跳转到主要内容
搜索

Antibody-Drug Conjugate (ADC) Services

Smarter ADC Development Starts Before First-in-Human (FIH) Studies

Consult our ADC Experts

Critical decisions in ADC development are often made with incomplete insight

Antibody drug conjugates (ADCs) are inherently complex therapies composed of multiple interdependent analytes, including intact ADC, total antibody, and payload, each with distinct pharmacokinetic, efficacy, and safety profiles. Balancing targeted payload delivery with narrow therapeutic windows while understanding how payload exposure, disease biology, and systemic toxicities interact is critical for dose selection, clinical strategy, and regulatory confidence.

Certara helps organizations translate ADC complexity into decision grade evidence through integrated translational PK/PD, Physiologically Based Pharmacokinetic (PBPK) modeling, Quantitative Systems Pharmacology (QSP), Population PK (PopPK), exposure response (ER) modeling, and regulatory strategy support across development.

Why ADC development requires integrated MIDD strategies

Unlike monoclonal antibodies or small molecules, ADCs contain multiple interdependent analytes with distinct pharmacokinetic, efficacy, and safety profiles. These complexities can make dose selection, exposure interpretation, and benefit-risk assessment particularly challenging across development.

Multi-analyte complexity

ADCs contain multiple interdependent analytes with distinct pharmacokinetic and toxicity profiles.

Narrow therapeutic windows

Balancing efficacy with payload-driven toxicities requires optimized exposure-response and dose selection strategies.

Translational uncertainty

Disease biology, target expression, and payload properties can alter ADC disposition across patient populations.

Evolving regulatory expectations

Regulatory agencies increasingly expect integrated evidence to support dose optimization and labeling strategies.

How Certara supports ADC programs

Translational strategy & FIH planning

We apply translational PK/PD, PBPK, and QSP approaches to support FIH dose selection, escalation strategy, analyte characterization, tumor delivery assessment, and payload exposure evaluation.

Dose & regimen optimization

We use PopPK, ER modeling, and clinical pharmacology strategies to optimize dose selection, therapeutic windows, expansion strategies, and benefit-risk assessment as clinical data evolve.

Registrational strategy & label justification

We generate submission-ready MIDD evidence packages to support dose justification, labeling strategies, regulatory interactions, and global submission alignment.

From narrow therapeutic windows to defensible dose decisions

ADC development requires balancing efficacy, payload-driven toxicities, analyte complexity, and evolving regulatory expectations, often before complete clinical characterization is available.

Key decisions we help support:

  • FIH dose selection and escalation strategy
  • Interpretation of complex multi-analyte pharmacokinetics
  • Evaluation of on- versus off-target toxicity drivers
  • Dose and regimen optimization across development
  • Regulatory-ready benefit-risk and labeling strategies

Critical questions that define ADC success

ADC development decisions are often made before complete clinical characterization is available. Integrated modeling and simulation approaches can help reduce uncertainty around efficacy, toxicity, exposure relationships, and dose optimization throughout development.

Questions we help answer:

Which analytes are most informative for decision-making?
What FIH dose and escalation strategy best balance efficacy and safety?
How should exposure-response relationships guide dose and regimen optimization?
What factors are driving on-target versus off-target toxicities?
How can integrated evidence strengthen regulatory confidence and labeling strategies?

When to leverage ADC development services

ADC programs often encounter critical inflection points where integrated modeling, simulation, and regulatory strategies can help reduce uncertainty and support more informed development decisions.

药物早期开发

  • FIH dose selection
  • Escalation strategy planning
  • Translational PK/PD assessment
  • PBPK and analyte characterization

Clinical Optimization

  • ER evaluation
  • Therapeutic window characterization
  • Dose and regimen optimization
  • Benefit-risk assessment

Regulatory & Lifecycle Support

  • Labeling strategy support
  • Submission-ready MIDD evidence generation
  • Global regulatory interactions
  • Post-marketing dose optimization strategies

Built for complex ADC development

Our ADC Services are trusted across 80+ oncology assets navigating increasingly complex dose optimization and development requirements.

