Albert brings extensive expertise in global drug development, with a focus on oncology, rare diseases, dermatology, and immunology. He is Managing Partner at GDS Partners LLC, advising biotech leaders on development strategy, fundraising, risk assessment, and stakeholder engagement. Albert serves as an Industry Representative on the FDA’s Oncologic Drug Advisory Committee. Previously, he spent over a decade at Pfizer, where he helped build its oncology portfolio and served as Global Regulatory Franchise Lead for IBRANCE. His earlier leadership roles included senior regulatory positions at Onyx, Proteolix, Kosan Biosciences, and Bristol Myers Squibb, where he contributed to the groundbreaking development of ipilimumab (YERVOY).

Björn Carlsson is a seasoned regulatory affairs and clinical immunology expert with over 17 years in pharmaceutical development and regulatory strategy. As Vice President, Regulatory Science, he leverages 12 years at the Swedish Medicines Agency, including a decade as non-clinical assessor and two years leading a multidisciplinary clinical efficacy-safety group. In addition, he was the Swedish alternative delegate in the in the committee for advanced therapies (CAT) at the European Medicines Agency (EMA) for 9 years.  His expertise spans non-clinical development, Advanced Therapy Medicinal Products (ATMPs), and strategic regulatory planning, with a proven track record in scientific advice and complex authorisation procedures. Björn’s leadership in ATMP certification and cross-functional collaboration positions him as a key contributor to projects requiring deep regulatory insight and scientific rigor. 

Chantal van Gils is Vice President, Evidence & Value at SSI Strategy and a senior life sciences strategist with more than 20 years of experience across academia, industry, and CRO environments. A physician-scientist by training, she specializes in designing and delivering integrated evidence strategies that align clinical development with regulatory, HTA, payer, and commercial requirements. Chantal has led over 100 global and regional programs across oncology, rare diseases, and advanced therapies, with deep expertise in real-world evidence, health economic modeling, and market access. She is recognized for translating complex evidence needs into actionable strategies that support regulatory approval, reimbursement success, and long-term commercial value. 

Frits is a Medical Advisor with over 40 years of experience in regulatory affairs and clinical medicine. A specialist in internal medicine, he is an expert in endocrinology, diabetes, coagulation disorders, and biosimilars. He served 16 years as Chair of the Dutch Medicines Evaluation Board and was a long-standing member of the EMA’s CHMP, acting as Rapporteur or Co-Rapporteur for more than 30 products. Frits also chaired national initiatives on orphan diseases and medical ethics, providing deep insight into EU approval pathways and clinical strategy. 

Jan is a Medical Advisor and a specialist in haematology and internal medicine, with over 20 years of clinical and regulatory experience, including 12 years within European regulatory agencies. He has served at the Swedish Medical Products Agency and the Icelandic Medicines Agency, contributing to oncology and haematology assessments, the EMA Scientific Advice Working Party (SAWP), and as Iceland’s alternate member of the CHMP. A former clinical assessor and clinician, Jan brings deep insight into both medical practice and regulatory expectations. He supports the development of new medicines by combining clinical, scientific, and regulatory expertise to ensure effective, compliant, and practical strategies. 

Karl-Heinz Huemer is an expert in regulatory strategy, with a focus on neuroscience, ophthalmology, paediatric drug development, orphan products, and multiple therapeutic areas. He has extensive experience conducting scientific advice procedures, paediatric investigation plans, and EMA marketing authorization assessments, participating in approximately 300 scientific advice procedures and 400 paediatric investigation plans. Karl-Heinz has served as Austrian Delegate and member of the EMA’s CHMP Scientific Advice Working Party (SAWP) and Paediatric Committee (PDCO). He actively contributes to conferences, workshops, and online courses, and teaches at the Vienna University of Applied Sciences, leveraging his combined expertise in medical and biological research and regulation.

Mads Hansen is a haematologist with significant clinical and business expertise in haematology and oncology, alongside robust experience in planning and executing clinical trials in both academia and the pharmaceutical industry. His expertise extends to real-world evidence, registry-based trials, and clinical development strategies. Mads has served as chairman of the EORTC Lymphoma Group, external clinical assessor for the Danish Medicines Agency, and head of the Lymphoma and Myeloma Clinic at Rigshospitalet in Copenhagen. He has held senior roles in the pharmaceutical industry, including at Genmab and Amgen, and is the founder and managing director of ZEMA Pharma Consulting. He is the author of over 40 peer-reviewed publications.

