Maria Nyåkern

Maria Nyåkern Email and Phone Number

Founder and Director @ Nyåkern Nexus Research Institute
Sweden
Maria Nyåkern's Location
Madrid, Community of Madrid, Spain, Spain
Maria Nyåkern's Contact Details

Maria Nyåkern personal email

About Maria Nyåkern

I am a passionate leader and entrepreneur focused on making a positive impact in the MedTech and healthcare industries. As the founder and CEO of AKRN Scientific Consulting, a life-sciences consulting firm specializing in clinical research and regulatory services, I dedicated myself to advancing the field and delivering exceptional CRO services that support clients and stakeholders. Following AKRN's acquisition by NAMSA in 2022, my commitment to fostering young scientific talent and creating job opportunities for recent graduates remains unwavering. The clinical research field's talent shortage and fierce competition pose significant risks to organizations, a challenge that my company, Associates of Clinical Research (ACR) Consulting, aims to address.Beyond my business endeavors, I support emerging medical device and AI-based technologies through Nyakern Nexus Investments, furthering innovation and growth within the sector. My goal is to continue creating innovative products and research services that not only improve patient outcomes but also benefit society.Additionally, through Blue Bee Productions, I blend innovation with artistry to develop powerful, relevant stories. Storytellers play a crucial role in society, entertaining, informing, raising awareness of societal issues, and influencing policy changes.Expert domain: With a strong academic background and international scientific training, I have contributed to clinical research, built exceptional teams, and delivered outstanding business results. As a Subject Matter Expert (SME) on ISO 14155:2020 and EU MDR 2017/745, I am particularly interested in the European CE-mark process and clinical evaluation strategies, and the latest AI & MedTech trends in the field.

