Feeds:
Posts
Comments

Posts Tagged ‘life sciences research’

Urgent Request for Action on Proposed Rule Affecting Federal Funding Grant Review

Reporter: Stephen J. Williams, Ph.D.

Yesterday I received an email from the Mesothelioma Applied Research Foundation (MARFA), as well as Life Sciences PA and the American Association for Cancer Research (AACR).  This was on a little publicized proposed change to the NIH scientific review process allowing the Office of Management and Budget (OMB) to have direct authority over the funding of grants which had passed the rigorous scientific review process.  This proposed change by the current administration could negate decision made by NIH grant review panels as well as NIH program project directors and NIH administration as well as other funding agencies.

OMB has put a deadling of July 13, 2026 for comments by the public on this proposed change so it is of urgent matter that US scientists be informed of these potential changes.

I have included the three letters below: from MARFA, Life Sciences PA, and AACR.

From the Mesothelioma Applied Research Foundation

For decades, scientific breakthroughs in mesothelioma have depended on one essential principle: research should be guided by science.

A proposed rule from the Office of Management and Budget (OMB) could weaken that principle by allowing political appointees to override scientific peer review when making federal research funding decisions. It could also allow active federally funded research projects to be terminated if deemed inconsistent with changing agency priorities.

For the mesothelioma community, the stakes are especially high.

As a rare cancer, mesothelioma research already faces significant funding challenges. Every federal grant helps advance promising discoveries, supports clinical trials, and gives patients access to new treatment options. The proposal could also restrict international scientific collaboration—partnerships that are often essential for rare disease research, where researchers must work across borders to enroll enough patients and share critical scientific knowledge.

Learn more about the Proposed Rule and how it affects mesothelioma patients and research.

We need your voice.

Please take just a few minutes to submit a public comment asking OMB to protect independent scientific peer review, preserve ongoing federally funded research, and support international collaboration for rare diseases.

Submit your public comment here: https://www.federalregister.gov/documents/2026/05/29/2026-10817/regulation-for-federal-financial-assistance#open-comment

The comment period is open until Monday, July 13th. Don’t delay submitting your comments.

Every comment demonstrates that patients, families, researchers, clinicians, and advocates are paying attention and understand what is at stake.

Thank you for standing up for the future of mesothelioma research.

Together, we can help ensure that scientific discovery continues to be driven by evidence, collaboration, and the needs of patients.

 

From Life Sciences PA

To the Membership of Life Sciences PA:

Today, we are urging you to contact your United States members of Congress on Office of Management and Budget (OMB) proposed revisions to “Guidance for Federal Financial Assistance.” You can do so through the Life Sciences PA Advocacy Action Center.

The OMB proposal, which is currently accepting public comments, would make significant changes to how research funding decisions are administered across federal agencies, including the NIH and NSF. The public comment period closes in just one week, Monday, July 13, 2026, and public comments can be submitted HERE. However, it is equally important for U.S. Senators and Representatives to hear directly from their constituents on matters like this. We encourage your outreach beyond the public comment period.

For decades, independent, merit-based scientific peer review has been the foundation of federal research funding. Currently, the NIH is investing over $2.5 billion in more than 4,300 research projects across the Commonwealth. These investments have helped establish Pennsylvania as a global leader in research and development for innovative therapies and technologies. The revisions proposed by OMB put in jeopardy the transparency, predictability, and scientific integrity of that process.

Federal research investments are critical to the success of Pennsylvania’s leading life sciences ecosystem. They support scientific discovery at our academic research institutions, foster crucial partnerships with industry, and help advance the therapies and technologies that improve the lives of patients in the Commonwealth, across the country, and around the world. Maintaining certainty, consistency, and confidence in this established research funding process is essential to sustaining scientific progress and continued economic growth.

Life Sciences Pennsylvania is sharing our concerns with members of the Pennsylvania Congressional delegation, as well as submitting public comment reaffirming the importance of preserving an independent, science-driven research funding system. We urge you to share your perspectives by submitting concerns to your U.S. Senators and Representatives HERE.

 

From AACR

AACR Statement and Call to Action Concerning OMB Proposal to Rewrite the Rules for Scientists and Physicians Who Are Improving Public Health and Saving Lives

PHILADELPHIA – The American Association for Cancer Research (AACR) is deeply concerned that the recent action of the White House Office of Management and Budget (OMB) to propose a new set of regulations on how federal grants are awarded and managed is a major threat to the National Institutes of Health (NIH) and its lifesaving mission to accelerate progress for patients with cancer and the hundreds of other diseases that afflict millions of Americans.

