KIF1A

JANUARY 13, 2024

This process is regulated so we end up with the right number of neurons, which we can imagine with some simplified math: If you start with one progenitor and need eight neurons, it isn’t efficient for that progenitor to make a single neuron eight times.

DNA 105

DNA Regulations Drug Development Disease 105

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.

FDA 52

FDA Regulations Pharmaceuticals Production 52

Perficient: Drug Development

AUGUST 19, 2024

The vision is that all of the data can be aggregated, harmonized and used for better, faster and more informed decision making for Financial and Non Financial Risk Management. where’s my Insight”) The primary goal of data management, sourcing and aggregation effort will have to be converting data into informational insights.

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Regulations Government Marketing Compliance 109

NIH Director's Blog: Drug Development

APRIL 2, 2020

With so much information swirling around these days about the coronavirus disease 2019 (COVID-19) pandemic, it would be easy to miss one of the most interesting and significant basic science reports of the past few weeks. The protein is known to play a prominent role in the body’s complex system of regulating blood pressure.

Drug Development 52

Drug Development Drugs Science Medical Schools 52

FDA Law Blog: Biosimilars

APRIL 2, 2024

Under the heading “Facilitating Competition” are multiple initiatives designed to either hasten development of generic drugs or limit blockades to market. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

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FDA Biosimilars Production Marketing 104

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. E-mail: regs.comments@occ.treas.gov.

Regulations 52

Regulations Compliance 52

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. Cancer Cell [Internet].

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Small Molecule Drugs Clinical Pharmacology Trials 145

Advarra

AUGUST 10, 2023

Given the relatively small populations affected by any one rare disease or condition, a pharmaceutical company developing an orphan drug may reasonably expect the final approved drug to generate relatively small sales (when compared with the drug development costs) and consequently incur a financial loss.

Drug Development 52

Drug Development Disease Therapies Engineering 52

Perficient: Drug Development

NOVEMBER 1, 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.

Regulations 52

Regulations Compliance Production Marketing 52

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.

Clinical Research 72

Clinical Research Disease Research Clinical Trials 72

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 blog was co-authored by Carl Aridas and Joel Thimsen. Build a reliable risk management strategy using accurate estimations and predictions.

Regulations 52

Regulations Compliance International Science 52

Perficient: Drug Development

FEBRUARY 29, 2024

Geo-coding data with tags to comply with European regulations is also a possible target of opportunity. Compliance and Regulation This is related to, and can be used in conjunction with, data classification and security. In an increasing regulated data environment, it pays to make your data assets easy to regulate.

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Government Regulations Compliance Marketing 78

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.

Regulations 40

Regulations Pharmaceuticals Production Vaccine 40

FDA Law Blog: Drug Discovery

MARCH 13, 2023

Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ).

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Therapies Trials FDA Clinical Trials 98

FDA Law Blog: Drug Discovery

MARCH 7, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. FDA notes that the distinctions between responsibilities for these groups and DMCs should be clearly defined, particularly with respect to access to unblinded information.

Clinical Trials 105

Clinical Trials Trials FDA Regulations 105

Agency IQ

JUNE 26, 2023

FDA quietly kicks off process that could inform future rare disease regulatory reforms Reforms buried within the FY2023 omnibus spending bill require the development of a new report looking at the regulatory processes of the U.S. legislators have asked the FDA to study the way that rare disease drugs are regulated in the U.S.

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FDA Disease Regulations Production 40

Perficient: Drug Development

OCTOBER 30, 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.

Regulations 52

Regulations Compliance Government International 52

Perficient: Drug Development

NOVEMBER 14, 2023

Data privacy has become an increasingly complex subject, especially with the introduction of the California Consumer Privacy Act (CCPA) and similar regulations emerging in other states. Non-compliance with these regulations can result in hefty fines, as seen with Sephora’s recent $1.2

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Compliance Regulations Production Marketing 98

Drug Patent Watch

DECEMBER 11, 2024

Your Drugs Development Stage The stage of your drug development is a critical factor in selecting a CDMO. Adhering to industry standards, a preference exists for utilizing the same CDMO for both development and commercial manufacturing to enhance communication and timeline management. 2019, March 6).

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Pharmaceutical Companies Compliance Pharmaceuticals Drug Development 52

FDA Law Blog: Drug Discovery

MARCH 6, 2024

John counsels FDA-regulated entities on litigation, enforcement, and compliance matters including FDA inspections, Form 483s, Warning and Untitled Letters and Consent Decrees, internal investigations, and data privacy concerns. More information about the conference can be found here. S for reduced registration fees.

