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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 Contributors: Swapnil Waichale, Principal and 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…
The Role of RWE in Expediting the Drug Approval Process
Key Contributors: Lydia Edison (Project Manager), Rohit Mandlik (Project Manager), Rohit Dang (Engagement Manager), Mahendra Rai (Senior Director) The role of real-world evidence (RWE) in expediting the drug approval process. RWE refers to the use of…
Unlocking the Power of Data, Artificial Intelligence and Digital Innovations to Revolutionize Care for Rare Disease Patients
Posted by
Maria Kirsch , Scott Snyder , Faruk Capan , Pierantonio Russo, MD, FCPP, FAAP, STS on 7月 20, 20237/20/23
Rare diseases and developing and distributing the therapies that treat them create highly complex challenges for pharmaceutical manufacturers, and certainly for the patients and providers impacted by them every day. Because these diseases are often extremely…
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…
Health Disparity Solutions Build Healthier Communities and a More Equitable Medical Landscape
Achieving equity within healthcare is a harrowing but imperative goal for the industry. Lack of safe housing and healthy food, low income, ethnicity, race, rural living and other social determinants of health (SDOH) can have a…
A Comparison of Existing Real World Evidence (RWE) Guidelines
Key Contributors: Neel Patel, Associate Consultant- HEOR, APAC and Rajanikanth Manupati, Associate Consultant- HEOR, APAC In the fast-paced world of healthcare, where the development and approval of new therapies can take over a decade, the need…
Navigating the Complexities: Strategies for Asian Pharma Companies Entering the U.S. Market
Key Contributors: Divayum Gupta (Analyst), Tanay Sharma (Consultant), Sowbhagya Suresh (Senior Consultant), Jinsol Kim (Engagement Manager) The United States holds a dominant position in the global pharmaceutical market, accounting for 45% of global sales in 2022.…