Nina Patel Lahanis
Associate Vice President, Safety Science
Expertise:
Nina Patel Lahanis has a strong background in global pharmacovigilance, medical communications, regulatory compliance, medical education and technology. With 10+ years of pharmacovigilance expertise and more than 25 years in biotech/pharma R&D and marketing, Nina’s leadership expertise spans from the research lab to post-commercialization. Nina has led global drug safety operations, provided educational product training, contributed to new and organic business development, and successfully streamlined integration processes for multiple organizations. She has worked in a variety of capacities spearheading new business initiatives and strategic publications planning and execution, and she has planned CME and non-CME programs for the majority of the top 25 pharma companies.
Nina has led pre- and post-pharmacovigilance activities, provided regulatory consultation on safety reporting; managed drug safety operations for the U.S., EU, and ROW; and has experience with Oracle Argus, ARISg, Empirica Trace and Oracle AERS safety systems. She is consistently recognized for identifying and implementing new services that solve industry challenges and trends as well as meet client needs. Nina is a strong leadership role model for internal teams as well as client teams. She has served in the U.S. Army as a research microbiologist at the Natick Soldier Systems Center and the Medical Research Institute of Infectious Diseases (Fort Detrick, Maryland) and continued to serve as a medical service officer in the Army Reserve and National Guard.
Nina holds a Bachelor of Science degree in microbiology from the University of Wisconsin and has completed master’s degree coursework in molecular biology for Harvard University.
Articles by Nina Patel Lahanis
Breaking Up Is Hard to Do: When to Leave Your CRO for Optimized Pharmacovigilance
During an intense year for biopharma innovation, the industry’s rapid growth is spotlighting a global need to bring pharmacovigilance practices up to speed. Executing superior pharmacovigilance practices from clinical trials throughout the product life cycle is both complicated and costly, which is why 60% of manufacturers decide against independently managing their pharmacovigilance needs and extensive safety data. Too often, pharmacovigilance is further complicated with siloed commercial services and disjointed datasets. We recognize that manufacturers develop a long-time relationship with contract research organizations (CRO) in clinical trials, and it’s tempting to remain with them in the next phase of the product’s life cycle – but how do you know when it’s […]
Supporting Successful Commercialization With Integrated Compliance
Compliance is an integral part of the entire biopharma, medical device and product lifecycle, yet it poses one of the biggest challenges for our customers. While they try to focus on driving value, innovation and patient centricity, customers find that much of their efforts and finances are still being invested in managing regulatory obligations. Challenges are spread across internal factors, such as obsolete and disconnected platforms, multiple silos and manual processes, to external factors like the changing regulatory landscape and increased scrutiny of regulators. These challenges prevent our customers from moving the needle of compliance from cost to value. In building an integrated compliance platform, EVERSANA has addressed the market […]
COVID-19 Vaccine Safety Briefing Report
As the world awaits the fast-approaching rollout of an approved COVID-19 vaccine, developing the planning to order, distribute and track COVID-19 vaccines in the United States and globally presents an unprecedented challenge. The Food and Drug Administration (FDA) released a detailed analysis that concluded that the Pfizer and BioNTech COVID-19 vaccine is effective and safe, leading the way for the FDA to grant the vaccine an emergency use authorization. While there is much enthusiasm around the shift from the development of the vaccine to its distribution phase, it’s critical to consider the various regulatory guidelines and approaches to monitoring the safety data in real time. Read our latest safety briefing […]
What Happens After a COVID-19 Vaccine Trial Succeeds? 4 Pharmacovigilance Challenges to Address During Commercialization
As pharma companies continue to develop COVID-19 vaccines around the world, they are faced with these questions: What happens when we succeed? How will we quickly and safely distribute the vaccine globally? Pulling off this rapid, international drug distribution safely will require excellence in agility and compliance integrated across commercial services. For pharma companies to successfully market the lifesaving COVID-19 vaccine, they’ll have to overcome pharmacovigilance challenges in four major areas of commercialization: Mass Data Collection Regulatory & Safety Reporting Patient Services Mass Manufacturing & Distribution Click here to read more about meeting these compliance standards in this article by Nina Patel Lahanis, Associate Vice President of Safety Science, EVERSANA […]
Compliance – The Competitive Differentiator to Commercialization: An Integrated Model Setting the New Global Standard
The Compliance experts at EVERSANA prove how integrated life science compliance has earned its seat at the table by demonstrating the value of increasing data-driven and technology-infused competitiveness in the successful commercialization of a new-age biopharma product.