pharmaphorum

MARCH 19, 2024

Join the 13th HPAPI summit to learn about the latest advancements in process development for highly potent drugs. Explore topics like Annex 1, GMP guidelines, and drug development strategies.

Drug Development 52

Drug Development 52

pharmaphorum

DECEMBER 14, 2020

Despite this progress, the vast potential to develop effective treatments that target the human microbiome is still limited by the complex challenges in developing them. The post 5th Microbiome Movement – Drug Development Summit Europe 2021 appeared first on.

Drug Development 52

Drug Development 52

Express Pharma

SEPTEMBER 20, 2023

In this video: Dhairy Sharma, Technical Sales, CILICANT Topic: Role of active packaging in drug development Key Takeaway: ACCUFLIP from Cilicant regulates Equilibrium Relative Humidity (ERH) within a specific range in order to protect medications from over-desiccation.

Packaging 52

Packaging Drug Development 52

Express Pharma

JUNE 16, 2023

In this video: Dhairy Sharma, Technical Sales, CILICANT Topic: Role of active packaging in drug development Key Takeaway: ACCUFLIP from Cilicant has been designed to regulate Equilibrium Relative Humidity (ERH) within a specific range in order to protect medications from over-desiccation.

Packaging 52

Packaging Drug Development 52

Express Pharma

MAY 24, 2023

The programme comprised various discussion topics for project and portfolio management teams. The day also explored the relationship between IPR and Portfolio through topics like competitive intelligence for portfolio designing led by Dr Mandar M Kodgule, Chairman and CEO of IQGEN-X Pharma.

Biosimilars 77

Biosimilars Communication Drug Development 77

Express Pharma

JULY 29, 2023

In this video: Manisha Chaudhari, Senior Technical Application Expert, Merck Lifescience, India Topic: Addressing pharmaceutical & biological product development challenges with innovative excipients Key Highlights: 1) Predictive formulation promises to increase speed, reduce cost and create better outcomes in drug development 2) In the first (..)

Drug Development 52

Drug Development 52

pharmaphorum

MARCH 10, 2017

With market access being referred to as the “fourth hurdle” in drug development (beyond efficacy, safety and quality), it is vital that the requirements for both approval and access are addressed early in the process.

Drug Development 52

Drug Development 52

Outsourcing Pharma

FEBRUARY 24, 2021

The annual event, moved to the virtual realm thanks to COVID-19, offers content on remote monitoring, drug development technology and other key topics.

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Drug Development 55

Express Pharma

SEPTEMBER 14, 2023

There will also be expert talks on topics such as revolutionising weighing processes, speeding up bioprocess development to democratising biologics drug development.

Drug Development 52

Drug Development 52

LifeProNow

APRIL 6, 2023

A systematic review is a type of research that summarizes the findings of multiple studies on a particular topic. What is the role of HEOR in drug development and pricing? They are conducted by comparing the costs and outcomes of different healthcare interventions. What is a systematic review, and why is it important in HEOR?

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Drug Development 130

Express Pharma

OCTOBER 19, 2023

The company informed that it is equipped to support the clinical manufacturing of a wide range of dosage forms, including oral solids, liquids, topicals, and films. We look forward to leveraging these capabilities to support our customers’ drug development needs, enabling them to bring life-changing medicines to patients worldwide.”

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Dosage Drug Development 102

Pharmaceutical Technology

MAY 4, 2023

Forge Biologics and global life sciences company Labcorp have announced a strategic adeno-associated virus (AAV) gene therapy development and manufacturing collaboration. Topic sponsors are not involved in the creation of editorial content. This will improve accessibility to services for AAV-mediated gene therapy programmes.

Drug Development 102

Drug Development 102

Putting Patients First Blog

JUNE 20, 2023

ET for an in-depth discussion of the FDA’s fourth guidance on patient-focused drug development (PFDD). The meeting will be an opportunity for members of both organizations to explore important topics covered in the guidance and help inform our and our members’ comments. June 21 from 3 – 4 p.m.

Drug Development 52

Drug Development 52

pharmaphorum

FEBRUARY 23, 2022

As investment in gene therapies continues to grow rapidly, more effectively engaging patients throughout development has become a priority for any company serious about building safer and more meaningful gene therapy programs.

Drug Development 52

Drug Development 52

PharmaTech

SEPTEMBER 19, 2022

fast-growing, end-to-end CDMO service provider in Nashville, TN that offers development, testing, and fill/finish cGMP manufacturing for sterile injectable and topical products – all under one roof. Discovery the industry's best kept secret.a

Drug Development 40

Drug Development 40

Pharmaceutical Technology

FEBRUARY 16, 2023

It may offer opportunities for third-party collaborations to guide the new cell therapies and drugs development, if successful. It enables quick evaluation of a patient tumour response to a range of cancer drug modalities within 14 days of obtaining harvested samples of tumour cells.

Drug Development 96

Drug Development Communication 96

FDA Law Blog: Biosimilars

MARCH 6, 2024

The American Conference Institute (“ACI”) will be hosting a series of go-to forums on critical topics including novel therapeutics, cosmetics/personal care products and Paragraph IV disputes. HP&M is proud to have our professionals participating in these important events. On March 20-21, Counsel John W.M.

