Cambridge, Massachusetts, United States
Multidisciplinary scientist and leader with 17+ years experience advancing medical technology across all stages of research and development. 8 years direct personnel management experience with strong ability to collaborate across functions, internally and externally.
• Clinical imaging lead for Takeda Oncology and core Product Team member, accountable for oncology imaging strategy and execution from translation through Ph3 (protocol design, CRO selection/oversight, image-derived endpoints, data interpretation/communication, discovery research integration, BD&L due diligence). • Led collaboration with a Dutch academic imaging center to Zr-89 radiolabel the ADC study drug, including CMC tech transfer, cGMP labeling methods, hot IMPD for EMA CTA, and ops workflows for a First-in-Human PET substudy (NCT03449030). • Led Takeda’s participation in a precompetitive collaboration with ImaginAb, Pfizer, and AZ evaluating a CD8+ T-cell diagnostic radiotracer in ICI-treated patients (NCT03802123), aligning objectives, data-sharing, and timelines across partners. • Supported the clinical development of innovative immuno-oncology (SUMOylation inhibitor, anti-CD38 attenuated IFNα fusion), conditionally activated bispecific T cell engager, cell therapies (cord blood-derived allo CAR-NK and IL7-CCL19 armored auto CAR-Ts), and the Ph3 for mobocertinib. • Defined and executed the oncology image data analytics strategy including development of a deep-learning model to quantify MTV from FDG PET in a Phase 1 allogeneic CAR-NK cell therapy. • Provided interim imaging leadership for rare disease programs post-Shire acquisition, including neonatal brain MRI in a Ph2b, and imaging support for gene therapy assets built on a liver-expression AAV platform. • Collaborated cross-functionally (clinical development, discovery, clinical pharmacology, etc.) on biomarker plans and imaging biomarker development, translation, and deployment. • Initiated and led a cross-functional Cell Imaging Working Group to develop novel imaging methods for tracking the fate of cell therapies, including collaboration with UCSD on MRI-based cell imaging technology. • Represented Takeda in external consortia including the FNIH Biomarkers Consortium and the ImmuneImage IMI.
• Led the Research Imaging Sciences team and was accountable for translational imaging strategy and execution across Oncology, Cardiometabolic Disorders, Inflammation, and Neuroscience therapeutic areas, including leadership over an $8M facility containing PET, SPECT, CT, MRI, optical imaging, radiolabeling, and data analysis capabilities. • Oversaw functional budget planning and execution, prioritized portfolio level imaging activities, and managed external collaborations with CROs and academic partnerships to deliver innovative studies on time and within budget. • Served as imaging SME across Amgen R&D, including on development teams, in BD&L due diligence for imaging-related technologies, and on cross-functional teams focused on imaging study design, while communicating strategy, progress, and results to stakeholders and R&D leadership. • Contributed translational imaging data and analyses to support resubmission of romosozumab (EVENITY®) BLA [761062] to the FDA, helping to successfully address key cardiovascular safety questions. • Led development of cardiac MRI methods for preclinical heart failure models including T1-mapping measurement of cardiac fibrosis, quantification of right ventricle pathology in PAH, late gadolinium enhancement to measure MI, and MRS of PCr/ATP ratio.
• Drove end-to-end build-out of radiolabeling facilities for peptides and large-molecules, recruited and managed a PhD, postdoc-trained radiochemist dedicated to imaging probe development. These capabilities delivered impactful results for multiple programs including assessing half-life extension technologies for the bispecific T-cell engager (BiTE®), measuring biodistribution of non-opioid analgesics targeting Nav1.7, and developing novel imaging probes to track T cells for immuno-oncology programs. • Established collaborations to source small-molecule PET tracers from UCLA, USC, and SOFIE Biosciences, including the bespoke PDE10A PET tracer AMG 580, 18F-FAC for T cell imaging in immuno-oncology programs, 18F-FTHA for assessing fatty acid metabolism in cardiometabolic programs, and 18F-FHBG for understanding the MoA of IMLYGIC® (1st FDA-approved oncolytic virus), and experiments to support out-licensing of AMG 479 to NantWorks, LLC. • Proactively communicated with cross-functional stakeholders to identify early opportunities for imaging to impact programs, contribute to biomarker plans, anticipate future imaging technology needs, and establish and align team expectations. • Generated imaging data and analyses for biomarker plans, early Proof of Concept studies, safety assessments, and Mechanism of Action studies.
• Recruited to the newly formed RIS department to build and lead its Nuclear Medicine Laboratory; established a $2.5M state-of-the-art PET, SPECT, and CT imaging lab, SOPs, and data analysis workflows. Managed the lab budget, academic collaborations, outsourced studies, and managed one direct report. • Collaborated with cross-functional team in all Therapeutic Areas to conceive, design, execute experiments, and to analyze, interpret, and present data to management on behalf of teams. My work impacted numerous program decisions, resulted in two publications, two invited lectures, and identified a PET imaging biomarker for a First‐In‐Human trial of an anti‐proliferative therapy (highlighted in an invited lecture to Nature.com). • Successfully proposed a lab expansion to management (impact, budget, FTE) by working with program teams to identify the compelling scientific needs, using outsourced vendors to generate proof-of-concept data, and by partnering with Facilities and EHS to calculate construction costs and timelines. • Managed one direct report, completed Amgen Management Training (Performance Coaching, Leveraging Differences), served as PI of Imaging department's IACUC protocol, and served on the Amgen Radiation Safety Committee.
• Established cGMP production of an immuno-PET radiopharmaceutical for an industry-sponsored First in Human PET radiotracer trial, including transferring the bench-scale radiolabeling to clinical scale in the GMP suite, cGMP batch process documentation and release criteria, validation runs, cGLP product characterization, and successful sponsor QA audit. • Developed innovative molecular imaging tracers and methods for oncology and cardiovascular applications, including PET and infrared imaging of photothermal tumor ablation using gold nanoparticles which resulted in a highly cited publication and widespread press coverage. • Recipient of postdoc travel award to the 18th International Symposium on Radiopharmaceutical Sciences to present on a novel Cu-64 PET tracer and Ga-68 generator evaluation.