Certara combines ADC-focused clinical pharmacology, pharmacometrics, mechanistic modeling, and regulatory strategy into one integrated team, helping sponsors move from uncertainty to evidence and from fragmented analyses to cohesive ADC development strategies.

ADC-focused expertise

Deep experience supporting first-in-human dose strategy, exposure-response analysis, PBPK, QSP, and global regulatory submissions for complex ADC programs.

Integrated team

Clinical pharmacology, Pharmacometrics (PMx), PBPK, QSP, and regulatory experts working together as one integrated program team.

Submission-ready evidence

Clear, defensible MIDD strategies designed to support global regulatory interactions, dose justification, and accelerated development timelines.

Global scale and platform strength

Backed by deep modeling expertise, regulatory familiarity, and scientific leadership across complex therapeutic modalities, including ADCs.

Expedited pharmacometrics support for time-sensitive ADC development programs

When timelines compress, our ADC development services deliver high-quality, submission-ready pharmacometrics support for urgent regulatory needs, without compromising scientific rigor.

Support Includes

  • Time-sensitive PMx analyses supporting INDs, NDAs, BLAs, and MAAs
  • ER and PopPK deliverables aligned with regulatory expectations
  • Rapid-response support for health authority questions
  • Extension of internal teams during critical submission windows

认识我们的专家团队

Blaire Osborn, PhD
1 / 11
专家

Blaire Osborn, PhD

Senior Director, Clinical Pharmacology and Translational Medicine

Dr. Osborn has over 25 years of drug development experience in the areas of clinical pharmacology and pharmacokinetics. She has focused primarily oncology and anti-infectives. 在加入 Certara 之前，她是美国 FDA 临床药理学办公室 CDER 癌症药理学部门的评审员，参与 Project Optimus 下多剂量依据递交的评估工作。...
linkedin建立联系
Tong Zhu, PhD, FCP
2 / 11
专家

Tong Zhu, PhD, FCP

VP, Global Head, Clinical Pharmacology & Translational Medicine Certara Drug Development Solutions

Dr. Tong Zhu 拥有超过 25 年专注于转化医学、早期开发及临床药理学的丰富经验，对药物研发领域有着深厚的专业知识。对药物研发领域有着深厚的专业知识。她曾负责领导 Astellas 线粒体生物学重点战略，通过全球合作，帮助识别和开发针对线粒体生物学的创新药物。...
linkedin建立联系
Amandine Manon, PharmD
3 / 11
专家

Amandine Manon, PharmD

Senior Director, Clinical Pharmacology and Translational Medicine

Amandine joined Certara in 2020. She served as a Clinical pharmacologist in several pharmaceutical companies for 15 years. She has a proven track record in preclinical and clinical PK, clinical pharmacology with a special focus on oncology, drug development from early stages to Phase 3, and regulatory experience. Amandine graduated as a PharmD f...
linkedin建立联系
Justin Hay, PhD
4 / 11
专家

Justin Hay, PhD

Senior Director, Clinical Pharmacology Consulting

Dr. Hay joined Certara in 2022 with 25+ years of clinical pharmacology experience having started his career as Senior Clinical Scientist at the Centre for Human Drug Research (CHDR), Leiden. More recently he worked as Senior Pharmacokinetics Assessor and Deputy Unit Manager at the Medicine and Healthcare Products Regulatory Agency (MHRA), UK whe...
linkedin建立联系
Kathryn Brown
5 / 11
专家

Kathryn Brown

Senior Director, iDD

Kathryn 是 Certara 综合药物开发部的临床药理学顾问和团队领导。此外，她还领导复杂生物制剂综合业务领域，专门为客户提供细胞疗法、RNA 技术、基因疗法、融合蛋白、ADC、双特异性抗体等领域的专家支持。...
Florian Chassereau
6 / 11
专家

