Thesis Title : Assessing In vitro In vivo Relation/Correlation (IVIVR/C) for Inhaled Drugs
PhD supervisor : Dr. Sharvari Shukla
Biography :
Background
I am a seasoned pharmaceutical professional with over 15 years of clinical trial experience at Cipla Ltd and a successful track record in working at the interface of clinical, R&D and regulatory to ensure successful registration of inhaled respiratory products globally. My key skills are developing the scientific and operational strategy of assigned clinical trials and programs; protocol development; and ensuring the collection, analysis, review, reporting and publishing of high quality trial data in compliance with Cipla’s processes, GCP/ICH and applicable regulatory guidances.
Qualifications
- Bachelor of Science – Specialization in Microbiology/Biochemistry
- Master of Science – Specialization in Biotechnology
Additional certifications
Year |
Certifications |
Organization |
18 September 2004 till date |
Certified Clinical Research Professional |
Association of Clinical Research Professional, USA |
22 April 2009 till date |
Project Management Professional |
Project Management Institute (PMI), USA |
01 August 2013 Till date |
Program Management professional |
PMI, USA |
Research:
Research summary
Quantitative relationships between the particle deposition, absorption, and the drug clearance in the lung are yet to be determined for inhaled drugs used in asthma and COPD treatments. This research will assess if a robust in vitro in vivo relationship for inhaled drugs can be established using different modelling techniques.
My key research interests
- Analysis of complex in vitro and in vivo data and bring some sense to it through simplification
- Different types of modelling & simulation approaches to support pharmaceutical drug development
- Use of clinical trial design and simulation, utilizing quantitative methods to promote drug development, support decision-making in the respiratory area
- Different pharmacokinetic/clinical trial designs
Achievements :
- Led the clinical team at Cipla to achieve the first successful approval for Cipla’s generic inhaler in US and Europe.
- Ensured high quality standards in conduct of all PK/clinical trials that have led to successful site inspections from regulatory authorities.
- In Dec 2019, organized Cipla’s first-ever Technical Conclave on how Cipla can strengthen product risk assessment throughout the product life cycle to achieve launch excellence. A special focus for this Conclave was on modelling & simulation.
Conferences
Attended as a participant
Year |
Conference name |
Conference Organizer / Trainer |
21 and 22 November 2002 |
Foundations of Clinical Research and GCP |
Academy of Clinical Excellence, Bombay College of Pharmacy |
25-27 November 2003 |
Principles of Good Clinical Practice and Operational Aspects of Clinical Trials |
St John’s National Academy of Health Sciences, Bangalore |
24 January, 2004 |
Laboratory Accrediation Program Seminar |
The College ogf American Pathologists |
23-25 February 2004 |
Good Clinical Practice |
IQPC |
08-10 July 2004 |
International workshop of Clinical Research and Clinical Data Management for Global Submission |
Institute of Bioinformatics and Biotechnology, University of Pune |
09 September 2004 |
GCP & GLP |
Harold Neal, UK |
23-26 September 2004 |
JPGM Goldcon: 50 years of Medical Writing |
KEM Hospital, Mumbai |
19-23 November 2004 |
9th ARSR and 10th TPAIS |
Transpacific Allergy and immunology Society |
03 December 2004 |
Statistical errors in immunologic research |
American Academy of Allergy Asthma and Immunology |
09 December 2004 |
Fundamental Points of GLP and GCP |
David Ford |
23-27 May 2005 |
Fundamentals of Biostatistics & SPSS |
Biostatistics Resource and Training Centre, Christian Medical College, Vellore |
30 May – 03 June, 2005 |
Clinical Trial, Diagnostic Test and Cluster Design |
Biostatistics Resource and Training Centre, Christian Medical College, Vellore |
27 August 2005 |
Schedule Y – The new look |
Indian Drug Manufacturer’s Association |
17-21 September 2005 |
