Sandeep Jagtap
Bad Homburg,HE
Summary
MD physician with over 14+ years of expertise in Global Clinical Development of NCEs, Vaccines, Biosimilars and differentiated generics. Worked across different domains of clinical research functions such as clinical strategy, clinical development, medical writing, regulatory interactions covering multiple therapy areas like Ophthalmology, Women’s health, CNS, Pain, Dermatology, Oncology, Immunology, GIT, Respiratory etc. Results-driven leader adept at guiding high-performing teams and implementing strategic initiatives to drive business success. Known for fostering collaborative environment and achieving measurable milestones.
Overview
18
18
years of professional experience
Work History
Senior Director, Global Clinical Strategy
Viatris | Mylan + Upjohn
04.2019 - Current
- Global Clinical strategy lead for assigned therapeutic areas providing clinical strategic program leadership.
- Construction of comprehensive clinical development plan for novel products for the US, EU, and Emerging Markets as per regulatory expectations.
- Leading and supervising all aspects of clinical development that involves conception of study synopsis, preparation of clinical study protocol, review of essential clinical study documents, writing of regulatory briefing books, clinical oversight of ongoing studies, review of blinded and unblinded data, preparation of clinical study reports and regulatory interactions.
- Building a Target Product Profile and maintain up-to-date medical and competitive landscape knowledge of assigned development program.
- Spearheading the Global Clinical Studies and medical point of contact for CRO and researchers query resolution alongside examining safety data, trend analysis and safety signals from ongoing trials.
- Effectively contributing to regulatory filings, including NDA/BLA/MAA, resolving clinical queries from drug regulatory agencies (USFDA, EMA, PMDA) by taking a lead role in reviewing responses.
- Leading other team members in the data review, analysis and reporting of assigned clinical studies, with responsibility for overall content and accuracy of study report and final sign-off. Overseeing internal and external dissemination of results to Development Team, Investigators.
- Due diligence of new product in-licensing opportunities as a part of Global Healthcare Gateway based on risk/benefit ratio, unmet need characterization, competitive landscape, product positioning and making recommendation to business development teams.
- Staying abreast of literature and regulatory guidelines in order to be a team resource in terms of both medical background and clinical trial design.
- Key Projects:
- Clinical Development of low dose estrogen transdermal contraceptive patch for US market
- Clinical Development of progesterone only transdermal contraceptive patch for US market
- Clinical development of novel product for blepharitis for US market
- Clinical development of novel product for Dry Eye Disease for US market
Senior Manager | Clinical Development & Strategy
Lupin Ltd
02.2015 - 03.2019
- Led clinical development of biosimilars/NCEs in Oncology, immunology, nephrology, and ophthalmology for global markets.
- Ensured regulatory compliances were strictly followed in all the phases of clinical development.
- Designing of clinical development plan as per regulatory requirements.
- Medical writing/review of essential clinical study documents.
- Preparation of regulatory dossiers, responding to queries from USFDA, EMA, PMDA, TGA and DCG (I).
- Collaboration with CRO for trials around the globe and addressed medical queries from investigators & study team.
- Clinical development of India centric products by designing and executing BA/BE and phase 3 clinical studies, DCG (I) interactions.
- Dissemination of clinical research protocols and reports to SEC for regulatory approval and ensured effective clinical project planning and completion.
- New product ideation, evaluation and proof of concept studies execution.
- Consistent and robust medical support to emerging markets such as Asia, Africa, the Middle East, Latin America and addressed their queries.
- Providing training to the sales team on therapy area and products as per requirement.
- Key Projects
- Clinical development of LNP 3794, novel MEK inhibitor. Supported phase 2 study in patients with NSCLC
- Peg-filgrastim biosimilar clinical development for the US market. Supported immunogenicity study in patients with breast cancer
- Clinical development of Etanercept biosimilar for US, EU, Japan and India. Supported global phase 3 clinical study in rheumatoid arthritis
- Clinical development of Ranibizumab biosimilar for Global and India markets. Supported phase 3 studies in wet age-related macular degeneration
- Clinical development of intravitreal Bevacizumab. Supported Proof of Concept studies in wet age-related macular degeneration and diabetic macular edema
Senior Manager
Serum Institute of India Ltd.
12.2012 - 01.2015
- Clinical development of 10-valent pneumococcal conjugate vaccine (PCV10) in collaboration with Bill & Melinda Gates Foundation, USA and 15-valent pneumococcal conjugate vaccine (PCV15) in collaboration with Merck, USA.
- Development of protocol and other essential clinical trial documents.
- Sponsor's primary medical point of contact for Investigator /CRO/Study Team queries.
- Oversaw the Site feasibility, investigator selection, medical monitoring, start-up and closure, and presentations in various meetings, protocol and therapeutic area training for the clinical trial team.
- Regulatory submissions, protocol and study report presentations to SEC and addressed regulatory queries.
- Engagement in weekly PSRT (Protocol Safety Review Team) meetings to address safety issues.
- Development of RFP materials, budget negotiations, coordination for bid-defense, CRO facility visit and CRO selection.
- Coordinating with external funding partners for unique project needs, reporting on study progress.
- Coordination with ICMR and Health Ministry's Screening Committee (HMSC) for approval of foreign funded vaccine study projects.
Regional Medical Advisor
AstraZeneca Pharma India Ltd.
07.2011 - 12.2012
- Successful launch of patented new antiplatelet agent, Ticagrelor in India through various scientific activities.
