pharmaphorum

DECEMBER 2, 2022

This emphasises sponsors’ need for enrolment predictability. These problems are compounded with site-level concerns about protocol complexity, staffing shortages, low patient interest, and budgetary constraints — leaving sponsors to question how to plan trials that deliver against timeline commitments to support launch goals.

Compounding 98

Compounding 98

The FDA Law Blog

NOVEMBER 2, 2023

We are also aware that FDA spends a tremendous amount of time and resources answering the same questions for sponsors. These meetings have a question-and-answer format to provide clarity to sponsors about the particular topics at hand.

FDA 59

FDA Packaging Documentation Labelling 59

Pharma Marketing Network

JULY 25, 2023

Here are some examples of how sponsorships can be used to amplify healthcare awareness and education: Johnson & Johnson sponsors the Healthy Living Index. Pfizer sponsors the National Stroke Association. Komen sponsors the Pink Ribbon Girls. There are many different ways to sponsor a healthcare organization.

FDA 52

FDA 52

Pharmaceutical Technology

MAY 5, 2023

Covid-19 clinical trial activity remains high As the world shifts toward viewing Covid-19 as an endemic virus, the pharma industry is still pouring resources into developing new treatments. Though most ongoing Covid-19 trials have institutions like academic research centers as sponsors, industry sponsors a sizeable share of studies.

Vaccines 52

Vaccines 52

PQA

FEBRUARY 9, 2024

Enhance the impact of your attendance by becoming a sponsor of the meeting. Elevate Your Brand as a PQA Sponsor Sponsorship opportunities are available for the 2024 Annual Meeting, which will be May 14-16 in Baltimore, Md. The registration link is in the Member Resources Library. Make plans to join us!

59

59

Pharma Marketing Network

JULY 26, 2023

As new healthcare challenges arise and the pharmaceutical landscape evolves, the FDA may be allocating its resources to focus on other pressing issues, such as drug approvals, monitoring emerging health threats, and enhancing drug safety.

FDA 97

FDA Pharmaceutical Companies Pharmaceutical Companies Labelling 97

pharmaphorum

SEPTEMBER 14, 2022

By learning more about participation concerns and motivators, trial sponsors can understand the differing needs among populations and how to best integrate their feedback into trial design and recruitment strategies for stronger outcomes. Sponsors adapted strategies in real-time to update messaging (e.g., Reasons for “no” to trials.

Vaccines 98

Vaccines Medical Records Documentation Communication 98

pharmaphorum

NOVEMBER 20, 2022

Engaging with expert stakeholders from the inception of the vaccine discovery process and throughout clinical trial phases can enable sponsors to optimise their investment and stay ahead of competitors. These aspects will help sponsors to ensure programmes are streamlined for success.

Vaccines 98

Vaccines Immunization 98

IDStewardship

JUNE 21, 2022

Although everyone’s situation is different, if you are contributing to a brokerage account but have not first taken advantage of an employer-sponsored retirement account (remember that an employer match equals free money), an HSA (think triple-tax benefits), or Roth IRA accounts, you may be losing out on some big tax savings. .

130

130

pharmaphorum

SEPTEMBER 8, 2022

The Digital Medicine Society (DiME) is today releasing a new set of open-access resources to advance the use of nocturnal scratch in the treatment of atopic dermatitis (AD). . It is hoped today’s event will serve as a “blueprint for the broader development and deployment of digital endpoints in medical product development”.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

JANUARY 25, 2021

Hopefully, this increased transparency and accountability will translate into more collaboration among sponsors, regulators and other stakeholders — including patients — earlier in the drug development process. Sponsors will want to capitalise on the heightened public interest during 2021 and beyond by building trust.

Communication 124

Communication Patient Care FDA 124

Pharmaceutical Technology

MAY 24, 2023

The tools and resources for clinical development, particularly large-scale platform cGMP [current good manufacturing practice] manufacturing and regulatory evaluation of AAV therapies, will provide a much-needed standardised approach, enabling meaningful progress for rare disease gene therapy development.

