A patient-driven supply chain: Regulatory impacts and opportunities

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relative w-full h-full object-cover" src="https://media.licdn.com/dms/image/v2/D4E12AQHn3xxNGr-Kjw/article-cover_image-shrink_600_2000/article-cover_image-shrink_600_2000/0/1682423886275?e=2147483647&v=beta&t=E6apusVuNWOcdUKBTiVKN-YZsMHmP8AnxUPv315Ir_0" fetchpriority="high" data-embed-id="cover-image" alt="A patient-driven supply chain: Regulatory impacts and opportunities "> </div> </div>  </figure> <header> <section class="core-section-container relative my-3"> <h1 class="pulse-title text-display-md text-color-text lg:text-display-lg font-bold w-11/12">A patient-driven supply chain: Regulatory impacts and opportunities </h1> <div class="ellipsis-menu absolute right-0 top-0"> <div class="collapsible-dropdown flex items-center relative hyphens-auto"> <button class="ellipsis-menu__trigger collapsible-dropdown__button btn-md btn-tertiary cursor-pointer !py-[6px] !px-1 flex items-center rounded-[50%] " aria-expanded="false" aria-label="Open menu" 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base-card--link base-main-card flex flex-wrap py-2 pr-2 babybear:pr-0 base-main-card--link publisher-author-card"> <a class="base-card__full-link absolute top-0 right-0 bottom-0 left-0 p-0 z-[2]" href="https://uk.linkedin.com/company/biophorum-operations-group" data-tracking-control-name="article-ssr-frontend-pulse_publisher-author-card" data-tracking-will-navigate> <span class="sr-only"> BioPhorum </span> </a> <img class="inline-block relative w-6 h-6 " data-delayed-url="https://media.licdn.com/dms/image/v2/D4E0BAQEBRBKei42cqA/company-logo_100_100/company-logo_100_100/0/1680776119465/biophorum_operations_group_logo?e=2147483647&v=beta&t=504waO4AgwOC9V6TTQc7oGZIfKeMbKdi-RPi7ZLcqtE" data-ghost-classes="bg-color-entity-ghost-background" data-ghost-url="https://static.licdn.com/aero-v1/sc/h/cs8pjfgyw96g44ln9r7tct85f" alt="BioPhorum"> <div class="base-main-card__info self-center ml-1 flex-1 relative break-words papabear:min-w-0 mamabear:min-w-0 babybear:w-full ">  <h3 class="base-main-card__title font-sans text-[18px] font-bold text-color-text overflow-hidden "> BioPhorum </h3> <h4 class="base-main-card__subtitle body-text text-color-text overflow-hidden "> Connect Collaborate Accelerate </h4>  <div class="body-text text-color-text-low-emphasis base-main-card__metadata"> Published Apr 25, 2023 </div>  </div> <div class="base-main-card__ctas z-[3] self-center ml-3 babybear:ml-1 babybear:self-start"> <a class="base-main-card__cta btn-sm btn-secondary" href="https://www.linkedin.com/signup/cold-join?session_redirect=%2Fpulse%2Fpatient-driven-supply-chain-regulatory-impacts%3Ftrk%3Darticle-ssr-frontend-pulse&trk=article-ssr-frontend-pulse_publisher-author-card" data-tracking-control-name="article-ssr-frontend-pulse_publisher-author-card" data-tracking-will-navigate> + Follow </a> </div> </div> </div> </section> </header> <div data-test-id="article-content-blocks">  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>To ensure patient safety, the biopharmaceutical industry is heavily regulated, but some regulations can slow the delivery of medicines to the very people they are designed to help. </span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>With the development of new therapy types, as well as the desire to ship medicine directly to the patient, in certain situations this has become a real issue for the industry. </span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>Combine this with the lack of global harmonization, and it can be a difficult environment to navigate. </span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>It’s not just what we