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The pharmaceutical industry has undergone significant changes over the past decade, with a growing trend towards outsourcing key aspects of research, development, and manufacturing to third-party vendors. The Rise of Integrated CDMOs The global biotechnology and pharmaceutical services outsourcing market size was valued at $70.48
"Breaking the Patent Barrier: The Unseen Hurdles in Generic DrugDevelopment As the pharmaceutical industry grapples with rising costs and accessibility concerns, generic drugdevelopment has emerged as a beacon of hope. But what's driving these challenges, and how can the industry overcome them?
It is hard to ignore some of the most pressing, long-term trends driving the push to accelerate innovation and progress in drugdevelopment. As a result, biopharma and biotech companies working to bring their drug pipelines to the market require deep expertise from trusted partners to help deliver critical therapies for their patients.
It is becoming increasingly evident that generative artificial intelligence (GenAI) is a resourceful tool for helping pharmaceutical companies reduce manual tasks required by clinical trials. Long-term sustainability may benefit from identifying priority indications, exploring emerging mechanisms of action and refining development priorities.
However, the advanced nature of the drugs being developed has brought new challenges. Current challenges in CNS drugdevelopmentDrugdevelopment for the CNS is particularly challenging and researchers face several hurdles to producing effective and safe treatments, many of which are unique to the CNS.
Artificial intelligence (AI) has revolutionised many industries, yet its adoption in pharmaceuticaldrugdevelopment has been notably slower. For years, AI and machine learning (ML) were often dismissed as little more than advanced statistics with little practical value in drugdevelopment.
The regulatory environment in Japan for generic drugdevelopment is complex and has undergone significant changes in recent years. Regulatory Authority: Pharmaceuticals and Medical Devices Agency (PMDA) The PMDA is the primary regulatory authority responsible for overseeing the drug approval process in Japan.
The pharmaceutical industry, particularly the generic drug sector, faces significant challenges in adopting sustainable practices. This article outlines key considerations and strategies for developing a sustainable generic drugdevelopment strategy. “Generics are known for their cost-effectiveness.
This partnership brings together Altasciences’ extensive expertise in preclinical research and early clinical development with VoxCell’s groundbreaking tissue engineering technology, promising to deliver a more human-relevant, predictive, and efficient drugdevelopment paradigm.
As the pharmaceutical industry continues to evolve, drugdevelopers encounter new challenges and opportunities in their pursuit of innovation. These annual results provide valuable insights into the state of drugdevelopment, highlighting shifts in industry practices and illuminating emergent areas of focus.
In the vast realm of pharmaceutical research and development, there’s a fascinating intersection between ancient wisdom and modern science. This intersection is where pharmacognosy meets drug patents, creating a unique landscape that shapes the future of medicine. What is a Drug Patent?
This growth has created a competitive landscape where pharmaceutical companies must carefully evaluate and select the right CDMO partner to ensure the success of their projects. Your DrugsDevelopment Stage The stage of your drugdevelopment is a critical factor in selecting a CDMO.
The pharmaceutical industry is undergoing a significant transformation with the advent of machine learning methods. These methods have the potential to revolutionize the drug discovery process by enhancing the efficiency and accuracy of identifying and developing new drug candidates.
This partnership combines Altasciences’ comprehensive early-phase drugdevelopment capabilities with VoxCell’s cutting-edge 3D tissue technology to offer a more predictive and human-relevant preclinical testing environment.
"Unlock Hidden Profits in Pharmaceutical R&D: A recent analysis of top-selling medications reveals that companies that closely monitor their competitors' patent portfolios are 3x more likely to achieve a higher return on investment in drugdevelopment.
For decision-makers in the pharmaceutical and biotech industries, organoids represent a key innovation extending beyond existing in vitro models. Organoids are cultured cell structures that mimic the complexities of human organs, allowing researchers to study them under conditions that closely replicate real biological environments.
For decision-makers in the pharmaceutical and biotech industries, organoids represent a key innovation extending beyond existing in vitro models. Organoids are cultured cell structures that mimic the complexities of human organs, allowing researchers to study them under conditions that closely replicate real biological environments.
Revolutionizing Generic DrugDevelopment: The Power of Digital Transformation As the pharmaceutical industry continues to evolve, one thing is clear: digital transformation is no longer a luxury, but a necessity. For years, generic drug manufacturers have relied on traditional methods to develop and launch new products.
Accelerating Generic DrugDevelopment: Strategies for Success As a pharmaceutical professional, you know how crucial it is to navigate the complex landscape of generic drugdevelopment. The generic drugdevelopment process involves several stages, from patent research to regulatory approvals.
Drugdevelopment is plagued by complex challenges, but multimodal AI is unlocking new opportunities. By integrating diverse data sources – from genomics to clinical insights – this approach is accelerating drug discovery, improving patient stratification and boosting success rates.
Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. This approach not only helps maintain market exclusivity but also ensures a steady revenue stream for pharmaceutical companies.
Our annual look at the state of the drugdevelopment industry highlights a dual set of challenges complicating progress. Rising costs have become a persistent challenge for drugdevelopers, driven by a combination of internal and external pressures that have intensified in recent years.
