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GSK hires computational drug design expert Dr Kim Branson as new head of machine learning and AI

British multinational GlaxoSmithKline have hired computational drug design expert Dr Kim Branson as the company’s new Senior Vice President, Global Head of Artificial Intelligence and Machine Learning.

In his new role, the biotech veteran will oversee projects which use AI to identify novel targets for potential medicines.

Dr Branson brings to the role more than 15 years’ worth of experience in biotech and academia having held positions at a number of Silicon Valley firms including Gliimpse, Lumia and Hessian Informatics.

read more




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General Pharmaceutical Council appoints Laura Fraser as director for Scotland

The General Pharmaceutical Council has appointed Laura Fraser, former clinical fellow for the Scottish Chief Pharmaceutical Officer as the new Director for Scotland.

Fraser has held leadership roles in community pharmacy across Scotland including board member of Community Pharmacy Scotland. She has also worked for the Scottish Government as Clinical Leadership Fellow. Prior to her position as board member she was area and regional manager for nearly nine years.

read more




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MSD announce David Peacock as new Managing Director in UK and Ireland

MSD have announced that David Peacock will become Managing Director in the UK and Ireland, succeeding former director Louise Houson, with a start date of October 1st 2019.

Peacock brings with him a broad range of experience and perspectives from senior roles within the company in the United States, Singapore, Vietnam and Japan. Most recently, David was Chief of Staff to Kenneth Frazier, Chairman of the board and Chief Executive Officer of MSD.

read more




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Alligator Bioscience hires Chief Financial Officer in interim capacity

Andreas Johannesson has been announced as Alligator Bioscience’s new interim Chief Financial Officer (CFO), replacing ex-CFO Per-Olof Schrewelius who it was previously confirmed will no longer serve the company.

Johannesson’s career has spanned 15 years in the consumer goods sector, with him managing the finances of firms including TeamOlmed, Stenqvist, Fitness23Seven and Haldex.

He spent a further nine years of his career as a strategic consultant with a focus on consumer goods, five of which were spent at global consulting firm McKinsey & Company.

read more




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Immunron Chief Executive Officer Gary Jacob resigns amidst coronavirus cost-cutting

The Chief Executive Officer of Immuron, Gary S. Jacob, has resigned as CEO and as a member of the Board due to restructering taking place to prepare the company for a post-coronavirus world.

In a statement, the company said it was the first move to help the “preservation of capital to allow the company to weather the current trading conditions pending strengthening of the travel market. This will involve radical cost-cutting and deferring certain research and development activities.”

read more



  • Manufacturing and Production

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Preparing to Go Back to the Bedside During COVID-19: A Nurse-Turned-Bioethicist Reflects

This was the first time in a long time that I’ve renewed my nursing license with the thought that I might need it — that I might be needed.

The post Preparing to Go Back to the Bedside During COVID-19: A Nurse-Turned-Bioethicist Reflects appeared first on Bill of Health.




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Access to Drugs Before FDA Approval: Video Explainer with Christopher Robertson

In this video explainer, Christopher Robertson discusses the Right to Try Act and off-label use of pharmaceuticals with Alison Bateman-House.

The post Access to Drugs Before FDA Approval: Video Explainer with Christopher Robertson appeared first on Bill of Health.




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A $100 Million Biotech Deal Is Also A Tale Of Two Executives Facing Their Kids’ Deadly Diseases

“John, I’m very aware of your family’s journey, Twelve years ago I was one of the producers considering bidding on your life rights.”




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FDA update on COVID-19 actions and advisements

Over the past week, the agency has issued guidances, taken action to accelerate treatments and put a stop to fraudulent treatments for the pandemic-causing virus.



  • Markets & Regulations

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CAS open-access dataset to help COVID-19 research

CAS, a division of the American Chemical Society, has released a dataset of chemical compounds with known or potential antiviral capabilities.




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Novartis acquires digital therapeutics specialist Amblyotech

The pharmaceutical firm has purchased the company, which specializes in advancing treatments and diagnostics for ocular disorders.



  • Markets & Regulations

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Almac Discovery collaborates with Merck on DUB targets

The partnership will focus on generating novel small-molecule inhibitors against specific DUB targets for treatment of a range of diseases.




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Research collaboration drives to accelerate COVID-19 solutions

Led by Medable, the multi-company effort is geared toward ramping up development of treatments, diagnostics and other solutions for the pandemic-causing virus.




