Maria Nyåkern Email & Phone Number

Sweden

Madrid, Community Of Madrid, Spain

Madrid, Community Of Madrid, Spain

Madrid

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.

Swedish delegate and expert, ISO/TC194 WG 1 and WG 4

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.

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.

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.

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

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

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.

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

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

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.

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).

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

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, 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.

Philosophiae Doctor (Ph.D), Cell Biology

Activities and Societies: DISSERTATION: Actin microfilament dynamics ISBN 91-7265-646-8During my doctoral research under Professor Uno.

Department Of Microbiology, Tumor And Cell Biology (Mtc), Electron Microscopy

Used the Electron microscopy (EM) technique for obtaining high resolution images of individual actin filament specimens. We wanted.

Ph.D. Exchange, Biochemistry And Molecular Biology

Activities and Societies: Collaboration with Princeton University (1999-2001): Biochemistry and structure of actin and actin-binding.

L.Sc, Cell/Cellular And Molecular Biology

SPECIALIZATION: Actin micofilament dynamics and it’s role in muscle contraction and cell motility.

Maitrise 4Th Year, Virology And Molecular Biology

SPECIALIZATION: Virology and Molecular Biology

Master Of Science, Molecular Biology

SPECIALIZATION: Recombinant protein: mutating amino acids in actin to investigate its role in muscle contraction and cell motility.

Italian Studies

High School Diploma, Natural Sciences