• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 25
    • Directory
    • Microsites
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 25
  • Directory
  • Microsites
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    Hygienic Packaging Technology

    Trends in Solid Oral Dosage Delivery

    5 Reasons Paper Has No Place in Contract Manufacturing

    Injectable Drug Delivery Trends

    Pharmaceutical Manufacturing Equipment Trends
    Breaking News
    Online Exclusives
    Industry News
    Collaborations & Alliances
    Promotions & Moves
    Trials & Filings
    Financial Reports
    Bio News & Views
    Custom Sourcing News
    Packaging & Tracking
    CRO News
    Live From Shows
    Top News
    Jubilant Therapeutics Appoints Chief Scientific Officer

    Iontas and Fair Journey Biologics Partner with Quell Therapeutics

    Vetter Establishes Office in China

    AGC Biologics Expands Cell and Gene Facility in Italy

    Celonic to Boost Cell & Gene Therapy Production
    APIs
    Aseptic Processing
    Cleaning Validation
    Clinical Trial Materials
    Cytotoxics and High Potency Manufacturing
    Equipment
    Excipients
    Extractables and Leachables
    Facilities
    Fill/Finish
    Lyophilization
    Parenterals
    Process Development
    Process Validation
    Risk Management
    Scale-up/ Technology Transfer
    Solid Dosage/ Creams/ Ointments

    Vetter Establishes Office in China

    AGC Biologics Expands Cell and Gene Facility in Italy

    Celonic to Boost Cell & Gene Therapy Production

    Pharmaron Acquires Biomanufacturing Site in the UK from AbbVie

    Fujifilm Breaks Ground on Major Expansion of Biologics Facility in Denmark
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Reed-Lane Facility Virtual Tour

    Hygienic Packaging Technology

    Reshaping the Pharmaceutical Supply Chain

    Serialization: Level 5 Solution

    Covectra Introduces Next-Gen Serialization Solution
    Analytical Services
    Bioanalytical Services
    Bioassay Developement
    Biologics, Proteins, Vaccines
    Biosimilars
    Chemistry
    Clinical Trials
    Drug Delivery
    Drug Development
    Drug Discovery
    Formulation Development
    Information Technology
    Laboratory Testing
    Methods Development
    Microbiology
    Preclinical Outsourcing
    R&D
    Toxicology

    Vetter Establishes Office in China

    Data Management Trends

    AGC Biologics Expands Cell and Gene Facility in Italy

    Celonic to Boost Cell & Gene Therapy Production

    Pharmaron Acquires Biomanufacturing Site in the UK from AbbVie
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    Guide to Maintaining Validation of Older Facilities: Why, When and How

    The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021

    Top BioPharma Form Accumulus Synergy

    Global Biosciences Co. Selects ValGenesis VLMS

    Gene Therapy Co. Selects ValGenesis' SaaS Platform
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Almac Group

    Emergent BioSolutions

    Baxter BioPharma Solutions

    Alcami

    Syngene
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Cytovance Biologics

    Alcami

    Emergent BioSolutions

    Aphena Pharma Solutions

    Adare Pharma Solutions
    Webinars
    Live From Shows
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • Enewsletter Archive
      • Digital Edition
    • Directory
      • Companies
      • Categories
      • Corporate Capabilities
      • Add Your Company
    • Manufacturing
      • APIs
      • Aseptic Processing
      • Cleaning Validation
      • Clinical Trial Materials
      • Cytotoxics and High Potency Manufacturing
      • Equipment
      • Excipients
      • Extractables and Leachables
      • Facilities
      • Fill/Finish
      • Lyophilization
      • Parenterals
      • Process Development
      • Process Validation
      • Risk Management
      • Scale-up/ Technology Transfer
      • Solid Dosage/ Creams/ Ointments
      • cGMP Manufacture
    • Packaging
      • Capsules
      • Cold Chain Management
      • Injectables
      • Logistics
      • Serialization
      • Solid Dosage / Semi-solids
      • Supply Chain
      • Vials
    • Development
      • Analytical Services
      • Bioanalytical Services
      • Bioassay Developement
      • Biologics, Proteins, Vaccines
      • Biosimilars
      • Chemistry
      • Clinical Trials
      • Drug Delivery
      • Drug Development
      • Drug Discovery
      • Formulation Development
      • Information Technology
      • Laboratory Testing
      • Methods Development
      • Microbiology
      • Preclinical Outsourcing
      • R&D
      • Toxicology
    • Compliance
      • Filtration & Purification
      • GMPs/GCPs
      • Inspections
      • QA/QC
      • Regulatory Affairs
      • Validation
    • Top 25 Pharma & BioPharma
    • Contract Pharma Direct
    • Breaking News
    • Online Exclusives
    • Slideshows
    • Experts Opinions
    • Surveys
      • Outsourcing Survey
      • Salary Survey
    • Glossary
    • Videos
    • Podcasts
    • White Papers
    • Infographics
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • Supplier Microsite
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • eBook
    • Webinars
    • Events
      • Industry Events
      • Live from Show Events
      • Webinars
    • Classifieds / Job Bank
      • Classifieds
      • Job Bank
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Features