European Respiratory Society Annual Congress |
15th ERS Congress, Denmark |
22-23 September 2005 |
European Annual Conference and Exposition |
Association of Clinical Research Professionals |
02 March 2006 |
Audits and Inspections |
Bengt Agrell, GCP Consulting AB |
Year |
Conference name |
Conference Organizer / Trainer |
26-27 May 2006 |
A Good Clinical Practice Training Programme |
Omnicare Clinical Research |
04-06 October 2006 |
Successful Medical Writing |
Management Forum, UK |
04 February 2007 |
Clinical Trial Auditing |
Pinnacle Healthcare |
26-27 February 2007 |
Clinical Trial Directive & Clinical Trials Audits and Inspections |
Dr. Laura Brown University of Cardiff, UK |
06 March 2007 |
Quality Assurance in Spirometry |
Chest Research Foundation, Pune |
15 -19 September, 2007 |
European Respiratory Society Annual Congress (Sweden) |
European Respiratory Society |
24 October 2007 |
Pharmacovigilance |
Olivia Sobejko, Medical Advisor and QPPV, BMM Pharma, Sweden |
05 December 2007 |
Pharmacovigilance |
Christopher Speirs, Harefield Pharmacovigilance |
31 March to 04 April 2008 |
Professional project management |
Sabcons, project management consultants, Bangalore |
03 July 2008 |
Spirometry – Quality Assurance |
Chest Research Foundation, Pune |
04-08 October 2008 |
European Respiratory Society Annual Congress (Berlin) |
European Respiratory Society |
29 November, 2008 |
Quality, Ethics and Regulations in Clinical Research |
Cipla Ltd |
30 March 2009 |
Pulmonary Function Testing in Clinical Trials |
Vitalograph |
07 May 2009 |
Inhaler Technique |
Katrina McCarthy |
12-16 September 2009 |
European Respiratory Society Annual Congress (Vienna) |
European Respiratory Society |
23-24 April 2010 |
Best Practices in Clinical Study Project Management |
ACRP 2010, Tampa, Florida |
12-13 October 2010 |
Workshop on European Bioequivalence Considerations for Orally Inhaled products for local action |
IPAC-RS, Frankfurt, Germany |
21 October 2010 |
GCP Program |
Cipla Ltd |
23-24 November 2010 |
Workshop on Advanced Project Management in Clinical & Drug Development |
IBC Asia |
08 January 2011 |
MS Project for the Smart PM |
Sabcons, Project Management Consultants, Bangalore |
Year |
Conference name |
Conference Organizer / Trainer |
09-10 April 2011 |
MS Project 2007 |
Project Management Institute Mumbai Chapter |
09 July 2011 |
Pharmacovigilance |
Cipla Ltd |
14 July 2011 |
Meeting Regulatory Expectations [ANDA 505b2] |
Dr. Ravi Harapanhalli, Parexel |
25 September 2011 |
Program Management Certification Workshop |
Harbinger Consulting Solutions |
19-21 April 2012 |
Data Driven Decisions: From Preclinical to Post-Marketing |
Indian Association for Statistics in Clinical Trials (2nd Annual Conference) |
May 2012 |
Respiratory Drug Delivery |
RDD , Phoenix, Arizona |
18-23 May 2012 |
ATS – Annual Conference |
ATS, San Francisco |
04 July 2012 |
GCP Training |
Cipla Ltd |
05 July 2012 |
Project Management |
Cipla Ltd |
08 January 2013 |
Finance for Non-Finance Managers |
Indian School of Business, Hyderabad |
11-13 February 2013 |
Project, Program, and Portfolio Management |
Indian institute of management, Bangalore |
28 February 2013 |
MHRA Paediatrics Seminar |
MHRA |
08 March 2013 |
Strategies for Managing Pharmaceutical Patent Portfolio |
IIPRD |
19 April 2013 |
Introduction to Adaptive clinical trial designs across all phases of clinical trials |
Indian Association of Statistics in Clinical Trials |
21-23 May 2013 |
Partnerships in Clinical Trials – Russia-CIS and MENA |
Informa |
4th June 2013 |
Workshop on Statistical consideration in pharmaceutical science |
Chuck Bon |
24-25 October 2013 |
Nasal and Pulmonary Drug Delivery – Global Regulatory Trends |
Indian Pharmaceutical Association |
09 January 2014 |
Bioequivalence risk mitigation – standardizing study design and conduct |
Prof Umesh Banakar |
Nov 2014 |
RDD – Asia Conference |
RDD |
Sep 2015 |
Annual PMI conference, Hyderabad |
PMI |
Year |
Conference name |
Conference Organizer / Trainer |
Nov 2015 |
Investigator’s workshop FDA |
US FDA, Washington |
14th and 15th Apr 2018 |
Statistical Techniques and Research Methodology |
