Drug Discovery World

JANUARY 2, 2024

Cancer Research Horizon’s Innovation Summit 2023 took place on 21 November 2023 at the Royal Society of Medicine, and included talks from researchers translating their research, as well as networking with members of the entrepreneurial ecosystem. DDW’s Megan Thomas spoke to a range of attendees. That’s exactly what we’ve done.

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Drug Discovery World

MAY 8, 2024

In the clinical trial management and planning systems space, we are already seeing how the practical implementation of these tools is accelerating drug development and bringing innovative medicines to patients faster. There is now growing pressure for regulators to take action.

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Perficient: Drug Development

SEPTEMBER 6, 2023

The regulators feel that this proposed LTD rule would: Improve the resolvability of these banking organizations in case of failure, Potentially reduce costs to the Deposit Insurance Fund, and Mitigate financial stability and contagion risks by reducing the risk of loss to uninsured depositors.

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Agency IQ

JULY 8, 2024

What we expect European regulators to do in July 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Drug Discovery World

JUNE 30, 2023

Whether it be a monoclonal antibody to treat peanut allergy, or using artificial intelligence (AI) to identify influenza drug targets, each discovery reflects the level of scientific innovation and diversity of approaches being employed in drug development today. The top stories: Could a monoclonal antibody treat peanut allergy?

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Perficient: Drug Development

FEBRUARY 29, 2024

Perficient is excited to announce we’ve won the 2023 Acquia Partner Advocate of the Year Award for North America ! Our engagements range from implementing Drupal websites and portals to strategizing personalization and customer journeys, including clients in regulated industries like healthcare and financial services.

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Perficient: Drug Development

NOVEMBER 27, 2023

In the dynamic environment of highly regulated industries like healthcare and financial services, leaders often balance competing goals to delight customers while cutting costs. This has challenged many organizations to better optimize and intelligently automate business processes and experiences.

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Drug Discovery World

AUGUST 18, 2023

Real-world evidence is a high growth market segment as pharmaceutical and biotechnology customers, as well as regulating bodies, are increasingly looking to monitor and evaluate the safety of approved therapies and examine their effectiveness and value in the post approval setting. “We of adjusted earnings per share in 2024.

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Drug Target Review

SEPTEMBER 25, 2024

Classically, rational drug combinations are designed to target two nodes in the same oncogenic signalling pathway. BRAF and downstream mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors are combined to treat BRAF-mutated melanoma, for example.

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Perficient: Drug Development

AUGUST 16, 2023

Bank Closed By Regulators Almost all bank closures happen on a Friday so that regulators can work all weekend to reopen the bank on Monday. On Monday, July 31, 2023, all four branches of Heartland Tri-State Bank were reopened as Dream First Bank branches. In 2019, it expanded by buying its fourth branch from a competitor.

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Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. An updated Unified Agenda: The Unified Agenda is the U.S.

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

is pleased to announce it took top honors in two categories in the 2023 LMG Life Sciences Awards, which recognize the best life science practitioners and firms over the past 12 months from the United States, Canada, and Europe. is the largest dedicated food and drug law firm in the country.

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Drug Discovery World

AUGUST 22, 2024

Prolonging health span with drug development Life Biosciences aims to restore and prolong a patient’s health span by targeting the underlying biology of ageing and increasing the quality of years one spends in good health compared with just increasing the total number of years one lives.

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Perficient: Drug Development

OCTOBER 16, 2023

We’re excited to announce that Perficient has been ranked the fifth-largest healthcare IT consulting firm in Modern Healthcare’s 2023 survey. The annual survey ranked healthcare IT consulting firms according to 2022 provider revenue, the number of health IT contracts, and the number of healthcare IT consultants.

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Conversations in Drug Development Trends

NOVEMBER 10, 2023

 Instead, the medical community and regulating agencies need to balance all aspects when making decisions, working in partnership with their patients. Collaborating The post 3 Considerations of the Patient Perspective from the 2023 Pain Therapeutics Summit appeared first on Worldwide Clinical Trials.

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Drug Discovery World

JULY 20, 2023

The EMA has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of medicines. The use of AI is rapidly developing in society and as regulators we see more and more applications in the field of medicines.

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Perficient: Drug Development

NOVEMBER 22, 2023

So, without further adieu, here are our top insights from HCIC 2023. 1. Senior Strategist Kayla Brown speaks at HCIC 2023 on Consumer Centricity With an Enterprise Digital Experience Platform 4. A great digital experience simply can’t be created without cross-department collaboration.

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Drug Discovery World

MAY 6, 2024

Even before this, however, Amsterdam was established as an important centre for drug development. In a boost to cancer research for both regions, in November 2023, Cancer Research UK and the KWF Dutch Cancer Society (KWF) announced a multi-project strategic partnership. The CDD will sponsor and manage KWF-supported trials.

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Perficient: Drug Development

SEPTEMBER 19, 2023

Most Sustainable Dreamforce Ever 74% of structures were recycled or reused 5,500 square feet of biodegradable signage 10M gallons of water conserved 100% compostable meal packaging Multiple Net Zero Cloud sessions New Net Zero Cloud capabilities, including simplified ESG reporting for companies amid changing regulations; Einstein for Net (..)

