Dessy Long

Project lead of two global multi-site Phase I Immuno-Oncology studies (USA, EU, Australia); Set goals and overall strategy for successful execution of the clinical programs; Effectively manage projects with 20+ team members; Communicate program progress to senior management, ensuring advancement and transparency; Mitigate program risks; Sponsor oversight of vendors including regulatory submissions; Monitor clinical program study progress, ongoing review of clinical data, ensuring patient safety and GCP compliance; Manage a key collaboration with Roche; Oversee IP clinical supply and logistics, support CMC activities; Comprehensive review of study documents, incl. protocol amendments, ICF, DSUR, and CSR; Management of multi-million budget resulting in increased efficiency and 15% cost savings, incl. CRO contract negotiations.

Coordinate the activities of two Phase 1 immuno-oncology clinical studies and oversee the clinical operations of one Phase 1 immuno-oncology clinical study

Lead the operational and project management execution of two global Phase II studies in chronic hepatitis B and one multi-site Phase I oncology study; Implemented strategic operational improvements reducing timelines on average by 20%. Contributor to trial protocol design, integrating innovative methodologies. Timely provided crucial data for study decision-making. Developed presentations for Investigator meetings, DSMB meetings, SIVs, and lead site training. Managed study budget proactively, preventing cost overruns. Provided support to Pre-Clinical, Regulatory and CMC teams towards IND filing.

Established a comprehensive project management system for one phase I clinical study in rare mitochondrial diseases and for a large discovery R&D program ensuring the successful delivery of the teams’ objectives. Designed SharePoint site, serving as company’s main site for storage and sharing of data and reports. Identified, mitigated and communicated program risks to relevant stakeholders

Managed the bioanalytical activities for numerous phase I clinical studies (DDI, TQT, hAME, Absolute bioavailability, Hepatic impairment), and one phase III clinical trial which lead to the FDA approval of Sparsentan for IgA nephropathy; Oversaw over 80 preclinical studies; responsibilities included: management of GLP and non-GLP ADME, toxicology, pharmacology and bioanalytical studies to ensure studies are completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines; responsible for budgeting and forecasting of over $10-million for two clinical stage programs; development of documentation (including SOWs and CDAs) for contracting CROs and consultants; problem-solving of development issues through close interaction with R&D groups and CROs

 Set basis for and managed the first nano-lab at the VA for integrating nanotechnology and medicine in relevance to new therapeutics for hemophilia.  Independently conducted interdisciplinary research for determining the local blood coagulation at the single cell level.  Developed and implemented methods for screening of single proteins with preferential binding to different membrane curvatures with application in targeted drug delivery.  Trained postdoctoral fellows and medical doctors in Atomic Force Microscopy, Confocal, and Laser Scanning Microscopy techniques.

 Introduced a novel method for determining the focal adhesion of living migrating cells using AFM-Force Spectroscopy.  Managed a project for studying stem cells aging and its application in regenerative medicine by applying a fast and effective nano-indentation technique.  Oversaw an interdepartmental project on determination the mechanical properties of individual actin bundles involved in the acrosomal process of Limulus polyphemus.  Tutored researchers in nano-techniques during the Global Enterprise for Micro-Mechanics and Molecular Medicine Summer School

 Developed novel biomarkers for Cystic Fibrosis based on cell elasticity and single-molecule Quantum-dot fluorescence.  As visiting scientist at the University of Linz, Austria (2005) demonstrated for the first time individual antigen-antibody interactions on red blood cells utilizing innovative nano-recognition imaging.  Established long-term collaboration between the labs from Muenster and Linz.  Mentored two graduate students.  Taught human physiology course for medical students

 Established AFM-based methods for visualization of DNA packaging dynamics within chromatin fibers at a nanometer resolution.  Described the dynamic recognition of DNA lesion by single photolyase, in relation to skin cancer.  Taught incoming graduate students in lab based techniques.

Used advances in AFM and nanotechnology to gain new insights into the structure-function relationship of vital biomolecules. The findings have implications in the fundamentals of cancer research and drug discovery. Received national media coverage (prime-time Dutch TV news).

Dissertation: Adhesion of blood cells on modified glass surfaces. Designed a device for efficient and cost-effective biocompatibility testing.