iBIO https://ibio.org To promote, connect and engage the life sciences community Tue, 31 Mar 2020 16:39:03 +0000 en-US hourly 1 https://ibio.org/wp-content/uploads/cropped-android-chrome-512x512-32x32.png iBIO https://ibio.org 32 32 Takeda’s BioLife Plasma Services is looking for healthy individuals who have recovered from COVID-19 https://ibio.org/takedas-biolife-plasma-services-is-looking-for-healthy-individuals-who-have-recovered-from-covid-19/ https://ibio.org/takedas-biolife-plasma-services-is-looking-for-healthy-individuals-who-have-recovered-from-covid-19/#respond Tue, 31 Mar 2020 12:50:51 +0000 https://ibio.org/?p=5379 BioLife Plasma Services, part of Takeda, has implemented a unique protocol for collecting plasma from healthy individuals who have recovered from COVID-19 to enable development of a potential therapy for COVID-19, made from human plasma. You can read more about this here.

The more prospective healthy donors we can identify as early as possible, the sooner we may be able to initiate development of this potential treatment and the more therapies we can potentially provide.

If you know of someone who has fully recovered from COVID-19 and is no longer contagious (at least 14 days post-symptoms), and who might be interested in donating their plasma to support development of a therapy that may help individuals at high-risk of COVID-19, please ask them to contact our MedInfo Center at 1-877-TAKEDA-7 (1-877-825-3327). Contacting us to learn more does not obligate individuals to donate and we will treat individual data in line with all appropriate data privacy regulations.

With the SARS-CoV-2 virus continuing to spread and cases of COVID-19 continuing to rise worldwide, we count on the support of those who have recovered to help us with our efforts to develop a potential treatment for those most at risk.

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2020 Women’s Venture Competition Deadline is April 16th (Boston) https://ibio.org/2020-womens-venture-competition-deadline-is-april-16th-boston/ https://ibio.org/2020-womens-venture-competition-deadline-is-april-16th-boston/#respond Tue, 31 Mar 2020 00:30:19 +0000 https://ibio.org/?p=5376 The AIM-HI Accelerator Fund, a venture philanthropy organization created in 2019 with support from the National Foundation for Cancer Research, will conduct its 2020 Women’s Venture Competition later this year in Boston—originally scheduled for May 20 but potentially being moved to a later date due to the coronavirus. Women-led oncology start-up companies or female-led venture teams aspiring to soon establish such a business are eligible and encouraged to apply online by April 16.

Reviewing and judging will be conducted by panels comprised of some of the most respected minds in the cancer research, investment and technology commercialization fields
All participants will be offered access to intensive accelerator boot-camp programming by renowned training service provider Springboard Enterprises
The winning business will be eligible for $300,000 in AIM-HI investment

Learn more and apply here now!

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Medtronic Publishes Ventilator Design Specifications https://ibio.org/medtronic-publishes-ventilator-design-specifications/ https://ibio.org/medtronic-publishes-ventilator-design-specifications/#respond Mon, 30 Mar 2020 16:37:07 +0000 https://ibio.org/?p=5367 Medtronic is publicly sharing the designs for one of its ventilator models to help people across the world to devise options for rapid ventilator manufacturing.

The move is designed to help doctors and patients combat the impact of Covid-19.

The Puritan Bennet 560 has been on sale for ten years and is sold in 35 countries around the world. It is suitable for both adults and children and can be used in hospitals and in home settings.

The company has published product and service manuals as well as design requirement documents, manufacturing documents and schematics on its website for others to access.

Register with Medtronic to Download the Ventilator Files

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Help Illinois Manufacturers and Companies Address PPE Supply Chain Gaps https://ibio.org/help-illinois-manufacturers-and-companies-address-ppe-supply-chain-gaps/ https://ibio.org/help-illinois-manufacturers-and-companies-address-ppe-supply-chain-gaps/#respond Mon, 30 Mar 2020 12:38:29 +0000 https://ibio.org/?p=5345 Last week iBIO joined the Illinois Manufacturers Association (IMA) and Governor JB Pritzker to announce the formation of the Essential Equipment Taskforce and iBIO’s COVID-19 PPE Response Fund.

