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Type: 12: ProfDevelopment clear filter
Monday, June 16
 

2:15pm EDT

Harnessing the Power of Generative AI: From Prompt Engineering to Actionable Insights
Monday June 16, 2025 2:15pm - 3:15pm EDT
Component Type: Session
Level: Basic

This session will provide the transformative potential of Gen AI like ChatGPT. The session will explore the art of prompt engineering and the potential of LLM-based QnA system and will equip the attendees with the practical skills to harness the power of Gen AI.

Learning Objectives

Recognize Gen AI’s potential to enhance productivity; Discuss how to master prompt engineering techniques (zero-shot learning, few-shot learning, and chain of thought); Identify how to frame questions, analyze responses, and extract actionable insights more effectively.

Chair

Kevin Lee, MS

Speaker

Twenty Percent More Productivity with ChatGPT? Discover how Prompt Engineering is a Game Changer for Professional Development
Kevin Lee, MS

Harnessing Generative AI for Scientific Intelligence and Information Extraction
Ankush Chandna, MSc


Speakers
avatar for Ankush Chandna

Ankush Chandna

Data Science Lead, Research and Development Excellence, ZS Associates , United States
KL

Kevin Lee

Data Scientist, Clinvia, United States
Kevin Lee is a Data Scientist and Biometrics Leader with 20 years of experience in Big Data, Cloud, Open-Source Programming, Data Sciences and Machine Learning in pharmaceuticals. His leadership and passion for innovation drive continuous advancement in Pharma. Recently focused on... Read More →
Monday June 16, 2025 2:15pm - 3:15pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Session

3:45pm EDT

Mastering the Power of Words: Elevate Performance and Compliance through Confident Communication
Monday June 16, 2025 3:45pm - 4:45pm EDT
Component Type: Session
Level: Intermediate

This session will include techniques for having robust documentation to deliver clear, confident messages and strategies which improve individual and team performance, confidence and compliance using insights backed by data and real-world examples.

Learning Objectives

Discuss the Impact of Language and how the choice of words and tone can influence performance, collaboration and compliance in the workplace; Recognize practical techniques and strategies for communicating with confidence in various professional scenarios; Describe ways to enhance performance through effective communication.

Chair

Tony Johnson, MS

Speaker

Panelist
Ana Sharma, MPH

Panelist
Anne Marie Inglis, PhD


Speakers
avatar for Anne Marie Inglis

Anne Marie Inglis

Senior Director, Clinical Operations Asset Lead, GSK, United States
Dr. Inglis has over 25+ years of experience in clinical research, spanning all phases of research, specializing in clinical operations. While at Mallinckrodt Pharmaceuticals, she led the initiative to define the Risk Based Quality Management approach within Clinical Development. In... Read More →
TJ

Tony Johnson

Senior Director, Clinical Quality, Mallinckrodt Pharmaceuticals, United States
AS

Ana Sharma

Global Head of Quality, Abivax, United States
Monday June 16, 2025 3:45pm - 4:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Session
 
Tuesday, June 17
 

10:30am EDT

Resilient Leadership: Overcoming Isolation and Adversity
Tuesday June 17, 2025 10:30am - 11:30am EDT
Component Type: Session
Level: Intermediate

In the ever-evolving pharma/biotech landscape, leaders face challenges that test their professional and personal resilience. The past year has seen a significant strain on the industry, marked by the disruption of new technologies (and expectations associated with it), the failure of promising compounds, economic pressures, and layoffs. As leaders, we are often left to shoulder the weight of these challenges, managing not only our own emotional burden but also the morale of our teams and the broader organizational impacts. This presentation, delivered by a panel of seasoned professionals in the regulatory writing space, will explore the often-unspoken loneliness of leadership in times of upheaval. We will share personal insights from our career journeys, addressing the ways in which leadership can feel isolating, especially when navigating industry setbacks. In addition, we will provide practical strategies for coping with these burdens, drawing from experiences in career pivots, reskilling/retooling, and personal resilience. We will discuss ways to maintain emotional well-being, foster collaboration, and lead with transparency, even in the face of industry-wide adversity. Attendees will leave with actionable strategies to support their teams and themselves, and insights into how to continue leading effectively in times of uncertainty.

Learning Objectives

Discuss the unique emotional and professional challenges faced by regulatory writing leaders during periods of significant change; Describe developing strategies for maintaining personal resilience and emotional well-being while leading teams through industry-wide setbacks and economic pressures; Recognize ways to implement actionable techniques for fostering skill development, reskilling, and collaboration to effectively support both individual and team growth during challenging times.

