Meet the experts at Precision for Medicine.
Maham Ansari, MS, RAC is a Senior Director, IVD Regulatory Affairs. Her focus is on companion diagnostic co-development programs, where she leverages her regulatory expertise to secure approvals in the US, Europe and beyond for companion diagnostics with a specific focus on gene therapy. She brings more than 16 years of global regulatory leadership experience in the medical device and in vitro diagnostics industry, spanning major multinationals to small start-ups, including full life cycle management across all stages of product development, execution of global regulatory strategies, and post-market surveillance.
Sheila Antonio is the Vice President of Global Data Management at Precision for Medicine. She has more than 25 years of clinical research industry experience in Clinical Data Management. Sheila is well-known as a highly driven technical subject matter expert for managing clinical trial data, SAS programming, and EDC database design and development. She has been a key leader at various contract research organizations (CROs) in developing the mission, values, and strategic goals to create efficient and driven Clinical Data Management teams. Sheila develops programs that focus on thorough technical trainings, as well as effective and positive communications which lead to overall data quality improvements and successful team collaboration.
Nancy Bates is an Associate Director of Data Management at Precision for Medicine with over 20 years of data management experience, having worked in both the CRO and pharmaceutical space. She has successfully managed Data Management projects for many programs and excels at process analysis and process improvements. As a leader, she is a champion for her team members, helping to train and support them as they progress in their careers.
Robert Bauer is an Executive Director of Operational Strategy at Precision with over 20 years of clinical trial operations experience from both the sponsor and CRO perspectives. He has led teams in the conduct of trials from Phase I through IV and has experience across a wide variety of trial designs. Bob has experience across many therapeutic areas some of which include rare diseases, oncology, depression, schizophrenia, and substance use disorders.
Angelina Bisconte is an authority in utilizing human primary biological tissue and cells in research and drug discovery. She is a developer of translational biomarkers for Phase I/II clinical programs in autoimmunity, inflammation and cancer, and is an 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. She serves as a strategist in multi-parametric single-cell flow cytometry and analysis of flow cytometry data. Additionally, Angelina maintains a broad network of contacts at clinical sites and research hospitals, experienced with IRB submissions and clinical protocols. She is a scientific leader for Precision’s Biomaterials commercial sourcing.
Saoussen Brun is a Senior Director of Project Management at Precision for Medicine. She brings more than 18 years of Clinical and Project Management experience to the Precision team. Saoussen’s expertise covers a wide variety of therapeutic areas, with strong experience in oncology and neurology indication. She leads and motivates high-performing teams under tough deadlines to meet both project goals and company targets.
Phil Cyr, MPH, is Senior Vice President of Customer Solutions for Precision Value & Health with responsibility for cell and gene therapy. Phil has over 26 years of health economics, outcomes research, health policy, and payer experience, including a strong record of conducting published research, conducting health technology appraisal within a U.S. payer, and interacting with global HTAs. Phil and his team have built the health economic evidence and value demonstration strategy for over 15 gene therapies.
Kennon Daniels is a scientific and regulatory in vitro diagnostic authority, specializing in the development of US regulatory strategies and FDA marketing submissions for IVD assays and instruments. Her expertise spans all aspects of product development, analytical and clinical trial protocol designs, Q-Submissions, IDEs, de novos, 510(k)s, and pre-market approval platforms.
Traci Fulton is Vice President of Project Management at Precision for Medicine, providing senior level oversight and support for clinical trials spanning rare disease, oncology and CNS indications. Ms. Fulton brings over 21 years’ experience with CRO teams, supporting the conduct of clinical trials across all phases, with over 18 years of her career focused on execution and delivery for complex clinical trials in oncology and rare diseases. She is passionate in her approach to support trials and her drive to support advancements in the treatment for underserved patient populations.
Jo-ann Fabia Gonzales is an experienced regulatory affair professional with more than 20 years of experience in biotechnology. Her career has a rich focus on medical devices and IVD regulatory support.
