THE BEST INDICATOR OF FUTURE REMS IS PAST REMS
Insights into the type of REMS program which may be required can be found by looking at recently approved REMS or those already in the marketplace. The FDA often relies on precedents when determining REMS requirements. For some products, the FDA has required Shared System REMS; for these, multiple sponsors must operate together under one REMS. UBC has the knowledge gained from designing and implementing multiple REMS across different therapeutic areas and targeting different risks.
3H Medi Solution Expands DCT Expertise and Client Offerings to Enhance Patient Recruitment, Home Health, and Next-Generation Study Solutions in Japan
3H Medi Solution Inc., a leading Japanese clinical trial company, today announced its selection of THREAD to expand decentralized research capabilities and improve access to clinical research for patients in Japan. 3H Medi’s deep recruitment, home visit support and overall clinical study delivery capabilities combined with THREAD’s proven technology platform and consulting services offer clients enhanced offerings. This new offering aims to power modern, patient-centered clinical research in Japan.
Collaboration to Support Sanofi’s Commitment to Building Patient-Centric, Modern Clinical Research Infrastructure across the Global Enterprise
THREAD, the leading technology and consulting service provider enabling electronic clinical outcome assessments (eCOA) and decentralized clinical trials (DCTs), announced today its five-year collaboration with innovative global health care company, Sanofi. THREAD will serve as the sole provider of unified decentralized clinical trials (DCTs) and electronic clinical outcome assessments (eCOA) technology for Sanofi’s Integrated Patient Platform (IPP), part of its global Act4Patients program.
Founded in 1978, Biogen is a leading global biotechnology company that has pioneered multiple breakthrough innovations including a broad portfolio of medicines to treat multiple sclerosis, the first approved treatment for spinal muscular atrophy, and two co-developed treatments to address a defining pathology of Alzheimer’s disease. Biogen is advancing a pipeline of potential novel therapies across neurology, neuropsychiatry, specialized immunology and rare diseases and remains acutely focused on its purpose of serving humanity through science while advancing a healthier, more sustainable and equitable world.
Biogen Social Responsibility
As a purpose-driven company, we believe serving humanity through science has never mattered more. For Biogen, that includes bolstering our commitment to corporate responsibility, caring deeply about making a positive difference for patients, our employees, the environment and the communities where we live and work. Climate, health and equity are deeply interrelated challenges that demand bold action, and that’s why we are working to advance a healthier, more sustainable and equitable world.
DGE’s Supplier Diversity & Economic Inclusion For Pharma & Healthcare
Supply chain professionals and executives in the health and pharma spectrum are invited to attend the premiere Supplier Diversity & Economic Inclusion for Pharma & Healthcare Summit, streaming online on March 7-8th, 2023.
DGE’s Clinical Research in Latin America Summit To Address Gaps in Regional Collaborations
Professionals and executives from the pharma, medical device, biotech, and life science medical fields, are invited to attend the premiere Clinical Research in Latin America Summit by DGE, streaming online on February 9-10th, 2023.
Dynamic Global Events (DGE) Announces Partnership with Healthcare Businesswomen’s Association (HBA)
Dynamic Global Events (DGE) announced today that they are partnering with the Healthcare Businesswomen’s Association (HBA) for the 9th Advancing Women’s Leadership Skills & Opportunities in Pharma & Healthcare Conference (AWLC).
Dynamic Global Events (DGE) Announces Partnership with InvestorBrandNetwork (IBN)
Dynamic Global Events (DGE) and InvestorBrandNetwork (IBN) announced today that they entered into a partnership for the AI and Machine Learning Drug Development Virtual Conference.
Lessons Learned When Implementing A Risk Management Program:120 REMS Programs and Counting
Insights into the type of REMS program which may be required can be found by looking at recently approved REMS or those already in the marketplace.
It’s the biopharmaceutical industry’s mission to find lifesaving treatments. It’s also our responsibility to help patients access them.
Principles on Conduct of Clinical Trials Communication of Clinical Trial Results
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents research-based pharmaceutical and biotechnology companies. Our members discover, develop, manufacture and market new medicines and vaccines to enable patients to live longer and healthier lives.
UBC Guide: 5 Steps to Mastering Pharmacovigilance Signal and Detection Management
When a signal is detected, further investigations are warranted to assess if a true casual relationship exists.
UBC Case Study: Pharmacovigilance Data Migration, Database Support and High-Volume Case Processing for Six Oncology Products on an Expedited Schedule
UBC seamlessly assembled a pharmacovigilance program for our client including the migration of over 11,000 existing cases for six products
Medical congress planning tips from industry leaders
Life science organizations are using technology to optimize congress insight-gathering and drive strategy.