traditionally think of as regulations either. The environment is impacted by more than just the expectations of the EMEA, FDA, MHRA, and other bodies. </span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>No-one wants to risk the quality of the supply or impact the patient, however, with the giant leaps in technology some of the regulatory requirements now need to evolve. </span> </p> </div> <div class="inline-articles bg-color-surface-new border-hidden rounded-sm p-1 mx-auto my-1.5 mamabear:w-2/3 inline-articles__after"> <h2 class="text-xl font-medium ml-1.5 my-1 text-color-text mamabear:text-center">Recommended by LinkedIn</h2> <div class="flex flex-wrap mx-0.5 babybear:mx-1.5"> <div class="content-author-card flex flex-col max-w-[270px] h-auto rounded-md border-1 border-system-gray-30 border-solid pb-1.5 inline-article mx-auto my-1 border-hidden papabear:w-[219px] babybear:min-w-full mamabear:min-w-full h-auto bg-color-canvas-tint"> <a class="no-underline" data-tracking-control-name="inline-recommended-articles" data-tracking-will-navigate href="https://www.linkedin.com/pulse/supporting-launch-biosimilars-syneos-health-316ge"> <img class="content-image w-full h-[150px] bg-cover rounded-t-md object-cover" data-delayed-url="https://media.licdn.com/dms/image/v2/D4E12AQFrfN9dnUhAfg/article-cover_image-shrink_720_1280/article-cover_image-shrink_720_1280/0/1707318962215?e=2147483647&v=beta&t=pHxoSQrxQHoKsNobR0zaJvgAJnrN59UrVciJgGf0J_g"> <div class="inline-article-title text-md text-color-text font-bold pl-2 pt-1 pr-1.5">Supporting the Launch of Biosimilars</div> <div class="inline-article-meta px-2 mt-1 font-sans text-xs font-normal text-color-text-low-emphasis h-full"> <span class="inline-article-author pt-0.5"> Syneos Health </span> <span class="before:middot pt-0.5 inline-article-published-date"> 9 months ago </span> </div> </a>  </div> <div class="content-author-card flex flex-col max-w-[270px] h-auto rounded-md border-1 border-system-gray-30 border-solid pb-1.5 inline-article mx-auto my-1 border-hidden papabear:w-[219px] babybear:min-w-full mamabear:min-w-full h-auto bg-color-canvas-tint"> <a class="no-underline" data-tracking-control-name="inline-recommended-articles" data-tracking-will-navigate href="https://www.linkedin.com/pulse/fda-21-cfr-part-11-definitive-guide-shouvik-mondal"> <img class="content-image w-full h-[150px] bg-cover rounded-t-md object-cover" data-delayed-url="https://media.licdn.com/dms/image/v2/D5612AQEa2BUxk4ki1A/article-cover_image-shrink_720_1280/article-cover_image-shrink_720_1280/0/1666193148627?e=2147483647&v=beta&t=aAyFgnK4CGkj6pWJG9Xi9xRshyyO9sDHKRKv4AKJL4o"> <div class="inline-article-title text-md text-color-text font-bold pl-2 pt-1 pr-1.5">FDA 21 CFR Part 11: The Definitive Guide</div> <div class="inline-article-meta px-2 mt-1 font-sans text-xs font-normal text-color-text-low-emphasis h-full"> <span class="inline-article-author pt-0.5"> Shouvik Mondal </span> <span class="before:middot pt-0.5 inline-article-published-date"> 2 years ago </span> </div> </a>  </div> <div class="content-author-card flex flex-col max-w-[270px] h-auto rounded-md border-1 border-system-gray-30 border-solid pb-1.5 inline-article mx-auto my-1 border-hidden papabear:w-[219px] babybear:min-w-full mamabear:min-w-full h-auto bg-color-canvas-tint"> <a class="no-underline" data-tracking-control-name="inline-recommended-articles" data-tracking-will-navigate href="https://www.linkedin.com/pulse/revolutionizing-pharmaceutical-submission-process-role-puppe-afdpe"> <img class="content-image w-full h-[150px] bg-cover rounded-t-md object-cover" data-delayed-url="https://media.licdn.com/dms/image/v2/D4E12AQFi_VWtnGYn0g/article-cover_image-shrink_720_1280/article-cover_image-shrink_720_1280/0/1708274181207?e=2147483647&v=beta&t=PR_Qwc8jeIAkxbYCA6VUA90fnQIBV7KmosvrNX9dcBY"> <div class="inline-article-title text-md text-color-text font-bold pl-2 pt-1 pr-1.5">Revolutionizing the Pharmaceutical Submission Process:…</div> <div class="inline-article-meta px-2 mt-1 font-sans text-xs font-normal text-color-text-low-emphasis h-full"> <span class="inline-article-author pt-0.5"> Dr. Anita Puppe </span> <span class="before:middot pt-0.5 inline-article-published-date"> 9 months ago </span> </div> </a>  </div> </div> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>Clearly, the challenges posed by raising a deviation for every temperature excursion during shipping remain, despite having a wealth of data to support brief excursions outside the labelled conditions. The biopharma industry in fact, the wider pharmaceutical industry, would like to see a change in this area. </span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>Customs’ expectations for instance don’t consider the needs of a time critical, temperature sensitive, bespoke medicine made in a batch size of one. There is an expectation that customs can hold and even open shipments as they pass through a border. It makes sense to be able to randomly check what is being shipped into your country, especially if the paperwork isn’t comprehensible, but for individualized medicines this poses a big risk. Given that customs’ expectations in terms of paperwork are often not clear, there is an increase in the potential risk of a shipment being stopped. Any delay can result in the medicine no longer being fit for use, impacting on the patient who then has their treatment paused while a new batch is made for them. This risk needs to be addressed. </span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>When we talk about shipping directly to patients, many additional regulations come into play: GDPR, and pharmacy regulations which require the medicine to have been dispensed by a pharmacist in the country (or a particular State in the US) are just two. The biopharma industry faces countless challenges as it seeks to develop new modalities of drug and put the patient at the heart of its supply chains. </span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>This landscape is why BioPhorum has brought together a group of industry experts, to map out the current challenges and create a comprehensive picture of the regulatory landscape as it impacts on the effective distribution of medicines. This group will also recommend where and how changes must be made to truly prioritize the patient’s needs. </span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>If you want to get involved contact Phorum Director Lesley Holt at </span><span class><a href="https://www.linkedin.com/redir/redirect?url=http%3A%2F%2Fmailto%3Alesley%2Eholt%40biophorum%2Ecom&urlhash=9xC7&trk=article-ssr-frontend-pulse_little-text-block" target="_blank" data-tracking-control-name="article-ssr-frontend-pulse_little-text-block" data-tracking-will-navigate data-test-link>lesley.holt@biophorum.com </a></span><span class> </span> </p> </div>  </div>   </article>  <code id="ugcPostUrl" style="display: none"></code> <code id="ugcPost" style="display: none"></code> <code id="disableLinkedinShareRedirectLink" style="display: none"></code> <code id="ugcPostUrn" style="display: none"></code> <code id="signInUrl" style="display: none"></code>  <div 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grow-1 items-stretch leading-[16px] comment-with-action my-1.5"> <div> <a href="https://uk.linkedin.com/in/davidawallace?trk=article-ssr-frontend-pulse_x-social-details_comments-action_comment_actor-image" data-tracking-control-name="article-ssr-frontend-pulse_x-social-details_comments-action_comment_actor-image" data-tracking-will-navigate> <img