Chris Ingram, BSc (Hons) is Head of Regulatory Consultancy (Europe) for Precision for Medicine. Chris received his BSc(Hons) in immunology and pharmacology from the University of Strathclyde and has since spent over 21 years working in regulatory affairs with a focus on clinical development. Chris’ regulatory expertise covers clinical development across all phases, regulatory strategy, marketing authorisations, scientific advice, orphan drug designation and paediatric investigation plans across a wide variety of therapeutic areas, including but not limited to, oncology, CNS, metabolic, endocrinology, analgesia and cardiovascular.
Ryan Kurz is a Director of Statistical Programming with more than 20 years of experience supporting clinical trials.
Rosa Canals López has 15 years of experience in managing Phase I-IV clinical trials, including >7 years of Clinical Management experience. Her focus is on Phase I studies and CAR-T, with additional experience in oncology, hematology, pediatrics, infectious diseases, cardiology, and nephrology.
Todd Luttrell is Director of Project Management and a PMP-Certified professional with over 20 years of drug discovery and development experience within both public and private sectors.
Tiziana Magnani is a Senior Project Manager at Precision in Milan, Italy. She has dedicated more than 20 years to project management and clinical research in different settings and brings more than 15 years of experience in the academic world and in the management of large multi-professional teams to Precision.
Rob Maiale is a leading content strategist and creator with more than 15 years of experience in healthcare marketing and brand development. His specialties include pharma, diagnostics, med-tech, patient education, translational research and clinical development.
Scott has over 15 years of experience leading informatics, data science and software development operations, providing strategic guidance across a variety of data-centric spaces, ranging from development of complex biomarker signatures for use in patient selection, to deployment of enterprise software solutions to pharmaceutical and biotechnology companies. After identifying a need in the market for improved tracking and management of biological samples as well as the need for solutions to manage complex streams of associated biomarker data, Scott co-founded QuartzBio in 2014 as a translational informatics consultancy, which has grown into a fully connected suite of SaaS solutions supporting clinical sample inventory management and biomarker data management for the biotech and pharmaceutical sectors. As General Manager of QuartzBio, Scott continues to lead and support QuartzBio’s business strategy, product innovation and overall revenue growth.
Michelle Martell is an Executive Director of Data Management with over 20 years of data management experience, having worked in both the CRO and pharmaceutical company space. A Certified Clinical Data Manager (CCDM), Michelle excels as an outside-the-box thinker who emphasizes quality and good clinical practice, while respecting client needs, budget, and timeline considerations. With proven success as a study leader, Michelle also contributes regularly to the technical aspects of the job, including database builds and programing from study start up to database lock. She has successfully managed multiple studies across several therapeutic areas and deployed a number of clinical data management systems.
Ed Matthews is a biostatistician with 26 years’ experience in medical statistics, having worked on multiple clinical studies, in a wide cross-section of therapeutic areas, focused on oncology, and in all clinical phases (I to IV). He is practiced in working on a variety of study requirements, including SAPs, electronic Case Report Forms (eCRFs), Clinical Study Reports (CSRs), protocols, clinical summaries and ISS/ISE, both in the UK, Europe and globally. Ed also has many years’ experience of PK analysis, in guiding and training both Statisticians and non-Statisticians, and experience with data safety boards as both an attendee and chair.
Olya Demireva is a Senior CTM bringing over 15 years of experience. She is a certified psychiatrist and clinical immunologist with 15 years of clinical research in CNS diseases and solid medical scientific background in biological psychiatry with focus on Major Depression and Bipolar Disorders, and neuro-psycho-immunology. Her experience in clinical research spans over almost all therapeutic areas with emphasis on Oncology, Pulmonology, Cardiovascular Diseases, Sleep Disorders, Hematology, Endocrinology and Rare Diseases across phases I-IV.
