Putting Patients First Blog

APRIL 7, 2025

At the same time, as insights generated by AI increasingly shape the selection of drug targets, biomarkers, or dosing strategies that inform regulatory submissions, it is essential that any AI-derived outputs used to support regulatory decision-making meet appropriate standards of empirical validation and scientific transparency.

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Documentation Communication Pharmaceutical Manufacturing Labelling 52

Pharmaceutical Technology

JUNE 22, 2023

The European Commission’s (EC) plan to test a novel scheme to incentivise antimicrobial drug development companies remains beset by questions amidst the bloc’s drive to tackle the growing threat of antimicrobial resistance (AMR). However, additional initiatives that de-risk the development process are still needed, says Ruiz.

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Putting Patients First Blog

APRIL 14, 2023

Driven by the work of the Food and Drug Administration on patient-focused drug development (PFDD), many companies in the biopharmaceutical community have devoted significant resources to better understand patient populations and are working to bring to market products that best suit their needs. Sincerely, Randall L.

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Drug Pricing Drug Development Documentation Communication 40

Putting Patients First Blog

APRIL 30, 2024

Key Points of Support Conciseness and Focus of Key Information The NHC supports the FDA’s emphasis on beginning the informed consent document with concise, focused presentations of key information. The importance of using plain language in health communications is well-documented in literature.

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Documentation Communication Mayo Clinic Drug Development 52

European Pharmaceutical Review

FEBRUARY 1, 2024

What are the top three trends impacting the cardiovascular drug development space today? Even though patients are on these existing therapies that are well-documented and most likely safe and effective, there are many patients who still have cardiovascular disease, the leading cause of death.

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Documentation Diabetes Pharmaceutical Companies Pharmaceutical Companies 97

pharmaphorum

JANUARY 18, 2022

million in 2020 and with the rapid growth of the industry, is expected to grow at a CAGR of 8.95% up to 2027. Smart device developers. Training device developers. Drug developers. Understand requirements to facilitate the documentation preparation needed to obtain a NB Opinion. Medical Device Engineers.

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Packaging Documentation Vaccines Drug Development 52

pharmaphorum

OCTOBER 28, 2020

Data defines modern therapeutics, but this is almost uniquely confined to the clinical trial stages of drug development. The omission of medicines from the feedback revolution is curious and potentially damaging. Research supports this conclusion, showing an alarming lack of patient trust.

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Putting Patients First Blog

FEBRUARY 6, 2024

The price of progress: funding and financing Alzheimer’s disease drug development. Exploring new uses for existing drugs: innovative mechanisms to fund independent clinical research. autm.net/AUTMMain/media/Partner-Events/Documents/Economic-_Contribution_University- Nonprofit_Inventions_US_1996-2015_BIO_AUTM.pdf 16 Lanahan, L.,

Communication 40

Communication Documentation Drug Development 40

FDA Law Blog: Biosimilars

JULY 9, 2024

Procedures for Submitting the DAP Sponsors should describe the DAP clearly and concisely, with limited cross-referencing to previously submitted documents. For drugs, the relevant CDER/CBER Division may or may not provide feedback; sponsors with specific questions may include them as a topic for discussion in meetings with FDA.

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Drug Development Communication Documentation Labelling 59

European Pharmaceutical Review

JANUARY 16, 2023

“Clearly the number one challenge in 2022, as mandated by the EU GMP Guidelines for the Manufacture of Sterile Medicinal Products Annex 1 1 , is the development of a Contamination Control Strategy (CCS),” Tony Cundell noted. He warned, “Implementation of a CCS will require more than writing documents.”.

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FDA Law Blog: Biosimilars

MARCH 13, 2024

The PTE application states “[u]nder the terms of the AMENDED AND RESTATED DEVELOPMENT AND COMMERCIALIZATION LICENSE AGREEMENT between Pfizer Inc. effective May 12, 2020), Patent Term Extension Applicant OPKO Biologics Ltd., and OPKO Ireland Ltd. through OPKO Ireland Ltd., exclusively licensed U.S. 7,553,941 to Pfizer Inc.

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Documentation Drug Development 59

Putting Patients First Blog

SEPTEMBER 26, 2024

Disparities in clinical trial participation have been well-documented, with certain populations, particularly racial and ethnic minorities, women, pregnant and lactating people, older adults, and people with disabilities, often underrepresented in clinical research. NHC commitment to ensure representativeness in all policy work.

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Communication Clinical Pharmacology Documentation Drug Development 52

Pharmaceutical Technology

APRIL 27, 2023

LNPs are an adaptable, modular technology and when combined with microfluidic mixing, have the potential to accelerate development and commercialisation timelines and provide drug developers with an early foothold into a largely untapped market.

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Vaccines Drug Development Documentation Communication 52

pharmaphorum

APRIL 8, 2021

These previously-unknown antiviral properties of the drug surprised even its manufacturer, Eli Lilly, said Shields. “We We published our hypothesis in the Lancet on February 4 in 2020. When we submitted our clinical trial documents, we got feedback within a few days, which sped everything up,” he said. “If

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Drug Development Vaccines Documentation Communication 93

Putting Patients First Blog

MARCH 29, 2023

We encourage Congress to work with the FDA to analyze the impacts of these factors and consider ways to support this progress in future pandemic responses and apply the lessons to other areas of drug development including emerging new needs that have arisen due to COVID-19 infections, including supporting individuals with Long COVID.

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Insurance Coverage and Processing Vaccines Documentation Hospitals 40

FDA Law Blog: Biosimilars

OCTOBER 13, 2024

We have heard over and over again how the potential for a priority review voucher has allowed small companies with limited resources to invest in the development of drugs for rare pediatric diseases. Notably, it was reauthorized in 2016 (until 2020) and in 2020 (until 2024). After all, this is what incentives are for.

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Documentation Drug Development 64

Express Pharma

OCTOBER 31, 2024

In a recent interview, Suneela Thatte, VP and Head – Healthcare R&D for India, Merck KGaA Darmstadt discussed the evolution and strategic significance of the company’s Global Capability Center (GCC) in India, established in 2020. Merck too set up its GCC in India in 2020. It was a 15–20-member team when we started in 2020.

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Drug Development Hospitals Process Improvement Documentation 105