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PIL Diagnostics |
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Center Overview
Company Overview
Today most pharmaceutical companies are dealing with highly esoteric study protocols, calling for the development of novel biomarkers that better measure the safety and efficacy of new therapies. Concurrently, personalized medicine is an evolving field with emphasis on researching biomarkers to aid diagnoses. Of note, clinical pharmacogenomics and theranostics (companion diagnostics) are areas where diagnostics have entered the arena of being used in conjunction with drug treatments. Developing companion diagnostics is prompting pharmaceutical companies to closely work with the diagnostic industries, research institutions and laboratories in order to consider the nuances of diagnostic development.
Physicians Immunodiagnostic Laboratory Inc. (PIL); and its subsidiary PIL Diagnostics combine a full service CLIA & CAP accredited clinical laboratory, with a clinical trials/research group focused on introducing innovative diagnostics for both physician and pharmaceutical clients. The ability of PIL to develop novel biomarkers which can then be utilized as additional inclusion criteria has the potential to reduce study patient populations, accelerate trials (by managing timelines), and reduced costs. Our primary corporate goal is to address unmet medical needs and improve patient care by using cutting edge technologies, understanding of disease processes, and therapeutic options. The company continues to foster a culture of innovation, quality, and personalized service, while enjoying a reputation as a resource for esoteric tests development.
Clinical Research Experience
General Services
PIL is structured to provide the highest quality of services to our clients. Each department ensures optimal handling of patient samples beginning with the stringent preservation of sample integrity.
Positive patient ID is assured throughout the pre-analytical and analytical process. Patient results are turned around efficiently and accurately within 24 hours for most tests.
Our comprehensive test menu includes chemistry, hematology,
immunology, serology, immunohematology, special chemistry, urine
chemistry, microbiology, toxicology, molecular biology, endocrinology
and cytology.
PIL utilizes technologically advanced platforms, procedures and
customized assay panels providing our physicians and pharmaceutical
clients with rapid turnaround times in order to better manage their
patients.
PIL also offers consulting services to the biopharmaceutical, nutraceutical, medical device and in vitro diagnostic industries, for the conduct of clinical trials in the therapeutic area of Sleep Medicine and Early Drug Development Unit (for the conduct of translational research; Phase 0, Phase 1, and PK/PD/Bioequivalence studies), through its strategic partner "Translational Research Group, Inc. (TRGI)", http://www.providenceclinical .com
Esoteric & Custom Assay Capabilities
Core Technology Expertise
- Immunoassays
- ELISA
- Immunogenicity
- Multiplexing
- Mesoscale Discovery (MSD)
- Pierce Searchlight
- Luminex
- Flow Cytometry
- Enzyme Assays
- Kinetic
- Homogeneous
- Molecular Biology
- RT-PCR
- Genotyping
- Sequencing
- Microarrays
- Biochemistry
- Mass Spectrometry
- HPLC
- Lipid Profiling
- Oncology
- Immunohistochemistry
- Fluorescent in situ hybridizatation (FISH)
- Circulating Tumor Cell Detection
At the heart of our program is our commitment to full-service, organized study management. From contract signature to study closure, a dedicated team is responsible for overseeing each study and delivering the data on time. Staff members are thoroughly trained in protocol management, laboratory processes and client relations.
Project Managers develop detailed project plans at project onset, with all tasks, timelines and milestones delineated. They monitor these plans and document progress to share with the sponsor, ensuring strict adherence to protocol deadlines.
We proactively work with investigator sites to expedite every aspect of subject data collection, sample shipping and reporting. Our team provides investigator sites with training in the use of all clinical supplies and materials.
Quality and Documentation are critical to the success of the study and are fundamental in our project management. We confirm that all necessary validation and quality control procedures are in place and monitored throughout the trial.
Services and Commitments
- Dedicated staff for efficient communication and support of your protocol
- Protocol-specific requirements implemented in testing, reporting and specimen storage systems
- Customized Investigator manuals, requisition forms and shipping instructions
- Protocol-specific collection kits -- designed, manufactured and shipped directly to investigator sites
- Nationwide logistical network of trained couriers for specimen pick up and shipment
Clinical Data Management
Sponsors and investigator sites can use the Internet to compile or access data in our expandable data repository. This unique access allows for early and interim statistical reporting. Our Data Management system is designed to offer the flexibility and quality assurance necessary to meet all study requirements.