AACR strongly opposes many of the changes that OMB has proposed in its recently issued rule, titled “Regulation for Federal Financial Assistance.” A considerable number of the regulations included in the rule, if finalized, will be extremely disruptive to the lifesaving research that the federal government funds and oversees, mainly through NIH.

Therefore, AACR calls on the Administration to abandon this harmful proposal, as proceeding along these lines will irreparably damage NIH, an agency that is widely revered as the world’s leading medical research enterprise for its support of the innovative discoveries and groundbreaking treatments that are increasing survival rates and enhancing the quality of life for patients.

According to OMB, the intention of these proposed revisions is to improve transparency, accountability, and oversight of federal awards while reducing administrative burden and ensuring responsible stewardship of taxpayer resources. While AACR shares these goals and supports efforts to strengthen the effectiveness, integrity, and accountability of federal grant programs, a significant number of the provisions in this proposal would in fact increase administrative complexity, create uncertainty for grant recipients, reduce transparency in funding decisions, and undermine the merit-based processes that have effectively guided federal research investments. In short, this OMB proposal is reckless and does not meet the high U.S. standards required for a meritorious, impactful research grant program.

AACR has identified several especially concerning provisions in this OMB proposal that will severely set back our nation’s medical science enterprise and delay the groundbreaking treatments that are pivotal to improving patient outcomes and saving lives:

  • OMB proposes to markedly expand the power of political appointees to override expert assessment of scientific merit by subjecting every federal research funding decision to political review. These politically appointed officials are unlikely to have subject-matter expertise and would also be instructed to determine whether grant proposals are aligned with the Administration’s political priorities, regardless of their scientific merit. If political appointees are required to provide oversight of federal grant decisions and are allowed or encouraged to ignore the advice of highly qualified scientists, it will threaten the significant progress in patient outcomes that has been achieved over many decades.The merit review process, in which scientific experts in a particular field are brought together to review scientific proposals and assign scores that are based on the quality of the application and its potential to advance new knowledge, has underpinned many discoveries that have led to major improvements in public health. This objective approach to scientific review establishes a foundation of trust within the broader scientific community and throughout the U.S. population. Revising the rules to establish an environment that sidesteps traditional and transparent scientific metrics will weaken overall confidence in the U.S. research enterprise. [This area corresponds to provision 200.205 in the OMB proposal.]
  • OMB proposes to expand agency authority to suspend or terminate awards based on changing political priorities at the agency or program goals that no longer align with the Administration’s concept of “Gold Standard Science,” which is a term the Administration uses to terminate research not because it is unsound, but because it does not fit a preferred political or methodological agenda. These suspensions and terminations could take place regardless of whether the recipient is performing the project based on the previously approved scope of work. Therefore, an active grant, including a multi-year award that is already underway, could be terminated because of a political or ideological agenda.This OMB-proposed provision would create uncertainty for researchers, institutions, and patients. As one example, this proposed change may have an adverse effect on patient accrual to cancer clinical trials, as patients with cancer may be less likely to enroll if ongoing support for these clinical trials is uncertain. Cancer research often requires years of sustained investment, and permitting political appointees to discontinue support for a grant or clinical trial after the grant or clinical trial has already been awarded or begun threatens scientific progress, wastes taxpayer resources, and destabilizes research programs and studies on which patients are relying for their survival. [This area corresponds to provisions 200.340; 200.341; and 200.342 in the OMB proposal.]
  • OMB proposes to create additional barriers to scientific collaboration by imposing undue restrictions on international partnerships that are often essential for making advances against cancer and other human diseases. Modern cancer science relies on global networks of researchers, clinical trial participants, data resources, and specialized expertise. Limiting these collaborations will slow the pace of discovery and innovation. As one example among many, international collaborations are vitally important for pediatric cancer research. Because childhood cancers are rare, pooling global patient data, resources, and expertise accelerates clinical trials, drives breakthroughs in drug-resistant subtypes, and bridges survival disparities across high- and low-income countries. [This area corresponds to provisions 200.202 and 200.220 in the OMB proposal.]
  • OMB proposes to prohibit all federal funding related to diversity, equity, and inclusion. OMB’s justification includes vague language that could be interpreted in ways that restrict research on cancer disparities, access to care, and differences in outcomes among all patient populations. Cancer touches every community, yet, sadly, its burden is not shared equally. A person’s race, ethnicity, income, ZIP code, insurance status, access to screening, ability to enroll in a clinical trial, and proximity to overall high-quality cancer care shape whether cancer is found early, treated effectively, and ultimately cured. [This area corresponds to provisions 200.218 and 200.300 in the OMB proposal.]
  • OMB proposes to restrict activities that are fundamental components of innovative scientific research and that are essential to how research findings are shared and translated into patient benefit. Provisions in the OMB proposal to limit funding support for scientific publications, journal subscriptions, and attendance at scientific conferences would hinder the ability of researchers to disseminate discoveries, learn about emerging advances, and establish highly productive collaborations. [This area corresponds to provisions 200.432; 200.454; and 200.461 in the OMB proposal.]

