Broad Institute

JANUARY 9, 2025

Tan and K.

Engineering

LifeSciVC

MAY 14, 2025

At the molecular level, gravity underlies sedimentation and convection, the central principles that govern fluid dynamics. Gravitys influence on biology is so pervasive that many of its effects go unnoticed and unappreciated. In microgravity, these certainties fail, freeing biological processes to unfold in novel ways.

Science

Codon

FEBRUARY 13, 2025

By training PLACER on structures stored in the Protein Data Bank, the team taught the model to predict atom arrangements that follow the physical and chemical rules governing protein-small molecule interactions. Credit: Lauko A.

Small Molecule

Perficient: Drug Development

APRIL 7, 2025

This leads to: Slow query startup times for interactive users Cluster spin-up delays due to metadata prefetch slowness Support escalation from unrelated teams The CREATE OR REPLACE Reset In other blogs , I have said that predictive optimization is the reward for investing in good governance practices with Unity Catalog.

Government

Drug Patent Watch

DECEMBER 9, 2024

This patent was later revoked after the Indian government challenged it, citing ancient Ayurvedic texts that documented this use of turmeric. The Turmeric Patent Controversy: A Cautionary Tale In 1995, the University of Mississippi Medical Center was granted a U.S. patent for the use of turmeric in wound healing.

Drugs

Drug Target Review

MAY 14, 2025

The challenges lie in regulated industries where governance frameworks for standard quantitative models dont necessarily apply to LLMs. The challenges lie in regulated industries where governance frameworks for standard quantitative models don’t necessarily apply to LLMs.

Drugs

The Pharma Data

JUNE 13, 2025

This forward-thinking collaboration reflects a growing recognition within both industry and government that Japanese biotechnology companies have tremendous scientific prowess, but frequently face significant barriers when attempting to translate their innovations into commercial applications.

Research

The Premier Consulting Blog

NOVEMBER 6, 2024

What regulatory division governs ICPs? By offering better symptom control, reducing exacerbations, and simplifying treatment regimens, these products help patients lead more active, comfortable, and fulfilling lives. ICPs are subject to rigorous regulatory scrutiny due to their complexity.

Production

Broad Institute

JANUARY 13, 2025

By removing manual bottlenecks in data collection, organization, governance, and analysis, Manifold enables researchers to focus on discovery, unlocking the full potential of their data without technical barriers. Founded in 2016, Manifold is an AI-powered platform accelerating biomedical research.

Science

FDA Law Blog: Biosimilars

JULY 23, 2025

Pete brings nearly a decade of high-level government experience to HP&M’s Enforcement and Litigation practice, with a particular focus on complex regulatory and litigation challenges involving the U.S. Prior to his government service, Pete was a litigation associate at Williams & Connolly LLP and clerked for the Honorable Mark R.

Government

PPD

JULY 29, 2025

Detailed governance, oversight and management processes Dedicated hub leads ensure operational efficiency and regulatory adherence, coordinate resources, monitor performance metrics and align with sponsor goals.

Clinical Trials

Drug Target Review

NOVEMBER 28, 2024

Challenge 2 : Life sciences data is often privileged or proprietary Data privacy and security are paramount when dealing with sensitive data, such as patient records governed by HIPAA or other regulatory frameworks. This raises an important question: does life sciences require a new system of record?

Science

The Pharma Data

JUNE 16, 2025

The company was recognized as “Best CEO”, “Best CFO”, “Best Company Board”, “Best Investor Relations (IR) Program”, and “Best ESG (Environmental, Social, and Governance) Program” — a testament to its well-rounded excellence.

Government

Codon

JULY 28, 2025

Companies weigh market size, reimbursement potential (the likelihood insurers or governments will pay for the therapy), and the level of existing competition before deciding which vector to use for their gene therapy. Some diseases occur so rarely that they face treatment barriers due to unfavorable economics of scale.

Immune Response

Broad Institute

APRIL 5, 2025

Liu became an HHMI investigator in 2005 and joined the JASONs, academic science advisors to the US government, in 2009. He earned his PhD in 1999 and became assistant professor of chemistry and chemical biology at Harvard University in the same year. In 2016, he became a core institute member at the Broad Institute.

Science

Drug Target Review

JULY 10, 2025

Prior to Flatiron, Josh was at MIT studying computer science and working with researchers at Massachusetts General Hospital to use ML and NLP to predict patient response to cardiac resynchronisation therapy.

Metabolic Stability

Perficient: Drug Development

MAY 14, 2025

Navigate to PIM (Privileged Identity Management) Step 3 : In the Azure portal, navigate to Identity Governance and select Privileged Identity Management (PIM) to manage privileged access. The screenshot below shows that the Demo-Group security group will be created and assigned to its corresponding subscription.

Government

Drug Target Review

JUNE 19, 2025

With government and grant funding tightening,” Atwood adds, “labs are under pressure to do more with less, especially in resource-intensive areas like antibody discovery.” “With government and grant funding tightening, labs are under pressure to do more with less, especially in resource-intensive areas like antibody discovery.”

Analytical Chemistry

Drug Patent Watch

JANUARY 21, 2025

By increasing access to affordable medications, biosimilars can also help to reduce healthcare costs for employers, insurers, and governments. The benefits of biosimilars extend beyond individual patients, with the potential to reduce healthcare costs for employers, insurers, and governments. Share your thoughts in the comments below!

