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ahiddenpath · 2 years

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Life Update

It me, yuh gurl.

Long personal post about... Dealing with... *Waves hands* Everything.

Hey my boops, how ya doin?

I’m feeling sort of... Hm, what’s the word? Pensive? Ruminative? These days. I guess I’m wondering: is my life where I want it to be? If not, what do I want? Stuff like that. It’s a normal and common thing, I’m sure.

My life has been kind of wild since... Actually, since I broke my foot in three places and nearly tore my ankle tendons in late 2017. I spent about three months nonmobile, then another six in physical therapy to regain motion in my ankle/foot. My grandmother passed in 2018 (while I was still in PT), and my family fractured after that (basically squabbling over her possessions, which weren’t valuable, but old grievances were involved, too). I started therapy after that, and I spent over two years really focused on that- which I think is some of the hardest/most difficult work you can do, at least by choice. The pandemic started while I was still in therapy, and I’m still trying to wrap my brain around the loss of over two years of my life??? Which is still ongoing????

So, uh, yeah, actually... My sense of being displaced in time and my own life is making more sense, now that I wrote that out.

One of the big things on my mind recently is work. I’m a researcher at a biotech, annnnnd our current capital will run out in Q4, based on our financial reports. So, uh, under five months, and of course, they would have to close shop well before they hit $0 to take care of expenses (paying out vacation days to employees and paying any business debts, for example).

Biotechs are volatile, they start and close all the time, and layoffs are common when big projects are dropped. Our company projected income for the year from collaborations, and literally none of those deals have panned out. It’s looking bad- but I’ve never been between jobs or unemployed since I was 16, so, um, a break would be amazing? So I’m torn between applying to get ahead of it and taking it easy and letting the chips fall.

I’ve always been focused on planning for my future, like... For as long as I can remember. My family is... Well, I knew I’d have to support myself and be independent ASAP since I was a child. I can’t go to my family for emotional support, advice, or a basic understanding and acknowledgement of who I am as a person. I certainly can’t go to them for financial support; it just isn’t there. My mom expected me to financially support her, in fact, and when she first saw the house I bought two years ago, she spent the whole visit insulting me because I told her she would not be moving in. (My therapy session after that was a whole thing, lemme tell ya what). It’s sad how much of my life has pointed directly towards achieving financial security, knowing that I have no place to land. Every decision, every plan. And, like, it worked, or at least it has so far, which is undeniably a good thing!

But I need to figure out how to shift from “everything I do is strategized to promote economic security” to “uh hey babe, darling, sweetie pie, being happy and appreciating the moment is kind of what life is made of.” And yet, here I am feeling hypocritical as heckin heck, because of course you need economic security to appreciate the moment! You can’t be enjoying a croissant and a hot cocoa on your day off if you are stretching to afford a pound of spaghetti noodles for like $1.60, or whatever that costs with recent inflation- or if you’re working your second or third job on your day off.

I think I’ve been mourning things that are difficult to articulate these days, too. I... Don’t know if I’ll have children, that’s the big thing. Listen, no shade to people who choose to reproduce- in fact, I admire hope in the face of adversity- but I don’t know if there will be a tenable planet for my theoretical kiddo within thirty years- or sooner. I’m a biopharma research scientist, not a climate scientist, but I can interpret data, and my formal summary: that shit be scary. And my country, the USA, is catapulting backwards in terms of rights and dignities. Plus, you know, late stage capitalism hellscape, etc.

And what about the loss of time since 2020? I planned to spend my early 30s travelling- I am sadly an untravelled person- and now it’s heckin hard to even plan a domestic trip (fuel prices, pilot shortages, etc). Like many people, I’ve spent the time since 2020 terrified of being sick and losing loved ones, stuck inside far more, and trying to navigate how to behave in the face of deadly unknowns- and incredibly frustrated by my country’s response. It actually kind of reminds me of the Thanos snap. Obviously, we didn’t, like, dematerialize, but as of this writing, there have been over a million recorded covid deaths in the states. Lives came to a halt, and so many people lost so much- high schoolers missing out on activities and postponing college or opting for remote, babies and toddler missing periods of socialization, on and on and on. And then, after a few weeks, we pushed on as normal, even though nothing was normal???

So, yeah. I feel like I’m passing my hands over my body and feeling holes that aren’t physically there. They are there, but they can’t be seen or easily explained. And I bet most people feel this way. Global trauma, my guys.

I have exactly zero advice, except to be gentle with ourselves and each other. I hope I’ll have the courage to focus on being happy, and not on how messed up the world is and wondering if the holes are expanding. In the face of uncertainty, working harder and hoarding what we have and forgoing fun things in the name of security is... The exact instinct of someone with an anxiety disorder who has focused on security all her life. And I’m willing to bet you don’t need a mood disorder or a past of security-based insecurities to feel this way.

So... Here I am, struggling to absorb everything that has been, everything that is, and a future that is more unsure than ever. That’s it, really, even after that honkin’ wall of text. I hope you’re hanging in there, and that you have fun things going on, even if they’re small- maybe especially if they’re small. Much love to you, my dears.

#hidden's life

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sciencespies · 4 years

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Will These Consortia Lead The United States To Global Quantum Supremacy?

https://sciencespies.com/news/will-these-consortia-lead-the-united-states-to-global-quantum-supremacy/

Will These Consortia Lead The United States To Global Quantum Supremacy?

In the global race for leadership in quantum information science, a promising new era for computer, communications, and sensing applications, the United States has a unique advantage: A long tradition of government-academia-industry collaboration to achieve new technological breakthroughs.

Conceptual artwork of a pair of entangled quantum particles or events interacting at a distance.

getty

The most prominent example of such a successful collaboration is the internet, launched a half century ago as a government-sponsored initiative that included academic research centers and private companies developing new hardware and software. Last month, the Department of Energy (DOE) announced the development of a national quantum internet, “bringing the United States to the forefront of the global quantum race and ushering in a new era of communications.” DOE’s 17 National Laboratories will serve as the backbone of the planned “virtually unhackable” internet, which will require “intense coordination” between various Federal agencies, academic institutions, and industry.

The DOE expects the quantum internet to be one of the implementation pathways of the National Quantum Initiative Act. The Act, which was passed nearly unanimously by both houses of Congress and signed into law by President Trump on December 21, 2018, committed $1.2 billion in funding to promote quantum information science over an initial five-year period. It called for the establishment of a program of research, development, and setting of standards; the creation of the National Quantum Coordination Office; investment in exploratory research and new research and engineering centers; and the training of scientists and engineers in quantum information science.

Recommended For You

The National Quantum Initiative Act also led also to the establishment last year of The Quantum Economic Development Consortium (QED-C), overseen by the U.S. National Institute of Standards and Technology (NIST), and working to create a robust U.S. quantum ecosystem and marketplace, develop standards and quantum-trained workforce, and coordinate partnerships with government agencies.

