Experience

Menarini Silicon Biosystems

• Italy
• Biotechnology
• 100 - 200 Employee

• Chief Global R&D Officer

  • Sep 2020 - 3 years 4 months



SCIEX

• United States
• Biotechnology
• 700 & Above Employee

• Chief Technology Officer

  • Jul 2019 - Apr 2020

  Framingham SCIEX, a Danaher Company, is a mass spectrometry manufacturer. Responsible for establishing the company's technology vision, strategies, plans for growth as well as the Program Management Office. Further maintaining and improving technological advancement in the company, monitor technology trends and evaluate how technology can be used to enable new business growth and to preempt a direct or indirect competitor’s attempts to use technology to dislodge SCIEX market position.



PerkinElmer

• United States
• Biotechnology Research
• 700 & Above Employee

• Vice President, Research & Development, Diagnostics

  • Nov 2015 - Jun 2019

  Waltham, MA USA PerkinElmer, Inc. (NYSE: PKI) is a leading provider of products, services and solutions to the diagnostics, research, environmental, industrial and laboratory services markets. Drove innovation, research and development of PerkinElmer's diagnostics product and IP portfolio by leading and managing multiple projects and teams developing novel diagnos-tics including PCR, immunochemistry, mass spec assays, NGS workflow and screening technologies. Led IVD R&D and Program Management… Show more PerkinElmer, Inc. (NYSE: PKI) is a leading provider of products, services and solutions to the diagnostics, research, environmental, industrial and laboratory services markets. Drove innovation, research and development of PerkinElmer's diagnostics product and IP portfolio by leading and managing multiple projects and teams developing novel diagnos-tics including PCR, immunochemistry, mass spec assays, NGS workflow and screening technologies. Led IVD R&D and Program Management organizations of around 400 people, with a budget of more than $50M, in nine different locations across North America, China and Europe, resulting in numerous high value product launches. Reported to President. • Launch of the Vanadis NIPT screening system. This IVD system was developed from feasibility to launch between January 2016 and November 2018. Conversion of the ex-isting customer base to this platform would result in $1 billion additional revenues. • Brought the Ionics Qsight MSMS system from “garage” to IVD market (acquired from Ionics, Bolton Canada) and launched two key mass spec newborn screening assays (Ne-oLSD MSMS kit and NeoBase 2 non-derivatized MSMS kit) testing 80 million babies a year. • Built a Molecular Diagnostics team in China that developed a market leading (by num-ber of donations) multiplex NAT blood screening assay and new viral monitoring assays (HIV, HBV, HCV) with at least comparable performance to the best western competitor. Development and launch of the SuperFlex point of care random access immunoanalyzer in China, with an assay menu based on chemiluminescence detection. Show less



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Vice President, Global Head, Diagnostics Development

  • Jun 2014 - Oct 2015

  Cambridge, MA USA Lead a group of ~70 scientists and engineers to develop companion diagnostic assays sup-porting the Novartis Oncology portfolio. Applied technologies included digital PCR, IHC, FISH, immunochemisty, Sanger and Next Generation Sequencing. My group’s objective was on-time delivery of clinical trial assays (CTA) to enable the trial’s First Patient First Visit (FPFV). Reported to SVP & Global Head CDx. • Initiated a deal between Novartis and ThermoFisher to develop and commercialize… Show more Lead a group of ~70 scientists and engineers to develop companion diagnostic assays sup-porting the Novartis Oncology portfolio. Applied technologies included digital PCR, IHC, FISH, immunochemisty, Sanger and Next Generation Sequencing. My group’s objective was on-time delivery of clinical trial assays (CTA) to enable the trial’s First Patient First Visit (FPFV). Reported to SVP & Global Head CDx. • Initiated a deal between Novartis and ThermoFisher to develop and commercialize to-gether with Pfizer a companion diagnostic on the Ion Torrent NGS platform for non-small cell lung cancer (NSCLC) across multiple drug development programs. • Companion assays were developed or under development for Tasigna, BKM120, MEK162, BGJ398, INC280, PKC412 and BYL. Show less



Diadexus

• Biotechnology Research
• 1 - 100 Employee

• Senior Vice President, Research & Early Development

  • Aug 2013 - Jun 2014

  South San Francisco Responsible for building a research team and creating a strong patent portfolio. Initiated and oversaw nineteen US patent applications (five U.S. utility patent applications and fourteen provisional patent applications) and six PCT applications. This represents in total twelve patent families, which were achieved with a small team of four direct reports and by working cross functionally to harness ideas.



