Archives: Speakers

Kathrin Schirner, PhD is a Clinical Scientist at CSL Innovations with extensive experience across clinical development, medical monitoring, and drug safety. She currently supports a global immunology and respiratory development program, leading cross-functional clinical activities, regulatory interactions, and safety management processes. Previously, she served as Global Safety Lead for hematology and gene therapy products, providing strategic safety leadership throughout clinical development and post-marketing phases. Kathrin holds a PhD in Biomedical Sciences from Newcastle University, UK and completed postdoctoral research at Harvard Medical School, Boston, MA, specializing in microbiology and antibiotic discovery.

Jens Heyn is a physician-scientist and Senior Global Clinical Development Manager with extensive experience in leading global clinical development programs across oncology, immune-oncology, ophthalmology, and biosimilars. He has more than 15 years of clinical and academic experience at the University Hospital of the University of Munich (LMU) and, since 2020has worked in Clinical Development at Sandoz, where he leads global clinical development programs across the drug development lifecycle. Since 2024 he also served as Professor at LMU Munich, combining his academic and clinical expertise with extensive experience in pharmaceutical drug development.

Marco Groß-Langenhoff is a pharmaceutical professional with ~20 years of experience in Medical Affairs, Value Evidence, Oncology Development, New Product Planning, HEOR, Marketing, and in academia. He has significant experience across the lifecycle from pre-PoC to pre-, peri- and post-launch in building and implementing medical strategies at country, regional and global level with a focus on oncology across GU, GI, Thoracic Oncology, and Hematology. His current role is New Product Planning Lead in Global Value Evidence at Astellas Pharma, supporting multiple oncology assets in early-stage development.

Jordi Canes Ruiz is a Clinical Project Delivery Lead at SOLTI, a leading academic cancer research group. With over a decade of experience in clinical research, he oversees the delivery of international clinical trials and specializes in study start-up, operational strategy, resource planning, and collaboration across sponsors, investigators, CROs, and research institutions.

Dr. Tobias Suiter, MD is a physician and clinical development professional with more than 30 years of experience in the pharmaceutical and biotechnology industry. Trained as a specialist in Internal Medicine, he has held senior medical and leadership roles at companies including CSL Behring, Baxter/Takeda, Biogen and Pharming, with a particular focus on rare diseases and specialty medicines.

Throughout his career, Tobias has contributed to clinical development programmes from first-in-human development through later-stage clinical trials and regulatory approval, including programmes in rare diseases where small patient populations and limited clinical evidence require careful assessment of dose, safety and benefit-risk. Several medicines he has worked on have subsequently gained regulatory approval.

Since 2021, he has worked as an independent consultant, advising biotechnology and pharmaceutical companies on clinical development strategy. His experience includes first-in-human clinical development in rare diseases, trial design, benefit-risk assessment, regulatory strategy and the use of pragmatic and adaptive development approaches where appropriate.

He currently serves as Advisor, Clinical Development, Haemastatx, supporting the development strategy for a novel therapeutic programme in rare bleeding disorders. His approach combines scientific rigor and development efficiency with a strong focus on patient needs and clinically meaningful outcomes.

Dr. Ashesh Kumar is CEO and Director of Biologics & Licensing at Paras Biopharmaceuticals Finland, where he leads the company’s biologics development, as well as technology licensing and strategic partnerships. He has 20+ years of leadership experience in biologics development and scale-up, with expertise spanning recombinant proteins, biosimilars, microbial production technologies and biopharmaceutical process development.

Prior to joining Paras Biopharma, Dr. Kumar led Medipolis GMP Oy in Finland and its GMP biopharmaceutical development activities, overseeing multiple process development and commercialisation projects. He holds a Ph.D. in Biosciences & Biotechnology from the Indian Institute of Technology Roorkee and has also undertaken management studies at Harvard Business School and Jamnalal Bajaj Institute of Management Studies.

Steffen Heß is a recognized expert in health data with extensive research experience in the use of healthcare data. His work focuses on the scientific analysis of health data, and he brings an in-depth understanding of the health data ecosystem from both a research and practical perspective. Since 2020, he has led the development of the Health Research Data Centre (FDZ Gesundheit) and guided it through to its launch in 2025. The FDZ Gesundheit provides nationwide statutory health insurance claims data for research, enabling important analyses of healthcare delivery in Germany.