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Medidata analysis shows COVID-19 impact on trials

The companyâs global analysis from thousands of studies and sites indicates dramatic shifts in enrollment across several countries since the pandemic began.




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NEW: The 2020 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers

I am pleased to announce our new 2020 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers, available for purchase and immediate download.
We’re offering special discounted pricing if you order before March 22, 2020.

The 2020 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers is a truly unique resource. With 203 proprietary charts, exhibits, and data tables, this 11th edition provides a comprehensive, fact-based, and non-partisan tool for understanding the entire U.S. drug pricing, reimbursement, and dispensing system.

The full document clocks in at 374 pages. I can safely say there is nothing else available that comes close to this report.

The chart below illustrates the depth and breadth of the 2020 edition. The numbers indicate the report chapter that corresponds to, explains, and analyzes each channel flow.

[Click to Enlarge]

Below, you can read more info and some behind-the-scenes tidbits.

P.S. If you would like to pay by corporate purchase order or check, please email Tamra Feldman. If you preordered the report, you should have already received an email with download instructions. Please contact us if you did not receive the email.
Read more »
        




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The Drug Channels Coronavirus Industry Impact Survey

It’s a unique and troubling time. We are all of course concerned about the coronavirus and its disruption to our personal and professional lives.

I presume that life will return to normal later this year. But what happens then? Will there be long-term changes to how the drug channel operates? Will we see permanent changes in behavior, policy, and industry structure?

To answer these questions, I want to tap the collective insights of Drug Channels’ 30,000+ audience.


This survey should take 10 minutes or less. I will provide a full review of the results next week on Drug Channels. The survey will close on March 20.

You can respond anonymously. Any information you provide will be kept confidential. Per Drug Channels' long-standing policy, I never publish, release, or disclose any personal data without your permission.

Thanks in advance for sharing your insights.

Regards,
Adam

        




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Coronavirus Industry Impact: Patients, Pharmacies, and Wholesalers (Part 1)

I hope you are staying healthy and are managing to navigate your work-at-home mandates.

Last week, I tapped the collective insights of the Drug Channels’ audience. Nearly 700 readers shared their perspectives and projections for how the coronavirus pandemic could ultimately affect behavior, policy, and industry structure. Thank you to everyone who took the time to respond.

I will share the results over three articles this week:
  • Today, in Part 1, I will review the responses relating to patient behavior, pharmacies, and wholesalers. 
  • In Part 2 (tomorrow), I’ll focus on expectations for pharmaceutical manufacturers and third-party payment. 
  • In Part 3 (Thursday), I’ll examine how the coronavirus may affect the public perception of the industry’s participants.
P.S. A special shout out to the respondent who hoped that the coronavirus would not impact the quality of Drug Channels memes. Never fear, dear readers: Drug Channels will remain the internet’s top destination for pharmaceutical-related humor!
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Coronavirus Industry Impact: Manufacturers, Public Policy, and Payers (Part 2)

Today’s post is the second in our three-part investigation of the ultimate impact of the coronavirus on the drug channel. Here is a link to the first part of our survey analysis: Coronavirus Industry Impact: Patients, Pharmacies, and Wholesalers (Part 1). That article includes details about the methodology and respondents.

Today, I review how people in the industry think coronavirus will affect:
  • Federal drug pricing legislation
  • FDA new drug approvals
  • Public support for single-payer health insurance
  • Third-party payment for prescription drugs
I also highlight survey respondents’ comments on whether the current situation will bring overseas pharmaceutical manufacturing back to the United States.

Tomorrow, I’ll examine survey responses that address how the coronavirus may affect the public’s perception of the industry’s participants. In the meantime, remember that every day is no pants day when you work from home.
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Coronavirus Industry Impact Survey: Winners and Losers (Part 3)

Today is the final installment of our three-part investigation into the coronavirus’ ultimate impact on the drug channel.

Below, I examine expectations about how the coronavirus will affect the public’s perception of various industry participants. We explore what our survey respondents said about:
  • Pharmacies
  • Pharmaceutical manufacturers
  • Hospitals
  • Wholesalers
  • Pharmacy benefit managers and plan sponsors
  • Insurance companies.
In these early stages of this crisis, my crystal ball is as cloudy as yours. Let’s hope that the country will stabilize within a few months. I may then rerun the survey to determine how (if at all) everyone’s perspective has changed.
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Expanding How CoverMyMeds Helps Patients Access Their Medications

Today’s guest post comes from David Holladay, President of CoverMyMeds and Austin Raper, Healthcare Writer at CoverMyMeds.

