Rethinking Clinical Trials

SEPTEMBER 28, 2023

In the initial PARENT trial, intervention families had better performance on receipt of well child care, and patients reported better patient experience and fewer emergency department visits. Discussion Themes -What did stakeholder engagement change in the process? Parents loved the text messaging service.

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Rethinking Clinical Trials

AUGUST 23, 2022

Participating organizations included FDA, NIH, academic institutions, pharmaceutical and device companies, patient advocacy groups, community groups, and data groups, and representatives from each organization had opportunity to extend invitation to others. Ask and engage community partners. It was held virtually on April 28-29, 2021.

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Clinical Trials Clinical Trials Trials Medicine 130

Pharmaceutical Technology

MAY 2, 2023

Immuno-oncology (IO) agents have transformed the cancer therapeutics landscape, driving long-term remissions in a subset of patients who historically had limited options. All currently approved CAR-Ts are autologous, with the patient’s T-cells being genetically engineered to target antigens expressed by the cancerous cells.

Genetic Engineering 130

Genetic Engineering Antibody Clinical Trials Clinical Trials 130

Pharmaceutical Technology

FEBRUARY 10, 2023

This is not the first treatment to come with a high price tag. The three agreed on a confidential price, and the TLV determined whether the drug was cost effective for the eligible patient population. million, according to GlobalData’s Price Intelligence (POLI), making it the most expensive drug in the world.

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Gene Therapy Marketing Gene Drugs 263

Rethinking Clinical Trials

NOVEMBER 21, 2023

The Nudge study wanted to find out if nudges could help patients improve medication adherence by promoting behavioral change through positive reinforcement. The Year 1, UG3 Phase, aims were to develop and program a nudge message library using iterative N of 1 studies to optimize content for a range of diverse patients.

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Clinical Trials Clinical Trials Trials Development 141

Rethinking Clinical Trials

AUGUST 30, 2023

   Speaker Gabriela Schmajuk, MD, MS Professor of Medicine UCSF and the San Francisco VA Slides Keywords Patient-Reported Outcomes, Rheumatoid Arthritis, EHR Key Points Clinicians rely on patient-related outcomes (PROs) to track disease and function over time in patients with rheumatoid arthritis (RA).

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Trials Clinical Research Coordinator Medicine Clinical Trials 141

Rethinking Clinical Trials

DECEMBER 6, 2022

This study asks how can we better facilitate health behaviors in patients with chronic diseases and can we leverage technology? that focused on patients with heart failure and diabetes, two rapidly growing conditions that are highly morbid. Patients did not get text messages about pill adherence.

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Trials Clinical Trials Clinical Trials Compliance 130

Rethinking Clinical Trials

MARCH 6, 2024

The dietician met with the patient to share education about nutrition, portion size, recipes to make food taste good, and information via an optional diabetes self-management program. 500 patients were randomized to intervention or control groups, with a utilization of 465 and 349 participants completing the 6-month HbA1c lab sample.

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Clinical Trials Clinical Trials Medicine Trials 141

Rethinking Clinical Trials

NOVEMBER 9, 2022

We engaged fellows by making them part of the research team, ensured mentorship, networking, etc. The CardioNerds fellows enrolled 54% women compared to 45% non-fellow enrolled and 71% BIPOC compared to 23% non-fellow enrolled patients. The fellows were responsible for 45% of enrollment during the time of the trial. Learn more.

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Clinical Trials Clinical Trials Trials Development 130

Rethinking Clinical Trials

AUGUST 28, 2023

The American College of Physicians guideline states that “physicians and patients should treat acute, sub-acute and chronic LBP with non-drug therapies.” Patients in the usual care arm clinics are then scheduled to see a PCP. Presenters also shared challenges regarding scheduling and patient insurance coverage.

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Rethinking Clinical Trials

MARCH 21, 2023

Goldberg Distinguished Professor and Chief of Oncology Physician-in-Chief, North Carolina Cancer Hospital Director, Cancer Outcomes Research Program University of North Carolina Slides Keywords Patient-reported outcomes, Oncology, Clinical Trials Key Points Symptoms are common in cancer care. Quality of life (QOL) was assessed at 6 months.

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Clinical Trials Clinical Trials Trials Research 130

Rethinking Clinical Trials

OCTOBER 26, 2023

Many people do not know they have Hepatitis C (about 40% of patients). PCORnet is engaging with sites to support the ITAP clinical study for de novo clearance of a qualitative POC HCV test-to-treat platform.       Speakers Rachael L. Fleurence, PhD, MSc Senior Advisor National Institutes of Health Joshua M.

