News
Please check this page for announcements from CDDG, including new partnerships, upcoming meetings and other important company news to pass along.
CDDG RELEASES INDUSTRY REPORT ON AUTOIMMUNE DISEASE DRUG DEVELOPMENT
Seattle, WA, September, 2024- Early clinical data from CAR-T and other B cell-targeting approaches are generating broad excitement and substantial investments in new drug development for autoimmune disease, including lupus, scleroderma and other difficult to treat diseases. New therapeutic approaches are leveraging decades of research and cutting edge modalities that hold promise to break through existing efficacy ceilings and potentially reset disease. To help make sense of this space, CDDG has released a free report: New Therapeutic Approaches for the Treatment of Autoimmune Disease: Is the Ability to Induce Tolerance or Reset Disease Around the Corner? We provide a scientific overview of autoimmunity and dive into several of the emerging approaches garnering excitement, the major players and what we view as key factors for success. A free copy of the report is available through this website.
CDDG announces new clinical drug development expertise
Seattle, WA, May, 2024- CDDG is happy to announce that Jan L Hillson MD has joined CDDG as a Partner. Jan is a rheumatologist and clinical immunologist with 20 years of experience in academic research, patient care and teaching, and more than 15 years of experience in the biotech industry spanning translational, preclinical, early and late clinical development. Jan has extensive drug development experience and was previously at ZymoGenetics (acquired by Bristol Myers Squibb), Momenta (acquired by Johnson & Johnson), Chemocentryx (acquired by Amgen), Alpine Immune Sciences (acquired by Vertex), and Provention Bio (acquired by Sanofi). She contributed to the development of Taveneos® (avacopan) for vasculitis, Tzield® (teplizumab) for type 1 diabetes and nipocalimab (FcRn blockade) for hemolytic disease of the fetus and newborn.
In addition, other experienced drug development consultants have recently joined CDDG as Affiliates, expanding the breadth of clinical expertise we can offer our clients. Niti Goel, MD is a board-certified rheumatologist with over 25 years of academic, preclinical to late-stage drug development, and medical affairs experience. Niti is highly knowledgeable in autoimmune, autoinflammatory, and musculoskeletal diseases and previously held leadership roles at Trial Spark, Abcuro, Kezar Life Sciences and others.
Philip E Silkoff MD is a pulmonologist and senior clinical trial physician executive with more than twenty years of experience in the pharmaceutical and medical device industry across all phases of drug and medical device programs. Phil had successful academic and industry careers including appointment as Associate Professor at National Jewish Health, the University of Colorado and clinical development oversight of respiratory programs at Janssen. Please reach out to learn more or discuss your next project.
CDDG ANNOUNCES THE RETIREMENT OF FOUNDING PARTNER
Seattle, WA, May, 2024- It is with bittersweet feelings that we announce the retirement of Wayne Tsuji as an active member of the Cascadia Drug Development Group. Wayne is retiring from pharmaceutical development consulting to focus on family and completion of a few ongoing engagements. Wayne was an original Founding Partner when we launched CDDG in 2016 and has been an invaluable key to our success. He has deep expertise in rheumatology and clinical development and approaches every project with unrelenting curiosity. Another great thing about Wayne is his easy charm and his eagerness to build personal connections and help others. We'll greatly miss working with Wayne but wish him the very best in the next chapter of his life! Stay tuned for announcements about new experts that have now joined the CDDG.
CDDG announces strategic partnership with Vindhya Datasciences
Seattle, WA, May 4, 2023- The Cascadia Drug Development Group (CDDG) and Vindhya Data Science (Vindhya) are excited to announce that they've entered a strategic partnership. CDDG provides drug development consulting services, including strategic guidance for immunologic disease and expert support of translational science. Vindhya has deep expertise in bioinformatics, data science, machine learning and AI and can help biopharmaceutical companies answer complex questions in drug discovery and development. Pharma and biotech companies are increasingly relying on these computational tools to accelerate and de-risk their programs, and this unique CDDG-Vindhya partnership that combines deep drug development knowledge and computational biology will empower our clients to make smart drug development decisions. Both companies share the same high standards of quality, extensive industry experience and take a personalized approach with their clients.