First, David discusses how CoverMyMeds supports medication access. Then, Austin highlights key findings from CoverMyMeds’ 2020 Medication Access Report. This new report includes industry research, patient interviews, novel survey data, and strategies for boosting patients’ medication access.

Read on for David’s and Austin’s insights.
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Drug Channels News Roundup, March 2020: Sanofi’s Gross-to-Net Bubble, Drug Pricing Findings, Amazon Replaces Express Scripts, and Drug Channels Video

First, let me say thank you to all of the healthcare workers who are putting themselves at risk during this crisis.

As I noted last week, many of the crucial issues for our healthcare system will remain after we all get through this challenging period. In that regard, here’s a look at some noteworthy news from the past month:
  • Sanofi discloses new data about insulin prices
  • Excellent new academic research on list vs. net drug prices
  • Three notable researchers overturn their earlier research on drug costs
  • Amazon switches PBM vendors for some of its employees
Plus, we unveil the teaser trailer for Drug Channels Video!

P.S. Join the more than 9,000 followers of my daily links to neat stuff at @DrugChannels on Twitter. My recent tweets have highlighted such topics as:
  • How GoodRx shares patients’ prescription data
  • 2019 drug trend at Prime Therapeutics
  • Controversy about the independent pharmacy market
  • A new $5 generic mail order program, Medicare Part D reform
  • Retail pharmacy’s future
  • Job openings at Amazon 
  • Frozen cookie dough
  • And much more!
I have also been tweeting many under-the-radar stories about how the coronavirus affects drug channels.
Read more »
        




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Industry Update and COVID-19 Impact: Join Me for Two Live Video Webinars (May 1 and May 8)

This May, join Dr. Adam J. Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels, for two live video webinars:

You can purchase replays of these events using the links above.

Dr. Fein will help you navigate this challenging time in U.S. drug channels. These 75-minute live events will be broadcast via Zoom from the new Drug Channels Video studio. See details below.


You can sign up for either one of these crucial educational opportunities for only $300 per site per event. We are offering special pricing of $500 if you sign up for both events.

An unlimited number of people may watch at one location. However, we recognize that it may be difficult to gather your team in one location, so we are offering significant discounts for multiple viewing sites. Please contact Paula Fein (paula@drugchannelsinstitute.com) to get special pricing information for 5 or more locations. If you purchase access for multiple sites, we will contact you for the name and email address of a contact person at each location.

Read on for more information about the events.


To help people affected by COVID-19 and the caregivers who are supporting them , DCI will donate 20% of all profits from these events to The Center for Disaster Philanthropy’s COVID-19 Response Fund. This charity has earned a 4-star Charity Navigator rating and is a trusted philanthropic partner of Google, Coca Cola, UPS, Verizon, and many other organizations. The fund supports preparedness, containment, response, and recovery activities for those affected by the coronavirus and for the responders.


WHAT YOU WILL LEARN

We will help you and your team better understand key industry dynamics and how COVID-19 may alter the industry.

Dr. Fein will share DCI’s latest market data and trends from The 2020 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers.

Topics for Industry Update and COVID-19 Impact: Retail & Specialty Pharmacies:
  • The key trends for retail and specialty pharmacy markets
  • The new normal for prescription demand
  • How COVID-19 will change the U.S. payer mix
  • Will the 340B program be disrupted?
  • What’s next for specialty pharmacies
  • The outlook for prescription profits
  • The future for the drugstores’ front-end profits
  • New opportunities for pharmacists as providers
  • My reflections on life in a pandemic world and beyond

Topics for Industry Update and COVID-19 Impact: PBMs & Payers:
  • The key trends for PBMs
  • An update on the latest prescription data
  • What the changing U.S. payer mix means for PBMs and insurers
  • The outlook for benefit design
  • PBMs' role in Managed Medicaid
  • More on the 340B Drug Pricing Program
  • Disruption to the buy-and-bill channel
  • Promise and perils of vertical diversification
  • Further reflections on life in a pandemic world

PLUS: Dr. Fein will take your questions during the event. CLICK HERE to submit questions to Dr. Fein in advance of the events.