Our secure, web-based product, DataPassport Clinical Trials (DPCT), utilizes web technology for rapid test ordering and result retrieval from single or multiple investigator sites via the Internet. The software has been specifically designed to address clinical trial reporting requirements.
The study parameter design incorporated into DPCT allows PIL to deliver reporting formats and electronic data files specific to your study's needs. Data files can be formatted according to definitions and software formats established by sponsors. Invalid entries generate an instant Verification Form for correction by the investigative site.
Features and Tools
- Remote data access via the Internet for real-time results including adverse event data
- Protocol-specific data entry restrictions promote use of proper data formats
- Customized data validation checks for clean data at point of entry
- Secure information storage with 128-bit encryption; multi-level access protection passwords
- A point-and-click, PC-based interface operating on a Windows platform for easy training
Logistical Support
Nationwide logistical network for specimen pick up and shipment.
Supplies & Logistics
- Customized Investigator manuals, requisition forms and shipping instructions.
- Protocol-specific collection kits -- designed, manufactured and shipped directly to investigator sites.
Customized Collection Kits
- Kits are labeled for the appropriate visit(s).
- Each collection kit is be labeled with the expiration date.
- Each kit contains the appropriate collection materials for the visit-specific testing.
- Customized visit-specific lab requisition forms are provided in each kit.
Facility Description
Quality & Compliance
PIL is licensed by the State of California, certified by the U.S. Department of Health and Human Services and accredited by the College of American Pathologists (CAP).
In addition, our Quality Assurance Program spans all areas of clinical medicine, from specimen pick-up and test performance to delivery of timely and accurate results. Any questionable or abnormal findings are confirmed. All laboratory equipment is on a regularly scheduled preventive maintenance program.
U.S. Department of Health and Human Services
CLIA Laboratory Certification No.: 05D0887857
Medicare Provider No.: 05887857
California Department of Health Services
License Laboratory ID No.: CLF10774
Medi-Cal Provider No.: LAB87857F
State License No.: 209552
Proficiency Testing Programs:
College of American Pathologists (CAP)
Investigator Experience
Background & Experience
Alfred Ramzi, MD, CEO, PIL Diagnostics Inc. (Founder)
Dr Ramzi founded Physicians Immunodiagnostics Laboratory in 1994, as a
multi-disciplinary corporation to focus on the development of
biomarkers into novel diagnostic tests. Dr. Ramzi’s expertise is in
the development and application of biomarkers across multi-disease
disciplines, utilizing a broad range of technology platforms. The PIL
laboratory is a fully licensed CLIA and CAP laboratory. Dr Ramzi’s
primary goal is to work with Academic Institution, Pharmaceutical, and
Biotechnology Companies to address unmet medical needs. Prior to PIL,
Dr. Ramzi was the laboratory director for Pathology Associated Lab
Inc. where he led a team of laboratory managers and scientists to
establish the laboratory operational infrastructure. Prior to
Pathology Associated Lab, Dr Ramzi was the Director of Infectious
Disease Department at Specialty Laboratories, where he managed a large
group of scientists and technologist and oversaw the development and
testing of more than 300 commercial and in-house tests. Dr. Ramzi has
an M.B.-BCH Medical Degree from Cairo University, Egypt and worked as
a Clinical Pathology in Ain Shams Medical Center Egypt prior coming to
the United States.
Nasry Yassa, President and COO, PIL Diagnostics Inc.
