News Telemedicine https://tentelemed.com Telemedicine technologies Thu, 27 Jun 2024 15:17:31 +0000 en-US hourly 1 https://wordpress.org/?v=6.6.1 https://tentelemed.com/wp-content/uploads/2022/08/cropped-favicon-telemedecine-32x32.png News Telemedicine https://tentelemed.com 32 32 Standards in Sync: Accelerating Medical Research – EUCROF Webinar https://tentelemed.com/standards-in-sync-accelerating-medical-research-eucrof-webinar/ Thu, 27 Jun 2024 15:16:59 +0000 https://tentelemed.com/?p=13148 25 September 2024 from 4:00PM to 5:30PM (CEST)

Webinar Overview

It has been demonstrated that using standards from the start of clinical research studies (i.e. protocol and CRF development) can save significant time and resources and results in higher quality research. Unfortunately, it is not always clear how to select the appropriate standards for the purpose and how to ensure they are robust and will achieve the desired goals. All too often in the standards development world, we are faced with competing standards, new ‘standards’ development when standards already exist, or mapping data into a standard after the study has ended. These redundancies and inefficient methods incur costs in terms of resources, money and, in some cases, risks to patients (i.e. all of us). They may also have a negative effect on the data. This workshop is the first of a series of 3 and is organized in the context of xShare, a three-year Horizon Europe project that envisions expanding the European Electronic Health Record exchange Format (EEHRxF) to improve interoperability within the European Health Data Space (EHDS). It is the hope that these new interoperability capabilities and this collaborative work will enable a greater alignment of data quality between care and research, to transform data into valuable knowledge with benefits for all. We will cover the research use cases that are the focus of xSHARE and the standards that are being employed in a synchronized manner.

Attendees of this webinar will learn:
a) Overview of the EU xSHARE project
b) Rationale and benefits of using standards in the planning stage of clinical research studies
c) Characteristics of robust standards and achieving semantic interoperability at the source
d) Examples of complementary implementation of standards, including xSHARE
e) Five principles of developing and implementing synchronous standards

Presenters

Rhonda Facile ​

VP, Partnerships and Development

CDISC

Rhonda Facile is currently VP, Partnerships and Development at CDISC where she oversees strategy and new project development. Rhonda has over 25 years of clinical operations experience. She has worked in a global CRO, pharmaceutical and biotechnology companies in the United States and abroad.  She has experience in clinical trial monitoring, program management, regulatory affairs and standards development.

At CDISC, Rhonda brings together, key and diverse stakeholder communities, including the clinical community, global regulatory authorities, national health agencies, global biopharmaceutical and vendor organizations to forward clinical informatics and the use of CDISC standards.  Rhonda represents CDISC at ISO TC215, the HL7 Accelerator Vulcan Operations Committee and at numerous other collaborative organizations and partnerships.

Ms. Facile holds an MS from St. Edwards University and a BA from the University of Texas at Austin.

Rhonda has instantiated the body of peer-reviewed articles on CDISC standards implementation published in the Journal of the Society of Clinical Data Management (SCDM) and has authored and co-authored publications that are published in journals such as Journal of Medical Internet Research (JMIR) and Drug Discovery, and in several meeting proceedings.  Rhonda also contributed to chapters in the textbook Achieving Diversity, Inclusion, and Equity in Clinical Research Guidance Documentation 1.1, Cambridge and Boston, MS: Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center), published in 2021.

 

Rebecca Daniels ​Kush

Founder and President Emeritus

CDISC

Rebecca Daniels Kush is currently President of Catalysis and Founder and President Emeritus of the Clinical Data Interchange Standards Consortium (CDISC). She is on the Board of the Learning Health Community; serves as an Associate Editor of the Learning Health Systems Journal (Wiley); and, chairs the Advisory Council for the Vulcan HL7 FHIR Accelerator.

Dr. Kush served for 20 years as President and CEO of CDISC, which was formed as a volunteer group in 1997 and was incorporated as a 501c3 non-profit standards development organization (SDO) in 2000. CDISC Europe Foundation was founded in 2011, enabling participation in IMI and EU collaborations.  CDISC has developed and harmonized a suite of global clinical research data standards to support clinical research in therapeutic areas that affect well over 1.5 billion lives. These standards are required for the submission of data to support regulatory reviews and approvals of new products by the U.S. FDA and Japan’s PMDA and are endorsed by other regulatory agencies (EU, Korea and China).

Dr. Kush retired from the leadership position at CDISC in 2017 and spent six years as Chief Scientific Officer for Elligo Health Research, a start-up in Austin, TX focused on expanding research opportunities to community clinicians and leveraging healthcare data for research.  She participated in two FDA grants associated with the harmonization of common data models and identifying academic data partners to test use cases for these projects.