Chest Research Foundation, Pune |
25th June 2018 |
Data Science: R basics |
HarvardX – Online Certification |
22nd, 23rd and 24th Nov 2018 |
3 day Pop PK/PD modelling workshop |
Dr Murray Ducharme |
17th to 19th July 2019 |
11th PAGIN Workshop on Population Pharmacokinetics, Data Analysis and Visualization |
ACTREC (Tata Memorial, Kharghar). |
2nd and 3rd Mar 2020 |
4th Annual Biowaivers and Bioequivalence Workshop |
Treffen Media |
Participated as a speaker at the following conferences
Year |
Conference |
Topic taken at the conference |
Organizer |
20-21 April 2005 |
GOI/WHO – development of SOPs, Guidelines, Training modules for GCP |
Monitoring |
CDSCO and BYL Nair Hospital . |
20 Feb 2007 |
GOI/WHO -training of investigators |
Sponsor Responsibilities |
CDSCO and BYL Nair Hospital |
20 May 2009 |
Clinical Trials Summit Asia 2009 |
Outsourcing Clinical Trials |
Visiongain |
25 June 2009 |
Project Management Conclave, 2009 |
Project Management in Clinical Trials |
Project Management Institute |
22 January 2010 |
Clinical Trial Congress 2010 |
Enhancing global clinical trial management through information technology |
Ideas Exchange |
April 2010 |
RDD 2010 |
Pulmonary Absorption After |
RDD |
24-25 May 2010 |
2nd annual Clinical Trials and Partnering Conf |
Project Management in Clinical Trials |
IBC Asia |
07 June 2013 |
4th Annual Clinical Trials Asia Summit 2013 |
Panel discussion – Schedule Y |
Visiongain |
18 March 2014 |
IPAC-RS |
Challenges in the development of orally inhaled products |
IPAC-RS |
Publications
- Peer reviewed journal articles
- Comparative bioavailability of two hydrofluoroalkane formulations of formoterol fumarate both delivered by pressurized metered dose inhaler (PRC/CRD/28/08). Arzneimittelforshung 2010;60(2):81-86
- Comparison Of The Bronchoprotective Effects Of Two Salbutamol Sulphate HFA Metered Dose Inhalers Using Methacholine Challenge Testing. RDD 2010
- Evaluation Of The Rate And Extent Of Pulmonary Absorption After Administration Of Two Salmeterol HFA pMDI Formulations In Healthy Volunteers RDD 2010
- Comparative Efficacy and Safety of Two Formulations of Ipratropium Bromide (IB) HFA
- pMDI in Patients with Chronic Obstructive Pulmonary Disease (COPD) Journal of Health Science 2014;2: 591-598
- Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India. The AAPS Journal 2015; DOI: 10.1208/s12248-015-9787-8
- Pharmacokinetics of Orally Inhaled Drugs. The AAPS Journal. 2015 May; 17(3): 769–775
- Efficacy and safety of ipratropium bromide/salbutamol sulphate administered in a hydrofluoroalkane metered-dose inhaler for the treatment of COPD. International Journal of COPD 2016:11 1–8
- Assessment of lung deposition and analysis of the effect of fluticasone/salmeterol hydrofluoroalkane (HFA) pressurized metered dose inhaler (pMDI) in stable persistent asthma patients using Functional Respiratory Imaging. Expert Review of Respiratory Medicine 2016; DOI: 10.1080/17476348.2016.1192464
- Efficacy and Tolerability of Fluticasone Propionate /Salmeterol MDI Compared With Concurrent Fluticasone Propionate and Salmeterol MDI in Adult Patients with Persistent Asthma: A Randomized, Double-Blind 12-Week Study. Int J of Pulmonary & Respiratory Sciences 2017; 2(2):DOI: 10.19080/IJOPRS.2017.02.555583
- Bioequivalence of Two Formulations of Salmeterol Xinafoate/Fluticasone Propionate HFA pMDI in Healthy Volunteers. J of Bioequiv 2017;9(6):536-546
- Comparison of Pharmacokinetic and Pharmacodynamic Effects of Two Hydrofluoroalkane Formulations of Salmeterol. J of Bioequiv 2017;9(3):405-411.
- Comparison of Systemic and Pulmonary Bioavailability of Fluticasone Propionate HFA pMDI 250 Mcg per Actuation With and Without Spacer Device in Healthy Volunteers. J of Bioequiv 2017;9(3):399-404.
- Poster presentations
- Evaluation of Tiotropium Rotacaps once daily in patients with Chronic Obstructive Pulmonary Disease over 4 weeks. [1930]:ERS ’05
- Salmeterol/fluticasone combination product (SFC) provides better asthma control compared to high dose fluticasone (FP) in symptomatic patients with asthma. [2771]:ERS ’05.
