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Monday, June 16
 

10:15am EDT

IQVIA Innovation Theater: Advancing Clinical Trials with Generative and Agentic AI
Monday June 16, 2025 10:15am - 10:45am EDT
TBD
Component Type: Session

We will explore how AI can enhance clinical trials resulting in increased efficiency and precision. Hear from representatives from IQVIA and NVIDIA to 1)Gain insights into how AI will transform workflows in clinical trials, and 2) Explore “what if” scenarios that can help sponsors review different eligibility criteria and parameters to determine what may impact recruitment goals and quantify each option. Join us to discuss how AI will pave the way for more efficient and effective drug development.

Speaker

Speaker
Raja Shankar, MS


Speakers
avatar for Raja Shankar

Raja Shankar

Vice President, Machine Learning, IQVIA, United Kingdom
As the Vice President of Machine Learning in IQVIA’s Research and Development Solutions, Raja leads the development, selling and delivery of AI-led life sciences innovation through pilots, platforms, products and services. His current focus is on AI to augment life science R&D across... Read More →
Monday June 16, 2025 10:15am - 10:45am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

10:15am EDT

Lokavant, Inc Innovation Theater: Applying the Scientific Method to Clinical Trials: Building the Evidence for AI-Driven Transformation
Monday June 16, 2025 10:15am - 10:45am EDT
TBD
Component Type: Session

Clinical trials rely on historical data, causing inefficiencies in site selection, patient matching, and execution. To drive change, the industry must apply the scientific method—testing AI-driven approaches to optimize outcomes. Lokavant leads this shift, improving protocol-matching accuracy by 20% and using predictive analytics. CEO Rohit Nambisan shares real-world evidence of AI’s impact on de-risking trials and accelerating enrollment. Learn why pharma leaders now see AI as a necessity.

Speaker

Speaker
Rohit Nambisan


Speakers
avatar for Rohit Nambisan

Rohit Nambisan

CEO & Co-Founder, Lokavant, United States
Trained as a neuroscientist, Rohit Nambisan is a product executive with experience leading product development organizations in pharma, medical devices, personalized medicine, health IT, healthcare data and analytics, and AI. Prior to co-founding and leading Lokavant, Rohit was most... Read More →
Monday June 16, 2025 10:15am - 10:45am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

12:55pm EDT

PCM Trials Innovation Theater: Insights from Across the Care Continuum - How Community-Based Research Supports Trial Success
Monday June 16, 2025 12:55pm - 1:25pm EDT
TBD
Component Type: Session

This panel brings together experts from across the research continuum to explore how community-based research models contribute to trial success. Through real-world experiences and case studies, panelists will discuss the operational, medical, and regulatory considerations of integrating community research into clinical trials. Attendees will gain insights into how these approaches work together to improve patient reach, retention, and overall trial efficiency.

Speaker

Speaker
Mark McKenzie, MD

Speaker
Thad Wolfram


Speakers
avatar for Tajuana Barron

Tajuana Barron

Vice President Project Management Global Clinical Trials, PCM Trials, United States
Tajuana Barron is the Vice President of Project Management responsible for project delivery. Ms. Barron joined PCM Trials in 2022 with over 30 years of clinical research experience working for Pharma companies and CROs. Prior to joining PCM Trials, Ms. Barron served as a Senior Director... Read More →
avatar for Mark McKenzie

Mark McKenzie

Chief Medical Officer, EmVenio Research, United States
Mark McKenzie, MD is the Chief Medical Officer responsible for strategies and new initiatives in the clinical and therapeutic areas. He also provides medical and clinical oversight to EmVenio’s team of principal investigators involved in trials at community research sites globally... Read More →
avatar for Thad Wolfram

Thad Wolfram

Chief Strategy Officer, EmVenio Research, United States
With a foundation of more than 20+ years in clinical trials, healthcare, and the pharmaceutical industry, Thad Wolfram brings a wealth of knowledge and experience to EmVenio. As President, he is focused on the growth of hybrid and decentralized trial capabilities and increased clinical... Read More →
Monday June 16, 2025 12:55pm - 1:25pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

12:55pm EDT

AlphaLife Science Innovation Theater: GenAI in Action - Demo and Real-World Case Studies Transforming Medical Writing in Global Pharma
Monday June 16, 2025 12:55pm - 1:55pm EDT
TBD
Component Type: Session

This session will showcase a GenAI-powered platform for Medical and Regulatory Authoring, transforming global pharma operations. Real-world case studies highlight how the platform reduces CSR and protocol preparation time by 50%. Key features include integrated authoring solutions, scalable content reuse, GenAI-driven quality control, and change management strategies. Designed for medical writers, regulatory executives, and digital innovation professionals aiming to streamline processes.