Prior to founding CDISC, Dr. Kush worked with the U.S. National Institutes of Health (NIADDK center at the Indian Medical Center in Phoenix, Arizona); a global clinical research organization (CRO); and biopharmaceutical companies headquartered in the U.S. and Japan. She served for five years on the U.S. Federal Health IT Standards Committee (HITSC), three years on the DIA Board, four years on the HL7 Board and was also on boards for ACRES, Litmus Health and Saama (an AI/technology company).

Dr. Kush earned her doctorate in Physiology and Pharmacology from the University of California San Diego School of Medicine and a B.S. in Biology and Chemistry with honors from the University of New Mexico.

She has authored publications that are published in journals such as New England Journal of Medicine, British Medical Journal, Science Translational Medicine, International Clinical Trials, Journal of Biomedical Informatics, DIA Journal, Applied Clinical Trials, and the Learning Health Systems Journal. She edited and authored chapters for a CenterWatch book on eClinical Trials and authored chapters for three editions of the Springer Clinical Research Informatics textbook, the latest released in 2023.

Attendance Fee

The participation in this webinar is free of charge.

Deadline for registration

24 September 2024 at 6:00PM

How to register?

1) Go on the REGISTRATION PAGE and click on the red button « RESERVE A SPOT »

2) Check your order and click on the green « CHECKOUT » button

3) Fill in all the necessary information and validate your order

Confirmation

You will receive 2 confirmation emails:

A) One from Eventbrite with your invoice

B) One from « LiveStorm », the day before the webinar, with all the necessary information to connect the D-Day!

Questions?

Should you have any questions about registration, invoices or connection, do not hesitate and contact us by email at webinar@eucrof.eu

By registering to the webinar, you give your authorisation to the webinar organizers to use your email address and personal information to communicate with you about this event and future initiatives. To stop receiving their communications, please contact the organizers directly at info@eucrof.eu.

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Addressing Data Management Challenges With Automation https://tentelemed.com/addressing-data-management-challenges-with-automation/ Thu, 27 Jun 2024 15:03:10 +0000 https://tentelemed.com/?p=13145 Applied Clinical Trials Online

ACT: How can data management challenges be addressed? Specifically, is there any opportunity to address them with artificial intelligence (AI)?

Lacroix: There is a lot of opportunity across the life cycle to assist with this and it’s interesting because historically it was always: we want to throw people at some of these problems. I think it’s important to mention that people are not always the answer. Specifically in data management, there’s a shortage of resources. There’s a shortage of resources with the appropriate skill sets to manage the complexity, so we really do need to look at innovative processes and technologies to assist with managing this complexity; AI is one of those. When we’re talking about all of the data and the high volume of data coming in, and specifically these adaptive trial designs, AI can help us with processing those large volumes of data to be able to automate and we need to build in automation for ingestion of these continual data flows, and utilize artificial intelligence to help us interrogate that data to be able to gain those insights, specifically around these adaptive trials, because of the ongoing decision making that happens throughout the course of these trials.

Utilizing automation is what we do at eClinical Solutions, as far as automating all those data sources into a clinical data management platform, elluminate, where the tool and the technology helps us to not only ingest, but to standardize and harmonize that data in a way that unifies that data so that we can look at that data more holistically and cohesively for that decision making for these adaptive trials. The data cleaning part of it is specifically for data management, it’s a big area that this can help with. As these large volumes of data continue to grow, we can’t continue to throw edit checks at it or line listings at it. We need to use more smart and innovative tools to be able to process and interrogate that data.

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Why early market access planning is crucial in CGT commercial strategy https://tentelemed.com/why-early-market-access-planning-is-crucial-in-cgt-commercial-strategy/ Thu, 27 Jun 2024 14:47:56 +0000 https://tentelemed.com/?p=13141 Fiercebiotech

Experts recommend that CGT manufacturers proactively design a comprehensive market access strategy early in clinical development and commercial planning timelines, ideally more than three years prior to launch. This strategy should focus on addressing the nuanced market access challenges for such treatments, including but not limited to, distribution network design, tailored commercial site engagement, and early payer communication planning.

Designing an optimal limited distribution network (LDN) for launch

The complexity associated with advanced therapies requires a precisely designed network of limited treatment sites to ensure the safe distribution of patient-specific doses to sites of care that are capable to administer. “Sites need to be engaged early to confirm they have the capabilities to offer the product, and they will ask for as much detail as possible to understand who the patients are, what the patient and product journey look like, and the financial considerations, especially what is reimbursable,” says Fran Gregory, Vice President, Emerging Therapies, Cardinal Health. “Assuming the site has all the internal capabilities to administer, they will also need dedicated personnel to be trained on ordering procedures, product handling requirements and all patient care considerations,” she says.