    The Human Parts of Mouse Models

    The PDX model system has come back into focus

    The Human Parts of Mouse Models
    Related CONTENT
    • PCI Biotech, RXi Pharma Extend Research Collaboration
    • UK’s Innovation Agency Backs Plasticell
    • INTERPHEX New Product Showcase
    • PAREXEL Appoints SVP, CFO
    • DCAT Week ’17 Growth Brings New Opportunities
    Julia Schueler, Head of in vivo Operations, Oncotest, a Charles River company 10.11.16
    Preclinical studies in oncology are frequently based on the use of mouse models. On average, the protein-coding regions of mouse and human genomes are 85% identical and the mouse genome can be easily manipulated.

    But as the saying goes, close only counts in horseshoes.

    The genomic identity between H. sapiens and M. musculus cannot compensate for significant species differences that, unfortunately, influence the outcome of experiments in not-so-beneficial ways. One good example is the failure of 9-AC in Phase II clinical trials despite very impressive preclinical data: the compound failed due to its small therapeutic window in humans as compared to mice.1

    To overcome this limitation, multiple efforts have been undertaken to establish and characterize large collections of patient-derived tumor xenograft (PDX) models—mice implanted with cancerous tissue from human patients—for cancer research.

    Although this model system dates back to the late 1980s, it recently came into focus due to its ability to predict clinical outcomes and its utility in biomarker development. PDX models mainly retain the histological and genetic characteristics of the donor tumor and remain stable across passages, which other human tumor mouse models lack due to the selection process they undergo during their establishment, in vitro, on plastic. Since they can preserve cell-autonomous heterogeneity, human tumor xenografts in immunodeficient mice have also led to valuable insights into the biology of human cancers.

    PDX and the tumor microenvironment
    With that said, PDX models have their own set of speed bumps to contend with. For one, the high cost of developing such models has led to a “productivity gap.” PDX models have also been associated with high failure rates of new drugs particularly in early clinical development.1-3 This lack of translational capability may originate from the fact that in PDX the human non-malignant cells, otherwise referred to as the tumor microenvironment (TME), get replaced within a few days by their murine counterparts.4 Fortunately, we’re gaining a much better understanding of the pivotal role TME plays in cancer biology. This is leading us to new drug targets that either modulate the TME in order to support more effective tumor cell killing or evoke an anti-tumor immune response.5,6 Parts of the murine TME are being replaced with immune cells and stromal components of human origin to produce what is essentially a humanized version of a PDX mouse model.

    This marriage between PDX and humanized mice has enormous relevance, especially in the development and testing of immune-oncology drugs. After struggling for years to make immunotherapies stick, researchers sparked a renaissance in cancer treatment with so-called checkpoint inhibitors that target the T-cell co-inhibitory receptors CTLA-4 and PD-1. Checkpoint inhibitors, which block the molecules that switch off immune cells, thus increasing tumor immunogenicity, are largely why Science magazine named cancer immunotherapy its breakthrough of the year in 2013.7

    The pipeline is now filled with compounds targeting PD-1 and CTLA-4 in solid and blood tumors, and humanized mice engrafted with PDX tumors represent one of the most novel ways to measure the immune responses induced by such compounds against human tumors growing in a human tumor environment.

    The reasons are clear. The co-culture of patient immune cells and patient derived tumors in an in vivo setting can theoretically trigger the study of novel therapies targeting tumor-immune interactions and in parallel allow for novel insights into tumor biology. No other model offers this much flexibility. But because the TME is made up of multiple components, it is also technically challenging to reproduce in a living animal. Triple immunodeficient mouse strains like NOD/Shi-scid/IL-2Rγnull (NOG) or NOD. Cg-Prkdcscid Il2rgtm1Wjl/SzJ (NSG) have made the process easier, as human non-malignant cells engraft to a high extent in these animals.

    Given the basic role of the immune system in tumor biology, the need for immunocompromised mice might be the most obvious drawback of PDX models. Tumor cells are broadly thought to be antigenic due to their multiple mutations in coding exons resulting in a phenotypic make-up reasonably different from the normal cells they evolved.8 However, most tumors eventually progress and evade the immune surveillance by inducing immune tolerance. The pro-inflammatory microenvironment in the tumor tissue established by CD8+ T cells, tumor-associated macrophages (TAM), natural killer (NK) cells, and others leads to an immune suppressive signaling cascade enabling the tumor to evade immune surveillance.

    The ability to influence the immune system is often related to prognosis: the cytotoxic to regulatory T-cell ratio is a strong prognostic marker in many solid tumors.9 The fact that macrophage and CD4+ T-cell recruitment following intensive chemotherapy in breast cancer patients is associated with significantly reduced recurrence-free survival follows the same line. In the light of these encouraging findings the need for predictive and robust preclinical models suitable for immune-oncology studies is getting more and more indispensable.

    Building a Mighty Mouse
    What’s involved in building these humanized PDX models? Mice supplemented with human immune cells should meet at least three criteria:
    (a) All lineages and subsets of human hematopoietic cells should develop in the mouse host, and be maintained in proportions and localizations similar to those observed in healthy humans
    (b) The cells should be functional, that is they should be capable of mounting innate and adaptive immune responses in vivo
    (c) The cells should allow for testing of therapeutic interventions and faithfully predict the outcome in clinical settings10

    Two basic approaches are used to generate humanized mice. One involves the engraftment of hematopoietic stem cells (HSC) from different sources, the other approach involves injecting mice with human peripheral blood mononuclear cells (PBMC) (see Figure 2).

    In the latter, one can encounter challenges when engrafted human T-lymphocytes show xeno-reactivity against foreign major histocompatibility (MHC) class I and II molecules and other antigens of murine origin. As a result, inflammatory cells, namely T lymphocytes, infiltrate different organs and kill the animals after several weeks, a process known as xenograft-versus-host disease (xGVHD).11 However, the co-transplantation of human hematopoietic stem cells together with cancer cells seems to enable the co-existence of MHC-mismatched cells without inducing rejection.12

    Despite the risk of xGVHD, treatment experiments are mainly performed using PBMC-humanized mice. As long as the influence of xGVHD on tumor growth is taken into account, these experiments provide valuable insights into the possible benefit of new immunomodulatory compounds.13 On the other hand, HSC-humanized mice, which are rising in popularity, offer a broader time window of up to four months for treatment experiments. The lack of xGVHD also facilitates the read-out of these studies with respect to anti-tumor activity and side effects.14

    Humanized PDX performance
    Studies by our group and others proved the feasibility of this model for drug screening purposes in an immune-oncology setting. The studies, which focused on non-small cell lung cancer (NSCLC), found that growth behavior of the subcutaneously implanted PDX models of NSCLC were not affected at all by the engraftment of HSC in the murine host, meaning that take rates and doubling times were not influenced by presence of human immune cells. The histological structure of the tissue and cells of the investigated PDX models were similar when implanted subcutaneously in humanized or immunodeficient mice, and still closely resembled the patient donor material.15

    In several studies, the experimental checkpoint inhibitors targeting CTLA-4 and PD-1 depicted anti-tumor activity in traditional xenografts as well as PDX of NSCLC. Combination therapy promoted T cell expansion in most of the examined models. And the use of humanized mice in a single mouse trial format (Figure 3),16 turned out to be a cost-effective in vivo screening approach, with one tumor-bearing animal per tumor model and treatment scheme. The approach also perfectly mirrored clinical diversity of tumor responses to a specific treatment.

