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The next posting will be on January 2, 2023

FDA’s Cybersecurity Plans

Cybersecurity among the top priorities of the FDA https://www.fda.gov within the Office of Digital Transformation (ODT), protects people and data in today’s environment of increased cybersecurity threats.

ODT will also identify, prioritize, and validate cybersecurity governance, standards, and solutions to support the secure adoption of emerging technologies across the agency. These activities will drive and inform FDA’s ongoing modernization efforts.

ODT includes the Office of Information Management and Technology (OMIT), the Office of Information Security (OIS), and the Office of Data, Analytics, and Research (ODAR). ODT published the report November 2022 titled “Our People Centered Approach to Driving Change at FDA” at https:///www.fda.gov/media/1632591/download

FDA recognizes the risks associated with operating a global information technology enterprise and as result, developed the Cybersecurity Modernization Action Plan (CMAP). FDA’s goal is to strengthen FDA’s ability to protect sensitive information, modernize cybersecurity capabilities, and improve situational awareness to decrease overall security risks to the agency.

Key CMAP objectives are to:

• Establish a comprehensive Zero Trust approach to facilitate new digital services and modernization efforts

• Promote software assurance best practices to include security measures at every stage of the development lifecycle
• Enhance interoperable and secure data exchange and collaboration across FDA and public health partners
• Leverage Artificial Intelligence/Machine Learning (AI/ML) technologies to enhance cyber detection and response capabilities
• Integrate counterintelligence and insider risk principles with the Zero Trust model to enable an intelligence-driven approach
• Prioritize and invest in FDA’s cybersecurity workforce

CMAP will result in enhanced visibility and situational awareness, enhanced threat protections, and reduced latency and speed to the Cloud.

In addition, other FDA action plans includes developing:

• The Technology Modernization Action Plan in place to modernize FDA’s technical infrastructure and operations, enhance developing technologies, and increase communication and collaboration with external stakeholders
• The Data Modernization Action Plan to overhaul FDA;s approach to technology and data by developing consistent, repeatable data practices across FDA

Go to https://fda.gov/about-fda/office-commissiioner/office-digital-transformation for more information on the Office of Digital Transformation (ODT)

NIAID Awards Contracts & Grants

The National Institute of Allergy and Infectious Diseases (NIAID) within NIH https://www.niaid.nih.gov, has awarded $12 million to three institutions to develop antiviral therapies to treat diseases caused by viruses with pandemic potential. Approximately $61.5 million over five years will be awarded.

The new product development contracts are part of the Antiviral Program for Pandemics (APP) which aims to accelerate the discovery, development, and manufacturing of antiviral medicines. Antivirals are treatments that fight viral infections by acting directly against the virus.

The new contracts will support the development of promising antiviral candidates from late stage preclinical studies through investigational new drug applications enabling activities and clinical testing.

NIAID already supports nine Antiviral Drug Discovery (AVIDD) Centers for Pathogens of Pandemic Concern, https://www.niaid.nih.gov/research/antiviral-drug-discovery-centers-pathogens-pandemic-concern  The Centers conduct research on the early stage identification and validation of novel viral targets along with identifying the early-stage characterization of antiviral drug candidates.

The new product development contracts were awarded to Microbiotix, Inc., Worcester, Mass funding for $2,069,416, to Oregon Health and Science University in Portland with funding for $4,696,452, and the Baruch S. Blumberg Institute, Doylestown, Pennsylvania with funding for $5,493,876.

In other news, NIAID has awarded the Texas Biomedical Research Institute, https://www.txbiomed.org and the Access to Advanced Health Institute (AAHI) in Seattle, https:////www.aahi.org, a $3.5 million five year grant titled Innovation for Tuberculosis Vaccine Discovery grant.

“Tuberculosis is an infectious disease that causes immense human mortality and suffering for thousands of years. This collaboration is exciting because we are bringing scientists with different expertise together to tackle this challenge”, according to Associate Professor Gillian Beamer, VMD, PhD.

The researchers at AAHI are developing several TB vaccine candidates. They are building on extensive experience designing protein and RA vaccine candidates based on AAHI’s immune-enhancing platforms incorporating adjuvant technology. Adjuvants are technology in which components make vaccines more effective by enhancing the body’s immune response.

As these TB vaccines advance further, AAHI researchers plan to investigate different ways to make them thermostable, so they can last for several months at room temperature or several years in standard refrigerators. This would eliminate the need for extreme cold storage as was required for the first generation of mRNA COVID-19 vaccines.

Dealing with Pain Management

Today, clinicians are often faced with a variety of treatment options when faced with a patient experiencing chronic pain. Meanwhile, ongoing efforts to address the public health crisis of opioid misuses has resulted in a decline in opioid prescribing among providers.

With many options to consider when treating a patient with chronic pain, primary care providers could greatly benefit from tools to facilitate decision-making around appropriate treatment plans that consider a patient’s history and input along with the balance of risks and benefits.

Researchers Christopher Albert Harle, and Ramzi Georg Salloum at the University of Florida https://www.ufl.edu received a grant from AHRQ https://www.ahrq.gov for $2,952,700 (Grant Number R18 HS028584).

Drs. Harle and Salloum believe that primary care providers delivering the right treatment for patients should involve shared decision-making and could benefit from implementing tools to facilitate the process.

The goal to scale and disseminate interoperable Chronic Decision Support (CDS) tools for chronic pain treatment such as MyPAIN and PainManager have been selected in clinics at the University of Florida Health and the OneFlorida Clinical Research Consortium.