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FDA Compliance Pharmaceuticals Pharmaceutical Companies 59

Perficient: Drug Development

MARCH 6, 2024

However, full adherence to HHS guidance and HIPAA regulations is non-negotiable, so in light of recent guidance, change is completely warranted. With the Salesforce Marketing Cloud Personalization suite, marketers can keep up wit h evolving regulations and consumers’ growing demand for privacy, while building loyalty through personalization.

Marketing 122

Marketing Regulations Compliance Science 122

Perficient: Drug Development

JULY 28, 2023

By providing valuable data-driven insights, Viva Insights enables enterprises to make informed decisions that foster a more productive and thriving work environment. By analyzing trends and patterns, enterprises can make informed decisions to optimize workflows, identify areas of improvement, and support their workforce effectively.

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Compliance Production Regulations 97

Pharmaceutical Development Group

DECEMBER 19, 2021

Effective use of Real World Data (RWD) and Real World Evidence (RWE) can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services , expedite a FDA Pre-Submission Review, and lead to FDA Approval. Author Information William E. Spanogle, Ph.D.

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FDA Approval FDA Clinical Trials Drug Development 52

Pharmaceutical Development Group

FEBRUARY 1, 2022

Effective and consistent compilation of NME & NCE Product and Process Development for inclusion in the electronic submission can reduce costs and timelines. Author Information William E. has over 30 years of management, full spectrum Regulated Life Sciences, RA, QA, EU-MDR, QMS, PMS, CSV/CSA, and R&D experience.

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FDA Drug Development Science Pharmaceuticals 52

Perficient: Drug Development

JANUARY 24, 2024

Before I begin, I just want to caveat everything with the fact that HIPAA is a complex regulation open to interpretation, and in the end your legal and compliance teams need to be comfortable with how you handle data and the risk associated with those methods. The other part of the definition is what constitutes “health information.”

Licensing 96

Licensing Licensing Production Regulations 96

Perficient: Drug Development

NOVEMBER 12, 2024

Prior Authorization, In a Nutshell The CMS Prior Authorization mandate , which goes into effect on January 1, 2026, aims to reduce guesswork for healthcare consumers and the administrative burden on care teams, and to improve patient/member care by streamlining processes and enhancing the exchange of health information.

Engineering 105

Engineering Regulations 105

Perficient: Drug Development

OCTOBER 28, 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.

Regulations 52

Regulations Compliance Production 52

Drug Target Review

SEPTEMBER 19, 2023

This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938. However, building that scalable process with minimal batch variability is a challenge.

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Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

Fierce BioTech

OCTOBER 26, 2023

Eva Gil Berglund, PhD Justin Hay, PhD Paola Coppola, MSc Duration 60 Minutes Clinical pharmacology information comprises more than 50% of a drug label. Inadequate clinical pharmacology development programs can cause sponsors to have significant issues during the review period or impact the approvability of their marketing applications.

Clinical Pharmacology 52

Clinical Pharmacology Drug Development Regulations FDA 52

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

We know, for example, the use of viral vectors results in antibody production that could inhibit future administration of gene therapies using the same or similar viruses, which will inform treatment decisions by patients with their doctors.

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Therapies FDA FDA Approval Treatment 119

Pharmaceutical Development Group

JANUARY 7, 2022

Effective and consistent use and application of Data Standards can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services, 505(b) NDA, IND Consulting , NDA Consulting, BLA Consulting , and effective FDA Pre-Submission collectively resulting in FDA Approval.

FDA 52

FDA FDA Approval Biosimilars Regulations 52

Perficient: Drug Development

NOVEMBER 14, 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.

Regulations 52

Regulations Government Compliance 52

ACTO

DECEMBER 17, 2024

Such cross-functional collaboration ensures consistent implementation from drug development through commercialization. The Foundational Pillars ACTO believes in implementing four foundational pillars that will ensure responsible AI solutions that address pharmas highly regulated parameters, while providing value.

Compliance 52

Compliance Government Pharmaceutical Companies Pharmaceuticals 52

Perficient: Drug Development

OCTOBER 24, 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. Traditionally, trading was manual.

Regulations 52

Regulations Compliance Engineering Marketing 52

Conversations in Drug Development Trends

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA. Our mission is a lofty one.

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FDA Trials Clinical Trials Disease 96

Drug Target Review

DECEMBER 20, 2024

Artificial intelligence (AI) has revolutionised many industries, yet its adoption in pharmaceutical drug development 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 drug development.

Clinical Trials 52

Clinical Trials Trials Pharmaceuticals Drug Development 52

H1 Blog

SEPTEMBER 26, 2023

Data Sharing Beyond Borders One of the most difficult aspects is sharing data between countries – especially when it comes to patient health information , which must remain secure while navigating a variety of different laws. From legal considerations to data privacy regulations, the challenges facing these teams can be daunting.

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Trials Clinical Trials International Regulations 59