- Regional subject matter expert for internal stakeholders in the life cycle management of products and provide an understanding of local medical community, clinical practice trends, real or perceived gaps in current scientific knowledge and medical treatment.
- Active participation in monthly brand strategy meetings. Successfully conducted CMEs, institutional meets, train the trainer programs, advisory board meetings, International speaker programs.
- Development, engagement and management of KOLs through various planned scientific activities. Participated as a speaker in various scientific activities.
- Work closely with KOLs on phase IV non-interventional studies in cardiology.
- Rigorous training sessions for newly recruited sales team of more than hundred medical representatives as well as newly recruited MSLs. Highly appreciated for conducting effective training sessions on ACS and Ticagrelor.
PG Tutor
Pd. Dr. D.Y. Patil Medical College, Pune
03.2008 - 04.2011
Resident Doctor
Kashibai Navale College & Hospital, Pune
03.2007 - 02.2008
Education
MD - Pharmacology
D Y Patil Deemed University
01.2011
MBBS - undefined
Maharashtra University of Health Sciences
01.2006
Skills
- Clinical Development
- Clinical Strategy
- Due diligence of new product opportunities
- ICH-GCP and relevant US/EU regulatory guidelines
- Medical monitoring
- Data Interpretation & Presentation
- Project Management
- New product ideation through unmet need characterization
LANGUAGES KNOWN
English
Hindi
Marathi
Hobbies and Interests
Hobbies: Reading, travelling, playing cricket
EXTRACURRICULAR ACTIVITIES & ACHIEVEMENTS
CPhI P-MEC India 2021 - Panelist on "Planning for a successful tomorrow - Commercial landscape & market access for Biosimilars." Attended the 11th annual clinical trial submission 2020 as a panelist for discussion on "Planning and operating an adaptive clinical trial—challenges and the best practices to achieve." An invited faculty member of the Canvas of Clinical Pharmacology Workshop 2020 "An Approach to Clinical Trial Design" at KEM, Mumbai Invited as speaker for 14th Biosimilar Congregation, 2019 to deliver talk on "Clinical strategy for global biosimilar development." Successful execution of global phase 3 study of etanercept biosimilar Construction of 15 detailed clinical development plans for various products Successful interactions with Global regulatory agencies (USFDA, EMA, PMDA) for 9 products Successful evaluation of more than 100 new product ideas/in-licensing opportunities MD Gold medalist Received Best Regional Medical Advisor award in AstraZeneca
Publications
- Publication of “Pharmaceutical Research in India: Current Status and Opportunities” in Proceedings of the Indian National Science Academy June 2020
- Publication “Evaluation of hypoglycemic and lipid lowering activity of Caralluma fimbriata extract in dexamethasone induced diabetic rats.” in American Journal of Pharmatech Research 2013; 3(4).
- Poster presentation on “Evaluation of hypoglycemic and lipid lowering activity of Caralluma fimbriata extract in dexamethasone induced diabetic rats.” in Annual Conference of Research Society of B J medical College Feb 2012
- Paper presentation on “Awareness of Pharmacovigilance amongst Specialist Medical Practitioners.” in Annual Conference of Indian Pharmacology Society at Kolkata in Dec 2009. Dec 2009
- Poster presentation on “Effect of lamotrigine on working memory in rats.” in Annual Conference of Indian Pharmacology Society at Kolkata in Dec 2009. Dec 2009
MD THESIS
Evaluation of hypoglycemic and lipid lowering activity of Caralluma fimbriata extract in dexamethasone induced diabetic rats.
Timeline
Senior Director, Global Clinical Strategy
Viatris | Mylan + Upjohn
04.2019 - Current
Senior Manager | Clinical Development & Strategy
Lupin Ltd
02.2015 - 03.2019
Senior Manager
Serum Institute of India Ltd.
12.2012 - 01.2015
Regional Medical Advisor
AstraZeneca Pharma India Ltd.
07.2011 - 12.2012
PG Tutor
Pd. Dr. D.Y. Patil Medical College, Pune
03.2008 - 04.2011
Resident Doctor
Kashibai Navale College & Hospital, Pune
03.2007 - 02.2008
MBBS - undefined
Maharashtra University of Health Sciences
MD - Pharmacology
D Y Patil Deemed University
Similar Profiles
SONIA BEATRIZ BARRIOSSONIA BEATRIZ BARRIOS
MOZA DE EVENTOS ,AYUDANTE DE JARDINERIA at +MOZA DE EVENTOS ,AYUDANTE DE JARDINERIA at +
BHARATLAL SAINBHARATLAL SAIN
TEAM LEADER at MYLAN LABORATORIES LIMITED (A VIATRIS COMPANY)TEAM LEADER at MYLAN LABORATORIES LIMITED (A VIATRIS COMPANY)
Arunkumar MRArunkumar MR
Senior Team Leader - Quality Assurance at Viatris Company (Mylan Laboratory)Senior Team Leader - Quality Assurance at Viatris Company (Mylan Laboratory)
Zahid ShafiqZahid Shafiq
IT Support Engineer at Fly Atlas PlusIT Support Engineer at Fly Atlas Plus
Ana Barreira SchulzAna Barreira Schulz
Talent Acquisition Specialist Europe at Antech Diagnostics (part of MARS Petcare)Talent Acquisition Specialist Europe at Antech Diagnostics (part of MARS Petcare)