Planning for a thoughtful LDN first includes assessing potential site readiness via a checklist of qualifications tailored to the product. Manufacturers should consider geographic spread of the network and proximity to patients, as well as their internal capacity to onboard the sites. A phased onboarding approach allows for the model to expand after launch. This model, which today largely exists in academic medical centers, will continue to evolve as new-to-market products with enhanced safety profiles seek expanded networks, including community practices to broaden patient access. Product specific distribution needs, such as storage, shipping, logistics, and financial management may also impact network design success at launch.

Tailoring provider engagement to site-specific access needs

Just as each CGT product and patient has unique access needs, so too have the healthcare providers administering these therapies and the sites of care where they operate. To administer advanced therapies such as CGT, sites may need to hire and train dedicated personnel, as well as scale their site capabilities requiring significant investment and time.

Once a preliminary LDN is established, CGT manufacturers may begin to develop detailed site profiles, noting individual challenges and pain points that their sites of care may experience. Many different departments and teams are involved in the successful commercial handling and administration of these products, requiring coordinated cross-functional communication between the CGT manufacturer and the site teams. 12-24 months pre-launch, CGT manufacturers should outline the anticipated product, financial, and communication flows at each site, and engage with the appropriate stakeholders in each department to provide clarity on the timing of key activities and communication.

Treatment site engagement is also elevated by a thoughtful and tailored field reimbursement strategy. By equipping your field team with resources and expertise to support providers with anticipated access challenges, tailored to site sophistication and payer mix, CGT manufacturers can educate their provider network with best practices, anticipated hurdles, and expectations for contracting and prior authorization. Pre-launch, manufacturers should leverage access journey mapping and understanding of access barriers to develop detailed playbooks and governance plans to inform field team engagement with sites. These playbooks may include key resources, best practices, and talking points tailored to site-specific needs and level of comfort with handling complex prior authorization and claims adjudication processes.

Engaging payers early during pre-approval information exchange

Payers require early and in-depth education to prepare for the launch of a novel therapy, which is even more pronounced for CGTs. In the US market, a fragmented network of hundreds of commercial payers is further sub-divided at the plan level. CGT’s present unique challenges in that even with potential long-term durability, high upfront costs are not aligned with a model designed for annualized budgets. Payers are looking for clarity as to what criteria may be appropriate to manage these products, sometimes further limiting access by including clinical trial criteria beyond FDA label language. Ensuring equitable patient access to these life-saving therapies will require new and innovative financing models, and payers are already signaling their expectation for CGT manufacturers to play a role in shaping these contracts. “The budget impact of these products is significant, and we know all stakeholder groups are willing to work together to find innovative payment solutions” says Anna Catalanotto, Senior Manager, Commercial Development, Advanced Therapy Solutions (ATS) at Cardinal Health. “But numerous challenges hinder the impact and feasibility of these discussions today: alignment on the contract design, the selection of and tracking of outcomes, as well as the administrative burden to collect patient follow-up data in our healthcare system where patients frequently switch payers and providers,” she says.

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FDA Releases Facility Readiness Guidance https://tentelemed.com/fda-releases-facility-readiness-guidance/ Thu, 27 Jun 2024 14:39:56 +0000 https://tentelemed.com/?p=13138 Biopharm International

FDA published a final guidance document on June 18, 2024 that provides applicants with information on FDA’s policy for assigning a goal date for a facility’s inspection readiness as certified on Form FDA 356h, submitted as part of an original abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). The way the agency incorporates a program enhancement agreed upon by both the agency and industry is explained in the guidance document.

A goal date was assigned without consideration to facility readiness in the commitment letter related to Generic Drug User Fee Amendments (GDUFA) authorization for fiscal years 2018–2022. A later commitment letter (GDUFA III) established the incorporation of facility readiness into the goal date assignment. FDA now generally assigns a 15-month goal date and will defer assessment if the facility is not ready at the time the application is submitted. Because FDA may not be able to complete assessment of an application until all facilities are ready, the change allows the agency to focus resources on substantially complete applications that have facilities ready for inspection.

The final guidance, Facility Readiness: Goal Date Decisions Under GDUFA Guidance for Industry, does not apply to facilities involved in bioequivalence and clinical studies, amendments submitted after a complete response or tentative approval, or supplements or amendments to a supplement.

According to the document, “FDA uses a facility’s readiness for inspection designation in the Establishment Information section of Form FDA 356h to assign an application’s goal date” and considers a facility ready when it complies with current good manufacturing practices (CGMPs). Facilities should have operations, methods, and product formulation that match those described in the application. Data should be complete, accurate, and consistent with the application. The facility should also be ready for commercial manufacturing. FDA assesses these criteria by using Compliance Program (CP) 7346.832 Preapproval Inspections. Considerations in CP 7346.832 (Part III, section 1, NDA/ANDA Inspectional/Audit Coverage, Objectives, and Techniques) may be useful for applicants. Recommendations are also provided by FDA in the January 2022 guidance, Good ANDA Submission Practices, section V.D., Facilities.

“FDA has experienced cases where facilities were not aware they were listed on Form FDA 356h. This often results in a greater likelihood that a facility will be unprepared for an inspection. FDA recommends that applicants notify each facility that the facility is listed on the applicant’s Form FDA 356h and inform the facility whether the applicant has checked the “yes” or “no” box in the Establishment Information Field 28 of Form FDA 356h to identify the inspection readiness of each manufacturing or testing facility listed. When signing Form FDA 356h, an applicant certifies that the information in the application is complete and accurate. Inaccurate representation of facility readiness may cause a delay in or refusal to approve an application,” the agency states in the document.

The guidance document discusses how to report facility readiness to FDA. It also details how a goal date is assigned based on the completed Form FDA 356h in the ANDA.

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Communiqué de presse : Heva & Telemedicine Technologies signent un partenariat https://tentelemed.com/communique-de-presse-heva-telemedicine-technologies-signent-un-partenariat/ Wed, 19 Jun 2024 12:19:56 +0000 https://tentelemed.com/?p=13011 Communiqué de presse
Paris, le 19 juin 2024

 

 Heva et Telemedicine Technologies signent un partenariat visant à accélérer les innovations dans la collecte et l’analyse des données de santé

Convaincus du potentiel d’innovation dans les outils numériques destinés aux médecins et aux patients, Heva, filiale de Docaposte et marque de La Poste Santé & Autonomie, et Telemedicine Technologies s’associent pour développer des solutions de collecte de données adaptées aux nouveaux enjeux des acteurs de la santé.

Ce partenariat vise notamment à coconstruire des solutions plus ergonomiques, permettant d’améliorer la qualité des données collectées auprès des patients, en particulier celles des accès précoces, dont l’exploitation reste très dépendante de la qualité et la quantité des informations collectées.

En digitalisant les essais cliniques, Heva et Telemedicine Technologies soutiennent la décentralisation des études au service de l’amélioration de la qualité des données collectées et de l’expérience patient.

Heva, qui a rejoint Docaposte en 2022, est spécialisé dans la donnée de santé depuis plus de 20 ans. Heva accompagne ses clients pour exploiter toute l’intelligence de la donnée de santé, grâce à ses capacités d’analyse, d’expertise scientifique et sa maîtrise des technologies (intelligence artificielle, machine learning, plateformes) appliquées aux données de santé.

Telemedicine Technologies développe des solutions en recherche clinique et épidémiologiques destinées à faciliter la collecte de données primaires, via notamment la plateforme logicielle Cleanweb, qui permet de gérer toutes les données d’une étude clinique dans une même solution intégrée.

Le partenariat entre Heva et Telemedicine Technologies vise à combiner l’expertise en analyse de données de santé de Heva avec les ressources de CleanWeb pour développer des solutions numériques innovantes garantissant la qualité, la pertinence des données collectées et faciliter leur exploitation secondaire.

Cécile Badiola-Lagardère, Directrice Générale d’Heva, précise les enjeux de ce partenariat : « Heva poursuit sa stratégie partenariale de développement en s’associant à un partenaire agile et innovant. L’objectif est de renforcer nos capacités digitales de collecte des données de qualité et de nous adapter aux attentes des professionnels de santé et des patients. Au travers de nos travaux conjoints, nous voulons répondre aux enjeux d’ergonomie et d’automatisation qui freinent aujourd’hui l’exploitation des données de santé en vie réelle ».

Pour Yoanni Th. Matsakis, Président de Telemedicine Technologies : « ce partenariat s’inscrit parfaitement dans notre stratégie de création de valeur pour nos clients qu’ils proviennent du monde académique ou industriel : transformer les données en connaissance. C’est une reconnaissance des innovations de notre plateforme CleanWeb et un renforcement de la CRO Alliance nous permettant d’accélérer conjointement, notre développement à l’international. »

 

Contacts presse :

 

Heva

 

Patrice Lemonnier

patrice.lemonnier@laposte.fr

01 55 44 25 35

 

Telemedicine Technologies

 

Dr Philippe Haran

philippe.haran@tentelemed.com

06 60 62 57 22

 

A propos d’Heva

Heva est une filiale de Docaposte et une marque de La Poste Santé & Autonomie, un acteur clé de la valorisation des données de santé. Nous servons les acteurs du secteur de la santé avec une large gamme d’expertise et de capacités d’innovation, de la génération et la collecte à l’analyse avancée/IA pour la recherche clinique et l’expertise médicale et scientifique.

