Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Genital Warts (Condylomata Acuminata). 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.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Cervical Intraepithelial Neoplasia (CIN). 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.

Contract Manufacturing 100

Contract Manufacturing Dermatology Hormones Production 100

Drug Discovery World

FEBRUARY 12, 2024

In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. Cameron Ross, SVP, Generative AI, Elsevier “AI has the potential to dramatically shorten one of the most costly areas of early drug development – small molecule discovery.

Genome 139

Genome Genomics Life Science Gene Therapy 139

XTalks

JANUARY 17, 2024

Estimates based on publicly available information suggest more than 40 percent of all new therapies in development are cancer treatments. There are many aspects of oncology drug development that are driven by the unique nature of the treatments being developed and the needs of the patients, their caregivers and the doctors that treat them.

Clinical Trials 124

Clinical Trials Clinical Trials Trials Gene Therapy 124

XTalks

NOVEMBER 1, 2023

The revolution in clinical research is here, and it’s embodied by a single, powerful word: “patients.” The inclusion of patients during clinical development is not only a moral imperative but a strategic necessity in modern medical research. The result of sponsors listening to patients?

Clinical Trials 87

Clinical Trials Clinical Trials Trials Clinical Development 87

pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine. About the author.

Clinical Trials 104

Clinical Trials Clinical Trials Trials Clinical Research 104

Pharmaceutical Technology

JULY 18, 2022

There have recently, however, been some notable developments towards improving the care of bronchiectasis patients. These include the ongoing clinical development of AstraZeneca’s Fasenra (benralizumab), Insmed’s brensocatib and Novartis’ icenticaftor (QBW251). Fasenra (benralizumab), an interleukin (IL) 5?

Marketing 147

Marketing Trials Development Protein 147

pharmaphorum

DECEMBER 2, 2022

Beyond developing trial strategies and optimising protocols to avoid amendments and mitigate other risks, sponsors need insights to support enrolment strategy. Historically, sponsors and clinical research organisations alike have depended on core countries and sites for conducting their studies because of their predictability and reliability.

Trials 96

Trials Clinical Trials Clinical Trials Clinical Research 96

Advarra

NOVEMBER 29, 2022

However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines. Recent Problems in Cell and Gene Therapy Development. Recent Problems in Cell and Gene Therapy Development.

Gene Therapy 52

Gene Therapy Gene Production Clinical Trials 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 Future of Clinical Trials is Now. Ken Getz, Professor of TUFTS CSDD, is the keynote speaker for day one (May 20). Day 2 – Friday, May 21, 2021.

Clinical Trials 52

Clinical Trials Clinical Trials Clinical Development Trials 52

The Pharma Data

DECEMBER 15, 2020

It is funded by the world’s leading charities dedicated to diabetes research, JDRF, and Diabetes UK, guided by both organizations’ strong commitment to facilitate deep interrogation of consolidated community-wide trial data as a means to accelerate clinical research and therapeutic development for T1D.

Development 40

Development Insulin Drugs Clinical Trials 40

XTalks

JANUARY 17, 2024

Lupus, a complex autoimmune disease, has brought a substantial challenge to researchers and healthcare professionals. Understanding this condition and its various manifestations, as well as developing effective treatments, has been the focus of ongoing investigation in lupus clinical research for many years.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Life Science 52

pharmaphorum

FEBRUARY 11, 2021

As the COVID-19 pandemic heralds a major shift towards remote, virtual and hybrid clinical trial models, patient engagement is becoming even more relevant, but every country will have its own rules on how to interact with patients and their representative organisations.

Clinical Trials 89

Clinical Trials Clinical Trials Trials Clinical Research 89

pharmaphorum

JUNE 8, 2021

But we are glad to see the situation for innovative drugs in Asian markets improving, especially in mainland China and South Korea, where policies, societies and regulations are actively promoting innovation. “At That indicates Chinese biopharmas’ determination to lead the development of innovative drugs in the region.”.