Speaker

Speaker
Sharon Chen


Speakers
avatar for Sharon Chen

Sharon Chen

Founder and CEO, AlphaLife Sciences, United States
Sharon Chen is a visionary leader at the intersection of computer science and life sciences, boasting over 25 years of pioneering software development experience. As the Founder and CEO of AlphaLife Sciences, she drives innovation in generative AI-powered clinical development solutions... Read More →
Monday June 16, 2025 12:55pm - 1:55pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

1:35pm EDT

Evernorth Health Services Innovation Theater: Empowering Case Managers - Bridging Patient Education and Oncology Clinical Trial Enrollment
Monday June 16, 2025 1:35pm - 2:05pm EDT
TBD
Component Type: Session

Case managers play a crucial role in educating patients about their treatment options, including access to cutting-edge oncology clinical trials. Attendees of this session will learn about success in supporting research enrollment through a collaboration between Cigna Health Plan and Leal Health to guide patients through the process starting with awareness, to receiving a personalized list of precise trial matches, and partnering with a dedicated trial navigator.

Speaker

Speaker
Ria Westergaard, PharmD

Speaker
Anthony Gulotta


Speakers
avatar for Anthony Gulotta

Anthony Gulotta

Head of Sales and Strategic Partnerships, Leal Health, United States
Anthony Gulotta is a tech executive with a track record of launching and scaling AI-driven startups. As the founding sales team member at Leal Health, he leads sales and strategic partnerships across payers, sponsors, and providers. With deep industry connections and a strong belief... Read More →
avatar for Ria Westergaard

Ria Westergaard

Head of Product Strategy and Innovation, Evernorth Clinical Trial and RWE Solutions, United States
Ria Westergaard is an experienced leader with background in clinical research and pharmacy benefit management. At Evernorth, the health services division of The Cigna Group that serves more than 180 million people, Ria's role focuses on designing solutions that use integrated health... Read More →
Monday June 16, 2025 1:35pm - 2:05pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

1:35pm EDT

Parexel Innovation Theater: Agility in Action - Reshaping the Clinical Research Workforce
Monday June 16, 2025 1:35pm - 2:05pm EDT
TBD
Component Type: Session

The drug development landscape is evolving rapidly, characterized by increasing complexity, innovative trial designs, advanced technologies & AI, and the integration of real-world data. Outsourcing models are adapting to these changes, with a growing trend towards hybrid (blending FSO/FSP outsourcing) approaches. We’ll share our comprehensive research findings that examine these shifts, with recommendations for driving innovation and efficiencies while cultivating the workforce of the future.

Speaker

Speaker
Stephen Pyke, MSc

Speaker
Jenny Denney


Speakers
avatar for Jenny Denney

Jenny Denney

EVP, Global Head Parexel FSP, Parexel , United States
avatar for Stephen Pyke

Stephen Pyke

Chief Clinical Data and Digital Officer, Parexel, United Kingdom
Stephen is responsible for leading and directing Parexel’s enterprise patient data strategy. He is also leading the development of Parexel's AI strategy. Stephen trained as a statistician, and began his career in academia (London), where he held various research and teaching positions... Read More →
Monday June 16, 2025 1:35pm - 2:05pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

1:35pm EDT

Taimei Technology Innovation Theater: Transforming eClinical Platform - The New Era of Agentic AI in Data and TMF Management
Monday June 16, 2025 1:35pm - 2:05pm EDT
TBD
Component Type: Session

Embrace the future of Data Management and TMF management with the power of Agentic AI. These intelligent systems automate processes, including protocol -> CRF/DVP -> eCRF/EC, and document filing -> QC. By leveraging the power of LLM and eClinical platform capabilities, we can experience a new era of clinical operations where AI is not just a function of an eClinical platform, but an integral part of the process, driving smarter, more efficient outcomes.

