pharmaphorum

APRIL 20, 2021

The Non-Small Cell Lung Cancer (NSCLC) Drug Development Summit is the definitive industry-led forum for drug development in the largest solid tumor indication. The post Non-Small Cell Lung Cancer Drug Development Summit appeared first on. View the event guide now for more details!

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pharmaphorum

NOVEMBER 17, 2020

As such, the TGFß for Immuno-Oncology Drug Development Summit (January 26-28) is the ONLY industry-focused meeting dedicated to pharma, biotech, and academia who will share their latest data, best practices, and top tips to expedite TGF-beta candidates into the clinic in a safe and efficacious manner.

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Drug Development 52

pharmaphorum

DECEMBER 16, 2020

The 9 th Neurodegenerative Drug Development Summit is the industry’s definitive and unrivalled forum focused on revealing hot and promising pockets of innovation in drug discovery for neurodegenerative diseases and combating translational challenges by shining a light on pioneering companies leading the way to meet this dire medical need.

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Drug Development 40

pharmaphorum

NOVEMBER 27, 2020

New models of drug development are fuelling life-changing advantages in the rare disease space, previously an economic no-go area for pharma and biotech companies. Chairing the event, the company’s Prashant Shah, said: “Rare disease, by definition, means it affects a fairly small number of patients.

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Drug Development 132

pharmaphorum

MAY 4, 2022

This technology could more accurately reflect drug development in the human body by incorporating multiple cell types and introducing microfluidic channels that can provide a controlled nutrient fluid flow or concentration of the drug that the organ is exposed to.

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Compounding Drug Development 143

PharmaShots

MARCH 3, 2023

deep expertise in RNA-targeting and clinical drug development. Danvatirsen is an antisense oligonucleotide (ASO) that targets STAT3 and has shown clinical activity in 2 P-II studies Ref: Prnewswire | Image: Flamingo Therapeutics

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Drug Development 40

FDA Law Blog: Biosimilars

MAY 19, 2024

Speakers at the Scientific Workshop will include Dr. Peter Marks, Director of FDA’s Center for Biologics Evaluation and Research, Dr.

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Drug Development 59

pharmaphorum

OCTOBER 11, 2022

In addition, RCTs don’t have to rely on two different data sources, which may have different operational definitions, assessment methods, and measurement timing. Prior to data collection, baseline information must be established in order to ensure that variable definitions of both groups are as identical as possible. Discussion.

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pharmaphorum

DECEMBER 4, 2020

With momentum building for antigen specific immunotherapies, ASIT 2021 will be the only antigen-specific summit offering thought-leading content to drive the field towards a more precise and ethical antigen-specific approach to drug development. This is the industry’s definitive antigen specific drug development forum.

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Immunity Immunization Medical Schools Drug Development 52

European Pharmaceutical Review

NOVEMBER 9, 2023

MANUFACTURING Continuous direct compression: opening up faster access to oral dose medication Deborah McElhone, CPI’s Medicines Manufacturing Innovation Centre IN-DEPTH FOCUS: QA/QC MICROBIOLOGY Bioburden and sterility testing: how to conserve gene therapy product Kathy Zagaroli, Senior Director of Quality Control at Kiniksa Pharmaceuticals Tom Bujold, (..)

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Biosimilars Drug Development 98

pharmaphorum

APRIL 1, 2021

We speak to the company’s CEO and co-founder, Szabolcs Nagy, to find out why moving beyond traditional biotech drug development is a good fit for the country’s ecosystem. It’s incredibly exciting to see what can be done with the right data and digital expertise combined with experienced drug developers.

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pharmaphorum

APRIL 29, 2021

The 3 rd Annual Blood-Brain Barrier Summit is dedicated to helping drug developers enhance drug delivery across the Blood-Brain Barrier (BBB) to enable effective treatments for neurodegenerative diseases. DOWNLOAD THE PROGRAM HERE.

