Sponsored Webcast: Navigating the AI Revolution: Embracing Change and Thriving in the Future of AI-i

Registration Fees & Deadlines

Learning Objectives

• Understand the current state and future potential of AI in pharmaceutical drug development and regulatory affairs

• Explore the impact of AI on clinical development, and regulatory affairs

• Identify best practices for implementing AI solutions in the pharmaceutical industry

• Gain insights from industry experts on successfully navigating the AI revolution in a regulated environment

Who Should Attend?

Regulatory Affairs Professional

Audience Learning Level

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.

Speakers

David Truloff
Senior Director of Regulatory Affairs Therapeutic Area, Obesity and Liver Disease, Novo Nordisk

David is a a seasoned professional with 20 years of experience in the pharmaceutical industry, and a dynamic leader known for his ability to motivate teams and create innovative solutions. David's expertise lies in regulatory strategy, team management, and driving digital and organizational transformation. Throughout his professional journey, David has led teams of specialists and professionals, driving regulatory strategies for innovative treatments for diabetes, obesity, and rare bleeding disorders. During his 17-year tenure at Novo Nordisk A/S, David has spearheaded numerous projects, such as Fit4Takeoff, a cross-organizational initiative aimed at accelerating the delivery of innovations to patients via digitalization, process and mindset. David's leadership style emphasizes the development of colleagues, building strong and diverse teams, and implementing forward-looking feedback systems. He is passionate about aligning business goals with strategy, fostering a culture of sustainable performance, leveraging digitalization and new ways of working. He is a Doctor of Veterinary Medicine from the University of Queensland, Australia. He has also completed executive education and leadership talent development programs at Novo Nordisk.

Hao Zhu
Director of the Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Science, Center of Drug Evaluation and Research
U.S. Food and Drug Administration (FDA)

Hao Zhu received his PhD in pharmaceutical sciences and Master in statistics from the University of Florida. He started his career in modeling and simulation teams in Johnson & Johnson and Bristol-Myers-Squibb. Hao joined FDA as a pharmacometrics reviewer more than 16 years ago. He served as a clinical pharmacology team leader for more than six years and a QT-IRT scientific lead for two years before becoming the deputy director at FDA’s Division of Pharmacometrics. His division reviews the pharmacometrics related submissions and supports pharmacometrics-related policy development.

Lo Ann Thomas
Senior Director Global Regulatory Intelligence, AstraZeneca

Lo Ann Thomas has been with AstraZeneca Pharmaceuticals for 24 years and has held several positions within regulatory policy and intelligence. Currently, Lo Ann is senior director of global regulatory intelligence with a focus on the cardiovascular, renal, metabolism and neuroscience portfolio. Lo Ann has led numerous projects throughout her career and most recently is the business lead for the development and implementation of a global guidance and regulation platform to manage commenting and impact assessments in partnership with Deloitte. She has served as project manager for a number of internal working groups including PDUFA, pediatrics, and pharmacovigilance. Prior to joining AstraZeneca, Lo Ann was with for the former DuPont Pharmaceuticals Company for 10 years and worked in both regulatory affairs and analytical R&D. Lo Ann holds a master’s degree from Temple University in quality assurance/regulatory affairs and the RAPS Regulatory Affairs Certificate for Medical Devices.

Andrew Robertson
Vice President, Head of Global Regulatory Policy and Innovation, Takeda

Andrew Robertson is the vice president and head of global regulatory policy and innovation at Takeda. Throughout his career, Andrew has combined his background in science, law, and policy to advance healthcare innovation and patient access to medicines globally. In his current role, Andrew oversees the global regulatory policy activities of Takeda R&D affecting pre-clinical, clinical development, regulatory approval, and post-market strategy, and has spearheaded multiple strategic initiatives combining digital, AI, and data-driven approaches to regulatory contexts. Andrew held multiple roles in industry, academia and government prior to Takeda, including a Faculty Research position at the UK Wellcome Trust Sanger Institute, and as a Science Policy Advisor for Health and Human Services Office of Preparedness and Response. His recent first-author publications discuss Cloud-based Platforms in Regulatory Affairs (Nature Reviews, 2020), Data-driven Regulatory Intelligence (Nature Reviews, 2021), and the Importance of Regulatory Predictability (JAMA, 2023). He has a JD from UC Berkeley School of Law, and a PhD in Structural Biochemistry from the University of Cambridge. He is a member of the California Bar.

Elizabeth Rosenkrands Lange
Head of US Regulatory Policy and Intelligence, EMD Serono

Elizabeth Rosenkrands Lange is the head of US regulatory policy and intelligence at EMD Serono, a business of Merck KGaA, Darmstadt, Germany. She has extensive experience working in regulatory policy at DKMA/EMA, FDA and industry. Elizabeth is the co-chair of the DIA Regulatory Policy and Intelligence Committee.

Jadhav Pravin
CEO, Vivpro Corp

Jadhav Pravin is an internationally recognized drug development and digital transformation leader. One of the founders and CEO of Vivpro Corp. He is a creative quantitative scientist and leader focusing on improving and protecting population health. He has held several leadership positions in FDA, Merck, and Otsuka, spanning over 18 years. He has pioneered several innovative drug development pathways and digital transformation of drug development. Jadhav received his BPharm and MPharm from India, a PhD. in Pharmaceutical Sciences from the Medical College of Virginia Commonwealth University (VCU), and an MPH from Johns Hopkins University, Bloomberg School of Public Health. 

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions