Just want to do a write up about one of my favorite characters from my big epic fantasy series I would love to have the spoons to write down someday…….
Carry on.
So I’m reworking the divine language right now of this series right now, so the creator god doesn’t have an official name. She shall be called Turtle here, as in “World Turtle,” although also not.
Now, from her children’s perspective - the greater gods Dragon and Phoenix (again real names tbd) and the mortals - she is epic, wise, gentle and methodical.
By the standards of her own race, she’s a hyperactive teenager that is directly responsible for every single mistake that occurs in the story.
That is, being an energy being that decided to experiment giving inanimate matter “souls.”
And giving herself brain/soul damage creating the mortals.
Now, to her credit, if she’s been older i.e. bigger, this would have been survivable. Painful, stupid, and force her to reset back to the juvenile stage again a lot sooner that normal, but survivable.
Sadly, she was too young to realize at the time how severely she destabilized herself tearing out bits of her body/soul/self/mind to create mortals to amuse Dragon and Phoenix on the planet they’d created.
Fortunately, Turtle accidentally created a backup clone of her less-insane pervious version.
It just…. took about 10,000 years to fully mature.
And Dragon and Phoenix went insane themselves over a thousand years ago for technically unrelated reasons…
(reason A is a direct result of the creation of a noisy planet full of noisy bit addictive creatures. reason B is a specific case of “bitch can’t take a hint….”)
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Access New Resources for Hosting Externally Led Patient-Focused Drug Development Meetings
by Julien Rashid, Associate
The U.S. Food and Drug Administration (FDA) and patient organizations use patient-focused drug development (PFDD) meetings as a tool to listen to patients and gather their perspectives. During these meetings, patients give their views on living with their conditions and current and future therapies. In 2013, FDA launched the PFDD initiative with plans to host 20 condition-specific meetings, a goal they have since surpassed. In 2015, after two years of demonstrated success, FDA shared the mantle and gave patient organizations the chance to host PFDD meetings (often called “externally led PFDD meetings”). Since then, patient organizations have successfully amplified the voices of patients through nearly 20 additional meetings.
Perhaps you’ve heard about the value of these meetings, or you’re considering or currently planning one. The success of previous meetings may make it look easy, but don’t be mistaken: PFDD meetings are not cut-and-paste. Each event is unique and requires months of planning, but there have been enough meetings that common practices and lessons learned can be shared, and organizations don’t have to start from scratch. For this reason, FasterCures is excited to announce that we are unveiling three new resources based on lessons from the field, specifically designed for those who are interested in hosting externally led PFDD meetings: the PFDD Readiness Assessment, the Smart Practices from Patient Community Leaders planning guide, and the PFDD Community Toolbox.
These tools are described below. Before continuing, we recommend that you read our background blog on PFDD meetings and FDA resources and visit our PFDD Resources webpage if you haven’t already.
The PFDD Readiness Assessment
How do you know when your organization and your community are ready for a PFDD meeting? This self-guided PFDD Readiness Assessment is designed to help you answer that question by asking you to reflect on the knowledge and capacity of your organization and the context of therapy development for your community. To use the Assessment, answer each question and tally your points as you go. At the end, evaluate your status using the scoring key. We’ll continue to update the Assessment with links to new resources.
PFDD Meetings: Smart Practices from Patient Community Leaders
This extensive guide details common practices, lessons learned, and considerations for planning PFDD meetings. The guide is based on interviews conducted with community leaders that have planned and hosted externally led PFDD meetings, and it has been checked for accuracy by FDA. It is organized chronologically into three planning sections: Section 1: Steps to Take Before Submitting a Letter of Intent, Section 2: Planning Your PFDD Meeting, and Section 3: Preparing for Post-Meeting Outcomes. Each section includes topics relevant to that planning period depending on where you are in your planning.