Drug Development 52

Drug Development 52

pharmaphorum

MARCH 12, 2021

This summit is the first of its kind, uniting thought leaders in BCMA therapeutics drug development to discuss their challenges and future directions, with the aim to o vercome key obstacles when designing a clinical trial, addressing the rationale for combinations and determining mechanisms of relapse.

Drug Development 52

Drug Development 52

European Pharmaceutical Review

JULY 4, 2024

It begs the question of why only two botanical drug products have obtained FDA approval and fulfilled the Botanical Guidance definition of a botanical product. The worldwide trend of using botanical drugs and strategies for developing global drugs. BMB Reports. 2017;50(3):111–6. Premier Consulting [Internet].

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pharmaphorum

OCTOBER 5, 2020

The AI-ML: Drug Discovery and Development Summit is the industry’s definitive guide to translating the wealth of tech available to successfully implement a working and practically effective drug discovery and development platform. Visit our website: www.ai-drugdiscovery.com. drugdiscovery.com.

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Drug Development 52

pharmaphorum

MARCH 29, 2021

The way NICE reviews new medicines is about to go through its biggest change in years – but what do the proposals mean for the future of drug development in the UK? By definition they have smaller populations and, therefore, smaller evidence basis. It is likely to particularly benefit rare disease medicines.

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pharmaphorum

JULY 26, 2022

The 5th Annual Targeted Protein Degradation Summit returns to Boston as the most comprehensive, definitive event of the year, uniting 700+ large pharma, innovative biotech and world-renowned academics to discuss the full breadth of protein degrader drug development.

Drug Development 52

Drug Development 52

pharmaphorum

SEPTEMBER 20, 2021

For the pharma industry, the pandemic’s changes were both abrupt and industry-altering, requiring companies to rapidly adapt their approaches to drug development and commercialisation. However, as more precision therapies and biologics enter the market, pharma needs to shift its definitions of success.

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Communication Drug Development 98

Express Pharma

FEBRUARY 28, 2024

By definition, rare diseases are those diseases with a prevalence rate of one case in a population of 10,000 people. Automation and robotics enable quicker and more precise testing, enhancing quality control and expediting drug development. Rare diseases are of two types: primary and secondary.

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Drug Development 109

pharmaphorum

NOVEMBER 3, 2022

We see how digital measures of adherence ensure that sample size calculations hold and drug developers can accurately evaluate the safety and efficacy of new molecules. Other tools enhance patient centricity, inclusivity, generalisability of findings, participant retention, and technical success, while reducing timelines.

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Drug Development Communication 81

Pharmaceutical Technology

DECEMBER 16, 2022

Sosei Heptares and Eli Lilly and Company have signed a partnership for the discovery, development and commercialisation of small molecules that modulate new G protein-coupled receptor (GPCR) targets linked to diabetes and metabolic diseases.

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Diabetes Drug Development 52

pharmaphorum

FEBRUARY 28, 2022

The problem in effectively treating rare diseases is that the incidence within a country’s population is usually low – the definition of a rare disease is a condition that affects 200,000 people or fewer. of the global population affected.

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Drug Development Hospitals 104

FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

By Riëtte van Laack — The dietary supplement exclusionary clause is, as its name suggests, a clause in the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of dietary supplement. That clause excludes those ingredients that were first marketed as drug ingredients. What led to NPA’s lawsuit?

Drug Development 59

Drug Development 59

pharmaphorum

OCTOBER 16, 2020

By definition, however, trial master files represent a much richer and more detailed source of data on a drug and how it performs. For instance, provided a drug has not failed a trial on safety, the side effects it caused in one population could constitute on-target effects in another.

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Drug Development Immunity Immunization Pharmaceutical Companies 105

Pulses

AUGUST 31, 2023

Despite the increasing popularity, definitive classifications of these terms remain elusive, and too often, are used interchangeably. Understanding the differences can assist educators in developing curricula aligned with the available resources, space requirements, and learning context (see Table 1).