Avec plus de 30 ans d’expérience en recherche clinique et en économie de la santé, Heva aide ses clients à exploiter l’intelligence de leurs données au travers d’une approche hybride combinant la technologie et l’humain.

Heva a intégré les expertises d’Inadvans et d’Axonal Biostatem pour étendre son champ d’action et créer de nouvelles synergies combinant expertise médicale, confiance numérique et engagement éthique.

Nos domaines d’expertise :

  • Réalisation de projets cliniques avec des méthodes et des outils innovants (décentralisation des études , digitalisation des études , bras contrôle synthétique, essais émulés )
  • CRO expérimentée capable de gérer un projet de bout en bout (collecte de données primaires, chaînage avec base de données médico-administratives, data visualisation et communication des résultats)
  • Intégrateur de données multi-sources / valorisation des données (génération de données, sourcing, mobilisation d’un écosystème de données, contractualisation)
  • Des savoir-faire et des produits « DATA / IA BY DESIGN » pour réaliser les études (analyses descriptives,  comparatives et prédictives , machine learning, Process mining, auto-encodeurs..)
  • Plateformes technologiques d’exploitation de la donnée et entrepôts de données de santé

 Pour plus d’informations : www.hevaweb.com / www.axonalbiostatem.com

 

 A propos de Telemedicine Technologies

Telemedicine Technologies est un éditeur de solutions collaboratives e-Santé, leader dans le domaine de la Recherche Clinique avec sa solution CleanWEB, plateforme internet sécurisée dédiée à la gestion électronique des études cliniques et des registres. Telemedicine Technologies est également un acteur engagé dans le cadre de l’évaluation du suivi des patients à domicile, avec des objets connectés et dans la médecine à distance avec des valises connectées.

Nous avons mis en place plus de 7.000 études, avec plus de 20.000 centres investigateurs dans 64 pays et plus de 50.000 utilisateurs dans le monde, au service de plus de 3 millions de patients dans nos bases.

Modules et services disponibles:

  • eCRF,
  • ePRO
  • Designer
  • CTMS
  • eTMF et eISF
  • Agenda partagé
  • eConsent,
  • Imagerie médicale,
  • Monitoring et Remote Monitoring
  • rSDV,
  • Vigilance,
  • Randomisation,
  • DataVisualisation
  • Programmes d’accès précoce ou compassionnels (MAP)

Pour plus d’informations : www.tentelemed.com

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14th Meeting of the CleanWeb™ Users Club https://tentelemed.com/14th-meeting-of-the-cleanweb-users-club/ Thu, 30 May 2024 09:52:21 +0000 https://tentelemed.com/?p=12545 June 18, 2024 – 2:00 PM – 3:00 PM CEST

Join us for the 14th meeting of the CleanWeb™ Users Group. This webinar is free and open to all our users. This afternoon traditionally serves as an opportunity to review the latest features developed for our users and to present upcoming developments. During this webinar, you will also have the chance to interact with the CleanWeb™ teams from Telemedicine Technologies and ask your questions via the online chat during the session. We look forward to seeing you there!

Register here: https://register.gotowebinar.com/register/6069457452981969248?source=LinkedIn+post

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Yes, Agile Can Work in Medtech https://tentelemed.com/yes-agile-can-work-in-medtech/ Thu, 30 May 2024 09:37:06 +0000 https://tentelemed.com/?p=12541 Med City News

Three tips to succeed in a highly regulated environment.

Medical devices take multiple years and millions of dollars to bring to market. Regulations play a huge role: medtech manufacturers must meet a range of requirements to get devices approved – or risk wasting their investment.

The high cost of failure encourages many manufacturers to embrace a methodical, regulation-first approach to development. But the tradeoff is patient care. The slower the pace of development and approval, the longer patients go without treatment options that could dramatically impact their lives.

Manufacturers need a way to get products to market faster without creating regulatory risk. Even so, many hesitate to embrace an Agile methodology: it can feel too breakneck for a highly regulated environment.

With a few adaptations, though, Agile can work in this space. Here, I’ll share three tips to help bring the benefits of Agile to medtech manufacturing.