Researchers are going to:

• Adapt and tailor Pain Manager, AHRQ’s interoperable CDS Tool for implementation in primary care clinics affiliated with the OneFlorida Clinical Research Consortium
• Evaluate the effect of tailored implementation support on Pain Manager’s adoption for pain treatment shared decision making
• Establish the feasibility and obtain preliminary data in preparation for a multisite pragmatic trial targeting the effectiveness of Pain Manager

The use of MyPAIN and PainManager will aid clinicians in collaboratively addressing chronic pain with their patients. It will allow them to share their understanding of the patient’s condition, discuss individual patient goals, and help patients make decisions about what care and treatment is going to be used.

The researchers will tailor the functionality and user interface of the existing Pain Manager tool through a series of interviews and design sessions with both patients and primary care clinicians.

They will then implement the tool into EHRs across eight clinics within the OneFlorida Clinical Research Consortium system to support shared decision-making for pain treatment. 

Collaborating to Enhance Care

Evernorth https://www.evernorth.com is entering into a multi-year strategic collaboration by investing in VillageMD https://www.villagemd.com, one of the largest independent primary care groups in the U.S. with expertise in value-based care.

By collaborating with VillageMD, Evernorth will create a value -based care model to allow patients to move seamlessly between virtual, digital, and in-person physicians. By collaborating with VillageMD, healthcare costs will be reduced and patients will receive appropriate care at the right time.

As part of the collaboration, Evernorth will bring their suite of health services to VillageMD’s physicians and patients, including specialty care capabilities such as chronic condition management. VillageMD’s physicians will also benefit from Evernorth’s real time data and clinical insights at the point of diagnosis to help determine optimal treatment paths.

In another move, MDLIVE https://www.mdlive.com, an Evernorth company, has announced the next evolution of their rapidly growing virtual primary care program to help patients with chronic conditions. Beginning in 2023, millions of people with MDLIVE Virtual Primary Care covered through their health or employer, will also have access to the chronic condition management program. It will initially be available for patients with hypertension and expand throughout the year to other common chronic conditions.

Qualified patients will work with their MDLIVE primary care doctor to develop a personalized care plan that includes condition management and lifestyle goals, lab tests, medication management, and any necessary referrals to other health providers. In between regular visits, their care team will track their progress with remote monitoring through connected devices, such as blood pressure cuffs and blood glucose monitoring devices. 

NASA Testing Remote Delivery

A new remotely controlled drug delivery implant could one day provide extended, adjustable medication for patients who need daily medicine but lack medical access. This could even apply to those on a spacecraft heading for Mars.

The Houston Methodist Research Institute researchers have developed such an implant. They are going have the International Space Station (ISS) National Laboratory https://www.issnationallab.org test the implant’s ability to be controlled in space from a device on Earth.

The goal is to improve the implant’s ability to transmit signals to Earth and ensure that the drug delivery system is safe for humans. The implant uses nanofluidics technology that combines membranes with very small nanochannels to deliver a controlled drug dose through diffusion.

The researchers will attempt to control the implant using Bluetooth and a Blackberry device on Earth to test different frequencies to determine if the implant can precisely deliver and adjust doses on command. The results will serve as a critical step toward the implant’s future use in space for travelers who may need safe, automated access to a medication that requires frequent dosing.

The team has also designed implants with multiple reservoirs that allow different drugs to be dosed simultaneously. The implant could be pre-programmed, facilitating its function when communications are not possible or delayed because of distance from Earth.

According to Alessandro Grattoni, Professor, Nanomedicine at Houston Methodist Research Institute, “Eventually, doctors on Earth will be able to control drug delivery implants wherever patients are located whether from remote locations on Earth to distance space by using an application on their smartphone or computer.”

Program to Help MS Patients

Helius Medical Technologies https://heliusmedical.com has introduced breakthrough technology for MS patients to help with gait deficiency to improve their walking ability. The technology known as Portable Neuromodulation Stimulator (PoNS), is available commercially by prescription to patients in the US. from 22 and older.

With the availability of new technologies and therapies, the ability to research and treat MS is rapidly growing. Studies have shown that the brain can make new connections after injury and rehabilitation by using PoNS therapy which can improve gait functionality and mobility.

PoNS a neuromuscular tongue stimulator to generate electrical pulses for stimulation of the facial nerves, can provide treatment for motor deficits if used as an adjunct to a supervised therapeutic exercise program.

In addition, the therapist can connect the controller to a computer and view PoNS therapy usage data via software developed specifically for the PoNS device. The data obtained enables the therapist to obtain important information on the individual’s adherence to their therapy regimen.

The Therapeutic Experience Program (TEP), a Helius-sponsored, open label observational, interventional multi-center is going to participate in a research clinical trial designed to assess adherence to PoNS therapy in patients with MS in a real world clinical setting.

So far, neurologists and neurorehabilitation therapists at 10 to 12 U.S. Centers of Excellence, have expressed an interest in doing the clinical trial to become early adopters of PoNS Therapy in order to advise the broader medical community.

For example, one of the first Centers of Excellence to announce a TEP partnership with Helius, was New York University-Langone Health. It was also recently announced that the Oregon (OSHU) Multiple Sclerosis Center considered one of the top programs in the country for the treatment and care of MS, will also take part in the TEP program. 

The TEP study will be conducted at ten to twelve Centers of Excellence across the U.S. with an estimated four PoNS devices per site. Enrollment is expected to continue into 2023. A total of fifty to 60 patients with MS are expected to take part in the program.

Go to https://clinicaltrials.gov/ct2/show/NCTo5437276 for more information on the upcoming clinical trial to assess adherence to PoNS therapy in patients with MS. The clinical trial is titled: TEP Study for Improvement of Gait in People with MS.