Insights

Only one out of 24 dermal drug candidates reaches the market. The key reason for development failure is often a lack of information on drug availability and the drug‘s mode of action in the skin. This leads to expensive late-stage clinical trial failures and ultimately to delayed patient benefits.

dOFM is a sampling technology that enables continuous monitoring of pharmacokinetics and pharmacodynamics of drugs in skin tissue. This webinar presents preclinical dOFM models and early clinical pilot studies that can be used to provide crucial information predicting the outcome of a main clinical study. The effectiveness of this approach will be demonstrated by presenting selected case studies that illustrate the predictive power of dOFM results for the clinical efficacy of drugs in development. The ability of gaining such insights at the early phase of drug product development is a key factor for pharma companies to follow a „Win Quick Fail Fast” strategy.

Our Speakers

Thomas Birngruber, PhD Deputy Director Joanneum Research HEALTH, Head of Research Group Biomedical Tissue Monitoring

Thomas Birngruber has a background in biomedical engineering, inter-disciplinary medical research and in-vivo sampling techniques. He has more than 15 years of experience with the use of Open Flow Microperfusion (OFM) and other sampling techniques in different tissues (brain, dermal, and adipose tissue). He has led the optimization and standardization of dermal OFM in the last few years.

Contact: thomas.birngruber@joanneum.at

Wen-Kai Hsiao, PhD Business Developer, Biomedical Tissue Monitoring

Wen-Kai Hsiao has a background in mechanical engineering. Prior to joining Joanneum Research HEALTH he worked in a broad range of fields including academia, entrepreneurship, and advanced process development for the pharmaceutical industry.

Contact: wen-kai.hsiao@joanneum.at

Register for our webinar "New Ways to Derisk and Accelerate Dermal Drug Development" here

FORCE REPAIR: Innovating Chronic Wound Treatment

Petra Kotzbeck and Thomas Birngruber joined a multidisciplinary team of 14 European partners to share and coordinate efforts, knowledge, and wound management expertise in a first kick-off event. “We finally met all consortium members in person at the kick-off event of the recently funded EU project FORCE REPAIR Wounds. The aim of the project and its international research team is to create a smart, multifunctional, and cost-effective 3D-printed wound dressing for innovative chronic wound treatment.” says Petra Kotzbeck, group leader at JOANNEUM RESEARCH COREMED –Centre for Regenerative and Precision Medicine. Chronic wounds affect up to 2% of the population in the industrial world with a significant increase expected. The healing of chronic wounds is challenging, and current therapies remain insufficient and costly. FORCE REPAIR aims to advance chronic wound management by developing a 3D-printed wound dressing to help control bacterial infection and inflammation. The novel biomaterials-based therapy will relieve skin tension and stimulate healing by combining innovative biocompatible technologies with pro-regenerative active ingredients. 

FORCE REPAIR:  https://lnkd.in/grS2Ufx7

Contact: Thomas Birngruber

Smart4Fabry: Nanotechnology to combat the metabolic disorder Fabry disease

Thomas Birngruber and his team at the HEALTH Institute of JOANNEUM RESEARCH are researching the efficacy of new drug formulations based on nanocapsules.Fabry disease is a rare hereditary disease in which organs are damaged because certain substances cannot be broken down in the body. Fabry disease is currently treated with enzyme replacement therapy, an expensive treatment that has to be repeated frequently. "The approach taken in the Smart4Fabry project uses a formulation that delivers the enzyme to the body packaged in nanocapsules. This allows the medication to circulate in the blood for longer, be distributed more effectively in the tissue and exert its effect over a longer period of time," says Birngruber. Researchers at the HEALTH Institute have compared various nanoformulations and measured the amount of medication that can be transported across the blood-brain barrier into the brain using cerebral open flow microperfusion. 

Read more: https://lnkd.in/g4rUmbem 

Contact: Thomas Birngruber 

MDR compliance

We made it! Our current quality management system according to EN ISO 13485 as well as our class IIa medical device, the open-flow microperfusion catheter and all corresponding disposables, successfully achieved the transition to MDR compliance. We thank everybody in our team for their effort, paper-work and patience to achieve this major milestone in regulatory compliance at our institute.

Our current certificates are available here:

EN: https://www.joanneum.at/en/get-to-know-us/get-to-know-us/quality-management

DE: https://www.joanneum.at/lernen-sie-uns-kennen/lernen-sie-uns-kennen/qualitaetsmanagement

Optimized Clinical Dermal Open Flow Microperfusion Study Design to Demonstrate Bioequivalence Based on Cutaneous Pharmacokinetics

The specific aims of this research include comparing in vivo cutaneous pharmacokinetic (PK) measurements by independent techniques such as dermal open flow microperfusion (dOFM), dermal microdialysis (dMD), or spectroscopic tomography; exploring the removal of the topical formulations at different time points and characterizing the resulting PK profiles of the test product and the reference standard; developing data analysis techniques; and identifying appropriate PK endpoints for the evaluation of topical BE. The outcomes of this research are expected to help US Food and Drug Administration (US-FDA) improve the efficiency of current BE approaches for topical generic products with compositional differences relative to the reference standard.

Read more about Optimized Clinical Dermal Open Flow Microperfusion Study Design to Demonstrate Bioequivalence Based on Cutaneous Pharmacokinetics here

This project is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD007669 totaling $1,500,000 funded by FDA/HHS. The contents are those of the authors and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

JOANNEUM RESEARCH HEALTH is seeking a limited number of clinical partners to adopt the Clinical Dermal Open Flow Microperfusion ( dOFM™) development approach. 

For the last decade, JOANNEUM RESEARCH HEALTH has been pioneering the use of our proprietary dermal Open Flow Microperfusion (dOFM™) technology to support the translational development of dermal drug products. By obtaining pharmacokinetics and pharmacodynamics data at or near the sites of action in skin, dOFM™ studies have been able to rapidly derisk/endorse drug development decisions. As we are seeking long-term, synergetic partnerships, we are open to innovative propositions to create a win-win arrangement with potential partners. Please forward your letter of interest (LOI) until December 31, 2022

For further inquiry and LOI submission, please visit our dedicated landingpage: Call for Partnership