Marketing 104

Marketing Drugs Regulation Development 104

WCG Clinical

SEPTEMBER 11, 2023

Now regulators expect sponsors to engage stakeholders in protocol design and take operational feasibility into consideration. Download the full 2023 Avoca State of the Industry Report for more findings with a 360-degree view across clinical research stakeholders. It’s time to listen.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

XTalks

APRIL 24, 2023

“Rare disease clinical trials are complex due to the additional scientific, medical, operational and regulatory requirements of newly emerging advanced therapies, such as gene therapy,” says Dr. Terence Eagleton, MB BS, Senior Medical Director at the global clinical research organization (CRO) Medpace.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

XTalks

MARCH 13, 2023

The US Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) held a recent town hall where three experts from the regulator provided guidance on how to design and conduct gene therapy clinical trials for rare diseases.

Gene Therapy 52

Gene Therapy Clinical Trials Clinical Trials Gene 52

XTalks

MAY 20, 2021

Today is Clinical Trials Day 2021 — a day for recognizing the importance of clinical research in protecting and improving global health. As the efforts to develop a vaccine against SARS-CoV-2 intensified, clinical research groups found themselves designing trials to evaluate them under the confines of tighter timelines.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Vaccination 105

The Pharma Data

DECEMBER 17, 2020

Kurtz brings more than 26 years of experience in global manufacturing, engineering, supply chain, CMC development and program management for drugs and devices at various stages of development. Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs.

Development 52

Development Gene Therapy Engineer Life Science 52

The Pharma Data

JANUARY 7, 2021

NASDAQ: GLTO) a NASDAQ listed biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced the appointment of Dr. Anne Prener to its Board of Directors. “We Before that, Dr. Prener was Global Therapeutic Area Head of Hematology and Vice President, Clinical Research Hematology at Baxalta.

Gene Therapy 52

Gene Therapy Life Science Production Clinical Development 52

pharmaphorum

APRIL 7, 2021

Genmab’s success has been founded on Darzalex (daratumumab), the blockbuster multiple myeloma drug that it developed in partnership with Johnson & Johnson’s Janssen unit. Genmab has its roots in a company called Medarex, which was one of the first to develop fully human antibodies in transgenic animals in the late nineties.

Antibody 65

Antibody Life Science Development Regulation 65

pharmaphorum

MAY 19, 2022

“If the European Health Data Space (EHDS) and the rules surrounding access to the data are not carefully thought through, with the involvement of all stakeholders, there could be unintended consequences that limit the utility of the data for developing innovative medicines,” said the organisation. Huge potential. Significant challenges.

Genome 52

Genome Genomics Medicine Research 52

Worldwide Clinical Trials

FEBRUARY 22, 2023

Richie Kahn: I’m a public health and advocacy guy by training, a clinical researcher by trade, and a patient advocate by necessity. At Canary Advisors , we concentrate on patient-focused drug development, making sure sponsors, regulators, and other key stakeholders can better align with what’s most meaningful to patients.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Research 130

XTalks

MAY 11, 2023

Clinical trials are essential for the development of new treatments for rare diseases, but they can be complex and challenging to execute. Patient input is a crucial component of rare disease clinical trials, as it can provide valuable insights into the patient experience and inform decisions about study design and implementation.

Clinical Trials 97

Clinical Trials Clinical Trials Trials Development 97

The Pharma Data

JANUARY 25, 2021

The AD-SAB will work closely with NervGen as the Company plans its upcoming preclinical studies and clinical trials and in the analyses of the results from these studies. He has developed new diagnostic tests for Alzheimer’s disease, as well as new preclinical models. About NervGen. Corey Davis Ph.D.,

Clinical Development 40

Clinical Development Containment Development Research 40

The Pharma Data

JANUARY 24, 2021

Management of the Company believe that the proposed acquisition will strengthen PharmaDrug’s product pipeline, intellectual property portfolio and pharmaceutical development expertise. Research and development efforts will be led by Dr. Paul Van Slyke. . – January 25, 2021) – PharmaDrug Inc.

