• 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
    High Drug Loading Amorphous Solid Dispersions

    Parenteral Drug Delivery Trends

    Selecting the Right Outsourcing Model for Emerging Biotech

    Inhaled Drug Delivery Technology

    The Future of Biologics: Accelerating Production, Reducing Costs
    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
    J&J’s Single-Dose COVID-19 Vax Issued EUA

    Icon to Acquire PRA Health Sciences

    Phlow Corp. and USP Form Alliance

    BMS Expands Cell Therapy Manufacturing Capabilities

    Novo Nordisk Invests $80M in Tablet 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

    BMS Expands Cell Therapy Manufacturing Capabilities

    Novo Nordisk Invests $80M in Tablet Production

    Arcline Investment Acquires ChargePoint Technology

    Solid Dose Market Trends

    CatSci Opens New Site in UK
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Reshaping the Pharmaceutical Supply Chain

    Covectra Introduces Next-Gen Serialization Solution

    Bormioli Opens New Glass Research Center

    Centrient Pharmaceuticals to Acquire Astral SteriTech

    Seasonal Vaccine Manufacturing
    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

    Icon to Acquire PRA Health Sciences

    BMS Expands Cell Therapy Manufacturing Capabilities

    Ashfield Engage, Popit Form Digital Monitoring Collaboration

    AMRI Contributes to Efforts to Increase COVID-19 Vax Supply

    CatSci Opens New Site in UK
    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
    Syngene

    Flow Sciences

    Reed-Lane

    Emergent BioSolutions

    Baxter BioPharma Solutions
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Aphena Pharma Solutions

    Alcami

    Baxter BioPharma Solutions

    PCI Pharma Services

    Flow Sciences
    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
    Expert's Opinion

    Maximizing Potential

    Creatively navigating the clinical supply chain challenges during COVID-19

    Maximizing Potential
    Sharon Courtney, Logistics Services Manager, Almac05.04.20
    Covid-19 poses an unprecedented threat to the continuity of supply of vital medications to patients enrolled in clinical trials around the world. To rise to the rapidly developing clinical supply chain challenges caused by this global pandemic, sponsors are reviewing protocols, seeking expert guidance from their contract development and manufacturing organization (CDMO) and acting with agility by implementing necessary strategic actions.
     
    Quarantines, travel restrictions, site closures and limited site personnel, are some of the factors contributing to this increased level of risk, which is presenting unprecedented challenges to those tasked with delivering the right drug to patients, at the right time and at the right temperature. Sponsors and their partners are working closely to ensure patients receive their treatments amidst changing circumstances and increasing restrictions. Delays are not an option and it is mission critical to deliver for patients. There are several key strategies for companies involved in the clinical supply chain.
     
    Supply chain agility
     
    The close dialog and established processes between sponsor and supporting CDMO organizations will facilitate monitoring of the status of clinical sites and patients activities that will drive actions across the supply chain. For instance, there may be changes in patient recruitment levels, study start-up activities, maintenance requirements and possible changes to the timelines for key protocol milestones.
     
    This will drive a managed and agile approach to clinical supply inventory strategies i.e. shipping to sites, stock held at sites or changes to the overall quantities of supply. Incorporation and alignment of supply chain managers, IRT/IXRS project staff and sponsor clinical professionals is essential, as they will be able to adjust these parameters to facilitate the fluctuations in patient availability during the COVID pandemic. Supply chain managers will also provide alternative solutions to particular study considerations—such as switching to a just-in time approach for packaging of supplies that is more in line with “on demand” need at the patient level.
     
    Disruption demands distribution flexibility
     
    Direct to patient via site
    Given Covid-19 and the acceleration of this pandemic, increasing numbers of patients are unable to travel to site due to Government restrictions on movement. In cases where patients can no longer travel to site, a Direct to Patient via Site model ensures continuity of drug supply to the patient’s home. This service provides for patients that have critical needs, leveraging mechanisms typically employed in normal circumstances when patients cannot visit clinical sites due to, for example, their age, illness or proximity.
     
    Although a DTP via Site distribution model may represent a feasible solution for many sponsors, its viability will depend on several factors, including participating countries. Many EU nations, the USA and China support the DTP via Site model, yet a significant number of countries do not. With the landscape changing so rapidly, prioritizing access to real time information is key. As such, sponsors should seek expert guidance from their CDMO partners.
     
