Drug Patent Watch

JANUARY 14, 2025

Benefits of the Portfolio-Centric Approach Risk mitigation Increased profitability Broader market presence Therapeutic Area Dominance Some manufacturers are choosing to become the Gordon Ramsay of specific therapeutic areas. Case Study 3: Modeling the Future of Generic Drugs Who says you need a crystal ball to predict the future?

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Perficient: Drug Development

MARCH 6, 2024

In December 2022, the Department of Health and Human Services released a bulletin announcing additional compliance requirements for healthcare marketers when it comes to third-party trackers. However, full adherence to HHS guidance and HIPAA regulations is non-negotiable, so in light of recent guidance, change is completely warranted.

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The Premier Consulting Blog

OCTOBER 30, 2024

To support this, the Innovative Technologies and Advanced Manufacturing Hub (I-TEAM Hub) was created. As outlined earlier in this blog, innovative manufacturing techniques are key for producing superior quality medicine, as improvement in quality manufacturing can limit drug shortages due to quality-related issues.

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Perficient: Drug Development

NOVEMBER 6, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

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Drug Patent Watch

MARCH 26, 2025

The Unseen Hurdles of Generic Drug Development: Lessons Learned As the pharmaceutical industry continues to evolve, one thing remains constant: the pursuit of affordable, high-quality medications for patients worldwide. However, the journey to bringing a generic drug to market is often fraught with challenges.

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Perficient: Drug Development

NOVEMBER 19, 2024

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

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PPD

JANUARY 2, 2025

Its ability to maneuver persistent drug development challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success.

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Drug Target Review

APRIL 7, 2025

For example, transcriptomic processes are showing the potential to identify and track failures in gene expression and gene regulation of amyloid and tau-related biomarkers, understood as precursors to the onset of Alzheimers disease (AD).

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Drug Patent Watch

DECEMBER 10, 2024

The pharmaceutical and biotechnology industries are heavily regulated, and navigating these regulations can be a significant challenge for companies, especially those with limited experience. Contract Development and Manufacturing Organizations (CDMOs) play a crucial role in helping companies overcome these regulatory hurdles.

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Drug Target Review

JULY 18, 2023

Artificial Intelligence (AI) is poised to transform the field of target discovery in drug development, offering immense potential to enhance efficacy, personalised medicine, and accelerate the development of innovative compounds. Cavlan explains that “they are brilliant at developing and bringing new drugs to market.”

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Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that requires a deep understanding of regulatory requirements and guidelines. Regulatory expertise plays a crucial role in ensuring that generic drugs meet the necessary standards for quality, safety, and efficacy. EU, and other regions. EU, and other regions.

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PPD

JUNE 17, 2025

Biopharmaceutical and biotech drug developers have faced increasing challenges in recent years. In the past decade alone, the time needed to complete a clinical trial has increased by 20–30%, and the cost to bring a new drug to market has risen to an average of about $2.6

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The Premier Consulting Blog

APRIL 13, 2025

On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).[ from approved products in other countries) to inform doses and development. Legislation with delayed implementation In 2021, the FDA Modernization Act 2.0

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Drug Target Review

JUNE 11, 2025

Drug development 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. Highlighting data integration.

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Drug Target Review

AUGUST 7, 2024

The pharmaceutical industry is undergoing a major shift towards the development of breakthrough medicines and advanced therapies. This continued innovation highlights the complexity of the drug development process, particularly as the field is highly regulated by health authorities around the world.

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Drug Target Review

APRIL 30, 2025

Faster time-to-market and reduced costs. By integrating AI into the manufacturing process, the developer achieved higher consistency across batches, improved overall product quality, and reduced time-to-market – all critical factors in ensuring patients receive timely and effective treatment. The result?

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Drug Target Review

JULY 7, 2025

Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drug development due to their close genetic, anatomical and physiological resemblance to humans. Institutions must invest in secure housing, specialised veterinary care and rigorous training for handlers.

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Fierce BioTech

APRIL 28, 2025

Accelerating Time-to-Market: Balancing Speed, Compliance, and Operational Excellence jpiatt Mon, 04/28/2025 - 14:42 Tue, 06/24/2025 - 10:00 Resource Type Webinar Promotion Start Thu, 05/01/2025 - 08:30 Promotion End Sat, 11/01/2025 - 08:30 In the highly competitive world of drug development, few things matter more than getting to market first.

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Drug Target Review

JULY 4, 2023

The drivers behind the demand for ADCs Providing more targeted therapeutic options in the oncology space has underpinned the rapid growth of the ADC market; between 2016 to 2020, the US ADC market grew by 45 percent to a value of nearly $1.5 3D rendering of Antibody Drug Conjugate Molecules.