For decades, the framework that supports America’s scientific research enterprise through agencies such as NIH and the National Cancer Institute has fueled transformative discoveries in cancer prevention, detection, treatment, and survivorship. This established system has reduced the U.S. cancer death rate by 35% since 1991, resulting in more than 4.8 million U.S. lives saved. This progress has been made possible because of research funding decisions guided by the rigorous review of grant applications by scientific experts and their assessment of these grants to improve public health—NOT guided by political and ideological considerations.

If this OMB-proposed regulation is ultimately finalized, it will severely weaken the U.S. federal research grant program that has supported American innovation and medical breakthroughs for decades. It will also upend the collaborative and evidence-based model that has resulted in U.S. leadership in cancer research and medical science.

 

Click here for Instructions on how to Submit a Comment to OMB

Click here to Contact Your Members of Congress about the proposal

It is imperative that all US scientists respond to this potential disasterous change.  NIH grant review panels take their time out of their schedule to volunteer to review grants and committ great effort and time to this labor of love.  In addition, those who write the grants have spent countless hours, days and months meticulous preparing exellent grants for review.  These scientists show an utmost committment to the conduct of great science and a dedication to their field of expertise.  Many volunteer countless hours and resources for their research, the scientific community and for patients. And most importantly, scientists include verbage and material in grants BASED ON SOUND SCIENCE, not their opinions.

Please take some time to respond to your lawmakers before July 13, 2026

Thank you

 

Read Full Post »

UPDATED on 3/28/2016

SAN FRANCISCO — What briefly appeared to be a potential bidding war for Affymetrix, a genetics analysis technology maker, fizzled out on Monday after the company chose to stick with a takeover bid from Thermo Fisher Scientific over a higher bid from a Chinese-backed suitor.

In a statement, Affymetrix reiterated its support for the $14-a-share offer from Thermo Fisher that it accepted in January.

http://www.nytimes.com/2016/03/29/business/dealbook/affymetrix-to-stick-with-thermo-fishers-takeover-proposal.html?&moduleDetail=section-news-3&action=click&contentCollection=DealBook&region=Footer&module=MoreInSection&version=WhatsNext&contentID=WhatsNext&pgtype=article 

UPDATED on 3/23/2016

Affymetrix Postpones Stockholder Meeting as Origin Ups Acquisition Offer; Board Backs Thermo Bid

UPDATED on 3/21/2016

Former Affymetrix Execs Offer to Buy Company in Alternative to Thermo Fisher Deal

NEW YORK (GenomeWeb) – Origin Technologies Corporation, founded by former Affymetrix executives for the purpose of purchasing the company, proposed today to acquire Affy for $16.10 per share in an all-cash transaction valued at approximately $1.5 billion.

The proposal comes about a week before Affy shareholders are scheduled to vote on a different deal, Thermo Fisher Scientific’s proposed acquisition of Affy for approximately $1.3 billion, which the boards of directors of both firms unanimously approved in January.

According to a letter sent by Origin to Affymetrix today, its proposal represents a 75 percent premium to Affymetrix’s unaffected closing share price of $9.21 on the last trading day prior to the announcement of Thermo Fisher’s proposed acquisition.

Fully financed by SummitView Capital, Origin said its all-cash offer represents a 15 percent premium for Affy stockholders relative to the proposed transaction with Thermo, under which stockholders would receive $14.00 per share in cash.

As part of the offer, Origin also pledged to fund payment of the $55 million termination fee that would be due to Thermo under the terms of Thermo and Affy’s January agreement.