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Pharmaceutical Manufacturing Drug Development Pharmaceutical Companies Pharmaceutical Companies 59

Pharma Leaders

JUNE 8, 2023

The FDA has selected the initial applications for participation in its Advancing Real-World Evidence (RWE) program, which allows pharmaceutical sponsors four meetings with the agency to discuss proposals to use RWE in drug development, according to Kimberly Smith, RWE analyst in CDER’s Office of Medical Policy. Related Topics

Drug Development 40

Drug Development 40

Pharmaceutical Technology

APRIL 14, 2023

Twist Bioscience CEO and co-founder Emily Leproust said: “With the dramatic increase in interest around cell and gene therapies, the addition of Twist CAR and TCR Libraries offers an important and differentiated tool to enable the development of the next generation of treatments for those suffering from a wide range of diseases.

Drug Development 98

Drug Development 98

FDA Law Blog: Biosimilars

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 ). By Larry J.

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Drug Development Immunity Immunization 98

pharmaphorum

JUNE 15, 2022

The 5 th International Cannabinoid-Derived Pharmaceuticals Summit brings together drug developers working on the complex production of both plant-based, biosynthetic and synthetic endocannabinoid system modulators.

Drug Development 52

Drug Development 52

Pharmaceutical Technology

JUNE 8, 2023

These solutions will help drug developers address the challenges of regulatory compliance, production scalability, quality assurance and cost-effectiveness. Topic sponsors are not involved in the creation of editorial content. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Vaccines Drug Development Immunity Immunization 52

Express Pharma

JUNE 29, 2023

One such research project will focus on novel media for purification to help advance drug development and discovery. The post Waters Corporation and Princeton University signs multi-year research collaboration appeared first on Express Pharma.

Drug Development 52

Drug Development 52

Pharmaceutical Technology

JUNE 10, 2023

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Drug Development 40

Drug Development 40

Pharmaceutical Technology

JUNE 10, 2023

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Drug Development 40

Drug Development 40

Pharmaceutical Technology

DECEMBER 27, 2022

Drug pricing was a hot-button topic, and William Newton found that while e-commerce chains could cut insulin prices , any major change won’t happen overnight. Tracking drug development. Alzheimer’s disease drugs were constantly in the news, and not always for the right reasons.

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Vaccines Drug Development Drug Pricing 122

pharmaphorum

FEBRUARY 11, 2016

The first in a trilogy of webinars focussed on the topic; Unlocking the value; the economic equation and part of the IMS Health Practical Insights series. Answering this paradigm is where real world evidence can step in.

Drug Development 52

Drug Development 52

Pharmaceutical Technology

JUNE 1, 2023

Strathclyde Institute of Pharmacy and Biomedical Sciences head professor Yvonne Perrie said: “This centre will provide new capabilities for mRNA-based drug development and manufacture of cost-effective vaccines and therapeutics in the UK, boosting not only economic growth but also security of supply.”

Vaccines 97

Vaccines Drug Development 97

pharmaphorum

JULY 8, 2022

Such real-world evidence (RWE) provides insights on the usage, benefits, and risk of a drug beyond that provided by traditional clinical trials. RWE is a rich source of information with applications to drug development, comparative effectiveness studies, and post-market experience.

Drug Development 52

Drug Development 52

European Pharmaceutical Review

JULY 13, 2023

3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside. 2,10 This data can help to inform the optimal drug candidates to take forward into clinical trials and inform pre-clinical research to iteratively develop medications for different clinical indications.

Compounding 82

Compounding Drug Development Clinical Pharmacology Documentation 82

Syner-G

MAY 4, 2022

Need assistance with determining if your drug or biologic qualifies for one or more of the above programs or preparing/submitting your requests to FDA? Category: Regulatory Affairs , Drug Development Consulting.

Documentation 52

Documentation Drug Development Communication 52

pharmaphorum

MARCH 24, 2021

Ken will provide a compelling look at how the COVID-19 pandemic has transformed the drug development operating environment and explore where the industry will be post-pandemic. The speaking delegation represents a ‘Who’s Who of RBQM’ and the agenda will cover topics relevant to both Subject Matter Experts and RBQM Rookies alike.

Drug Development 52

Drug Development 52

Pharmaceutical Technology

APRIL 21, 2023

Samyang Holdings Biopharm Division CEO Young-Joon Lee stated: “LG Chem has exceptional research and development expertise in innovative drug development and a number of promising new drug pipelines. Topic sponsors are not involved in the creation of editorial content.

Drug Development 52

Drug Development 52

Pharmaceutical Technology

FEBRUARY 19, 2023

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Drug Development 40

Drug Development 40

Pharmaceutical Technology

JUNE 10, 2023

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Drug Development 52

Drug Development 52

Pharmaceutical Technology

JUNE 10, 2023

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Drug Development 52

Drug Development 52

FDA Law Blog: Biosimilars

AUGUST 28, 2023

Lenz, Principal Medical Device Regulation Expert — Following up on our first post discussing Digital Health Technologies (DHTs) ( here ), this post will focus on development and qualification of DHTs for use in clinical trials for drug development.

Drug Development 59

Drug Development 59