FDA seeks comments on Increasing "Patient Access to At-Home Use Medical Technologies"

FDA's CDRH division is seeking public input on "advancing health equity and facilitating access to medical devices designed to be safe and effective when used outside of traditional clinical settings, for example, medical devices intended for use in the home".

From the website:

In particular, CDRH seeks comment from the public on the following questions:

• How can the FDA support the development of medical technologies, including digital health technologies and diagnostics, for use in non-clinical care settings, such as at home?
• What factors should be considered to effectively institute patient care that includes home-based care?
• What are ways that digital health technologies can (a) foster the conduct of clinical trials remotely and (b) support local or home-based healthcare models?
• How can the FDA facilitate individuals accessing medical technologies in remote locations when they are unable or unwilling to access care in clinical settings?
• What processes and medical procedures, including diagnostics, do you believe would be ideal for transitioning from a  hospital and/or healthcare setting to non-clinical care settings, for example, home use or school/work use?
  • What medical technologies could be ideal to transition to use in non-clinical settings? What aspects of those technologies could potentially benefit from modifications to optimize use in non-clinical settings?
• What design attributes and user needs would facilitate the use of medical technologies, including diagnostic and therapeutic devices, for use in a non-clinical setting, for example home use?
• For digital health technologies, what design attributes could better facilitate their use by diverse patient populations outside of a clinical setting? What other factors are important to consider which may improve use and acceptance of different digital health technologies by diverse patient populations (for example, older adults, non-English speakers, lower literacy)?
• What potential methods and strategies for evidence generation and data analysis could facilitate the regulatory review of medical technologies intended to be used in non-clinical settings, for example home use or school/work use?

Please submit all public comments to the docket (FDA-2023-N-1956), available at Regulations.gov. The public comment period will end on August 30, 2023.

Submit Comments by August 30

 

AAPS PharmSci 360 Conference Program is Available (22-25 October in Orlando)

The AAPS PharmSci 360 Conference Program has been posted.  The conference will be held in the Orange County Convention Center, Orlando, Florida from 22-25 October.   You can register and book your hotel here.

If you're not familiar with PharmSci360, it is a conference that offers scientific presentations and posters across all fields of drug development along with career development sessions and a solution center with extensive vendors.

Pick any of the 5 Science Tracks (Discovery and Basic Research, Bioanalytics, Preclinical and Translational Science, Formulation and Delivery, Manufacturing & Analytical Characterization) or mix and match presentations to focus on the development of specific modalities.

Join me and your peers to discuss the latest science and network with others from around the globe.

Recent publication: "Considerations for drug development biomarker assays in the clinical laboratory"

I'm pleased to share that a Commentary, co-authored with John Allinson and Steven Piccoli, has been published ahead of print in Bioanalysis, "Considerations for drug development biomarker assays in the clinical laboratory” (link). In it, we consider the differences between FDA BMV and clinical laboratory biomarker regulations and the reliability of the data. Specifically, the challenges clinical laboratory biomarker data used to support safety and efficacy endpoints in regulatory filings face due to their operational practices that differ than those recommended in the BMV, while being accepted for medical decision in patient care.

I have to acknowledge Erica Troksa, who challenged me to think about this issue several years ago and change my perspective; ultimately leading to this publication. 

Here is the first paragraph:

"Of late, the phrase 'context of use' (COU) has become widely used to describe the performance characteristics required in a biomarker assay used in drug development programs.  In clinical laboratories, including those supporting clinical trials, biomarker assays have been established to support the medical community in the diagnosis, treatment and monitoring of patients with various diseases.  Advances in therapeutic modalities has expanded the number of diseases for which therapies are being developed. Frequently, clinical laboratories have biomarker assays used in disease treatment that are now being evaluated for use in clinical trials to demonstrate the safety and efficacy of new therapies, and in some cases the biomarkers act as a number of different study endpoints, including predictive and prognostic, while some aspire to be surrogate endpoints. The introduction of the term COU has raised a number of questions in the scientific and regulatory communities due to the shift from one regulatory environment (medical practice) to another (new therapy approval).  In this article, we will review the issues, similarities and differences in the expectations and approaches between these two regulatory perspectives on measuring biomarkers; in particular looking at the question of why pivotal biomarker assay data from clinical laboratories used for medical decisions is not, in some cases, perceived as acceptable by health authorities when considering the approval of new drug therapeutics."

