Kalpesh Joshi

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• Insight gathering, conceptualization, development, approval, initiation, monitoring, report writing, and publication of Strategic medical affairs studies to fill up key evidence gaps in the literature for neuroscience assets
• Clinical development and launch of neurosciences assets across India, China, Mexico, Brazil, Turkey, Taiwan & Korea.
• China Wellbutrin registration studies, Requip CR study
• US-FDA sNDAs and post-approval safety studies (PASS) for Ropinirole 
• ISS studies aligned to the asset strategy 
• VEO/HEOR & reimbursement activities 
• Clinical science expert for early pipeline for clinical development secondments (n = 3, total duration = 1.5 years) 
• Contributed “medicine vision” for each asset with an elaborate strategy for its clinical development plan as a clinical lead (n = 3) 
• Contributed to the design, development, execution, publication, and communication of the key registration studies (n =8) 
• Supported Medical writing activities for protocol, ICF, CRF, CTD dossiers (m2.5), CSRs, Clinical summaries, and publication 
• Driven scientific communication like publications, posters, and speaking at conferences (see below)
• Phase I & II assets in tuberculosis – took part in medical monitoring, dose-escalation meetings, investigator meetings, and managing ethical & safety incidents.  
• Phase III/IV studies (n = 4) for a neuroscience asset–driven medical monitoring, safety and regulatory discussions, strategic decisions about launch and publication
• Early pipeline neuroscience asset activities – participation in medicine vision, disease modeling and consortia engagement work 
• Medical writing: Authored various publications, posters, conference abstracts, oral presentations, Video-on-demand lectures, clinical research protocols, safety and regulatory-related documents. 
• Scientific Communications and publications [Also see below bibliography] 
• Developed robust Sci-Comms plan for conference participation, medical booth, impactful medical affairs presentations, GSK-led medical education, scientific workshops, and emailers. 
• Safety, labeling, and regulatory activities: This includes partnering with safety, regulatory, and labeling teams for various risk management plans, ensuring timely completion of regulatory reports, and conducting safety studies for GSK assets. These activities encompass:
• Safety assessment of signals – review of clinical databases, literature, and ACO creation 
• Label updates: GDS, NCDS etc. 
• Safety reports: Reviewing, supporting, and writing DSUR, PSUR & PBRER
• Risk mitigation plans (REMS, RMPs – EuRMP, GRMP etc.)
• Participating in a periodic safety review meeting (SRT). At times, contributions like a medical writing/review of the clinical section of SRT briefing documents were needed. 
• RTQs: EMA queries and labeling updates – Hiccups for ropinirole, ICD for ropinirole, erythema multiformae for lamotrigine, cardiac channel abnormalities associated with lamotrigine etc.
• CTD modules – e.g., review and update of clinical over-view or post-approval document. It also consists of supporting the clinical trial data or replying to specific queries. (E.g., China). 
• Medical Device - writing up EU-MDR compliant clinical evaluation reports (CERs) for medical devices (Imitrex)
• Paediatric investigation plans (retigabine & Sumatriptan).  
• Social listening for safety assessment of an established product
• Provide strategic medical direction for PIRCs including medical assessment, and contribution to comms. Package & to decide DHCPL (in case of product recall). 
• Epidemiology study for Ropinirole using GPRD database
• Audits and inspections – I have undergone two audits and one external ongoing regulatory inspection for a medical device 
•  Strong medical Affairs expertise – Neurosciences (11.5 years – above country role)
• Developed, approved, and executed strategic medical affairs business plans for antidepressants, anti-anxiety, bipolar, Parkinson's disease, and epilepsy assets.
• Led digital innovation projects, including content development for promotional emailers and non-promotional mass emailers. Won EMA gold award for E-reach
• Activated social media for disease awareness campaigns, receiving a silver award for the Carerhood project.
• Engaged in license expansion and business development activities, notably achieving label expansion for levetiracetam in Taiwan.
• Demonstrated excellence in product development and product launch across China, India, Brazil, Mexico, Korea, Taiwan, and the Gulf as well as a strong presence across Southeast Asian countries like Thailand, Indonesia, Malaysia, Philippines, and Vietnam. 
• Previously ABPI medical signatory (now GSK-code signatory) 

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• Strategic medical Affairs studies & ISSs (n = 7)
• Real-world studies and registries (n=2)
• Medical (people) leadership: 5 medics (MSLs and medical advisors) and 4 clin-ops team members (total 9) – built high performing medical team who led various above studies end-to-end.  
• Medical Communication (Scientific & KOL engagement) Activities: Planning and successful execution of standalone meetings, satellite symposia, and conferences.
• Participated as a speaker  in various local-country (India in earlier roles) and above-country conferences
• Generating and synthesizing medical insights: Advisory boards, Face-to-Face or digital meetings with HCPs- 
• Train the trainer – An excellent coach and trainer for medical reps, PMs, trainers (SFE), team & medics.
• Oncology – I was responsible for an oncology portfolio for a brief period of time which covered lung cancer. I was responsible for medico-marketing, 

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• To drive medical support to generic pharma: Product training to field force, Medico-marketing activities, focus-group meetings, advisory board meetings, stand-alone meetings, Driving and developing campaigns, Product launches and BD activities and Conferences and standalone meetings
• Established adverse event (AE) reporting and medical information system 

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• Part-time role in various CROs working as a study physician for BA/BE studies
• Medical writer for oncology & immunology – palbociclib, Lenvatinib, Eltrombopag, Octreotide LAR, Letrozole, alkylating agents, and an SLE asset in the development 

APSMB: Advanced Program for Strategic Management for Business Executives

Indian Institute of Management (IIM-Lucknow), Lucknow 

Fellowship in Diabetes

Dr DY Patil Medical College and Hospital, Nerul, Mumbai

M.D.: Pharmacology  

Topiwala National Medical College and BYL Nair Hospital, Mumbai 

Ongoing

10/2020

06/2008