FDA 96

FDA 96

pharmaphorum

JULY 9, 2021

While a larger company like Takeda obviously has more resources to put towards these efforts than some of the smaller, more specialised players in the rare disease space, Zaeske says that the size of an organisation has little impact on the value they can bring to a collaboration.

Medical Records 121

Medical Records Hospitals FDA 121

PQA

NOVEMBER 3, 2023

Specialty medications require a lot of resources to manage, and so specialty pharmacies want to be sure their patients can access and use their medications. Applications for the 2024 Summer Executive Internship, sponsored by PQS, the MPH Practicum Program and the 2024-2025 APPE cycle are due by December 15, 2023.

Specialty Pharmacies 52

Specialty Pharmacies 52

PQA

AUGUST 16, 2023

The viewpoints presented during these events do not necessarily reflect those of PQA.

52

52

The Checkup by Singlecare

APRIL 5, 2024

However, it’s only available to qualified applicants without private or government-sponsored insurance (aside from Medicare) who aren’t receiving assistance from other programs. Government-sponsored assistance programs Medicare Part D beneficiaries can apply for Medicare Extra Help.

Insurance 52

Insurance Insurance Coverage Labelling Hospitals 52

PQA

DECEMBER 1, 2023

-- Melissa Viscovich, PQA Chief Operating Officer Leveraging Trust to Improve Health Equity Outcomes A recent RxE2-sponsored pilot project sought to understand the feasibility of documenting health-related patient race and ethnicity information at the community pharmacy. Learn more in the Member Resources Library.

Community Pharmacies 59

Community Pharmacies Documentation Communication 59

The Checkup by Singlecare

APRIL 5, 2024

According to a 2023 survey of 2,133 companies about their employer-sponsored health insurance, the average copay was $11 for first-tier drugs, $36 for second-tier drugs, $66 for third-tier drugs, and $125 for fourth-tier drugs. Most BCBS companies house links to their formularies in the member benefits or resources sections of their website.

Insurance 78

Insurance Documentation Insurance Coverage FDA 78

The FDA Law Blog

MARCH 26, 2024

But this litigation coincided with FTC’s recent intervention into antitrust issues in the Orange Book during which the FTC asked 10 sponsors in November 2023, including both Teva and Amneal, to delist device patents.

FDA 59

FDA Dosage 59

PQA

JANUARY 27, 2023

Enhance the return on your attendance by becoming a sponsor of the meeting. Elevate Your Brand as a PQA Sponsor Sponsorship opportunities are available for the 2023 PQA Annual Meeting, which will be held May 10-12 in Nashville, Tenn. A registration link is available in the Member Resource Library. Register today!

Community Pharmacies 52

Community Pharmacies Insurance 52

pharmaphorum

MARCH 23, 2022

Amy’s 25+ years in marketing and strategy span consumer and healthcare markets and leverage deep industry knowledge to engage teams and clients, and streamline the process of managing commercialisation resources for maximum impact.?

Communication 105

Communication Pharmaceutical Companies Pharmaceutical Companies 105

Roots Analysis

MARCH 14, 2023

Patient Outreach Methods and Retention Strategies In order to meet the enrollment goals, sponsors, clinical research organizations and patient recruitment firms adopt a diverse range of patient outreach and recruitment strategies.

Medical Records 52

Medical Records 52

ISPE

JUNE 22, 2023

Through virtual and in-person programming, Women in Pharma provides ISPE members the resources necessary to challenge the status quo and make an impact on both a personal and professional level. Here’s what you can look forward to, and what you might have missed.

Communication 98

Communication Patient Care 98

PQA

DECEMBER 2, 2022

Your Next Engagement Opportunities Network, Learn and Collaborate with PQA PQA is accepting applications for the PQA Summer Executive Internship, sponsored byPharmacy Quality Solutions and the Advanced Pharmacy Practice Experiential (APPE) Rotation. Each PQA member organization's Key Contact has received an email with voting instructions.

