Early-stage biotech teams often struggle to translate scientific innovation into first-in-human readiness. This webinar provides practical guidance to help teams build a clear, scalable development pathway that aligns regulatory strategy, CMC, quality, and clinical planning. Reducing risk, avoiding delays, and staying inspection-ready without overbuilding internal structures.
Biotech startups and early-stage companies face a critical transition when moving from scientific innovation to first-in-human clinical trials. At this stage, early strategic decisions often determine whether development progresses smoothly or becomes slowed by regulatory questions, CTA delays, and costly rework.
Fragmented regulatory planning, limited internal quality and pharmacovigilance infrastructure, and misalignment between development stages are common challenges across early biotech programs. These gaps frequently remain hidden until late in development, when timelines and budgets are already under pressure.
Based on real-world regulatory interactions and development experience, this webinar explores the full journey from early strategic planning to first-in-human readiness highlighting how regulatory strategy, scientific advice, CMC and GMP preparedness, and early clinical and safety oversight must work together as a coherent pathway.
Rather than focusing on individual services, the session provides a practical roadmap to help biotech teams make better early decisions, align critical activities, and progress toward first-in-human studies with greater confidence and control.
向最优秀的人学习
Our speakers combine deep expertise in early-stage biotech development, regulatory affairs, and clinical readiness. They will share practical insights to help teams align strategy, reduce risk, and accelerate progress toward first-in-human trials.
Global Head Regulatory Affairs
Ángeles is Global Head of Regulatory Affairs at QbD Group, with over 17 years of experience in biotechnology and pharmaceutical development. She has extensive expertise in regulatory strategy, compliance, and interactions with FDA, EMA, MHRA, and other national authorities. Throughout her career, Ángeles has advised companies on regulatory pathways, risk assessment, and expedited product development, building high-performing teams and achieving key regulatory milestones to accelerate development and ensure market success. She is also passionate about the potential of data and AI to transform regulatory strategy in the life sciences sector.
Director Regulatory Affairs UK
Sacha has over 20 years of experience in European Regulatory Affairs with expertise spanning product development to post approval. Her educational background includes a degree in pharmacology and medical sciences, complemented by a master’s in clinical research. Sacha’s career has predominantly focused in supporting companies in developing clinical strategies and driving regulatory activities engaging with regulatory agencies through scientific advice leading MAA submissions. Currently she is a Principal consultant with QbD Group, where she continues to support clients and leads project teams to develop robust strategies in their clinical development. Sacha actively contributes to the profession and leads the introductory course for TOPRA
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Is this for you?
This webinar is ideal for decision-makers and technical leaders shaping early-stage biotech development, including: Learn from our experts
Founders, CEOs, and COOs of biotech startups who are guiding early development strategy and preparing their organizations for first-in-human milestones.
Regulatory Affairs Directors and Managers responsible for defining regulatory pathways, managing CTA readiness, and engaging with health authorities.
Heads of CMC and Technical Operations overseeing process development, manufacturing strategy, and GMP preparedness for early clinical supply.
Clinical Development and Clinical Operations leaders planning first-in-human studies, trial execution, and cross-functional alignment.
QA and GxP Compliance leads in early clinical development responsible for building scalable quality systems and inspection-ready frameworks.
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