The rise of digital opinion leaders
Opinion leaders – both traditional KOLs and DOLs – have a tremendous influence on HCPs.
The KOLs have spoken: virtual engagement is here to stay
Leading pharmaceutical and medical device companies rely on input from key opinion leaders—KOLs—to drive their critical projects forward. Now, at the dawn of a new era of virtual work, these organizations are freed from the timeframes and travel budgets that once constrained KOL engagement.
MSL Training, Neurology
A US-based medical affairs team wanted to conduct new-hire MSL training focused on neurology topics.
Social Listening, Medical Conference – Within3 Select
Life science companies invest significant resources in annual medical conferences and other in-person and hybrid events, and it’s important to maximize this investment through adequate preparation, meaningful participation, and actionable post-event activities.
Unlocking the Secrets of Virtual Work
The way pharmaceutical and medical device teams work has changed forever, prompting some experts to predict that everything from day-to-day interactions to how clinical trials are conducted will experience a transformation.
4 Technologies Disrupting Insights Management for Medical Affairs
Medical affairs teams rely on insights to drive strategy and enable business decisions with far-reaching implications for their organizations, and for consumers who rely on life-changing treatments and devices. But the processes surrounding insight-gathering are varied, complex, and time-consuming.
Best Practice Guide: Transforming Insights into Business Value
Life science organizations are facing a new world and unprecedented challenges. A global pandemic revealed vulnerabilities in processes from supply chain management to clinical trial recruitment and execution. As the global crisis progressed, pharmaceutical and medical device teams pivoted to virtual tools for much of their communication and collaboration.
Digital Opinion Leaders: Where, Who, and How
Life science and pharma companies have long looked to key opinion leaders (KOLs) for insights and advice. KOLs are highly respected and highly influential within their often large networks of peers. They are usually researchers, physicians, or other healthcare providers (HCPs) and extremely knowledgeable about their particular areas of expertise – it’s not surprising that the industry has recognized and embraced their value as strategic partners.
UBC Pathway REMS Connect Overview
Improve prescriber experience, increase compliance, and reduce cost of REMS (Risk Evaluation & Mitigation Strategy) administration
UBC Partners with Seqster to Advance Patient-Centric Clinical Trials
UBC, a late-stage research and patient support services organization has partnered with Seqster PDM, Inc. (“Seqster”), the leading patient-centric healthcare technology company, to provide nationwide health record interoperability with patient engagement.
H1: Trial Landscape Fast Facts
Trial Landscape, our clients can leverage unique clinical insights for data driven decision-making, easily segmenting and analyzing patient populations, to facilitate more diversity and inclusion in clinical trials.
Digital Leaders as KOLs
Gone are the days when Conferences & Pubs defined the KOL landscape. Social media has transformed thought leadership, and if you’re not engaging Digital Opinion Leaders, then your teams will be a step behind some of the most meaningful work.
Rising Star Identification
Our client, a top 25 Global Pharma company, needed to better understand the top global key opinion leaders in pulmonary disease and oncology.
The Value of Claims Data
Our client was planning a launch of a product within a new indication. To ensure they were targeting the right audience, they wanted to better understand the treatment landscape across a total of five indications.
The Value Claims Data
H1 has worked with the top Pharmaceuticals and Life Sciences Companies to help them better understand the HCP Universe. Specifically, H1 clients were seeking to increase MSL engagement.
Engaging Community Leaders Effectively
In reviewing the work done across those organizations, H1 uncovered an interesting trend. In companies where Medical Affairs teams engage both the top thought leaders and community treatment leaders; the MSL teams reported approximately 20% more engagements with HCPs as compared to those teams not engaging both types of thought leader.
Bringing Clinical Trials to Patients Wherever They Are
Mobile Clinical Services (MCS) uses a patient-centric approach to transforming clinical trials, allowing for a suite of clinical trial visit services to be conducted at any time, wherever the patient may be by using a centrally managed network of country coordinators and mobile service providers.
Putting the Patient First: Decentralized Trial Design Increases Enrollment and Representation
Traditionally, clinical trials follow a standardized format, whereby the participant in the trial must attend the clinical site or sites for the purposes of screening, enrollment, treatment administration and data collection.
Technologies, tools and processes to support patient-centric oncology trials
There is a gap between the number of patients needed to participate in new cancer trials and the number who give consent to take part. Decentralized clinical trials (DCTs) are helping to address this gap by increasing the reach of clinical studies beyond conventional research sites.
Pulmonary Inflammation Home Visit Case Study in Australia
While adoption/acceptance/use of Mobile Clinical Services (MCS) is growing /increasing in most regions around the world, a number of Asia-Pacific countries remain hesitant to commit to this new approach to clinical trials.
