Névine is a highly accomplished thought leader with extensive experience across all phases of drug development.  She is a recognized industry expert in drug development with a focus on state-of-the-art clinical programs which facilitate regulatory reviews and approvals.  She is frequently sought out to facilitate and drive health authority interactions to positive outcomes.  She has been successful in bridging the interfaces between discovery, development, and the launch of new medicines to ensure patient unmet needs are addressed in a timely manner. Névine embraces innovation and embedding new approaches into a business.  She excels at problem solving, pioneers ground-breaking ideas, and creates solutions that stand the test of time.

During her 25-year career at GlaxoSmithKline (GSK) and AstraZeneca (AZ), Névine built several industry leading teams of quantitative experts to deliver traditional biometrics pipeline support and to generate additional value through advanced analytics methods. She led the Enterprise Data & Analytics initiative at AZ, a differentiated and competitive program to harness the power of data across the entire company. Beyond her focus on data, she has been a key contributor to development strategies and numerous health authority interactions for over 200 drug projects across oncology, cardiovascular, metabolic, respiratory, inflammation, urology and renal diseases.

Névine is currently a strategic consultant dedicated to advancing healthcare.  Her projects include 1) significant initiatives bringing together multiple shareholders to answer complex scientific questions eg ctDNA, COVID19 Data Lab 2) addressing regulatory and policy challenges, 3) general organizational constructs. She also provides niche consultancy in leadership. She most recently became a strategic consultant to the FDA (Office of the Principal Depute Commissioner) advising on real-world evidence approaches to COVID19.

Previously, Névine was Senior Vice-President, Biometrics & Information Sciences at AZ where she drove innovation and seamless delivery from a data perspective in a $4B R&D organization with a very dynamic pipeline. During this period of restructure and change, Névine’s team was recognized for reliable delivery of drug projects, structured thinking and creative solutions. Névine embedded data science thought leadership in drug project teams, in therapeutic leadership teams and at the highest level of governance. She herself was a core member of the Late-Stage Product Committee, which made the final decisions for pipeline investments, where her objective assessment, cross-functional expertise and organizational acumen distinguished her contributions.

Prior to joining AstraZeneca, Névine held multiple senior leadership positions at GSK. In her last role, she built and led a cross-functional team accountable for the robustness of the pipeline.  In other roles at GSK, Névine was accountable for the quality and timeliness of quantitative input to drug development (early and late stage) and played a key role in numerous regulatory interactions.

She has a master’s degree in Statistics from Waterloo University in Ontario, Canada and a Bachelor of Science degree in Mathematics from McGill University in Montreal, Quebec. She is fluent in English and French and a dual US/Canadian citizen.

Névine was a member of the Clinical Data Interchange Standards Consortium (CDISC) Board of Directors from 2014-2019 and is now a member of ANOVA’s Scientific Advisory Board.   She was a reviewer for The Lancet and an author/coauthor of over 25 peer reviewed publications in biostatistics/medical journals. She is a frequent speaker and panelist at scientific conferences.

Statistical & Data Science Thought Leadership

• Board member of Clinical Data Interchange Standards Consortium (CDISC); Chair of Finance Committee in 2016 and key board member overseeing founding CEO transition to a new CEO.
• Scientific Advisory Board member of ANOVA.
• Key member of FDA Blue Ribbon Panel for Individual Bioequivalence (IBE); Co-chair of Red-Ribbon PhRMA panel for IBE; invited to sit on FDA advisory committee to review IBE; member of PhRMA QTc expert panel.
• Author/coauthor of 25+ publications in peer reviewed biostatistics and medical journals; Statistical Reviewer for The Lancet.
• Thought leader, frequent speaker and numerous industry panel engagements.

Drug Development

• Member of governance boards at Astra Zeneca and GlaxoSmithKline with 28 Phase III investment cases approved and 23 Phase II initiations during 2017-2018 at AZ.
• Key contributor to development strategy for 200+ drug projects across all therapeutic areas. Expertise in cross-functional considerations: translational science, clinical, safety, commercial and pricing.  Sought after leader for resolving complex challenges.
• Instrumental in transformation of the pipeline at AZ by including well-developed data science components in addition to traditional biometrics.
• Recognized by CEO, Chairman of R&D and CMO for leadership and integrity during Avandia crisis. Key figure responding to NEJM which reported an increase in myocardial infarction and cardiovascular deaths. Following a congressional hearing and an FDA Advisory Committee meeting, the product remained on the market and was subsequently fully exonerated.
• Worked with non-profit Friends of Cancer Research to create a collaboration with FDA, pharmaceutical companies and diagnostic vendors where multiple data sets are harmonized to evaluate whether circulating tumor DNA predicts patient response.

Strategy & Vision

• Established industry leading, well-respected global teams of quantitative experts in research and development. At the request of AZ’s senior executive team, Névine’s remit was expanded to lead the enterprise wide Data & Analytics initiative within the company.
• Drove both innovation and seamless delivery in a $4B R&D organization at AZ from a data perspective, through a combination of technical, organizational and operational acumen.
• Led development of departmental strategic plan to scale up and expand the joint impact of quantitative disciplines in drug development.
• As a consultant to the Bill and Melinda Gates Foundation, helped to drive the creation of the International Covid19 Data Alliance and leads the first scientific project within the Alliance.

Transformational Change & Operational Excellence

• Reformed and elevated the Biometrics and Information Sciences organization, including managing relocation of two of three global sites and the turnover of one third of the staff.
• Grew her organization from 250 to 650 FTEs in seven global locations with a budget of $100M over four years to meet worldwide drug pipeline demands.
• Member of AZ Quality Council to ensure transformation was achieved with breakthrough improvements in quality.
• Developed the metrics to monitor delivery of the pipeline at AZ and for harmonizing of executive roles in late-stage development organization.