Florian Chassereau

Director, Clinical Pharmacology, Certara Drug Development Solutions

Florian Chassereau is Director, Clinical Pharmacology at Certara Drug Development Solutions, with over a decade of experience in the pharmaceutical industry. He excels in supervising and managing project teams across various therapeutic areas, focusing on early and late-stage development of small molecules and biologics. His key contributions in...
Mirjam Trame, PharmD, PhD
7 / 11
专家

Mirjam Trame, PharmD, PhD

VP, Certara Drug Development Solutions, Head of Pharmacometrics USA – Division II

Mirjam is an expert in pharmacometrics and oncology drug development, serving as Head of Pharmacometrics USA – Division II at Certara Drug Development Solutions. With expertise spanning complex biologics, she supports exposure-response analysis, dose and study optimization, and regulatory strategy, with a special focus on radiotherapeutics and c...
Adekemi Taylor, PhD
8 / 11
专家

Adekemi Taylor, PhD

VP Regional Lead USA, Division 1, Quantitative Science Services

Adekemi 专注于定量药理学策略与分析（涵盖群体药代动力学、PK/PD、疗效与安全性暴露-效应反应及浓度-QTc 模型构建），以支持监管申报、研究设计与整体药物开发。

Dr. Felix Boakye-Agyeman, MD, PhD
9 / 11
专家

Dr. Felix Boakye-Agyeman, MD, PhD

Vice President, Consulting

Dr. Felix Boakye-Agyeman is Vice President of Pharmacometrics within the Certara Drug Development Services (CDDS) group at Certara, a global leader in model-informed drug development. Certara partners with more than 2,300 organizations worldwide and has contributed over 99% of all new drug approvals in the past decade. At Certara, Dr. Boakye-Agy...
Floris Fauchet, PharmD, PhD
10 / 11
专家

Floris Fauchet, PharmD, PhD

Senior Director, Pharmacometrician & Team Lead, Certara

Floris Fauchet is a Senior Director and Pharmacometrician at Certara, where he leads the Europe/Africa 1 team. A pharmacist by training, he completed his PhD before joining Sanofi, where he spent four years in the oncology group working across both small‑molecule and antibody–drug conjugate (ADC) programs. Since joining Certara in 2018, Floris h...
Georgi Kapitanov, PhD
11 / 11
专家

Georgi Kapitanov, PhD

高级总监

Georgi Kapitanov, PhD is a Senior Director in Certara’s Applied Simulations group, where he leads QSP strategy across multiple programs and therapeutic areas. He joined Certara through the acquisition of Applied BioMath and previously worked in Pfizer’s Translational Modeling and Simulation group within Pharmacometrics, Dynamics, and Metabolism.

Proven impact in complex ADC development

Trusted by sponsors, Certara delivers integrated expertise for submission-ready decisions, led by global experts, including former FDA and EMA reviewers, with Project Optimus experience since 2022.

Contact an ADC expert
80
Oncology assets supported across ADC development
20
Years experience in oncology drug development

Explore ADC resources

查看全部
1 / 6
网络研讨会点播

Extending the Value of Antibody–Drug Conjugates: Model-Informed Labeling, Expansion, and Market Access

Learn how model-informed strategies support ADC labeling, dose optimization, and market access through integrated evidence across the drug development lifecycle.
立即观看
2 / 6
网络研讨会点播

Right Dose, Right Regimen: Model-Informed Strategies for Antibody–Drug Conjugates (ADCs)

Watch this on-demand webinar to learn how model-informed strategies using PopPK, PBPK, and QSP can optimize dose and regimen decisions for antibody-drug conjugates (ADCs).
立即观看
3 / 6
视频

ADC Development & Differentiation Strategies | Quantitative Systems Pharmacology & MIDD