Decentralized Research Playbook
The current public health crisis has accelerated collecting data in a decentralized manner. The biopharmaceutical industry had already begun to harness transformative approaches to collecting data in novel ways, including from remote sources across a wide range of settings and using diverse modalities.
DGE’s 2nd Rx TO OTC Symposium To Discuss Novel Digital Tools and eCommerce Breakthroughs to Maximize Success at Launch
Lifescience and pharma professionals are invited to attend the 2nd Rx to OTC symposium being held on November 11-12, 2021.
DGE’s Advancing Diversity, Equity & Inclusion (“DEI”) In Pharma & Healthcare Conference to Discuss Maximizing The Power Of Diversity for Superior Business Results
Lifescience and healthcare professionals across all department functions, and consultants are invited to attend DGE’s Advancing Diversity, Equity & Inclusion (“DEI”) In Pharma & Healthcare Conference, streaming live online November 4-5, 2021.
DGE’s 2nd REMS Virtual Summit to Draw Pharmaceutical and Life Science Professionals
Dynamic Global Events (“DGE”) is proud to announce its 2nd Risk Evaluation and Mitigation Strategies (“REMS”) virtual summit. This two-day event, scheduled for October 11-12, 2021, will be an excellent avenue for life science professionals to develop decision making skills to adapt to anticipate FDA feedback with ease.
DGE’s 7th Advancing Women’s Leadership Skills & Opportunities in Pharma & Healthcare – Virtual Conference On Women Leadership Roles
Pharma professionals, healthcare providers, influencers, and healthcare-related industries are invited to attend DGE’s 7th Advancing Women’s Leadership Skills & Opportunities in Pharma & Healthcare being held on September 22-24, 2021, as a live online event.
What you need to know about Digital Opinion Leaders
Digital Opinion Leaders may already be influencing your audience. Here's how you can engage with them and leverage their reach.
DGE’s 2nd Clinical Trial Agreements Conference to Negotiate Budgetary Restraints, Reduce Risks, and More in an Evolving Landscape
Dynamic Global Events (“DGE”) invites biopharma and medical device industry professionals to join them online September 16-17, 2021, for the 2nd Clinical Trial Agreements Conference.
DGE’s 2nd Human Factors Engineering & Usability Studies Congress To Offer An Online Educational Tour On Decentralized Medical Testing For Different User Groups
Professionals and executives in pharmaceutical, biotech, and medical device companies are invited to attend DGE’s 2nd Human Factors Engineering & Usability Studies Congress being held on September 9-10, 2021.
DGE’s Pharma Employee Engagement & Experience Summit For Fostering The New ‘Normal’ Work Environment
Pharmaceutical, biotech, and medical device professionals/employees are invited to attend DGE’s Pharma Employee Engagement & Experience Summit on August 30-31, 2021.
DGE’s Blockchain Pharma & Life Sciences Summit To Bring Together Industry Leaders For A Consolidated Global Blockchain Management System
Medical professionals are invited to attend DGE’s Blockchain Pharma & Life Sciences Summit on August 23-24, 2021 to learn successful strategies of successfully using the decentralized technology to boost trust and improve transparency throughout the life science ecosystem including regulators, contract manufacturers, physicians, and patients.
DGE’S 2nd Electronic Trial Master File Forum To Showcase Leading Industry Faculty For Tips On TMF Technology For Successful Clinical Research
Clinical researchers, medical managers, pharma companies, and life science professionals are invited to attend the 2nd Electronic Trial Master File (“eTMF”) Forum on August 16-17th, 2021.
DGE’S 4th Digital Strategy & Innovation For Medical Affairs Summit To Gear Medical Professionals For The Digital Revolution Era
On July 28-30, 2021, medical officers and healthcare professionals are invited to attend DGE’s 4th Digital & Innovation For Medical Affairs Summit to learn and upskill with the progressive technologies and novel policies of the digital era.
DGE’s Chief Patient Officer Summit to Offer Innovative Ideas for a Smooth Patient Experience
Chief Patient officers and leaders of engagement, advocacy, communications and support services, are invited to attend the inaugural Chief Patient Officer Summit on July 22-23, 2021, organized by DGE.
DGE’s 2nd Medical Writing Innovation Strategies Conference for Life Sciences.
Biopharma medical writing and communications professionals are invited to attend DGE’s 2nd Medical Writing Innovation Strategies Conference for Life Sciences live streaming on June 29-30, 2021.