Life Technologies

• United States
• Biotechnology Research
• 700 & Above Employee

• Vice President, R&D, Medical Sciences

  • Aug 2012 - Jul 2013

  Foster City, CA & Benicia, CA • Developed GSK MAGE-A3 gene signature companion diagnostic for an antigen-specific immunotherapeutic in non-small cell lung cancer (NSCLC) and melanoma patients. The assay development was successful, however the drug failed in clinical trial. • Played a key role helping LifeTechnologies to develop IVD instruments for PCR and NGS. March 2013: 510(k) Premarket Notification for the QuantStudio DX Real-Time PCR instrument. September 2014: Filing of the Ion PGM Dx system with the FDA. • Built… Show more • Developed GSK MAGE-A3 gene signature companion diagnostic for an antigen-specific immunotherapeutic in non-small cell lung cancer (NSCLC) and melanoma patients. The assay development was successful, however the drug failed in clinical trial. • Played a key role helping LifeTechnologies to develop IVD instruments for PCR and NGS. March 2013: 510(k) Premarket Notification for the QuantStudio DX Real-Time PCR instrument. September 2014: Filing of the Ion PGM Dx system with the FDA. • Built effective R&D infrastructure to support IVD development programs demonstrated by very high employee engagement scores (81% - 94% engagement index, 90 % - 97% manager index). • Identified acquisition targets for Life Technologies and participated in due diligence. Compendia Bioscience being the key acquisition in our area.

• Vice President, R&D, Molecular Diagnostics

  • Feb 2010 - Jul 2012

  Benicia, CA Responsible for the development of Life Technologies' standards, calibrators and controls under AcroMetrix brand name. Reported to GM Molecular Diagnostics. • Shifted focus of R&D from infectious diseases to oncology and Next Generation Se-quencing (e.g. FFPE-based oncology materials to control Next Generation Sequencing work flow). • Successfully integrated AcroMetrix into Life Technologies, without losing any R&D re-sources. AcroMetrix increased its growth rate (> 20%) and market… Show more Responsible for the development of Life Technologies' standards, calibrators and controls under AcroMetrix brand name. Reported to GM Molecular Diagnostics. • Shifted focus of R&D from infectious diseases to oncology and Next Generation Se-quencing (e.g. FFPE-based oncology materials to control Next Generation Sequencing work flow). • Successfully integrated AcroMetrix into Life Technologies, without losing any R&D re-sources. AcroMetrix increased its growth rate (> 20%) and market share after the first year of integration. • Oversaw development of the EZ Validation software to allow validation of lab developed assays using AcroMetrix materials. • Built R&D and manufacturing capabilities supporting SynTura virus technology in the U.K. SynTura represented up to 30 % of AcroMetrix revenues.



Acrometrix

• Vice President, Research & Development; Corporate Officer

  • Apr 2006 - Jan 2010

  Benicia, CA Led innovation, product strategy, R&D and design control processes. • Participated as corporate officer in successful sale of the company. One of three key individuals to represent AcroMetrix on the Deal Team in its formal sale process. • LifeTechnologies demanded as a prerequisite for the deal for me to commit to stay for at least three years, the only employee on whom the deal was contingent. • Built effective Research and Development organization. Launched over 30 new products… Show more Led innovation, product strategy, R&D and design control processes. • Participated as corporate officer in successful sale of the company. One of three key individuals to represent AcroMetrix on the Deal Team in its formal sale process. • LifeTechnologies demanded as a prerequisite for the deal for me to commit to stay for at least three years, the only employee on whom the deal was contingent. • Built effective Research and Development organization. Launched over 30 new products between April 2006 and February 2010, including IVD blood screening products. New product launches led to near doubling of AcroMetrix sales within 3 years. • Developed standardized materials for Qiagen/DXS therascreen KRAS RGQ PCR Kit, enabling successful FDA submission as a companion for Erbitux and Gilotrif. • Increased product value proposition. Minimized lot to lot variability, showing no drift over time, allowing us to charge a 30% plus premium. This resulted in im-proved gross margin also by lowering COGS and manufacturing scrap rate. • Wrote, established and maintained an ISO 13485 and FDA QSR compliant design control process. • Identified a scientific network of KOLs for scientific direction and strategic. • Shifted strategy from infectious diseases to oncology and Next Generation Se-quencing. Show less



Roche

• Switzerland
• Biotechnology Research
• 700 & Above Employee

• Research Leader

  • Feb 1997 - Apr 2006

  Pleasanton, CA Responsible for development of complex assays on new systems • Led development of the Roche Cobas TaqMan HIV-1 test on fully automated COBAS AmpliPrep/COBAS TaqMan system. US (PMA), European (CE) and Japan (IVD). • Representing reagents development during system development of the COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) system. • Headed team that developed sample prep chemistry for the CAP/CTM system. • Launched COBAS TaqMan HIV-1 test for low/medium throughput market (CE-IVD). •… Show more Responsible for development of complex assays on new systems • Led development of the Roche Cobas TaqMan HIV-1 test on fully automated COBAS AmpliPrep/COBAS TaqMan system. US (PMA), European (CE) and Japan (IVD). • Representing reagents development during system development of the COBAS AmpliPrep/COBAS TaqMan (CAP/CTM) system. • Headed team that developed sample prep chemistry for the CAP/CTM system. • Launched COBAS TaqMan HIV-1 test for low/medium throughput market (CE-IVD). • Led international Japanese, Swiss, US team to develop real time nucleic acid test for the detection on Mycobacteria; assay was approved in Japan 6 months ahead of schedule.

• Director, Development

  • Dec 1992 - Jan 1997

  Kaiseraugst, Switzerland Responsible for the development of the COBAS® Core anti-HIV-1/2 DAGS assay - the worldwide first fully automated anti-HIV test