    At the end of the day, our investigations confirmed the general benefit of PDX in mice engrafted with human immune cells, and in combination with the well described advantages of the PDX-based platform, such as preserved tumor heterogeneity and clinical relevant molecular make-up, this assay format provided an additional step toward the development of new immunotherapies.

    The investigation of immune cell subsets like monocytes or natural killer cells is another area of preclinical investigation being done in humanized PDX models, with encouraging results. The co-injection of human monocytes in parallel with the lung cancer drug bevacizumab in PDX-bearing animals improved the anti-tumor activity of the monoclonal antibody markedly. In contrast, the application of human monocytes alone did not influence the tumor growth of the NSCLC PDX investigated in this study.17 Monocytes and macrophages have been reported to induce antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis of tumor cells in the presence of IgG anti-tumor monoclonal antibodies, like bevacizumab. By confirming these observations in a PDX-based NSCLC in vivo model, the study highlighted the suitability of PDX for immuno-oncology approaches by supplementation of the murine host with human immune cells.

    Chimeric antigen receptor T-cell therapies, where immune cells are genetically modified to hunt down and destroy cancer cells, have also proved to be highly efficient in hematological malignancies as well as solid cancers.18,19 CAR-T, meaning a T cell expressing an antigen-specific or antibody-based chimeric receptor with antibody specificity and T-cell effector or regulatory function, was first described in the 1980s by Eshhar et al.20 Clinical21,22 as well as preclinical studies23,24 now show encouraging data in hematological as well as solid tumors. The availability of large PDX collections comprising a broad range of different specific tumor types enables the preclinical testing of CAR-T cells targeted against most of the tumor-specific antigens currently under investigation. 

    Conclusion
    The establishment of PDX models that recapitulate the complexity and genetic heterogeneity of human cancer is an invaluable research tool, enabling insights into tumor biology and strategies for developing new innovative approaches for anticancer treatment. Combining highly immunosuppressed mouse strains like NOG/NSG and second generation mouse models opens up new possibilities for innovative and predictive preclinical platforms reflecting clinical reality specifically in the context of immuno-oncology research.

    At the end of the day, the quality of animal research will have a major impact on the translational value of all PDX-based experiments. Quality in this context begins at the animal facility, which should meet internationally accepted standards provided by AALAC (Association for Assessment and Accreditation of Laboratory Animal Care).

    The read-out and interpretation of the data is also key. In many research groups, the design of animal studies, the experimental execution, and the evaluation of the data are under the purview of one, non-masked, person. Several studies elucidated that certain weaknesses, including this lack of masking, limit their translational value to human application.25 Moreover, rigorous criteria have to be implemented to define anti-tumor activity. Repeated measures of tumor burden by caliper are common practice irrespective of the investigated tumor type or study context. These simplistic criteria often used in mouse models do not match the challenging criteria of clinical or pathological investigations. These obvious discrepancies unfortunately contribute to conflicting opinions about the reliability of mouse models in predicting clinical outcomes3 and necessitate the implementation of additional metrics, such as histopathological examinations and overall survival for immune-modulatory drugs, which primarily target immune cells rather than tumor cells.

    On the other hand, among all innovative models and read-outs, the subcutaneously implanted patient derived tumor xenograft remains the core area of preclinical in vivo models because it is easy to follow and still discovers as many drugs as more sophisticated tumor models.

    What will the future look like for preclinical drug testing of immunotherapies? PDX models are an important part of the preclinical tool box, and a good complement to genetically engineered mouse models or cell line derived xenografts. Although establishment, characterization and validation of PDX models has been in existence for decades, their value in oncology drug development and tumor biology research is really just starting to emerge. Continued improvements in the PDX platform should bring us closer to more clinically relevant models and help to secure the future of PDX research. 