DGE’s Next-Gen MSL Excellence Symposium
Medical Science Liaisons (MSLs), along with pharma companies and other life science professionals, are invited to attend DGE’S inaugural Next-Gen MSL Excellence Symposium being held on June 23-24, 2021.
2nd Medical Affairs Leadership Forum
The COVID-19 impact has brought a paradigm shift in the responsibilities of medical professionals. This ‘new normal’ requires updates and revised training of medical professionals to adapt to the new hybrid work environment.
Omnichannel Marketing Strategy Symposium
As marketing gets personalized and consumers expect to be reached on their channel of preference, pharma companies are spending significantly on marketing and sales.
Risk-Based Quality Management Summit
The worldwide impact of COVID-19 has shifted the landscape of clinical trials forever. On June 3-4 2021, biopharmaceutical and medical device companies are invited to attend the Live Streaming of the Risk-Based Quality Management Summit.
4th Virtual Clinical Trials Conference
As the impact of COVID-19 is felt stronger than ever, the need for virtual clinical trials is now more essential, than ever. In wake of the rising need for virtual clinical trials. The 4th Virtual Clinical Trials conference will be live-streamed on 17 18TH May 2020.
KOL & Thought Leader Engagement Summit
The COVID-19 fear increases as the pandemic spreads its way into the second year of impacting people’s day-to-day affairs, not only in the United States but throughout the world, the role of KOLs becomes even more important role in each stage of the drug life cycle.
UBC Pathways® REMS Connect Improve prescriber experience, increase compliance, and reduce cost of REMS (Risk Evaluation & Mitigation Strategy) administration
UBC’s REMS Connect extends our industry leading REMS platform, enabling prescribers to link directly into the platform with an ‘in-workflow’ direct connection originating within their own electronic medical record (EMR) system.
DGE’s Women’s Executive Leadership Virtual Workshop 201 to Empower Leaders to Build Teams that Deliver Superior Results
Described as relatable, dynamic, passionate, and inspirational, Colleen Hauk – the event’s speaker – has made a name for herself as a seasoned trainer, speaker, and co-author of two books. Colleen always seeks to empower her audiences and clients to expand their minds beyond what is expected so that they can strike a balance between leadership and their personal lives.
Dynamic Global Events’ BioPharma BD&L Summit Accelerates Alliances, Licensing and Partnerships
Companies view mergers and acquisitions (“M&A”) as opportunities to broaden their portfolio, expand to international markets and increase leverage and scale.
InvestorBrandNetwork (IBN) and BioMedWire (BMW) Announce Collaboration with Dynamic Global Events (DGE) to Serve as Official Media Partners for Upcoming 2021 Events
InvestorBrandNetwork (“IBN”), a multifaceted communications organization engaged in connecting companies to the investment community through 50+ brands, today announced it will partner with Dynamic Global Events (“DGE”) as an official media partner for upcoming conferences in 2021
Avoid Audience “ZOOM OUT” – 10 Tips to Master Your Virtual Scientific Meetings Today!
Many of us spend hours in back-to-back virtual meetings these days. While these video engagements are convenient and relatively simple to set up, they also bring a number of challenges for presenters – including for those delivering scientific content and engaging with healthcare professionals (HCPs).
2020 FDA YEAR IN REVIEW
The COVID-19 pandemic has had a massive impact on the life sciences industry. Companies have pivoted entire production lines to manufacture critical products, such as personal protective equipment (PPE) and diagnostic tests.
Catch a Rising Star. The Science and Art of Identifying and Engaging Emerging or “Rising Star” Experts
External experts are sought-after advisors for life science companies, where they inform critical decisions along the entire product lifecycle of a drug. These experts use the knowledge and experience they acquired over the course of their careers to help companies address challenges like identifying unmet medical needs, clinical trial design, stratification of patient populations, label extensions, product positioning, regulatory challenges and many others.
Risk Management & REMS
Maximize product performance by managing risk before, during, & after launch with the industry’s most comprehensive global suite of solutions available.
Alucio™ Adds Clovis Oncology to its Growing Roster of Life Science Customers
Alucio™, a fast-growing provider of cloud-based software for the life sciences industry, today announced that Clovis Oncology has selected Alucio’s Beacon as its scientific exchange platform.
Alucio™ Adds New Mobile Capabilities to its Beacon Scientific Exchange Platform
Alucio™, a fast-growing provider of cloud-based software for the life sciences industry, today announced the release of new features for Beacon’s mobile phone users.
Alucio™ Joins The Board Challenge Initiative as a Charter Pledge Partner
Alucio™, a fast-growing provider of cloud-based software for the life sciences industry, announced today that it has joined The Board Challenge(www.theboardchallenge.org) initiative created to improve the representation of Black directors in corporate US boardrooms.