Decisions made long before a compound reaches humans shape everything that follows. Which indication to pursue. Which asset to advance. What dose to start at. How to design the first study.
This three-part series follows that path from end to end, exploring how modeling and simulation supports the decisions that matter most at each stage: discovery-stage feasibility and indication strategy, translational modeling and the work behind an IND, and real-time optimization of First-in-Human studies.
Certara experts address the challenges early development teams face most often, from limited data for go/no-go calls to defending a starting dose to regulators.
Designed for discovery leaders, portfolio and strategy teams, and emerging biotechs building a de-risked path to the clinic.
Explore sessions
Strategy Starts at Discovery: Using QSP to Choose the Right Indication, the Right Asset, and the Right Path to First-in-Human
A promising target is not the same as a viable program. This session demonstrates how Quantitative Systems Pharmacology can be applied at the earliest stages of development to test whether a therapeutic concept warrants investment, covering indication selection, unmet need, mechanism prioritization, research target product profile development, and differentiation, and how these assessments contribute to a strategic roadmap toward First-in-Human.
Attendees will learn how to:
- Apply QSP-enabled feasibility assessment to evaluate indication selection, unmet need, and differentiation potential before committing significant investment.
- Prioritize compounds and mechanisms and shape research target product profiles using mechanistic modeling.
- Identify the knowledge gaps, critical experiments, and milestones needed to help de-risk a program ahead of clinical entry.
演讲嘉宾：
Date & Time
AMER: Tuesday, October 6th, 10:00am-11:00am
EMEA & APAC: 2026 年 10 月 8 日, 星期四 | 4:00 – 5:00pm JST, 9:00 – 10:00am CEST
Confidence Before the First Dose: Translational Modeling, Safety Margins, and a Defensible IND Package
Entering humans requires answering a deceptively simple question: what starting dose, and why? This session covers the EIH-enabling work required ahead of an IND/CTA, including the translational modeling that bridges preclinical safety & pharmacology data to predicted human exposure, calculated safety margins, and selection of a starting dose that is both defensible to regulators and efficient enough to reach a pharmacologically relevant concentration range without unnecessary escalation cohorts.
Attendees will learn how to:
- Translate preclinical data into human exposure predictions and defensible safety margins.
- Select a starting dose that balances participant safety with study efficiency and timeline.
- Use modeling to strengthen IND strategy and anticipate regulatory questions.
Date & Time
October 27th, 4:00 – 5:00pm JST, 9:00 – 10:00am CET and 10:00 – 11:00am EDT
Every Cohort Is a Decision Point: A Model-Informed Approach to First-in-Human Studies
Most First-in-Human studies are run well and still end with questions on a pathway to Phase 2 . The reason is that doses are selected prior to the start of the study on the basis of preclinical data, and adjustments are made on safety and sometimes PK data. This session presents a model-informed approach that designs FIH studies which yield optimal data to support program decisions and the next phase of development, through the use of relevant biomarkers and real time analysis and rapid reporting.
Attendees will learn how to:
- Design FIH studies which support proof of principle and onward development
- Connect dose justification, biomarker strategy, and protocol design into a single model-informed plan.
- Use real-time PK and PK/PD analysis to guide adaptive dose escalation decisions between cohorts.
Date & Time
November 10th, 4:00 – 5:00pm JST, 9:00 – 10:00am CET and 10:00 – 11:00am EST
Kevin Hershberger, BPharm, MBA
Vice President Nonclinical Development Sciences, CertaraKevin 在制药行业拥有 25 年的从业经验，主要从事项目领导工作，提供综合项目管理服务，包括统筹计划、目标产品特征（TPP）、客户财务规划，涉及融资、业务拓展、客户提案及供应商筛选。He has held leadership and management roles at Brighton Biotech, deCODE Genetics, Parke-Davis, Pfizer and Takeda.
Colin Callaghan, RPh, MBA
Senior Director, Program LeadershipColin has 33 years in the pharmaceutical industry primarily in multi-disciplinary drug development leadership roles, including 25 years with early development/early-stage programs.
At Certara, Colin leads numerous programs in Oncology, CNS, Infectious Disease and Global Health therapeutic areas and supports biotech companies with their funding initiatives. Prior to Certara, Colin worked for very large (Pfizer, Wyeth-Ayerst), mid-size (Celldex), and start-up (Kolltan, Iterum, Maxwell BioSciences) pharmaceutical companies as well as consultant firms (Deloitte and Lachman Consultants) in drug development, business operations and process improvement roles. He earned an undergraduate degree in Pharmacy from Rutgers University and an MBA degree from the University of North Carolina – Wilmington.
Marc Presler, PhD
Director, QSPMeet Marc Presler, a member of Certara QSP’s Team! Marc has leveraged deep expertise in fundamental biology and quantitation to support over 70 drug programs. He sees models as powerful tools that help integrate evidence to improve decision-making in drug development.
His contributions have ranged from clinical trial design, first-in-human dose projections, to initial concept design, working with collaborators spanning large pharma to pre-seed biotechs.
Marc is particularly excited about bringing biosimulation insights into the earliest stages of drug discovery. He is currently working on developing the “industrial” capabilities that will allow the analysis of discovery pipelines at scale:
What if biosimulation were used to ensure favorable pharmacology for every new drug concept at the beginning of a program?
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