Partha Gokhale

• Strategic Medical Leadership: Led the successful market introduction of Spesolimab in key regional markets – Turkey, Saudi Arabia, UAE and India.
• Innovation: Implemented a Rare Disease model for effective pre-launch preparation of a Novel Oncology drug in DDLPs and other indications saving costs across the IMETA organization.
• Early Medical Affairs Strategy: Developed and implemented early medical affairs strategies, ensuring seamless execution across IMETA OPUs.
• Strategic Partnerships: Leveraged CT involvement through early medical affairs engagement to build advocates and gain comprehensive understanding of the therapeutic area landscape.
• Talent Development: Contributed to the development of a roadmap for Medical Manager career development and an MSL 2.0 project, enhancing the skills and capabilities of senior medical affairs personnel throughout the regional operating Unit demonstrating matrix leadership.

1. Product Registration: for Ofev (Nintedanib) in SSc ILD, 3 months ahead of schedule providing additional 3 months of product exclusivity before LOE.

2. People Management- Led a high performance team of 6 MSLs, 2 Medical Advisors and 2 Medical managers in the Specialty Business Unit of BI India

3. Digital Innovation: Conceptualized a Virtual MDT for ILD Diagnosis during COVID pandemic in collaboration with the Indian Chest Society, showcasing strategic use of technology in healthcare.

4. Strategic Ideation & Brand Growth: Implemented the innovative “Right Dose Right Patient” strategy for Pradaxa. Along with the Reversal advantage with Praxbind, this strategy ensured a healthy growth for the brand in the post LOE period.

5. Stroke Awareness & Intervention: Implementation of a mass stroke awareness program that achieved a Guinness World Record.

6. Collaboration in Independent Medical Education: Ideation and implementation of an innovative 6-month stroke education program for young neurologists in collaboration with Calgary University Canada and Indian Stroke Association (CASTLE).

7. Collaboration for Increasing Market Access: With Government Affairs created a film for a mass awareness program on Stroke, with the objective of improving market access.

8. Project Orion (Pipeline Assets Project): Successfully implemented a pipeline assets project at L-60 months, leading to a market research and market access study with IQVIA. Aimed at lobbying with corporate for clinical trial inclusion for forthcoming indications.

9. Real World Evidence- Protocol Design for Metalyse Registration: Designed a RWE study in collaboration with the Global Therapy Lead for Metalyse registration in India in acute ischemic stroke, demonstrating strategic planning and collaboration in clinical research.

• Strategically spearheaded the establishment of the Clinical Research Department at Boehringer Ingelheim India, paving the way for enhanced research capabilities, fostering innovation, and supporting the company's expansion and growth in the Indian market.
• Led a high-performance team of 46 individuals including Medical Monitors, Global Project Managers, Clinical Research Managers, Local Project Managers, Clinical Team Leads, Clinical Research Associates, and Administrative Assistants.
• Strategically expanded global clinical trials to Sri Lanka and Bangladesh, diversifying research locations and establishing key partnerships with pre-qualified CROs for essential services."
• Contributed to the successful registration of six new products and 11 new indications in BI India.
• US FDA inspections: Served as the primary contact person and principal responder for 6 US FDA site inspections in India (4NAI+ 2 VAI) and 51 local authority (DCGI) site inspections from 2010.
• Participated in BI Global Leadership Development program in 2017 and BI Regional Leadership Development program in 2012 resulting in enhanced leadership capabilities and a broadened global and regional perspective.
• Recipient of BI Regional Award For excellence in Asia-Mena region in 2011 and 2012.
• Quality Improvement : Strategic planning and rigorous quality control measures enhanced the quality of clinical trials conducted in India, as evidenced by annual audit report metrics. My strategic risk management approach led to India being recognized as the country with the lowest risk for conducting studies in the Asia region in 2011, marking a significant milestone in our strategic journey as a country.

• Served as a Regional Medical Monitor for Global clinical studies for China, ASEAN and India.

• Management of Global Clinical studies for Wyeth, India
• Therapy area focus- Psychiatry, Oncology and Vaccines (Prevnar)

• Medical Advisor for Respiratory, Cardiovascular and Rheumatology
• Protocol writer and Designer for Respiratory studies for European ANDA.

• Collaborated with the drug development team in Kopran's new drug development division for novel IND and NDA, providing inputs into the animal pharmacology and designing the early clinical studies.