 

 

Sciex Webinar: Driving more sensitive and selective bioanalysis using accurate mass spectrometry

 Sciex is having a webinar, Driving more sensitive and selective bioanalysis using accurate mass spectrometry  on Thursday, 29Jun23 at 10AM ET (getting in before Agilent's 3 hr webinar that I posted yesterday.

 From the Registration page (Register here).

Quantitation of small and large molecule therapeutics in biological matrices is important during drug development. Quadrupole-based liquid chromatography coupled with mass spectrometry (LC-MS) has been routinely adopted for the quantitation of therapeutics in bioanalytical laboratories. Advances in accurate mass spectrometry have enabled it to become a complementary option for quantitative bioanalysis. These advances include greater selectivity, improved mass resolution and the flexibility of time-of-flight (TOF) MS/MS for data analysis.

These advances include greater selectivity, improved mass resolution and the flexibility of time-of-flight (TOF) MS/MS for data analysis. Here, quantitative analysis was performed on the ZenoTOF 7600 system, where the application of the Zeno trap enhanced overall MS/MS sampling efficiency and boosted quantitative sensitivity for bioanalysis. 

What will you learn?

• How to achieve low-level quantitation of small and large molecules in challenging biological matrices using the ZenoTOF 7600 system, featuring the Zeno trap for enhanced MS/MS sampling efficiency
• How to streamline quantitation methods by collecting data over a wide MS/MS range for flexible post-acquisition data processing
• How to increase productivity with a user-friendly interface and integrated platform for data acquisition, processing and management for routine bioanalysis using SCIEX OS software

Webinar with 3 presentations on "Agilent’s Theory of Mass Spectrometry: Life Science Edition"

Agilent’s Theory of Mass Spectrometry: Life Science Edition

Thursday, June 29, at 08:00 PDT / 10:00 CDT / 11:00 EDT 

In the words of Albert Einstein, “We cannot solve our problems with the same thinking we used when we created them.” It takes outside-the-box thinking to continue to innovate and push the limits of what is possible. Each day, you and your team work tirelessly to push those boundaries and create a better world, and Agilent is here to help you every step of the way. Instrument intelligence and innovation are of utmost importance, and together we can discover endless possibilities.

Join this webinar series to learn how Agilent's intelligent and innovative mass spectrometry solutions are helping to pave the way to new discoveries in the field.

Session 1 - Accelerating analysis in the biopharma laboratory
08:00 PDT/ 10:00 CDT/ 11:00 EDT

Session 2 - Multi-omic, mass spectrometry-based elucidation of mechanisms of L-asparaginase toxicity in a mouse model of cancer
09:00 PDT/ 11:00 CDT/ 12:00 EDT

Session 3 - Elucidating cellular metabolism with a full suite of next-generation omics tools
10:00 PDT/ 12:00 CDT/ 13:00 EDT

Register here: https://view6.workcast.net/register?cpak=3398767658905354&referrer=SelectScience-Promo-1

FDA published notification on 6 guidance documents

 FDA released a number of final and draft guidance last Friday (2Jun2023):

Recently Posted Guidance Documents

• 6/22/2023 - Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry: Guidance for Industry
• 6/5/2023 - Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals
• 6/2/2023 - Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment: Draft Guidance for Industry
• 6/2/2023 - Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: Guidance for Industry and Food and Drug Administration Staff
• 6/1/2023 - Guidance for Industry: Action Level for Inorganic Arsenic in Apple Juice
• 6/1/2023 - Migraine: Developing Drugs for Preventive Treatment

Interesting is that the first two are dated for later in the month.

The first one will have a lot of interest due to the number of therapeutic proteins in drug development.  The second is of interest for those who would have to conduct the studies, as well as analyze the samples to determine if immune-suppression or -stimulation is occurring.