Marlene Schwarz Email & Phone Number

Watertown

SME providing technical expertise and leadership in polymeric material selection, formulation, testing, and imaging techniques for enhancing mechanistic understanding and product performance of Lyndra’s LYNX™ gastric drug delivery platform. • Led formulation development activities of product segments that breakdown at a specific time and pH in coordination with the drug delivery and location within the gastric system. Formulations are under evaluation in clinical trials. • Designed and directed physical characterization / material science studies assessing the impact of material attributes and morphology on product performance. • Championed imaging techniques, including scanning electron microscopy (SEM/EDS), and Confocal Raman Microscopy (CRM) which provided insight into polymer function, performance, and drug delivery mechanism in the gastric environment. Sourced, purchased, maintained, and trained multiple engineers on function of in-house instrumentation critical to process/formulation development and manufacturing. • Collaborated with other members of product development, R&D, and manufacturing teams to resolve technical challenges and issues that arose during scale-up and technology transfer.

Contributed to technology and product development efforts at Boston-area start-up medical device companies; work ranged from polymer materials characterization and analysis, imaging / physical / chemical test method development, coating formulation and process, through review of in vivo experimentation. • Assisted start-up by identifying potential product development and manufacturing organizations (CMO); carried out initial manufacturing feasibility assessment, participated in discussions between client and CMO, and reviewed work proposals, making recommendations regarding CMO selection. • Developed plans to initiate work on a drug eluting device coating, including building an infrastructure capable of generating product for initial feasibility evaluations. • Aided client with development of a bioresorbable polymer drug release coating for the surface of a medical device; evaluated novel test methods through analysis of coating and drug release. • Worked to resolve issue of catheter mechanical failure in vivo; guided analysis and physical understanding and provided insight into issues in manufacturing process impacting catheter quality.

Worked to develop polymeric substrates containing covalently attached lipase for incorporation into a point of care medical device for the digestion of fats in enteral formulas taken by patients with pancreatic insufficiency.

• Technical lead for polymer-drug formulation and coating process development. Recommended potential polymers and formulations to attain varied drug release, and for evaluation in animal studies to assess vascular response to the drug release. Based on the results, formulations were selected and scaffolds prepared for two clinical trials.• Responsible for collecting, analyzing and presenting information on potential drug releasing formulations and comparisons to competitive drug releasing vascular products. • Gathered information and relevant data, organized, and wrote sections of regulatory submission documents, such as, the scaffold and drug CMC sections for an Early Feasibility Submission (EFS) IDE to the FDA, European submissions, and process specifications and related documents.• Developed models of drug dose and release within tissue corresponding to the scaffold geometry.

• Developed the coating formulation and coating process for the TAXUS™ drug eluting stent. BSC sales increased from $2.9B to $5.6B after the TAXUS™ US product launch.• Directed experimentation and wrote sections of the TAXUS™ PMA submission to FDA• Technical leader of multi-site, cross functional team which developed the coating formulation for the next generation Promus™ drug eluting stent; clinical trials were initiated on time in July 2010• Led team that evaluated 300+ different polymers and polymer blends for drug eluting coatings, which included coordination of collaborations with universities and outside companies polymerizing novel block copolymers for drug delivery device/stent coatings• Carried out due diligence to determine BSC investment opportunities in diverse areas such as bioactive / prohealing surfaces, vascular sealants, and new polymeric coatings for drug eluting stents (DES)• Reviewed, analyzed and summarized competitor / landscape patent activity in key product areas, including a monthly patent summary used by BSC legal department to track technology advances• Championed and patented novel coating techniques for medical devices (air suspension, roll coating)

Phd, Chemical Engineering

Dissertation Title: Compatibilization of Immiscible Polymer Blends by the Addition of a Block Copolymer

Bs, Chemical Engineering

Activities and Societies: Tau Beta Phi, Alpha Lambda Delta, Phi Eta Sigma, Regents Scholarship recipient