1. Identify your minimally regulated viable product

There’s a common saying in medtech: there’s no such thing as a regulated MVP.

That’s true, in a sense. You can’t get a product to market until it gets regulatory approval. And it’s not going to get approved until it’s nearly complete. More often than not, that process involves clearing sky-high regulatory hurdles and can drag out your time to release.

But what if you could lower the barrier for approval? Enter the minimally regulated viable product (or MRVP).

As the name suggests, this concept anchors your product development to the feature set with the lowest regulatory burden. These features are often simpler and faster to build. What’s more, they’re still highly valuable to your users.

For instance, let’s say you’re building a diabetes management app that collects and analyzes data from a wearable sensor. It also lets users track their diet, activity, and other health data in one place.

Certain features – like diet and activity tracking – have a low regulatory burden (or may not have one at all). But they can still have an impact on patient outcomes. You can make this feature set your MRVP to get a release out fast.

But speed to market isn’t the only benefit. When you launch an MRVP, you can deliver value to patients sooner while building brand affinity for your product. And as you learn from those users, you can iterate to better meet their needs.

2. Make regulatory burden a roadmapping vector

Effective Agile development in medtech uses regulatory burden as a vector throughout the full product roadmap. In other words, you can assess the burden of each feature set to prioritize and schedule development.

For example, let’s say you have five distinct feature sets:

  • Diet and activity tracking
  • Continuous glucose monitor integrations
  • Medication management (logging, reminders, etc.)
  • Telehealth communications (via secure chat, for instance)
  • Personalized care recommendations

You can rank their regulatory burden alongside other factors, like development complexity and their centrality to the product. Then, you can front-load valuable but lighter lifts – and remove the dependency on the heaviest. Along the way, you can parallel track feature sets so they’re ready if they need to be independently released.

This approach lets you get more features to market in less time than a traditional roadmap. It also lets you achieve relatively quick wins. Maybe you learn that users value certain features more than you expected. Or you find that they’re using those features in new ways that could inform the rest of your product development. Each insight builds momentum toward a successful end product.

3. Focus on freedom to release

As the Agile principle goes, the best marker of progress is working software. That thinking can apply to many medical devices. But to create working software, it’s important to embrace “freedom to release”: the ability to push out new features with minimal friction.

That might sound counterintuitive in an environment with as many regulations as medical care. But the steps we’ve discussed so far let you keep regulations from becoming roadblocks.

With an MRVP, for instance, you can plant a flag in the marketplace. With each successive release, you can entrench your brand among existing users and expand to new ones. The feedback you gather along the way – via product reviews, for example – can both inform future developments and serve as valuable social proof to help win over new users.

The bottom line? Freedom to release ensures steady progress – which is a lot better than a monthslong stall.

Prioritize patients with an agile development cycle

It’s worth emphasizing that medical device regulations aren’t an enemy: they ensure patient safety at every stage of use. Even so, it’s important to balance regulatory demands with patients’ immediate care needs. And snail-paced development can delay effective treatment for years.

With Agile thinking, you can speed up the full product development cycle, from ideation to execution to release. That means patients see value faster – and you can more quickly see ROI.

This post appears through the MedCity Influencers program. Anyone can publish their perspective on business and innovation in healthcare on MedCity News through MedCity Influencers.

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Integrated Biosciences and Illumina Ventures Labs Collaborate on Novel Therapeutics Targeting the Transcriptome https://tentelemed.com/integrated-biosciences-and-illumina-ventures-labs-collaborate-on-novel-therapeutics-targeting-the-transcriptome/ Thu, 30 May 2024 09:33:42 +0000 https://tentelemed.com/?p=12538 BioPharm International

The partnership will create therapeutic assets and new discovery platforms and potentially reshape drug discovery.

Integrated Biosciences, a biotechnology company that uses synthetic biology and machine learning to develop next-generation therapeutics for age-related diseases, announced on May 28, 2024, that it is collaborating with Illumina Ventures Labs to create novel therapeutics targeting the transcriptome. Integrated Biosciences will integrate the company’s drug discovery engine with Illumina sequencing.

Integrated Biosciences, which is developing a portfolio of preclinical-stage assets to treat multiple age-related diseases, stated in a press release that the partnership “will generate additional therapeutic assets and new discovery platforms that hold the promise of reshaping drug discovery” (1). The partnership will include monetary and scientific support and allow Integrated Biosciences to discover and design new classes of small-molecule therapeutics that shape the transcriptomes and methylomes of cell populations. The company plans for these drug candidates to be applicable to diseases where cell state and identity are important, including diseases related to aging and development.