The PFDD Community Toolbox
Many organizations developed tools and resources for PFDD meetings during their planning process. The PFDD Community Toolbox is a collection of materials that were donated by organizations that have hosted meetings. You’re encouraged to reference or adapt these tools for your PFDD planning purposes.
A Note on These Tools
FasterCures developed these three tools based on internal expertise and interviews with patient advocacy groups that have hosted PFDD meetings. While FDA provided input on the accuracy of the content in the Smart Practices guide, all of these tools represent the perspective of FasterCures alone and do not necessarily reflect the perspectives of the organizations involved or the FDA. These tools do not set standards and will continue to evolve along with patient-focused drug development.
Direct all questions related to externally led PFDD meetings to the FDA’s PFDD Program Staff.
PFDD leva 81 finalistas universitários aos distritos da Zambézia
PFDD leva 81 finalistas universitários aos distritos da Zambézia
81 jovens membros da Associação dos Estudantes Finalistas e Universitários de Moçambique na Zambézia serão alocados em diversos distritos no presente ano de 2019, o evento enquadra-se da realização da 14ª edição do Projecto Férias de Desenvolvimento do Distrito.
A informação foi avançada nesta sexta feira em Quelimane, pelo Coordenador Províncial da Associação dos Estudantes Finalistas e…
Estella Lugo, second from rightt, a CMT patient and medical outreach manager for the Hereditary Neuropathy Foundation, an Inspire partner, speaks on “The Voice of the Adult CMT Patient” panel today. “I have fallen 53 times this year so far,” she said, “but I have gotten up 54.” #PFDD #FacesOfCMT https://www.instagram.com/p/BoRyFQBFmVV/?utm_source=ig_tumblr_share&igshid=1ikcai58ng1a5
Your One-Stop Shop to Track Patient-Focused Drug Development Meetings
by Julien Rashid, Associate
Today, we’re unveiling a new resource: our PFDD Meeting Tracker.
In 2012, the U.S. Food and Drug Administration (FDA) launched its Patient-Focused Drug Development (PFDD) initiative. PFDD serves as a venue for patients to inform the FDA’s Center for Drug Evaluation and Research’s (CDER) assessments of benefit-risk for drugs and treatments.
While the FDA has listed every internally led and some externally led PFDD meetings, we saw an opportunity for a complete, collated list of past and future PFDD meetings. If you plan to host a PFDD meeting or if you are just interested in patient-focused drug development, use our tracker to locate resources from past PFDD meetings and to identify future meetings you might want to attend.
You can download a PDF version of our tracker (updated July 6, 2018). It includes all past and upcoming meetings; host organization(s); links to meeting reports, agendas, and video recordings; and information on attendance, public comments, surveys, and consultants. You can also find a more limited version of this tracker online.
On our tracker, you’ll notice there are missing links; those web pages are no longer available. If you have information about an upcoming or past meeting that could be included in this tracker, please contact Julien Rashid. We will be updating it as new information about meetings become available.
Our next blogs on this topic will feature best practices and lessons learned from organizations that have hosted PFDD meetings. Follow us to keep ahead of PFDD news, updates, and resources.
Related Resource:
·Introducing the Externally Led PFDD Blog series: Getting familiar with FDA Resources
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Introducing the Externally-Led PFDD Blog series: Getting familiar with FDA Resources
by Julien Rashid, Associate
“Patient-focused drug development” might sound redundant. Drug development, by default, should be focused on patients, yet, that has not been the reality. In 2012, as part of its commitment to serve the public, the U.S. Food and Drug Administration (FDA) launched its Patient-Focused Drug Development (PFDD) initiative. PFDD is a platform for patients to inform the FDA’s Center for Drug Evaluation and Research’s (CDER) assessments of benefit-risk for drugs.
Through the initiative, the FDA has conducted condition-specific meetings that convene patients, regulators, researchers, developers, and health-care professionals. These meetings differ from typical multi-stakeholder meetings where the patient voice is often diluted. During PFDD meetings, only patients are given the mic.