Maria Nyåkern's Current Company Details
Nyåkern Nexus Research Institute

Nyåkern Nexus Research Institute

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Founder and Director
Sweden
Maria Nyåkern Work Experience Details
  • Nyåkern Nexus Research Institute
    Founder And Director
    Nyåkern Nexus Research Institute
    Sweden
  • Nyakern Nexus
    Founder And Managing Partner
    Nyakern Nexus Jun 2021 - Present
  • Ie University
    Adjunct Faculty Professor
    Ie University Sep 2024 - Present
    Madrid, Community Of Madrid, Spain
  • Acr (Associates Of Clinical Research)
    Founder & Chief Executive Officer
    Acr (Associates Of Clinical Research) Apr 2024 - Present
  • Medical Device Strategy Consultant
    Clinical Development & Strategy Consultant
    Medical Device Strategy Consultant Jan 2023 - Present
    Madrid, Community Of Madrid, Spain
  • Blue Bee Productions
    Co-Founder & Producer
    Blue Bee Productions Jan 2023 - Present
    Madrid
  • Åkrn Scientific Consulting
    Founder & Chief Executive Officer
    Åkrn Scientific Consulting Jan 2018 - Feb 2023
    As the founder and CEO of AKRN Scientific Consulting I was responsible for the day-to-day business, leading the organization and developing the corporate culture to motivate employees and drive revenue. Provided strategic vision to align the company internally and externally to enable innovation and expansion in the medical device B2B sector. ÅKRN provides Clinical and Regulatory Consulting for the Medical Device and in-vitro Diagnostic Industry and was acquired by NAMSA in 2022.
  • Iso - International Organization For Standardization
    Expert In Iso/Tc194 Biological And Clinical Evaluation Of Medical Devices
    Iso - International Organization For Standardization Jan 2022 - Jan 2023
    Swedish delegate and expert, ISO/TC194 WG 1 and WG 4
  • Medical Device Hq
    Speaker & Medical Device Expert Iso 14155
    Medical Device Hq Jan 2022 - Jan 2023
    Worldwide
    Medical Device Research Advisor specializing in clinical research and the development and testing of medical device technology, including AI-integrated device, to ensure research meet ethical guidelines and legal requirements.
  • Esame Pharmaceutical Business School
    Speaker
    Esame Pharmaceutical Business School 2019 - 2022
    Madrid, Community Of Madrid, Spain
    ESAME Pharmaceutical Business SchoolPart of the MMEC: Máster en Monitorización de Ensayos Clínicos de ESAMEMedical Devices, Clinical Evaluation and Clinical Investigations.
  • Ephos
    Speaker
    Ephos 2019 - 2022
    Madrid, Community Of Madrid, Spain
    EPHOS - School of PharmaStudiesPart of the EPHOS Master Program: Máster en Monitorización y Gestión de Ensayos ClínicosMedical Devices, Clinical Investigations, and Clinical Evaluation.
  • Abbott
    Clinical Research Consultant
    Abbott 2018 - Oct 2021
    Brussels Area, Belgium
    Abbott Vascular addresses the unmet need of patients with structural heart defects through innovative, first-in-class therapy. Involved in operational clinical study management/consulting of Abbott Vascular/St Jude Medical structural heart studies. FIM, CE mark, post approval studies (PAS) and CE mark PMCF studies. Transcatheter heart valve (THV) therapies with MitraClip® and transcatheter aortic valve implantation (TAVI) provides a valid therapeutic option in high-risk or inoperable patients with heart failure (HF). The Trifecta™# GT Heart Valve is indicated for both conventional surgery and minimally invasive procedures.Functions:• Strategic and operational clinical study management• Collaboration across business units and with external stakeholders• Maintain strong professional relationship with principal investigators, KOLs, hospitals
  • Exthera Medical
    Clinical Research Consultant
    Exthera Medical Nov 2015 - Sep 2019
    Berkeley, Ca, United States.
    ExThera’s proprietary Seraph® Microbind® Affinity Blood Filter is a first-of-its kind technology designed to capture and remove a broad range of bacteria, viruses, toxins and pro-inflammatory cytokines from whole blood. This is a revolutionary medical device that address unmet clinical needs in the treatment of bloodstream infections and pathogen-reduction in blood banking.I was working on the FIM CE Mark Study. Generation of Clinical Evaluation Reports (CER), Clinical Study Reports (CSR), Instructions for Use (IFU) and similar. Functions:• Clinical study management• Collaboration across business units and with external stakeholders• Maintain strong professional relationship with principal investigators, KOLs, hospitals
  • Cordis
    Clinical Research Consultant
    Cordis Sep 2017 - Sep 2018
    Brussels Region, Belgium
    The INCRAFT® AAA Stent-Graft System is an advanced Endovascular Aneurysm Repair (EVAR) technology designed for the treatment of infrarenal abdominal aortic aneurysms (AAA). Functions: Involved in strategic and operational clinical study management/consulting of the 150-patient INSIGHT postmarket clinical follow-up (PMCF) study at 25 sites in the European Union to evaluate the safety and effectiveness/performance of Incraft in subjects with abdominal aortic aneurysms (AAA) requiring endovascular repair in routine clinical practice.
  • Medtronic
    Clinical Research Consultant
    Medtronic Dec 2015 - Feb 2017
    Bakken Research Center, Maastricht Area, Netherlands
    Real world ANCHOR registry of Aptus Heli-FX™ EndoAnchor System (Heli-FX) in patients with complex abdominal aortic aneurysm (AAA) anatomy. Functions:• Strategic and operational clinical study management• Collaboration across business units and with external stakeholders• Maintain strong professional relationship with principal investigators, KOLs, hospitals
  • Stryker
    Clinical Research Consultant
    Stryker Sep 2016 - Jan 2017
    Madrid Area, Spain
    The Trevo® ProVue™ Retrieval System is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts.Functions:• Supporting Stryker Neurovascular in developing the Acute Ischemic Stroke (AIS) therapy in Spain, with emphasis on mechanical thrombectomy using the Trevo® Retrieval System.• Working with key stakeholders and KOLs (Interventional Neuroradiologists, Neurologists, EMS) to identify national/hospital-specific hurdles to adoption of mechanical thrombectomy• Acting as a Clinical Resource to clinicians and sales teams, supporting Stryker’s commitment to first class products and therapy knowledge
  • Trivascular, Inc
    Senior Clinical Research Manager
    Trivascular, Inc Oct 2010 - Apr 2015
    Santa Rosa, California
    Senior Manager reporting to VP with the responsibility to lead the European climical affairs team and clinical studies related to Endovascular Aneurysm Repair (EVAR). Experience in pre and post market clinical studies supporting product license applications (CE Mark), market access, and product reimbursement. Trivascular Inc. is a global medical device company focused on the clinical development and commercialization of innovative technologies to advance minimally invasive endovascular repair of abdominal aortic aneurysms (EVAR) using the Ovation® AAA stent graft system.Functions: • Managed start up and implementation of the OVATION registry, the second largest real-world registry for any single EVAR stent graft, in close collaboration with the Commercial Team to engage with new customers and successfully expand into new markets and increase of market share. Execution follow up and reporting of FIM (CE mark study) for Ovation AAA stent graft in Germany.• Established the European clinical organization, including contracting with CROs, vendors and managing direct reports and a team of consultants to coordinate the clinical and regulatory affairs activities in the local markets.
  • Ethicon, Inc.
    Clinical Research Consultant
    Ethicon, Inc. Oct 2010 - Dec 2010
    Madrid Area, Spain
    Generated educational material and presented the clinical and medical aspects of complications with bleeding during surgery in a series of online Webinars for Sales and Marketing staff and HCP to support the Ethicon blood management campaign (2010).
  • Cordis
    Clinical Research Project Manager
    Cordis Oct 2007 - Oct 2010
    Brussels Area, Belgium
    Project Management of clinical trials. Percutaneous Coronary Interventions (PCI). The global e-SELECT registry is one of largest post-market surveillance studies for a drug-eluting stent (DES), conducted in 30 countries and with more than 15,000 patients enrolled. The registry evaluated the safety and performance of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent in routine clinical practice to measure the incidence of acute and late stent thrombosis and Major Adverse Cardiac Events (MACE). Additional analyses were performed in patient sub-populations, such as diabetes, in-stent restenosis (ISR), acute myocardial infarction (AMI) and multivessel coronary disease.Functions:• Managed project, CRAs and global suppliers• Authored several peer-reviewed publications, and podium-presentations/posters• Managed EU clinical study start up; patient recruitment, IRB/IEC approvals• Training of physicians/nurses; investigator meetings• Development of protocol, case report forms, and informed consent• Data management and biostatistics
  • Alma Mater Studiorum – Università Di Bologna
    Postdoctoral Scientist
    Alma Mater Studiorum – Università Di Bologna Sep 2004 - Oct 2006
    Bologna Area, Italy
    Researched the pathophysiology of the Myeloid Dysplastic Syndromes.Key achievements:• Identified Akt kinase in the PI3K signaling pathway as a biomarker that is important in evaluating the pathophysiology of the myeloid dysplastic syndromes and its progression into acute myeloid leukemia.• Leading a drug development project on the effects of perifosine (a novel protein kinase inhibitor) in combination with traditional chemotherapy drugs in different cancer cell models.• Two first-author papers published (4 papers in total).
  • Stockholm University
    Predoctoral Fellow
    Stockholm University Jan 1998 - Jun 2003
    Stockholm, Sweden
    During my doctoral research under the guidance of Professor Uno Lindberg at Stockholm University, I investigated the structural role of actin filaments in cell motility. Our work specifically focused on understanding the conformational changes within the actin microfilament system, which are crucial for cellular movement. This research also explored the broader implications of these structural dynamics, particularly their potential roles in memory formation and consciousness.One of our key findings was the demonstration that the polymerization of gelsolin-capped actin filaments is efficiently promoted by the binding of tropomyosin. We discovered that this process is integral to the formation of the leading edge in advancing cells, a critical step in cellular motility. The intricate regulation of actin filament dynamics, facilitated by proteins like tropomyosin and gelsolin, underscores the complexity of cellular movement and its potential links to higher-order functions.This research not only contributed to the understanding of cellular mechanics but also provided a fascinating lens through which to consider the biological underpinnings of cognitive processes. The actin microfilament system's ability to undergo rapid and precise conformational changes parallels the dynamic nature of neural networks in the brain. The idea that structural plasticity at the molecular level can influence synaptic connectivity, and thus memory formation, presents an intriguing avenue of exploration.My doctoral research not only deepened my understanding of the structural role of actin filaments in cell motility but also profoundly shaped my ongoing interest in exploring the intersection of biology, consciousness, and artificial intelligence. This work has inspired me to continue investigating how the principles of cellular and molecular dynamics can inform the development of AI systems that emulate the complexity of human cognition.