“We are serving as a kind of industry association,” says Dr. Celia Merzbacher, QED-C Deputy Director, providing a forum for discussing the emerging industry and facilitating government agencies’ access to “the industry’s collective voice.” The consortium has about 170 members, including large corporations, startups, research centers, national labs, and various non-profits. Its work is currently organized around four technical advisory committees: highlighting the most promising commercial use cases, helping define standards and benchmarks, identifying enabling technologies, and developing a “quantum-ready” workforce.

Dr. Celia Merzbacher, Deputy Director, Quantum Economic Development Consortium

QED-C

Workshops on specific topics are a primary way for the consortium to gather input from its members that helps identify research needs and recommendations for follow-up investigations conducted by members in collaboration with government sponsors. “There is a lot of work still to be done to make something that’s even just a demonstration,” says Merzbacher. “This is why it’s important and reasonable for the government to be investing heavily the way it does right now.”

The Chicago Quantum Exchange is another meeting place for collaboration and community creation for National Laboratories (Argonne and Fermi), universities (University of Chicago, University of Illinois at Urbana-Champaign, University of Wisconsin-Madison, and Northwestern University) and a number of large corporations (e.g., Boeing, Applied Materials, JPMorgan Chase) and startups (e.g., Rigetti Computing).

“In this emerging field, science and engineering come together,” says David Awschalom, Liew Family Professor in Spintronics and Quantum Information at the University of Chicago, a senior scientist at Argonne National Laboratory, and Director of the Chicago Quantum Exchange. “You need to work with companies because the most advanced engineering is happening in the industrial world,” he adds.

There are about 150 quantum scientists across the four participating universities and, assisted by an NSF-sponsored program, graduate students can do their PhD with two advisors, one of them from one of the member companies. “It gives students a real sense of what it is to do research in industrial setting,” says Awschalom, and familiarity with real-world, practical business challenges. “In the quantum world, the application, the technology, and the science, are all connected with one another. You design the system based on the application. So it very important to know what might these things be useful for.”

What will be the “use cases” or “killer apps” in the new era of quantum information and why should the business world pay attention to these emerging technologies now?

“Quantum communications is already happening,” says Awschalom. In February, Argonne National Laboratory and the University of Chicago announced a 52-mile quantum network that “taps the unique properties of quantum mechanics to eventually ‘teleport’ information virtually instantaneously across a distance.” It serves as the foundation for the “unhackable” quantum internet mentioned above, because quantum states change when observed.

“For information security it is an asset, not a liability,” observes Awschalom, as the presence of an outside listener would actually change what is communicated over the network. “Developing a communication system based on the laws of quantum physics gives you a built-in security,” says Awschalom.

For financial services companies keen on secure communications, this could be the first useful application of quantum information science, and now is the time to explore it. “It makes perfect sense that JPMorgan Chase and Goldman Sachs have powerful and impressive quantum groups today,” says Awschalom.

Another already happening area is quantum sensing. “Because of quantum’s sensitivity to its environment, we work very hard to protect qbits [the basic units of quantum information] from the external world. For a sensor, you can take the opposite approach. Purposely expose it to the world and it becomes an extraordinary precise sensor,” explains Awschalom.

Quantum sensing is already used to precisely measure magnetic fields. Recently, researchers demonstrated the world’s smallest magnetic resonance imaging (MRI), scanning the magnetic field of single atoms with unprecedented resolution. Other researchers have demonstrated magnetic resonance spectroscopy and imaging of single molecules. “Imagine how our world will change if I can do MRI with single molecule resolution. It will revolutionize biology and chemistry—it’s not an exaggeration,” Awschalom asserts.

David Awschalom, Liew Family Professor at the University of Chicago and Director, the Chicago … [+] Quantum Exchange

Chicago Quantum Exchange

While quantum computing may eventually have an even bigger practical impact than quantum communications and quantum sensing, it is not there yet and may not be there for a while. “The challenge is that there isn’t today a quantum computer that provides an advantage [i.e., surpasses the capabilities of today’s supercomputers] but this is very dynamic,” says Merzbacher. “These things are happening very quickly,” says Awshalom, advising companies to get ready today by developing a “workforce with knowledge of quantum science and engineering.”

Next month, the Chicago Quantum Exchange is launching certificate programs in Quantum Engineering and Technology. It is aimed at professionals working for companies as engineers or computer scientists or industrial researchers who could be oriented towards quantum engineering. “We think there are thousands and thousands of engineers who could be highly impactful in the quantum field if they could be slightly retrained,” says Awschalom.

He also advises companies to hold quantum-related workshops, bring in knowledgeable people to discuss possible quantum applications and their impact on their specific business and what steps they should take today. Another way for companies to get closer to the quantum state-of-the-art is to fund PhD students working on a topic relevant to their industry.

“The Pharmaceutical industry may be more organized than others, they want to be prepared, “ says Merzbacher. QED-C has collaborated with the Pistoia Alliance and QuPharm to establish a cross-industry community of interest to “explore the opportunities for quantum computing to enhance the efficiency and effectiveness of biopharma R&D.” A recent survey conducted by these organizations found that 31 percent of life science organizations polled are set to begin quantum computing evaluation this year and a further 39 percent are planning to evaluate next year or have quantum computing “on their radar.”

All together now—academia, government, and industry—joining forces on the way to quantum supremacy.

#News

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maleenhancementmd · 4 years

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ccrpsorg · 4 years

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Clinical Research Associate Training Guide

Why Become a Clinical Research Associate?

CCRPS is one of the only major US-based ACCRE, ACCME, ANCC, ACPE, and Transcelerate Biopharma accredited CRA certification courses that accepts students with no prior background for certification. This is because our course is thorough and created by Senior CRAs who have been in the field for long enough to understand what you need to know to begin working and applying. The course can be completed in as little as 7 days with dedicated full-day study time.

Nonetheless, for those who have always wanted a career in medicine or have a gap year before medical school; Clinical Research Training is the next step to getting a head start in your career. Because the position is unlike actually working in the lab and requires a management role; you get 1-on-1 connections with physicians and medical staff that can lead to a better application for medical school and other medical careers later on.

Best of all; many of these positions accept remote staff (and some allow you to travel 45-75% with full expenses including travel, accommodation, meals, and other per-dime expenses covered). Clinical Research Training can help you save money while also increasing your salary. CRA’s with our level of training can expect to make between $6,500-$12,000 a month with an estimated promotion rate of 33% a year; an amount that is not common in other science-degree careers.

Many CRA students are actually matriculated foreign doctors who opted not to take the USMLE or repeat their residency training. In fact, some of our Clinical Research Training Students come to us immediately after moving to the U.S. and questioning what to do with an MBBS degree in US.

Unlike what you’ve learned during your 3-8 years in university or graduate school; the information needed for Clinical Research Training after your degree. Is rarely a repetition of any course you’ve taken before and thus we have 110 Clinical Research Training modules (more than any other course available) to make you get the position you want as a CRA.

2. Clinical Research Associate Certification Qualifications

Over 1.9 million students receive a bachelors of science every year. While a few go on to PhD, Masters, and Medical programs; many are ready to start clinical research certification online to start a career in the frontiers of medical research and patient care. As a new student applying to the science job market, you may only find internships or recognize that even entry-level science jobs requires 1-2 years of experience. More so, you may realize many of these jobs require intense labor in the lab or just did not meet your expectations for your science degree. This is why a career as a CRA should be considered with clinical research coordinator training. We train over 100 students each month in clinical research coordinator training and clinical research associate training (depending on prior background).

A Clinical Research Associate or Coordinator directs and supervises clinical trials that are run by physicians, nurses, and other science-degree holders. Unlike the jobs you currently can apply to on the market, a position as a CRA is actually much more difficult to obtain. While many generic courses exist on the market; we have seen that many of these students cannot find a job afterwords because of the lack of content depth. This is why our course offers a Senior Clinical Research Associate level of training with 110 intense modules. This science-based medical position is now a high-demand job which can be done privately for pharmaceutical companies such as Pfizer, or academically in medical schools. We have the largest number of clinical research courses online.

3. Why Take a CRA Certification Course

The role of the clinical research associate is very important in clinical trials to ensure that medical devices, new treatments and new drugs are approved for patients' use.

This field is taken as a certificate program course in many schools. You may also discover the availability of associate degree programs depending on the school. These programs can be completed in two years and can be offered through both the online and the hybrid formats. Hybrid formats combine both online and on-campus courses together.

If you opt for an online program, different platforms like emails and discussion boards are used to ensure and promote interaction between the students as well as with the lecturers. Online learning platforms are used to upload the syllabus, course materials, lectures and assignments. Some online programs include field work as part of their requirements, in order to gain first hand experience working with clinical trials and patients. Depending on the school, they may have a list of approved clinical research institutes and other facilities. Otherwise, you will have to find a facility for yourself and get the school's approval.

These certificate programs are generally designed for professionals that are already in the medical fields like medical assistants, nurses etc, and are interested in moving to the field of clinical research. They may therefore ask for a copy of your CV or resumé or they may ask for a letter from your employers to verify that you have the needed medical experience. Some programs may require just an undergraduate degree in a medical science or life science related field.

Clinical research associates are trained to assist clinical researchers and investigators in the coordination, administration and management of clinical trials. During this training, different courses will be taught revolving around subjects like safety procedures, subject recruitment, regulatory requirements, drug development, accountability, trial management, medical terminology etc.

The importance of the role of the clinical research associate means that companies that conduct clinical trials are usually very selective, the need to comply with strict regulations often inform their decision when making a choice of their clinical research associate. It is therefore very difficult to get a job as a clinical research associate without previous experience of clinical trials. Many companies require around at least two years experience in clinical monitoring as a clinical project assistant or clinical trial administrator before considering applicants for this important role.

In applying for the post of a clinical research associate, ensure that you read the job description and indicate or highlights the relevant experience on your curriculum vitae. Your cover letter should be specific to the company you're applying to. Do not use a one-for-all cover letter. Personalize your cover letter to each company and highlight the skills that fit the specific requirements of the role. Not all companies advertise their vacancies, so you can try to find out about other unadvertised vacancies, you might get more chance with that.

Further certification can enhance your resume such as the ACCRE accredited CRA program which contains 110 learning modules for Clinical Research Associate Training and Placement

4. The Best CRA Certification Course for Entry-Levels

CCRPS Course covers double to triple the amount of course content than other courses. While many courses are simply 5-20 simple interactive modules, our course covers 140 dense modules in thorough detail. After each session, students can ask their questions privately with the course instructor, all of whom have 15+ years of CRA experience. We offer clinical research courses distance learning.

There is a huge shortage of well-trained CRAs, but many companies are reluctant to hire untrained entry-level clinical monitors because of patient and trial safety. Because of this, even the beginner entry-level jobs require certification or training. Most courses provide very light training that may look good because of the company names, but alone is not sufficient to pass the interview rounds a company conducts. Because we prepared our modules to stand by you even as a Senior Clinical Research Associate, we find more of our students with no background quickly passing their interview rounds. Our program is considered one of the top clinical research graduate programs online.

Currently, 82% of our students are hired within the first month of taking the course. Students with limited background or those looking to gain extra experience are offered a remote internship of up to 6 months during the time they are interviewing. This advantage allows many students with limited experience to get hired with a higher paying job than previously offered. For exam, nurses are offered our clinical research nurse training and can additionally take our clinical research management training.

While a majority of our students are physicians, a majority of the CRA workforce are Science Grads and Nurses. We train at a Senior CRA level for all students regardless of background because clinical research monitoring is vastly different from any lab or science course you may have taken. Clinical research associates are given the protocol of a study including all medical protocol that must be followed but because they do not diagnose or treat, the medical knowledge is supplemental but not sufficient in this career path. This is the main reason why our Clinical Research Training includes all possible scenarios you may face at the protocol and guideline level in your future company.

5. How to get Experience for Clinical Research Associate Jobs

Learn about our partnerships with dedicated clinical research recruiters by inquiring. We provide an 8 module job application preparation section in our CRA certification course.

CCRPS, like other educational institutes, is only associated with educating and certifying clinical research professionals so we do not provide job placement. We want to make sure you apply with your best foot forward. Below are links we readily refer to graduates who are looking for job support. Having a great CV and cover letter are essential to applying for jobs. Recruiters are paid by the company which hires you and thus are free for searching employees. Be realistic but also be driven. Make sure you get continue reaching out until you get a true rejection from any job you apply to as they may never have seen your application if you received no response.

Clinical Research Job Advising: Kunal at ClinicalTrialPodcast

Free Resume Review: TopCV TopCV provides a free review and feedback for your current resume.

Resume Distribution: ResumeRabbit Resume rabbit distributes your resume to 60 job posting sites.

Clinical Research Recruiters: I-Recruit I-Recruit distributes your resume to clinical research recruiters.

Clinical Research Job Bulletin: Indeed Indeed usually provides the most uptodate job bulletin for clinical research jobs

Always use a cover letter specific for the company and job when applying if you are not using a recruiter.

Clinical Research Associate Certification

Receive more information about the course by speaking with our 24/7 chat and phone advisors right now.

ICH GCP TRAINING

The ICH GCP training modules go over the entire ICH GCP guidelines in detail. They teach you how to apply them rather than just understand the protocols. This is the essential basis of Clinical Research Training.

15 MODULES

1. An Introduction to Clinical Research

2. An Overview of ICH GCP

3. Code of Federal Regulations

4. FDA 21 CFR Part 11 ( Part 1 and 2)

5. ICH GCP E6 Section 5 - Sponsors Responsibilities

6. ICH GCP E6 Section 4 - Investigators Responsibilities

7. ICH GCP E6 Section 4 - Investigators Responsibilities – Informed Consent Form

8. Reporting Responsibilities of the Investigators

9. Ethics of Research Involving Children

10. Ethics of Research Involving Mentally Incapacitated

11. Ethics of Research Involving Pregnant Women and Fetuses

12. Ethics of Research Involving Prisoners

13. ICG GCP 5.5 Trial Management – Data Handling and Record Retention

14. ICH GCP E6 and E2A - Adverse Events

15. Safety of Human Subjects in Clinical Research

Reference Modules - to be used for reference purposes only:

a) Common Terminology Used In Clinical Research

b) Commonly Used Abbreviations and Terms in Clinical Research

QUALITY MONITORING

The quality monitoring modules are needed to work as a supervisor on clinical trials. This is the section not available in any other entry or introductory clinical research training course with more detail than many new Senior CRAs know. These modules allow you to obtain the application, examples, and guidelines needed to monitor trials with ease in your new position.

45 MODULES

1. Duties and Responsibilities of a Clinical Research Associate

2. Designs of Clinical Trials

3. Phases of Clinical Trials

4. Pre-Clinical Trials

5. Stakeholders in Clinical Research and Their Relationships

6. Contract Research Organization- CRO

7. Randomized Controlled Trials

8. Types of Monitoring Visits

9. Site and Investigator Selection

10. Site Qualification Visit

11. Routine Monitoring Visit

12. Monitoring Tools and Notes

13. Checklists for Pharmacy Monitoring and Inspection Visits

14. Site Close Out Visit

15. Source Documents

16. Inclusion Exclusion Criteria in Clinical Research

17. Interactive Voice Response System - IVRS

18. Protocol in Clinical Research

19. Protocol Deviations and Violations

20. Institutional Review Board

21. Quality Control in Clinical Research

22. Data Safety Monitoring board- DSMB

23. An Overview of Remote Monitoring

24. Centralised Versus Onsite Monitoring

25. Electronic Data Capture and Remote Data Capture Basics

26. Remote Monitoring of Clinical Trials and EMRs

27. Blinding in Clinical Trials

28. Communication between Blinded and Unblinded Staff

29. Investigational Product Storage and Dispensing

30. Investigational Product Accountability in Clinical Trials

31. Adverse Drug Reactions

32. Basics of Adverse Event Monitoring

33. Adverse Event Reporting

34. Risk Based Monitoring

35. Pharmacovigilance (Part 1)

36. Pharmacovigilance (Part 2)

37. Safety Reporting Requirements for Sponsor Investigators

38. Investigator Initiated Multi Center Trails

39. IND and NDA Process

40. Guidelines for Designing and Completing Case Report Forms

41. Do’s and Don’ts of a Case Report Form Design

42. Introduction to Bioresearch Monitoring (BIMO)

43. Clinical Trial Management System-CTMS

44. Minimising Source Data Queries in Clinical Trials

45. Role of Local and Central Labs in Clinical Trials

REGULATORY TRAINING

Regulatory training allows you to understand and apply the FDA regulation guidelines to each individual trial you will supervise after your Clinical Research Training.

15 MODULES

1. Regulatory Documents in Clinical Research

2. Regulatory Affairs

3. Essential Regulatory Documents Guidance and Binder Tabs -Part 1

4. Essential Regulatory Documents Guidance and Binder Tabs - Part 2

5. Electronic Regulatory Submission and Review

6. Financial Disclosure- Duties and Strategies for Clinical Studies

7. Financial Disclosures and Conflicts of Interest in Clinical Research

8. FDA Form 1572 - Part 1

9. FDA Form 1571 - Part 2

10. Delegation of Authority Log – DOAL

11. Investigators Brochures

12. Protocol Continuing

13. IND Application

14. Trial Master File Reference Guide

15. Trial Master File and DIA Model

AUDIT AND INSPECTIONS

The auditing and inspections modules train you to prepare clinical trials for auditing by your company, government organisation, or academic organisation after your Clinical Research Training.

SUBJECT RECRUITMENT, RETENTION AND COMPLIANCE

5 MODULES

1. Compliance Requirements in Clinical Trials

2. Subject Recruitment and Retention (Part 1 and Part 2)

3. Increasing Subject Compliance in Clinical Trials

4. Ethical Consideration Associated with Investigator Payment and Patient Recruitment

5. Advertisement aid in Subject Recruitment and Retention6 MODULES

1. Audits and Inspections in Clinical Trials

2. FDA Warning Letter

3. Site FDA Audit Inspection Checklist

4. How to Survive Through an FDA Inspection

5. Do and Don’ts during an FDA Inspection

6. Mock FDA Audits

MISCONDUCT AND FRAUD

2 MODULES

1. Scientific Misconduct in Research and How to Prevent It

2. Misconduct in Research – Detecting Falsification

WRITING QUALITY MONITORING REPORTS & FOLLOW UP LETTERS

These modules immerse you in understanding, applying, and learning to write monitoring reports, follow up letters, and professional write-ups required in the CRA position after each clinical site visit or review after your Clinical Research Training.

16 MODULES

1. Site Monitor Transition Letter

2. Checklist of Activities for Pre-Study Visit Qualification

3. Pre-study Visit Assessment and Monitoring Questionnaire

5. Pre-Study Visit Follow Up Letter

6. Site Initiation Visit Agenda

7. Site Initiation Visit Confirmation Letter

8. Site Initiation Visit Report

9. Site Initiation Visit Follow Up Letter

10. Site Monitoring Visit Confirmation Letter/Fax

11. Site Monitoring Visit Report

12. Site Monitoring Visit Follow Up Letter

13. Site Close Out Visit Confirmation Letter

14. Site Close Out Visit Agenda

15. Site Close Out Visit Report

16. Site Close Out Visit Follow Up Letter

COMPETENCY TESTING FOR A CRA

The competency testing of your Clinical Research Training modules is the next step needed to ensure that you are ready for your interviews. We establish our CRA’s as future leaders in the clinical trial industry by ensuring you have the full education needed to be promoted in your career quicker than without the course.

CRA Certification Modules also cover the following roles:

CLINICAL RESEARCH COURSES

Below are our ACCRE accredited clinical research certification programs:

While several careers exist with a science degree, the best exposure to a medical career with a science bachelors is through Clinical Research Training. This can be taken as early as your senior year of college to prepare for a job directly out of university.

CRA positions right out of undergrad are nearly impossible to get due to the yearly 1.9 million graduates of science degrees (and approximate 2,000 applications per position). This is why Clinical Research Training is an essential investment in your career.

CRA positions after hiring will cover the expenses of travel, housing, food, and more if visiting clinical sites. Most pay $6.5-12k a month with the potential to move on to a CRA position after 2 years.

While many positions will fund or reimburse your CRA training; securing an initial position is the tough part. This is why our Clinical Research Training provides 110 clinical research training modules and interview preparation with a Senior CRA and Physician of 25 years.

Our Clinical Research Training makes almost anyone interested in making use of their science degree in medicine possible. We take on students with no medical background to full-on doctors looking for a better position due to their international medical degree.

We also offer private Principal Investigator Training for practicing physicians.

See available positions here to understand why CRA certification is essential to obtaining a career in medicine with a science degree.

CLINICAL RESEARCH ASSOCIATE CERTIFICATION

Online modules and competency exam with 60 day period of completion - Use to enhance knowledge for promotion to CRA, SrCRA, or other management levels in clinical trials. Can be taken by physicians, nurses, and bachelors, masters, and PhD graduates. No clinical research background required for enrollment and certification.

ICH GCP CERTIFICATION

Online modules and competency exam - No clinical research background required. ICH GCP certification is required by all jobs working with clinical trials.

CLINICAL TRIALS ASSISTANT CERITIFCATION

Online modules and competency exam - Minimum of high school degree or GRE is required. Use for jobs that require clinical trials experience and knowledge. No clinical research background required

CLINICAL RESEARCH MONITOR CERTIFICATION

Online modules and competency exam - No clinical research background required. Bachelors degree required.

CLINICAL RESEARCH NURSE CERTIFICATION

Online modules and competency exam - No clinical research background required. RN or BSN required.

FOR CLINICAL RESEARCH ASSOCIATE ENTRY LEVEL TRAINING

Learn about the PayScale and promotion methods for Clinical Research Associates by scrolling below.

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globyzbiopharmaservice-blog · 4 years

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Clinical Trial Supplies and Its Various Attributes

Successful clinical trial supplies optimization is vital and certainly, people spend too much time trying to make forecasts 100% precise. Once a project starts, it is very unusual for the real to look like the prediction?

People spend hours in a hopeless challenge to produce the faultless estimation only to result in the right forecast altered again the next week and so on. It is clear that people need some intensity of estimation in order to manage supplies but should this prediction be at a top more common level with an improved focus on the capability to respond to transforms. For example when setting up the IVRS or IRT systems for research and requesting quotes from possible vendors, how many of them actually assess the rate and time of potential changes? It is impossible to anticipate the modifications required, therefore how can you be expected to calculate the price and time of something that is unknown? Whilst the literal changes required may not be observable at the initial stage of a medical study there is no reason why you cannot work with your vendors to make system and clinical supply chain design as flexible as probable. Numerous IRT or IVRS vendors have now established advanced systems that can reply faster and run more economically to changes required whilst the arrangement is live. Some other areas that should be taken into consideration when designing flexibility into supply chains are kit designing and Clinical labeling. Clinical Supply kits should be designed to give the utmost flexibility to allow for astonishing adjustments are dosage or visit frequency. Do you regularly consider which countries are likely to be added as emergencies if enrollment doesn't go as intended and if these are known are country requirements and languages for dependent areas included in the pamphlet label from the start? There are numerous models, clinical trial supplies optimization, and forecasting devices available on the internet. They are designed to make the procedure more exact and to a level, they possibly do add some value. However, as the fact going in is usually based on the greatest guess and assumptions it is indispensable that the estimation coming out, whilst development on the customary spreadsheet or paper-based approach, will never be 100% perfect. Globyz Biopharma Services is a renowned name for sourcing and supply of commercial medicines or comparators for clinical trial studies across all therapeutic regions. It is the utmost destination for global sourcing, GMP-compliant storage, Clinical Packaging, clinical distribution, clinical labeling, and cold-chain supply solutions. Whether you need commercial medicine sourcing or complete clinical supply services including attaining, packaging and labeling, storage, and distribution or regulatory consulting, you have customized and optimal solutions tailored to your clinical trial needs as a flawless expansion of your supply chain. The company has years of experience and possesses outstanding expertise in managing the legal issues, planning, and supply chain challenges of sourcing, storing, and distributing pharmaceuticals for clinical trials. Globyz Biopharma Services is focused to provide customized solutions with the uppermost level of quality and service to make the name just perfect for comparator sourcing and supply partner for the customer’s clinical trial material necessities and services. to know more about the company and its work and services, visit the website.

#Clinical Supply #Clinical Distribution #Clinical labeling

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googlenewson · 4 years

Link

If you’re worried you might have COVID-19, how does the coronavirus testing procedure actually work? And how much does it cost? The answer is: It’s complicated, confusing, and a lot of people simply don’t know the intricacies of the situation—including the financial burden a U.S. patient with suspected coronavirus might have to bear.

Fortune reached out to all 51 state public health departments in the country (each state and the District of Columbia), urgent care centers, pharmacy giants, the Centers for Disease Control (CDC), and multiple other agencies to figure out how the process plays out. Most didn’t respond or declined to comment.

Here’s what we know so far.

Why was the U.S. slow to test for coronavirus?

It’s unclear why the CDC and the Trump administration decided to develop their own test instead of using those already in place in countries with major outbreaks. Manufacturing issues for the CDC’s coronavirus test significantly slowed down the process in the U.S.

According to the CDC’s latest numbers, there have been a total of 60 cases of COVID-19 (the official name for disease caused by the new coronavirus strain) in the U.S. and six reported deaths, all of them in Washington state. Those cases now span a dozen states: California, Oregon, Washington, Arizona, Illinois, Wisconsin, Florida, Georgia, New York, New Hampshire, Massachusetts, and Rhode Island, with Georgia and New Hampshire reporting the newest known cases.

That number is expected to swell significantly in the coming weeks and months as the CDC fixes its test and distributes it to state and local labs across the nation.

On Monday, Tom Frieden, former CDC director and former commissioner of New York City’s health department, held a public briefing to discuss the U.S. response to coronavirus to date. Frieden, as many public health officials have done, praised China’s rapid response and containment efforts and pointed to the lessons learned and mistakes made in America’s own quest to quell the pathogen.

“In 2009, with the H1N1 flu epidemic, and with the Ebola outbreak in 2014, the CDC’s labs and contractors created high quality tests very quickly,” he said in response to a question from Fortune during the briefing. “This time there’s clearly been a glitch in that process. I think it’ll be important when things quiet down to have a review and figure out what went wrong.” He went on to emphasize his confidence in the medical professionals at the CDC.

President Trump appointed Vice President Mike Pence as the leader of the administration’s coronavirus response. On Sunday, Pence said that the CDC’s manufacturing capacity for testing would ramp up significantly by the end of the week, and that state and local laboratories would be able to conduct their own initial testing without having to send samples to a federal CDC lab—a critical tool in containing the outbreak, according to Frieden.

In addition to the CDC test, the Wadsworth Center, a research lab within the New York State Department of Health, developed its own FDA-approved test, the first of its kind. The center partnered with hospitals to expand testing.

Who gets tested for coronavirus?

Fortune reached out to every state health agency in the country to ask about the status of coronavirus testing. Most declined to comment, did not reply, or pointed to a press release. A handful—Wyoming, Wisconsin, Utah, Hawaii, Louisiana, New York, Arkansas, Indiana, and Idaho—directly answered questions either via email or by phone.

