BioSciPons bridges the gap between science and people, academia and business, regulatory agencies and manufacturers.
A bridge between two worlds.
Post-Marketing Clinical Follow-Up (PMCF) gap analysis: Let's find the gaps in clinical evaluation & performance studies
Post-Marketing Surveillance Update Report (PSUR): Get your PSUR peer-reviewed & published in a indexed medical journal
Instructions-for-Use (IFU): Simplify the language in the user manual
Patient-Report Outcomes & Surveys: Which questions matter the most to your patients and users?
I worked in medical academic research for more than 15 years in different international institutions (e.g., Yale University). Throughout the years, I've authored several peer-reviewed medical articles, and was honoured to receive the European Science Slam award - a testimony of my creativity, enthusiasm and ability to communicate science to lay audiences. I'm is able to distill complex scientific ideas in a way that is both informative and entertaining.
In 2006, I was a Marie-Curie Early Stage Researcher (Universitätsmedizin Charité Berlin). In 2011, a Postdoctoral fellow at the Yale Cardiovascular Research Center (YCRC). In 2013, I was honoured Fellow of the American Heart Association (FAHA). In 2012, received the European Science Slammer title. And, in 2021 I was nominated Young Science Journalist of the Year by the Association of British Science Writers (ABSW).
My scientific expertise in neuroscience, cardiovascular, oncology, molecular biology and biostatistics allows me to understand the clinical writing needs of innovative medical devices; and, support manufacturers in navigating the regulatory waters of certification.
I'm an active delegate of the Regulatory Affairs Professional Society (RAPS), the best way to have the latest insights on the global regulatory affairs landscape.
In 2022, my work "Creativity in Regulatory Affairs" was selected for the RAPS annual conference. In 2023, I presented "How to use Total Product Life Cycle and Good Machine Learning Practice as your lighthouse when developing and deploying Artificial Intelligence-enabled Medical Devices" at the RAPS Euroconvergence 2023, in Amsterdam.
I'm also an accredited science and medical journalist by the World Federation of Science Journalists WFSJ and the Medical Journalist Association MJUK, with several authored articles in different media platforms.
Regulatory Science and policy are my interests, with a wish to see the field moving forward as a way to assess the safety, efficacy, quality, and performance of all medical-related products.
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By understanding the importance of writing and wording, not only in written form to peers but also to deliver valuable information to the consumer, BioSciPons is favoured by start-ups, small and medium enterprises (SMEs) in the medical and biotechnology field.