Scheduling Appointments 52

Scheduling Appointments Nursing Homes Dosage Medication Delivery 52

PQA

DECEMBER 20, 2023

This guest blog is one in a series by sponsors of the 2023 PQA Leadership Summit on elevating clinical quality assurance. Delivering the highest quality of clinical services is paramount in ensuring healthcare resources don’t go to waste. The views shared in this series are those of the author and do not reflect any PQA positions.

Patient Care 81

Patient Care 81

The Checkup by Singlecare

MARCH 21, 2024

However, major insurance companies tend to offer several different types of plans, whether employer-sponsored or individually obtained. Novo Nordisk, the manufacturer of Wegovy, sponsors NovoCare, a website with resources that help people check insurance coverage , manage the cost of medication, and more.

Insurance 98

Insurance Insurance Coverage FDA 98

The FDA Law Blog

FEBRUARY 7, 2023

For 510(k) devices, sponsors could wait to establish a quality system that covers all post-market requirements until device development is further along. There are many resources that provide information and guidance for each of these required elements.

Documentation 98

Documentation FDA Labelling 98

pharmaphorum

SEPTEMBER 11, 2020

In a recent analysis, the Tufts Center for the Study for Drug Development reported that more than two-thirds of all sponsors are using at least four different data sources. The hurdle lies in transferring those results to the sponsor swiftly and in a useable format. Potentially catastrophic setbacks.

Data Entry 97

Data Entry Documentation 97

The Checkup by Singlecare

MARCH 7, 2024

The compounding nature of medical debt becomes apparent when one bill leads to another, creating a snowball effect that can be overwhelming when financial resources are limited. Individuals with employer-sponsored health plans can open health savings accounts (HSAs) or flexible spending accounts (FSAs).

Insurance Coverage 98

Insurance Coverage Insurance Hospitals Documentation 98

pharmaphorum

AUGUST 12, 2020

Sponsored this year by Boehringer Ingelheim , the programme is now in its third year. Individuals taking part have access to workshops, resources and events throughout the year to share challenges and experience, learn from experts and collaborate to co-design solutions.

98

98

The FDA Law Blog

AUGUST 21, 2023

The GAO Report further explained that the agency did not have the resources to regulate the estimated 100,000 OTC drugs marketed through the monograph process. Thus, the Court presumed, there is no reason that the sponsors could not add stronger pregnancy warnings. More than a few have taken far longer—literally decades.

Labelling 40

Labelling FDA Vaccines Communication 40

Roots Analysis

FEBRUARY 7, 2023

Specifically, the clinical stage is exceedingly resource intensive, involving high costs and greater risks. This not only enables them to attract more business opportunities from sponsors, but also grants them an edge over competing service provider entities.

40

40

PQA

NOVEMBER 18, 2022

The members can now access specialized resources, which include in-home primary and specialty care visits, medication management, dialysis and transplant coordination, palliative care, and social services. A registration link is also available in the Member Resources Library.

Nursing Homes 52

Nursing Homes Dosage 52

pharmaphorum

OCTOBER 27, 2022

The Guidance will act as a non-binding and evolving resource for companies and provide additional clarification about communications with healthcare professionals (HCPs), healthcare organisations (HCOs), patient organisations (POs), and other stakeholders, including the general public. What are the key points from the Guidance?

Communication 98

Communication Packaging Documentation Pharmaceutical Companies 98

The FDA Law Blog

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. For more on FDORA’s other provisions, see HPM’s complete summary here ).

FDA 64

FDA 64

pharmaphorum

AUGUST 31, 2021

Myth 2: Implementing an ECA requires too much money, time and resource. Pushing molecules through the pipeline is already a monumental task, requiring multiple inputs from multiple stakeholders over a period of months, along with significant funding and resources. About the authors.

FDA 89

FDA Insurance Coverage Documentation Insurance 89

PQA

NOVEMBER 4, 2022

Thank you to our member organizations, who are sponsoring this year’s summit. The health plan offered through SCAN will include care navigation services from Included Health, in which members can receive assistance in finding peer groups, support groups and community resources. Their support enhances our programs.

Immunization 52

Immunization 52