The departments Fortune spoke to presented a common narrative: CDC-cleared coronavirus tests are finally making it to state and local labs. The CDC has stated that as many as 40 public health labs across the country can conduct coronavirus testing at the moment.

“In Arkansas, today, our state public health lab is testing,” said Dr. Jennifer Dillaha, medical director for immunization and outbreak response in Arkansas, on Monday. “Today is the first day that we’ve been able to do our own test.”

According to Dillaha, the CDC has provided guidelines to help state agencies make judgments on who to test, but discretion will fall to the individual agencies—although she doesn’t think there will be much variance between public health departments’ procedures.

In Arkansas, assessing that risk relies on a combination of factors including whether or not someone has been to a region where the outbreak is prevalent or had contact with an infected individual. If the U.S. continues to see a “community spread” of coronavirus—the term used when the source of infection is unknown—it’s expected that more people will be tested.

How is coronavirus testing done?

The coronavirus test is a combination of a nasal swab and an oral swab. Dillaha said medical professionals might only take one or the other, but labs prefer to have both.

As of now, urgent care centers and organizations like CVS’s health clinics cannot conduct coronavirus tests on site, according to a CVS spokesperson. That may be a possibility in the future should private commercial entities develop their own coronavirus tests; as of now, samples collected at hospitals, urgent care centers, and doctors’ offices are sent to public health labs cleared to conduct the reviews.

Dillaha says that Arkansas public health labs can conduct the test within four hours. Initial results are shared with medical professionals and patients, and then samples would be sent to a CDC lab for final confirmation.

How much does the coronavirus test cost?

Any coronavirus test conducted in a public health lab using an FDA-approved test should, theoretically, be free to the patient.

“Those people are all tested by the CDC. It’s not based on whether or not someone would be able to pay,” said Dillaha. “Of course no test is free. Someone is bearing the cost.”

She notes there are ongoing conversations between federal and state authorities on how to finance the tests and that she doesn’t know all the intricacies of the payment situation.

Representative from Utah, Wisconsin, and New York’s health departments concurred, saying FDA-approved tests (the CDC test and the Wadsworth Center test) that are tested in public health facilities are free to patients.

But the fragmented nature of the American health system complicates the issue significantly. For instance, even though the coronavirus test itself is free, the associated hospital stay, doctors’ visit, or quarantine may not be—and depending on the quality of one’s insurance, a patient with a suspected case may face thousands of dollars in medical costs. An urgent care visit or hospital stay related to coronavirus may not be fully covered.

New York Governor Andrew Cuomo announced in a tweet on Monday that he had issued a directive “requiring NY health insurers to waive cost sharing associated with testing for #coronavirus, including emergency room, urgent care and office visits.” He added that anybody in the state covered by Medicaid would not have to pay for coronavirus-related care. It’s unclear how this would play out for those with private insurance.

More must-read stories from Fortune:

—How to think about COVID-19 —Coronavirus spreads to a previously healthy sector: corporate earnings —Coronavirus is giving China cover to expand its surveillance. What happens next? —Coronavirus shows why we need vaccines before, not after, an outbreak —Before coronavirus, there were SARS and MERS. Do epidemics ever really end? Subscribe to Fortune’s Brainstorm Health newsletter for daily updates on biopharma and health care.

from Fortune https://ift.tt/3ctbQ05

#World News

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dinafbrownil · 4 years

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Readers And Tweeters: More Than Two Sides To Every Story

Letters to the Editor is a periodic feature. We welcome all comments and will publish a selection. We edit for length and clarity and require full names.

Dispensing The Facts — Or Dispensing With The Facts?

Kaiser Health News and PolitiFact HealthCheck’s rating of our advertisement on House Speaker Nancy Pelosi’s drug pricing legislation, H.R. 3, ignored key facts and third-party data that backed up the assertions made (“Pharma’s Take On The Pelosi Drug-Pricing Bill: Fair Warning Or Fearmongering?” Dec. 5).

In our ad, we correctly stated that H.R. 3 “would siphon $1 trillion or more from biopharmaceutical innovators over the next 10 years.” The Congressional Budget Office (CBO) estimates that just one part of the legislation (Title 1) would reduce revenues to the biopharmaceutical industry as high as $1 trillion. In addition, an analysis from Avalere, a leading health care consulting firm, found that H.R. 3 could “decrease manufacturer revenues by $1T for CYs 2020-2029 in the Medicare and commercial markets.” The KHN story excluded the Avalere analysis while providing no evidence that the impact was less than the amount estimated by CBO and others.

Moreover, our ad directly quoted CBO’s preliminary estimate, which said the bill “would result in lower spending on research and development and thus reduce the introduction of new drugs.” Despite being an exact quote, KHN still chose to rate this as “mostly false,” even though every person quoted in the article acknowledged there would be a reduction in new medicines.

The story also ignored a study from Vital Transformation, an economic consulting firm, which found H.R. 3 could result in at least 56 fewer innovative medicines from emerging biotech companies over 10 years. The impact on the entire industry would be much greater.

We stand by the claims we made in our advertisement and reject KHN’s analysis of our ad and the impact H.R. 3 would have on biopharma innovation.

― Robert Zirkelbach, executive vice president of public affairs, PhRMA, Washington, D.C.

The simple argument that a tradeoff exists is "mostly false"!? I agree the industry overplays the effect size but come on!

— Ben Ippolito (@ben_ippolito) December 5, 2019

— Ben Ippolito, Washington, D.C.

I was very glad to see Kaiser Health News look into and expose the false and misleading advertisements from the Pharmaceutical Research and Manufacturers of America (PhRMA) that had been running in “Politico PM Playbook” over the past few weeks leading up to the House vote on H.R. 3, “The Lower Drug Costs Now Act of 2019.”

This is exactly the kind of spotlight that we need more of on an industry that is pouring hundreds of millions of dollars into lobbying and false advertising in an attempt to stop any meaningful action that would threaten their record profits. We at Accountable.US are doing everything we can to expose the corruption, influence-purchasing and coziness between the pharmaceutical industry and the Trump administration, but we need the media to step up as well to help people cut through Big Pharma’s false advertisements and learn the truth.

Because to be clear: Corruption and lies may be par for the course in Washington, D.C., during the Trump era, but this is an issue that can’t be seen as simply another run-of-the-mill falsehood by a D.C trade organization. The cost of prescription drugs is a matter of life and death for millions of Americans and it’s an issue that elected officials have made commitments to address. But if the pharmaceutical industry is able to spread false and misleading information to policymakers and the public unchallenged and with impunity, then this critical work becomes far more difficult.

That is why following the Kaiser Health News analysis, I wrote a letter to the publisher and top editors of Politico requesting that the false advertisements be removed from the website and that further advertisements from PhRMA using assertions that have been labeled false be rejected.

― Kyle Herrig, president, Accountable.US, Washington, D.C.

