7:30 – 8:30
Breakfast | Testimonials | Headshots
8:30 – 8:40
Sheila Rocchio, CMO
Welcome & Opening Remarks
8:40 – 9:00
William Feehery, CEO
The Certara Way of Increasing Success in Drug Development
For the last 15 years, Certara has been leading the biosimulation revolution in medicine development. Discover how modeling combined with data, advanced scientific knowledge, and AI work together to power breakthrough medicines and increase the certainty of success throughout the drug development lifecycle.
9:00 – 10:00
Max Kanevsky, Piet van der Graaf, Patrick Smith, Christopher Bouton
Next Generation Model-Informed Drug Development: Moving with Certainty from molecule to market
Learn how Certara’s solutions are connecting biosimulation, data, analytics, and drug development expertise together to improve R&D productivity by reducing silos and optimizing resources across. This session will discuss:
- How the next generation of biosimulation applications are evolving
- The Certara Cloud Platform connects data across phases to accelerate approvals
- The role of AI in advancing biosimulation and decreasing time to submission
Speakers:
Max Kanevsky, MS, Chief Technology Officer, Certara
Piet van der Graaf, PharmD, PhD, Senior Vice President, Quantitative Systems Pharmacology
Patrick F. Smith, PharmD, President, Drug Development Solutions, Certara
Chris Bouton, PhD, Senior Vice President & Head of AI, Certara
10:00 – 11:00
Dr. Scott Gottlieb and William Feehery
Keynote Session: Fireside chat
Hear firsthand the perspectives of Dr. Scott Gottlieb who served as the 23rd commissioner of FDA and is a renowned expert on drug development, regulatory policy, and public health in this special fireside chat session with Certara’s CEO Bill Feehery. They will discuss how drug developers can more effectively collaborate with regulators to improve development productivity and the approval of important new medicines across the adoption of key technologies both by industry. They will also discuss the frameworks needed for fully leveraging biosimulation across drug development, impact, opportunities and challenges that AI presents to regulatory and drug development leaders. Don’t miss this chance to learn how regulators can more effectively collaborate to improve development productivity and the approval of important new medicines.
Speakers:
Dr. Scott Gottlieb, Former FDA Commissioner
William Feehery, PhD, Certara CEO
11:00 – 11:15
Networking Break and Demo Bar Sessions
Simcyp™ Simulator Demo
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.
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
Role of quantitative approaches across the drug development continuum
This session will focus on the role modeling and simulation plays throughout drug development from “molecule to market” including how it impacts regulatory decisions. Our panelists will share use cases that will help think about enabling decision making.
Facilitators:
Dr. Karen Rowland Yeo, SVP, Client and Regulatory Strategy, Certara
Rik de Greef, MSc, Senior Vice President, Global Quantitative Sciences Services, Certara Drug Development Solutions
Dr. Fran Brown, Senior Vice President, Drug Development Science, Certara Drug Development Solutions
Panelists:
Alison Betts, PhD, Global Head of DMPK & Modeling, Takeda
Tarek A. Leil, PhD, Head, QSP, Data Science, and Specialty Medicine Clinical Pharmacology at Daiichi Sankyo, Inc.
Dr. Matthew Rizk, Executive Director, Merck & Co., ASCPT 2024-2025 President-Elect
Ananth Kadambi, PhD, Vice President of Real World Evidence & Modeling Solutions, Certara
Dr. Larry Lesko, Clinical Professor & Director, Center for Pharmacometrics & Systems Pharmacology University of Florida College of Pharmacy
Track 2: End to End Clinical Data Flow Automation
Location: The Pavilion Hub
11:15am to 11:45am: Customer Spotlight - "How Can I Put This? - Using a pre-defined spreadsheet to explain your Pinnacle 21 Enterprise Issues"
Pinnacle 21 Enterprise (P21E) compliance issues are common in clinical studies, and even if using alternative compliance tools, regulatory agencies will likely utilize P21E in their review process, necessitating explanations for any unresolved issues. Providing these explanations, as outlined in reviewer guides and regulatory expectations, can be challenging due to the need for concise, appropriate, and transparent wording. To address this, Lilly has implemented a unique approach using a pre-defined spreadsheet containing fix tips and suggested wording for common P21E issues. This approach streamlines the issue-resolution process, improves quality and speed, and ensures consistency in explanations, although adjustments may be needed in specific situations. The presentation discusses the rationale behind the spreadsheet, its development, maintenance, and guidance for handling issues not covered by the provided explanations.
Mike Lozano, MBA, Associate Director - Data Standards, Eli Lilly and Company
11:45am to 12:30pm: Customer Spotlight - "Bringing Data Management Inside – Collaboration of DM and Programming Through Direct Data Review"
The integration of Pinnacle 21 Enterprise (P21E) into the collaboration between Statistical Programming and Data Management teams has yielded significant value since the concept was first proposed in 2021. This presentation will delve into the operational and procedural advantages of Data Management's engagement in P21E (i.e. Direct Data Review), highlighting features such as custom Fix Tips, issue assignment, and their contributions to issue explanations necessary for regulatory submissions. Christine will highlight key process flows, the role of P21E in data optimization, and the strategic planning involved in the P21 validation cycle.
Christine Rossin, MBA, Sr. Director, Electronic Submissions, Pfizer
Track 3: Regulatory Sciences Strategy, Automation & Insights
Location: The Broad Hub
11:15-11:45: Gen AI in regulatory writing and submissions
Speaker: Heather Graham, MSc, Vice President - Regulatory Writing & Scientific Publications, Certara
11:45-12:30: Using Natural Language Processing for Transparency & Disclosure and Redaction
Collaboration is key to striking the right balance of data utility, participant anonymity, and business confidentiality in a product dossier. Discover how Certara helps clients meet transparency and disclosure requirements for Health Canada Public Release of Clinical Information (PRCI) and EMA Policy 0070 submissions.