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Clinical Research Clinical Trials Clinical Trials Research 141

World of DTC Marketing

SEPTEMBER 7, 2022

In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. For DTC, the model will become one of collaboration with patients as they help them navigate the complex system of American healthcare.

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Pharma Companies Marketing Drugs Production 210

Pharmaceutical Technology

APRIL 5, 2023

More than a decade after the first patient was treated with a CAR-T therapy, six therapies relying on the same principles have been approved by the US Food and Drug Administration (FDA) and marketed to thousands of patients. BL: The ISCT engages with professionals in 65 countries. How can we better educate the patients?

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Gene Therapy Gene Engineer Production 147

Rethinking Clinical Trials

JULY 19, 2023

About 6-12 months after enrollment, patients were assessed for the primary outcome, which was the prescription of all 3 recommended therapies. of the patients ended up being prescribed all 3 therapies, and 37.9% of patients were prescribed all 3 therapies across the intervention sites. In the usual care arm sites, 14.5%

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Trials Cardiology Medicine Nurses 130

pharmaphorum

AUGUST 17, 2020

In this article Joanna Carlish, managing director of financial services at Tag Americas , and Robb DeFilippis, Tag Americas’ managing director, life sciences, go head-to-head to discuss marketing within a regulated industry. Engagement channels. Virtual connections.

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Regulation Marketing Sales Branding 91

Rethinking Clinical Trials

FEBRUARY 28, 2024

But there are concerns to developing DCTs including lack of standardization and validation, regulatory and ethical uncertainties, engagement vs. coercion, data security and privacy issues, technological literacy and access, resistance to change and adoption, and lack of “safe” sharing. from 2021 to 2026.

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Clinical Trials Clinical Trials Trials Clinical Research 141

Rethinking Clinical Trials

MARCH 1, 2023

S1800A was a Phase II randomized study of ramucirumab plus pembrolizumab versus standard of care for NSCLC patients previously treated with immunotherapy performed within the Lung-MAP platform. The study does not include tissue specimen collection, image submission, or patient-reported outcome instruments.

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Clinical Trials Clinical Trials Trials Packaging 130

Rethinking Clinical Trials

FEBRUARY 9, 2023

This trial tested the hypothesis that the use of a platform-agnostic, EHR-embedded VTE risk model with integrated CDS would 1) increase rates of appropriate Thromboprophylaxis, and subsequently 2) reduce thromboembolism, compared to usual medical care in hospitalized, medically-ill patients.

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Clinical Trials Clinical Trials Trials Development 130

pharmaphorum

JANUARY 31, 2023

This lack of trust in such a crucial industry can lead to decreased compliance, poor treatment adherence, and negative health outcomes for patients. Additionally, when patients are prescribed medication, they are often unaware of the mechanism of action, potential side effects, interactions, and contraindications.

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Clinical Trials Clinical Trials Trials Vaccination 52

XTalks

JANUARY 28, 2022

Kimmtrak has also become the first bispecific T cell engager to be FDA-approved for the treatment of a solid tumor. Up to 50 percent of patients will develop metastatic disease, mainly spreading to the liver, making treatment difficult and limited. Kimmtrak has a price tag of $18,760 per vial, which amounts to a weekly dose.

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FDA Approval Development Licensing Licensing 98

pharmaphorum

APRIL 5, 2022

Kimmtrak (tebentafusp) has been cleared to for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM), mirroring its label in the US. Uveal melanoma is a rare cancer of the eye, which in the majority of patients is localised.

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Rethinking Clinical Trials

SEPTEMBER 22, 2022

The Danish Nationwide Registries include the Danish Patient Registry (a registry of every inpatient and outpatient contact in the Danish free-for-all public healthcare system); the Danish Medicines Registry (a registry of every filed prescription at any pharmacy in Denmark including information on pill strength, pack size, etc.); Key Points.

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Trials Cardiology Vaccination Vaccine 130

XTalks

FEBRUARY 27, 2024

Skyclarys (omobaloxone) was approved in 2023 for the treatment of adults and pediatric patients 16 years of age and older with Friedreich’s ataxia, a rare, neurological disease​​. Sarepta hopes to clarify Elvidys’ effectiveness in older children in a confirmatory trial.