Learn how model-informed drug development (MIDD) and quantitative systems pharmacology (QSP) support antibody-drug conjugate (ADC) differentiation, dose selection, and translational success from discovery through clinical development.
立即观看
4 / 6
博客

ADC 首次人体（FIH）剂量选择：成功设计 FIH 研究的关键

Optimize ADC First-in-Human Dose Selection with model-informed strategies and exposure–response insights to design safer, more effective FIH studies.
查看详情
5 / 6
网络研讨会点播

Start right, finish strong: 抗体-药物偶联物（ADC）研究成功之道

Learn how to build regulatory-ready first-in-human (FIH) dose strategies for antibody-drug conjugates (ADCs). Discover how PBPK, QSP, and translational modeling support safe starting doses and submission-ready packages.
立即观看
6 / 6
案例研究

肿瘤学剂量选择中模型引导的决策信心

查看详情

Advance your ADC development with confidence

Whether defining your first-in-human dose, optimizing activity and regimen, or preparing for regulatory submission, Certara helps ADC teams reduce uncertainty and make confident, model-informed decisions.

Define a defensible FIH dose and escalation strategy
Optimize dose, regimen, and therapeutic index
Interpret multi-analyte PK and payload dynamics
Build submission-ready evidence for regulatory success


Related offerings

Certara 复杂生物制剂服务为 CAR-T、单克隆抗体与基因疗法提供先进支持。信赖我们的专长以驾驭监管路径并提升成功。

了解更多信息

分析和策略，其主要目的是确保实现成功的药物开发计划。

了解更多信息

我们经验丰富的定量药理学服务团队可帮助量化药物与患者之间的相互作用，优化开发和监管选择。

了解更多信息

选择 Certara 定量系统药理学 (QSP) 咨询服务，利用计算建模和实验数据加强药物开发。

了解更多信息

Certara 在模型引导的肿瘤药物开发、给药以及监管策略和提交申请方面具有丰富的经验，已帮助推进成百上千个肿瘤学方案。

了解更多信息

提供战略指导与端到端支持，助力应对全球监管路径，确保从临床前阶段到上市批准的高效合规药物开发。

了解更多信息

Pharmacometric support for NDA, BLA, and MAA submissions, including electronic submission packages, labeling content, and expedited delivery options to keep timelines on track.

了解更多信息

Certara IQ 是一款基于人工智能的 QSP 建模软件，能够扩展定量系统药理学应用，提供经过验证的模型、工作流程及符合监管要求的洞察。

了解更多信息

ADC Model Pack 包含多种经过验证的 QSP 模型，适用于具有或不具有亲和力的单特异性和双特异性抗体-药物偶联物（ADC）。

了解更多信息

常见问题解答

How do you determine the right first-in-human (FIH) dose for an ADC?

We integrate PK/PD, PBPK, and QSP to predict tumor delivery, payload exposure, and toxicity, enabling a defensible starting dose and escalation strategy before clinical data are fully available.

Why is dose optimization more complex for ADCs?

ADC efficacy and safety are driven by multiple components and analytes, not a single exposure metric. This requires integrated, model-informed approaches to understand therapeutic index and optimize dosing.

When should we engage ADC modeling and simulation services?

The greatest impact comes early, during FIH planning, dose escalation design, or when uncertainty exists around toxicity, therapeutic window, or regimen strategy. Early insight helps avoid costly delays and rework.

How does model-informed drug development (MIDD) support regulatory success for ADCs?

MIDD provides quantitative, submission-ready evidence to support dose selection, labeling, and benefit–risk decisions, aligning with global regulatory expectations and enabling more efficient interactions with health authorities.

What ADC development decisions can Certara help us address?

We support critical decisions across the lifecycle, including:

  • FIH dose and escalation strategy
  • Exposure–response and therapeutic index
  • Multi-analyte PK interpretation
  • Dose and regimen optimization
  • Regulatory strategy and label justification

沪ICP备2022021526号
Powered by Translations.com GlobalLink Web Software