REASONS TO CONVENE
Dive deep into your core product
Find your tribe and learn directly from product owners during Tuesday’s user group meetings.
Discover new solutions
See how other customers have moved with certainty through development with “new to you” solutions on Wednesday and Thursday.
See the future
Where is biosimulation headed next? Will we ever automate our way to full data standardization? Find out from thought leaders inside and outside of Certara.
Celebrate the present
How do you improve on three engaging days with fellow innovators? By adding one unforgettable night. Stay tuned for details on Wednesday night’s social event.
AI in Drug Development
Can GPTs speed compound identification? Where is biosimulation headed next? What's new in regulatory submissions? Find out from thought leaders inside and outside of Certara.
May 14: Phoenix User Group Meeting or Real World Applications of PBPK Workshop
May 15-16: Track 1: The Business Application of Modeling and Biosimulation in Drug Development
May 14: GenAI's Impact on Regulatory Writing Roud Table
May 15-16: Track 3: Regulatory Sciences Strategy, Automation & Insights
May 14: Pinnacle Live
May 15-16: Track 2: End to End Clinical Data Flow Automation
our schedule
Customers using Phoenix™, Pinnacle 21 / Formedix, or Simcyp™ are invited to join us on Tuesday for product-specific sessions.
Pinnacle Live
Phoenix UGM
PBPK Real World Applications Workshop
GenAI's Impact on Regulatory Writing
9:15
Welcome
10:00
Product Overview, Vision, and Roadmap
CTO Max Kanevsky and product leaders present on the end-to-end platform, covering study build through TFLs and submission, including integration with Certara Cloud.
Regulatory Update
FDA and PMDA experts Michael Beers and Seiko Yamazaki present on implications of the latest changes from Health Authorities, including best practices for optimizing study data for global multi-agency submissions, with tips for emerging agencies NMPA, EMA, MFDS.
Break
Metadata Repository Exploration
Product leaders Erin Erginer and Darren Bill provide their first-hand experience of how integrated form design and study build truncates timelines toward SDTM via options for full automation for metadata-driven SAS programming.
12:00
Customer Spotlight - Using ryze for study automation, from start to finish
12:30
Feedback session breakouts
Pick your booth. Visit our live support desk for troubleshooting bugs and/or our product design usability testing to improve the user experience of our next release.
1:00
Networking Lunch
Enjoy a meal while engaging with industry peers and representatives from Certara.
1:45
Integrations: P21E, Formedix ryze, Certara Cloud
Head of Certara Cloud, Phillip Johnston, presents how Certara’s increasingly unified platform simplifies user and asset management, and allows cross-study and cross-product insights to emerge.
2:15
Expert Discussion Panel
Try to stump our product SME and engineering experts with your most challenging edge cases, standardization ambiguities, techniques for process change.
3:00
Customer Spotlight - An Approach to SDTM and ADaM Programming
3:15
Break
4:00
Stack Rank Your Pain Points
Add to our pre-event survey of client requests, discuss in small groups with our experts which problems’ solutions would have the highest ROI for your organization and the industry.
4:45
From Forms to SDTM: Acceleration Approaches
5:00
Closing Remarks and Survey
9:15
Welcome
10:00
Product Overview, Vision, and Roadmap
Customer Spotlight - Phoenix Hosted
Break
Customer Spotlight - Integral
Jocelyn Webb, Associate Director, Global Pharmacokinetics, Charles River Laboratories
11:30
Phoenix Cloud Sneak Preview
MODERN TOOLS FOR PopPK
Intro to User Feedback Session
1:00
Networking Lunch
2:30
User Feedback Session - Discussion of Key Challenges
3:00
User Feedback Session - Summarize and Vote
3:15
Break
4:45
Masterclass on Phoenix Templates
5:00
Closing Remarks and Survey
9:00
Interactive Usability Study (concurrent with Welcome Reception, stop by!)
PBPK Real World Applications Workshop: Special Populations
From real world cases studies, learn how Simcyp PBPK can be used to predict PK in special populations.
Facilitators:
Dr. Karen Rowland Yeo, SVP, Client and Regulatory Strategy, Certara
Dr. Hannah Jones, SVP, PBPK Consultancy Services, Certara
Dr. Iain Garder, VP, Head of Translational DMPK Services, Certara
Presenters:
- Analyzing Drug Transfer into Semen: Leveraging Simcyp Lactation Module for Safety Assessment Caroline Sychterz, Associate Director CP&P-QSP&PBPK, Bristol Myers Squibb
- Physiologically Based Pharmacokinetic Modeling and Simulation to Inform the Dose of Asciminib in Pediatric Patients with Chronic Myeloid Leukemia in Chronic Phase Heidi J. Einolf, Ph.D., Executive Director, PK SCIENCES / Translational Medicine, Novartis Pharmaceuticals Corporation
PBPK Real World Applications Workshop: Biopharmaceutics
From real world cases studies, learn how PBPK can be used to address biopharmaceutics questions.