    References
    1. Takimoto CH. Why drugs fail: of mice and men revisited. Clinical cancer research : an official journal of the American Association for Cancer Research. 2001 Feb;7(2):229-30.
    2. Johnson JI, Decker S, Zaharevitz D, Rubinstein LV, Venditti JM, Schepartz S, et al. Relationships between drug activity in NCI preclinical in vitro and in vivo models and early clinical trials. British journal of cancer. 2001 May 18;84(10):1424-31.
    3. Talmadge JE, Singh RK, Fidler IJ, Raz A. Murine models to evaluate novel and conventional therapeutic strategies for cancer. The American journal of pathology. 2007 Mar;170(3):793-804.
    4. Hylander BL, Punt N, Tang H, Hillman J, Vaughan M, Bshara W, et al. Origin of the vasculature supporting growth of primary patient tumor xenografts. Journal of translational medicine. 2013;11:110.
    5. Cavazzana-Calvo M. Nature. 2010;467:318-22.
    6. Mullard A. Nature Rev Drug Discov. 2010;9:905-6.
    7. Couzin-Frankel J. Breakthrough of the year 2013. Cancer immunotherapy. Science (New York, NY). 2013 Dec 20;342(6165):1432-3.
    8. Heubeck B, Wendler O, Bumm K, Schafer R, Muller-Vogt U, Hausler M, et al. Tumor-associated antigenic pattern in squamous cell carcinomas of the head and neck--analysed by SEREX. European journal of cancer (Oxford, England : 1990). 2013 Mar;49(4):e1-7.
    9. Liu K, Yang K, Wu B, Chen H, Chen X, Chen X, et al. Tumor-Infiltrating Immune Cells Are Associated With Prognosis of Gastric Cancer. Medicine. 2015 Sep;94(39):e1631.
    10. Rongvaux A, Takizawa H, Strowig T, Willinger T, Eynon EE, Flavell RA, et al. Human hemato-lymphoid system mice: current use and future potential for medicine. Annual review of immunology. 2013;31:635-74.
    11. King MA, Covassin L, Brehm MA, Racki W, Pearson T, Leif J, et al. Human peripheral blood leucocyte non-obese diabetic-severe combined immunodeficiency interleukin-2 receptor gamma chain gene mouse model of xenogeneic graft-versus-host-like disease and the role of host major histocompatibility complex. Clinical and experimental immunology. 2009 Jul;157(1):104-18.
    12. Wege AK, Schmidt M, Ueberham E, Ponnath M, Ortmann O, Brockhoff G, et al. Co-transplantation of human hematopoietic stem cells and human breast cancer cells in NSG mice: a novel approach to generate tumor cell specific human antibodies. mAbs. 2014 Jul-Aug;6(4):968-77.
    13. Sanmamed MF, Rodriguez I, Schalper KA, Onate C, Azpilikueta A, Rodriguez-Ruiz ME, et al. Nivolumab and Urelumab Enhance Antitumor Activity of Human T Lymphocytes Engrafted in Rag2-/-IL2Rgammanull Immunodeficient Mice. Cancer research. 2015 Sep 1;75(17):3466-78.
    14. Wege AK, Ernst W, Eckl J, Frankenberger B, Vollmann-Zwerenz A, Mannel DN, et al. Humanized tumor mice--a new model to study and manipulate the immune response in advanced cancer therapy. International journal of cancer Journal international du cancer. 2011 Nov 1;129(9):2194-206.
    15. Oswald E, Klingner K, Lenhard D, Niedermann G, Schüler JB. Abstract 5023: NSCLC PDX model for the evaluation of immuno-oncological treatment strategies. Cancer research. 2015 August 1, 2015;75(15 Supplement):5023.
    16. Christina Gredy JBS, Nina Zanella, Heinz-Herbert Fiebig, Thomas Metz. Abstract 2890: Single mouse trials, a concept using patient-derived tumor xenografts for large scale in vivo screens. .  AACR Annual Meeting 2015, 04/2015; 2015; Philadelphia, PA, USA; 2015.
    17. Cordula Tschuch KK, Anne Löhr, Yana Raeva, Teppo Haapaniemi, Eva Oswald, Julia B. Schüler. Abstract 590: Co-injection of human monocytes improves the in vivo antitumoral activity of bevacizumab in two NSCLC PDX models. Cancer research. 2016; 07/2016; (76(14 Supplement). ).
    18. Kakarla S, Gottschalk S. CAR T cells for solid tumors: armed and ready to go? Cancer journal (Sudbury, Mass). 2014 Mar-Apr;20(2):151-5.
    19. Maus MV, Grupp SA, Porter DL, June CH. Antibody-modified T cells: CARs take the front seat for hematologic malignancies. Blood. 2014 2014-04-24 00:00:00;123(17):2625-35.
    20. Gross G, Waks T, Eshhar Z. Expression of immunoglobulin-T-cell receptor chimeric molecules as functional receptors with antibody-type specificity. Proceedings of the National Academy of Sciences of the United States of America. 1989 Dec;86(24):10024-8.
    21. Yang Y, Jacoby E, Fry TJ. Challenges and opportunities of allogeneic donor-derived CAR T cells. Current opinion in hematology. 2015 Nov;22(6):509-15.
    22. Zhang Y, Zhang W, Dai H, Wang Y, Shi F, Wang C, et al. An analytical biomarker for treatment of patients with recurrent B-ALL after remission induced by infusion of anti-CD19 chimeric antigen receptor T (CAR-T) cells. Science China Life sciences. 2016 Apr;59(4):379-85.
    23. Cherkassky L, Morello A, Villena-Vargas J, Feng Y, Dimitrov DS, Jones DR, et al. Human CAR T cells with cell-intrinsic PD-1 checkpoint blockade resist tumor-mediated inhibition. The Journal of clinical investigation. 2016 Aug 1;126(8):3130-44.
    24. Shiina S, Ohno M, Ohka F, Kuramitsu S, Yamamichi A, Kato A, et al. CAR T Cells Targeting Podoplanin Reduce Orthotopic Glioblastomas in Mouse Brains. Cancer immunology research. 2016 Mar;4(3):259-68.
    25. de Jong M, Maina T. Of mice and humans: are they the same?--Implications in cancer translational research. J Nucl Med. 2010 Apr;51(4):501-4.