Maria Nyåkern Skills

Medical Devices Abdominal Aortic Aneurysm Endovascular Interventional Cardiology Cell Biology Cardiology Clinical Trials Clinical Development Clinical Research Regulatory Affairs Medical Affairs Management Cross Functional Team Leadership Ce Marking Cancer Regulatory Submissions Medical Writing Gcp Drug Eluting Stents Cell Signaling Sustainability Children's Yoga Organic Cotton Clinical Monitoring Good Clinical Practice Iso 13485 Clinical Evaluation Report Class Iii Medical Devices Medical Device Directive Clinical Research Associates Mdr 2017/745 Medical Device Regulations Iso 14155 Pmcf Post Market Surveillance Clinical Site Management Minimally Invasive Procedures Patient Recruitment Mdr

Maria Nyåkern Education Details

Frequently Asked Questions about Maria Nyåkern

What company does Maria Nyåkern work for?

Maria Nyåkern works for Nyåkern Nexus Research Institute

What is Maria Nyåkern's role at the current company?

Maria Nyåkern's current role is Founder and Director.

What is Maria Nyåkern's email address?

Maria Nyåkern's email address is ny****@****ail.com

What schools did Maria Nyåkern attend?

Maria Nyåkern attended Stockholm University, Karolinska Institutet, Princeton University, Stockholm University, Université Paris Diderot, Stockholm University, University Of California, Berkeley, Broman Gymnasiet.

What are some of Maria Nyåkern's interests?

Maria Nyåkern has interest in Human Rights, Science And Technology, Children, Disaster And Humanitarian Relief.

What skills is Maria Nyåkern known for?

Maria Nyåkern has skills like Medical Devices, Abdominal Aortic Aneurysm, Endovascular, Interventional Cardiology, Cell Biology, Cardiology, Clinical Trials, Clinical Development, Clinical Research, Regulatory Affairs, Medical Affairs, Management.

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