    CDMO to patient                                                                                                                                                                   
    If the clinical site has closed or key staff are no longer able to travel to a site due to an increase in restrictions and lockdowns, a CDMO to Patient distribution solution may be utilized. In the challenging scenario where a site may be closed, supplies are shipped to the patient’s home directly from its CDMO facility without compromising product integrity and ensuring GxP compliance throughout. Additionally, some regulatory authorities are evolving their trial management criteria in order to facilitate this solution under specific conditions. The regulators such as the FDA and MHRA are becoming more open minded to alternative approach to ensure the patient is at the forefront of any actions or decisions made. By combining experienced project management and reliable courier services, the delivery of essential clinical supplies to patients globally is maintained.
     
    Site supportive strategies
     
    Remote drug monitoring
    As many clinical studies require a blinded/unblinded monitor to visit the clinical sites, this can be very challenging if at all possible during this pandemic. For an active clinical study, it is essential that the participating sites are compliant with the dosing requirements of the trial. Dosing and dispensation records can be reviewed remotely to ensure accuracy and completeness. A remote drug monitoring approach can eliminate the need for the Clinical Research Monitor to visit the site and the paperwork and procedures provided can assist in organizing the documentation at the clinical site.
     
    Temperature control
    Sponsors need to ensure the quality and integrity of the drug product throughout the supply chain and the journey of any temperature controlled pharmaceutical product needs the perfect environment to ensure efficacy. Regulations require the sponsor to provide proof the drug product remained within the labelled temperature conditions from manufacturing through to the clinical site. An end-to-end temperature management strategy provides the assurance that medication is fit for use, that all temperature data is collated, stored, and accessible to the sponsor and the material is available for dispensing to the patient.
     
    Business continuity and risk mitigation
    All the response strategies outlined rely on the bedrock of an effective Business Continuity Plan. This ensures the health and wellbeing of personnel, suppliers and vendors, site operations and the minimization of risk to business operations. An effective Business Continuity Plan also safeguards the management of resources to ensure quality, capacities and service levels are maintained for sponsors. This provides sponsors with the assurance of a managed response to the evolving situation, clear lines of communication, information and promotion of close dialogue to ensure the timely provision of clinical materials. This also provides a platform for supply chain flexibility that can be infused across all studies as they react to changing recruitment and site supply strategies, alongside any changing “on the ground” realities led by the Governments and local Health Authorities worldwide.
     
    Safeguard timely, compliant and cost-effective patient supply
     
    We live in unprecedented, uncertain, challenging and concerning times. As great members of our general public the world over are becoming patients due to the Coronavirus, sponsors are not only providing for existing patients on active clinical trials but also moving to accelerate the commencement of new trials. This is part of the wider research drive they are involved in to find a vaccine/treatment for Covid-19, requiring increasing supply chain flexibility and novel approaches from all partners involved in the clinical supply chain.
     

    Sharon Courtney is Almac’s Logistics Services Manager. She is an international logistics specialist having worked for 18 years in clinical supply chain operations. She has expert knowledge in a number of key areas within the end to end supply chain process including management and control of temperature sensitive shipments; risk mitigation; developing and managing robust relationships with transport partners; chain of custody responsibilities; active and passive shipping solutions and import/export country knowledge.

    Related Expert's Opinion

    • Clinical Trials | Information Technology
      Top 5 Things to Know Before Selecting Clinical Trial Technology

      Top 5 Things to Know Before Selecting Clinical Trial Technology

      Look for a future-proof model, innovative vendors - not cutting-edge technology, and focus on user-centered design and interoperability.
      Andres Garcia, Co-founder and CTO Florence 02.08.21

    • Clinical Trials
      The Future of Clinical Trials Series: Part II

      The Future of Clinical Trials Series: Part II

      Greater awareness will ensure diversity is no longer an afterthought and patients will be at the center of every aspect of clinical research.
      Jena Daniels, Rasmus Hogreffe, Ingrid Oakley-Girvan, Dr. Michelle Longmire, Medable 01.26.21