    Julia Schueler, DVM, PhD, is head of in vivo operations at Oncotest, a Charles River company based in Freiburg, Germany.
    Related Searches
    • Analytical Services
    • Drug Development
    • Drug Discovery
    • Preclinical Outsourcing
    Suggested For You
    PCI Biotech, RXi Pharma Extend Research Collaboration PCI Biotech, RXi Pharma Extend Research Collaboration
    UK’s Innovation Agency Backs Plasticell UK’s Innovation Agency Backs Plasticell
    INTERPHEX New Product Showcase INTERPHEX New Product Showcase
    PAREXEL Appoints SVP, CFO PAREXEL Appoints SVP, CFO
    DCAT Week ’17 Growth Brings New Opportunities DCAT Week ’17 Growth Brings New Opportunities
    Drug Development in Today’s Changing Healthcare Market Drug Development in Today’s Changing Healthcare Market
    Marken Opens New Hub in Chicago Marken Opens New Hub in Chicago
    Kite Pharma Expands Partnership with NCI Kite Pharma Expands Partnership with NCI
    Rho Wins NIAID Contract for Clinical Services Rho Wins NIAID Contract for Clinical Services
    Catalent Biologics Forms New Advisory Board Catalent Biologics Forms New Advisory Board
    Kite Pharma Acquires T-Cell Factory B.V. Kite Pharma Acquires T-Cell Factory B.V.
    Kite Pharma, NCI Expand CRADA Kite Pharma, NCI Expand CRADA
    Crown Bioscience Acquires Molecular Response’s PDX Business Crown Bioscience Acquires Molecular Response’s PDX Business
    Aethersys Gets Orphan Status in EU for MultiStem Aethersys Gets Orphan Status in EU for MultiStem
    Initial Results in for BioLineRx AML Trial Initial Results in for BioLineRx AML Trial

    Related Features

    • Analytical Services | Information Technology | Laboratory Testing
      Business Intelligence For (and From) the Lab

      Business Intelligence For (and From) the Lab

      How a digital ecosystem can harness the most data-rich environment in the CDMO.
      Bob Voelkner, VP Sales and Marketing, LabVantage 01.27.21