“All drugs act by modifying cellular components, and nucleic acids are particularly important. This partnership is a nexus to using small molecules to systematically target RNA expression and DNA modifications across cell types, such that we can control exactly how cells behave,” said Felix Wong, PhD, co-founder of Integrated Biosciences, in the press release (1). “We will generate unprecedented large-scale datasets that provide maps of cell states and how to alter them, charting the course for definitive cures for age-related diseases.”

“Illumina Ventures supports innovative companies that are pursuing breakthrough science, and our partnership with Integrated Biosciences, through our Illumina Ventures Labs, represents an investment in the intersection of healthcare, genomics, and sequencing,” said Ron Mazumder, PhD, partner at Illumina Ventures, in the release. “Integrated Biosciences is an outlier early stage company that has already pioneered breakthroughs in drug discovery. Illumina Ventures is convinced that, with our unique support and resources, Integrated Biosciences will unlock novel therapeutic candidates and modalities that bring next-generation sequencing to the forefront of drug discovery.”

Sarclisa is currently approved in more than 50 countries, including the United States and the EU, in combination with pomalidomide and dexamethasone for treating certain patients with relapsed refractory MM (RRMM) who have had two or more prior therapies, including lenalidomide and a proteasome inhibitor, and who progressed on last therapy. The mAb is also approved in 50 countries, including in the US, in combination with carfilzomib and dexamethasone, for treating patients with RRMM who have had one to three prior lines of therapy, and in the EU for patients with MM who have received at least one prior therapy.

Sarclisa is also in multiple ongoing Phase III clinical studies in combination with current standard treatments across different MM indications and is under investigation for treating other hematologic malignancies. According to Sanofi, the product’s safety and efficacy has not been evaluated by any regulatory authority outside of its approved indication.

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Navigating Robotic Process Automation, ICH E6(R3) Changes, and Outsourcing in Clinical Trials https://tentelemed.com/navigating-robotic-process-automation-ich-e6r3-changes-and-outsourcing-in-clinical-trials/ Thu, 30 May 2024 09:29:42 +0000 https://tentelemed.com/?p=12535 Applied Clinical Trials Online

With ambitious goals to accelerate clinical trials, increase efficiency, and lower costs, many leading life sciences companies are prioritizing transformation initiatives. Still, challenges persist with managing risk-based approaches, meeting new and changing regulatory requirements, and improving the relationship between sponsors and sites. Advancing trial master file (TMF) processes can help move the industry forward and help companies manage change more seamlessly.

I sat with some of the top minds in TMF to understand the trends shaping their strategy and discuss what the very near future will look like in clinical operations. Here are the six trends that will significantly impact TMF and the future of clinical trials.

1. Automation to reduce manual or high-volume activities

The industry is turning to bots and robotic process automation (RPA) to enable automation of high-volume manual processes. These bots typically don’t eliminate tasks requiring human review, action, or processes subject to inspection findings but drive critical efficiencies for TMF functions.

To complete tasks like document classification, quality review, and reconciliation, a top 20 biopharma deploys a fleet of more than 10 bots. “We call them digital workers,” says the company’s head of TMF. “They have their own user IDs and system access privileges. Each bot has a TMF ‘manager’ for training and performance measurement.”

These human and digital workers are both seen as integral parts of the company’s TMF strategy. “The digital workers take care of standardized, transactional tasks while human workers focus on decision-making, defining strategy, and managing stakeholders.” Over four years, the company estimates successfully automating more than 1,000,000 transactions with its fleet of bots and saving 200,000 hours of work for its TMF team.

2. Snapshot views of TMF health becoming a reality with comprehensive study scores

More companies are adopting risk-based approaches for TMF management. These approaches can improve TMF quality by focusing effort on the highest-risk documents. For example, a company following risk-based practices can allot more time to the quality control of documents critical to inspection readiness—like a site’s training record and qualifications—than to lower-risk activities, like site email communication.

A large biopharma, for example, implemented risk-based reviews and created a weighted formula to assess its TMF health holistically. The formula combined quality, timeliness, and completeness metrics into a single study health score.

Now, the company can compare study health across its studies and partner contract research organizations (CROs). It also helps compliance managers engage more effectively with study managers, improving TMF health.

“We’ve seen a broader embrace of the importance of TMF,” says one of the top 20 biopharma’s TMF business operations lead. “Our compliance manager is not a traffic cop who points out everything wrong with the TMF. Instead, they provide solutions.”

Since piloting this program, the company has improved the starting TMF health score average for new studies by 180%. This demonstrates the effectiveness of combining a risk-based approach with study health scoring.

