XTalks

MAY 15, 2024

Ovid Therapeutics is a biopharmaceutical company focused on the development of medicines for epilepsies and seizure-related neurological disorders. Dr. Levin has practiced medicine at university hospitals in England, South Africa and Switzerland. Subscribe to the Xtalks Life Science Podcast to never miss a new episode.

Life Science 69

Life Science Medicine Clinical Research Development 69

pharmaphorum

DECEMBER 22, 2022

The life sciences industry is flexing towards innovation in new areas, faster than ever before, and increasing patient care in astonishing ways. The life sciences industry will collaborate and share lessons learned with other verticals that are currently exploring the same concept, such as “Self-Sovereign Identity” (SSI).

Clinical Research 97

Clinical Research Research Clinical Trials Clinical Trials 97

Pharmaceutical Technology

NOVEMBER 17, 2022

Horizon Therapeutics and Johns Hopkins University School of Medicine have entered a multi-year scientific partnership for advancing autoimmunity and inflammation research. The research scientists at the company and experts at Johns Hopkins University School of Medicine aim to identify new metabolic pathways.

Research 130

Research Life Science Medicine Development 130

XTalks

DECEMBER 21, 2022

The past year has been a strong one for life sciences industries, from pivotal gene therapy approvals to continued innovations in the biotech and medical device spaces. Here are some of the top life science trends and topics from 2022. The life sciences continued to be driven by advanced technologies during the past year.

Life Science 52

Life Science Gene Therapy Gene Clinical Trials 52

XTalks

APRIL 13, 2022

The webinar concluded with Kyle Haas, Associate Director, Clinical Trial Management, Medpace, speaking about the operational and study start-up considerations for pediatric rare disease clinical research. Aspects of Pediatric Medical Research. Challenges in Pediatric Rare Disease Clinical Trials.

Clinical Trials 98

Clinical Trials Clinical Trials Clinical Research Trials 98

Velocity Clinical Research

MARCH 23, 2025

But clinical trials arent the health services primary focus and, when faced with mounting pressure post-pandemic, it abruptly pulled the plug on all under-recruited studies in its pipeline. This caused further delays and prompted some pharmaceutical companies to question whether the UK remains a viable destination for testing new medicines.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Life Science 52

ACRP blog

MARCH 14, 2023

Women’s History Month in March offers a great opportunity to celebrate the vital role of women in all aspects of clinical research. Women account for as many as 70% to 80% of clinical research professionals, and the opportunity to advance is there for anyone who wants it.” View complete schedule.

Clinical Research 59

Clinical Research Research Clinical Trials Clinical Trials 59

XTalks

DECEMBER 13, 2023

Ulrike Buchwald, MD, Scientific Associate Vice President, Global Clinical Research and Pneumococcal Vaccine Section Head. Dr. Platt completed her training in Internal Medicine at Rutgers/Robert Wood Johnson Medical School, and Infectious Diseases Fellowship at New York Presbyterian/Columbia University Medical Center.

Life Science 52

Life Science Vaccination Vaccine Scientist 52

XTalks

JANUARY 16, 2025

The clinical advancement follows a thorough review of Phase I trial data under the FDAs Regenerative Medicine Advanced Therapy (RMAT) designation. Called exPDite-2, the registrational trial meaning a trial designed to gather the necessary data for potential regulatory approval is slated to begin in the first half of 2025.

Trials 104

Trials Clinical Trials Clinical Trials Gene Therapy 104

XTalks

AUGUST 22, 2023

Yet, 41 percent of people in the US have no knowledge of the clinical research process, and 91 percent say they’ve never been given the opportunity to participate in a trial, according to SCORR Marketing. The availability of new medicines is reliant upon individuals’ willingness to contribute to clinical trials.

Clinical Trials 97

Clinical Trials Clinical Trials Trials Clinical Research 97

XTalks

NOVEMBER 15, 2024

Bexicaserin’s development has also gained regulatory support in Europe, where the European Medicines Agency’s (EMA) Paediatric Committee endorsed its potential use in children as young as two. She noted that DEEp OCEAN is a step towards inclusivity in clinical research.

Trials 97

Trials Clinical Trials Clinical Trials Genetics 97

XTalks

MAY 20, 2022

Doctors and physicians rely on the results provided by a clinical scientist to make an accurate prognosis, diagnosis and assessment for a patient’s treatment plan. What is it Like to Work as a Clinical Scientist? A clinical scientist is often synonymous with: Clinical Research / Clinical Laboratory Scientist.