(Founder)
Prior to PIL diagnostics, Nasry was the Vice President, Office of
Technology Management at Pathway Diagnostics where he managed a
multi-disciplinary organization working to identify and in-license
novel technology from discovery companies, academia and bio-pharma in
all disease areas. At Pathway he led a team of executives and
scientists during a significant growth period of the company that
included strategic IP acquisitions and partnerships. Mr. Yassa also
held the position of Vice President of Operation at Pathway
Diagnostics and was responsible for establishing the laboratory
operation infrastructure. Prior to Pathway, Nasry was the Technical
Director of the Development Department at Specialty Laboratories,
where he oversaw the development and manufacturing of more than 300
in-house tests in wide range of areas as; Immunology, Coagulation,
Special Chemistry, Molecular Biology and Molecular Genetics. At
Bio-Rad Laboratories he worked as a Manufacturing Engineer and then
the Manager of the P3 facilities, where he was responsible for the
entire production operation of the HIV-1 immuno-blot assay. At Roche
Molecular Systems, he served as a Research Scientist and then as a
Manager of Product Development, to oversee the development and
production of HIV-1 PCR assay. At Ortho Diagnostics, Mr. Yassa had the
position of Research Associate working on the R&D of Diagnostics ELISA
assays for infectious diseases. Nasry started his career at Nichols
Institute in their RIA manufacturing facility as a Manufacturing
Chemist, after graduating from Cal State University Long Beach, with
Bachelor of Science in Medical Microbiology and Minor in Clinical
Chemistry. Nasry also has Master Degree in Bio-Chemistry from the
University of Alexandria, Egypt.
Louris Khalaf, MBA, MS (ASCP), Chief Technology Officer, PIL
Diagnostics Inc. (Founder)
Prior to PIL Diagnostics Mrs. Khalaf was the founder and Chief
Operation Officer of Physicians Immunodiagnostics Laboratory, where
she led a team of executives and technologists to establish the
laboratory operation infrastructure, during a significant growth time
of the laboratory. Prior to Physicians Immunodiagnostics Laboratory,
Mrs. Khalaf held the position of Head of Microbiology Department at
Pathology Associated Laboratories in Santa Monica, CA where managed a
group of CLSs to generated more than 2000 Bacteriology, Virology,
Mycobacteriology, Mycology, and Parasitology reports daily. Prior to
Pathology Associated Laboratories, Mrs. Khalaf was a Microbiologist at
the Lafayette General hospital where she oversaw the development of
more than 100 test methods in wide range of Microbiological
techniques. Mrs. Khalaf Graduated from USL (University of Southwestern
Louisiana) BS, MS1988 in microbiology, ASCP American society for
Clinical Pathology Microbiologist Specialists 1990, and Obtain her MBA
specializing in Hospital administration 1996.
Kil Un Lee, M.D., Medical Director PIL Laboratory
Concurrently with his position as Medical Director at PIL, Dr. Lee is
Staff Pathologist in Anatomical & Clinical Pathology, and Chairman and
Medical Director, Department of Pathology & Laboratory Medicine,
White Memorial Medical Center (Los Angeles, CA). Prior to this, he
was Staff Pathologist, Department of Pathology and Laboratory
Medicine, Emory University Medical School and Director of Blood Bank,
Grady Memorial Hospital (Atlanta, GA). Dr. Lee received his Doctor of
Medicine from Chonnam University Medicine School (Korea), and had his
Pathology Residency at Emory University Medical Center (Atlanta, GA).
JoAnn Yatabe, PhD, SM (AAM/ASCP), Vice President & Chief Scientific
Officer PIL Diagnostics Inc.
Prior to PIL Diagnostics, Dr. Yatabe, a clinical microbiologist and
specialist in infectious and tropical diseases, was the Technical
Director of Microbiology at Specialty Laboratories, Inc. In that
capacity, Dr. Yatabe was in charge of seven subspecialty diagnostic
laboratories (Bacteriology, Virology, Mycobacteriology, Mycology,
Diagnostic Immunology, DNA/Molecular Technology and Parasitology)
which generated more than 5000 reports daily. Dr. Yatabe has also been
Adjunct faculty at the UCLA School of Medicine, USC School of Pharmacy
and California State University School of Medical Technology. She
served as the Hospital Epidemiologist/Specialist Microbiologist at the
UCLA Hospitals and Clinics and has also been with Medical Assistance
Programs, WHO and PAHO working in Madagascar, South America, Africa
and Asia. Dr. JoAnn Yatabe has a BS in Biology from USC, and graduated
with honors for a MPH in Laboratory Practice from the University of
Michigan, and a MS in Immunology and a PhD in Infectious and Tropical
Diseases from UCLA. Dr. Yatabe holds specialty boards in microbiology
with the National Registry of Microbiology, American Academy of
Microbiology and the American Society of Clinical Pathologists. She is
a certified Clinical Laboratory Consultant and Clinical Laboratory
Scientist with the National Credentialing Agency for Laboratory
Personnel, Inc. Dr. Yatabe has a California state license as a
Clinical Microbiologist Specialist and New York state license as a
Laboratory Director in Bacteriology, Parasitology, Mycology, Virology,
Mycobacteriology and Diagnostic Immunology.
