R&D
COVID - 19
IDRI Joins the war against coronavirus.
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RNA Vaccines
IDRI has used this vaccine platform to successfully develop candidate vaccines against emerging pathogens such as Zika, Chikungunya, and yellow fever viruses.
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Adjuvant Formulation
IDRI is a world leader in adjuvant development. Multiple formulations have entered clinical testing with vaccine candidates against tuberculosis, malaria, HIV/AIDS, pandemic influenza, shingles, schistosomiasis, leishmaniasis, leprosy, and hookworm.
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Manufacturing
IDRI provides cGMP drug product manufacturing for preclinical, Phase 1, and 2 clinical studies with a batch capacity of up to 10,000 vials of drug product. Our Quality Control team performs release and stability testing on manufactured drug product lots.
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IDRI is a nonprofit biotech organization taking a comprehensive approach to develop new solutions for infectious disease. We combine the high-quality science of a research or academic organization with the product development capabilities of a life science company, including an onsite GMP manufacturing facility.

Our Pipeline
DISCOVERY

IDRI conducts pioneering research on the biology, immunology, treatment and prevention of disease with an enviable record of peer-reviewed federal and foundation funding.

DEVELOPMENT

IDRI scientists are world-experts in process and product development. Our formulations team has innovated the methods to inexpensively produce, at scale, global health solutions that can be locally made and survive the toughest of shipping, storage, and health system conditions.

DEPLOYMENT

IDRI is committed to sharing our technology worldwide and to provide access to those who need it most. IDRI adjuvants are made on five continents, locally owned by partners in India, South Africa, Brazil, Korea and Europe.

Our goal is to create vaccine platforms and technologies to combat the worlds most devastating infectious diseases.

Filling a Unique Niche
ACADEMIA

Deep basic and translational research
Early-phase or partnered clinical research
Discovery and Innovation
Limited ability to manufacture or scale

INDUSTRY

Focused Research
Developing products for market
Discovery and Innovation
Ability to manufacture specialty products at scale

IDRI Formulations
STAGE OF DEVELOPMENT AND NUMBER OF CLINICAL PARTICIPANTS

We are a leader in manufacturing and development of vaccines and adjuvants for research and early clinical trials

RESEARCH & DEVELOPMENT OPEN
RNA VACCINES

RNA vaccine technologies can be quickly adapted to target new and emerging pathogens when epidemics hit, and readily manufactured in pre-optimized processes. IDRI has a promising vaccine platform that uses a replicating RNA molecule to express viral antigens, formulated and delivered to injection sites with a nanostructured lipid carrier system that can be stockpiled for use in future epidemic situations.

ADJUVANTS

Adjuvants are an important part of an outbreak response, dramatically increasing vaccine availability. Adjuvants provide three key benefits to vaccine development:

  • Improves a body’s immune response to the antigen.
  • Broadens and lengthens duration of vaccine protection.
  • Reduces the amount of antigen needed for production.
GLOBAL HEALTH

IDRI is working to eliminate death by the most common cancers that affect women and children, by developing and advancing lower cost, more effective and readily available immunotherapies. Our immune-stimulating adjuvants and formulations are also currently in active trials with vaccines to combat HIV, TB, leprosy and other neglected diseases. Our focus is on innovation and manufacture of vaccine platforms and therapies to aid in pandemic response and reduce the burden of infectious disease and cancers around the globe

PRODUCT OPEN
FORMULATION DEVELOPMENT
  • Drug Product Presentations
  • Macromolecules
  • Small Molecule Drug and Adjuvant Formulations
CHARACTERIZATION
  • Biophysical characterization
  • Physicochemical characterization of vaccine adjuvant and small molecule drug formulations
ANALYTICAL METHODS
  • IDRI provides analytical development and quality control services to support formulation development, manufacturing, product release and stability studies.
  • New methods may be developed and qualified, and existing compendia methods verified as needed.
MANUFACTURING OPEN
cGMP SERVICES

IDRI performs formulation development, fill & finish services, and ICH compliant stability studies in its state-of-the-art labs and cGMP facilities. Our formulation development services focus on liquid, emulsion and liposome formulations.