Facilitator:
Dr. Nikunjkumar Patel, Sr. Director PBPK Consultancy, Certara
Presenters:
- Leveraging Simcyp VBE for Food Effect Biowaiver: BMS Experience Gaohua Lu, Ph.D., Senior Director, Head of PBPK Bristol Myers Squibb
Optimal Use of PBPK Modeling During Early Development of Oncology Candidates Balaji Agoram, Vice President, Head of Clinical Pharmacology and pharmacometrics, Arcus Biosciences
Physiologically Based Pharmacokinetic Modeling to Evaluate the Gastric Acid Modifier Effect on Rimegepant Exposure Richard Bertz, SVP, Clinical Pharmacology & Pharmacometrics, Biohaven
Panelists:
PBPK Real World Applications Workshop: DDI featuring Simcyp and The Drug Interaction Database (DIDB)
From real world cases studies, learn how Simcyp PBPK and The Drug Interaction Database (DIDB) can be used to predict DDI.
Facilitators:
Dr. Karen Rowland Yeo, SVP, Client and Regulatory Strategy, Certara
Dr. Hannah Jones, SVP, PBPK Consultancy Services, Certara
Dr. Iain Garder, VP, Head of Translational DMPK Services, Certara
Presenters:
- Assessing DDI Liability of Oncology Drugs Using PBPK Modeling Amitava Mitra, PhD, FAAPS, Executive Director, Clinical Pharmacology, Kura Oncology, Inc.
- High Impact Application of a Continuous LEARN, CONFIRM and INFORM – PBPK Modeling Strategy for Evaluation of DDIs in a Disease Population Jennypher Mudunuru, PH.D, DMPK Modeling. Research Technologies, GSK, USA
- PBPK Applications in DDI Evaluation for Drugs Approved by the FDA in 2023 Dr. Jingjing Yu, Associate Director, Drug Interactions Solutions, Certara
Gen AI’s impact On Regulatory Writing
Hear the impact of generative AI on medical writing. Our panelists, Demetrius Carter and Heather Graham, will discuss the different approaches across people, process and technology, share thoughts around concerns across compliance implications and highlight and upskilling.
Facilitators:
Demetrius Carter, Senior Vice President, Regulatory Services, Certara
Heather Graham, Vice President, Regulatory Writing and Scientific Publications, Certara
Breakfast
Welcome & Opening Remarks
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.
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
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, Certara CEO
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
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, 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, Global Head of DMPK & Modeling, Takeda
Tarek A. Leil, 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, 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
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, 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, Sr. Director, Electronic Submissions, Pfizer
Track 3: Regulatory Sciences Strategy, Automation & Insights
11:15-11:45: Gen AI in regulatory writing and submissions
Speaker: Heather Graham, 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
Lunch
Maximum Impact: Effective Use of Generative AI for Drug Development
Generative AI has taken the world by storm. However, there are still concerns about effective use of these tools within life science R&D. In this session, Dr. Ravi Pathak and Nick Brown will explore key considerations needed for leveraging generative AI and specialized use cases that are making an impact today.
Speakers:
Dr. Ravi Pathak, Director and Head (LSD), US Medical Affairs at Takeda Pharmaceuticals
Nick Brown, Certara.AI Global Portfolio Leader
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, Senior Director, Biostatistics, Certara
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, Senior Vice President, Regulatory Services
Chris Bouton, Senior Vice President & Head of AI, Certara
Networking break
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
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
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: Branden Boe, Senior Statistical Programmer Catalyst Clinical Research
Track 3: Regulatory Sciences Strategy, Automation & Insights
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, Vice President, Global Submissions and Submission Leadership, Certara
Bob Stumpo, Senior Director, Head of Medical Writing, CSL Behring
Reflections on 20 years of trail blazing, change agent and leader in Drug Development
CERTARA 15 YEAR ANNIVERSARY & CLIENT APPRECIATION CELEBRATORY EVENT
Breakfast
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, Senior Director, Certara
Amy Porter, Associate Principal Medical Writer, Certara
Richard Bertz SVP, Clinical Pharmacology & Pharmacometrics, Biohaven
Greg Peterman, Patient Advocate
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
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, Vice President, Pharmacometrics, Certara
Panelists:
Dinesh de Alwis, Sr. Vice President, Clinical Development, Generate Biomedicines
Lisa Hendricks, VP Global Head Pharmacometrics, Novartis Biomedicine
John Davis, Vice President and head of Clinical Pharmacology at Regeneron Pharmaceuticals
Break & networking
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
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, Senior Vice President, and Head of QSP
Mirjam Trame, Vice President, Certara Drug Development Solutions
Panelists:
Balaji Agoram, Vice President, Head of Clinical Pharmacology and pharmacometrics, Arcus Biosciences
Jin Jin, 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, Head of PRD Clinical Pharmacology, Pfizer
Weifeng Tang, M.D., Ph.D., Executive Director, Head of CPQP Vaccines and Immune (V&I) Therapies and Neuroscience, Clinical Pharmacology and Quantitative Pharmacology (CPQP), AstraZeneca
Track 2: End to End Clinical Data Flow Automation
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, 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
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, Senior Director, Global Submissions and Plain Language Summary Lead, Certara
Lee Holland, 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
Lunch
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
Tales from trenches: Different approaches to the digital transformation journey
Panelists will share lessons learned while modernizing R&D to improve productivity and how partnering with Certara supported their key goals, initiatives and outcomes.