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Drug Discovery World

NOVEMBER 8, 2023

Harnessing AI, researchers have significantly expedited the drug discovery process, achieving what traditionally takes years in just 30 days. This method not only promises more efficient drug development but could also revolutionise clinical research and accelerate trials. NY Post 20 March 2023. Chem Sci 2023;14:1443-145.

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Cytel

JUNE 2, 2023

Data submissions are very regulated, but every drug and drug development are different. What follows is an introduction to the ISS/ISE from a stats perspective, which I recently shared at the Italian CDISC User Network on May 12, 2023.

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Fierce BioTech

OCTOBER 26, 2023

Are Gaps in Your Clinical Pharmacology Program Jeopardizing Your Drug’s Approval? pesurya Thu, 10/26/2023 - 14:05 Tue, 12/05/2023 - 11:00 Resource Type Webinar Julie Bullock, PharmD Krithika Shetty, PhD Blaire Osborn, Ph.D. On Demand Start Date Tue, 12/05/2023 - 12:00

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The Premier Consulting Blog

NOVEMBER 12, 2023

This feedback prompted the FDA to release a second paper in 2021 titled “ Artificial Intelligence/Machine Learning (AI.ML)-Based Software as a Medical Device (SaMD) Action Plan ,” which outlined the agency’s five-pillar approach to regulating AI/ML. AI will be able to identify trends in manufacturing-related deviations. (

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PPD

OCTOBER 18, 2023

Continued expansion of the biotech industry is occurring in parallel, with an estimated compound annual growth rate of 13.96% from 2023-2030. 1 With this growth comes increased demands for laboratory services at all steps across the development process.

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Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Law Blog: Biosimilars

AUGUST 23, 2023

This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.

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Drug Discovery World

APRIL 13, 2023

BC Platforms has used its technology solution to link its data partner sites in its growing Global Data Partner Network, with over 50 million patient lives that meet both GDPR and HIPAA regulations. This has created the foundational infrastructure and legal pathway to patient-level RWD data with an unprecedented breadth and reach.

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Drug Discovery World

OCTOBER 18, 2023

We’re beginning to see their potential come to fruition, with the FDA having approved three treatments as of January 2023 — for retinal dystrophy 1 spinal muscular atrophy, 2 and haemophilia B. What’s more, rodents are used widely across preclinical R&D, so most drug development labs already have the infrastructure to utilise them.

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Drug Target Review

JANUARY 5, 2024

Scientists from the Centre for Genomic Regulation and the Wellcome Sanger Institute have found the allosteric control sites in the KRAS protein, the highly sought after targets for drug development. For the purposes of drug discovery, it’s like turning the lights on and laying bare the many ways we can control a protein.”

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Conversations in Drug Development Trends

FEBRUARY 22, 2023

What will have the greatest impact on rare disease patients in 2023? I was fortunate to understand how the clinical development sausage is made and was frustrated by the fact that we could do a better job to incorporate the patient perspective into the studies we design and the therapies we commercialize.

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Drug Discovery World

AUGUST 3, 2023

Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance. There is, however, one cannabis-derived drug product that the FDA has approved, which is Epidiolex (cannabidiol).

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Drug Target Review

JULY 4, 2023

1 Regulators invest significant consideration balancing quality-of-life measures with overall survival when assessing novel oncology treatments. Antibody drug conjugated with cytotoxic payload. antibody linked to a biologically active cytotoxic (anticancer) payload or drug 3d rendering. 2022 [cited 2023 Feb 10];30(2):71.

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Perficient: Drug Development

FEBRUARY 15, 2024

This blog was co-authored by Perficient Risk and Regulatory CoE Member: Alicia Lawrence The announcement of significant amendments to the New York State Department of Financial Services (NYSDFS) regulations on December 1, 2023, represents a pivotal moment for entities operating within New York’s financial sector.

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Drug Discovery World

AUGUST 1, 2023

Pre-clinical data has shown that the platform could regulate target antigen- dependent gene expression as a means to improve upon both the efficacy and safety of first-generation CAR-T cell therapies. DDW Volume 24 – Issue 3, Summer 2023 The post Synthetic biology: Innovating in drug discovery appeared first on Drug Discovery World (DDW).

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Perficient: Drug Development

FEBRUARY 15, 2024

This blog was co-authored by Perficient Risk and Regulatory CoE Member: Alicia Lawrence Perficient’s Risk and Regulatory Center of Excellence (CoE) remains at the forefront of evolving financial rules and regulations, ensuring readiness to tackle emerging challenges and safeguard financial institutions and its customers.

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Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Read AgencyIQ’s analysis of a lower court’s ruling.

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Perficient: Drug Development

JULY 12, 2023

Perficient provides risk management to more than 500 financial services organizations, many of whom have multiple bank regulators. Often an organization will have a state-charted non-member bank, which has the FDIC as its primary federal regulator.

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