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
Administration Of Two Salmeterol Formulations In Healthy Volunteers

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 

 

 

  1. 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
  2. Comparison Of The Bronchoprotective Effects Of Two Salbutamol Sulphate HFA Metered Dose Inhalers Using Methacholine Challenge Testing. RDD 2010
  3. Evaluation Of The Rate And Extent Of Pulmonary Absorption After Administration Of Two Salmeterol HFA pMDI Formulations In Healthy Volunteers RDD 2010
  4. Comparative Efficacy and Safety of Two Formulations of Ipratropium Bromide (IB) HFA 
  5. pMDI in Patients with Chronic Obstructive Pulmonary Disease (COPD) Journal of Health Science 2014;2: 591-598
  6. 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
  7. Pharmacokinetics of Orally Inhaled Drugs. The AAPS Journal. 2015 May; 17(3): 769–775 
  8. 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
  9. 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
  10. 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
  11. Bioequivalence of Two Formulations of Salmeterol Xinafoate/Fluticasone Propionate HFA pMDI in Healthy Volunteers. J of Bioequiv 2017;9(6):536-546
  12. Comparison of Pharmacokinetic and Pharmacodynamic Effects of Two Hydrofluoroalkane Formulations of Salmeterol. J of Bioequiv 2017;9(3):405-411.
  13. 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 

 

  1. Evaluation of Tiotropium Rotacaps once daily in patients with Chronic Obstructive Pulmonary Disease over 4 weeks. [1930]:ERS ’05
  2. Salmeterol/fluticasone combination product (SFC) provides better asthma control compared to high dose fluticasone (FP) in symptomatic patients with asthma. [2771]:ERS ’05.
  3. Safety of Beclomethasone HFA pMDI (HFA BDP) compared with Beclomethasone CFC pMDI (CFC BDP) over 12 weeks. (CP/28/02). [3285]:ERS ’05
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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
  9. Comparison of two intranasal triamcinolone acetonide formulations in patients with seasonal or perennial allergic rhinitis (CT/10/06). ERS 2008
  10. 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
  11. Clinical equivalence of two HFA formulations of salmeterol xinafoate in asthmatic patients using 12 hour serial spirometry (CT/03/07). [P2049]: ERS’09
  12. 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
  13. 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
  14. Comparison of Salmeterol/Fluticasone propionate combination vs monotherapy with Fluticasone propionate in patients with mild to moderate asthma (CT/05/06); P1990 ERS ’09
  15. 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
  16. Comparison of systemic bioavailability of two formulations of Budesonide Nebulized suspension in healthy patients (CT/16/07); P2053: ERS’09
  17. 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
  18. A comparative study on systemic pharmacodynamics effects of two HFA formulations of salmeterol xinafoate in healthy subjects (PRC/CRD/36/08). E2034; ERS’10
  19. 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
  20. 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
  21. Comparison of the bronchoprotective effects of two salbutamol sulphate HFA pMDI using methacholine challenge testing (CT/02/07). P3980: ERS’11
  22. Pharmacokinetic evaluation of two HFA pMDI formulations of salmeterol xinafoate administered through a spacer in healthy subjects (PRC/CRD/02/11): P3982: ERS’11
  23. Evaluation of the systemic exposure between two formulations of beclomethasone dipropionate in healthy subjects. Inhalation Asia Workshop June 2013.
  24. Evaluation of the pulmonary deposition between two formulations of beclomethasone dipropionate in healthy subjects. Inhalation Asia Workshop, June 2013.
  25. Evaluation of the systemic pharmacodynamic effects of two HFA formulations of salmeterol xinofoate/fluticasone propionate HFA (SM/FP) pMDI 25/250 mcg. ERS’17. 
  26. Assessment of pulmonary deposition between two formulations of salmeterol xinofoate/fluticasone propionate (SM/FP) HFA pMDI 25/125 mcg per actuation. ERS’17