We specialize in manufacturing large and small molecules in liquid formulations, vaccines and adjuvants in liquid forms, emulsions and liposomes. Customization of complex adjuvant formulations based on emulsions and liposomes have long been part of IDRI’s core expertise.

ANALYTICAL METHODS

IDRI provides analytical development and quality control services to support formulation development, manufacturing, product release and stability studies. New methods may be developed and qualified, and existing compendia methods verified as needed.

STABILITY STUDIES

We work with clients to execute their protocol, design a protocol, or mutually design the right stability study to accommodate any special needs associated with a client’s drug product. The protocol specifies frequency of testing and storage conditions (temperatures, position); appropriate stability-indicating methods; and degradation products that may be stability limiting.

IDRI IN THE NEWS
LEADERSHIP
EXECUTIVE LEADS
Corey Casper, M.D., MPH
CEO
Corey Casper, M.D., MPH
CEO

At IDRI, Dr. Casper oversees a scientific portfolio of vaccines, therapeutics, and diagnostics that together provide comprehensive solutions to global health problems. Prior to coming to IDRI, Dr. Casper had a long career at the Fred Hutchinson Cancer Research Center as Full Member, Associate Cancer Center Director and Founding Head of Global Oncology. At Fred Hutch, he designed and managed complex projects, including the construction and operation of one of the first comprehensive cancer centers in sub-Saharan Africa and clinical trials of viral diseases / antiviral medications, cancer biologics, and cancer genomics.

In addition to his executive leadership and research activities, Dr. Casper is a committed educator and clinician. He holds an appointment as Professor of Medicine and Global Health at the University of Washington, where he is also the Associate Director of the Center for AIDS Research. Dr. Casper cares for patients with infectious complications of cancer at the Seattle Cancer Care Alliance and the University of Washington Medical Center.

Dr. Casper received his medical degree from Cornell University, completed a residency in Internal Medicine at the University of California – San Francisco, and a fellowship in Infectious Disease at the University of Washington, where he also earned a Masters of Public Health. His work as Principal Investigator of more than $50 million in peer-reviewed grant funding led to key scientific contributions. These include the development and deployment of diagnostic assays for tumor viruses, leadership of multi-phased international clinical trials from conception to publication culminating in FDA licensure, epidemiologic and cost effectiveness analyses, and translational studies of the virologic and immunologic basis of infectious diseases and cancer.

Neil O'Connor, MBA
COO, CFO
Neil O'Connor, MBA
COO, CFO

Neil joined the IDRI team in February 2020. With more than 25 years’ combined experience as a CFO and COO, Neil oversees IDRI’s support functions (Finance & Accounting, HR, IT, Facilities and Procurement).

Neil began his career at accounting firm Ernst & Young in Cape Town, South Africa and lived and worked in several European countries. He was transferred to the US in 1995 by a leading international transportation and logistics company. Neil possesses deep operational and finance experience in organizations ranging from startups to $3b+ multinationals and his diverse background includes business optimization expertise in manufacturing, professional services and technology.

Neil obtained his Bachelor of Commerce Degree (in Accounting and Finance) from the University of Cape Town in South Africa and his MBA from UCLA’s The Anderson School of Management.

Cynthia Shumate
General Counsel
Cynthia Shumate
General Counsel
SCIENTIFIC LEADS
Anna Marie Beckmann Ph.D.
EVP, Product Development
Anna Marie Beckmann Ph.D.
EVP, Product Development

Anna Marie Beckmann is the Vice President of Product Development and Regulatory Affairs at IDRI. She is responsible for guiding products through the transitional phase from pre-clinical research to evaluation in clinical trials. In the regulatory affairs arena, her group provides the necessary documentation to the U.S. Food and Drug Administration for review and approval of IDRI’s vaccine and adjuvant candidates in human clinical trials. She is also responsible for IDRI’s vaccine and adjuvant candidates in human clinical trials. She is also responsible for IDRI’s in-house pilot manufacturing facility that produces cGMP adjuvant formulations for Phase 1 vaccine clinical trials.

