Recorded Webinar: Streamlining Collaborations and Drug Development using CDD Vault
Collaborative Drug
AUGUST 1, 2023
Streamlining Collaborations and Drug Development using CDD Vault and ELN
How to Ensure Compliance in Generic Drug Development
Drug Patent Watch
APRIL 14, 2025
"Compliance in Generic Drug Development: 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.
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Generic Drug Development: Avoid These Common Pitfalls
Drug Patent Watch
APRIL 24, 2025
"Warning: Are You About to Fall into the Generic Drug Development Trap? As a seasoned pharma professional, I've seen it time and time again: promising generic drug candidates that fail to deliver due to avoidable pitfalls. Don't let this happen to you. " #GenericDrugs #Pharma #RegulatoryCompliance
Introduction to My Spring Boot Blog Series: Embarking on a Learning Journey Together
Perficient: Drug Development
NOVEMBER 21, 2023
As I navigate this powerful framework, I’ve decided to document my experiences, insights, and newfound knowledge in a blog series. As I navigate through the various facets of Spring Boot, I aim to provide clear and insightful content that is accessible to beginners, seasoned developers, and anyone else eager to join me on this venture.
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Altasciences at ARVO 2025: An Eye on the Future of Ophthalmic Drug Development by Gretchen Green
Alta Sciences
JUNE 26, 2025
Her extensive background allows her to support clients at every stage of the drug development process, from initial proof of concept to NDA-enabling studies. [1] 1] [link] ; This blog was originally published in June 2025. conference locations.
Compliance Challenges in Generic Drug Development: Lessons Learned
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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Drug Discovery Industry Roundup with Barry Bunin — July, 22 2024
Collaborative Drug
JULY 22, 2024
Is Revolutionizing Drug Development. Holy Grail for Weight-Loss Drugs Is Sleep Apnea? DNA Discovery that Could Help Find Pancreatic Cancer Cure.
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Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development
FDA Law Blog: Drug Discovery
NOVEMBER 10, 2024
These studies are crucial because understanding the natural course of a disease helps in designing better clinical trials and defining meaningful endpoints for future drug development. The rest of this blog will focus on the Clinical Trials Grants Program.
Altasciences At CPHI Americas 2025
Alta Sciences
JULY 3, 2025
Altasciences At CPHI Americas 2025 pmjackson Thu, 07/03/2025 - 13:41 In the ever-changing drug development 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.
How FSP Models Help Biotech Companies Augment Their Clinical Development Needs
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. This blog explores the value of functional service provider (FSP) models and how they help biotech companies augment their clinical development needs.
The Growing Trend of Patient-Led Clinical Research in Rare Disease
Conversations in Drug Development Trends
OCTOBER 29, 2024
Increasingly, patients and patient-led organizations are playing a pivotal role in shaping drug development, underscoring the importance of collaboration between patient organizations, CROs, and pharmaceutical and biotechnology companies.
Navigating CMC: Key Lessons from Industry Leaders on Ensuring Success in Drug Development
DS in Pharmatics
SEPTEMBER 26, 2024
Discover key strategies for mastering CMC in drug development from industry leaders. Our blog covers expert insights on early-stage de-risking, CMO selection, and leveraging AI to drive success.
AI Unleashed: Transforming Drug Discovery from Theory to Practice
Plenge Gen
JANUARY 7, 2025
When I last wrote about AI on this blog three years ago, I spoke of it being a tool with the potential to transform scientific discovery, but the application I described was primarily theoretical. … The post AI Unleashed: Transforming Drug Discovery from Theory to Practice appeared first on Plenge Gen @rplenge.
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FDA Eliminates Animal Testing: Impact on Biotechs
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
When is a Confirmatory Trial “Underway” or Conducted with “Due Diligence” Enough for Accelerated Approval? FDA Explains Its New Authorities
FDA Law Blog: Drug Discovery
JANUARY 30, 2025
Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance). This blog post focuses on interpreting these new authorities with respect to timely conduct of confirmatory trials. Tobolowsky & Charles G. Raver & James E.
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October CMS: A Modern CMS for Developers and Creators
Perficient: Drug Development
MAY 27, 2025
It’s simple to manage pages, media, blog entries, and plugins. Business owners benefit from a clean, easy-to-use admin interface to manage their content, announcements, services, or blog posts. Personal Websites and Blogs Ideal For: Writers, bloggers, or professionals maintaining a personal web presence.
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Illuminating Choices: A Guide to Selecting Fluorescent Dyes and Ligands
addgene Blog
MARCH 21, 2024
Seeing inside these specimens has offered illumination on biochemical processes that are crucial in the world of biological research, medical therapy, and even drug development (Grimm & Lavis, 2022). If you’re struggling to select the right fluorescent tools, this blog is here to help.
