Scott Vanderwerf Email & Phone Number

Minneapolis, MN, US

Minneapolis, MN, US

Seongnam-si, KR

• Developed global regulatory strategies and clinical research programs to support the development of wearable drug delivery systems, including a wearable closed-loop automated insulin delivery device
• Planned/directed clinical studies in Australia and U.S.
• Led regulatory affairs, including European submissions (CERs) and pre-submissions/communications with the FDA

Seongnam-si, KR

• Provided regulatory, quality and clinical support as required for FDA compliance and CE marking
• Wrote and reviewed documents such as clinical protocols, human factors protocols, IFUs, DFMEAs/FMEAs, etc.
• Authored company’s first CER application and led interactions with the notified body

• Criterion Edge provides regulatory writing services for the medical device, pharmaceutical and biologic industries.
• Managed clinical evaluations of medical devices for EU MDD and MDR certifications
• Authored and reviewed clinical evaluation reports (CERs) and clinical evaluation plans (CEPs)
• Led interactions with clients
• Managing timelines and deliverables compatible with client-specific processes
• Led/trained teams of medical writers to complete projects within tight deadlines

• Authored and reviewed CER sections in accordance with EU guidelines, e.g., state-of-the-art evaluations, screening/appraisal of literature, extraction and analysis of clinical data, and demonstration of equivalence

Portland, Oregon, US

• Circumvent Pharmaceuticals is a drug discovery and development company focused on inherited neurodegenerative diseases.
• Developed regulatory strategies for a small-molecule drug to treat Batten disease, a rare pediatric neurodegenerative disease
• Prepared pre-IND briefing package and EU pediatric investigation plan
• Identified new therapeutic indications, collaborations and strategic partnerships

• Pacific Diabetes Technologies (PDT) is developing technologies that combines continuous glucose monitoring and insulin infusion into a single device for patients with type 1 diabetes. My roles included:
• Developed short-term and long-term regulatory strategies that aligned with company strategic goals.
• Led all interactions with the FDA. Composed and submitted regulatory documents, including IDE applications, amendments, supplements, pre-submissions, meeting materials and responses to inquiries.
• Directed preclinical and clinical studies. Management of clinical trials included serving as the liaison to clinical teams, composing clinical trial documents (such as protocols, case report forms, training materials.
• Provided guidance to chemistry, engineering and QA teams to improve device performance, safety and user experience.
• Directed intellectual property strategy, managed patent portfolio, prepared patent applications, communicated with patent offices, and composed responses to office actions.

My roles included regulatory affairs, clinical development, research, and patent management.

Portland, Oregon, US

HIGHLIGHTS: Evaluated new OHSU technologies for patentability and commercial potential, identified and built relationships with licensing partners, and assisted with the development of term sheets (financial modeling, researching deal comparables, etc.).

Portland, Oregon, US

While conducting postdoctoral research in three OHSU laboratories, I studied molecular mechanisms and identified potential therapeutic targets for (a) methamphetamine (METH) addiction, (b) the parasitic disease leishmaniasis, and (c) Amyotrophic Lateral Sclerosis (ALS). HIGHLIGHTS: Designed innovative proteomics-based strategies to measure METH-induced.

Doctor Of Philosophy (Ph.D.), Biochemistry And Molecular Biology

Bachelor Of Science (B.S.), Biochemistry

Technology Entrepreneurship Certificate Program