Speaker

Speaker
Kevin Lu


Speakers
avatar for Kevin Lu

Kevin Lu

CTO, Taimei Technology, United States
Kevin Yiming Lu is Chief Technology Officer at Taimei Technology. Since joined Taimei in 2018, Kevin led the R&D effort of TrialOS, the digital platform of life science, and is responsible for Taimei's global technical strategy. Kevin has extensive experience in database, cloud computing... Read More →
avatar for Shou Yuan

Shou Yuan

Director, Global Solutions, Taimei Technology Inc., United States
Shou leads customer success efforts at Taimei Technology, fostering enduring relationships with CROs and Sponsors to align with their needs. He oversees global customer success and consulting teams, ensuring top-tier service delivery. Shou spearheads strategic planning and product... Read More →
Monday June 16, 2025 1:35pm - 2:05pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session
 
Tuesday, June 17
 

9:45am EDT

Aris Global Innovation Theater: Successful Implementation of Gen AI in Pharma - Strategy, ROI, and Cultural Transformation
Tuesday June 17, 2025 9:45am - 10:15am EDT
TBD
Component Type: Session

Global pharma companies are successfully implementing Gen AI across safety and regulatory workflows, driving efficiency and measurable ROI. Emmanuel “Manny” Belabe, Global Head of Operational Excellence at ArisGlobal, will discuss key strategies for implementation success, overcoming cultural challenges, and ensuring adoption.

Speaker

Speaker
Emmanuel Belabe


Speakers
avatar for Emmanuel Belabe

Emmanuel Belabe

Senior Global Head, Operational Excellence, ArisGlobal, United States
Emmanuel Belabe, better known as “Manny”, has worked within ArisGlobal in a number of different roles over his 15 years with the company. During that time, he developed an approach that sought to educate clients on best practices for leveraging ArisGlobal products, while advocating... Read More →
Tuesday June 17, 2025 9:45am - 10:15am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

9:45am EDT

Clario Innovation Theater: Striking the Balance - Integrating Patient-Friendly Solutions Without Compromising Quality Science
Tuesday June 17, 2025 9:45am - 10:15am EDT
TBD
Component Type: Session

There is a critical balance to be struck, ensuring that study designs and digital endpoint solutions are not overburdensome to participants, but are still sufficiently robust to generate the quality data required to determine drug efficacy, safety, and impact to quality of life. In this engaging panel, we’ll review why maintaining patient focus is essential for success in today’s clinical studies, and how to do so successfully while maintaining the scientific rigor needed to achieve study goals.

Speaker

Speaker
Todd Rudo, MD

Speaker
Jay Ferro, MBA

Speaker
Kelly Dumais, PhD

Speaker
Stacy Hurt, MBA, MHA


Speakers
avatar for Kelly Dumais

Kelly Dumais

Director, eCOA Science and Consulting, Clario, United States
Dr. Kelly Dumais is a scientist with over 13 years of experience in behavioral and life science research. She has expertise in the implementation of electronic clinical outcome assessments (eCOA) and the development and validation of patient-reported outcomes (PROs) to support labeling... Read More →
avatar for Jay Ferro

Jay Ferro

Chief Information, Technology and Product Officer, Clario, United States
Always striving for excellence, Jay heads up Clario’s development, information technology and strategic sourcing initiatives. With over 25 years’ experience of working as a global technology leader, Jay has a wealth of knowledge which helps drive changes that are critical to managing... Read More →
avatar for Stacy Hurt, MBA, MHA

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel , United States
Stacy is a globally recognized advocate in patient communities, ensuring patients/caregivers voice their experience & feedback at early stages to improve drug development. She promotes clinical research accessibility for people with disabilities, for equal access to better treatments... Read More →
avatar for Todd Rudo

Todd Rudo

EVP & Chief Medical Officer, Clario, United States
Dr. Todd Rudo provides medical and scientific leadership across Clario. He has nearly 20 years of clinical cardiology & pharmaceutical research experience, with a career predominantly focused on drug safety. Dr. Rudo has board certifications in cardiology, cardiac electrophysiology... Read More →
Tuesday June 17, 2025 9:45am - 10:15am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

9:45am EDT

IQVIA Innovation Theater: The Future is Now - Transforming Regulatory Processes through AI, ML, NLP, and RPAs
Tuesday June 17, 2025 9:45am - 10:15am EDT
TBD
Component Type: Session

In today's rapidly evolving regulatory landscape, AI/ML, NLP, & RPA are revolutionizing regulatory activities in the biopharma industry. Discover how these advanced technologies are transforming regulatory workflows, enhancing efficiency, and ensuring compliance. Attendees will learn about leveraging AI and ML for proactive regulatory intelligence, informed decision-making, dynamic task management, knowledge institutionalization, resource optimization, and real-time compliance monitoring.

