PerkinElmer

FEBRUARY 18, 2021

Dr. Eckelt conducted 23 hour-long, 1:1 interviews over five months in 2020 to gather market insights on how the top 20 Pharma are increasing productivity, efficiency, and speed of drug discovery in the short and long-term. A PerkinElmer White Paper offers a detailed look at the findings. Small molecules are making a comeback.

Biochemical Assays 52

Biochemical Assays Drugs Small Molecule Pharma Companies 52

H1 Blog

NOVEMBER 15, 2023

The compensation provided to KOLs should also be fair-market value for their time and effort, and not an inducement for them to prescribe or recommend specific products. For more information on how to build effective and compliant engagement plans, download our white paper: How AI Can Save Medical Affairs from Drowning in Data.

Compliance 59

Compliance Science Regulations Pharmaceutical Companies 59

Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic. At a February 2024 joint workshop with the U.S.

Regulations 40

Regulations Trials Science Clinical Trials 40

The Pharma Data

DECEMBER 28, 2020

Our new directors are well-recognized for their leadership and accomplishments in the biopharmaceutical, biotechnology and pharmaceutical industries, as well as in public capital markets and corporate governance.” Mr. Weild is a globally recognized leader in capital formation and capital markets structure. David Weild IV.

Pharmaceuticals 52

Pharmaceuticals Government Pharmaceutical Companies Therapies 52

Agency IQ

JULY 21, 2023

In 2019, the advocacy organization, Friends of Cancer Research (FOCR) organized a multi-stakeholder initiative comprised of industry, government, and academia to find out. In parallel, FOCR developed a white paper that provided an overview of the potential regulatory applications for ctDNA in oncology.

FDA 40

FDA Clinical Trials DNA Treatment 40

The Pharma Data

JANUARY 7, 2021

The pharmaceutical product landscape is rapidly and fundamentally changing with profound impact on research and development strategy and technology needs. Emerging Technology Needs and Value Proposition for Strategic Partnerships with Contract Development and Manufacturing Organizations (CDMOs).

Production 52

Production FDA Pharmaceuticals Marketing 52

The Pharma Data

MARCH 20, 2021

The Kluyver Center for Genomics of Industrial Fermentation in Delft, Holland, is a consortium of several different Universities and Research Centres. We would like to thank Frederick Aboka for providing us with this initial insight into his research project, and are pleased that we were able to supply him with the CO2 sensor InPro 5000.

Bioinformatics 52

Bioinformatics Production Laboratories Engineering 52

The Pharma Data

SEPTEMBER 9, 2020

. Transition to advanced analytics platforms to accelerate a product’s time-to-market. Develop a fully automated environment to significantly boost research efforts. Improve productivity and data integration by driving the use of semantic systems.

Production 52

Production Laboratories Compliance Government 52

PPD

JULY 16, 2024

Our recent white paper explores the many ways in which a functional service provider (FSP) engagement delivers key pharmacovigilance (PV) capabilities necessary across the product life span and across different geographical regions. This research ultimately influenced the creation of a new submission process for the client.

Compliance 52

Compliance Regulations Production International 52

Conversations in Drug Development Trends

APRIL 4, 2024

Understanding and implementing the ICH M10 guidelines is not just a regulatory requirement; it’s a step towards more efficient and effective pharmaceutical research. Select the right partner with experience meeting regulatory standards for all target markets.

Small Molecule 80

Small Molecule Clinical Trials Pharmaceuticals International 80

PPD

DECEMBER 19, 2023

According to industry figures, the use of FSP models grew from 28% to 41% in just three years (2018-2021); by 2022, our internal research shows that nearly two-thirds of outsourcing budgets were allocated to FSP or hybrid FSP/FSO models. Read our white paper to learn the keys to successfully implementing functional service partnerships.

International 52

International Research Pharmaceuticals Drug Development 52

PPD

JULY 9, 2024

Biotech and biopharma companies, however, must do all of this in the face of wildly fluctuating workloads — particularly during the post-marketing phase. Download our white paper The post FSP Flex Hub Teams Maximize Efficiency Across Lifecycle Maintenance appeared first on PPD. Let’s connect.

Compliance 52

Compliance Production Clinical Research Marketing 52

PPD

JUNE 17, 2024

Each model delivers a distinct set of capabilities to the study sponsor: In an FSP arrangement, the contract research organization (CRO) performs a specific function or multiple functions (clinical operations, pharmacovigilance, etc.) Download our white paper The post The Power of Bespoke Hybrid FSP/FSO Solutions appeared first on PPD.

Clinical Trials 52

Clinical Trials Clinical Development Trials International 52

Agency IQ

NOVEMBER 10, 2023

Read AgencyIQ’s analysis of FDA’s QMM White Paper here.] In addition, a new Office of Pharmaceutical Quality Research (OPQR) will oversee all research and a new Office of Quality Assurance (OQA) will oversee training and development of staff as well as enterprise project management and the Quality Management System.

Pharmaceuticals 40

Pharmaceuticals Small Molecule Science FDA 40

Agency IQ

MAY 10, 2024

BY LAURA DIANGELO, MPH | MAY 9, 2024 9:20 PM CDT Background: Servicing and remanufacturing – and why the difference matters Medical device regulatory oversight does not end at the point of market access, nor do the manufacturing requirements after distribution. Remanufacturing versus servicing: What it is and why it matters.

FDA 40

FDA Regulations Compliance Production 40

The Pharma Data

MARCH 20, 2021

In today’s Information Age, content marketing gets three times more leads than paid search advertising (Content Marketing Institute, 2017). While marketing teams know the value of marketing content, producing high-quality content can present a huge challenge to an in house marketing team. Choosing the Medium.

Marketing 52

Marketing Production International Science 52

Codon

APRIL 30, 2023

This study sheds light on how, exactly, AI-generated text differs from the real stuff, and how it could be used to (soon) write entire research papers. If approved, these wouldn’t be the first gene therapies on the market, but they would be the first gene therapies for a disease that affects something like 100,000 Americans.

Vaccine 52

Vaccine Engineering DNA RNA 52

Codon

APRIL 30, 2023

This study sheds light on how, exactly, AI-generated text differs from the real stuff, and how it could be used to (soon) write entire research papers. If approved, these wouldn’t be the first gene therapies on the market, but they would be the first gene therapies for a disease that affects something like 100,000 Americans.

Vaccine 52

Vaccine Engineering DNA RNA 52

FDA Law Blog: Biosimilars

JANUARY 24, 2024

Fast-forward to March 2023, when The White House OSTP issued a document per Executive Order 14081, titled “ Bold Goals for U.S. Biotechnology and Biomanufacturing; Harnessing Research and Development to Further Societal Goals.”

Small Molecule 69

Small Molecule Government Production Pharmaceuticals 69

Agency IQ

FEBRUARY 21, 2024

Given the widespread use of CDISC for clinical research and HL7 for electronic health record (EHR) data, the two organizations have partnered to create mapping guides to streamline the flow of data from EHRs to CDISC submission-ready datasets, and vice versa. CMS in the United States ).

Science 40

Science Regulations International FDA 40

Drug & Device Law

JULY 31, 2023

It’s an interesting topic; Eric recently wrote a paper on it , and Bexis is putting together a “white paper” for the Product Liability Advisory Council on the same subject. no[r] a marketing product” under Lanham Act). Leading Market Technologies, Inc. , Gray Loon Outdoor Marketing. Paragon 28, Inc.

Production 52

Production International Trials Government 52