Speaker: Evan Richardson, Senior Director, Transparency and Disclosure, Certara
12:30 – 1:30
12:45 Lunch and Learn with Clint Rosenfeld and Fred Mahakian | The Broad Hub
Lunch | Testimonials | Headshots
Hear how visionary leadership and the right technology organized workflow among the pharmacometric team at Charles River Laboratories.
Speakers:
Clint Rosenfeld, Global Head of Pharmacokinetics, Charles River Laboratories
Fred Mahakian, Senior Director of Product, Certara
1:30 – 2:15
Dan Hartman, Sandra Visser, Dave Mitchell, Thomas Peppard
Drug Development as a team sport: Designing more informative clinical trials
An informative trial is designed to have the best chance to complete on time, answer its research questions definitively, and effect policy change or a go/no-go decision. Using data from recent research, this session will discuss the areas of greatest opportunity to impact the success of clinical trials and the value of an integrated drug development team approach.
Speakers:
Dr. Dan Hartman, Director, Integrated Development, Gates Foundation
Sandra Visser, PhD, Vice President, Precision Medicine, GlaxoSmithKline
Dave Mitchell, PhD, Senior Vice President, Certara
Thomas Peppard, MS, Senior Director, Biostatistics, Certara
2:15 – 3:00
Demetrius Carter & Chris Bouton
Generative AI for Regulatory Submissions and Medical Writing
Generative AI has the ability to streamline document production and improve drug development timelines for regulatory writing deliverables.
Learn how regulatory and medical writing experts at Certara are utilizing CoAuthor powered by Certara.AI to create a next generation solution for AI-enabled medical writing.
New capabilities will be revealed at this session.
Speakers:
Demetrius Carter, MBA, Senior Vice President, Regulatory Services
Chris Bouton, PhD, Senior Vice President & Head of AI, Certara
3:00 – 3:30
Networking break and Demo Bar Sessions
Certara Biometrics Services
This demo session will highlight our Biometrics practice area including what makes Certara unique and examples of client projects
Explore Certara’s Drug Interaction Database (DIDB®)
An introduction to DIDB use cases and value, the Human in vitro Drug Metabolism Dataset, and the Clinical Drug Interaction Dataset.
Simcyp™ Biopharmaceutics
Experience Simcyp Biopharmaceutics, an integral part of our Simcyp suite, offering advanced model-informed formulation development capabilities. Explore user-friendly formulation design and comprehensive virtual bioequivalence trial setup, with expert support available for all technical inquiries.
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.
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.
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
Integrated Approaches to Support the Due Diligence Process
This session will share what approaches are being utilized to support due diligence efforts for investors evaluating programs in both discovery and clinical phases. Panelists will discuss the type of evidence required to trigger funding for the next critical decision point along with types of studies and methods that can be employed as part of diligence efforts within time and funding constraints.
Facilitator: Dr. John Burke, Co-Founder and the President and CEO of Applied BioMath
Panelists:
Dr. Fran Brown, Senior Vice President, Certara Drug Development Solutions
Dr. Devin Rosenthal, Vice President & Head of Due Diligence, NovaQuest Capital Management
Dr. Karen Hong, Co-Founder and Co-Owner, Cold Spring Bio
Dr. David de Graaf, CEO, Reverb Therapeutics
Track 2: End to End Clinical Data Flow Automation
Location: The Pavilion Hub
Customer Spotlight - "Boost Biostatistical Capabilities with the ryze Study Data Tabulation Model (SDTM) Engine"
The evolution of Data Sciences will continue to rely on gains in data standardization, efficiency, accuracy, and compliance. In this discussion, Branden will share the Catalyst vision to utilize the innovations and opportunities enabled by the ryze SDTM engine to automate and enhance the support and delivery of biostatistical analysis. The opportunities include:
- Standardizing CRF design
- API-driven data pulls
- Data visualization
- SAS validation and finalization of SDTM datasets
- CDISC compliance through ryze
- Efficiency gains expected in SDTM production
- Super user collaboration on standards and SDTM mapping through ryze
Attendees will gain an understanding of the flow of data from raw retrieval to biostatistical summaries and recognize the potential efficiencies this process affords.
Speaker: Brandy Boe, Senior Statistical Programmer Catalyst Clinical Research
Track 3: Regulatory Sciences Strategy, Automation & Insights
Location: The Broad Hub
Tackling Big Submissions: When to Start, Who to Involve, How to Accelerate
Pharmaceutical companies are facing ever-increasing pressure to deliver new drugs to market faster. This pressure is most intense on the final steps leading to marketing submissions. This session will share how expectations are evolving, strategies for reducing time to submission, and common pitfalls. Panelists will discuss from personal experience what’s realistic and how to handle team and organizational pressures.
Speakers:
Steve Sibley, MS, Vice President, Global Submissions and Submission Leadership, Certara
Bob Stumpo, Senior Director, Head of Medical Writing, CSL Behring
4:15 – 5:00
Amin Rostami
Reflections on 20 years of trail blazing, change agent and leader in Drug Development
Explore the transition of modeling and simulations from an academic nicety to an industrial necessity and a regulatory requirement with Amin Rostami, SVP R&D and CSO at Certara. Gain insights into the conduct of virtual clinical studies, the reusability of models, determinants of success in drug development, and the implications for future regulatory submissions, while exploring some cutting-edge scientific advancements.
Speaker:
Amin Rostami, PhD, FCP, FAAPS, FJSSX, FBPS, Senior Vice President R&D and CSO, Certara
5:30 – 10:00