PFDD meetings are facilitated large group discussions. Many meetings have a webinar component to enable participants to engage remotely. At meetings, patients discuss the daily impact of their conditions. They tell stories to highlight their unmet needs, and they describe the shortcomings and advantages of current therapies and treatments (the full range, not just FDA-approved products).
At first, every PFDD meeting was led by the FDA. In the Prescription Drug User Fee Act V, the FDA laid out a set of criteria to guide its selection of diseases to address. To date, the FDA has conducted 25 meetings. Its next PFDD meeting, for chronic pain, is scheduled for July 9, 2018.
Of course, it would be impossible for any organization, even the FDA, to host PFDD meetings for every condition that meets its criteria. In late 2015, the FDA announced an expansion of its PFDD initiative; it called on patient organizations to follow its trail and host externally led PFDD meetings modelled on its map. Since then, more than 10 organizations have hiked forward.
These initial externally led meetings have amplified the patient voice, bolstered the impact of patient organizations, and fostered collaboration – but with 10,000 diseases, a few more than 10 meetings isn’t enough. More patients need to be heard.
This is why we’ve launched our Externally Led PFDD Blog Series. We want to highlight patient organizations that have hosted PFDD meetings, to bolster those that are planning to, and to inspire those that haven’t yet considered it.
The FDA is the primary source for information on the PFDD initiative, and through our series we aim to supplement its resources. In the coming months, our series will provide a PFDD meeting tracker, best practices and lessons learned from past PFDD meeting hosts, and perspectives on how the PFDD initiative continues to evolve. Follow our series to keep abreast of PFDD developments and insights for success. Also, our June 7 webinar featured a discussion of the key learnings from the FDA’s PFDD initiative and forecasts for its future.
To spark the wick, here is an annotated list of FDA resources for externally led PFDDs.
FDA’s PFDD meeting resources
It’s important to note that the FDA will participate in, but will not officially sponsor or endorse externally led PFDD meetings. The FDA encourages patient organizations to take the lead and has provided resources to facilitate this. We’ve collated these resources below.
Background on internal and external PFDD meetings
To understand what the FDA’s Patient-Focused Drug Development initiative is, see this short explanation:
· CDER Patient-Focused Drug Development (web page)
For a summary of externally led PFDD meetings and considerations on whether a meeting is appropriate for the disease or condition you represent, see this slideshow and web page:
· Externally-led Patient-Focused Drug Development Meetings (slideshow)
· Externally-led Patient-Focused Drug Development Meetings (web page)
Hosting an Externally Led PFDD Meeting
While formal approval from the FDA isn’t required, the first step for hosting an externally led PFDD meeting is to submit a Letter of Intent (LOI):
· Guidelines for Developing a Letter of Intent (LOI) for Externally-Led Patient Focused Drug Development Meetings (PDF)
The FDA recommends modelling externally led PFDD meetings on its internally led meetings. Here is a database of FDA’s past meetings and resources from those meetings:
· PFDD: Disease Area Meetings Held in Fiscal Years 2013-2017 (web page database)
You can find some examples of externally led PFDD meetings on this page (stay tuned for a more comprehensive PFDD tracker with external links from FasterCures this summer):
· External Resources or Information Related to Patients’ Experience (web page with links)
The FDA provides output from internally led meetings, including reports that summarize patients’ perspectives. These “Voice of the Patient” reports are used to inform condition-specific benefit-risk frameworks for drug assessment. Output from externally led meetings doesn’t have to be Voice of the Patient reports, but the FDA has established a useful model that most patient organizations have chosen to follow:
· FDA’s internal Voice of the Patient Reports (web page database)
A Critical Time to Bring the Patient Voice to FDA’s Patient-Focused Drug Development Meeting on Opioid Use Disorder
By Cynthia Grossman, Director, Science of Patient Input
Two years ago, I attended a public meeting on the Food and Drug Administration’s (FDA) Patient-Focused Drug Development (PFDD) for psoriasis. The FDA was interested in gathering the perspectives of patients to understand how they experience the symptoms and daily impacts of psoriasis and their experience with and hopes for treatments.