- Safety of Beclomethasone HFA pMDI (HFA BDP) compared with Beclomethasone CFC pMDI (CFC BDP) over 12 weeks. (CP/28/02). [3285]:ERS ’05
- Non inferiority comparison of Salmeterol HFA (SM-HFA) pMDI with Salmeterol CFC (SM-CFC) pMDI in adolescents and adults with persistent asthma.(CP/19/03). [P2151]:ERS’07
- Non inferiority comparison of Formoterol HFA (FM-HFA) pMDI with Formoterol CFC (FM-CFC) pMDI in adults and adolescents with persistent asthma (CP/05/03). [P2153]:ERS’07
- Non inferiority efficacy of Ipratropium – Salbutamol HFA (IB/SAL-HFA) pMDI compared to Ipratropium Salbutamol CFC pMDI in patients with COPD.(CP/04/03). [P3593]:ERS’07
- Comparison of a combination of HFA propelled Fluticasone 125 mcg and Salmeterol 25 mcg (FP + SM 125/25) with two separate single preparation pMDIs in adult with persistent asthma. (CP/07/05). [P3607]:ERS’07
- Non-inferiority comparison of budesonide HFA (BUD-HFA) pMDI with budesonide CFC (BUD-CFC) pMDI in patients with persistent moderate asthma (CT/01/06) ERS 234; ERS 2008
- Comparison of two intranasal triamcinolone acetonide formulations in patients with seasonal or perennial allergic rhinitis (CT/10/06). ERS 2008
- Comparison of the effects of beclomethasone HFA (BDP HFA) pMDI with beclomethasone CFC (BDP-CFC) pMDI on 10 hour urinary cortisol in healthy subjects (CT/01/07). ERS 2008
- Clinical equivalence of two HFA formulations of salmeterol xinafoate in asthmatic patients using 12 hour serial spirometry (CT/03/07). [P2049]: ERS’09
- Comparison of systemic pharmacodynamic effects of two HFA formulations of formoterol fumarate delivered by pressurized metered dose inhaler in healthy subjects (PRC/CRD/32/08). [P2042]: ERS’09
- Evaluation of the bronchoprotective effects of Salmeterol HFA and Salmeterol CFC in adult patients with chronic stable mild to moderate asthma (RML 268) P4177: ERS ’09
- Comparison of Salmeterol/Fluticasone propionate combination vs monotherapy with Fluticasone propionate in patients with mild to moderate asthma (CT/05/06); P1990 ERS ’09
- A double blind, single dose, four period, crossover study to demonstrate the equivalence between the two HFA formulations of formoterol fumarate using serial spirometry measurements over 12 hours (CT/04/07) ; P2039 ; ERS’09
- Comparison of systemic bioavailability of two formulations of Budesonide Nebulized suspension in healthy patients (CT/16/07); P2053: ERS’09
- Comparison of efficacy and safety of two HFA formulations of Fluticasone propionate: a double blind, randomized, multicentric, parallel group study in patients with persistent moderate asthma (CT/06/06): P2051 ERS’09
- A comparative study on systemic pharmacodynamics effects of two HFA formulations of salmeterol xinafoate in healthy subjects (PRC/CRD/36/08). E2034; ERS’10
- Comparison of pulmonary and systemic absorption of two HFA formulations of salmeterol in healthy subject (PRC/CRD/39/08 & PRC/CRD/35/08). P4535 ERS’10
- Evaluation of the efficacy and safety of two formulations of Ipratropium bromide HFA pMDI in patients with mild to moderate chronic obstructive pulmonary disease (COPD) (CT/03/06) [P1318]: ERS’10
- Comparison of the bronchoprotective effects of two salbutamol sulphate HFA pMDI using methacholine challenge testing (CT/02/07). P3980: ERS’11
- Pharmacokinetic evaluation of two HFA pMDI formulations of salmeterol xinafoate administered through a spacer in healthy subjects (PRC/CRD/02/11): P3982: ERS’11
- Evaluation of the systemic exposure between two formulations of beclomethasone dipropionate in healthy subjects. Inhalation Asia Workshop June 2013.
- Evaluation of the pulmonary deposition between two formulations of beclomethasone dipropionate in healthy subjects. Inhalation Asia Workshop, June 2013.
- Evaluation of the systemic pharmacodynamic effects of two HFA formulations of salmeterol xinofoate/fluticasone propionate HFA (SM/FP) pMDI 25/250 mcg. ERS’17.
- Assessment of pulmonary deposition between two formulations of salmeterol xinofoate/fluticasone propionate (SM/FP) HFA pMDI 25/125 mcg per actuation. ERS’17