Shoreh Ershadi, Pharm.D., Ph.D., NRCC, NRCT, ASCP, Diplomate of
the American Board of Antiaging Health Practitioner, Senior Vice
President of Medical Affairs (ANTIAGING, Preventing Medicine and
Toxicology) PIL Diagnostics Inc.
Concurrent to her position at PIL Diagnostics, Dr. Ershadi is the
President and CEO of the ANTIAGING Institute of California, Inc. a
(Global) leader in providing the highest quality health promoting
products to help prevent cardiovascular diseases, cancer,
osteoporosis, liver & kidney disease, Alzheimer’s, Parkinson’s, skin
aging and other chronic diseases that develop as we age. Prior to PIL
Diagnostics, Dr. Ershadi served as the President for Clinical
Laboratory Consultants, Los Angeles, CA. A Consulting Firm offering
best-of-breed tools and techniques to assess performance in Clinical
Laboratories, effectiveness of processes, and readiness of employees
to embrace future developments. Prior to CLC, Dr Ershadi was the
Laboratory Director for Great Smokies Diagnostic Laboratories - A
Leader in Functional Medicine. Asheville, NC. Where she was
overseeing Clinical Laboratory Testing and Total Laboratory Quality
Assurance. Dr. Ershadi held a position of Technical Director,
Specialty Laboratories, Santa Monica, Establishing the Departments of
Toxicology and Automated Systems. Dr. Ershadi was an Adjunct
Professor, California State University, Domingues Hills School of
Public Health, Medical Technology program. Dr. Shoreh Ershadi has a
Ph.D. in Clinical Biochemistry, Major in Endocrinology, Medical
School, University of Newcastle upon-Tyne, England., MSc. In Clinical
Biochemistry, Medical School, University of Newcastle upon-Tyne,
England. WHO Scholarship, and a Pharm.D., Doctotrate in Pharmacology,
Tehran University, Tehran, Iran. ( Magna Cum Laude )
W. John Masterson, M.D., Ph.D., Scientific Investigator PIL
Diagnostics Inc.
Prior to PIL Diagnostics, Dr. Masterson served as a tenured Professor
of Pathology for the University of Southern California School of
Medicine. Concurrently he served as Chief of Immunology /
Immunopathology Unit at the Los Angeles County + University of
Southern California Medical Center. Other highlights of his career
include: Supervisory Medical Officer GS-14 and Head, Oncology Unit,
Division of Virology, Bureau of Biologics, FDA; Director of USC
Infection Diseases Laboratory and of USC Molecular Pathology
Laboratory within the USC Clinical Laboratories, USC School of
Medicine. Dr. Martin received his M.B., B.S. (M.D. equivalent) with
First Class honors from the University of Sydney (Australia), and
later received a Ph.D. in Immunology from the University of Melbourne
(Australia).
John C. Hiserodt, M.D., Ph.D., FCAP: Senior VP of IHC, PIL
Diagnostics Inc.
For more than 25 years, Dr. John C. Hiserodt has dedicated his
professional career to the practice and teaching of Clinical and
Forensic Pathology. Prior working with PIL Diagnostics as a Senior
Vise President of IHC, Dr Hiserodt worked at Pathway Diagnostics as
the Co-Laboratory Director and Chief Pathologist, prior to that he
held the position of Medical Director for Impath Predictive Oncology,
as well as, a founder and Medical Director of both Seacliff
Diagnostic/Medical Anatomic and Forensic Pathology Consulting Service.
