• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 20
    • Directory
    • Microsites
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 20
  • Directory
  • Microsites
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    Newsmakers: Darren Shirley

    Are You Prepared for the 2023 DSCSA Deadline?

    Rethinking the Changing Role of the CRO

    23rd Annual Salary Survey

    Pharma 4.0 and the Modernizing Power of Digital Technology Transfer
    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
    Phastar Appoints Chris Schoonmaker as Chief Operations Officer

    Charles River Labs Opens Plasmid DNA CoE in Cheshire, UK

    EQT Private Equity Acquires SPT Labtech from Battery Ventures

    Shimadzu Scientific Instruments Extends HQ Campus

    Vetter’s Newest Clinical Manufacturing Site Completes First Customer Fills
    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

    Shimadzu Scientific Instruments Extends HQ Campus

    Vetter’s Newest Clinical Manufacturing Site Completes First Customer Fills

    Batavia Enters Commercial Manufacturing Business

    CoreRx Expands Capabilities

    Pierre Fabre and Lonza Enter Manufacturing Agreement
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Tubular Glass Primary Packaging for Pharmaceutical, Biotech and Diagnostic Containment

    How to Improve the Cold Chain System in Remote Locations

    Sentry Biopharma Services: Protecting Pharmaceutical Integrity

    Yourway to Build New Flagship European Depot

    Newsmakers: Darren Shirley
    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

    Charles River Labs Opens Plasmid DNA CoE in Cheshire, UK

    EQT Private Equity Acquires SPT Labtech from Battery Ventures

    Ixaka & Minaris Sign Tech Transfer & GMP Manufacturing Agreement for Cell Therapy Candidate

    MasterControl and Elemental Machines Form Biomanufacturing Partnership

    Charles River and Ziphius Vaccines to Manufacture saRNA-based Vaccine
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    Should Remote Pharma GMP Audits End After COVID?

    Why is Big Pharma Increasingly Adopting 505(b)(2)?

    Sentry Biopharma Services: Protecting Pharmaceutical Integrity

    Selkirk Pharma Appoints New Head of Quality

    Be Safer by Doing Less: The Future of Zero Touch AE Case Processing
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    CMC Pharmaceuticals

    Biosynth Carbosynth

    Qosina

    IDT Biologika

    Vector Partners Limited
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    CMC Pharmaceuticals

    Biosynth Carbosynth

    Qosina

    IDT Biologika

    Vector Partners Limited
    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
    • White Papers
    • Podcasts
    • Infographics
    • Supplier Microsite
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • 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
    Expert's Opinion

    Advanced Therapies: Adding a New Layer of Complexity to Clinical Trials

    Overcoming the challenges of a new and changing clinical trial landscape

    Advanced Therapies: Adding a New Layer of Complexity to Clinical Trials
    Related CONTENT
    • SGS Health Science
    • Coriolis Pharma
    • Trial Runners
    • Mogene
    • Biopharma Over 20 Years
    Erin Finot, Global Head of Immuno-Oncology, IQVIA Biotech11.18.19
    Advanced therapies (ATs), defined for this article as cell and gene therapies, are pushing the frontiers of medicine because they can potentially improve quality of life by eliminating disease. Whereas traditional small molecule or biopharmaceutical therapies treat the symptoms of a disease, ATs restore or establish normal function through the modification of human cells (cell therapy), or of DNA or RNA (gene therapy).
     
    The FDA has approved 17 ATs1 to date, and the number of ATs in development is rapidly growing as they are applied to additional diseases. Currently, the majority of ATs focus on oncology, as the rates of most cancers are on the rise and there is a great unmet need in this area (Figure 1).


    While the AT pipeline addresses many areas of
    interest, the greatest focus is on oncology.
    AT trials are intensely complex; they come with requirements and considerations above and beyond what is typical for traditional clinical trials. Sponsors face major challenges, particularly site selection, navigating additional regulatory requirements, and managing logistical demands of the AT manufacturing process, the AT itself, and any associated biospecimen handling. These must each be addressed directly to increase the chance of clinical success.
     
    Steering through the site selection process
    Site selection for AT trials requires finding a suitable institution, one that can handle the required coordination and integration of efforts from specialized disciplines. Biotech companies should prepare to invest extra time during qualification and initiation visits to confirm that sites are truly prepared to handle their studies.
     
    There are several ways to search for potential sites. A good place to begin is to explore Foundation for the Accreditation of Cellular Therapies (FACT) accredited institutions, which have built up their infrastructure and capabilities to meet globally recognized advanced therapy standards. Sponsors can also use a CRO-partner database or subscription database to gain insight into a site’s past performance. Finally, call on investigator relationships, thought-leader support, and specialized networks to choose sites best suited to the clinical trial.
     