IMPORTANT STUFF TO KNOW
  • After you register, you will receive an email with the information you will need to access our live video webinar and add it to your calendar. We will also send you reminder emails one day and one hour before the event.
  • Watch and listen via any device with a web browser (computer, iPad, iPhone/Android, etc.)
  • After each event, you’ll receive a downloadable PDF with the event slides.
  • If your plans change and you can’t make it on May 1 or May 8, we will provide an opportunity to watch a replay of the live video events. Unfortunately, we are unable to offer refunds.
  • Pembroke Consulting clients receive free access to the webinar. Contact Tamra Feldman (admin@drugchannels.net) for details. We will automatically refund payments from anyone at a Pembroke client who purchases access using their corporate email account.

        




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Four Unexpected Ways that the COVID-19 Medicaid Boom Will Affect PBM and Pharmacy Profits

The U.S. economy is in a medically-induced coma. Unemployment is soaring. Companies are teetering on the brink of bankruptcy. It is unclear when our lives will return to their pre-pandemic state.

One thing seems apparent: As people lose jobs and health insurance, Medicaid enrollment will jump, perhaps by as much as 20% to 30%. This will have profound implications for the drug channel.

Today, I focus on how this increase will affect retail pharmacies and pharmacy benefit managers (PBMs). Below, I review Medicaid enrollment trends, how states manage prescriptions, and the factors driving the coming boom in Medicaid enrollment.

As I explain, many (but not all) retail pharmacies will benefit from Medicaid growth. PBMs, however, will not fare as well. Read on and see if you agree.

In early May, Drug Channels Institute will host two live video webinars: Industry Update and COVID-19 Impact: Retail & Specialty Pharmacies (May 1) and Industry Update and COVID-19 Impact: PBMs & Payers (May 8). CLICK HERE TO LEARN MORE AND SIGN UP. DCI will donate 20% of all profits from these events to The Center for Disaster Philanthropy’s COVID-19 Response Fund.

Read more »
        




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What Is Payer Intelligence—And How Can It Be Combined With Technology to Enhance Patient Access?

Today’s guest post comes from Scott Dulitz, Chief Strategy Officer at TrialCard. Scott discusses how combining payer intelligence with market-leading technology can enhance patient access.

TrialCard recently acquired Policy Reporter, a healthcare software solutions company that provides payer intelligence to the biopharmaceutical, medical device, and diagnostics industries. To learn more, schedule a demo of Policy Reporter or contact Scott (scott.dulitz@trialcard.com).

You can also register for Trialcard’s upcoming webinar: Leveraging Payer Intelligence in Patient Service Programs.

Read on for Scott’s insights.
Read more »
        




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Medication Access During Uncertain Times—Improving Provider Workflows to Help Patients in Need

Today’s guest post comes from Miranda Gill, Senior Director of Provider Network at CoverMyMeds.

Miranda reviews how the pandemic affects the ability of healthcare workers to complete administrative responsibilities like prior authorization. She then outlines how electronic automation is helping patients get needed medications while face-to-face interactions are restricted.

Learn more about healthcare IT solutions for providers and patients in CoverMyMeds’ 2020 Medication Access Report, or schedule a virtual meeting.
Read more »
        




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The Top 15 Specialty Pharmacies of 2019: PBMs Stay On Top

In Drug Channels Institute's list of the top 15 pharmacies of 2019, we show that many of the largest U.S. pharmacies are now central-fill mail and specialty pharmacies operated by PBMs and insurers.

To complement that broader ranking, we present below our exclusive list of the top 15 pharmacies based on specialty drug dispensing revenues. Consistent with our previous analyses, PBMs and insurers have retained their dominance over specialty drug channels, while smaller pharmacies are facing increased competition and profit pressures.

I see upside for specialty pharmacies in the aftermath of the pandemic. This growth will come at the expense of provider-administered drug channels. I expect the top companies’ share will increase in 2020, due to mergers and business transitions among the largest PBMs. However, the increasing role of government payers may create opportunities for smaller pharmacies.

This Friday, I’ll discuss how COVID-19 will affect the specialty pharmacy market during the first of my two live video webinars.

Over the next two weeks, Drug Channels Institute will host two live video webinars: Industry Update and COVID-19 Impact: Retail & Specialty Pharmacies (May 1) and Industry Update and COVID-19 Impact: PBMs & Payers (May 8). CLICK HERE TO LEARN MORE AND SIGN UP. Contact Paula Fein (paula@drugchannelsinstitute.com) for our special promo codes for multiple viewing sites. DCI will donate 20% of all profits from these events to The Center for Disaster Philanthropy’s COVID-19 Response Fund.