Etleva Pashaj, MD is a strategic, innovation-driven, drug discovery veteran—as well as a board-certified oncologist—with extensive international (EMA and FDA) regulatory experience. She has a record of excellence in clinical development, medical monitoring and medical strategy, and managing and mentoring cross-functional and global teams for phase 1-4 onco-hematology studies.
Chris Monaco has thirty-five years of expertise in the clinical research and pharmaceutical services industry supporting Phase I-IV clinical trials across a variety of therapeutic areas, including FIH, P1/2, dose escalation, and expansion oncology clinical trials. Currently, she is responsible for the administrative management of CSAI-Oncology Solutions services at both the department and team levels, driving process improvements for consistent quality across deliverables. Additionally, Chris supports business operations, resource management, and JReview implementation for applicable clients. Her passion shines through her leadership, commitment to excellence, and service delivery.
Frances Murphy is a leading authority in clinical CROs, focused on client services and regional growth implementation. Murphy is a dedicated proponent of harnessing truly personalized medicine to develop more effective treatments for patients and brings a high ethical standard to discussions and values transparency and collaboration.
Joseph Neal is a biopharmaceutical industry leader noted for applying cross-functional resources to highly technical issues. Impressive track-record in supply chain strategy, manufacturing operations and support, new facility design and start-up, tech transfer, and R&D process development. Equally capable of driving shop floor tasks and strategic objectives through senior levels.
Tracey Owens is a Director of Project and Clinical Trial Management at Precision, having 28 years of experience in managing Phase I-IV clinical trials. Tracey is highly experienced in providing directional oversight on rare disease, CNS, psychiatric and oncology clinical trials. Her experience notably includes: ALS, bipolar disorder, epilepsy, major depressive disorder, schizophrenia, idiopathic hypersomnia, CIDP, traumatic brain injury, multiple myeloma and dementia (including Alzheimer’s and Parkinson’s Disease.)
Meredith Latino is the Director of Medical Writing at Precision for Medicine. She earned a PhD in Molecular and Cellular Biology from Tulane University and brings more than 16 years of experience to the Precision team, including 9 years of medical writing and 8 years of academic research/writing.
Darren Davis, PhD, is a visionary leader with more than 25 years of distinguished biotechnology and clinical translational research experience. He founded ApoCell in 2004 and later was instrumental in developing and commercializing the ApoStream® rare-cell liquid biopsy technology. Globally, Darren is a recognized cancer researcher and the author of more than 100 peer-reviewed publications. He is dedicated and committed to improving the lives of patients with debilitating diseases.
Richard Macaulay is Vice President at Precision of Global Pricing & Access Strategy, bringing more than a decade of consulting experience in pricing and market access. He has collaborated with companies across the commercialization spectrum in established and emerging markets to answer strategic questions in pricing, positioning, evidence development, value communication and access (including in asset/indication prioritization, evidence generation plans, value communication tools, and negotiation frameworks).His experience spans a wide range of therapeutic areas, with particular interest in areas where access can be most challenging: oncology and rare diseases.
Pharma industry veteran and expert at biomarker-driven clinical trial design and execution. Leader of 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.
Fred Snikeris, PhD is an established biometrics executive with extensive Pharmaceutical R&D and CRO experience. He has built self-sustaining global multi-site biostatistics departments in support of late phase and early phase clinical development and preclinical research efforts.
Dr. Laura Lozza is Senior Director for Cell Biology at Precision for Medicine. She has long-standing expertise in immune monitoring and immune assay development with a particular focus on flow cytometry assays. Her focused on human immunology, including characterizing the regulatory activities of CD4 T cells, as well as analyzing the response of human dendritic cells in tuberculosis disease and BCG vaccination. She was a leader in establishing Precision’s Cell Biology Lab in Berlin which supports assay development and validation utilizing flow cytometry as well as other cell biology technologies.
