複雑な製剤（ドラッグプロダクト）を知っています

Annelies Paridaens is Director of Project Management at Ardena Ghent. She brings extensive experience in clinical supply and a strong track record in managing complex pharmaceutical development programs. At Ardena, Annelies focuses on ensuring efficient project execution, aligning stakeholder expectations, and maintaining high quality standards across development activities. She is known for her structured approach, pragmatic leadership style, and clear communication, as well as her ability to navigate complex technical and regulatory challenges. She works closely with internal stakeholders and international clients, translating technical requirements into clear project strategies and fostering collaborative partnerships. Annelies is committed to supporting the efficient advancement of innovative therapies and contributing to Ardena’s mission of accelerating the path from molecule to medicine.

Daan Vanhaecke is Group Leader for Formulation Development and Production at Ardena. As an industrial pharmacist, he combines hands-on technical expertise with a structured and quality-driven approach across GMP manufacturing and pharmaceutical development environments. Prior to joining Ardena, Daan built experience across several pharmaceutical companies, contributing to equipment qualification for ATMP manufacturing and Quality Assurance oversight activities. At Ardena, he is responsible for the day-to-day management of GMP production projects and associate scientists, including troubleshooting technical and GMP compliance challenges to ensure projects are delivered on time, within budget, and in compliance with cGMP standards. Daan brings experience across both QA and manufacturing environments and works closely with internal stakeholders and clients to support the successful development and production of innovative therapies.

Wannes Deckers is Associate Director of Quality and serves as a Qualified Person (QP) at Ardena. He brings extensive experience in pharmaceutical quality assurance and investigational medicinal product manufacturing within GMP-regulated environments. Wannes began his career through a Trainee Qualified Person program at MSD, where he built a strong foundation in cGMP compliance. Throughout his career, he has held multiple quality and pharmaceutical leadership roles, including Industrial Pharmacist and QP at Air Liquide Medical, as well as Responsible Person (GDP) for VitalAire NL. Prior to joining Ardena, he worked as a Project Engineer and consultant at Pfizer, supporting Pre-Approval Inspections (PAI) for analytical operations across several biosimilar programs. At Ardena, he focuses on phase-appropriate GMP manufacturing and successfully led the implementation of the company’s aseptic manufacturing facility, including cleanroom and isolator qualifications and aseptic manufacturing processes. He currently combines QP responsibilities with broader quality leadership activities across pharmaceutical operations. Wannes obtained his Master in Drug Development and his degree in Industrial Pharmacy from Ghent University.

Laure Descamps is Senior Formulation Scientist at Ardena, specializing in solid dosage development and process understanding. She supports formulation design, process optimisation, and early-phase drug product development for complex pharmaceutical programs. At Ardena, Laure applies her expertise to developing robust formulation strategies that support the efficient advancement of complex molecules toward clinical evaluation. Her work focuses on formulation development and process understanding across early-stage drug product development activities. Laure obtained her Master’s degree in Drug Development and Industrial Pharmacy and earned her PhD from Ghent University’s Laboratory of Pharmaceutical Process Analytical Technology. Her doctoral research focused on tabletting behaviour, material characterisation, and compression challenges in collaboration with industry partners.

Dr. Raja Yekkala is Business Development Director at Ardena. He brings more than 20 years of experience across pharmaceutical sciences, CMC development, analytical sciences, drug product development, clinical supply, and manufacturing support. At Ardena, Raja focuses on strategic business development for integrated pharmaceutical development and manufacturing programs in both human and veterinary applications. He supports clients throughout the full development journey, from early-stage activities through clinical phases, working closely with multidisciplinary teams across formulation development, analytical development, GMP manufacturing, regulatory affairs, project management, and clinical supply. His expertise includes comparator sourcing strategies, clinical trial supply planning, and the coordination of complex clinical supply programs supporting global development activities. Over the course of his career, he has contributed to bringing several dozen compounds into clinical development. Prior to transitioning into business development leadership roles, Raja held scientific and project management positions at Ardena and Pharmavize, where he managed complex CMC programs, clinical supply manufacturing activities, and cross-functional development projects. Earlier in his career, he worked as a research scientist at KU Leuven, contributing to pharmaceutical analysis, method development, and pharmacopoeial monographs adopted by the WHO. Raja is a pharmacist by training and obtained his PhD in Pharmaceutical Chemistry and Drug Analysis from KU Leuven, Belgium. He is author and co-author of multiple peer-reviewed scientific publications, contributor to internationally recognized pharmacopoeial monographs, and co-inventor of a patent related to pharmaceutical formulation technologies.