CDDG joins the Evergreen Bioscience Innovation Cluster
Seattle, WA, July 28, 2022- CDDG is pleased to announce that they have joined as a founding member of the Evergreen Bioscience Innovation Cluster, a newly formed, grant funded initiative. The mission of the cluster is to make Washington State and the Mountain Northwest a magnet for companies providing and consuming expert life and health science contract research, development, and manufacturing services of medicines and medical devices, by enhancing workforce development and services to pharmaceutical and medical devices companies. This mission is aligned with the aspiration of CDDG to promote a vibrant and sustainable life science industry in the Cascadia region. CDDG will provide strategic input relevant to therapeutic development and leverage its extensive network to help build a robust innovation cluster in the region. More information about the organization can be found here.
CDDG-supported project may soon be tested in COVID-19 clinical trial
Seattle, WA, March 31, 2020- We are pleased to announce that a fast-track regulatory application was submitted to the Chinese Center for Drug Evaluation by a CDDG client to test their novel immunomodulatory drug for protective activity against SARS-CoV-2, the virus that causes COVID-19. The novel pegylated interferon-lambda molecule, developed by Prosit Sole Biotechnology Co. Ltd. and Orphanon USA, is expected to stimulate an antiviral response that confers short term protection in mucosal tissues against a variety of viruses, including coronavirus. CDDG has worked closely with Prosit Sole and Orphanon to advance their preclinical data package and prepare for regulatory filings. This includes an imminent IND submission to initiate clinical development for other viral-related indications soon after the immediate emergency situation has been resolved.
CDDG announces new Affiliates
Seattle, WA, March, 2020 - CDDG has expanded the breadth of expertise available to clients through the addition of new Affiliate consultants. Like all other CDDG Affiliates, these experts bring considerable industry background and seasoned know-how in their areas of focus and can be added to client project teams seamlessly.
Kathryn Stein, PhD, is an immunologist who has over 40 years of experience in biotechnology as a senior manager at the FDA and as an executive in industry. Katy is an expert in many aspects of drug development for biologics, particularly related to regulatory aspects of protein manufacturing and quality specifications. During her 22 years at the FDA Dr. Stein was a leader in developing policies to regulate polysaccharide-protein conjugate vaccines, monoclonal antibodies and other recombinant DNA-derived products. She was lead or co-author on all of the guidance documents published by the FDA with respect to monoclonal antibodies and a co-author of the FDA guidance on comparability. CDDG is thrilled to welcome Katy to the CDDG.
Susan Pederson is a bioanalytical scientist with over 25 years of industry experience supporting nonclinical and clinical drug development programs for large molecule (LM) biologics. Her experience covers pharmacokinetic methods, anti-drug antibody methods and neutralizing antibody assays, both cell based and ligand binding assay formats. She has supported programs from early phase proof of concept studies, as well as IND enabling studies through post approval Phase IV clinical trials. Susan’s expertise is an excellent complement to the other preclinical areas that CDDG supports.
Jun Yan, Pharm. D, is a regulatory medical writer with 15 years of experience in the pharmaceutical industry. Jun was a medical writer at Centocor (now Janssen Biotech) and MedImmune (now AstraZeneca) and a Labeling Reviewer at the Food and Drug Administration. She has written and compiled many regulatory documents and manuscripts for pharmaceutical and biotechnology companies of all sizes, including Covance, Parexel, and Amgen. She has contributed to new drug applications and biologics license applications that led to product approvals and can support most therapeutic areas. CDDG is excited to welcome Jun and looks forward to continuing to support regulatory writing needs of our clients.
Scott Taylor has 25+ years of industry experience, including at Immunex and Amgen and has supported multiple functional areas from target discovery to early development. His areas of expertise include bioinformatics, genomics, genetics, computational biology, biostatistics, and data visualization and previously at Amgen Scott played a leading role in genomics analyses that helped clarify the mechanism of action for AMG 785 (romozozumab), a Sclerostin inhibitor which was approved and marketed as EVINITY®. Scott adds considerable depth to the computational biology support CDDG can offer its clients.
