7:30 – 8:30
Breakfast | Headshots
8:30 – 9:15
Richard Bertz, Greg Peterman, Raj Bhardwaj, Amy Porter
Medicines that Matter
During this session we follow the drug development journey to its ultimate destination, the patient. We bring together different perspectives from the Biohaven Nurtec® ODT development process including the impact and quality of life benefits of the therapy from patient advocate Greg Peterman.
Speakers:
Raj Bhardwaj, PhD, Senior Director, Certara
Amy Porter, PhD, Associate Principal Medical Writer, Certara
Richard Bertz, PhD, SVP, Clinical Pharmacology & Pharmacometrics, Biohaven
Greg Peterman, Patient Advocate
9:15 – 10:00
Klaus Romero
KEYNOTE SESSION: The Regulatory Scientist Perspective on MIDD
As quantitative methods become a standard part of regulatory review and submission, the expectations and insights that modeling brings to regulatory scientists continues to evolve. This session will cover the following topics using examples and case studies from collaborations across the industry.
- What do regulatory scientists most care about when it comes to quantitative models
- What critical questions must models answer, what further questions do they present?
Speaker:
Dr. Klaus Romero, Chief Executive Officer and Chief Science Officer, Critical Path Institute
10:00 – 10:45
Dinesh de Alwis, Lisa Hendricks, John Davis
Success Stories Using MIDD to Accelerate Drug Development across Phases
This session features industry leader discussing their approaches to MIDD across therapeutic areas, phases and indications. Learn how different organizations working with a variety of patient populations and indications are maximizing the value and insights of MIDD across the development continuum.
Moderated by:
Dr. Karen Rowland Yeo, SVP, Client and Regulatory Strategy, Certara
Mirjam Trame, PharmD, PhD, VP, Certara Drug Development Solutions, Head of Pharmacometrics USA – Division II
Panelists:
Dinesh de Alwis, PhD, Sr. Vice President, Clinical Development, Generate Biomedicines
Lisa Hendricks, VP Global Head Pharmacometrics, Novartis Biomedicine
John Davis, PhD, Vice President and head of Clinical Pharmacology at Regeneron Pharmaceuticals
10:45 – 11:15
Networking break and Demo Bar Sessions
Applied BioMath Assess™
Discover the impact of Applied BioMath Assess firsthand! Join our demo to explore how Assess facilitates precise dose predictions, experiment prioritization, study design optimization, and early-stage confidence building in R&D.
Simcyp™ Simulator
Join us for an insightful demo on Simcyp’s pivotal role in drug development! Discover real-world applications through compelling case studies, explore our platform offerings including the PBPK Simulator, and delve into the regulatory impact of PBPK modeling.
Certara’s Centers of Excellence
Certara’s Centers of Excellences made up of experts and thought leaders, responsible for identifying, developing and disseminating best practices & innovative methodologies, while serving as a beacon of expertise and collaboration across our departments, teams and stakeholders.
Secondary Intelligence™ User Tour (recorded demo)
The Secondary Intelligence platform deciphers off-target interactions of your small-molecule compound across 100+ receptors, offering traffic lights ratings for each interaction based on clinical side effect likelihood. Curated by nonclinical safety experts, our demo provides insightful graphics and auto-generates detailed Word reports, optimizing drug development decisions.
Track 1: Value of MIDD
Track 2: Clinical Data
Track 3: Reg Sciences & Medical Writing
Track 1: The Business Impact of Modeling and Biosimulation in Drug Development
Location: The Forum
How QSP and PMX Complement the Drug Approval Process
Discover the collaborative power of Quantitative Systems Pharmacology (QSP) and Pharmacometrics (PMX) in expediting drug approval.
Facilitators:
Piet van der Graaf, PharmD, PhD, Senior Vice President, and Head of QSP
Mirjam Trame, PharmD, PhD, Vice President, Certara Drug Development Solutions
Panelists:
Balaji Agoram, PhD, Vice President, Head of Clinical Pharmacology and pharmacometrics, Arcus Biosciences
Jin Jin, PhD, Executive Director and Senior Fellow, Global Head of Modeling and Simulation, Clinical Pharmacology, Genentech
Dr. Larry Lesko, Clinical Professor & Director, Center for Pharmacometrics & Systems Pharmacology University of Florida College of Pharmacy
Gianluca Nucci, PhD, Head of PRD Clinical Pharmacology, Pfizer
Track 2: End to End Clinical Data Flow Automation
Location: The Pavilion Hub
Cross-team Collaboration Panel
Unlock the power of collaboration in study data management! From data collection to analysis and regulatory compliance, learn how other organizations are using effective collaboration to drive efficiency, enhance data quality, and accelerate the pace of innovation.
Join us for a panel discussion on cross-team collaboration within the clinical trial study data pipeline. Our panelists will share valuable insights, strategies, and best practices for fostering seamless collaboration – and time savings - across departments and stakeholders involved in the complex process of managing clinical trial data.
Moderator:
Alice Perry, Director of Customer Success, Certara
Panelists:
Lauren Shinaberry, MS, Director of the Clinical Data & Reporting Standards, AbbVie
Prathima Surabhi, Director, Standards Developer, Astra Zeneca
Veerle Coenen, Associate Director, Data Standards Manager, Galapagos
Track 3: Regulatory Sciences Strategy, Automation & Insights
Location: The Broad Hub
11:15-12:00: Plain Language and AI: An overview of the current regulatory landscape and discussion on AI use options
In the past, regulation has had difficulty keeping up with new technology, and AI is no different. We will discuss how generative AI can assist in meeting current plain language regulations, AI’s impact on future regulations, and aspects of plain language that AI currently does not address.
Speakers:
Laura Sheppard, MBA, MA, Senior Director, Global Submissions and Plain Language Summary Lead, Certara
Lee Holland, PharmD, Associate Director, Plain Language Summaries, Certara
12:00-12:45: The Experts Have Spoken: Your Outlook on People, Process, and Technology
Join us to learn what your peers articulated as the most pressing concerns and promising opportunities facing today's regulatory professionals. Your facilitator, Trevor Standish, will present results from focus groups and surveys conducted on Tuesday, focused on the themes of people, processes, and technology. This session will start a conversation that will continue after Certainty. Be a part of it!
Speaker: Trevor Standish, Product Director, Certara
12:45 – 1:45
Lunch | Headshots
1:45 – 2:45
Leif Pedersen, Andrea de Souza, Mark Mintz, Dimitris K. Agrafiotis, Milind Kamkolkar
Current state of digital transformation and the impact to business outcomes
This panel will discuss the current state of digital transformation for the biopharmaceutical industry. What has already taken place, what is currently happening and what must happen to drive positive impact on cost of drug development, shorten the drug development cycle, and the ability to make the right decisions as early as possible.
Moderator: Leif E. Pedersen, President, Chief Commercial Officer, Certara
Panelists:
Andrea de Souza, MBA, Innovative Digital Transformation and Artificial Intelligence (AI) Leader
Mark Mintz, Chief Information Officer, Charles River Laboratories
Dimitris K. Agrafiotis, PhD, Director, Arsenal Capital Partners
Milind Kamkolkar, Co-Founder and Chief Business Officer, Network Bio
Maria Tsiper, PhD, Executive Director, Purdue Office of Industry Partnerships, Purdue University
Anastasia Christianson, PhD, Data Science, AI, and Digital Transformation Senior Executive
2:45
Closing Remarks
3:00 – 4:00
Headshots
3:00 – 4:00