Anna Marie was a Senior Fellow in the STD Training Program at the University of Washington and a faculty member at the Fred Hutchinson Cancer Research Center, where her research focused on the pathogenesis of human papillomavirus infections (HPV) and the relationship between HPV infections and human anogenital cancers. In 1998 she joined Corixa Coporation as Director of Regulatory Affairs and worked on early stage clinical development of vaccines for infectious diseases and cancer.

Anna Marie Beckmann earned her Ph.D. from the Department of Immunology and Infectious Diseases at Johns Hopkins University School of Public Health. Her thesis was focused on the pathobiology of infection with the human papillomaviruses JC and BK.

Christopher Fox, Ph.D.
VP, Formulations
Christopher Fox, Ph.D.
VP, Formulations

Since joining IDRI in 2007, Dr. Fox has led development of cGMP vaccine adjuvant formulations for clinical evaluation of vaccine candidates against a variety of infectious diseases. He currently serves as principal investigator on NIH contracts to develop a first-in-human intranasal vaccine against amebiasis and to develop a thermostable tuberculosis vaccine through Phase 1 clinical testing. Moreover, he leads a BARDA-funded effort to establish a large-scale adjuvant manufacturing hub for pandemic influenza preparedness and an NIH R01 grant to develop sustainable raw material sources for vaccine adjuvant formulations using bioengineering and chemical engineering approaches. Dr. Fox has also directed technology transfer of adjuvant formulation manufacturing to institutes in India, Brazil, South Africa, and Romania. These local capacity building efforts were recognized in 2015 with the WGHA Pioneers of Global Health Rising Leader Award. Dr. Fox has authored >80 publications including serving as editor for the Springer Methods in Molecular Biology volume entitled “Vaccine Adjuvants: Methods and Protocols” published in 2017. Prior to joining IDRI, he obtained his Ph.D. in bioengineering at the University of Utah and his B.S. in biological engineering at Utah State University.

Ryan Kramer, Ph.D.
Director, Process and Product Development
Ryan Kramer, Ph.D.
Director, Process and Product Development

Ryan Kramer is a Senior Scientist at IDRI and Manager of the Characterization and Product Development group. Ryan is responsible for characterization of vaccine antigen and adjuvant components and for vaccine formulation development to achieve thermostable products that do not depend on the cold-chain for distribution to developing countries. Ryan has worked in a wide range of disease fields including cancer, HIV, tuberculosis, leishmaniasis, anthrax, West Nile virus, leprosy, hookworm disease, schistosomiasis, chikungunya virus, and shigellosis.

Before joining IDRI, Ryan was a postdoctoral fellow at the Macromolecule and Vaccine Stabilization at the University of Kansas, under the supervision of Russ Middaugh and David Volkin. He worked on over 12 contract and research formulation development projects characterizing different macromolecular systems and biotherapeutics, using state of the art analytical biophysical instrumentation.

Ryan obtained his Ph.D. in biochemistry from Texas A&M University where he developed a mutational approach for increasing protein solubility. As a graduate student, Ryan received a Molecular Biophysics NIH predoctoral training grant and Texas A&M Regents’ Graduate Fellowship. He served as Vice President of the Biochemistry Graduate Student Association and organized the 18th annual Biochemistry and Biophysics research competition.

Ryan graduated summa cum laude from Washington State University and received his B.S. in biochemistry. Ryan is an Eagle Scout and member of Order of the Arrow.