In the race to accelerate drug discovery, artificial intelligence (AI) has already proven itself to be adept in areas like target identification, virtual screening and molecular generation. This question – “Can we make the drug?” – is far more than a logistical concern. is reshaping how drug discovery teams think about feasibility.
"The Patent Paradox: How Biosimilars Are Redefining the Future of DrugDevelopment As the pharmaceutical industry grapples with the complexities of biologic innovation, a new strategy is emerging: leveraging biosimilars to break down barriers to market access.
The pharmaceutical industry relies heavily on Contract Development and Manufacturing Organizations (CDMOs) to streamline the drugdevelopment and manufacturing process. Here are the top 10 CDMO services you might not have known you needed… Source
The Unsung Heroes of Generic DrugDevelopment: The Power of Partnerships As we navigate the complex landscape of pharmaceuticals, it's easy to overlook the crucial role that partnerships play in bringing affordable, life-saving medications to market. When it comes to developing generic drugs, partnerships can take many forms.
Generic drugs play a crucial role in providing affordable healthcare options to millions of patients worldwide. One of the key tools that generic drug manufacturers rely on to navigate the complex regulatory environment is the FDA’s Product Specific Guidances (PSGs).
Absorption, distribution, metabolism, excretion and toxicity – collectively known as ADMET – are among the most critical and challenging hurdles in small molecule drug discovery. Data sharing without compromise Drug discovery has long been characterised by a strong culture of secrecy. Image credit: UGREEN 3S / Shutterstock.
Mass spectrometry imaging (MSI) enables the direct detection and quantitation of active pharmaceutical ingredients (APIs) and metabolites within tissue sections, making it widely regarded as a promising technique in the field of pharmacology and toxicology.
The partnership represents a major financial and strategic milestone for Revolution Medicines, which has built a robust pipeline of targeted therapies aimed at cancers driven by mutations in the RAS family of genes—some of the most prevalent and historically difficult-to-drug oncogenes in human cancer.
Leveraging Machine Learning to Accelerate DrugDevelopment Discover how CDMOs are using machine learning to speed up drugdevelopment, cut costs, and improve quality. Download this free white paper to see how ML is transforming pharmaceutical manufacturing.
At the forefront of this movement is DrugPatentWatch, a powerful tool that's providing unprecedented visibility into the world of drug patents. Join the conversation and learn how DrugPatentWatch is revolutionizing the way we think about drugdevelopment and access. Read the full story here: [link] "
Image credit: Crystal Eye Media / Shutterstock The role of SPICA and manufacturing capabilities Drugdevelopment in the radiopharmaceutical space is particularly resource intensive. Shared goals in cancer drug discovery For all its internal capabilities, RMX does not operate in isolation. This is where the SPICA Center comes in.
A personal journey to Alltrna Michelle Werner’s career has spanned over 20 years in the pharmaceutical industry, where she developed her expertise in oncology drugdevelopment at leading companies such as Bristol Myers Squibb, AstraZeneca, and Novartis.
Now take a step further: envision testing drugs in these organoids to identify the ones that can treat disease safely and effectively without needing to run expensive clinical trials first. 12 Testing drugs in vitro in organoid cultures A clear validation of the utility of organoids is in drug discovery and development.
This shift in focus is especially critical in toxicology, where accurate target analysis plays a vital role in identifying toxic effects and ensuring patient safety, particularly as the field transitions from traditional drugs to the promising realm of biotherapeutics, especially for rare diseases.
Altasciences At CPHI Americas 2025 pmjackson Thu, 07/03/2025 - 13:41 In the ever-changing drugdevelopment world, staying agile is essential to enabling more informed decisions, faster. It’s a challenge that affects a large percentage of new drug candidates—one we’re passionate about helping to solve. Why does that matter?
Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drugdevelopment due to their close genetic, anatomical and physiological resemblance to humans. Conventional models often fail to predict cardiac side effects, especially with biologics.
On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drugdevelopment, starting with monoclonal antibodies (mAbs).[ One great example is the FDAs 505(b)(2) New Drug Application (NDA) pathway. Legislation with delayed implementation In 2021, the FDA Modernization Act 2.0
AI in Pharma: Benefits, Risks and the Road Ahead AI is revolutionizing the drugdevelopment process, streamlining and accelerating every stage, from research to approval and marketing. This whitepaper explores the benefits and risks of AI in the pharmaceutical industry and examines its future.
For a contract research organization (CRO), it can play an integral role in increasing the quality and speed of drugdevelopment while reducing costs, repetitive manual tasks, and human error. This can result in failed runs and wasted reagents.
"Compliance in Generic DrugDevelopment: A Critical Component of Success As the generic drug industry continues to grow, ensuring compliance with regulatory requirements has become a top priority for pharmaceutical companies.
The approach could offer a new angle on a disease that has thus far resisted most conventional drugdevelopment strategies. It’s been like a detective story,” says Stephen Pinkosky, Vice President of Drug Discovery and Early Development at Esperion.
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