Read more »
        




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Drug Channels News Roundup, April 2020: Drug Pricing Outlook, COVID-19 Data Tracker, Community Oncology Clinics, and My Favorite Chart of 2020

Rumor has it that Spring has finally reached our worldwide headquarters here in beautiful downtown Philadelphia. (See photo at right.) While we wait to go outside, please enjoy this month’s selection of noteworthy news:
  • The outlook for drug prices
  • A outstanding (and free!) resource for tracking COVID-19 daily data
  • What’s up with community oncology practices?
Plus, I share my favorite chart of 2020 (so far).

P.S. Join the more than 9,200 followers of my curated links to neat stuff at @DrugChannels on Twitter. My recent tweets have highlighted: Prime Therapeutics new gene therapy offering, AmerisourceBergen’s laudable deal with the Justice Department, the Costco/Instacart deal, Rite Aid’s new CEO, clinical trial trends, vaccine pricing, and much more! I have also been tweeting under-the-radar stories about how the coronavirus is affecting drug channels.

Tomorrow (May 1), Drug Channels Institute will host the first of two live video webinars: Industry Update and COVID-19 Impact: Retail & Specialty Pharmacies. We'll host the second video webinar—Industry Update and COVID-19 Impact: PBMs & Payers—on May 8. CLICK HERE TO LEARN MORE AND SIGN UP. Contact Paula Fein (paula@drugchannelsinstitute.com) for our special promo codes for multiple viewing sites. DCI will donate 20% of all profits from these events to The Center for Disaster Philanthropy’s COVID-19 Response Fund.

Read more »
        




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Insurers + PBMs + Specialty Pharmacies + Providers: Will Vertical Consolidation Disrupt Drug Channels in 2020? (rerun)

This week, I’m rerunning some popular posts while I prepare for this Friday’s video webinar: Industry Update and COVID-19 Impact: PBMs & Payers.

Life was very different when I originally published today’s article. 2020 is not turning out to be quite what any of us expected. However, the pandemic has exposed some intriguing pros and cons of vertical consolidation. Click here to see the original post and comments from December 2019.


The largest insurers, PBMs, and specialty pharmacies have now combined into vertically-integrated organizations. As I explain below, these companies have also been rapidly integrating with healthcare providers.

I also provide an updated look at these companies and highlight strategies that they are using—or could use—to control the channel. I believe that these insurer / PBM / specialty pharmacy / provider organizations are poised to restructure U.S. drug channels by exerting greater control over patient access, sites of care/dispensing, and pricing.

If they can effectively coordinate their sprawling business operations, they will pose a substantial threat of disruption to the existing commercial strategies of pharma companies.

Will they succeed by better managing care and costs, or merely by extracting higher profits from our convoluted system?
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Express Scripts vs. CVS Health: Five Lessons From the 2020 Formulary Exclusions and Some Thoughts on Patient Impact (rerun)

This week, I’m rerunning some popular posts while I prepare for this Friday’s video webinar: Industry Update and COVID-19 Impact: PBMs & Payers.

Today's rerun highlights one of the most effective tactics that PBMs have developed to extract deeper discounts from brand-name drug makers. COVID-19 seems likely shift the U.S. payer mix away from commercial health plans. Expect even tighter formulary management and more restrictions as PBMs work even harder to cut costs for their plan sponsor clients.

Click here to see the original post and comments from January 2020.




For 2020, the two largest pharmacy benefit managers (PBMs)—Express Scripts and the Caremark business of CVS Health—have again increased the number of drugs they have excluded from their standard formularies. The 2020 formulary exclusion lists are available below for your downloading pleasure.

Below, I highlight my key takeaways from the 2020 lists:
  • The number of exclusions
  • Management of specialty drugs
  • Indication-based formularies
  • The slow adoption of biosimilars
  • The PBMs’ patient-unfriendly exclusions in the hepatitis C category
Formulary exclusions have emerged as a powerful tool for PBMs to gain additional negotiating leverage against manufacturers. The prospect of exclusion leads manufacturers to offer deeper rebates to avoid being cut from the formulary. Exclusions are therefore a key factor behind falling brand-name net drug prices.