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FDA Programs to Support Advanced Manufacturing: Where Innovation Meets Regulation
The Premier Consulting Blog
OCTOBER 30, 2024
To prevent this learning curve from becoming a roadblock on the path to regulatory approval, the FDA has developed several collaborative programs to support advanced manufacturing. What is advanced manufacturing?
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What are the five pillars of drug development consulting services?
DS in Pharmatics
APRIL 18, 2025
Discover the five pillars of drug development consulting: regulatory compliance, clinical trials, preclinical research, CMC, and market access.
Guest Blog: Reflecting on the 2024 Society of Toxicology of Canada Symposium, by Ria Falvo, Director, Reporting
Alta Sciences
JANUARY 31, 2025
Guest Blog: Reflecting on the 2024 Society of Toxicology of Canada Symposium, by Ria Falvo, Director, Reporting pmjackson Fri, 01/31/2025 - 15:47 Ria Falvo, Director of Reporting, and Rina Massarelli, Associate Director of Safety Reporting, in Toronto, Ontario, for the 2024 STC Symposium.
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The Sun Has Started to Set on the Rare Pediatric Disease Priority Review Voucher Program – But It Can Still be Saved
FDA Law Blog: Drug Discovery
DECEMBER 23, 2024
As we blogged recently, the program has had scheduled sunset dates from its very beginning, which have been repeatedly extended. The first sunset date is the authority to grant a priority review voucher to a rare pediatric disease product application for a drug that has not been designated as a drug for a rare pediatric disease.
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The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs
FDA Law Blog: Biosimilars
APRIL 8, 2025
Leading FDAs implementationof the Drug Competition Action Plan (DCAP). The DCAP was an initiative launched in 2017 to remove barriers to generic drug development, approval, and market entry (see our previous post here ). facilitating the twice annual updates to the Off-Patent, Off-Exclusivity List ).
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The Role of the FDA’s Oncology Center of Excellence in Advancing Cancer Care
The Premier Consulting Blog
JANUARY 14, 2025
In this blog, we outline how the OCE gets involved in product reviews and offer a high-level summary of the programs and resources available for guiding oncology product development. Determining a new products pathway The OCE does not receive regulatory applications directly from sponsors who are developing new cancer therapies.
HCL Commerce V9.1 – Coexistence of the Headless Next.js Ruby & Aurora Storefronts
Perficient: Drug Development
MAY 14, 2025
This blog series will focus on each of these components separately. Part 2 of this blog series will focus on the coexistence of the Next.js Other Blogs in the Series HCL Commerce V9.1 HCL Commerce v9.1 release saw a major change in features, functionality, and technology. Ruby & Aurora Storefronts. The Power of the Next.js
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Time for change: non-human primates in drug research
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. Food and Drug Administration (FDA). Bailey J, et al. Trends in Non-Human Primate Use for Research and Testing.
Import Data From Merlin to Finish Your Migration to Sitecore
Perficient: Drug Development
JUNE 26, 2023
I did not add all the necessary fields for an actual blog article (date, author, etc). In our example, we start by importing categories then importing the blogs. When I import the blogs, I can simply join the category array from Merlin with a vertical bar ‘|’ to store in Sitecore. Merlin gave each category a GUID.
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Salt Lake City
Alta Sciences
JUNE 26, 2025
MENU logo-altasciences EN - Main navigation Proactive Drug Development Solutions Compare Us Facilities About Us Resource Center Careers News & Events 30th Anniversary Celebration Contact Us Participate in a study Français Home Current: Salt Lake City Salt Lake City Share this page Submitted by pmjackson on Thu, 06/26/2025 - 15:11 Image Downtown (..)
More Uncertainty and Less Advice from FDA Means Companies will Need to Even More Carefully Chart their own Course to Achieve their Goals
FDA Law Blog: Biosimilars
APRIL 1, 2025
While much may be in flux, the central tenet of drug development remains the same, develop drugs that are safe and effective drugs for patients, through streamlined, efficient, and cost-effective development programs. Therein lies the opportunity.
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Deploying a Scalable Next.js App on Vercel – A Step-by-Step Guide
Perficient: Drug Development
JUNE 2, 2025
Today, in this blog, we will cover the step-by-step process of deploying a Next.JS Whether you are giving the shot to a blog or a site, Vercel ensures optimal performance with zero-config deployments. app on Vercel. We will also cover some best practices and key configurations to ensure the optimal performance in production.
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Reports Document FDA Review Delays: What Drugmakers Should Know Now
FDA Law Blog: Drug Discovery
APRIL 21, 2025
One area drawing increasing attention is how these changes will affect the drug development and review process. As reported by the Wall Street Journal last week , reviews of both innovative and follow-on drugs have been caught in a traffic jam, largely due to a leadership vacuum at the Center for Drug Evaluation and Research (CDER).