    • Clinical Trials
      The Future of Clinical Trials Series: Part I

      The Future of Clinical Trials Series: Part I

      What will 2021 have in store for an industry in flux?
      Alison Holland, Head of Decentralized Trials, Medable, Maria Fotiu, Executive Vice President of Decentralized Solutions, Syneos Health 01.19.21


    • Clinical Trials | Drug Development | Information Technology
      Virtual Clinical Trials: The Future of Dermatology Studies

      Virtual Clinical Trials: The Future of Dermatology Studies

      COVID-19 has created lasting impacts for clinical trials and a host of benefits have arisen from the adoption of virtual and hybrid models.
      Sonja VanWye, RN, MSN, Director, Dermatology Strategy, IQVIA Biotech 01.15.21

    • Clinical Trials | Drug Development
      The Slow – But Desperately Needed – Evolution of Oncology Clinical Development Designs

      The Slow – But Desperately Needed – Evolution of Oncology Clinical Development Designs

      Appropriate adaptive designs in early stages of development can accelerate timelines and reduce costs, and help focus on the most promising agents.
      Jürgen Hummel, MSc, Senior Director, Statistical Science, PPD, and Lead of PPD’s Adaptive Design Working Group 01.07.21

    • Drug Development | Industry News | Regulatory Affairs
      The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021

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

      A look at EUA standards and approvals, unavoidable pitfalls, Operation Warp Speed, FDA’s use of Real-World Evidence, and a slow return to "normalcy".
      Chad Landmon, Michelle Divelbiss and Alex Alfano, Axinn, Veltrop & Harkrider LLP's Intellectual Property and Food and Drug Administration Practice Groups 01.05.21


    • Cold Chain Management | Logistics
      COVID-19 Vaccine Distribution: The Air Cargo Industry’s Greatest Challenge

      COVID-19 Vaccine Distribution: The Air Cargo Industry’s Greatest Challenge

      How the air cargo logistics community is embracing technology to close critical gaps in the cold chain.
      Chris Jones, EVP, Marketing and Services, Descartes 12.15.20

    • Clinical Trials | Information Technology
      Life Sciences Strive for Greater Agility

      Life Sciences Strive for Greater Agility

      Embracing real-time drug safety monitoring during and post COVID will continue to propel the industry forward.
      Ronan Brown, SVP of Integrated Technology & Compliance, and Joe Rymsza, VP, Global PV & Regulatory Technology Solutions, IQVIA 12.14.20

    • Clinical Trials | Drug Development | Information Technology
      Advances in Intelligent Automation

      Advances in Intelligent Automation

      The future of medicine relies on further digital transformation and automation-enabling solutions to improve drug development and monitoring.
      Updesh Dosanjh, Practice Leader, Technology Solutions, IQVIA 12.14.20


    • Drug Development
      Navigating Uncertainty: Considerations for Life Sciences 2021

      Navigating Uncertainty: Considerations for Life Sciences 2021

      With vaccines against COVID-19 on the horizon, our focus is shifting to 2021 and the major issues life sciences companies face and reasons for optimism.
      Arda Ural , EY Americas Health Sciences and Wellness Industry Leader, Ernst & Young LLP 12.11.20

    • Information Technology | Supply Chain
      The Pandemic & The Pharma Industry: 3 Things to Know

      The Pandemic & The Pharma Industry: 3 Things to Know

      The importance of vendor contract visibility, an increase in intense legal scrutiny, and new technology for greater agility and control.
      Colin Earl, CTO at Agiloft 11.16.20

    • Clinical Trials | Information Technology
      AI and Advanced Analytics

      AI and Advanced Analytics

      Equipped with the right tools, CROs are better positioned to develop optimal protocols, rapidly identify patients to enroll, and preempt study issues.
      Paul Oliver, Medidata 11.13.20


    • Clinical Trials | Information Technology
      eCOA: Addressing Barriers to Faster Deployment in Clinical Trials

      eCOA: Addressing Barriers to Faster Deployment in Clinical Trials

      Clinical Outcome Assessments are an increasingly important tool in clinical research.
      Paul O'Donohoe, Scientific Lead, eCOA and Mobile Health, Medidata 11.13.20