    • Clinical Trials | Information Technology | R&D
      Decentralized Trials Fuel AI Revolution in Clinical Research

      Decentralized Trials Fuel AI Revolution in Clinical Research

      The life sciences industry is giving clinical a full makeover, dramatically improving how new therapeutics are developed.
      Nick Moss, Vice President of Analytics and Machine Learning, Medable 11.17.20

    • Biologics, Proteins, Vaccines | Biosimilars | Drug Development
      Biopharma Contract Manufacturing: Robust Growth Ahead

      Biopharma Contract Manufacturing: Robust Growth Ahead

      The biopharmaceutical contract manufacturing market is projected to reach $6.3 billion in 2020, and it will continue to grow over the next five years.
      William Downey, HighTech Business Decisions 11.17.20


    • Drug Development | Drug Discovery | R&D
      R&D Outsourcing Trends

      R&D Outsourcing Trends

      Highly specialized drug products and capacity needs drive increased reliance on contract service providers.
      Kristin Brooks, Managing Editor, Contract Pharma 10.14.20

    • Drug Development | Preclinical Outsourcing
      Preclinical Planning for Successful Drug Development

      Preclinical Planning for Successful Drug Development

      When the preclinical pressure is on, appropriate planning can make sure timelines are achievable.
      Mingyi Trimble, WuXi AppTec 09.09.20

    • APIs | Drug Development | Risk Management
      Small-Molecule Drug Development: Advantages of an Integrated, Phase-Based Approach

      Small-Molecule Drug Development: Advantages of an Integrated, Phase-Based Approach

      Small-molecule drug development has become more complex and challenging, leading to greater reliance on CDMOs.
      Sarah Bethune, Cambrex 09.09.20


    • Biologics, Proteins, Vaccines | Drug Development | Regulatory Affairs
      Expediting a COVID-19 Vaccine: FDA Approval Process

      Expediting a COVID-19 Vaccine: FDA Approval Process

      The pressures of the pandemic are pushing sponsors and FDA to look at both efficacy and speed in developing a vaccine.
      Kristin Brooks, Managing Editor 09.09.20

    • Drug Development | Regulatory Affairs
      Guidelines in Toxicology: A Blessing and a Curse

      Guidelines in Toxicology: A Blessing and a Curse

      A look at the evolution of drug development regulatory guides.
      Sarah Gould, Senior Principal Scientific Advisor, Charles River 09.16.19

    • Drug Discovery
      Drug Discovery Technology Trends

      Drug Discovery Technology Trends

      Combining native mass spectrometry with fragment-based drug discovery in medicinal chemistry
      Sally-Ann Poulsen, Professor of Chemical Biology, Griffith Institute for Drug Discovery (GRIDD), Griffith University 09.16.19


    • Drug Development
      Flex Your Outsourcing Model to Maximize Drug Development

      Flex Your Outsourcing Model to Maximize Drug Development

      How to choose—and optimize—combinations of service models to fit your needs.
      Timothy King, Executive Director, Functional Service Partnerships (FSP), PPD 09.16.19

    • Biologics, Proteins, Vaccines | Drug Delivery | Drug Development
      Knowledge Sharing: Biologics Development and Delivery

      Knowledge Sharing: Biologics Development and Delivery

      The increasing importance of sharing information to build awareness and better manage the complexities of drug development.
      Fran L. DeGrazio, Vice President of Scientific Affairs and Technical Services, West Pharmaceutical Services 09.16.19

    • Drug Development
      Improving Your Development Program

      Improving Your Development Program

      Seven lab science trends driving the future of drug development.
      Jenifer Vija, Liam Moran, Chris Loosbroock and Eric Snyder, Charles River 05.07.19


    • Drug Development
      Technical Advantages of Continuous Flow Chemical Synthesis

      Technical Advantages of Continuous Flow Chemical Synthesis

      Continuous flow chemistry is known for its ability to handle hazardous reactions safely, but can also unlock many other technological benefits.
      Shawn Conway, Engineering R&D Director, Cambrex High Point 04.05.19