Speaker

Speaker
Michelle Gyzen


Speakers
avatar for Michelle Gyzen

Michelle Gyzen

Sr. Director, Strategic Solutions - Regulatory Affairs & Drug Development, IQVIA, United States
Michelle has over 20 years of experience in pharmaceuticals, biotech, and medical devices. A senior director with expertise in designing large-scale regulatory outsourcing programs, offshore resource modeling, and regulatory tech integration and automation. In her current role, Michelle... Read More →
Tuesday June 17, 2025 9:45am - 10:15am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

11:45am EDT

Arnold Ventures Innovation Theater: Biosimilars Today - Who is Winning the Global Race?
Tuesday June 17, 2025 11:45am - 12:15pm EDT
TBD
Component Type: Session

The global biosimilars market is growing rapidly. Today, there are over 50 biosimilars approved in the U.S. and over 120 biosimilars approved in Europe. However, only about 10% of the over 100 biologics expected to lose market exclusivity in the next decade have a biosimilar currently under development. This session will examine the different landscapes of biosimilar regulation and uptake in the global market today, focusing on a comparative analysis between the Europe and the United States.

Speaker

Speaker
Mariana Socal, MD, PhD, MS

Speaker
Gillian Woollett, PhD, MA


Speakers
avatar for Mariana Socal

Mariana Socal

Associate Professor, Johns Hopkins Bloomberg School of Public Health, United States
Dr. Socal is an associate professor at the Johns Hopkins Bloomberg School of Public Health. Prof. Socal researches ways to improve access and affordability of prescription drugs, including generics and biosimilars, gene therapies, insulins, and the global pharmaceutical supply chain... Read More →
avatar for Gillian Woollett

Gillian Woollett

Vice President, Head Regulatory Strategy and Policy, Samsung Bioepis, United States
Dr. Gillian Woollett joined Samsung Bioepis in November 2021 as VP, Head Regulatory Strategy and Policy, US (SBUS), to stand up a U.S. presence for science-based regulatory strategy and policy in the leading global market for biologics. Previously, she was SVP and Principal Regulatory... Read More →
Tuesday June 17, 2025 11:45am - 12:15pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

12:25pm EDT

Lilly Innovation Theater: Modernizing Clinical Trials through Digital Health Technologies
Tuesday June 17, 2025 12:25pm - 12:55pm EDT
TBD
Component Type: Session

Join Lilly for a hands-on presentation on the impact of digital health technologies (DHTs) in clinical trials. Discover how DHTs enhance patient experiences and increase access through an in-person demonstrations of the tools. During this presentation, Lilly will introduce DHT Templates, developed by BIO membership, designed to standardize the inclusion of DHT data within product submissions and provide a predictable approach to regulatory review.

Chair

Lauren Tobe, JD

Speakers
LT

Lauren Tobe

Director, Regulatory Policy and Strategy, Eli Lilly and Company, United States
Lauren Tobe serves as the Director of Regulatory Policy at Eli Lilly and Company where she focuses on advancing digital health technologies, artificial intelligence, and medical devices. Her role involves collaborating with industry leaders, regulators and other important stakeholders... Read More →
Tuesday June 17, 2025 12:25pm - 12:55pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

1:05pm EDT

Syneos Health Innovation Theater: From Pilot to Powerhouse - Scaling AI for Life Sciences
Tuesday June 17, 2025 1:05pm - 1:35pm EDT
TBD
Component Type: Session

2025 is the year to scale AI—but only a fraction of pilots make it to production. Discover why, where to invest now, and how to align emerging tech with real business needs. Hear real-world use cases in protocol optimization and clinical trial monitoring and discover how to align tech with true business needs. If you're ready to turn AI ambition into enterprise value, this session is a must-attend.

Speaker

Speaker
Rachel Belani-Barker

Speaker
Georgia Lytra

Speaker
Dyke Simpson


Speakers
avatar for Rachel Belani-Barker

Rachel Belani-Barker

Managing Director, Syneos Health Consulting, United States
avatar for Georgia Lytra

Georgia Lytra

Engagement Manager, R&D Advisory, Syneos Health , United States
avatar for Dyke Simpson

Dyke Simpson

Executive Managing Director and Lead, Data, AI & Analytics Services Practice, Syneos Health , United States
Tuesday June 17, 2025 1:05pm - 1:35pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

3:00pm EDT

Certera Innovation Theater: Generative AI Beyond the CSR - Automating the Submission Dossier
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
TBD
Component Type: Session

Generative AI adoption within the regulatory writing field has made tremendous progress over the last year. However, to maximize ROI, teams need to identify ways to expand automation beyond traditional benchmarks and clinical study report (CSR) applications. In this session Certara will share practical approaches for leveraging generative AI across the submission dossier from pre-clinical module 3 documents to PK study reports to PBRERs and more.