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In search of the perfect assay description
The ChEMBL-og
DECEMBER 13, 2023
A set of well-defined and structured assay descriptions would be valuable for the drug discovery community, particularly for text mining and NLP projects. This Blog post will consider the features of the 'perfect' assay description and provide a guide for depositors on the submission of high quality data. Q uestions?
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Applying Artificial Intelligence to Transform the Patient Enrollment Paradigm in Clinical Research
PPD
JULY 29, 2024
In today’s data-driven world, AI has become valuable and indispensable, enabling organizations to extract valuable insights from vast amounts of data, make informed decisions and drive innovation across different sectors — including drug development.
HP&M Attorneys Receive Accolades: Top Lawyer Under 40 and WWL: Life Sciences 2023 Global Elite Thought Leader
FDA Law Blog: Biosimilars
JUNE 27, 2023
James is recognized as helping fundamentally shift the culture to consider the patient voice as an integral part of drug development. Mr. Karst, a co-author of the FDA Law Blog, provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs.
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Gretchen Green
Alta Sciences
JUNE 26, 2025
MENU logo-altasciences EN - Main navigation Proactive Drug Development Solutions Compare Us Facilities About Us Resource Center Careers News & Events 30th Anniversary Celebration Contact Us Participate in a study Français Home Current: Gretchen Green Gretchen Green Share this page Submitted by pmjackson on Thu, 06/26/2025 - 15:12 Image gretchen-green.jpg (..)
Integrating Real-World Data into Coveo Search Using the Generic REST API Source Connector
Perficient: Drug Development
DECEMBER 3, 2024
This blog will guide you through indexing content from API endpoints into Coveo using the Generic REST API source. For this blog, we’re using a sample API. For this blog, I’m using Free fake and reliable API for testing and prototyping. And handle content from diverse repositories efficiently.
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The Power of Human Tissue Models in Preclinical Research
Reprocell
OCTOBER 3, 2024
This blog is the second in a series exploring the critical role of safety pharmacology in drug discovery. In our previous post, we discussed the importance of human tissue studies in ensuring drug safety.
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How to Automate Content Updates Using AEM Groovy Scripts
Perficient: Drug Development
FEBRUARY 27, 2025
In this blog, we’ll outline the key steps and best practices for using Groovy scripts to automate content updates. MoreAEM Insights Don’t miss out on more AEM insights and follow our Adobe blog ! However, manual updates, like rolling out a new template, can become tedious and costly when dealing with thousands of pages.
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How to Implement Schema.org in Sitecore
Perficient: Drug Development
OCTOBER 3, 2023
In this blog, we will be discussing Schema.org, the role of schema.org in SEO, and how to implement Schema.org in Sitecore. In the next blog, we will discuss these components in depth. What is Schema.org? Schema.org is a universal way to describe web pages with structured data. Thanks, and Stay Tuned.
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Postbot–An AI Bot that Generates Scripts for You
Perficient: Drug Development
JUNE 5, 2025
In the fast-paced world of software development, automated API testing is no longer optionalit’s essential. In this blog post, we’ll explore what Postbot is, its core features, and how you can start using it today. Stay tuned for more great features of Postbot in the upcoming blogs. Happy Reading!
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Using Merlin to Migrate Your Site to Sitecore
Perficient: Drug Development
JUNE 13, 2023
This makes it easier to break the site into pages that have similar DOM layouts (ie: blogs, news, products, etc) for the generate command. The entity_type option sets the name of the output file “blog_site_structure” creates url list file called “crawled-urls-blogs_site_structure_default.yml”.
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What Pharma Must Know About Responsible AI Implementation
ACTO
DECEMBER 17, 2024
Part 2 Our first blog covered the ABCs of Artificial Intelligence (AI) and AIs evolution. Such cross-functional collaboration ensures consistent implementation from drug development through commercialization. The stakes for AI adoption in the pharmaceutical industry have never been higher.
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Number 100
Perficient: Drug Development
SEPTEMBER 11, 2023
I have always enjoyed writing blogs and sharing my knowledge with others. This is my 100 th blog post! Series I write a lot of blog series. Until then, I’ve shared my screen reader blog and video with many people to show them how to use a screen reader as a native user would. I can’t believe I finally made it!
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HCL Commerce V9.1 – The Power of HCL Commerce Search
Perficient: Drug Development
MAY 20, 2025
This blog series will focus on each of these components separately. Part 3 of this blog series will focus on the capabilities of HCL Commerce Search powered by Elasticsearch. Other Blogs in the Series HCL Commerce V9.1 These capabilities allow for refined results, leading to a better end-user experience and higher conversions.
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Perficient Obsesses Over Outcomes to Drive Client Success Through Expertise and Innovation
Perficient: Drug Development
APRIL 17, 2025
This blog series celebrates Perficients recognition as a 2025 USA Today Top Workplace. In our last blog, we discussed how Perficient is Shattering Boundaries through our global delivery model and cutting-edge strategies. By building strong relationships , we develop customized solutions that go above and beyond their expectations.
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