Archives: Speakers

Cuento con casi tres años de experiencia en el área de negocio de Telefónica y en los últimos meses, me he especializado en proyectos de Big Data, incluyendo Smart Steps. Trabajo directamente con clientes de primer nivel en sectores como turismo, movilidad, retail, publicidad y administración pública, ayudándoles a aprovechar al máximo la herramienta. Combino visión estratégica y análisis de datos con una relación cercana con el cliente, impulsando la toma de decisiones y generando valor en distintos ámbitos.

Soy Juan Tapia Torán y llevo más de seis años trabajando en Telefónica como Project Manager, especializado en la gestión de proyectos de Big Data en la plataforma Smart Steps. Lidero proyectos de soluciones de Big Data dirigidas a los sectores de turismo, movilidad, retail y publicidad, apoyando a empresas y administraciones públicas en la toma de decisiones basadas en los Insights de nuestra plataforma. 

Dr. Philipp Schatz is a seasoned expert in precision medicine and in vitro diagnostics (IVD) with over 20 years of experience. Currently, he serves as the Global Regulatory Lead for IVD at Bayer, where he has spearheaded the development of regulatory strategies for oncology projects, achieving significant milestones such as the approval of Bayer’s first companion diagnostic in the US and Japan.

Prior to his role at Bayer, Dr. Schatz was a Diagnostic Expert in AstraZeneca’s Precision Medicine Unit and held various positions in CROs and the IVD industry. He has published over 20 peer-reviewed articles and is actively engaged in scientific committees, including the Precision Medicine Working Group of the EFPIA. Dr. Schatz holds a Doctor of Natural Sciences (Dr. rer. nat.) in Epigenetics from the University of Saarland. He is also a member of the Scientific Advisory Board for the PoC-ID Consortium, a work package leader for the BestAgeing consortium, and a member of both the European Society for Medical Oncology (ESMO) and the German Society of Cardiologists (DGK).

Talia Milosevic is a Director, Clinical Safety at the Surgical division of Edwards Lifesciences, global company,  focused on developing solutions for patients suffering from structural heart disease.

With more than 18 years of experience in patient safety and clinical research, Talia has a proven track record in safety risk management, cross-functional safety governance, and implementing safety strategies in complex environment of global medical device studies under various regulatory requirements.

Talia is passionate about advancing innovative therapies while ensuring the highest standards of patient safety.

Dr. Stephan Theinert is Head of Clinical Affairs and Development at EyeSense GmbH, a medical device developer based near Frankfurt, Germany, where he has led clinical and regulatory strategy since 2009, reporting directly to the CEO. With nearly 20 years of experience in clinical research across pre-clinical and Phase I–III trials — including first-in-human studies — he brings deep expertise in clinical pharmacology, medical devices (ophthalmology and diabetes), regulatory affairs, and design control.

He holds a PhD in Immunology from Humboldt University in Berlin and began his career in academic tumor immunology and infectious disease research before moving into international CRO leadership roles at PAREXEL and Momentum Pharma Services. Dr. Theinert has led multimillion-euro clinical programs, supported regulatory submissions for CE marking and ISO 13485 certification, and managed clinical trials in compliance with ICH-GCP and ISO 14155 under MPA, MDD/MDR.

Known for his strong project leadership and communication skills, he combines scientific depth with operational excellence across business development, clinical affairs, biocompatibility, risk management, usability/human factor, and regulatory strategy.

The AO Foundation is a surgeon-led, not-for-profit organization advancing patient care in trauma and musculoskeletal disorders through education, research, and innovation, powered by a global network of more than 500,000 surgeons.

With a PhD, 13 years of experience in clinical research, and an Executive MBA, Katrin Simioni combines scientific rigor with operational leadership as Deputy Head of Clinical Operations at the AO Foundation. AO Clinical Evidence comprises more than 30 experts across key clinical research functions, working with surgeons and industry partners to deliver medical device studies as well as large, international, multicenter observational research (cohorts and registries). This work focuses on understanding real-world treatments and outcomes, translating evidence into practical recommendations, and adopting evolving technologies to enable efficient, high-quality global data collection.

Maike Hiller is a Clinical Development Scientist at Philips with a focus on PMCF studies in the business unit Hospital Patient Monitoring. In her career in the MedTech industry over the past 20 years, she gained extensive experience from various positions in Product Management and Marketing, User Training, Business Development and Clinical Research. Her in-depth product knowledge reaches from class I to class III products in the clinical domain of Acute Care and spans product applications in very developed but also developing markets. In her Clinical Development role, she focusses on real world evidence generation in mixed method Post-Market-Clinical-Follow-up (PMCF) activities. Besides meeting regulatory EUMDR requirements and focusing on patient safety and closed loop product improvement, efficiency, scalability and cost-effectiveness are key aspects in her study designs. In this rather new domain of PMCF, she values knowledge and best practice sharing through different MedTech associations work groups and maintaining also an active dialogue with the different stakeholders on opportunities and limitations in this regulatory field.

I have spent over 25 years in the medical device industry focusing on two core challenges: identifying the essential clinical evidence needed for an innovative device and strategizing the most efficient way to acquire it. My work is driven by the conviction that innovation thrives when we eliminate excess overhead and are willing to cross geographic borders to get the evidence we need.