Speaker

Speaker
Nick Brown

Speaker
David Meats, II


Speakers
avatar for Nick Brown

Nick Brown

Director, Global Portfolio Leader, Certara.AI, Certara, United States
Nick Brown is Director, Global Portfolio Leader for Certara.AI; the life sciences-specialized GPT platform. Nick has over 10 years of experience driving AI adoption and customer success across life sciences, federal government and other industries. Prior to Certara, Nick led marketing... Read More →
avatar for David Meats

David Meats

Director, Regulatory Services & Medical Affairs Management, Certara, United States
Mr. Meats is a medical writing director with a diverse therapeutic area background that includes diabetes, oncology, immune-oncology, women’s health, musculoskeletal, and cardiac, with minor experience in other areas. He has extensive experience in all types of medical writing and... Read More →
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

3:00pm EDT

Milliman IntelliScript Innovation Theater: What are you Missing in Recruitment and Enrollment?
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
TBD
Component Type: Session

Current (pre-)screening methods are slow and expensive… but did you know that they also miss critical information? IntelliScript’s studies show that ineligible participants are randomizing into trials in shocking numbers. Irix® can fill the information gap and speed up enrollment by retrieving and interpreting health data on trial participants in a matter of seconds. Just collect a HIPAA authorization to access our proprietary, nationwide data and make better, faster eligibility decisions.

Speaker

Speaker
Alyssa Vincze


Speakers
avatar for Alyssa Vincze

Alyssa Vincze

Principal and Director, R&D, Milliman IntelliScript , United States
Alyssa is an actuary serving as Principal and Director of R&D at Milliman IntelliScript, a company with a long history of disruptive innovation in the life and health insurance sectors. She leads new product development and recently launched Irix®, a trial eligibility tool that leverages... Read More →
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session

3:00pm EDT

Weave Bio Innovation Theater: Advancing the Regulatory Lifecycle - Evolution of the Weave Platform
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
TBD
Component Type: Session

Clinical submissions demand extensive documentation, making manual processes slow and error-prone. AutoCT automates workflows for CSRs, protocols, and safety reports, reducing turnaround time, improving data quality, and enabling teams to focus on strategy. Learn about: AI-driven templates for rapid submission creation. Automated checks to reduce errors. Two-click data traceability. AI-assisted tools keep users in control. Join us for a live demo of AutoCT’s end-to-end workflow.

Speaker

Speaker
Brandon Rice


Speakers
avatar for Brandon Rice

Brandon Rice

CPO, Weave Bio, United States
Brandon leads Product at Weave, overseeing the development of AutoIND, an AI-powered platform streamlining IND preparation. His work focuses on building products that impact lives, deliver value, and enhance user experience. With a background in life science startups, he has worked... Read More →
Tuesday June 17, 2025 3:00pm - 3:30pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session
 
Wednesday, June 18
 

9:45am EDT

IQVIA Innovation Theater: Harnessing the Power of Artificial Intelligence in Medical Affairs - Driving Efficiencies and Preserving Trustworthiness
Wednesday June 18, 2025 9:45am - 10:15am EDT
TBD
Component Type: Session

The transformative potential for artificial intelligence (AI) in medical affairs is vast, accelerating insight and evidence generation from diverse real world data sources at unprecedented speed and scale. In this session we will explore the broad applicability of AI solutions - from chart and scientific literature review to strategic decision support, competitive landscaping and beyond - while emphasizing the crucial importance of expert validation and privacy for trust and compliance.

Speaker

Speaker
Niamh Catherine McGuinness, PhD


Speakers
avatar for Niamh McGuinness

Niamh McGuinness

Director of Pharma Solutions, Applied AI Science Team, IQVIA, United States
Niamh McGuinness is Director of Pharma Solutions with the Applied AI Science Team in IQVIA. Niamh leads a diverse group of experts who build AI solutions and utilize a suite of award-winning technology to help pharma customers protect participant privacy and surface critical insights... Read More →
Wednesday June 18, 2025 9:45am - 10:15am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  18: InnovationTheaters, Session
 
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  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials-Ops
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Impact-Product-Dev
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