David Rolf Email & Phone Number

Maple Grove, Minnesota

Philips bought Spectranetics in July, 2017. Supported the US market launch of Stellarex with published technical rationale for the outstanding clinical performance of this Drug Coated Balloon, especially in calcified lesions. Established stability program and technical know how for Stellarex products.. Led the design and execution of chemical degradation analysis studies evaluating safety of a new interventional technology being developed. Mentoring people in the development of intellectual property and exploration of new technologies. Participating in the Advanced Development Group focusing on identifying and evaluating new commercial technologies for treating and characterizing peripheral and coronary artery disease.

Maple Grove, Mn

Transitioned to Spectranetics as a result of a technology acquisition. Set up stability programs required for both foreign and US launches for Stellarex which was used for subsequent products.. Provided experienced guidance regarding establishing specifications, testing methodology, including validation, biological testing, and justifications of strategies. Expert at chemical and physical analysis and how to do it or where to get it done. Actively participated in the submission and FDA interactions associated with the Stellarex PMA submission. Achieved 2 year stability claim at launch for Stellarex. Broad ranging knowledge and experience including patents and IP development. Chemical expert with engineering practicality.

Plymouth, Mn

Developed anti-restenotic designs for peripheral artery disease, including drug coated balloons (DCB) for peripheal angioplasty. Specifics include test method development and validation, specification development and justification for drug coating components, mechanism of action investigations, and stability studies for US and OUS products. Supported PMA and IDE communications which launched one product in EU. Served as internal consultant to team members on a few different projects.

Maple Grove

Specified drug delivery coating materials on Drug Eluting Stents (DES), lubricious and release coating, novel closure devices and biodegradable polymers. These responsibilities utilize extended skills through other team members including test method evaluation, development, and validation, creation and modification of material specifications, writing portions of reg submissions, and intellectual property development. Mentored junior team members.

Minnetonka, Mn

OEM manufacturer of cardiac medical electrodes (monitoring, defibrillation, pacing), medical tape, and transdermal drug delivery devices. Sales around $15MM. Customers included Novartis, JnJ, Tycho, HP, Beiersdorf, Physio Control, EMPI, others. Broad experience in product discovery and development in a GMP environment. Experienced working with Quality, Regulatory, Manufacturing, Clinical and Marketing/Business development. Built R&D Team which evolved to spawn QA and Engineering departments. Led the development of intellectual property which produced significant business opportunities, royalties, and infringement settlements.

Mendota Heights

Worked in central research. Projects included polyacrylate synthesis and N-oxide surfactant synthesis in a novel polymer melt, fermentation products, and biodegradable polymers.

Phd, Bioorganic Chemistry

Activities and Societies: ACS, AAPS, Controlled Release Society

Bachelor Of Science (Bs), Chemistry

Activities and Societies: ACS student chapter