Margarida Menezes Ferreira is a regulatory expert with deep expertise in biological and advanced therapy medicinal products (ATMPs). During her long career at Infarmed, the Portuguese regulatory agency, she provided more than 150 national and European scientific advice, assessed numerous centralized marketing authorisations, and contributed to establishing the EU regulatory framework for ATMPs. She played a leading role in drafting EMA and European Commission guidelines on ATMP quality, comparability, GMP, and GMO requirements. Margarida also represented Portugal at the EMA for over two decades as a member of the Biologics Working Party, Cell Products Working Party, and the Committee for Advanced Therapies. She brings strong scientific and regulatory insight across R&D, development, and market access.

Marianne is a leading expert in regulated bioanalysis, with more than 25 years of experience in the pharmaceutical industry. She has deep expertise in pharmacokinetic, biomarker, and immunogenicity assays, and was an expert member of the ICH M10 Expert Working Group for Bioanalytical Method Validation and Study Sample Analysis. Marianne has extensive experience in designing and executing regulatory strategies for bioanalytical methods across large and small molecules as well as advanced therapies (ATMPs/CGTs). Her work focuses on biomarker-guided assay strategies, immunogenicity assessments, and regulatory-compliant bioanalytical approaches that support drug development, clinical trials, and precision medicine applications on a global scale. 

Dr Mel Walker is an expert in early commercial strategy, market access, pricing, and reimbursement, with extensive experience guiding companies in integrating payer and HTA requirements into drug development. He helps clients optimize product value from early target product profile (TPP) design through launch and reimbursement, across multiple therapeutic areas. Mel has deep knowledge of European payer and HTA systems, strategic HTA capabilities, and hands-on experience in payer engagement and early advice processes. He has held senior roles at Roche, GSK, and Otsuka, and co-founded BioPharma Futures. Mel regularly chairs international conferences on market access, HTA, and digital health, and has co-authored over 30 research papers and abstracts, as well as two book chapters.

Dr Patrick Salmon is a specialist in pharmaceutical medicine with extensive expertise in clinical development and regulatory strategy, particularly in rare diseases and orphan drug designation. With almost 25 years of experience at both national and EU levels, he provides companies with in-depth guidance on regulatory pathways, including EMA committee interactions and dossier preparation. Patrick is a Lecturer in Drug Information, Pharmacology, and Therapeutics at Trinity College Dublin and serves on the Management Committee of the Course in Pharmaceutical Medicine. His experience spans clinical trial applications, marketing authorization assessments, pharmacovigilance, and regulatory risk management, helping clients navigate complex therapeutic areas and succeed in development programs.

Dr Paula Salmikangas is an expert in biopharmaceuticals and advanced therapy medicinal products (ATMPs), with extensive experience in CMC, clinical development strategy, and European regulatory requirements. She provides technical and strategic guidance for drug development programs, leveraging her background as a former EU regulator, including Chair of the EMA Committee for Advanced Therapies (CAT). Paula has deep expertise in ATMPs, biosimilars, combined ATMPs, and clinical bioassays, supporting Clinical Trial Applications (CTA) and Marketing Authorisation Applications (MAA). She is also an Adjunct Professor of Biochemistry at the University of Helsinki, with extensive teaching and professional presentation experience, and has contributed to establishing regulatory guidelines for ATMPs in Europe. 

Thomas is a senior strategic advisor with extensive experience in regulatory leadership, drug development, and international regulatory collaboration. He brings more than 25 years of executive-level experience within European regulatory systems, including serving as the former Executive Director of the European Medicines Agency (EMA), where he transformed the organisation into a globally recognised regulatory authority between 2001 and 2011. Prior to his tenure at EMA, he held senior positions at the Swedish Medical Products Agency. Thomas now advises life science organisations and serves as a non-executive board member for several biotech and medtech companies. He is widely honoured for his contributions to pharmaceutical regulation, holding honorary distinctions from major professional and academic institutions.

Vidar has more than 25 years of experience in the pharmaceutical and biotech industry, spanning non-clinical development, clinical development, and medical affairs across multiple therapeutic areas, including neuroscience, infectious diseases, and immune-mediated inflammatory conditions. His background includes serving as a clinical assessor of vaccines and antivirals at the Swedish Medical Products Agency (MPA). Vidar has held senior roles in major pharmaceutical companies as well as in life science start-ups, bringing deep expertise in translational research, early clinical development, and strategic programme design. He holds an MD and PhD from the Karolinska Institute, where his research focused on Epstein-Barr virus-induced B-lymphocyte transformation. 

Yngve has extensive experience in clinical development, real-world evidence, market access, and health economics, with a strong track record of advising companies on development strategy and value demonstration. He excels at identifying the optimal connection between product potential and market needs, ensuring the generation of evidence required for access, pricing, and clear communication of value to stakeholders. Before his current advisory work, Yngve served as Executive Vice President at LINK Medical Research and has more than a decade of medical affairs and pharmaceutical development experience at Pfizer and Biogen. A certified clinical specialist in anaesthesiology, he also holds advanced degrees in management, economics, and health policy from leading European institutions.