Erika Dahl, Phd Email & Phone Number

Cambridge, Massachusetts, Us

Cambridge, Massachusetts, Us

Cambridge, Massachusetts, Us

Boston, Massachusetts, Us

•Provides program management lead for cross-functional teams (CMC, non-clinical, etc.) in early and late stage clinical development programs •Provides strategic regulatory guidance and support for the development of small molecule and biologic pharmaceutical products in the following therapeutic areas: cardiovascular disease, spinal cord injury, oncology, and gastroenterology (ulcerative colitis). •Author regulatory submissions including Type B meeting requests and briefing documents, Type C meeting requests and briefing documents, Scientific Advice briefing documents, IND submissions, CTA submissions, IND amendments, CTA amendments, IND annual reports, and Development Safety Update Reports. •Analyzes and develops various Quality Management System documents such as Quality Policy(ies) and Standard Operating Procedures.•Management of clinical trial operations including CRO selection, site start-up activities, and ongoing clinical trials.• Provides strategic development recommendations for pre-clinical products including indication assessment and clinical development planning. •Participates in strategic implementation of remediation activities for clients seeking to close organizational competency gaps that threaten compliance and quality.•Performs organizational and clinical trial gap analyses for clients experiencing significant growth or internal and/or external change.•Performs clinical due diligence for clients undergoing potential acquisition, mergers or investment.•Conducts literature reviews by gathering, interpreting, extracting, and summarizing data from relevant articles.

Boston, Massachusetts, Us

•Provides project management lead for cross-functional programs (CMC, non-clinical, etc.) in early clinical development including oversight of timelines and budgets.•Provides strategic regulatory guidance and support for the development of small molecule and biologic pharmaceutical products in the following therapeutic areas: cardiovascular disease, spinal cord injury, oncology, and gastroenterology (ulcerative colitis). •Author regulatory submissions including Type B meeting requests and briefing documents, Type C meeting requests and briefing documents, IND submissions, CTA submissions, IND amendments, CTA amendments, IND annual reports, and Development Safety Update Reports. •Analyzes and develops various Quality Management System documents such as Quality Policy(ies) and Standard Operating Procedures.•Management of clinical trial operations including CRO selection, site start-up activities, and ongoing clinical trials.

Boston, Massachusetts, Us

- Provides project management a variety of clients in clinical and quality development. - Provides strategic development recommendations for pre-clinical products including indication assessment and clinical development planning. - Participates in strategic implementation of remediation activities for clients seeking to close organizational competency gaps that threaten compliance and quality.- Performs organizational and clinical trial gap analyses for clients experiencing significant growth or internal and/or external change.- Performs clinical due diligence for clients undergoing potential acquisition, mergers or investment.- Conducts literature reviews by gathering, interpreting, extracting, and summarizing data from relevant articles.

Stella, a Blue Cross and Blue Shield of Minnesota company, is a strategic partnership company seeking to make healthcare easier to navigate.Work directly with the Stella team to summarize and identify favorable markets and competitors for a biometric screening tool.

Minneapolis And St. Paul, Minnesota, Us

Research focused on investigating differential regulation of signaling cascades in cardiac myocytes using a variety of approaches including primary cell culture, advanced confocal microscopy, molecular biology, and viral production. Recipient of Department of Pharmacology Matriculation Scholarship Led team research with Ph.D.s at the University of Minnesota Imaging Center to develop an advanced microscopy technique never achieved in mouse heart cells Co-authored two publications in Cell Signaling (cited thirty-six times) and The Journal of the American Heart Association (cited ten times). Published first author book chapter in Methods in Molecular Biology (cited one time)Oversee undergraduate researcher activities including experimental design and execution. Oral Presentations:International Society for Heart Research-North American Chapter Meeting (May 2017)Integrative Biology and Physiology Summer Student Colloquium (June 2016)Pharmacology Oral Preliminary Examination (August 2014)Pharmacology Second Year Student Talk (October 2013) Poster presentations:International Society for Heart Research-North American Chapter Meeting (May 2017) Zofia Zukowska Distinguished Lectureship (September 2016)Pharmacology Retreat (September 2015, September 2016, and September 2017)Cardio-Palooza (July 2015, July 2016, and July 2017)Visscher Symposium (May 2013, May 2014, May 2015, May 2016)Milne-Brandenburg Biomedical Research Recognition Day (May 2013 and May 2014)Other accolades:Number one chosen early career investigator abstract at the International Society for Heart Research-North American Section Meeting (May 2017).

Minneapolis And St. Paul, Minnesota, Us

National Institutes of Health funded commercialization strategy hub for University of Minnesota innovators interested in developing new technologies to address health problems.Work directly with over twenty faculty (average five faculty per cycle, four cycles completed) to develop commercialization strategies, regulatory and reimbursement pathways, and competitive intelligence analysisSupported projects have included pharmaceuticals, medical devices, and mobile applications. Faculty directly cite these items in applications for funding to the National Institutes of Health. The National Institutes of Health have commented on the merit of including this information. Organize and design web-based resources for current and future faculty applicants.Project management of deadlines, disbursements, and milestones

Minneapolis And St. Paul, Minnesota, Us

Analyzed the current intellectual property landscape through patent searches of epinephrine auto-injectors for use in establishing a portfolio for the pharmaceutical company, AdrenaCard Delivered in-depth report and oral presentation on the current $3.6 billion epinephrine auto-injector market which included key companies, market data, trends, and device comparisonsMarket reporting established future market potential in diabetes and psoriasis for AdrenaCard

Identified favorable medical soft tissue injury indications for compound pharmaceutical usingprimary scientific literature with the goal of moving toward a 340B pricing strategy.

Performed competitive intelligence analysis on the $107 billion global oncology market for a pre-market oncology pharmaceutical to identify market favorable lead compoundsGave recommendations of initial patient population for clinical trial design by analyzing clinical trial information, scientific literature, disease statistics, and current treatment modalities Performed patent and scientific literature searches for intellectual property analysis for drug repositioning company which established freedom to operate for their compounds of interest

Delivered due diligence report for a pre-market nanomedicine delivery platform that included summary of the platform’s technology, regulatory and technical background, and comparative analysis for fifteen other nanomedicine products Presented an oral presentation and written document to the board at Gopher Angels allowing them to confidently invest

Doctor Of Philosophy (Ph.D.), Pharmacology

Bachelor'S Degree, Biology, General

Human Biology