I found myself sitting near a family whose middle school aged son had been recently diagnosed, and it was difficult not to be struck by the courage he and his parents had to advocate for him and other young people living with psoriasis.
There were a few “aha moments,” not only for the FDA but also for many others in the room during this meeting. The most striking was that psoriasis is much more multi-faceted than many attendees had realized, including the social element of stigma as well as how symptoms such as itching can be extremely distracting and detrimental to patients’ daily lives - even when their psoriasis appears well managed from their clinical presentation.
The R&D system should be measuring and tracking those symptoms that matter most to patients, and the PFDD meetings can be a powerful platform to capture the voice of the patient and make the same information available to all, as many patients are living with multiple conditions.
Having had this experience, I have hope and anticipation about the April 17 PFDD meeting that the FDA is hosting on opioid use disorder.
Opioid abuse is ravaging the nation at an alarming rate. The surgeon general released a national advisory on April 5– the first national advisory issued since 2005 – asking Americans to educate themselves on how to administer naloxone, a drug used to treat opioid overdoses. In his statement, the surgeon general stated that 115 Americans die each day due to an opioid overdose – that is one person every 12.5 minutes.
Given the urgency we are faced with to aid communities suffering from opioid use disorder, I believe that the PFDD meeting is an opportunity to:
1) Stand up together across diseases and conditions
Opioid use disorder often occurs in conditions where pain is a primary symptom. Patient advocacy organizations across diseases have an opportunity to recognize subgroups of their patient communities living with opioid use disorder and support patients in elevating their voices to ensure their experience and unmet needs are understood and ultimately addressed.
2) Continue our efforts despite stigma
I have spent much of my career working in HIV/AIDS research and nearly a decade working on research to address HIV-related stigma. It was particularly heartbreaking to hear the stories about the negative impact of psoriasis-related stigma from patients during the 2016 PFDD meeting. If we are to realize the potential of including the perspectives of patients in medical product development and delivery, we need everyone to have equal opportunity to participate. Stigma can limit this opportunity. There may be increased difficulties for patients living with opioid use disorder to make it to the April 17 discussion. So we applaud the FDA for creating a mechanism in which patients and those with loved ones who are patients can register without a requirement to disclose their identities and for establishing a webcast in which those who cannot physically attend can still participate.
3) Elevate the unmet needs as expressed directly by patients
As we saw with the HIV epidemic, there is a lot of finger pointing around what caused the opioid epidemic and how to fix it. At the center of all of that are patients, and their unmet needs should drive and inform what happens next. Through the PFDD platform, FDA will ask patients questions related to the symptoms and daily impacts of opioid use disorder that matter most and the effect of current treatments and desired outcomes from treatment. As with many prior PFDD meetings, this one has the power to transform the conversation by placing patients at the center and drive not just product developers, but also everyone toward understanding the experience of patients living with opioid use disorder.
You can register to join the meeting on April 17 at FDA’s White Oak campus in Silver Spring, Md. or via webcast.
We are looking forward to this PFDD meeting serving as a platform to inform product development and perhaps even policy to reduce the negative impact of opioid use disorder on the lives of patients and their loved ones, and we will be closely following the outputs that result from the April 17 discussion.
FDA to focus on autism as part of its Patient-Focused Drug Development program
FDA to focus on autism as part of its Patient-Focused Drug Development program
US – Food and Drug Administration (FDA) released last week a list of conditions that it is planning to assess in the next two years. This will be part of the Patient-Focused Drug Development (PFDD) program. What the PFDD does is that it asks asks patients about their specific disease or condition, how they assess their treatment options that are currently available to them,as well as what their…