Sander Delahaye is Group Leader in Analytical Chemistry at Ardena Ghent. He brings extensive expertise in analytical method development, validation, and lifecycle management within GMP-regulated pharmaceutical environments, with a strong focus on chromatographic techniques and physicochemical analysis. Prior to joining Ardena, Sander worked at Ajinomoto OmniChem as Group Leader in Analytical Development, supporting the development and commercial manufacture of active pharmaceutical ingredients (APIs). During this time, he built extensive expertise in analytical method development and validation in accordance with ICH guidelines, with technical experience spanning GC, HPLC/UHPLC, and orthogonal analytical techniques, including Karl Fischer titrations. He also played a key role in GMP release testing, as well as the validation and troubleshooting of analytical methods for large-scale synthetic processes. After a decade focused on API analytical development, he transitioned to Ardena to broaden his expertise toward drug product development, supporting formulation development, release testing, and stability studies for clinical trial materials. Sander obtained his Master’s degree in Chemistry from Ghent University, followed by a PhD specializing in separation sciences. His doctoral research focused on the fundamental principles of supercritical fluid chromatography (SFC) and contributed to the understanding and optimization of this technique for complex analytical applications.

Seppe De Smet is Director of Analytical Development. He leads the definition and execution of analytical strategies supporting drug product development across the full product lifecycle at Ardena. He focuses on aligning scientific, regulatory, and client needs through phase-appropriate analytical approaches, control strategies, and lifecycle management. Throughout his career, Seppe has supported programs from preclinical development through clinical stages and commercialization, providing end-to-end analytical oversight tailored to each phase of development. He has worked across both CRO and biotech environments, combining project leadership with scientific expertise in small molecules and biologics. His experience includes method development, validation, GMP-compliant analytical operations, regulatory submissions, and CMC-related processes including manufacturing, quality control, and release testing. Seppe earned his PhD in Analytical Chemistry with a strong focus on chromatography. At Ardena, he supports clients through high-quality and pragmatic analytical solutions designed to accelerate development timelines while ensuring product quality and regulatory compliance.

Dr. Timothy Pas is Associate Director, Formulation Development and Production at Ardena. He leads a team supporting formulation development and GMP manufacturing activities for early clinical programs. Since joining Ardena, Timothy has progressed from Formulation Scientist to Group Leader and currently Associate Director. Throughout his career at Ardena, he has developed extensive expertise in oral and parenteral formulations, formulation development strategies, and GMP manufacturing operations supporting early-stage pharmaceutical development programs. Timothy obtained a Master’s degree in Drug Development and earned his PhD in Pharmaceutical Technology from KU Leuven, specializing in enabling technologies and galenic principles.

Julie De Smet is Director CMC Regulatory at Ardena, based in Ghent, Belgium. She brings extensive expertise in CMC writing, dossier development, and regulatory strategy, supporting pharmaceutical development programmes from early phase through commercial. Julie joined Ardena, then known as Pharmavize, in 2012 as Regulatory Affairs Officer and advanced through several leadership positions, including Regulatory Affairs Project Manager, Subject Matter Expert in CMC writing, and Associate Director of Dossier Development. Since 2021, she has co-led the CMC Regulatory Business Unit together with Anke Moret, with a strong focus on scientific content, dossier quality, and regulatory strategy. Julie obtained her Master’s degree in Pharmaceutical Sciences from Ghent University in 2006 and completed her PhD in 2012, specialising in analytical method development to support pharmacokinetic studies. In her current role, she collaborates closely with Anke to ensure high-quality regulatory deliverables and to strengthen the integration of scientific expertise and regulatory requirements across projects.

Anke Moret is Director CMC Regulatory at Ardena, based in Ghent, Belgium. She brings more than two decades of experience in regulatory affairs, with expertise spanning CMC regulatory strategy, operational management, and regulatory project leadership. Anke first joined Ardena, then known as HEA, in 2001 as Regulatory Affairs Assistant. After leaving the organisation in 2005, she returned in 2009 as Regulatory Affairs Officer and progressed through several key roles, including Senior Regulatory Affairs Officer and Regulatory Project Manager. Since 2021, she has co-led the CMC Regulatory Business Unit together with Julie De Smet, with primary responsibility for operational management and delivery excellence within the unit. Anke holds a Master’s degree obtained in 2000 and has built extensive expertise in regulatory operations and project management throughout her career in the pharmaceutical industry. In her current role, she works in close partnership with Julie to ensure efficient execution of regulatory projects and to drive continuous improvement across the team.

Ianは2025年にArdenaにUSマネージングディレクターとして参加しました。彼はCDMOと医療機器業界の両方で、複数の機能にわたる30年以上のグローバルな経験を持っています。IanはGEで19年間、品質、財務、サプライチェーン、技術サービス、商業運営に従事しました。その後、2013年にCatalentに参加し、セールスオペレーションのVPを務め、最近ではサマセットサイトのGMを務めました。彼は機械工学の学位と、ノースウェスタン大学ケロッグ経営大学院のMBAを取得しています。

Profile Arnout EveraertはArdenaのヨーロッパにおける製剤部門の責任者であり、ヨーロッパでの事業における製剤開発および製造戦略を指導しています。