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 

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

Participated as a speaker at the following conferences 

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