Maurice (Maury) Emery, PharmD, PhD has over 20 years in drug discovery and development. Maury spent 12 years at Amgen working on several small molecules and monoclonal antibodies for programs in diabetes, inflammation and oncology. He was the lead non-clinical ADME and clinical pharmacologist for the anti-PCSK9 monoclonal antibody (Repatha), approved in 2014. Maury also spent 3 years with the Seattle Genetics Clinical Pharmacology Group and served as the Amgen representative to SimCYP (PBPK modeling) Consortium. Most recently, Maury was at Esperion Therapeutics, where as a clinical pharmacologist he helped complete the NDA and MAA filings for a novel lipid lowering therapy (Nexlitol) and a fixed-dose combination with ezetimibe (Nexlizet), approved Feb 2020 by the FDA. He has experience across all stages of drug development in the areas of oncology, inflammation, metabolic and cardiovascular therapeutics and regulatory filing experience with the FDA, EMA, PMDA, SwissMedic, Australia, Health Canada.
CDDG welcomes a new partner
Seattle, WA, January 2020 - CDDG is pleased to announce that Bill Dougall, PhD, has joined the company as a full Partner. Bill has over 25 years of biotechnology and drug development experience and brings important expertise in cancer immunotherapy. Previously, Bill was a Scientific Director at Amgen, where he served as Global Research Leader for denosumab (anti-RANKL antibody) in oncology, which was approved worldwide in 2010 and is registered as Xgeva®. Prior to returning to Seattle to join CDDG, Bill and his family spent 3 years in Australia where he was Group Leader in Translational Cancer Immunotherapy and Senior Principal Research Fellow in Immunology in Cancer and Infection at QIMR Berghofer Medical Research Institute.
Bill brings to CDDG valuable experience with immunotherapy clinical trial design and a broad range of drug modalities such as antagonistic and agonistic antibodies/ligands, antibody-drug conjugates (ADC), and bispecific antibodies and he led successful development of drugs representing each of these modalities at least through IND-enabling studies. Bill managed the scientific teams responsible for development and Phase 1 testing of therapeutics including AMG 951 Apo2L/TRAIL (dulanermin), AMG 820 (anti-cFMS mAb; novel antagonist of CSF-1) and AMG 224 (an antibody-drug conjugate targeting BCMA for treatment of multiple myeloma). Bill is an author on 8 issued patents and over 85 scientific papers and has made frequent contributions to industry advisory boards or presented at international conferences.
CDDG is proud to welcome Bill to the team!
CDDG Announces a new partnership with pharmefex
Seattle, WA, March 5, 2018 - Cascadia Drug Development Group (CDDG; theCDDG.com) and Pharmefex (pharmefex.com) are pleased to announce the formation of a strategic partnership. CDDG provides oversight of drug development from discovery to early clinical development and offers subject matter expertise in several key translational sciences through their network of vetted affiliates. Pharmefex helps organizations to streamline process development, accelerate time to market, reduce cost of goods, manage technology transfers, prepare CMC submissions, and prevent and resolve manufacturing and compliance problems for recombinant proteins, and cellular immunotherapy products. This partnership is based on shared standards of quality and expands the scope of outstanding service CDDG and Pharmefex can provide their clients.
Cascadia Drug Development Group Announces New Clients
Seattle, WA, August 21, 2017 - Cascadia Drug Development Group’s mission is to provide a sustainable platform for therapeutic development and biotech creation in the Pacific Northwest and beyond. We’re pleased to announce two new client partnerships that represent an important step in that direction.
CDDG has entered into a working relationship with Amdax Therapeutics, a new biotech company spun out of the University of Washington’s Division of Rheumatology. CDDG is providing strategic guidance to the Amdax scientific leadership team in order to help execute a preclinical program with potential for the treatment of autoimmune disease.
CDDG has also been retained by Celimmune to help them advance a promising new treatment for celiac disease, a gluten-triggered immune response that impacts approximately 1% of the general population and can cause debilitating symptoms and potentially serious medical complications. Though rare, in non-responsive celiac disease (NRCD) and refractory celiac disease (RCD), abstinence from gluten alone does not resolve the symptoms and RCD type II can presage development of malignant EATL, a peripheral T cell lymphoma with poor prognosis/survival. Celimmune has completed two Phase 2 clinical trials (in NRCD and RCD-II, link) with assistance from CDDG and will be presenting results at upcoming scientific conferences. To learn more about how CDDG and our flexible operating model can help your biotech or startup succeed, just contact us.