The Essential Equipment Taskforce is a public and private sector partnership to help companies bridge significant gaps in the healthcare manufacturing supply chain and directly provide personal protective equipment and other supplies to the Illinois’ front-line healthcare workers so they can treat patients safely and efficiently.

Illinois manufacturers are stepping up to help supply needed PPE to our front line healthcare workers, but they need help. We need technical experts in legal, regulatory, engineering and other key services to help our manufacturers adjust their operations.

To coordinate our community’s support, iBIO has launched our Essential Equipment Taskforce Resource Center. The Resource Center helps manufacturers, suppliers, service providers and other members of the community support the Essential Equipment Taskforce’s efforts to bridge the gaps in our healthcare supply chain.

Essential Equipment Taskforce Center

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iBIO COVID-19 PPE Response Fund Announces First Major Donation and Order of Personal Professional Equipment https://ibio.org/ibio-covid-19-ppe-response-fund-announces-first-major-donation-and-order-of-personal-professional-equipment/ https://ibio.org/ibio-covid-19-ppe-response-fund-announces-first-major-donation-and-order-of-personal-professional-equipment/#respond Fri, 27 Mar 2020 17:32:56 +0000 https://ibio.org/?p=5302 On Monday iBIO joined the Illinois Manufacturers Association (IMA) and Governor JB Pritzker to announce the formation of the Essential Equipment Taskforce and iBIO’s COVID-19 PPE Response Fund. Working in partnership with IMA, we will bring additional supplies and resources to the state’s frontline healthcare workers and first responders so they can continue to test and treat patients safely and efficiently.

Thanks to the leadership of Horizon Therapeutics CEO Tim Walbert and the generous seed donations from Horizon Therapeutics to iBIO’s COVID-19 Response Fund, our BIO Business Solutions lab supply partner has already been able to source an order of 62,500 personal protective equipment (PPE) items valued at more than $400,000. 

The order includes PPE items listed by the state as most critically in need to protect Illinois’ frontline healthcare workers. These items will be sent to the Illinois Emergency Management Agency (IEMA), which will distribute products to the Illinois healthcare ecosystem to ensure that the supply is equitable.

With this fund and our community’s leadership, we are making an immediate impact. Join Horizon in supporting our frontline healthcare workers. Donate unused medical products or a make a finance donation to iBIO’s COVD-19 PPE Response Fund.

DONATE

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Abbott Lances Molecular Point-of-Care Five Minute Coronavirus Test https://ibio.org/abbott-lances-molecular-point-of-care-five-minute-coronavirus-test/ https://ibio.org/abbott-lances-molecular-point-of-care-five-minute-coronavirus-test/#respond Fri, 27 Mar 2020 16:36:03 +0000 https://ibio.org/?p=5383 Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the fastest available molecular point-of-care test for the detection of novel coronavirus (COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes. The test will run on the company’s ID NOW™ platform, providing rapid results in a wide range of healthcare settings such as physicians’ offices, urgent care clinics and hospital emergency departments.

The ID NOW platform is small, lightweight (6.6 pounds) and portable (the size of a small toaster), and uses molecular technology, which is valued by clinicians and the scientific community for its high degree of accuracy. ID NOW is already the most widely available molecular point-of-care testing platform in the U.S. today.

“The COVID-19 pandemic will be fought on multiple fronts, and a portable molecular test that offers results in minutes adds to the broad range of diagnostic solutions needed to combat this virus,” said Robert B. Ford, president and chief operating officer, Abbott. “With rapid testing on ID NOW, healthcare providers can perform molecular point-of-care testing outside the traditional four walls of a hospital in outbreak hotspots.”

Abbott will be making ID NOW COVID-19 tests available next week to healthcare providers in urgent care settings in the U.S., where the majority of ID NOW instruments are in use today. The company is working with the Administration to deploy tests to areas where they can have the greatest impact.

