Archives: Speakers

David Hilfiker (Dave) is an experienced leader in the pharmaceutical industry, currently serving as Senior Director, Head of RBQM at Daiichi Sankyo. He is known for applying his experience to optimize quality and speed during clinical development, leading to successful regulatory submissions and inspections. Dave stands out for his combined experiences in new drug review at the FDA and in industry regulatory affairs and R&D quality and compliance, making him a unique communicator within the field.

Dave is passionate about the pursuit of balance between competing forces (e.g., work and play, innovation and execution, art and science), incorporating this pursuit into personal and professional interests. He is above all family first – proud to be a husband and father to three fantastic young adults, a dog and a cat.

Lukáš is a passionate fraud fighter with years of hands-on experience working alongside dozens of banks across Europe. As the Lead Principal Solutions Consultant & Fraud Expert at ThreatMark, he specialises in decoding the psychology of fraud to help financial institutions stay ahead of evolving threats.

His ability to “think like a fraudster” allows him to detect, disrupt, and dismantle the kill chain of modern attacks. Working daily with fraud analysts to strengthen defence mechanisms, he ensures banks can stop malicious intent in real-time without impacting the user experience.

Magiyat has a biomedical background, with interdisciplinary experience in research and medicinal regulatory affairs.

Magiyat hold a Bachelor of Biomedical Science from the University of Surrey where she achieved a first-class result. Her dissertation topic titled ‘Investigating the role of antiviral sentinel PKR in the function of chemotherapy drug 5-FU’ – where she investigated whether the PKR protein kinase may be used as a specific target of 5-FU outside of viral infection and investigating in vitro conditions to achieve activation.

Magiyat completed a professional placement year at Haleon within Medicinal Regulatory Affairs, Product Lifecycle Management team. At Haleon, Magiyat led to streamline ways of working. In parallel, Magiyat managed the product cancellation requests, cross functionally, across the full brand portfolio and executed regulatory needs to meet regulatory specifications in over 30 markets. Passionate in driving positive change, Magiyat established the first regulatory network for placement students. Prior to Haleon, Magiyat completed an internship at Sumitomo Chemical ltd., within their legal, compliance and personal care departments. Throughout her time at university, she has worked as a student ambassador alongside her studies.

Originally from Azerbaijan, born in Baku, Magiyat speaks Russian, is family oriented and has a small cocker spaniel she adores. Her passions are for travel, being creative and trying new experiences. She has played piano for over 10 years, enjoys painting, trying new hiking trails with those close to her and is a keen country explorer! Magiyat also loves meeting new people and enjoys playing tennis when she has some free time.

Driven by patient centric impact, influencing change and innovative thinking, precision medicine is in key alignment with her motivations. Through the GSK graduate scheme, she is passionate in continuing her learning, professional growth and driving improvement.

Emma comes from an interdisciplinary background in Precision Medicine (PMed) device development, Neuroscience clinical research and AI Neuroimaging development. Her strengths lie in a strategic efficiency-driven mindset, combined with a curiosity and bubbly personality.

As a Precision Medicine Associate at GSK, and as part of GSK’s Future Leaders Programme as a Graduate, her focus is on operationally optimising biomarker strategies across GSKs portfolio, whilst simultaneously innovating and improving processes to accelerate and standardise pipelines with a data-driven purpose.

Prior to GSK, Emma worked in Neuroscience Research in various capacities. She worked at CRO IXICO, responsible for processing large quantities clinical trial data. She worked closely with GCP and created training data for development of AI neuroimaging processing methods to improve data analysis streamlining and accuracy. She also worked on the CogThy study at the University of Gothenburg and Sahlgrenska, investigating Graves’ Disease and the hippocampus, by leading the automation process for clinical trial MRI data by integrating and comparing brain segmentation software in supercomputer processing terminals. Additionally, she undertook an independent research project in collaboration with MedTechWest where she evaluated and improved the Machine Learning neuroimaging tool Pincram.