This is a dumb. I use blended feeds every day, and while they are usually thick, it still works just fine. EnFit is small, yes, but it’s not any smaller than the g-tube port. It’s a safety mechanism that differentiates it from IV ports so tube feds are administered incorrectly. https://t.co/6bJ7YEw8KS

— 𝙂𝙐𝙉𝙉𝘼𝙍 𝙀𝙎𝙄𝘼𝙎𝙊𝙉 (@G17Esiason) December 16, 2019

— Gunnar Esiason, Hanover, N.H.

This ‘Warmline’ Is All Ears To All

I am the president of a nonprofit organization, Peers in Cayuga County, in Auburn, N.Y. We have been offering a “warmline” since 2015 (“‘Warm’ Hotlines Deliver Help Before Mental Health Crisis Heats Up,” Dec. 9). It operates 24/7/365. We volunteer in Cayuga County and mostly work with people within the county. But, when it comes to the warmline, we answer the phone and listen and talk with whomever is on the phone. We have received calls from out of the county as well as out of the state. We believe in supporting anyone who needs help and are open to anyone calling in to get the support they need. Of course, we don’t know which resources to direct them to nationwide, but people are people and we can support anyone. With that in mind, I would like to have our number listed in as many ways as possible so we can help whoever wants it: (315) 246-3004.

― Margaret Phinney, Auburn, N.Y.

Extra Pointers For Patients To Ward Off Billing Fraud

KHN Editor-in-Chief Elisabeth Rosenthal makes many excellent points (“Analysis: In Medical Billing, Fraudulent Charges Weirdly Pass As Legal,” Dec. 16), but please allow a few comments.

First, not to apply a neck brace in such an accident when the patient has been unconscious would be medical malpractice ― period.

Second, the article ignores patient responsibility. When a patient has been out of the hospital for a while, pain management should transition to one’s personal physician. Depending on state law, it may require an office visit, but it’s your personal physician’s job.

Regarding being offered unnecessary medical equipment such as walkers or commodes, just say no and sign that you refuse it. It is your choice. Actually, it could be argued that accepting unnecessary medical equipment constitutes fraud.

Finally, Ms. Rosenthal reminds us of post-accident “pfishing.” Accident reports are easily accessible. Honest businesses never cold-call patients. If you haven’t been told a referral is being made to “X” office and to expect a call, hang up! (Some states have laws forbidding this; you may wish to inform your state attorney general’s office.) Follow your doctor’s recommendations and don’t get hooked!

— Gloria Kohut, Grand Rapids, Mich.

This! Medical billing is a game of greed, confusion, obfuscation, and fraud, plain and simple. After my last experience with CU Health, I have refused to get medical attention I still need because I can't stand or afford the hugely profitable billing scam. https://t.co/1NbGyVvkVD

— Sharon McCreary (@selfesteemfail) December 19, 2019

— Sharon McCreary, Denver

I love this article! I want to know when we are going to stop accepting this as OK. Some of these bills can really hurt people who live on a fixed income. The government needs to step in and stop allowing these things to happen.

― Michaela Reyes-Holmes, Thompson, Ohio

Health care is crazy town. No other part of the economy looks anything like this, because no other sector is as deeply screwed up by government misregulation. #GovtFailure #NotMarketFailure https://t.co/Hjr6qYaZgV

— Kurt Couchman (@KurtCouchman) December 19, 2019

— Kurt Couchman, Burke, Va.

from Updates By Dina https://khn.org/news/readers-and-tweeters-more-than-two-sides-to-every-story/

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josephborrello · 5 years

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Magnitude and Direction, Issue #38 | 26 Jul 2019

Hardware, Prototyping, and Fabrication

Make functional, affordable hinges out of PVC pipe. (Definitely a technique mechanical engineering teams on a shoestring budget should have in their back pocket.) ➰➰Via The Prepared, a great twitter thread on why it's rarely ever worth it to build your own computing infrastructure (even when you get to scale). The real reasons the US won't switch to the metric system.

Software and Programming

AI and Art History aren't two topics you'd necessarily expect to be associated, but this unlikely marriage is helping properly attribute artworkacross a range of genres. Web Curios, where I originally came across this link, framed the website as a great resource for tricking people into thinking your waiting for an update to finish instead of just browsing on your phone. I'll let you all decide how you'd like to leverage the linked resources. Lots of games from the past look like they were fun to play, but it can be hard to find a rulebook during archaeological digs. That problem is beginning to be addressed through machine learning, which is helping us understand how these ancient games were played. Computers are now better at bluffing than we are. One does wonder, though, if human players behave differently when they're playing against a computer. It's one of many experiments we can't necessarily test perfectly, the focus of my Moment of Inertia musings this week.

Science, Engineering, and Biomedicine

🔜⛈ Via Gareth's Tips, Tools, and Shop Tales, a method to forecast the weather using a cup of coffee. (Definitely something I'm going to try at home.) 🤮 When it comes to romantic relationships, we do indeed appear to have a "type", whether we want to or not. I sh*t you not, here is an academic paper on the socio-psychology of BS artists. Lots of great science content in this edition. Even the lowest-profile heart monitoring devices can be cumbersome to wear for long periods of time, limiting the clinical data that can be gathered. But what if all you had to do was get a tattoo? (Here's the original paper.) ‍ This past weekend was the 50th anniversary of the first moon landing. Neil and Buzz, however, weren't on the moon for a very long time, compared with the overall mission duration. In fact, a whole lot of the mission was just boring status updates from the astronauts and mission control. You can relive it all, in real time, though, through this highly accurate mission simulator.

Mapping, History, and Data Science

The story of how a janitor at Frito-Lay came up with Flamin' Hot Cheetos. (And sorry, the popcorn emoji was the closest thing to a cheeto I could find.) I've seen this article kicking around for a few weeks and decided to share it here as well, since it's just so interesting and deals with data that many of us wouldn't even consider analyzing: "Hedge Funds Are Tracking Private Jets to Find the Next Megadeal". From the majors to the minors, pretty much all baseball stadiums have netting behind the plate to protect spectators from foul balls. But, given where foul balls actually land, is the current netting setup sufficient?

Events and Opportunities

Is it just me, or is there more activity this summer than in summers past? Also, I don't mention this enough, but if there are upcoming events that I don't have listed here, and/or events you'd like me to share, feel free to drop me a line andlet me know. I'll add it!

Tuesday, 7/30 If you couldn't make it to NYDesigns' hardware accelerator lunch and learn last month, don't worry, they're holding an after-work happy hour to meet other potential cohort members, mentors, NYDesigns staff, and learn about the accelerator program.

Wednesday, 7/31 The NY Hardware Startup meetup isn't holding any formal meetings for the summer, but that won't stop them from getting together for some drinks at Other Half Brewing Co. for a summer happy hour.

Wednesday, 7/31 The Digital Health CT accelerator will be coming to NYC to hear pitches from local digital health startups competing for one of 10 spots in Digital Health CT’s zero-equity accelerator. Whether you’re interested in meeting experts in the field, connecting with startups, or contributing your own knowledge to the startup community, you're welcome to attend and share some food and drinks with you along the way! If you're interested in attending, RSVP here. If you're interested in pitching email Ben Fischbein at [email protected]. If you think your startup could be a fit for the program, you can apply here.