Chair

Robin Whitsell

Speaker

Panelist
Cathy Tyrrell

Panelist
Matthew Robillard


Speakers
MR

Matthew Robillard

Senior Director, Regulatory Strategic Writing, AbbVie, United States
Matthew Robillard is a Senior Director of Regulatory Strategic Writing for AbbVie, based in North Chicago, IL. Matt began his career with Abbott Laboratories in 1992 in Technical Communications, and in 1996 became a Medical Writer in the Hospital Products Division. His career has... Read More →
avatar for Cathy Tyrrell

Cathy Tyrrell

Head of Medical Writing and Disclosure, Seqirus, United States
avatar for Robin Whitsell

Robin Whitsell

President, Whitsell Innovations, Inc., United States
Founder and president of Whitsell Innovations, Inc., a medical writing firm headquartered in Chapel Hill, NC, Ms. Whitsell has over 25 years of experience, specializing in global submission strategy, regulatory medical writing, emerging technologies, and data visualization. Prior... Read More →
Tuesday June 17, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

1:45pm EDT

Charting New Courses: Reshaping Opportunities and Breaking the Expert Mold in Career Development
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
Component Type: Session
Level: Intermediate

This session outlines an approach to developing technical experts into global leaders by breaking the "expert trap" and aligning talent development with organizational growth strategy.

Learning Objectives

Identify strategies for breaking the "expert trap" and enhancing career growth for technical talent; Recognize how to align talent development with organizational growth through strategic initiatives; Identify methods to cultivate a diverse leadership pipeline in life sciences.

Chair

Amber Meriwether, JD, MA

Speaker

Industry Perspective
Elizabeth Iorns

Industry Perspective
Michael Torok, PhD

Industry Perspective
Cecilia Zvosec


Speakers
EI

Elizabeth Iorns

Science Exchange, CEO and Co-Founder, United States
avatar for Amber Meriwether

Amber Meriwether

Corporate Strategy, Astellas Pharma, United States
Amber Meriwether is a global leader with 20+ years in healthcare, driving initiatives that accelerate innovation and deliver measurable impact. As Director of Corporate Strategy at Astellas Pharma, she leads cross-functional teams to develop strategic capabilities and deliver key... Read More →
avatar for Michael Torok

Michael Torok

Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group, United States
Michael Torok, Ph.D. is the Global Head of Quality Assurance Programs at Genentech/Roche. He is energized and driven by the mission of positioning Quality to be an accelerant in developing new therapeutics, rather than a guardrail or "policemen". To enable this shift, cross-functional... Read More →
CZ

Cecilia Zvosec

Strategy & Insights, ZS, United States
Tuesday June 17, 2025 1:45pm - 2:45pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Session

4:00pm EDT

Getting the Work of Medicines Development and Manufacturing Done by Hook or by Crook: Attracting, Retaining and Developing Key Talent in the New World of Work
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
Component Type: Session
Level: Intermediate

This session will present two contrasting approaches to workforce development which address the challenges in attracting and retaining the ideal talent. First, what can pharma learn from other industries who have developed a remote, agile and on-demand talent base responsive to changing needs. Second a case study in meeting the challenge of extraordinary growth in product pipeline and expansion by implementing an integrated, multi-faceted, workforce development ecosystem in collaboration with academic institutions and other manufacturing companies that also builds and sustains the local economy.

Learning Objectives

Discuss how to maximize agility and attract the best talent to get the critical work of drug development and manufacturing done; Identify novel approaches to developing and retaining a skilled workforce capable of meeting the needs of a highly regulated industry; Recognize how the organization can achieve unprecedented agility by embracing the Future of Work tools and methodologies.

Chair

Denyse Baker, RAC

Speaker

Far Beyond Remote Work: NASA, The Ford Motor Company, and The New World of Work - Opportunities for Pharma
Sheila Mahoney Jewels, MBA

Looking Internally and Externally to Optimize Workforce Development
Dedric Day


Speakers
DB

Denyse Baker

Assoc. Vice President Global Quality Compliance, Eli Lilly and Company, United States
Denyse Baker is Associate Vice President of Global Quality Compliance with Lilly. She has more than 35 years of experience in the pharmaceutical industry including leadership roles with AstraZeneca, US FDA and PDA. Denyse’s expertise includes policy development, external engagement... Read More →
avatar for Dedric Day

Dedric Day

Senior Director- Strategic Talent Partnerships, Eli Lilly and Company, United States
Dedric Day has worked at Eli Lilly and Company for 22 years since graduating with a bachelor’s degree in chemical engineering from Rose-Hulman Institute of Technology. He has held leadership roles in engineering, operations, and technical services/manufacturing sciences in manufacturing... Read More →
avatar for Sheila Mahoney Jewels

Sheila Mahoney Jewels

Drug Development Multi-Functionalist, LifeSciHub , United States
Life sciences R&D Ecosystem Expert, Independent Small Business and Workforce Advocate, Software Platform Developer and Investor. Focus areas include: Regulatory and Clinical Operations, Strategic Patient Engagement, CMC, Real World Evidence, Pharmacovigilance, and Biometrics, Medical... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Session
 
Wednesday, June 18
 

10:30am EDT

Leader Effectiveness: Inclusive Leadership Practices to Improve Employee Engagement and Performance
Wednesday June 18, 2025 10:30am - 11:30am EDT
Component Type: Session
Level: Basic

This interactive workshop designed by a behavioral scientist from Tufts CSDD will provide an experiential learning experience covering levers that can enhance leadership effectiveness using an inclusive leader framework.