Going back to where her interest in PMed started, at Astra Zeneca MedTech spinout company OnDosis. She was part of a dynamic start-up team and wore many hats, including heading the company’s literature research and contributing to product development of PMed dosage devices Ondosis 01, 02 and 03, where she introduced multiple new functional design aspects aiming to improve their efficiency and accuracy.

Emma holds a Bachelor of Arts and Sciences (BASc) with a Neuroscience major and Economics and Bioengineering minors from University College London (UCL). Her Bachelor’s thesis received distinction as one of the best undergraduate research dissertations in the field at UCL for an independent participant-based primary research project, where she built an sEMG-device and investigated applications for biofeedback of sonified sEMG.

Originally from Sweden, Emma grew up close to the archipelago and moved to London in 2020. She has always had a soft spot for the snow and the sea, always loving skiing and more recently discovering surfing. Emma is an active dancer, practicing with a dance crew in South London and running children’s classes to bring the joy of dance to more people. She is also passionate about women’s rights, politics and sociology, and always loves a meaningful conversation. When she is not on her feet (or skis, surfboard or skateboard), she loves thought-provoking books and spending time with her loved ones.

Clara has an interdisciplinary, research-oriented background, holding both a BSc and an MSc with honours in Biomedical Engineering from Politecnico di Milano.

During her Master’s studies, she specialised in bioengineering for cells, tissues, and biotechnology, while consistently integrating her strong biological foundation with technical expertise in artificial intelligence and bioinformatics.

As part of the Erasmus+ programme, she spent six months at the Instituto Superior Técnico in Lisbon, deepening her knowledge of stem cell bioengineering and regenerative medicine. She then carried out her Master’s thesis at the international research centre Human Technopole in Milan, within the Population & Medical Genomics department, where she gained hands-on experience in single-cell multi-omics to study the immune microenvironment in paediatric acute myeloid leukaemia.

Following her degree, Clara worked as an Advanced Analytics Intern at Bayer Italia, applying her multidisciplinary skill set to generate data-driven insights in support of innovation and excellence in the pharmaceutical sector.

Her international and cross-disciplinary experiences have shaped an analytical, detail-oriented mindset that she brings to every project. Driven by a strong fascination for the potential of biological data and emerging technologies, Clara is particularly motivated by their application to precision medicine and patient-centred research. With a genuine desire to make a positive impact, she has recently started her career in pharmaceutical research through a GSK graduate scheme, where she is eager to continue learning, explore diverse roles, and contribute to technological and scientific innovation.

Stefan Seebacher is the IT program lead in the Clinical Trial Supply Program at Boehringer Ingelheim and is based in Biberach, Germany. In his role, he implements and supports data‑driven processes and solutions, working closely with cross‑functional teams to enhance reliability, efficiency, and strategic value within the clinical trial supply IT landscape.

Stefan has a strong academic background in information systems, holding a PhD from Karlsruhe Institute of Technology (KIT).

Michael Hoefling is currently Head of Digitalization and Automation, at Boehringer Ingelheim, based in Biberach, Germany.

He aims at advancing digital transformation and automation across drug product development for NCEs including clinical manufacturing. His work focuses on implementing innovative, robust, and state-of-the-art information technologies that comply with regulatory requirements and enhance efficiency, quality, and sustainability.

Michael is an IEEE Senior Member and holds a strong academic background in computer science, including B.Sc. and M.Sc. degrees from Umeå University (Sweden), a Diplom-Informatiker degree from the University of Wuerzburg (Germany), and a Ph.D. from the University of Tuebingen (Germany).

Hasegawa is a researcher at Morinaga Milk’s Food Function Research Institute who specializes in evaluating the functionality of probiotics. With a background in microbiology and biotechnology, she focuses on uncovering how Bifidobacterium contributes to human health through both clinical and fundamental research approaches.

In this session, she will present the scientific foundation behind the skin‑health benefits of Bifidobacterium breve M‑16V and explain how the strain supports skin wellness.