The arrival of the Abbott ID NOW COVID-19 test comes a week after the company launched its Abbott m2000™ RealTime SARS-CoV-2 EUA test, which runs on the m2000™ RealTime System located in hospital and reference labs around the world. Between the two platforms, Abbott expects to produce about 5 million tests per month.

About the ID NOW™ Molecular Platform
As the world leader in point-of-care diagnostics, Abbott is adding its expertise and scale to help fight the COVID-19 global pandemic. First introduced in 2014, ID NOW is the leading molecular point-of-care platform for Influenza A & B, Strep A and RSV testing in the U.S.

ID NOW is a rapid, instrument-based, isothermal system for the qualitative detection of infectious diseases. Its unique isothermal nucleic acid amplification technology provides molecular results in just minutes, allowing clinicians to make evidence-based clinical decisions during a patient visit.

About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The ID NOW COVID-19 EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

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CARES Act Summary – Key Provisions for Small Biotech Companies https://ibio.org/cares-act-summary-key-provisions-for-small-biotech-companies/ https://ibio.org/cares-act-summary-key-provisions-for-small-biotech-companies/#respond Fri, 27 Mar 2020 12:47:30 +0000 https://ibio.org/?p=5304 The Care Act has a number of provisions to support our startup ecosystem in Illinois, including a major small business loan program to help our emerging companies keep the lights on and their employees working during this difficult financial time – loans that, subject to certain conditions, could ultimately be forgiven and thus become grants. The bill also contains various tax relief mechanisms that will help ease the burden on our smaller companies in particular.

In addition, the bill contains some new requirements on our healthcare companies involved in drug development and manufacture with respect to drug shortage disclosure and risk planning.

A summery from BIO on the relevant provisions is below

 

BUSINESS ASSISTANCE

Sec. 1102. Paycheck protection program; Sec. 1105. Loan forgiveness 

Paycheck Protection Loans
Eligible businesses: Businesses with under 500 employees or meeting the SBA size standard for a given industry (for biotechs, the limit is 1000 employees). 

  • To simplify approval and disbursement, many of the usual SBA  requirements, such as personal guarantees and financial verification are waived.
  • For reference, the SBA affiliation guide is available here. 

Loans can be used for payroll, mortgage, rent and utility payments and other debt obligations.

Loan amount calculation: 2.5 times average monthly payroll (salaries of US-based employees up to $100,000 and certain benefits) plus the outstanding amount of a disaster loan made after January 31, 2020 (allows disaster loans to be refinanced as part of this loan). 

  • Maximum amount of loan is $10 million. 

Loan forgiveness: Eight weeks of payroll, mortgage interest, rent, and utilities eligible to be forgiven. 

  • Amount forgiven will be reduced if employee numbers or compensation are reduced during that period. 

Loans available for period Feb. 15-June 30, 2020. 

Sec. 2301. Employee Retention Credit for Employers Subject to Closure Due to COVID-19 

Refundable payroll tax credit for 50% of wages paid to employees during the COVID- 19 crisis. 

Credit is available to employers whose operations were fully or partially suspended due to a COVID-19-related shut-down order or whose gross receipts declined by more than 50% compared to the same quarter in the prior year. 

For employers with over 100 full-time employees, credit is available on wages paid to employees when not providing services due to COVID-19. 

For employers with 100 or fewer employees, all wages qualify for the credit. 

Sec. 2302. Delay of Payment of Employer Payroll Taxes

Payment of employer-side Social Security taxes incurred for the rest of 2020 is deferred until January 1, 2021. 

  • 50% of the deferred amount is due by December 31, 2021 and 50% due by December 31, 2022. 

Sec. 3606. Advance Refunding of Credits

Allows employers to receive an advance refunding of tax credits due for the new paid 

sick leave program created in previous Corona stimulus package. 