    Maneuvering through regulatory requirements
    Before enrolling patients, AT trials must gain regulatory approval for the investigational product, protocol, genetic tests, raw materials, and lab assays to be used in the study, which may vary by region. In addition to seeking standard approvals (e.g., from an Institutional Board Review and the FDA) and adhering to guidelines for the global International Conference Harmonization Good Clinical Practice, AT trials are also evaluated by country standards and specialized committees. There are global and regional standards to be met for every aspect of a trial, and they do not always match up across borders. ATs are a relatively new field of study and – in an effort to improve oversight, improve AT handling, and to uphold public safety – regulations have and will continue to evolve. When planning an AT trial, biotech companies should ensure that for the foreseeable future, their technology will be accepted in all countries in which they plan to operate to minimize expense and maximize safety of a trial.
     
    Coordinating logistics
    While an AT trial is under way, sponsors must meet massive logistical demands to successfully collect biospecimens from patients and run the manufacturing supply chain. Accurate communication and logistical planning are essential throughout the trial for maintaining compliance, tracking, and risk mitigation.

    Whether ATs are autologous (personalized therapies manufactured from a patient’s own cells) or allogeneic (small batch therapies made from a donor), manufacturing ATs follows a web-like supply chain. From starting material to final product, ATs are highly perishable and require intricate storage, labeling, traceability, packaging, and shipping and release requirements. Once an AT therapy has been administered, adhering to frequent biospecimen collection ensures safety, evaluates kinetics, and determines function or efficacy. Biotechs must have a predetermined protocol for how, when, and in what quantity biospecimens must be collected for the trial, as well as a plan to store, transport, and assay them.
     
    CROs can ease these complexities
    CROs can help sponsors overcome an AT trial’s many operational complexities, and support biotechs through the ever-changing AT regulatory landscape. For example,the imminent EU Clinical Trial Regulation (EU CTR 536/2014) will launch some of the most significant changes to clinical trial regulations in Europe in over a decade, introducing new procedures for clinical trial applications and protocols for notifying authorities and committees that oversee all interventional trials. These changes may incite uncertainty for smaller biotech companies with limited resources but, backed by a CRO with knowledge of the regulatory landscape, sponsors can navigate these developments with confidence.
     
    As advanced therapies evolve, we predict that administering them will become less complex and more universal. As the current manufacturing and regulatory processes become more established, sites beyond academic and high-powered medical institutions may one day be able to offer ATs. Although a shift toward more widely available advanced therapies may come with a host of additional complexities, this shift will bring these therapies to more patients who need them.

    Reference:
    1. U.S. Food and Drug Administration, “Approved Cellular and Gene Therapy Products.” https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products. Accessed 8 August 2019.2.



     
    Erin Finot is the Global Head of Immuno-Oncology at IQVIA Biotech and is regionally based in Charlottesville, Virginia. Mrs. Finot has 18 years of experience in clinical research and provides exceptional global knowledge of the drug development process, including an emphasis and fluency in adoptive cellular trials. She is responsible for the strategic direction and leadership of the team and oversees the delivery, quality, and services provided to the Immuno-Oncology portfolio. Mrs. Finot holds a BA in biology from the University of California, Berkeley, an MS focused in Immunology from the University of Virginia, and an MBA in Finance and Accounting from the University of Louisiana, Shreveport.
     
     
    Related Searches
    • immuno-oncology
    • labeling
    • biotech
    • clinical research
    Suggested For You
    SGS Health Science SGS Health Science
    Coriolis Pharma Coriolis Pharma
    Trial Runners Trial Runners
    Mogene Mogene
    Biopharma Over 20 Years Biopharma Over 20 Years
    Keynote: FDA’s Continuous Manufacturing Journey: Past, Present and Future Keynote: FDA’s Continuous Manufacturing Journey: Past, Present and Future
    Managing Outsourced Clinical Trials Managing Outsourced Clinical Trials
    AstraZeneca to Implement N-SIDE Suite for Clinical Trials AstraZeneca to Implement N-SIDE Suite for Clinical Trials
    Quality Metrics Feedback Quality Metrics Feedback
    FDA Extends CRADA with CluePoints FDA Extends CRADA with CluePoints
    Orchestra BioMed Appoints Chief Medical Officer Orchestra BioMed Appoints Chief Medical Officer
    FDA Approves Antibiotic for Community-Acquired Pneumonia FDA Approves Antibiotic for Community-Acquired Pneumonia
    Marken Expands Services for Home-based Clinical Trials Marken Expands Services for Home-based Clinical Trials
     The 4th World Congress on Clinical Trials in Diabetes The 4th World Congress on Clinical Trials in Diabetes
    Atlasciences Appoints Chief Scientific Officer Atlasciences Appoints Chief Scientific Officer