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Research Drugs Gene Therapy Clinical Trials 59

XTalks

JUNE 9, 2021

The historic and highly anticipated approval created a flurry of excitement in the Alzheimer’s disease space for patients, healthcare practitioners, advocacy groups and Biogen shareholders alike, as shares of the company jumped more than 50 percent after the announcement. Aducanumab Controversy and Price Tag.

Drugs 98

Drugs Clinical Trials Clinical Trials Trials 98

pharmaphorum

DECEMBER 17, 2021

Aduhelm (aducanumab) was approved by the FDA in June, but has been held back by a glacial rollout as clinicians have questioned the data on which the decision to clear the drug was based, plus a $56,000 per year price tag, which has in turn led to pushback by payers.

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Trials Sales Marketing FDA Approval 52

Drug Discovery World

MAY 22, 2023

But are these price tags a barrier to access? Its subsequent success with approval in the US shows us that some drugs will be unavailable to some markets and patients for now. The fact remains that the science behind the drugs is sound, there is direct patient need, and the medical benefits are pertinent. million per dose.

Gene Therapy 52

Gene Therapy Gene Drugs Contamination 52

pharmaphorum

JUNE 8, 2021

The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. ICER points to brain swelling and potential bleeding seen in approximately 30% of patients treated with aducanumab. Broad label questioned.

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Drugs Marketing FDA Approval Trials 98

pharmaphorum

SEPTEMBER 15, 2020

This gives them huge amounts of customer data that allows them to shape and personalise the way they engage with their customers, not least thanks to the direct-to-consumer sales model they often offer. Jeremy Richter, Tag. We’re all trying to find ways to automate. Build on the rapid responses to COVID-19.

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Branding Marketing Pharma Companies Life Science 118

pharmaphorum

JUNE 2, 2022

In 1983, the US Congress passed the Orphan Drug Act to encourage more pharmaceutical companies to engage in R&D to develop treatments for rare diseases through the offering of financial incentives. According to the organisation, 39% of orphan drugs cost more than $100,000 annually.

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Drugs Sales Marketing Development 52

Drug Discovery World

JUNE 14, 2023

We are a cell therapy company that uses a very specific receptor to engineer T cells and administer these engineered T cells back to solid tumour patients. We have now our lead product in a Phase I/II study, which is a HER-2 directed tag T cell product for patients with HER-2 positive solid tumours. AB: There have been many.

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Research Engineer In-Vivo Production 52

Intouch Solutions

AUGUST 25, 2021

In this POV, we evaluate the potential impact to the email channel and opportunities to continue to deliver ethical, quality email experiences and personalization for pharma customers, including healthcare providers (HCPs) and patients. Although a challenge, this change does not negate the benefit of driving engagement. The result?

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Marketing Regulation Engineer Branding 52

Delveinsight

DECEMBER 3, 2020

The agreement is for the investigational phase 1 gene therapy HMR59 that is given as a one-and-done shot into the eye to preserve vision in patients with geographic atrophy , which is a late-stage and severe form of age-related macular degeneration (AMD). It has already succeeded in a phase 1 test, with a second in patients with wet AMD.

Gene Therapy 52

Gene Therapy Gene Antibody Research 52

XTalks

AUGUST 17, 2020

Suri explains that in the case of cancer immunotherapy, the conventional “carpet bombing” approaches of broadly activating the immune system — or in cases of autoimmunity, broadly immunosuppressing it — has implications for patient safety. There is great unmet need in head and neck cancer as patients don’t have a lot of treatment options.

Protein 98

Protein Engineer Immune Response In-Vivo 98

Drug Discovery World

NOVEMBER 9, 2023

Klaus Wagenbauer, PhD, Founder & CEO, Plectonic, on: ‘Programmable DNA-origami-based T cell engagers: PTE’. These include: Xiaole Shirley Liu, PhD, CEO, GV20 Therapeutics, on: ‘AI-based target and antibody discovery from patient tumour profiles’.

Engineer 52

Engineer Antibody Protein In-Vivo 52

pharmaphorum

OCTOBER 4, 2022

A key part of this initiative was the establishment of the Cancer Moonshot Biobank, which will ask cancer patients to donate biospecimens and associated health information to aid research. The objective is to gather patient biospecimens longitudinally to understand how patients react to treatments and how cancer develops over time.

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Biobanking Clinical Trials Clinical Trials Trials 103

pharmaphorum

JUNE 15, 2021

The adoption of New Science – a unique combination of the best in science and health technology that address significant unmet patient needs – is delivering more precise and effective treatments, but often at a higher price tag, according to new research. A new economic reality is challenging profitability .

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