Read on for a look at this year’s exclusions along with some closing thoughts on what exclusions mean for patients.
Read more »
        




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Astronomers May Have Found the Closest Black Hole to Earth

At just 1,000 light-years away, an object in a nearby star system could be our nearest known black hole—but not everyone is convinced

-- Read more on ScientificAmerican.com




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Comets Prevent Ether from Accumulating in Space

Originally published in January 1859

-- Read more on ScientificAmerican.com




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'Breakthrough' COVID-19 Tests Are Currently Cheap, Fast--and Not Very Accurate

Antigen-based assays could be used in the home, but critics say their error rates are still an issue

-- Read more on ScientificAmerican.com




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DIY Tool Lets High Schoolers Practice Gene Editing  

With a few dollars, researchers replicated an instrument that typically costs thousands 

-- Read more on ScientificAmerican.com




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Scientist Mothers Face Extra Challenges in the Face of COVID-19

The pandemic is amplifying nearly every disadvantage that women in STEM already face. But institutions and the scientific community can help

-- Read more on ScientificAmerican.com




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To Prevent the Next Pandemic, End Unequal Access to Natural Resources

Safeguarding public health requires rethinking our relationship to the environment and the inequities that drive its destruction

-- Read more on ScientificAmerican.com




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Heat and Humidity Are Already Reaching the Limits of Human Tolerance

Events with extreme temperatures and humidity are occurring twice as often now as they were 40 years ago

-- Read more on ScientificAmerican.com




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ACRO Testifies About Clinical Trials In New Jersey

Washington, DC – October 24, 2017 – On October 19 ACRO Executive Director Doug Peddicord, Ph.D., testified at a public hearing of...




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ACRO Urges Modernization of the R&D Tax Credit

WASHINGTON – November 14, 2017 – As the Senate begins debate on a tax reform bill, the clinical research industry hopes that...




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John Ratliff of Covance Elected 2018 ACRO Chairman

WASHINGTON–(BUSINESS WIRE)–The Association of Clinical Research Organizations (ACRO) is pleased to announce that its Board of Directors has elected John Ratliff, CEO of Covance Drug...




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ACRO Opposes Fatally-Flawed Right-To-Try Legislation

In May of 2017 the Board of Directors of the Association of Clinical Research Organizations, which represents the world’s leading clinical research...




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Who’s in and who’s out? ACRO talks Inclusion-Exclusion Criteria

ACRO joins FDA public meeting to discuss trial risks and rationale, benefits and barriers Clinical trials have an enormous number of inter-related,...




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ACRO members talk UK competitiveness and enabling post-Brexit success

What happens to clinical research when the UK leaves the EU’s common market and regulatory structure? When public perceptions seem locked onto...




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Dr. Cynthia Verst of IQVIA Elected 2019 ACRO Chair

Washington DC – The Association of Clinical Research Organizations (ACRO) is pleased to announce that its Board of Directors has elected Dr. Cynthia Verst,...




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ACRO testifies before IRS and Treasury Department on proposed Base Erosion and Anti-Abuse Tax (BEAT) regulation

On Monday, March 25, 2019 ACRO provided testimony at a public hearing held by the Internal Revenue Service (IRS) and Treasury Department...




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ACRO expands membership with addition of three digital technology companies

The Association of Clinical Research Organizations (ACRO) is pleased to announce the expansion of its membership to include ERT, Oracle and Veeva. These new ACRO member companies, with their focus on digital technologies that enable global clinical trials, characterize the ongoing innovation and evolution of contemporary clinical research. ACRO now has 12 member companies.




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ACRO offers unique insights on risk-based monitoring of clinical trials, calls for adoption of RBM as a best practice

Following meetings with then-Commissioner Scott Gottlieb and senior leadership from the Center for Drug Evaluation and Research on the role of CROs and technology companies in designing and implementing risk-based monitoring (RBM) of clinical trials, ACRO this week submitted extensive comments on recent FDA Guidance.Increasing the use of innovative RBM technologies helps make clinical trials safer, more efficient and higher quality. ACRO’s comments offer unique insights into the recent expansion of RBM implementation and call for further increasing the use of these oversight technologies.




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New ACRO Report Quantifies Benefits of RBM for Quality Reviews

A new report based on a survey of ACRO members reveals that Risk-Based Monitoring (RBM) makes clinical trial quality review more efficient...




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A Consistent Approach to Risk Based Quality Management: Collaboration is Key

Developing, executing and overseeing clinical trials is a complex process. Yet it is essential to gain reliable evidence from clinical trials to...




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ACRO hosts Congressional Briefing on clinical research advancements

On Wednesday, October 23, 2019, ACRO hosted a Congressional Briefing on Capitol Hill. With the help of the Congressional Research & Development...




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ACRO Members Heed the UK Government’s Call for Volunteers in Response to the COVID-19 Pandemic

May 6, 2020 – (Washington, DC) – In an effort to fight the global COVID-19 pandemic, over 150 employees from clinical research...