    Related Content

    • Chemistry | Extractables and Leachables | Microbiology
      SGS Health Science

      SGS Health Science

      ...
      Jessica Martin, Marketing Director 10.26.21

    • Coriolis Pharma

      Coriolis Pharma

      ...
      Daniel Weinbuch, Dr. 07.01.21

    • Trial Runners

      ...
      seth p, marketing manager 11.20.20


    • Mogene

      ...
      Craig Morley, CEO 11.17.20

    • Biologics, Proteins, Vaccines | Biosimilars
      Biopharma Over 20 Years

      Biopharma Over 20 Years

      A look at the key trends that have impacted the biopharma industry over the years.
      K. John Morrow, Jr. and Eric S. Langer, BioPlan Associates 11.20.19

      Loading, Please Wait..
      Trending
      • Regulatory Report: Analytical Procedure Development
      • Pierre Fabre And Lonza Enter Manufacturing Agreement
      • Pfizer, BioNTech Adapt COVID Vax Against Omicron
      • Vetter’s Newest Clinical Manufacturing Site Completes First Customer Fills
      • Shimadzu Scientific Instruments Extends HQ Campus
      Breaking News
      • Phastar Appoints Chris Schoonmaker as Chief Operations Officer
      • Charles River Labs Opens Plasmid DNA CoE in Cheshire, UK
      • EQT Private Equity Acquires SPT Labtech from Battery Ventures
      • Shimadzu Scientific Instruments Extends HQ Campus
      • Vetter’s Newest Clinical Manufacturing Site Completes First Customer Fills
      View Breaking News >
      CURRENT ISSUE

      June 2022

      • Newsmakers: Darren Shirley
      • Are You Prepared for the 2023 DSCSA Deadline?
      • Rethinking the Changing Role of the CRO
      • 23rd Annual Salary Survey
      • Pharma 4.0 and the Modernizing Power of Digital Technology Transfer
      • CEO Spotlight: David Chang
      • Changes are on the Horizon for Single-use Systems in Pharmaceutical Manufacturing
      • CRO Industry Market Report

      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

      Kensing Acquires Vitae Naturals
      CoQ10 and Royal Jelly Supplementation May Improve High Intensity Exercise
      Shiitake Mushroom Extract Appears Helpful in HPV Infections
      Coatings World

      Latest Breaking News From Coatings World

      Sheboygan Paint Company Adds Rosey Malchow as Customer Experience Manager
      PPG to Announce Second Quarter 2022 Results July 21
      Evonik Unveils Range of Sustainable Liquid Polybutadienes
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      Researchers Develop New Apparatus for the Treatment of Cardiovascular Diseases
      NovaXS Unveils New Prototype of Needle-Free Injection Therapy Smart Medical Device
      Meddux Opens New Facility in Boulder, Colorado
      Contract Pharma

      Latest Breaking News From Contract Pharma

      Phastar Appoints Chris Schoonmaker as Chief Operations Officer
      Charles River Labs Opens Plasmid DNA CoE in Cheshire, UK
      EQT Private Equity Acquires SPT Labtech from Battery Ventures
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      Highlights from Paris Packaging Week
      Walgreens Boots Alliance Decides Not to Sell Boots and No7 Beauty Company Businesses
      WWP Beauty Unveils New Packaging Collections in Collaboration with Eastman
      Happi

      Latest Breaking News From Happi

      Evonik Holds Groundbreaking Ceremony for Commercial Rhamnolipid Production Facility
      CHT USA Hosts Groundbreaking Ceremony for $20 Million US Headquarters Expansion
      Azelis Expands Global Flavors & Fragrances Platform with Acquisition in India
      Ink World

      Latest Breaking News From Ink World

      Temporary Content Title
      Amcor Lift-Off Initiative Shortlists Start-ups for Seed Funding
      Barentz Highlights Lincoln MFG’s New ISO 9001:2015 Certification
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      Sibress launches FADS3D flexo plate measuring device
      Mike Brown appointed VP for Davis-Standard’s Canadian operations
      Constantia Flexibles introduces chemical resistant recycle-ready laminate
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Suominen Launches Hydraspun Reserve
      Richard Knowlson Receives Lifetime Technical Achievement Award
      Skylark Launches Thicker Label Closure Technology in North American
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      Tecomet Appoints Bill Dow as President & CEO
      Medacta, InSilicoTrials Partner on Orthopedic Device Development
      Researchers Develop Microfluidic Sensors to Improve Implant Survival Rates
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      Avery Dennison Launches New Dual-Frequency RFID Inlay
      Avery Dennison Highlights New Approach to Apparel with ADX Lab
      trinamiX Face Authentication Protects Users from Fraud Attacks During Mobile Payments

      Copyright © 2022 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