Expertise 2017-03-22T12:04:03+00:00

Our Experts

Veteran expertise spans the lifecycle of translational medicine
We're sorry, there are no results for "".
  • Angelina Bisconte

    Scientific Business Development Manager

    Authority in utilizing human primary biological tissue and cells in research and drug discovery. Developer of translational biomarkers for Phase I/II clinical programs in autoimmunity, inflammation and cancer. Expert in phenotypic cell-based assays using multiple primary cell systems such as T/Th17/T-regs, NK-T, B/Plasma/Plasmablasts, Myeloid cells, Dendritic cells (pDCc/mDCs), and MDSCs. Strategist in multi-parametric single-cell flow cytometry and analysis of flow cytometry data. Broad network of contacts at clinical sites and research hospitals, experienced with IRB submissions and clinical protocols. Scientific leader for Precision’s Biomaterials commercial sourcing.

    Name here
    979.575.4865
  • Anita Mehta-Damani, PhD

    Senior Vice President

    Expert in cellular immunology, vaccines, immuno-oncology, gene therapy, and personalized medicine. Extensive proficiency in innovative assay design, development, and validation for various bioanalytical methods including flow cytometry, ELISA, receptor-binding assays, and potency assays. Proven entrepreneur with extensive experience in academia and industry.  Successfully collaborated with over 75 companies to advance many therapeutic compounds from preclinical research into commercialization.

    Name here
    408-203-1381
  • Austin C. Speier

    Vice President Emerging Technologies

    Leading expert specializing in the design and execution of to-market regulatory and evidence development strategies for innovative, first-in-class medical products. Worked on over 200 medical devices, medical apps, diagnostics, and therapeutics across all clinical areas, with a focus on developing a strong evidence base, managing development risk, and securing product approval. Experience includes work with VC firms, strategic partners, and other investors to evaluate business opportunities and guide portfolio companies.

    Name here
    240-654-0730
  • Chad Clark

    President

    Recognized industry leader focused on combining cutting-edge technology, strategic program design, and operational excellence to help life sciences companies effectively address the increasing evidence demands and need to accelerate research initiatives. Previous experience spans the execution of phase I-IV clinical trials, specialty lab services, biospecimen logistics and banking, risk management, and patient support initiatives.

    Name here
    240.654.0730
  • Christopher A. Ellis

    Senior Director Business Development, Precision Oncology

    Long-established international clinical research executive, with a strong background in oncology clinical research. Specific expertise in support of Phase I-III programs. Serves as the primary business development contact for biotech and pharmaceutical clients on the east coast.

    Name here
    908-237-3227
  • David Parker, PhD

    Senior Vice President Diagnostics Solutions

    Strategic visionary and healthcare industry veteran operates at the intersection of reimbursement, health economics, clinical science, and marketing strategy. Expertise encompasses all aspects of market access, reimbursement, and evidence development strategy, with a particular focus on personalized medicine, advanced molecular and companion diagnostics, and targeted therapies. Has launched successful products, guided major investment and acquisition decisions, and driven favorable coverage and payment determinations by public and private payers alike. Speaker and author.

    Name here
    240-654-0741
  • Deborah Phippard, PhD

    Senior Vice President Research

    Pharma industry veteran and expert at biomarker-driven clinical trial design and execution. Led biomarker and drug development programs for pharmaceutical and diagnostics companies, as well as the National Institutes of Health. Spearheaded the discovery of pharmacodynamic biomarkers and novel targets for inflammatory disease therapy.

    Name here
    240.306.4115
  • Eugen Koren, MD, PhD

    Chief Science Officer Immunology

    Industry-leading expert in the immunogenicity of therapeutic proteins and gene therapy products. Leads development, validation, and implementation of assays for anti-drug antibodies. Assesses risks associated with anti-drug antibodies and predicts immunogenicity. Develops, validates, and implements PK assays for biotherapeutics.

    Name here
    240.654.0730
  • Gerald Messerschmidt, MD, FACP

    Chief Medical Officer Precision Oncology

    Oncologist, hematologist and vetran expert in clinical research, clinical practice, pharmaceutical, biologic products, medical devices, molecular biology, and immune modulation therapy. A primary consultant to the Moonshot 2020 program and authority in efficient clinical trial design that leads rapidly to product approval. Has continuous experience and ongoing credibility with the FDA and regulatory authorities in Europe, Japan, and other countries worldwide.

    Name here
    908-237-3227
  • Jared Kohler, PhD

    Senior Vice President Translational Informatics and Biometrics

    Extensive industry expertise across the pharmaceutical and biotech space—translational research, data management, and statistical support—with a focus in precision medicine-guided efforts in drug and diagnostic development. Subject matter expert in genomics. Pioneered approaches in biomarker data management and has led Biometrics operations on over 70 clinical studies.

    Name here
    240.306.4109
  • Jeffrey D. Seroskie, MS

    Vice President Precision Oncology

    Manages the execution and delivery of all clinical trials to ensure the highest quality service to its growing client base. Oversees the global governance for trials involving global partners. Has been a key member on the development teams for multiple registered products: Taxotere® (docetaxel), Tykerb® (lapatinib), Revlimid® (lenalidomide), Thalomid® (thalidomide), and Kyprolis® (carfilzomib).