Wei Zhou, president of the newly formed Origin, wrote in the letter to Affy today that Origin strongly believes that its offer is superior to Thermo’s based on several criteria.

First, it offers substantially higher value to Affy’s stockholders, he said. Additionally, Origin believes it is in a better position to help Affy achieve its potential as a standalone, global company focused on genomics and proteomics. The deal would also offer an opportunity to acquire new technologies in the complete human genome sequencing space, Zhou wrote.

If the Origin-Affy merger goes through, Origin would have a separate option of combining with another company founded by Zhou in 2009, Centrillion Technology Holdings Corporation.

SOURCE

https://www.genomeweb.com/business-news/former-affymetrix-execs-offer-buy-company-alternative-thermo-fisher-deal

 

Affymetrix: Sales $350 million, Acquisition Price $1.3 billion – Advantages: Cytogenetics, Genotyping and Gene Expression Analysis

Reporter: Aviva Lev-Ari, PhD, RN

Thermo Fisher Scientific Inc.

NYSE: TMOJan 12 1:13 PM EST
136.60Price increase1.72 (1.28%)

Thermo Fisher Scientific to acquire Affymetrix for $1.3 billion

WALTHAM, Mass. – Thermo Fisher Scientific Inc., announced Jan. 8 that it has agreed to acquire Affymetrix Inc. for $14.00 per share in cash, or roughly $1.3 billion. The transaction, approved by the boards of directors of both companies is pending shareholder approval and is expected to close in the second quarter this year.

Santa Clara, Calif.-based Affymetrix was founded in 1992 and is a pioneer in the field of

  • microarray technology, launching its
  • GeneChip line in 1994. Today, the company serves both the
  1. life sciences research and
  2. clinical markets

Over the past ten years, the company has broadened its portfolio of tools that enable both

  • multiplexed and
  • parallel analysis of
  • biological systems at the cell, protein and genetic level.

Notable acquisitions for Affymetrix have included genetic tools company ParAllele Bioscience (2005), genetic, protein and cellular analysis provider Panomics (2008), and eBioscience (2012), which included one of the world’s largest selections of

  • antibodies,
  • ELISAs, and
  • proteins

for life science research and diagnostics.

“The acquisition of Affymetrix will strengthen our leadership in biosciences and create new market opportunities for us in genetic analysis,” said Marc N. Casper, president and CEO of Thermo Fisher Scientific. “In biosciences, the company’s antibody portfolio will significantly expand our offering in the fast-growing flow cytometry market, and customers will have greater access to these products through our global scale and commercial reach. In genetic analysis, Affymetrix’s technologies are highly complementary and present new opportunities for us in targeted

  • clinical and
  • applied markets.”

According to Frank Whitney, president and CEO of Affymetrix, the acquisition will allow the company to continue to build upon the close relationships it has created with customers, while deepening its reach into the biopharma market. “We are excited about the opportunity to combine our portfolios and strengthen our position in high-growth markets such as

  • single-cell biology
  • reproductive health and
  • AgBio

According to information provided by Thermo Fisher, benefits of the acquisition include expanding its offerings of its antibody portfolio via the eBioscience line of products, which also includes

  • multiplex RNA,
  • protein assay
  • single-cell assays
  • genetic analysis capabilities via complementary products used in
  1. cytogenetics
  2. genotyping and
  3. gene expression.

Thermo expects Affymetrix will add $0.10 in adjusted earnings per share in the first full year of ownership, while creating $70 million in operational savings by year three. Affymetrix has annual revenues of approximately $350 million and will be integrated within Thermo Fisher’s Life Sciences Solutions business unit.

SOURCE

http://www.thejournalofprecisionmedicine.com/thermo-fisher-scientific-to-acquire-affymetrix-for-1-3-billion/

 

Other related articles published in this Open Access Online Scientific Journal include the following:

 

Gene Editing: The Role of Oligonucleotide Chips

Curator: Aviva Lev-Ari, PhD, RN

http://pharmaceuticalintelligence.com/2016/01/07/gene-editing-the-role-of-oligonucleotide-chips/

 

Articles on Immune-Oncology Molecules In Development @pharmaceuticalintelligence.com

Curators: Stephen J Williams, PhD and Aviva Lev-Ari, PhD, RN

http://pharmaceuticalintelligence.com/2016/01/11/articles-on-immune-oncology-molecules-in-development-pharmaceuticalintelligence-com/

 

 

Read Full Post »