Biosimilars

Drug Target Review

MAY 21, 2025

Blood centres already navigate complex logistical and regulatory challenges in managing the national blood supply, with biological therapies that must adhere to stringent guidelines similar to those governing CGTs. Extending these systems to support advanced therapeutics is not just logical, its practical and cost-effective.

Therapies

Drug Channels

JULY 15, 2025

Among them: manufacturers’ evolving market access strategies, which increasingly aim to offset—or circumvent—growing pricing pressure from both commercial and government payers. In our analysis below, we highlight five key forces driving this shift. Meanwhile, many patients remain adrift in the drug channel’s murky waters.

Government

PPD

DECEMBER 16, 2024

Top-tier CROs provide a full range of regulatory support , from submission strategy to post-approval maintenance, helping sponsors navigate complex landscapes, including: Early success Provide strategy development, module and content development, SME review, application publishing and maintenance submission Support a variety of submissions Assist with (..)

Drug Development

The Pharma Data

JUNE 13, 2025

mRNA Technology Transfer Programme Moves Into Phase 2.0,

Vaccine

Advarra

MAY 21, 2025

Existing SOPs, oversight models/governance, and QMS frameworks are being reassessed for readiness and relevance. Our advice is to begin with a thorough review of your documentation, then once the gaps are identified, updates can be planned and implemented. What needs to change?

Pharma Companies

The Premier Consulting Blog

OCTOBER 30, 2024

Navigating the uncertainty of advanced manufacturing While these programs can offer distinct advantages for sponsors who are developing advanced manufacturing technologies, a 2023 Government Accountability Office (GAO) study determined that regulatory challenges in this space persist and result in a level of uncertainty for sponsors.

Regulations

PPD

JULY 8, 2025

A new paradigm for AI training and governance Generative AI users must adopt a dynamic, life cycle-based approach to governance to ensure the responsible and effective deployment of AI technologies. This approach recognizes that generative AI models, like human professionals, require continuous assessment and improvement.

Clinical Research

Codon

APRIL 17, 2025

Such vascular differences are governed by auxin, a plant hormone that regulates leaf venation and shape. The researchers also note fewer free-ending veinlets and thinner vascular networks in mimic leaves, interpreting this as evidence of active mimicry.

Research

FDA Law Blog: Biosimilars

FEBRUARY 26, 2025

With all the change we are witnessing in the American model of regulation and governance, it might be tempting to ask if we are suddenly living in a post-compliance word. How will the imposition of tariffs and a burgeoning trade war affect domestic drug production and companies supply chain demands?

Compliance

Perficient: Drug Development

MARCH 18, 2025

Government Citizen Services Assists citizens with information about services. Employee Self-Service Agent Answers policy questions and performs HR/IT tasks. Career Coach Personalized career advice and action plans. Sustainability Sustainability Insights Provides insights on sustainability goals.

Production

Drug Patent Watch

DECEMBER 10, 2024

Government initiatives: Both countries have implemented policies to address patent thicket issues and promote innovation. Their approach to patent thickets reflects this: Strategic patenting: Companies in these countries often engage in strategic patenting to protect their technological advantages.

Licensing

ACTO

DECEMBER 17, 2024

The Foundation: Governance and Security Successful AI implementation begins with strong platform governance and security standards. Asserting Active Human Oversight and Robust Governance While AI offers powerful capabilities, human oversight remains essential.

Government

Drug Patent Watch

FEBRUARY 26, 2025

However, the patentability of biologics is governed by specific laws and regulations, such as the Biologics Price Competition and Innovation Act (BPCIA). This requires a deep understanding of the science behind biologics, as well as the regulatory framework governing their development and approval.

Drugs

Drug Patent Watch

MARCH 4, 2025

Stay up-to-date on regulatory requirements : Familiarize yourself with the latest guidelines and regulations governing pharmacovigilance. Train your team on pharmacovigilance best practices : Ensure that everyone involved in the development process understands the importance of pharmacovigilance.

Drug Development

Perficient: Drug Development

DECEMBER 10, 2024

Build for Trust : Incorporate contextual and toxicity guardrails, monitoring, decision transparency, and governance to ensure your AI systems are ethical and reliable. Success lies in building an organizational culture that embraces new processes, tools and workflows.

Government

Codon

JANUARY 5, 2025

America was experiencing wheat shortages, so the government sought to find ways to make bread with various grain substitutes. With the threat of American involvement in World War II looming, the government began to plan for conflict. Government was reluctant to sponsor Cohn’s fishing expedition while a war was on.

Laboratories

PPD

JUNE 17, 2025

The right FSP partner implements this structure in a way that ensures efficient governance and an optimized oversight infrastructure, thus ensuring that sponsors maximize the benefits of this model while preserving quality and compliance.

Clinical Development

FDA Law Blog: Biosimilars

JUNE 4, 2025

Ordinarily, a public health initiative of such magnitude would have been governed by a transparent multi-step process featuring public meetings and drawing on external scientific expertise. In other words, as you read this, the Assessments findings and recommendations are getting baked into federal government policy, for better or worse.

Drugs