    Name here
    908-237-3227
  • Judi Smith

    Vice President In Vitro Diagnostics and Quality

    Expert in IVD services spanning regulatory strategy, analytical and clinical study designs, protocol development, all FDA pre-market and post-market submissions, software lifecycle documentation, quality-system establishment, and laboratory developed test set-up per CLIA and FDA regulations.

    Name here
    240.316.3377
  • Julia Amo, MBA, PMP

    Chief Operating Officer Precision Oncology

    Expert strategist for the pharmaceutical, CRO, and healthcare industries. Offers extensive multi-disciplinary drug development experience at the project, compound, and portfolio levels. Takes a sophisticated approach to the operations, infrastructure, and growth of Precision Oncology.

    Name here
    908-237-3227
  • Karen M. Becker, PharmD

    Managing Director Translational and Regulatory Sciences

    Industry veteran focused on achieving FDA approvals for important new products. An authority on the strategic executions needed for truly innovative therapies to navigate the complex intersection of science, policy, and business. Expert in the entire FDA submissions process—including complex regulatory strategies, resolving significant post-market safety and regulatory compliance issues. Creator of many successful clinical and regulatory solutions for investors and their emerging companies, as well as global healthcare companies.

    Name here
    240-654-0737
  • Karen Richards

    Vice President In Vitro Diagnostics and Quality

    Leader and innovator in the GMP/ISO/FDA/EU-regulated in vitro diagnostic (IVD) industry. Spearheads regulatory approvals worldwide for both novel and traditional IVD assays and products, as well as laboratory developed tests in the United States. Builds ground-up quality systems, meeting the requirements of US FDA, ISO 13485, CLIA, and CAP.

    Name here
    530-885-8970
  • Merry Lee Bain, MS

    Vice President Medical Devices

    Industry veteran and renowned expert at guiding new medical devices through the FDA approval process, including the development and management of FDA submissions and the design and oversight of preclinical and clinical studies. Integral team member in the development of numerous devices, including implants, tissue-based devices, interventional radiology devices, and combination products, including antimicrobial-based devices.

    Name here
    240.316.3378
  • Patricia Devitt Risse, PharmD

    President Precision Oncology

    Executive leader of Precision Oncology. Founded ACT Oncology. Guides strategic protocol design and study optimization on behalf of the company’s sponsors. Has extensive experience in Phase I-IV trials for most indications, including solid tumor and hematologic malignancies. Leads integrated teams to combine the strength of biomarker insights with clinical outcome data to optimize the development pathway.

    Name here
    908-237-3227
  • Patricia Terek, MSc

    Senior Director Business Development, Precision Oncology

    Healthcare industry veteran of 30+ years bridges business development efforts and program implementation for optimal client satisfaction. Serves as the primary business development contact for biotech and pharmaceutical clients on the west coast.

    Name here
    908-237-3227
  • Rajiv Mahadevan, MBA

    Managing Director

    Key strategist with broad management expertise spanning operations, sales, business development and program management across the life sciences industry. Co-founded Applied Immunology that was acquired by Precision in 2016. Served as global health strategist for the Bill & Melinda Gates Foundation. Led business development efforts at 23andMe. Was centrally engaged in product development and commercialization for a multi-billion dollar novel therapeutic at Amgen.

    Name here
    650.387.1621
  • Robert Ott, MBA

    Vice President Business Operations, Precision Oncology

    Deep knowledge of the contract research/pharmaceutical services industry developed over 20+ years in the field. Provides project leadership and executive support to clients and directs operational functions, resourcing, and business strategy internally, structuring Precision Oncology operations to match client needs.

    Name here
    908-237-3227
  • Scott Marshall, PhD

    Managing Director Translational Informatics and Diagnostic Sciences

    Extensive industry expertise across the pharmaceutical and biotech space—Dx regulatory submissions, translational informatics, biomarker R&D—with a focus in precision medicine-guided efforts as well as strategy development and medical device/diagnostic development. Globally responsible for translational informatics R&D efforts. Has led the development of novel methodologies for patient stratification and biomarker guided clinical trial design.

    Name here
    240.306.4110
  • Tandy R. Tipps, PhD

    Vice President Precision Oncology Site Network

    Leads Precision Oncology Site Network with a clear focus on consistently optimizing start-up at both academic and community-based sites across the United States and Europe. Previously oversaw the world’s largest phase 1 program for cancer research and treatment at the renowned University of Texas MD Anderson Cancer Center.

    Name here
    908-237-3227
  • Teresa Hedrick, MT (ASCP), CCRC, CCRP, CCRA

    Director Clinical Trials

    Expert in laboratory testing and management, clinical trial coordination, clinical trial monitoring and management of in vitro diagnostic (IVD) clinical trials across multiple therapeutic areas. Optimizes team skills. Executed strategic design, planning, and implementation for over 40 pediatric and adult diagnostic, biologic, and pharmaceutical clinical studies.

    Name here
    240.316.3461
  • Tobias Guennel, PhD

    Senior Director Translational Informatics and Biometrics, Lead PATH Developer

    Extensive industry expertise across the pharmaceutical and biotech space—regulatory submissions, translational informatics, biomarker R&D—with a focus in precision medicine-guided efforts as well as strategy development and medical device/diagnostic development. Led numerous analytical R&D efforts and developed novel methodologies to harmonize and analyze data from high-throughput assays, translating it to value at the patient level.

    Name here
    240.306.4119