3. Increasing focus on risk-based TMF to meet ICH E6(R3)

ICH E6(R3) is imminent and expected to be finalized later this year. The new regulation will require TMF teams to approach data integrity, systems, and retention rules differently. Key changes include:

  • Guidance so companies can take a more thoughtful, risk-based approach to TMF management.
  • Expectations for essential or “potentially essential” records, with the types of records now listed as potentially essential influenced by a broader range of factors related to specific trials. This means sponsors and CROs must collaborate to define what “essential” really means.
  • Introduction of the role of digital systems in clinical trials explicitly. Now, investigator sites must ensure that their software systems are “fit for purpose.”
  • Reference to local laws for document retention. This will likely mean that inspection sites will shift most of this responsibility to sponsors. Companies will need to adapt to local regulations and develop new processes to manage retention.

4. TMF inspections are now remote, hybrid, and multi-agency

Remote and hybrid inspections are standard practice, and the FDA is beginning to team up with other global agencies, such as the EMA and MHRA. The collaboration includes attending each other’s inspections, understanding their approaches, and sharing learnings. While the insights shared can improve efficiency, the multi-agency approach increases complexity for sponsors.

Inspectors are also asking biopharmas to map the document lifecycle across sites, CROs, and their systems. To improve document identification, some companies are reviewing and reducing their alternate filing locations. This heightened scrutiny emphasizes the importance of updating inspection-readiness processes, including audit trails.

5. Outsourcing strategies are evolving as biopharmas consider tradeoffs

Organizations are insourcing areas such as medical monitoring, data management, and vendor oversight to increase their control and data ownership. This comes amid the industry’s pendulum shift toward insourcing.

Considering a cost-benefit analysis is beneficial to ensure the right operating model because CRO integration and training in sponsor systems can create inefficiencies. Depending on the outsourcing strategy, biopharmas will also adapt internal staffing numbers.

One top 20 biopharma has insourced 95% of its TMF management, deploying a team of over 60 clinical documentation associates (CDA) to work directly with study teams and conduct quarterly meetings. “The CDAs need to think critically about what documents are needed and influence study team members to drive outcomes,” said the biopharma’s associate director of TMF.

In contrast, another large biopharma outsources significant portions of its TMF management to CROs and consulting vendors. To drive TMF health, they aim to resource one TMF lead for every 10 trials, site-dependent.

“The role of the TMF lead is like the canary in the coal mine,” says the pharma’s associate director of TMF. “They help identify trends but are not responsible for the content. We’re pushing to have TMF leads identify trends and empower business functions to address those issues.”

Fast-growing biotechs may consider combining insourcing and outsourcing—including adapting their operating model on a study-by-study basis—to drive compliance while conserving resources.

6. Standardization of TMF data grows

The TMF Reference Model is now affiliated with the Clinical Data Interchange Standards Consortium (CDISC), signaling the ongoing industry shift toward standardization and uniformity in how eTMF systems are set up, including metadata expectations.

“We’re very excited about this change,” says one CDISC TMF Reference Model steering committee member. “One of the biggest efforts will be bringing the TMF Reference Model out of the spreadsheet and into the CDISC library.”

Standardization will drive improvements in how sponsors manage TMF, especially for companies automating processes across connected eTMF and CTMS. This creates consistency across sponsor environments, streamlining processes for CROs as well.

Advancing TMF for speed and agility

Arthur Conan Doyle wrote, “There is nothing more deceptive than an obvious fact.” In the case of clinical research, the documentation in the eTMF proves facts and serves as the backbone of studies. Leaders should understand the strategic importance of how the eTMF fits in the bigger picture as they evolve processes, optimize the trial operating model, and implement new technologies for greater speed and efficiency.

The industry can move toward more connected and efficient clinical trials by establishing a strong foundation for TMF management that enables connections across the study ecosystem. This is the future of drug development, and forward-looking companies are leading the way by driving positive change.

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A flexible solution for eTMF implementation in clinical research https://tentelemed.com/a-flexible-solution-for-etmf-implementation-in-clinical-research/ Tue, 30 Apr 2024 09:26:28 +0000 https://tentelemed.com/?p=11679 May 14, 2024 – 1:15 PM to 2:00 PM (CEST)

Join us for a comprehensive exploration of eTMF, where seasoned experts will discuss its significance, advantages, implementation challenges, regulatory compliance, and future trends. Our esteemed panel will share practical strategies and innovations to streamline eTMF utilisation in clinical trials. Our webinar will focus on an interactive demo of the CleanWeb™ eTMF module and will highlight how this solution streamlines the overall management of clinical trials. We eagerly anticipate your participation in this transformative webinar!

Register here : https://www.linkedin.com/events/aflexiblesolutionforetmfimpleme7185595833822646272/

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