Drugs 52

Drugs Containment Development Sales 52

XTalks

MAY 6, 2022

In this interview, Xtalks spoke with experts from eClinical Solutions , Katrina Rice, Chief Delivery Officer, Data Services; and Diane Lacroix, Vice President, Clinical Data Management, about clinical data management for modern day digital clinical trials.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Life Science 98

The Pharma Data

APRIL 12, 2022

vice president and global head of oncology clinical development at AbbVie. “Data obtained from this exploratory analysis holds promise for potential future clinical research,” said Jacqueline S. The BCL-2 family of proteins are known regulators of the apoptosis pathway.3 Garcia, M.D.,

Trials 52

Trials Medicine Protein Clinical Development 52

Worldwide Clinical Trials

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. Her fellow panelists represented a diverse group of stakeholders across clinical research, including patient advocates, sponsors, sites, and the FDA itself.

Trials 242

Trials Clinical Trials Clinical Trials Development 242

XTalks

NOVEMBER 19, 2021

While cardiac biomarkers hold much promise, there are a number of challenges in developing robust markers that can accurately reflect changes in disease biology linked to the mechanism of action of a therapeutic intervention. And [they] may ultimately take an even larger role with respect to safety and understanding pharmacodynamics.”.

Clinical Trials 98

Clinical Trials Clinical Trials Trials In-Vitro 98

The Pharma Data

NOVEMBER 10, 2020

We’re excited to be collaborating with Tiziana to support the development of a novel, oral therapy that could provide Crohn’s patients with another option in their repertoire of treatments to combat this devastating disease.”. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

Life Science 40

Life Science Clinical Trials Clinical Trials Trials 40

Advarra

AUGUST 10, 2023

Gene therapy has achieved notable successes, particularly in treating resistant or refractory B cell leukemias (achieving overall response rates around 90% or greater) and the speed with which COVID-19 vaccines were developed under the original Operation Warp Speed. Why Warp Speed for Rare Diseases? What is the FDA Proposing to do?

Gene Therapy 52

Gene Therapy Development Gene Drugs 52

The Pharma Data

DECEMBER 13, 2020

AMPK is a master regulator of several important metabolic pathways, including lipid metabolism, glucose control and inflammation, and is a novel target for NASH and additional chronic and rare metabolic diseases. Harrison, MD, Director, Summit Clinical Research. 14, 2020 07:00 UTC. About PXL770. About Poxel SA.

Trials 52

Trials In-Vitro Insulin Protein 52

pharmaphorum

NOVEMBER 3, 2022

Beyond digital clinical measures, digital solutions are maturing to address major challenges facing clinical research and offer enormous promise to support the key performance indicators (KPIs) for every member of our industry. We would like to see digital health technologies become a part of all clinical trials.

Clinical Trials 81

Clinical Trials Clinical Trials Trials Medicine 81

pharmaphorum

APRIL 22, 2021

Anne Kerber, VP, Head of Clinical Development, Europe at Kite, a Gilead Company, explains how the company works with researchers and physicians across Europe to expand patient access to cell therapy. This thought leadership series has been paid and developed by Kite, a Gilead Company.

Research 98

Research Clinical Trials Clinical Trials Trials 98

pharmaphorum

MAY 25, 2021

A recent pharmaphorum webinar , held in partnership with Savana and BREATHE – the Health Data Research Hub for Respiratory Health, heard that RWE is also accelerating the development of new and innovative therapies and treatments to improve patient outcomes. The benefits of RWE.

Big Data 125

Big Data Clinical Research Research Trials 125

Pharma Marketing Network

APRIL 30, 2021

Across the board, from rheumatology to neurology, outcomes that matter most to patients, have traditionally not been captured in clinical trials. How do we increase the diversity of clinical trials? Charlotte Jones-Burton, MD, VP, Clinical Development, Nephrology, Otsuka.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Regulation 52