Scientist 105

Scientist Life Science Clinical Research Doctors 105

pharmaphorum

DECEMBER 11, 2022

So, when a life sciences company embarks on a project of digital transformation or innovation, it’s really embarking on multiple projects that span the wide world of pharmaceutical operations. AI gets us closer to personalised medicine.”. I don’t think a life science company can solve it alone.

Life Science 137

Life Science Clinical Research Development Research 137

XTalks

APRIL 1, 2025

Patients with acute GVHD urgently need safer and more effective therapies, said Dr. John Koreth, principal investigator of the EQUATOR study and an associate professor of medicine at Harvard Medical School. It offers a differentiated mechanism of action that modulates the immune response without inducing broad immunosuppression.

Immune Response 94

Immune Response Trials Licensing Licensing 94

XTalks

DECEMBER 10, 2024

percent platelet response in a study published in The New England Journal of Medicine. Recent advancements in ITP treatments include CM313, an anti-CD38 monoclonal antibody that achieved a 95.5 While promising, CM313 requires intravenous administration, contrasting with rilzabrutinibs oral dosing and rapid 15-day response.

Trials 104

Trials Protein Clinical Development Drugs 104

Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

Clinical Research 52

Clinical Research Research Compliance Clinical Trials 52

XTalks

DECEMBER 10, 2024

Regulatory Standards for MASH Studies Both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have provided detailed guidance for drug development in MASH, highlighting that liver biopsy is necessary for determining disease progression as part of composite endpoints. Zabbatino.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Clinical Research 105

XTalks

FEBRUARY 1, 2021

Montreal, Canada-based Caprion Biosciences announced last week that the clinical research organization (CRO) will rebrand as CellCarta. In early January, Caprion-HistoGeneX announced their acquisition of Clinical Logistics Inc. ,

Life Science 98

Life Science Branding Genome Genomics 98

XTalks

MARCH 19, 2024

Additionally, she examines the limitations of prevalent paper-based assessments in current clinical practice and research, providing insight into the cascading impact of these challenges on the broader clinical research landscape.

Drugs 115

Drugs Clinical Research Clinical Trials Clinical Trials 115

pharmaphorum

OCTOBER 7, 2021

However, developments in genomic medicine are making huge strides to improve this situation, and these will also be discussed during the webinar. A board-certified paediatric haematologist/oncologist, Jeff has 12 years of academic faculty experience at the Johns Hopkins University School of Medicine. About IQVIA.

Genome 98

Genome Genomics Medicine Life Science 98

pharmaphorum

OCTOBER 27, 2022

However, fostering lasting and meaningful partnerships is not a simple task for life science companies. For centuries, botany played a fundamental role in the development of medicine. We explore how researchers unlocked the pharmaceutical properties of five key plants and how these plants continue to serve patients worldwide.

Life Science 105

Life Science Research Development Clinical Research 105

pharmaphorum

FEBRUARY 1, 2022

Attendees will learn more about how an SCA was used at the design and execution phases in a recent study of new treatments for relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) and will also receive an eBook ‘How to harness the potential of AI and real-world data for clinical research’. About the panel.

Clinical Trials 104

Clinical Trials Clinical Trials Trials Engineer 104

XTalks

OCTOBER 17, 2022

The global virtual clinical trials market is valued at $8.3 The COVID-19 pandemic has significantly impacted the market and many clinical research organizations (CROs) were quick to embrace decentralization capabilities. billion in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 5.7 billion by 2030.

Trials 98

Trials Research Clinical Trials Clinical Trials 98

XTalks

MAY 17, 2023

The Foundation for the National Institutes of Health (FNIH) announced this week that the Accelerating Medicines Partnership Bespoke Gene Therapy Consortium (AMP BGTC) has selected eight rare diseases for its clinical trial portfolio.

Gene Therapy 98

Gene Therapy Clinical Trials Clinical Trials Gene 98

XTalks

FEBRUARY 25, 2025

At the heart of the venture is a comprehensive care model that integrates over 200 pediatric oncology specialists from Texas Childrens Hospital many of whom are full-time faculty with Baylor College of Medicine with more than 100 pediatric clinicians and researchers from MD Anderson.