Learning Objectives

Identify specific inclusive leadership behaviors that can enhance individual and team-level outcomes; List the challenges and barriers associated with inclusive leadership practices; Discuss evidence-based ways to practice inclusive leadership that resonate with all employees.

Chair

Jennifer Kim, PhD

Speaker

What's Next for Developing Inclusive Leaders?
Christine Mayer-Nicolai, PharmD

Challenges of Leading Inclusively in Cross-Functional, Mixed Teams
Tamei Elliott, MS

Inclusive Leadership Strategies to Effectively Manage Teams
Ruby Madison Ford, MPH


Speakers
avatar for Tamei Elliott

Tamei Elliott

Associate Director, Scientific Programs, DIA, United States
Tamei Elliott, MS, serves as the Associate Director of Scientific Programs for the Americas region at DIA. In this pivotal role, she is responsible for identifying and prioritizing content areas and topics crucial to DIA constituents. Tamei assesses the implications of significant... Read More →
avatar for Ruby Ford

Ruby Ford

Research Analyst, Tufts School of Medicine, United States
Madison Ford is a Research Analyst at the Center where she conducts grant-funded research including survey and database design, quantitative and qualitative data analysis, and literature reviews. In 2021, Madison received her BS in Public Health from The University of Alabama. She... Read More →
avatar for Jennifer Kim

Jennifer Kim

Research Associate Professor, Tufts Center for the Study of Drug Development, United States
I'm a Research Associate Professor and Organizational Psychologist at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. My research focuses on health and work equity, examining strategies and interventions that can positively impact individual... Read More →
avatar for Christine Mayer-Nicolai

Christine Mayer-Nicolai

Vice President, Regulatory and Scientific Policy, Merck Healthcare KGaA, Germany
Dr. Christine Mayer-Nicolai, VP, Regulatory & Scientific Policy at Merck Healthcare KGaA, Germany is based in Darmstadt and Washington, DC. She is leading the development of Merck Healthcare regulatory policy priorities, identifying, and responding to global regulatory and legislative... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Session

4:00pm EDT

Business Agility: Recognizing Global Business Environment and Appropriate Strategies Adaptations
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
Component Type: Session
Level: Intermediate

The session aims to enhance the participant's ability to recognize the global business environment, focusing on critical factors influencing business strategy. We will illustrate adopting business and regulatory strategies to evolving landscapes.

Learning Objectives

Identify key factors and trends influencing the biotechnology and pharmaceutical industries; Evaluate the impact of these trends on business and regulatory strategies; Propose strategic adaptations to address evolving industry and regulatory challenges.

Chair

Lawrence Fine, PhD, MBA

Speaker

Beyond Borders: Impact of Economic Shifts on Regulatory Strategies in Obesity Care
Tetyana Fine, MS

Global Strategy Considerations for Biosimilar Approvals
Rosalyn Janine Bailey, MPharm, MS

Artificial Intelligence in Drug Development
Darshini Trivedi


Speakers
avatar for Rosalyn Bailey

Rosalyn Bailey

Executive Director NA & LATAM Head – Global Regulatory Affairs Solultions, Syneos Health, United States
Rosalyn Bailey, MS, is an experienced Regulatory Affairs leader with over 20 years in the drug development industry. As Executive Director of Global Regulatory Affairs Solutions at Syneos Health, she oversees regulatory teams across the Americas, guiding products through the regulatory... Read More →
avatar for Lawrence Fine

Lawrence Fine

Business Consultant, Lawrence Fine, LLC, United States
Extensive experience working with companies of various sizes, including Fortune 500 companies. Deep expertise in Technology, Healthcare, Hospitality and Biotechnology industries across different functions including but not limited to marketing, information technology, and personnel... Read More →
TF

Tetyana Fine

Director, Global Regulatory Affairs, Astrazeneca, United States
Fifteen (15) years of diverse biotechnology and pharmaceutical industry experience, including leadership, regulatory strategy development and execution, chemistry manufacturing and controls (CMC), and program and project management. Effectively direct multinational, cross-functional... Read More →
DT

Darshini Trivedi

Senior Director, Global Regulatory Affairs and Product Strategy, Amgen, Inc, United States
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  12: ProfDevelopment, Session
 
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