Tuesday, 8/6 Taste of Science is back at Ryan's Daughter for their next drinks-and-lectures event, focusing on infectious diseases.

Wednesday, 8/7 Starting next month, BioLabs@NYU Langone hosts "Larger Than Life Science" a free monthly event series open to everyone interested in building a strong support network for New York’s life science and healthcare innovators. The inaugural event will provide an opportunity to learn about the co-working lab model, explore the microbiome, and taste clinical nutritional goodies.

Friday, 8/9 Uptown nanotech enthusiasts, this is your moment! Nanotech NYC's next Nanonite Social is being held at Harlem Tavern.

Some other upcoming events to keep on your radar...

Tuesday, 8/13 Join the New York Biopharma networking group for their August meetup, back at Tir Na Nog in midtown.

Friday, 8/23 Join the New York Academy of Sciences for a brainy comedy night where local scientists will attempt to confirm the hypothesis that science does indeed have a sense of humor.

Wednesday, 9/25 Coming off their 1st birthday party, the NYC JLABS crew is taking a short break for the summer but will be back in September for their next Innovators and Entrepreneurs mixer.

Tuesday, 10/15 October may feel far away, but I promise you it's not and you'll want to be sure to mark your calendars for GRO-Biotech's next big event the Careers & Connections mini-conference andnetworking event, held concurrently with emerging healthcare technologies conference SINAInnovations.

Map of the Month

Here's a map of all (all?) the satellites orbiting the Earth right now.

Odds & Ends

⚙🔄➡ You've heard of dial-up internet, but what about crank-up internet?

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jamesgeiiger · 5 years

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Green Growth’s CEO dismisses doubts about the bid for Aphria that a short seller is calling a ‘fakeover’

Aphria Inc. shares fell 4.3 per cent to US$5.99 on Monday as investors questioned a hostile takeover bid for the Canadian marijuana producer from Green Growth Brands Ltd.

Columbus, Ohio-based Green Growth, which owns one cannabis retail store in the U.S., said on Dec. 27 it was planning to make a $2.8 billion unsolicited takeover offer for Aphria. Short-seller Hindenburg Research, which has previously targeted Aphria, immediately called the bid “non-credible” and raised questions about connections between the two companies.

Green Growth Chief Executive Officer Peter Horvath responded by phone Friday to some of those doubts. His comments have been edited and condensed.

Aphria targeted in $2.8-billion hostile takeover bid from U.S.-based Green Growth Brands

Why Shopify and Parex are welcome under the tree, but cannabis isn’t

Aphria the target of proposed class action following short-seller allegations that tanked stock

Q: Hindenburg Research alleges Green Growth’s offer isn’t actually a hostile takeover bid but a related-party “fakeover.” What’s your response?

A: I read the short report. There’s not much to comment on because we have a real business. Honestly, if Aphria wanted to construct … related-party transactions, why wouldn’t they just accept the offer? It is what it is, there’s nothing to debate. We’ve never hidden anything.

Q: What’s your relationship with Aphria Chief Executive Officer Vic Neufeld?

A: I met Vic once probably in September. Then in October, I saw him briefly when they were doing a legalization party. But I haven’t talked to him since.

Q: Your company’s second-largest shareholder is GA Opportunities Corp., a fund backed by Aphria and advised by Neufeld. Hindenburg calls it a “remarkable coincidence” that Aphria holds a major stake in its own hostile bidder through a fund advised by its own CEO. Did you know that?

A: We’ve held the line consistently that GA Opportunities was a fund that made an investment in us. We didn’t meet with the people that provided the money to them. We didn’t discuss it. It basically was brought to us, “Hey, we want to do a private placement with you,” and we accepted that. Normally we don’t ask who’s behind the money because normally the answer is very complicated.

Q: Hindenburg believes your bid to be an attempt to “generate the appearance of demand in the hopes of spurring credible offers” for Aphria. Is it?

A: No one at Aphria said, “Hey, please try to buy us.” I haven’t had that conversation. This pretty much happened independently. … I know that the folks in Canada on Bay Street are all pretty tightly knit and everybody knows everybody, so it doesn’t completely surprise me. I don’t think they made that investment hoping that we would buy them. That just seems really far-fetched.

Q: Hindenburg says the Schottenstein family — Green Growth’s biggest shareholder — was involved with Aphria just one year ago. What do you say to that?

A: The Schottensteins, as far as I know, do not own any Aphria stock. Therefore, this is an appropriate transaction. I know that the board of Aphria and the management team of Aphria were not involved in developing this idea. In fact, what’s very visible is that they’ve rejected the idea. I feel everything’s fine, above board and transparent.

Q: Hindenburg also raised concerns about two individuals, Shawn Dym and Adam Arviv, who both had directorship roles at Green Growth as recently as October and both have close ties with Aphria. What about that?

A: When we did the reverse takeover [of Xanthic Biopharma], we got a new board. Shawn represents a family trust, I believe. They put some feed money into us back in March, and as a result, Shawn had a board seat. Adam Arviv had a board seat and the Schottensteins had two board seats. So then the reverse takeover took place and we adopted the board from Xanthic. We’re still in the process of re-forming the board now.

Q: When did you get involved with Green Growth and whose idea was it to approach Aphria?

A: I got involved in looking at the idea of forming the company in December of 2017. I presented a business plan and then we formed the company March 1. … Like seven or eight days ago, Cannacord, our investment bankers, and Norton Rose, an M&A firm, brought to us the idea that this is a possibility to combine the companies.

Q: Did you question how your much smaller company would acquire a big one? How many retail locations does Green Growth have?

A: Right now we own one. We have a second that we have an option to buy in Nevada. We were awarded seven licences in Nevada. We also recently closed on a purchase of a Massachusetts licence that gives us a grow facility, a processing facility and three stores. We also are underway working with six different developers, who represent most of the malls in the United States. We believe that by the end of this year we’re going to have 300 mall kiosks.

Q: After reading the short seller’s report, are you reconsidering your offer for Aphria or do you have any new concerns about the relationship between your two companies?

A: We don’t want to put ourselves in a position that jeopardizes our existing business, which has a lot of upside. If there’s anything that would appear inappropriate, we wouldn’t allow this to take place. We’re not into get-rich-quick schemes. We’re looking at real assets, real value, a seasoned management, and a true operating capabilities. At the end of the day, this is going to be up to shareholders to decide. There’s no opportunity to pull a fast one here.

Bloomberg.com

Green Growth’s CEO dismisses doubts about the bid for Aphria that a short seller is calling a ‘fakeover’ published first on https://worldwideinvestforum.tumblr.com/

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mikemortgage · 5 years

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Green Growth’s CEO dismisses doubts after bid for much bigger Aphria raises eyebrows