    • Preparing to Adopt Intelligent Label Management

      Preparing to Adopt Intelligent Label Management

      The labeling process is highly complex and constantly in flux, making it ideal for digital transformation, but AI and ML cannot be implemented overnight.
      Kiran Chinnalla, Associate Director Global Regulatory Affairs, Julian Backhouse, Associate Director Regulatory Technology Product Management, Cham Williams, Associate Director Business Systems , IQVIA 11.13.20

    • Biologics, Proteins, Vaccines | Cold Chain Management | Logistics | Supply Chain
      Rising to The Occasion: The High Stakes of Vaccine Transport

      Rising to The Occasion: The High Stakes of Vaccine Transport

      How logistical precision can ensure safe and efficient delivery of the COVID-19 vaccine.
      Bill Brooks, Vice President of North America Transportation Portfolio at Capgemini 11.04.20

    Trending
    • Bormioli Opens New Glass Research Center
    • Arcline Investment Acquires ChargePoint Technology
    • Spark Therapeutics Appoints CTO
    • The Future Of Vaccines And Biologics
    • BMS Expands Cell Therapy Manufacturing Capabilities
    Breaking News
    • J&J’s Single-Dose COVID-19 Vax Issued EUA
    • Icon to Acquire PRA Health Sciences
    • Phlow Corp. and USP Form Alliance
    • BMS Expands Cell Therapy Manufacturing Capabilities
    • Novo Nordisk Invests $80M in Tablet Production
    View Breaking News >
    CURRENT ISSUE

    January/February 2021

    • High Drug Loading Amorphous Solid Dispersions
    • Parenteral Drug Delivery Trends
    • Selecting the Right Outsourcing Model for Emerging Biotech
    • Inhaled Drug Delivery Technology
    • The Future of Biologics: Accelerating Production, Reducing Costs
    • Business Intelligence For (and From) the Lab
    • Communicating Your Contracting Priorities to Your Drug Company Customers
    • COVID-19 Impact Report
    • The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021
    • 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

    Martin Bauer Group Acquires Majority Stake in Beverage Company Power Brands
    Gencor Announces Positive Results in VeriSperse Bioavailability Study
    PanTheryx Inc. Acquires TruBiotics Brand from Bayer HealthCare LLC
    Coatings World

    Latest Breaking News From Coatings World

    Mule-Hide Products Co. Promotes Steven Litaker to Territory Manager
    Terra Firma, Wanhua Announce New Distribution Partnership
    Gelest CEO Elected to National Academy of Engineering
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Axonics Buys Contura to Expand to Stress Urinary Incontinence
    Nurx Appoints Chief Medical Officer
    Median Technologies, UC San Diego to Partner on AI-Based Medical Imaging Technology
    Contract Pharma

    Latest Breaking News From Contract Pharma

    J&J’s Single-Dose COVID-19 Vax Issued EUA
    Icon to Acquire PRA Health Sciences
    Phlow Corp. and USP Form Alliance
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Universal Engraving Announces New President
    Raw Sugar Living Expands to Target with New Collection
    Supporting Female Beauty Brand Founders on International Women's Day
    Happi

    Latest Breaking News From Happi

    ACI and CBC Launch Webpage About ‘Quats’
    L’Occitane Launches Hand Cream Inspired by Women
    Kiehl’s Partners with Gyrl Wonder
    Ink World

    Latest Breaking News From Ink World

    Access Direct Mail Doubles Revenue with SCREEN's Truepress Jet520HD
    Etiflex Enters New Markets with Nilpeter FA-22 Installation
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    TLMI analyzes pandemic's effect on label industry in new report
    UEI names Ross Hutchison president
    Schreiner MediPharm and AARDEX partner for clinical trials
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    U.S. Nonwovens Rebrands as Radienz Living
    What You’re Reading on Nonwovens-Industry.com
    Texas Medical Technology Partners with My Protect Kit
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Pandemic Pain: NuVasive's 2020 Sales Fall 10 Percent
    Fusion Robotics Receives FDA Clearance for Spinal Navigation and Robotics System
    Kaia Health Unveils Next-Gen Complete MSK Care Solutions
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Comercial Kywi Improves Customer Service, Front-Store Operations with Zebra Mobile Solution
    Global Printed Circuit Board Market Projected to Reach $69.32 Billion by 2027
    Global Smart Glass Market to Register 6.8% CAGR Between 2021-28: Grand View 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