, medical ethics and the orbit of power In India, the primary guardrails that are supposed to be a check on the abuse of medical ethics do not function
    by Dinesh S. Thakur, Editorial, The Hindu, 4 July 2024
    https://www.thehindu.com/opinion/lead/trials-medical-ethics-and-the-orbit-of-power/article68364066.ece
  2. Guinea pigs: Editorial on the excessive use of Indians in global clinical trials
    Editorial, 2 October 2023
    www.telegraphindia.com/opinion/guinea-pigs-editorial-on-the-excessive-use-of-indians-in-global-clinical-trials/cid/1970402
  3. Study throws light on excessive use of Indians in global clinical trials
    by G.S. Mudur, 25 Sept 2023
    https://www.telegraphindia.com/india/study-throws-light-on-excessive-use-of-indians-in-global-clinical-trials/cid/1968685]
  4. Research finds over-recruitment of Indian participants in global clinical trials
    by Abhishek Awasthi, 25 Sept 2023
    ct.moreover.com/?a=51892518663&p=1pl&v=1&x=1-aLtb-NHVq9nKqQcb1Q1Q
  5. Clinical trials of new drugs over-recruiting Indians: Study
    by Teena Thacker, 27 Sept 2023
    https://health.economictimes.indiatimes.com/news/industry/clinical-trials-of-new-drugs-over-recruiting-indians-study/103970407
  6. What are the problems with India’s clinical trials registry? A way to ensure transparency in the process of a clinical trial is to make sure that all information is freely accessible in the public domain.
    by, Arkatapa Basu April 16, 2023
    https://www.thehindu.com/sci-tech/science/problems-with-indias-clinical-trials-registry-how-can-it-be-improved/article66741027.ece
  7. A tweet by TranspariMED on my recent editorial in Current Science, ‘Clinical trial transparency – status and prospects’.
    https://twitter.com/TranspariMED/status/1668920900266098691
  8. All foreign drug trials must have patients from India
    by Praveen Sikri, CEO, Ikris Pharma Network
    https://www.dailypioneer.com/2022/columnists/all-foreign-drug-trials-must-have-patients-from-india.html
  9. Political Squabbles Slow Drug Development for Rare Diseases
    PRNewswire, 6 Sept 2022
    https://www.benzinga.com/pressreleases/22/09/n28761027/political-squabbles-slow-drug-development-for-rare-diseases
  10. Affordability of Orphan Drugs Hinges on Global Collaboration
    Nisha Venugopal, 6 March 2023
    https://www.pharmacytimes.com/view/affordability-of-orphan-drugs-hinges-on-global-collaboration
  11. ICMR grants three-month extension to clinical trials database
    https://www.telegraphindia.com/india/indian-council-of-medical-research-grants-three-month-extension-to-clinical-trials-database/cid/1880553
    by G.S. Mudur, 16 Aug 2022
  12. Indian Council of Medical Research public database not ‘permanent’
    https://www.telegraphindia.com/india/indian-council-of-medical-research-public-database-not-permanent/cid/1870722
    by G.S. Mudur, 21 June 2022
  13. Clinical trial transparency: new publications and tools (summer 2021).
    https://www.transparimed.org/single-post/clinical-trial-transparency-tools
    by Till Bruckner, 4 September 2021
  14. Coverage of our collaborative work with Dr. Gaurav Sharma, ‘The lag in SARS-CoV-2 genome submissions to GISAID’
    https://www.downtoearth.org.in/news/governance/in-depth-what-ails-india-s-coronavirus-genome-sequencing-system-78804
    https://www.biorxiv.org/content/10.1101/2021.06.08.447365v1
    https://www.telegraphindia.com/india/covid-worrying-shortfall-lag-in-genome-sequencing/cid/1818705
    https://epaper.telegraphindia.com/imageview_363573_193959930_4_71_14-06-2021_4_i_1_sf.html
    https://www.news-medical.net/news/20210614/Delays-and-shortages-hit-SARS-CoV-2-genomic-surveillance-program.aspx
    Between June and September, 2021
  15. A Good Registry Means Accountable Clinical Trials. But Does India Have One?
    https://science.thewire.in/the-sciences/covid-19-clinical-trial-registry-india-medical-research-accountability/   
    By Shreya Dasgupta, 7 Sept 2020. 
  16. Clinical trial database hole
    https://www.telegraphindia.com/india/clinical-trial-database-hole/cid/1785110
    By G.S. Mudur,  3 July 2020
  17. Saberwal, G.
    Interview by BioStandups (August, 2017)
    http://www.biostandups.com/face-of-the-month/#1505358038267-1cd8a74f-9174
  18. Lack of innovation in work outsourced to pharma-biotech firms
    https://indianexpress.com/article/news-archive/web/lack-of-innovation-in-work-outsourced-to-pharmabiotech-firms/   
    By Mihika Basu, 10 Feb 2012
  19. Prospects poor for original drug discovery in India, finds study
    https://www.livemint.com/Politics/f0ve103YS9ybpLW3KRQvjM/Prospects-poor-for-original-drug-discovery-in-India-finds-s.html   
    By Jacob P. Koshy, 10 Feb 2012

Address

Institute of Bioinformatics and Applied Biotechnology
Biotech Park, Electronic City Phase I,
Bengaluru 560100,
India

Phone

285 289 00/01/02, extension 120

Email

gayatri[@]ibab(.)ac{.}in