Houria Bachtarzi, PhD, is a Director of Regulatory, CMC, Gene and Cell Therapies. She has a proven track record in product development and regulatory strategy, including virally vectored gene therapy products, in vivo and ex vivo genome editing, genetically modified cells for tissue regeneration, genetically engineered immune cells targeting cancer cells, and stem cell-based products. She is a member of the British Society for Gene and Cell Therapy (BSGCT) and the American Society of Gene and Cell Therapy (ASGCT).
Tobi Guennel, Ph.D., is the SVP of Data Management and Systems Integration, as well as the Chief Architect of the QuartzBio® Data Integration and Informatics Platform. Tobi supports life science companies in their quest to improve patient care and outcomes, leveraging a suite of fully connected, end-to-end SaaS solutions that are engineered specifically to address the challenges of both sample data and biomarker data management.
Amanda Woodrooffe, PhD. is an experienced leader of scientific operations for drug discovery in both the pharmaceutical and CRO industries. She is driven to provide actionable data enabling biopharmaceutical research and development. Collaborative partner ensuring licensing and scientific support for corporate development initiatives.
Eva Raschke, PhD serves as a subject matter expert for immune monitoring solutions at Precision for Medicine with a focus on the epigenetic immune monitoring technology Epiontis ID. She has supported the development, validation and clinical use of this technology platform in different roles since 2008. Eva obtained a Ph.D. in Molecular Biology from the Ludwig-Maximilians-University Munich.
Robert Snyder, PhD, is a seasoned expert with a 20-year track record in genomics, specializing in in vitro diagnostic assay development and bioinformatics. Committed to advancing medical science, he is proficient in regulatory V&V study designs and understands the nuances of orthogonal methods. A collaborative partner in biomedical development, Dr. Snyder champions the critical transition of biospecimens from benchtop to bedside.
Esther Mahillo, PhD, MBA, is Vice President of Operational Strategy and Feasibility at Precision for Medicine in Madrid, Spain. She has more than 25 years of experience in the clinical research arena (22 of them in global oncology trials), and is a master’s program professor at three different universities. In 2015, she was awarded the first prize of the Spanish Society of Medical Oncology contest for her work on the promotion of clinical research.
Jesus Garcia, PhD, is a tissue and liquid biopsy expert with extensive experience in a wide range of histopathology assays and digital pathology solutions. Part of the implementation of new technologies at MD Anderson Cancer Center in collaboration with immuno-oncology leaders. Currently focused on partnering with biopharma to develop tissue and liquid biopsy biomarker strategies for clinical trials, and to implement digital pathology and AI in the drug development process.
Vann Parker is the Head of Regulatory Consultancy (North America) for Precision for Medicine. He received his PhD in Molecular Biology from The California Institute of Technology and spent the past 30 years supporting biopharmaceutical and drug development. He currently focuses on strategies for clinical development and interactions with FDA and other regulatory agencies. In addition to support of pre-IND activities, Vann has supported sponsors throughout the drug development process including applications for Fast Track, Breakthrough Therapy and Orphan Designations, formal meetings with FDA and full NDA/BLA submissions.
Andy Kinley, Ph.D. is Vice President of Innovation and Clinical Science at Precision for Medicine. He is a clinical researcher with over 25 years of combined experience leading basic and clinical research in oncology and hematology. His early scientific career focused on cancer cell signaling, setting a foundation to complement his clinical research roles in trial design and implementation of effective strategies for oncology clinical trials. Andy specializes in immuno-oncology trials (checkpoint inhibitors, T-cell agonists, bispecifics, cytokines, oncolytic viruses, neoantigen cancer vaccines), including autologous and allogeneic adoptive cell therapies (CAR-T, TCR, TIL, NK cells). Today, Andy identifies and implements innovative tools, datasets, and services that can impact clinical trial execution including quality, patient diversity, site identification, and trial timelines.
