Pharmaceuticals – Page 5
-
JournalAI meets medtech:
big opportunities
require a
measured approachRegulatory Rapporteur February 2024 | Volume 21 | No.2 Abstract Artificial intelligence (AI) and machine learning (ML)-enabled digital health technologies have great potential to improve patient care, strengthen diagnostic capabilities and enhance treatment options. Governments and healthcare professionals understand ...
-
PodcastsRegRapPod − In Conversation with TOPRA’s RegOps SPIN
BONUS EPISODE: In Conversation with TOPRA’s RegOps SPIN
-
Industry newsScientists hail gram-negative-bacteria killing antibiotic
A novel class of antibiotic has been discovered that is effective against the extensive drug-resistant, gram-negative bacteria, Crab.
-
Podcasts
RegRapPod − January 2024
Vol.21 #1: In January 2024’s RegRapPod, host Alan Booth talks to Issue Editors Julie Warner and Ash Ramzan about biologics.
-
JournalInnovating and harmonising access and requirements amid the global regulatory challenges of biologics
This article provides an overview of the regulatory challenges of biologics facing the biopharmaceutical industry, focusing on the need for global regulatory harmonisation. These challenges are central to ensuring the safety, efficacy and accessibility of biologic therapies for patients worldwide. To navigate these regulatory challenges, a collaborative effort will be ...
-
JournalCell and gene therapy – navigating complexities in CMC development for optimisation of global regulatory strategies
Cell and gene therapy (CGT) products represent a frontier in modern medicine, offering precision treatments. Yet their development is affected by multifaceted challenges including chemistry, manufacturing, and controls (CMC). This article provides a comprehensive exploration of the complexities involved in CMC development and considers its role in establishing quality, safety ...
-
JournalThe changing face of oncology development – is cancer still ‘different’? A US perspective
Oncology development has traditionally been thought of as ‘different’; that the rules that applied to other therapy areas were not necessarily applicable to the development of treatments for cancer patients, who until relatively recently, had exceedingly limited treatment options. Dose finding was based on the paradigm adopted for cytotoxics and ...
-
JournalNavigating early drug development investment: a detailed guide to due diligence
Funding is undoubtedly one of the major challenges small and medium-sized companies face when developing a new therapy from the bench to the clinic and eventually to the market. Suitable partnerships and potential mergers and acquisitions are key drivers to take a drug development programme to the ...
-
-
EditorialThe increasing complexity of biological medicinal products
Regulatory Rapporteur January 2024 | Volume 21 | No.1 The world of biologics is shifting rapidly. In the more than 40 years since the introduction of the first biosynthetic human insulin in 1982, advances in scientific understanding and biotechnology ...
-
JournalArtificial intelligence in drug discovery
Regulatory Rapporteur January 2024 | Volume 21 | No.1 Introduction The recent publication of papers by the European Medicines Agency (EMA)[1] and the Food and Drug Administration (FDA)[2][3] has spurred the debate on ...
-
-
PodcastsRegRapPod − November 2023
Vol.20 #10: In the November 2023 episode of RegRapPod, podcast host Alan Booth talks to Issue Editor Leah Kleylein about the industry in North America.
-
Industry newsUS could ‘seize’ drug patents with unused Reagon-era law
The Biden administration sets new policy direction that could see the US federal government ‘seizing’ patents from publicly-funded medicines.
-
JournalHM5/MD1/IVD1: Process for regulations and implications of different legislation – how to follow and decide which regulation will impact your product development
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Chair: Bjørg Hunter, Director, Regulatory Affairs Digital Health & IVD, Novo Nordisk, Denmark. Speakers: James Bertram, Director, Office of Combination Products, U.S. Food and ...
-
JournalHM2: Improving the odds of regulatory success
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leader and speaker: Carlos Langezaal, Senior Director, Global Regulatory Affairs, Bristol Myers Squibb (BMS), USA. Speakers: Fred Senatore, Medical Officer, Clinical Team Leader Division of ...
-
JournalHM3: A spotlight onto the future – fireside chat
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leaders: Francesca Buttigieg, Director Regulatory Affairs, PTC Therapeutics International Limited, Switzerland. Sabine Haubenreisser, Principal Scientific Administrator - Stakeholders and Communication, EMA, the Netherlands. Speakers: Steffen ...
-
JournalHM6: Real-world evidence and the use of big data for regulatory decision making; DARWIN EU
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leaders: Marén Koban, Director Global Regulatory and Scientific Policy, Merck Healthcare KGaA, Germany. Àlmath Spooner, Head of Europe, Regulatory Policy and Intelligence, Abbvie, Ireland. Speakers: ...
-
JournalHM7: Paediatric investigational plans
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Chairs: Sandra Lourenco, Head of Regulatory Affairs, Arriello, Portugal. Andrea Laslop, Head of Scientific Office, Austrian Medicines and Medical Devices Agency, Austria. Speakers: Ignacio Malagon ...
-
JournalHM8: Regulatory mechanisms to expedite drug development and patient access (e.g. PRIME)
Regulatory Rapporteur December 2023 | Volume 20 | No.11 Session leader: Marie Uguen, Senior VP, Regulatory Affairs & Quality Assurance, SparingVision, France. Speakers: Laurence Campion, Regulatory Affairs Director, PTC Therapeutics France, France. Christian K. Schneider, ...