    • Drug Development | Preclinical Outsourcing
      Early Development Trends

      Early Development Trends

      Catalent’s president of oral drug delivery, Jonathan Arnold, talks trends and challenges in the early phases of drug development.
      Tim Wright, Editor, Contract Pharma 03.06.19

    • Drug Development
      Future Trends in the CDMO Space

      Future Trends in the CDMO Space

      And how to navigate them for successful drug development
      Guillaume Plane, Global Development and Marketing Manager, BioReliance End-to-End Solutions, MilliporeSigma 01.25.19

    Trending
    • Baxter Biopharma Solutions Enters Sterile Manufacturing Agreement For Novavax’ COVID-19 Vaccine
    • Four Female Leaders Appointed To Cell & Gene CDMO
    • Pharmaron Acquires Biomanufacturing Site In The UK From AbbVie
    Breaking News
    • Jubilant Therapeutics Appoints Chief Scientific Officer
    • Iontas and Fair Journey Biologics Partner with Quell Therapeutics
    • Vetter Establishes Office in China
    • AGC Biologics Expands Cell and Gene Facility in Italy
    • Celonic to Boost Cell & Gene Therapy Production
    View Breaking News >
    CURRENT ISSUE

    March 2021

    • Hygienic Packaging Technology
    • Trends in Solid Oral Dosage Delivery
    • 5 Reasons Paper Has No Place in Contract Manufacturing
    • Injectable Drug Delivery Trends
    • Pharmaceutical Manufacturing Equipment Trends
    • Oral Solids: Market & Technology Trends
    • Nutraceutical Manufacturing: Meeting the Challenges of Today, Planning for Tomorrow
    • 2021 Contract Manufacturing Survey
    • Small Molecule Development Trends
    • Challenges & Opportunities Facing Small & Emerging Biopharma Companies
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Diets High In Fructose Could Cause Immune System Damage
    Nestlé Acquires Premium Water Brand Essentia
    Kaneka Probiotics Announces Launch of L. plantarum DR7
    Coatings World

    Latest Breaking News From Coatings World

    Sherwin-Williams Announces Resignation of President, COO
    Ashland Completes Expansion, Relocation of Viatel Bioresorbable Polymers Manufacturing Facility
    Evonik Receives Sustainability Award from EcoVadis
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    FDA OKs First OTC Home Molecular COVID-19 Test
    FDA Approves Second Sight's Argus 2s Retinal Prosthesis
    Cross Border Venture Financing Rose in Final Quarter of 2020
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Sharp Appoints EU Qualified Person
    Baxter Biopharma Solutions Enters Sterile Manufacturing Agreement for Novavax’ COVID-19 Vaccine
    Metrics Contract Services Completes Russian Regulatory Inspection
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    It's International Women's Day—But What Does That Mean?
    e.l.f. Cosmetics and Chipotle Collaborate on Burrito-Inspired Makeup Collection
    Weekly Recap: Sephora Expansion, Ulta Partners with Loop, International Women’s Day & More
    Happi

    Latest Breaking News From Happi

    Cococare Appoints First Woman President
    Ross Highlights Triple Shaft Mixers
    Arm & Hammer Unveils Foot Wipes
    Ink World

    Latest Breaking News From Ink World

    Capital Printing Invests in 2nd Komori Press
    Arna Marketing Adds Canon’s ProStream, VarioPRINT iX Production Inkjet Presses
    Massilly North America Adds Koenig & Bauer MetalStar 3 Metal Decorating Press
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Xeikon details upcoming Xeikon Café TV seminars
    Resource Label Group acquires New England Label
    UV+EB-cured products rated 'easier to recycle'
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Arm & Hammer Launches Foot Wipes
    Kimberly-Clark Names Chief Research and Development Officer
    FPInnovations Develops Biodegradable Mask
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Australia Clears Conformis' iTotal PS Knee Replacement System
    Colfax Decides to Divide Its Businesses
    Stryker Corp.'s 2020 Sales Slip 3.6 Percent
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Comercial Kywi Improves Customer Service, Front-Store Operations with Zebra Mobile Solution
    Global Smart Glass Market to Register 6.8% CAGR Between 2021-28: Grand View Research
    Wearable Patch Market to Reach $27.8 Billion by 2027: Allied Market Research

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login