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.

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.
• 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..
• 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.

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.
• 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.
• 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.
• 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.

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.
• 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

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.

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 to.

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