SUPPLY CHAIN ISSUES 

Sec. 3101. National Academies report on America’s medical product supply chain security 

National Academies report to examine, in a manner that does not compromise  national security, the security of the medical product supply chain.

  • Dependence on critical drugs and devices that are sourced or manufactured outside the US, including potential economic impact of increased domestic manufacturing.
  • Provide recommendations to improve resilience of supply chain for critical drugs and address vulnerabilities. 

Sec. 3111. Prioritize reviews of drug applications; incentives

Prioritization of drug application review and inspections in order to prevent or mitigate a drug shortage. 

Sec. 3112. Additional manufacturer reporting requirements in response to drug shortages 

Section 3112(a) expands the current drug shortage notification provisions to include API and expands the universe of products that might need to make a shortage report. 

  • Provisions now include critical drugs necessary to respond to a public health emergency in shortage reporting requirements. 
  • Require the drug manufacturer to report on active pharmaceutical ingredients (API) and associated medical devices used to prepare or administer the finished dosage. 
    • Additional reporting by the drug manufacturer regarding the source of the API and any alternative sources for the API would be required if API is a reason for, or risk factor in, a discontinuation or interruption. 

Section 3112(b) adds the requirement of a risk mitigation plan for any drug that could qualify to make a shortage report. 

  • Drug manufacturers, API manufacturers, and manufacturers of medical devices used for preparation or administration of a drug are required to develop, maintain, and implement a redundancy risk management plan. 
    • The plan is subject to inspection during an inspection or a request from the Secretary.

Section 3112(e) adds to the annual reporting requirement for drugs and devices that each registered entity must annually report to FDA the number of drugs it produces. 

  • Annual reporting of product manufactured for commercial distribution.
  • Secretary can ask for interim report during declared public health emergency. o Includes exemption for certain biologics regarding reporting requirements at the discretion of the Secretary. 

Section 3112(f) inclusion of confidentiality provision stating, “Nothing in the amendments made by this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information.”

 

 

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FDA Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency https://ibio.org/fda-enforcement-policy-for-ventilators-and-accessories-and-other-respiratory-devices-during-the-coronavirus-disease-2019-covid-19-public-health-emergency/ https://ibio.org/fda-enforcement-policy-for-ventilators-and-accessories-and-other-respiratory-devices-during-the-coronavirus-disease-2019-covid-19-public-health-emergency/#respond Thu, 26 Mar 2020 22:17:04 +0000 https://ibio.org/?p=5232 The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from threats including emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.

FDA is issuing this guidance to provide a policy to help expand the availability of ventilators as well as other respiratory devices and their accessories during this pandemic.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the Secretary in accordance with section 319(a)(2) of the PHS Act.

Given this public health emergency, this guidance is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.

Download the final guidance document

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FDA Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry https://ibio.org/fda-temporary-policy-for-manufacture-of-alcohol-for-incorporation-into-alcohol-based-hand-sanitizer-products-during-the-public-health-emergency-covid-19-guidance-for-industry/ https://ibio.org/fda-temporary-policy-for-manufacture-of-alcohol-for-incorporation-into-alcohol-based-hand-sanitizer-products-during-the-public-health-emergency-covid-19-guidance-for-industry/#respond Thu, 26 Mar 2020 22:15:10 +0000 https://ibio.org/?p=5230 This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.

Download the final guidance document

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FDA Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency https://ibio.org/fda-enforcement-policy-for-face-masks-and-respirators-during-the-coronavirus-disease-covid-19-public-health-emergency/ https://ibio.org/fda-enforcement-policy-for-face-masks-and-respirators-during-the-coronavirus-disease-covid-19-public-health-emergency/#respond Thu, 26 Mar 2020 22:13:41 +0000 https://ibio.org/?p=5228 The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from threats including emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic.

FDA is issuing this guidance to provide a policy to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 respirators) for health care professionals during this pandemic.

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the Secretary in accordance with section 319(a)(2) of the Public Health Services (PHS) Act.

Given this public health emergency, this guidance is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.

Download the final guidance document

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