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Medication Dispensing Medication Labelling Packaging Labelling 78

pharmaphorum

APRIL 12, 2021

This is the definitive drug development forum for research teams to investigate how to modulate the cGAS-STING and Toll-like receptor (7/8/9) pathways both as monotherapies and as adjuvants in combinatorial approaches.

Immunity 52

Immunity Immunization Drug Development 52

Syner-G

MAY 4, 2022

These programs are intended to facilitate and expedite development and ensure that therapies for serious conditions are approved and available to patients as soon as it can be concluded that the therapies’ benefits justify their risk. Category: Regulatory Affairs , Drug Development Consulting.

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Documentation Drug Development Communication 52

Pharmacy Is Right For Me

JANUARY 25, 2023

There are so many different types of careers within the field of pharmacy—from research and drug development to pharmacy informatics! Right now, it’s definitely the feedback that we get from patients. Describe the most exciting or rewarding aspect of your role?

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Community Pharmacies Drug Development 130

Syner-G

APRIL 27, 2023

Once a drug or biologic has been granted orphan drug status, Sponsors may be eligible to receive benefits such as tax credits for some of their clinical trials or qualified clinical testing costs, a waiver of the prescription drug user application fee, and may be eligible for seven years of marketing exclusivity upon product approval.

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Drug Development Documentation 52

FDA Law Blog: Biosimilars

OCTOBER 2, 2023

Two weeks ago, FDA published a draft of its latest drug development guidance explaining how drug and biological product developers can use this pathway to meet the statutory standard for efficacy. The guidance’s second warning reminds drug developers that FDA regulations (i.e.,

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Drug Development Documentation Labelling Medical Records 64

FDA Law Blog: Biosimilars

MARCH 7, 2024

The new draft guidance maintains a recommendation from the 2006 guidance that “sponsors inform FDA about all DMC recommendations related to the safety of the investigational product, whether or not the adverse events that led to the recommendation meet the definition of serious.”

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Documentation Adverse Reactions Communication Drug Development 105

pharmaphorum

APRIL 28, 2022

Although they have, by definition, small addressable markets, the treatments cost just as many resources to develop as therapies for more common diseases – sometimes more, because of the added difficulty of finding sufficiently large patient populations for trials and finding disease experts to run them. “We’ll

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Immunity Immunization Pharmaceutical Companies Pharmaceutical Companies 59

Safe Biologics

DECEMBER 8, 2022

While the term “interchangeable biosimilar” has a precise legal definition in the U.S., The Lee bill would remove such data requirements. ”) Notably, the EMA statement does not weigh in on biosimilar substitution policy, which is left to individual member states.

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Biosimilars Communication Drug Development 100

Viseven

JANUARY 4, 2023

This article will cover the most important areas of AI influence on the pharma industry and new drugs development. From life-saving drugs discovery, development, and production to clinical trials, communication, and drug target identification — AI pharmaceutical is a definite game-changer.

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Drug Development Medical Records Communication Pharmaceutical Companies 52

European Pharmaceutical Review

FEBRUARY 7, 2023

This definition would encompass a broad range of technologies and products, including many medical devices incorporating software. The requirements included within the proposed AI Act draw inspiration from the regulation of medical devices and data privacy.

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Packaging Drug Development 117

Pharmaceutical Technology

JANUARY 31, 2023

The US omnibus bill passed in late December 2022 will give the agency greater powers to regulate accelerated approval drugs, while the Inflation Reduction Act’s lowering of drug prices will create an uncertain environment for drug developers, he said. asked panel chair Ipsita Smolinski, MD of consultancy Capitol Street.

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Drug Pricing Biosimilars Drug Development 52

European Pharmaceutical Review

JANUARY 13, 2025

3 Encouragingly, there are many examples of the life sciences sector seeking to embrace sustainable drug development; reconciling the drive for innovation with the need to reduce waste and emissions produced during the R&D process, as well as throughout the product lifecycle.

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Packaging Community Pharmacies Documentation Pharmaceutical Companies 52