Clinical Trials 82

Clinical Trials Clinical Trials Trials Research 82

pharmaphorum

OCTOBER 2, 2020

The five new NIHR National Patient Recruitment Centres (NPRCs) are set to shape the future of commercial clinical trials in the UK by offering new ways to conduct late-phase, large-scale research projects. Yan Yiannkou is a consultant gastroenterologist and Clinical Director of the NIHR Patient Recruitment Centre (Newcastle).

Clinical Trials 92

Clinical Trials Clinical Trials Clinical Research Life Science 92

XTalks

MAY 28, 2024

VivoSense , a pioneering company in the field of digital health technologies (DHTs) and digital endpoints for clinical trials, is aiming to enhance the efficiency and efficacy of clinical research. These guidelines provide a roadmap for integrating digital measures into clinical trials effectively.

Clinical Development 116

Clinical Development Development Clinical Trials Clinical Trials 116

XTalks

MARCH 13, 2025

Related: TNKase (Tenecteplase) Becomes First Stroke Medicine Approved by FDA in Almost 30 Years The Zipline access catheters unique design improves navigational ease and trackability, making it easier for doctors to reach challenging clot locations, much like a precision-guided delivery system in emergency services.

Doctors 59

Doctors Doctor Clinical Research Trials 59

XTalks

JANUARY 17, 2024

In this Xtalks Spotlight edition, Xtalks spoke with two oncology clinical research experts from Fortrea , Laura Vidal, MD, Medical Head of Oncology, EU (European Union), and Ken Morrison, PhD, Global Head of Strategic Delivery & Growth Oncology.

Clinical Trials 124

Clinical Trials Clinical Trials Trials Gene Therapy 124

Imperical Blog

JANUARY 15, 2020

Happy 2020 from Imperial Clinical Research Services! Imperial proudly provides clinical research-oriented blogs and ebooks provided by our diverse and knowledgeable subject matter experts (SMEs). The Secret to International Clinical Trial Shipments Clearing Customs.

Clinical Trials 52

Clinical Trials Clinical Trials Branding Clinical Research 52

XTalks

JANUARY 31, 2025

Vertex CEO Reshma Kewalraman called the approval a major milestone in acute pain management, noting that Journavx is the first new class of pain medicine in more than two decades. The twice-daily oral medication has demonstrated effectiveness across a range of pain types, including post-surgical and injury-related pain.

Sales 59

Sales Trials Clinical Research Marketing 59

pharmaphorum

OCTOBER 27, 2022

However, there is a general prohibition in the legislation of using celebrities to promote medicines. Jackie Mulryne, Partner, is a member of the Life Sciences practice group, and provides regulatory, policy, and compliance advice to clients in the pharmaceutical, medical technology, cosmetics, and foods sectors.

Life Science 98

Life Science Medicine Regulation Compliance 98

pharmaphorum

JANUARY 27, 2022

Still, it can be challenging to acquire a complete picture of how this technology is used overall in medicine. “I Walter says pharma can wield many of the book’s insights to improve its portfolios and help advance immersive technology in medicine. How pharma can leverage XR. To learn more about the IVRHA conference, click here.

Production 142

Production Development Behavioural Health Research 142

pharmaphorum

AUGUST 19, 2021

A common set of standards for randomised clinical trials (RCTs) aims to help researchers develop the drugs and interventions of the future – no matter what they do or where they are based. The GCTC has brought representatives from across the spectrum of clinical research together to develop and promote the adoption of new guidance.

Trials 105

Trials Clinical Trials Clinical Trials Life Science 105

XTalks

MAY 22, 2024

The organization’s robust portfolio features medical delivery systems and consumable products for infusion therapy, emergency medicine, general and regional anesthesia, home care, neonatal intensive care unit (NICU)/pediatric intensive care unit (PICU), oncology, pain management and respiratory care.

Life Science 95

Life Science Production FDA Approval Development 95

XTalks

MAY 21, 2024

Yesterday, on International Clinical Trials Day 2024, the global healthcare community came together to commemorate the significant advancements in clinical research and the vital role clinical trials play in improving patient care and outcomes.

Clinical Trials 64

Clinical Trials Clinical Trials Trials Clinical Research 64

pharmaphorum

MARCH 2, 2022

But today this is rapidly changing as a greater number of companies and research institutes explore potential uses for mental health disorders. A recent John Hopkins Medicine study showed that treatment with psilocybin relieved major depressive disorder for at least a year for certain patients. A growing pipeline.

Life Science 105

Life Science Clinical Trials Clinical Trials Trials 105