Prior to that, Dr. Hiserodt was the Vice President of Research &
Development of Meyers Pharmaceuticals. He has also served as an
Assistant Professor of Pathology at the University of California,
Irvine Center and the University of Pittsburg, as well as a Forensic
Pathologist and Deputy Coroner for the Allegheny County Cc in
Pittsburg, Pennsylvania. Dr. Hiserodt holds a California Medical
License, a California Clinical Laboratory/CLIA License, and a license
from the Drug Enforcement Agency. He is a member of the American
Society for Investigative Pathology and Medical Association, a
Diplomate to the National Board of Medical Examiners, The American
Board of Pathology and the of California, as well as a Fellow of the
College of American Pathologist. Dr. Hiserodt is co-owner of 3 United
States patents.
Alice Runge, MT (ASCP) Vice President, Cardiovascular Programs and
Clinical Trial Operations, PIL Diagnostics Inc.
Prior to PIL Diagnostics Alice Runge was the Director of
Cardiovascular Programs & Regulatory Affairs at Pathway Diagnostics
Corporation. Alice has over 25 years experience in Clinical
Laboratories. She was Assistant Education Coordinator of the UCLA
Medical Technology program. She developed objectives for the Medical
Technology Program as well as participated in the interview and
selection process of the students. Alice then moved to the laboratory
where she supervised Coagulation, Bone Marrow and Flow Cytometry
laboratories for more than 15 years. Her specialty is Coagulation; she
has taught medical technology students as well as Hematology fellows
and Pathology residents in the art and science of coagulation theory
and testing. She has been a presenter at the ICATH as well as ASCP,
and CAMLT meetings. Alice has been an instructor of Continuous Quality
Improvement program at UCLA. She also has been a CAP inspector. She is
on the Editorial Board of the ICATH journal. She has collaborated with
several UCLA Hematologist, Oncologist as well as Cardiologist in
research projects and publications. Prior to joining Pathway
Diagnostic, Alice was the Technical Director of the Coagulation
Department at Specialty Laboratories where she built a Coagulation
Laboratory. Alice is a licensed Medical Technologist, CLS, MT (ASCP).
She has received her medical technology training as well as a
bachelor's degree in Bacteriology from UCLA.
Karsten Liegmann, Vice President of Technology, PIL Diagnostics
Inc.
Prior to PIL Diagnostics, Karsten held the position of director of
technology transfer at Pathway Diagnostics Inc., where he conducted
research and development, introduction, and technology transfer of
low-cost, rapid, novel and easy to use diagnostics that are
appropriate for use in the pharmaceutical drug development programs,
he was also involved in directing the diagnostic platforms that are
being developed at Pathway including lateral flow immunodiagnostics,
ELISA, and nucleic acid-based techniques, and participated in the
validation and testing of over a 100 multiplexed assays. Prior to
Pathway Mr. Liegmann was a Research Scientist at Specialty
Laboratories, where he worked on clinical assay development in
Molecular Biology, Immunology, and Chemistry/Separations. He validated
assays utilizing techniques such as PCR, Sequencing, RIA, ELISA,
Automated Platforms, HPLC, and Tandem Mass Spectrometry. Before
Specialty he worked as a Research Associate at Sterogene
Bioseparations developing and producing chromatography products. He
holds a degree in Biotechnology from California State Polytechnic
University, Pomona, California.
Sherif Girees, Director of IHC, PIL Diagnostics Inc.
Prior to working with PIL Diagnostics, Mr. Girees worked at Pathway
Diagnostics as Director of Molecular Pathology were he developed novel
tests in immunohistochemistry, Fluorescence In-Situ Hybridization
(FISH) and Circulating Tumor Cells (CTC) for clinical trials. Prior to
that he held the position of Technical Supervisor at Impath Predictive
Oncology were he managed 100s of clinical studies. Mr. Girees also
held a position of Laboratory Manager for Huntington Medical Research
Institutes were he oversaw the operation of Visual Prostheses Program.
Mr. Girees holds a degree in Biotechnology from the University of
Alexandria, Egypt and a qualification in immunohistochemistry from the
USA Board of Registry and the American Society for Clinical Pathology.
Contact Information
For more information, please contact:
Nasry Yassa
President & COO
PIL Diagnostics
512 S Verdugo Drive
Burbank, CA 91502 USA
Phone: 800-363-6562
Fax: 818-955-8477
E-mail:
If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the E-mail form below. A representative from the research center will then follow up with you.