class="inline-block relative rounded-[50%] w-4 h-4 " data-delayed-url="https://media.licdn.com/dms/image/v2/C4E03AQHi63DQpf1i6Q/profile-displayphoto-shrink_400_400/profile-displayphoto-shrink_400_400/0/1548494402204?e=2147483647&v=beta&t=UVEnltIQ6ErLEGygkYSet3tmN9HC6KFcIpeZ_e62ZQE" data-ghost-classes="bg-color-entity-ghost-background" data-ghost-url="https://static.licdn.com/aero-v1/sc/h/9c8pery4andzj6ohjkjp54ma2" alt="David Wallace"> </a> </div> <div class="w-full min-w-0"> <div class="comment__body ml-0.5 mb-1 pt-1 pr-1.5 pb-1 pl-1.5 rounded-[8px] rounded-tl-none relative"> <div class="comment__header flex flex-col"> <a class="text-sm link-styled no-underline leading-open comment__author truncate pr-6" href="https://uk.linkedin.com/in/davidawallace?trk=article-ssr-frontend-pulse_x-social-details_comments-action_comment_actor-name" data-tracking-control-name="article-ssr-frontend-pulse_x-social-details_comments-action_comment_actor-name" data-tracking-will-navigate> David Wallace </a> <p class="!text-xs text-color-text-low-emphasis leading-[1.33333] mb-0.5 truncate comment__author-headline">Leading cross-industry collaborations to digitize and improve bio-pharmaceutical manufacturing</p> <span class="text-xs text-color-text-low-emphasis comment__duration-since absolute right-6 top-1 inline-block"> 1y </span> <div class="ellipsis-menu absolute right-0 top-0 !mr-0.5 babybear:!-top-0.5" data-test-id="comment__ellipsis-menu" data-feed-action="show-comment-dropdown"> <div class="collapsible-dropdown flex items-center relative hyphens-auto"> <button class="ellipsis-menu__trigger collapsible-dropdown__button btn-md 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focus:link-styled link:no-underline active:bg-color-background-container-tint focus:bg-color-background-container-tint hover:bg-color-background-container-tint outline-offset-[-2px]">  <icon class="ellipsis-menu__item-icon text-color-text h-[24px] w-[24px] mr-1" data-delayed-url="https://static.licdn.com/aero-v1/sc/h/iq0x9q37wj214o129ai1yjut"> </icon> Report this comment </a>  </li>  </ul>  </div> </div> </div> <div class="attributed-text-segment-list__container relative mt-1 mb-1.5 babybear:mt-0 babybear:mb-0.5"> <p class="attributed-text-segment-list__content text-color-text !text-sm whitespace-pre-wrap break-words comment__text babybear:mt-0.5" dir="ltr">And the BioPhorum IT for Cell and Gene Therapies program complements this with our toolkit to accelerate the design of digital solutions to support advanced therapies throughout the supply chain for personalized medicine. <a class="link" href="https://www.biophorum.com/resource/it-for-cell-and-gene-therapies?trk=article-ssr-frontend-pulse_x-social-details_comments-action_comment-text" target="_self" rel="nofollow" data-tracking-control-name="article-ssr-frontend-pulse_x-social-details_comments-action_comment-text" data-tracking-will-navigate>https://www.biophorum.com/resource/it-for-cell-and-gene-therapies</a>/ #celltherapy #genetherapy #biotechnology</p>  </div>  <ul class="comment__images-content list-none pl-0 overflow-hidden " data-test-id="comment__images-content"> <li data-position="0"> <img class="lazy-load object-cover max-w-full" data-delayed-url="https://media.licdn.com/dms/image/v2/D4E2CAQGcFTZtExflrw/comment-image-shrink_8192_480/comment-image-shrink_8192_480/0/1682434820935?e=2147483647&v=beta&t=mPUguYHp0y0uCkvE0-JjrygmY5sVstjZCgG9OndXnSc" data-ghost-url="https://static.licdn.com/aero-v1/sc/h/921ynb2z53z33mhm3061qvjag" alt="No alternative text description for this image"> </li> </ul> <div 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