Shivani Shah
Consultant, NAVLIN Market Access & HTA Consulting
Expertise:
Shivani Shah is Consultant at EVERSANA and has around 6 years of experience working as consultant in pharmaceutical and life-science industry.
Prior to joining EVERSANA, she has worked at one of the top ten Indian pharmaceutical companies such as Macleods Pharmaceuticals and Fortune 500 corporations like IQVIA.
Shivani specializes in the development and implementation of solutions that support critical commercial decision-making; specifically, in the areas of drug pricing & reimbursement strategy, health technology assessment and market access strategy primarily in Europe and Asia-Pacific. She has been involved in developing HTA and market access strategy, PRO strategy for products in clinical development phase, primarily in therapeutic areas including oncology, rare diseases, and cell and gene therapies.
Her academic training includes Bachelor of Pharmacy from Bombay College of Pharmacy, Mumbai, and Master of Sciences of Pharmacy, (MPharm) in Drug Development and Regulatory Sciences from Narsee Monjee Institute of Management Studies (NMIMS), Mumbai.
Articles by Shivani Shah
Preparing for Joint Clinical Assessments: How Early PICO Planning Ensures Smoother Submissions
Because the EU Health Technology Assessment (HTA) regulation will take effect in January 2025, pharmaceutical and medical device companies must prepare for a new era in health technology evaluations. The Joint Clinical Assessment (JCA), a core feature of the regulation (EU 2021/2282), promises a more streamlined, harmonized assessment process across Europe, particularly benefiting companies aiming to launch innovative therapies across multiple EU markets. However, being JCA-ready comes with its own set of challenges and opportunities. What is the JCA and why does it matter? The European Union’s (EU) Regulation 2021/2282 on health technology assessment (HTA) seeks to enhance access to innovative health technologies by minimizing duplication among national HTA bodies […]
Utilization of Indirect Treatment Comparison (ITC), External Control Arms (ECA) and Patient-Reported Outcome Measures (PROMs)
Health Technology Assessment (HTA) is crucial to assessing the effectiveness, safety and cost-effectiveness of healthcare interventions. Indirect Treatment Comparison (ITC) is one trend that has gained traction in the HTA space as a way to evaluate interventions and enable researchers to compare the effectiveness of two treatments indirectly. Additionally, utilizing External Control Arms (ECAs) uses historical data, real-world evidence or data from observational studies as a control arm in clinical trials, which can be especially beneficial when studying rare diseases or orphan drugs. PROMs, patient questionnaires or surveys, have become another central component of HTA to assess patients’ experiences. In this latest POV article, Shivani Shah, explores how the utilization […]