Dr. Hoffmueller is a veteran biochemist, industry expert, and cofounder of Epiontis. He holds a Master’s in Biochemistry from Humboldt University, a PhD from the Charité University Clinic, receiving the Charité Research Award, and an MBA from the Berlin School of Economics and Law, Berlin, Germany.
Lindsey Pierce, PhD is a Senior Clinical Project Manager with 10 years of experience. She brings a strong Oncology background that spans several disease groups, complementing her genomics research background.
Patricia Molina-Ortiz, PhD, is a passionate researcher with broad experience in molecular and cellular biology, as well as automated and manual imaging techniques. Her therapeutic experience spans immuno-oncology, hematopoiesis, and angiogenesis, with expertise in primary cell cultures and in vivo mice models.
Jie Yang, PhD is a Scientific Liaison for Precision for Medicine. An Immunologist by training with extensive industry expertise in designing translational assays for biomarker-guided clinical trials. Conducted postdoctoral research on immuno-oncology at MD Anderson Cancer Center. Led biomarker assay development and collaborated on the implementation of new technologies for pre-clinical and clinical studies conducted by pharmaceutical and biotech companies for drug development.
Travis Harrison, PhD, is Vice President of Bioassay Solutions at Precision for Medicine. He brings more than 20 years of bioanalytical assay experience to the Precision team with expertise in ligand-binding and cell-based assays. Travis has experience supporting clinical and nonclinical studies for a broad range of indications, with an emphasis on diagnostic assays to evaluate immune responses to gene therapies.
Estelle Roger is a senior program manager at Precision Medicine Group and supports strategies related to public funding of research and innovation. With more than 5 years building and managing R&D Tax incentives strategies for both CROs and pharmaceutical industries, Estelle’s expertise covers a meaningful panel of R&D tax relief regimes across North America and Europe.
Vincent Shortino is a Principal Clinical Trial Manager, bringing more than 20 years of experience to Precision. His experience spans all major therapeutic areas with a heavy emphasis on Cardiovascular and Rare Indications, across Phases I–IV. He brings solid perspectives inclusive of sites, pharma and CROs from his previous roles of Study Coordinator, Site Director, CRA, and Clinical Trial Manager.
Michael Towse is a dedicated communication specialist with a 20-year background spanning development across a diverse range of CRO environments; from business development to training. His diverse career includes working through the development of communication material, the delivery of communication and initiatives, and time spent on the strategic alignment of sales and marketing strategies to corporate objectives and those objectives central to motivating staff, building teams, and driving business forward.
Sarabeth Velazquez is an Associate Director of Project Management at Precision for Medicine, having 20 years of experience in managing Phase I-III clinical trials. Sarabeth’s expertise covers a wide variety of therapeutic areas in rare disease, oncology, dermatology, ophthalmology and cosmetic clinical trials. Her experience notably includes: abdominal bulging, submental subcutaneous fat, molluscum contagiosum, onychomycosis, neurofibromas, herpes labialis, hyperhidrosis, breast implants, colorectal cancer, solid tumors, breast cancer, ovarian cancer, lymphoma, cataracts, pulmonary arterial hypertension, classic galactosemia, and sorbitol dehydrogenase deficiency.
Reka Zsambok is a Director of Project Management, Senior Director Clinical Trial Management and Medical Director at Precision who brings 15 years of experience in managing Phase II-III clinical trials. Reka is experienced in providing directional oversight on rare disease, cardiology and oncology trials. Her experience covers a wide variety of therapeutic areas, with strong experience in Paroxysmal Nocturnal Hemoglobinuria, heart failure, AF, infections disease, stroke, Parkinson-disease, breast cancer and multiple myeloma. She provides strategic support to the project team.
Precision for Medicine is part of the Precision Medicine Group, an integrated team of experts that extends Precision for Medicine’s therapeutic development capabilities beyond approval and into launch strategies, marketing communication, and payer insights. As one company, the Precision Medicine Group helps pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.
