Tagged with Opinion,

Animal-Derived Ingredients in Medicines: A Call to Action

Opinion Animal-Derived Ingredients in Medicines: A Call to Action

Opinion Writing in the March 2024 edition of the DIA Global Forum magazine, Scott P. Commins of the University of North Carolina School of Medicine, Jasmine Uchi of VeganMed, and Sachin A. Shah of the University of the Pacific address the use of animal-derived ingredients (ADIs) in pharma and outline a…

Why Pharma Needs to Think Like Tarantino

Global Why Pharma Needs to Think Like Tarantino

Global Drawing inspiration from Quentin Tarantino’s directorial breakthrough in the early 1990s, Blue Spoon Consulting’s John Singer explores the pharma sector’s urgent need for a strategic overhaul to ensure success and sustain growth amidst looming patent expirations. Lex is the flagship investment column of the Financial Times. Its commentaries, currently written…

US Drug Pricing and Reimbursement: Players, Payers, PBMs, and Prospects

USA US Drug Pricing and Reimbursement: Players, Payers, PBMs, and Prospects

USA In late 2023, The Wall Street Journal published the article Generic Drugs Should Be Cheap, but Insurers Are Charging Thousands of Dollars for Them. This article examined interactions between patient health insurance prescription benefits, pharmacies, and pharmacy benefit managers (PBMs), and their collective impact on the prices that patients pay for their prescription…

Drug Shortages in the Global South: A Proposed Parallel Tech and Reg Transfer Framework

Africa Drug Shortages in the Global South: A Proposed Parallel Tech and Reg Transfer Framework

Africa Writing in the February 2024 edition of the DIA Global Forum magazine, Verena Pfaffinger and Ilona Baraniak-Lang of PharmaLex examine how the drug shortages seen in the global south during and after the COVID-19 pandemic can best be overcome through the adoption of decentralised manufacturing. The COVID-19 pandemic exposed…

EU Pharma Legislation: An Opportunity to Rethink

Europe EU Pharma Legislation: An Opportunity to Rethink

Europe Rainer Westermann of venture capitalist coalition Life Sciences Acceleration Alliance reviews the potential impact of the EU’s general pharmaceutical legislation on the investment climate for the EU life sciences sector. Building on his insights from last year, Westermann urges stakeholders to seize the opportunity caused by a delay in the…

JP Morgan 2024 In Review: Good Vibrations

USA JP Morgan 2024 In Review: Good Vibrations

USA Cardiff Advisory’s David H. Crean outlines the positive atmosphere and sentiment observed at JPM 2024, the annual healthcare financing conference held near San Francisco’s Union Square. Dr. Crean picks up some of the key trends to emerge from the conference around sustainability, deal flow, venture funding, and AI, and provides…

Rare Disease Moonshot: Europe’s Public-Private Coalition to Erase the Rare Disease “White Spots”

Europe Rare Disease Moonshot: Europe’s Public-Private Coalition to Erase the Rare Disease “White Spots”

Europe A new piece in the January 2023 edition of DIA’s Global Forum magazine lays out how a new coalition aims to transform the landscape for rare disease treatments in Europe and beyond. The knowledge and infrastructure required to unlock rare disease “white spots,” diseases where there is currently no…

Japanese Academic Clinical Data Can Now Be Used for Drug Registration

Japan Japanese Academic Clinical Data Can Now Be Used for Drug Registration

Japan Toshi Tominaga of Keio University Hospital, writing in the January 2023 edition of the DIA Global Forum magazine, outlines some recent updates to Japanese drug registration legislation, including how domestically generated academic clinical data can be utilised. Japan’s current regulatory framework for investigator-initiated trials (IITs) of drug candidates seems…

A Call for Collective Responsibility in Rare Disease Communities

USA A Call for Collective Responsibility in Rare Disease Communities

USA Drawing on her experience as rare disease patient advocacy group SYNGAP1 Foundation’s founder and former president, Monica Weldon argues for the need to standardize genomic testing practices, warns against the possible ethical implications of individualized medicine, and makes a cause for a more holistic approach within rare disease communities. …

The Evolution of US FDA Diversity Requirements in Clinical Research

USA The Evolution of US FDA Diversity Requirements in Clinical Research

USA The US Food and Drug Administration has increasingly recognized the importance of diversity and representation in clinical trials over the past few decades. This evolution reflects growing awareness across medicine that differences in age, gender, race, and ethnicity can impact disease risk, treatment response, and health outcomes. Darshan Kulkarni of…

3 Essential Characteristics for AI Impact in Clinical Research

Global 3 Essential Characteristics for AI Impact in Clinical Research

Global AI is the buzzword du jour across all industries, but what is needed for it to truly make a difference in clinical trials? Writing in December 2023’s DIA Global Forum magazine, Lokavant’s Rohit Nambisan lays out the three essential characteristics for AI impact in clinical research, foregrounding the vital importance…

New FDA Guidance Addresses Challenges with Cell and Gene Manufacturing Comparability and Complexity

USA New FDA Guidance Addresses Challenges with Cell and Gene Manufacturing Comparability and Complexity

USA Francesco Lanucara of PharmaLex, writing in the November 2023 edition of the DIA’s Global Forum magazine takes a look at how new guidance from the US FDA aims to tackle the myriad challenges of cell and gene therapy manufacturing comparability and complexity. Development of cell and gene therapy (CGT)…

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