Amit Lodha
Belle Mead,NJ
Summary
Experience research physician who's passionate about bringing a meaningful difference in the lives of patients and has over 14 years of pharma experience with an additional 3 years spent in clinical practice. Handled international projects of growing complexities over the years, and contributed meaningfully to BLA and sBLA submissions for biologics and conduct of late phase developmental studies for ocular gene therapies.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Sr. Global Program Safety Lead
Novartis Pharmaceuticals
East Hanover, NJ
06.2024 - Current
- Drive the strategy to ensure safety of the clinical trial participants in developmental studies
- Contribute to protocol development and maintenance of investigator brochure to ensure that the regulatory clinical documents reflect current understanding of the safety profile, and risk mitigation measures
- Drive the safety strategy for the development of safety profiling plans, as well as preparation of high quality regulatory documents, including the aggregate reports such as the DSUR
- Chair the safety management team, with overall accountability of signal detection, escalation and management based on periodic review of relevant safety information (pre-clinical studies, early and late phase clinical studies, published literature)
- Drive the safety strategy for health authority interactions including Type B and Type C meetings, pre-NDA interactions.
- Contribute to the development of high-quality submission dossier by driving the safety strategy for the clinical submission documents (incl. integrated safety summary, summary of clinical safety, and the clinical overview). Lead the strategy for responses to Information Requests on clinical dossier.
- Mentor safety leads to contribute independently to safety deliverables for early and late phase developmental projects
- Support quality organization with medical risk assessments for quality issues, including out-of-specification for clinical and commercial batches
Global Program Safety Lead
Novartis Pharmaceuticals
East Hanover, NJ
04.2018 - 06.2024
- Drive the safety strategy for developmental clinical studies to ensure safety of clinical trial participants
- Drive the safety strategy for submission dossier, including contributions to clinical summary documents (ISS, SCS, CO). Lead the strategy for responses to Information Requests on clinical dossier.
- Chair the safety management team and overall accountability for signal detection, escalation and management
- Lead safety strategy for health authority interactions including Type B and Type C FDA meetings
Sr. Pharmacovigilance Leader
Novartis Pharmaceuticals
East Hanover, NJ
11.2016 - 03.2018
- Participate in pre-NDA health authority interactions (incl. EMA, SwissMedic, TGA) for an ocular gene therapy (voretigene neparvovec) for inherited retinal dystrophy
- Lead the safety strategy for health authority responses to clinical submission dossier for an ocular gene therapy (voretigene neparvovec) for inherited retinal dystrophy
Sr. Pharmacovigilance Leader
Novartis Healthcare Private
Hyderabad, Telangana, India
04.2016 - 10.2016
Pharmacovigilance Leader
Novartis Healthcare Private Ltd
Hyderabad, Telangana, India
04.2013 - 03.2016
Sr. Pharmacovigilance Expert
Novartis Healthcare Private Ltd.
Hyderabad, Telangana, India
10.2011 - 03.2013
Manager, Pharmacovigilance
Lambda Therapeutics Pvt Ltd
Ahmedabad, Gujarat, India
04.2011 - 09.2011
Executive, Pharmacovigilance
Lambda Therapeutics Pvt Ltd
Ahmedabad, Gujarat, India
07.2009 - 03.2011
Resident Doctor
Sterling Hospitals Addlife Pvt Ltd
Ahmedabad, Gujarat, India
04.2006 - 06.2009
- Treating critical care subjects (including those on mechanical ventilator support) under the guidance of the treating consultant
- Responsible for the emergency room with stabilizing the patients, under guidance from consultant, and appropriate triaging of subjects to appropriate in-patient dept
- Maintaining the records of subjects to reflect the medical history, compliants on admission, vitals, intake/ output chart, lab reports, etc.
- Preparation of the discharge summary on patient discharge to reflect the clinical course, treatment as well as investigations conducted during the period of hospitalization
Education
Other Degree/Diploma - Any Other
Institue of Clinical Research; India (I.C.R.I.)
India03.2009
Bachelors/First Univ. Degree - Any Other
B. J. Medical College; Ahmedabad
India02.2007
Skills
- Team Leadership
- Work Planning and Prioritization
- Idea Development and Brainstorming
- Problem-solving aptitude
- Technical Presentations
- Resource Allocation
- Written and verbal communication
- Stakeholder Management
Languages
- Indian, Mother Tongue, Mother Tongue
- English, Fluent, Fluent
Publications
1. Igwe F, Lodha A, Ravindran A. Trends in the Cumulative Post-Marketing Reporting Rates of Retinal Vasculitis and/or Retinal Vascular Occlusion and Associated Vision Loss with Brolucizumab. Ophthalmol Ther. 2023 Feb;12(1):593-598. doi: 10.1007/s40123-022-00617-5. Epub 2022 Dec 5.
2. Marlow N, Reynolds JD, Lepore D, Fielder AR, Stahl A, Hao H, Weisberger A, Lodha A, Fleck BW. Ranibizumab versus laser therapy for the treatment of very low birthweight infants with retinopathy of prematurity (RAINBOW): five-year outcomes of a randomised trial. EClinicalMedicine. 2024 Apr 11;71:102567.
Certification
- Online Certification Course in HMX Pro Genetics—Gene Therapy at Harvard Medical School (Apr-Jun 2024)
Timeline
Sr. Global Program Safety Lead
Novartis Pharmaceuticals
06.2024 - Current
Global Program Safety Lead
Novartis Pharmaceuticals
04.2018 - 06.2024
Sr. Pharmacovigilance Leader
Novartis Pharmaceuticals
11.2016 - 03.2018
Sr. Pharmacovigilance Leader
Novartis Healthcare Private
04.2016 - 10.2016
Pharmacovigilance Leader
Novartis Healthcare Private Ltd
04.2013 - 03.2016
Sr. Pharmacovigilance Expert
Novartis Healthcare Private Ltd.
10.2011 - 03.2013
Manager, Pharmacovigilance
Lambda Therapeutics Pvt Ltd
04.2011 - 09.2011
Executive, Pharmacovigilance
Lambda Therapeutics Pvt Ltd
07.2009 - 03.2011
Resident Doctor
Sterling Hospitals Addlife Pvt Ltd
04.2006 - 06.2009
Other Degree/Diploma - Any Other
Institue of Clinical Research; India (I.C.R.I.)
Bachelors/First Univ. Degree - Any Other
B. J. Medical College; Ahmedabad