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Maximizing Potential: Essential Steps for Successful Commercialization of Cell and Gene Therapies
Introduction Cell and gene therapy (CGT) products have significantly enhanced the quality of life for millions of patients impacted by medical conditions that are untreatable with traditional medicines or surgeries such as certain cancers, inherited and…
Maximizing Product Launch Success: The Importance of Conducting Comprehensive Business Simulation Exercises
Product launch preparedness is a vital aspect of bringing new products to market, particularly in the pharmaceutical industry where patients’ health and well-being can be impacted, in addition to the brand’s success and overall reputation. As…
The Art of Simplifying Pharmacovigilance – Part IV: Streamlining Vendor Engagement for Marketing Authorization Holders
It is often overlooked how many vendors a Marketing Authorization Holder (MAH) engages with. The more you spread your resources, the more scattered your focus becomes. Conversely, the more you concentrate your efforts, the more you…
The Art of Simplifying Pharmacovigilance – Part III: Unlocking Efficiency Through Consolidation
Just a few years ago, accessing entertainment on television was simple. However, the emergence of Over The Top applications for streaming content has made it complex, requiring users to manage multiple accounts and subscriptions. Consequently, users…
The Art of Simplifying Pharmacovigilance – Part II: Change Adoption
Considerable effort is dedicated to inputting clean adverse event data into a safety database, even before conducting the analysis to extract insights. In this scenario, manufacturers are investing more resources in the process of inputting data…
The Art of Simplifying Pharmacovigilance – Part I: Connecting the Dots
The Art of Simplifying Pharmacovigilance – Part I: Connecting the Dots In the intricate realm of pharmacovigilance, there is an art — a delicate dance of connecting the dots. Like a skilled painter, vigilant professionals adeptly…
Commercial Key Success Factors (KSFs) for Global Drug Development Programs
Key Contributor: Robin Arnold, Executive Vice President Discover the essential commercial key success Factors (KSFs) that drive triumph in global drug development programs. In an era of diverse regulatory perspectives and reimbursement complexities, biotech companies face higher…
Specialty Pharmacies are Ready for the Biosimilar Boom. Are you?
The pharmacy benefit biologic market is primed for disruption, with Specialty Pharmacies (SPs) eagerly awaiting the pending market shift. While biosimilars have been available for nearly a decade in the United States, this year will be…
Position Your Future-Facing Strategy on Digital Therapeutics (DTx) in China
How can DTx resonate with current portfolios and capture incoming opportunities? Key Contributors: Robin Arnold, Executive Vice President; Jerry Song, Associate Principal; Qiwei (Alex) Li, Consultant The article discusses the potential of digital therapeutics (DTx) in China’s healthcare…
Overcoming the Commercialization Challenges of Personalized Cancer Immunotherapies
Personalized cancer immunotherapies are emerging as a revolutionary approach to cancer treatment, aiming to provide individualized therapies based on a patient’s specific genetic makeup. The FDA has not yet approved any personalized cancer immunotherapies, creating an…