Emily Voigt, Ph.D.
Scientist II
Emily Voigt, Ph.D.
Scientist II

Dr. Emily Voigt heads IDRI’s RNA vaccine development efforts, from early-stage preclinical development and testing through preparation for Phase I clinical trials. A trained vaccine immunologist, she serves as Key Scientist on a major NIH vaccine development contract targeting yellow fever and Zika viruses using IDRI’s NLC-delivered RNA vaccine platform, with plans to enter Phase I clinical testing by 2023. Additionally, Dr. Voigt serves as principal investigator on a Department of Defense-funded grant to further enhance IDRI’s RNA vaccine platform with the use of genetic adjuvants, and contributes vaccine immunology expertise to IDRI’s adjuvant development efforts. Dr. Voigt was previously a Research Fellow in the Mayo Clinic’s Vaccine Research Group, where her research focused on studies of human immune responses to viral vaccines. She earned her Ph.D. from the University of Wisconsin-Madison studying the interactions between replicating RNA viruses and the innate immune responses of the cells they infect.

cGMP TEAM
Linda Hawkins
Director, Quality Assurance and Compliance
Linda Hawkins
Director, Quality Assurance and Compliance

Ms. Hawkins is a biopharmaceutical and medical device quality assurance professional with more than 25 years of experience in establishing and overseeing quality management systems to meet US FDA and EU regulatory requirements.

Ms. Hawkins joined IDRI in 2010 as Director, Quality Assurance and Compliance and as part of the original GMP operations team. Previous experience includes Vice President of Quality and Regulatory, Vice President of Quality and Director of Quality Assurance for Dharma Therapeutics, Seattle, WA, 5 years; Quality Assurance Supervisor and Quality Assurance Engineer for Xcyte Therapies, Seattle, WA, 4 years; Quality Assurance Manager, Intracel Corporation, Issaquah, WA, 4 years; and Quality Assurance Manager, Molecular Probes, Eugene, OR, 3 years.

Ms. Hawkins’ experience includes quality control and quality assurance for clinical and commercial regulated drug and medical device products, quality system design and management, and ISO 9000 certification.

Ms. Hawkins’ education includes a Bachelor of Arts, Biochemistry, University of California, Berkeley, CA (1987); Biomedical Regulatory Affairs Certificate, University of Washington, Seattle, WA and educational courses in ISO 9000 lead auditing, , ISO 13485 implementation, medical device testing and design controls, US FDA and EU GMP regulations for drug and medical device products, and auditing.

Erik Laursen
Director, GMP Operations
Erik Laursen
Director, GMP Operations

Erik is a biopharmaceutical development and operational professional with more than 20 years of drug development, project management and manufacturing/operational experience in pharmaceutical and biotechnology companies in North America and Europe. In addition his experience includes business development; with in/out licensing; and buying and selling CMO [Contract Manufacturing Organization] services.

At IDRI, Erik is Director, GMP Operations. Previous to IDRI, he was with Rentschler Biopharma and CMC Biologics from 2005-2013 [CMOs], and at NeoRx, Seattle, for the preceding 5 years as Sr. Director, Manufacturing, and Director of Operations with responsibilities for radio pharmaceutical production, biopharmaceutical pilot manufacturing and contract manufacturing activities. Previously Erik held leadership positions in development and operations at ZymoGenetics in Seattle. He received his MS in Biochemical Engineering from the Technical University of Denmark

Lisa McNeill
Director, Quality Control
Lisa McNeill
Director, Quality Control

Lisa McNeill joined IDRI in late 2007. With more than twenty-five years of assay development and quality control experience in pharmaceutical and biotechnology companies in the United States, she is the Director of Quality Control at IDRI. Her primary responsibilities consist of leading her group of seven staff members in GMP lot release and stability testing of parenteral products, assay development, environmental monitoring and management of outsourced contract laboratory testing.

Prior to joining IDRI, McNeill served as a Senior Scientist in Quality Control for Dharma Therapeutics, a manufacturer of iontophoretic transdermal patches, from 2005. She came to Dharma from Xcyte Therapies, a T Cell therapy company, where she managed the Assay Development group, working on test methods for characterization of T cells, antibodies and magnetic bead-captured antibodies.

Previously, McNeill held a lab management position for almost ten years in Bill Harris’s developmental neurobiology laboratory at the University of California, San Diego, with a focus on Xenopus laevis retinal neuron pathfinding and targeting.

McNeill received her BA in Animal Physiology from the Revelle College at the University of California, San Diego.

IDRI is hiring

We respect compassion, scientific excellence, innovation and teamwork. Our staff of scientists and professionals is looking for qualified individuals to join our team.