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Perficient: Drug Development

MAY 22, 2025

The Compliance Content Bottleneck in Financial Services Content creation in financial services isnt just Marketings job. Slow go-to-market – regulatory reviews stall time-sensitive campaigns. Siloed collaboration – Marketing, Legal, and Compliance working in parallel, not together. Under what policy? All tracked.

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Perficient: Drug Development

AUGUST 19, 2024

I have even heard the phrase “Please check the report, I don’t understand the models and hence trust the number” So, in the risk function, while this is a race for data aggregation, structured data, unstructured data, data quality, data granularity, news feeds, market overviews, its also a challenge from an acceptance perspective.

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Drug Patent Watch

FEBRUARY 26, 2025

Understanding the Patent Landscape Biologic drugs are often protected by a combination of patents, including composition of matter patents, method of use patents, and formulation patents. However, the patentability of biologics is governed by specific laws and regulations, such as the Biologics Price Competition and Innovation Act (BPCIA).

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PPD

OCTOBER 17, 2024

There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. To find success among the competition, sponsors must have access to the necessary expertise and resources to approach this burgeoning market.

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Drug Target Review

APRIL 14, 2025

The antibiotic market has long faced significant barriers to innovation, with structural issues that make it difficult for new antibiotics to gain traction. As the demand for novel antibiotics remains limited due to the preference for cheaper generics, the market has struggled to incentivise much-needed breakthroughs.

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Conversations in Drug Development Trends

APRIL 29, 2025

On the last day of February every year is Rare Disease Day , a dedicated day to celebrate the rare disease community, including patients, families, caregivers, clinicians, researchers, regulators, and more. In an incredible feat of collaboration, they were able to rapidly put together a new event called Rally for Rare.

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Alta Sciences

NOVEMBER 15, 2024

4 Essential Topics to Cover in Your First CRO Meeting pmjackson Fri, 11/15/2024 - 19:22 Starting a partnership with a contract research organization (CRO) is a sometimes intimidating—yet exciting—first step in your drug development journey. It’s equally important to communicate your long-term plans.

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The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways.

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Drug Target Review

APRIL 7, 2025

Involved in various physiological processes, such as vision, taste, smell, immune response and neurotransmission, GPCRs are activated by various molecules including hormones, neurotransmitters and environmental stimuli, which trigger a cascade of cellular events that help regulate bodily functions. References Sun D, et al. doi:10.1016/j.apsb.2022.02.002.

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FDA Law Blog: Biosimilars

APRIL 2, 2024

Perhaps unsurprisingly given the extraordinary focus on drug pricing in the last decade, generic competition—FDA’s only real way to have an effect on drug pricing—tops this year’s list. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

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DrugBank

OCTOBER 4, 2024

However, ensuring that these structures comply with applicable tax laws and regulations is essential to avoid potential legal and reputational risks. Sophisticated valuation methodologies, such as the income, market, and cost approaches, are employed to estimate the fair value of individual patents or the entire IP portfolio.

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Perficient: Drug Development

FEBRUARY 12, 2025

The industry faces numerous challenges, including protecting sensitive data, navigating evolving regulations, and outdated legacy systems. To harness AIs potential effectively, its essential to develop a strategy that considers payment regulations to ensure consumer protection , data privacy , and ethical use of AI.

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Conversations in Drug Development Trends

JULY 3, 2025

In practice, these regulations created substantial bottlenecks. For instance, the regulations required patients to remain in close proximity to the healthcare facility for a full four weeks, which became difficult if the patient needed to transfer hospitals or lived far away from certified centers.

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Drug Patent Watch

JANUARY 9, 2025

Navigating the complex landscape of drug development and manufacturing can be a daunting task. Enter the Contract Development and Manufacturing Organization (CDMO) a lifeline for many startups looking to bring their innovative therapies to market. A: It’s never too early to start considering CDMO partnerships.

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The Pharma Data

NOVEMBER 24, 2020

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to. There’s absolutely no risk to you.

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FDA Drug Development Drugs Compliance 52

Perficient: Drug Development

NOVEMBER 22, 2023

People love superlatives In an HCIC keynote session, John Youshaei, Forbes writer and former marketing lead at YouTube and Instagram, explored core principles of writing for a consumer audience, especially on social channels. So, without further adieu, here are our top insights from HCIC 2023. 1.

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FDA Law Blog: Drug Discovery

JANUARY 30, 2025

For instance, the December 2024 guidance goes beyond the 2014 Expedited Programs for Serious Conditions Drugs and Biologics guidance (the last to deal substantively with accelerated approval) to describe FDAs expectation that sponsors take a proactive approach to ensuring confirmatory trials are completed within specified timelines.

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Perficient: Drug Development

FEBRUARY 26, 2025

This series of blog posts will cover main areas of activity for your marketing, product and UX teams in advance of, during and after site migration to a new digital experience platform. From business goals and priorities, page views, conversion rate, SEO considerations and marketing campaigns, to compliance and regulations.

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