Early clinical development is no longer just about progressing through study phases. It is about generating the right data at the right time to support critical decisions and value inflection points. In this session, we will explore how thoughtful Phase I study design, including combined SAD/MAD studies, early patient cohorts and adaptive protocols, can accelerate access to clinically meaningful data without compromising scientific integrity.
We will discuss how different design choices impact timelines to proof-of-concept and ultimately influence funding, partnering and portfolio prioritization decisions.
Using real-world examples, we will share practical approaches that can bring key milestones forward and shorten overall development timelines by months.
Ultimately, the aim is to help you reach your next value inflection point faster and with greater confidence.
Date: Wednesday, 9 December 2026
Time: 8:30 – 11:00
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Hub 2
Program
| 8:30 | Networking, registration and light breakfast |
| 9:00 | Welcome and introduction to Medicon Valley Alliance David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance |
| 9:05 | Session 1: Optimizing early development pathways to generate more insight, sooner Thomas Lodeweyckx, Director of Consultancy and Clinical Pharmacology, SGS Explore how innovative Phase I study designs can integrate multiple objectives within a single protocol, accelerate progression from healthy volunteers to patients and create opportunities for earlier proof-of-concept. |
| 9:40 | Session 2: Turning strategy into high-quality clinical execution Haiko Pillu, Director Operations Clinical Pharmacology Unit, SGS Learn how efficient startup processes, rapid access to PK and safety data and robust dose-escalation governance can help sponsors shorten timelines while maintaining scientific quality and participant safety. |
| 10:05 | Session 3: Choosing the right early-phase development strategy Thomas Lodeweyckx, Director of Consultancy and Clinical Pharmacology, SGS Through practical case examples, discover how different development pathways, from traditional sequential approaches to integrated and adaptive designs, can help sponsors make more informed decisions and reduce uncertainty earlier in development. |
| 10:25 | Interactive Q&A Panel Moderated discussion and open floor for audience questions. |
| 10:30 | Networking and coffee Opportunity for participants to connect with the speakers and one another |
| 11:00 | End of Good Morning Meeting |
Speakers
| Thomas Lodewecyx
As Director of Consultancy and Clinical Pharmacology at SGS, Thomas Lodeweyckx helps pharmaceutical and biotechnology companies make better early development decisions and reduce risk before critical milestones are reached. As the lead consultant for SGS’s Phase I consultancy services, he advises sponsors on clinical development strategy, study design and program optimization to maximize the value of early clinical data. A recognized Belgian clinical pharmacologist and thought leader in early drug development, Thomas combines scientific, medical and operational expertise to help sponsors overcome development challenges, build confidence in go/no-go decisions and accelerate the path from candidate selection to clinical proof of concept. |
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| Haiko Pillu
As Director Operations at SGS’s Clinical Pharmacology Unit in Belgium, Haiko Pillu leads the operational delivery of early-phase clinical studies, with responsibility for clinical, technical and study coordination activities. With more than 20 years of experience in clinical research operations at SGS, he helps pharmaceutical and biotechnology companies navigate the complexities of early-phase development with confidence. Haiko’s expertise spans first-in-human, proof-of-concept, and complex early-phase studies, ensuring sponsors benefit from efficient execution, proactive risk management, operational flexibility and high-quality data. His focus is on delivering a seamless study experience that supports faster development decisions while maintaining the highest standards of patient safety, quality and regulatory compliance. |
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| Georgy Pletnev
As Business Development Manager at SGS Pharma Clinical Research, Georgy Pletnev helps pharmaceutical and biotechnology companies connect with the right experts, capabilities and services to support their clinical development goals. Working closely with sponsors and SGS subject matter experts, he facilitates discussions around early-phase development, clinical operations and biometrics solutions to help organizations find the support best suited to their needs. By understanding each sponsor’s unique challenges and objectives, Georgy brings together the expertise required to support informed decision-making and advance development programs efficiently. His collaborative and consultative approach helps clients access the right support and fully leverage SGS’s clinical research capabilities.
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