Development of Innovative in Vitro Diagnostics (DNA microarray) Kits for Infectious Diseases

We have identified and successfully presented to Swiss investors an innovative diagnostic technology. The DNA array based technique was initially developed by Ass. Prof. Dr. Ladislav Burysek of Protean, CZ. Several products based on the technology are being brought to the market by Hutman Diagnostics AG of Basel, Switzerland.
Svobi was one of the important founding shareholders of Hutman Diagnostics until exiting Hutman in April 2014 to concentrate on other early stage projects.

Pharmaceutical API and Dosage Form Development

Proprietary Cytostatic Dosage Form (Value Added Generic)

Being a billion turnover cytostatic drug with the API patent expiration in 2010, docetaxel was for years in the centre of interest of the generic community. Numerous patent hurdles in the complicated API synthesis were solved by only a few companies.

Likewise, the formulation was covered by several patents prolonging the originator market exclusivity effectively till 2014. Several solutions were devised by generic companies, all of these changing the composition in a way that clinical trials (bio-equivalence and beyond) were required to approve the formulation.

Xenia and Michal are the co-authors of and brains behind the I.Q.A.'s key formulation patent covering an out-of-the-box solution of a formulation being at the same time "essentially similar" to the originator one and noninfringing upon the originator's patents. The product was out-licensed to major pharmaceutical companies.

Michal was a project manager to the research and supervised the technology development and transfer as a CSO.

Dex-ibuprofen Proprietary Dosage Forms (Value Added Generics)

Dex-ibuprofen is an active enantiomer of the well established pain killer ibuprofen. Thus the use of dex-ibuoprofen instead of racemic ibuprofen allows for cutting the dose to about one half, increasing the compliance and ease of administration of smaller size tablets or capsules and decreasing the burden on the body by the inactive isomer.

However, being a nicely crystalline hydrophobic compound with a melting point of about 50ºC, dex-ibuprofen is notoriously difficult to formulate in solid dosage forms. Its very unpleasant taste makes it difficult to formulate any reasonably palatable liquid dosage form (e.g. syrup).

Applying fresh and nonobvious approach, we have solved both obstacles and  we have developed two proprietary dosage forms based on dex-ibuprofen, i.e. easy to produce, rapid dissolution tablets, and a taste masked syrup. Xenia and Michal are authors of the respective patents.

Michal was a project manager to the research and supervised the tablet technology development and transfer as a CSO.

Drug Development

Fast and Budget Track to Phase II Clinical Trials (NME, Anti-HIV and Cytostatics)

The customer, a computer aided drug design centre of undisclosed multinational company was developing new molecular entities with expected anti-HIV activity and a novel path mechanism of action. The internal development facilities were not able tp follow wth the fast pace of the drug design group.

To speed up the development, the customer hired small pharmaceutical development company to provide turn-key solution and bring the compounds as fast as possible to Phase I clinical trial. The chemical sythesis, toxicology, ADME/toxicokinetics and safety pharmacology studies were fully outsourced. In parallel, the Clinical Trial Application and Dossier were developed. This resulted in Phase I study being finished within 24 month after the NME were synthesized for the first time.

Xenia and Michal were important palyers in the team, Xenia's responsibility being the regulatory issues, Michal was a project manager and ADME and toxicokinetic studies GLP study manager.

Same approach was applied for the new cytostatic drug in the hand of the small US based biotech.

GXP management and implementation

GMP Implementation in China Based Biotechnology Company

A biogeneric development project was run for a customer, a major multinational generics company. While the Chinese producer possessed good technical  equipment and know how, their GMP was initially far inferior to the GMP standards acceptable for the EU and US market.

The site was developed during repeated visits connected with the specific know how transfer on the product manufacturing and standardization.

The site was successfully audited by the team of auditors of the customer in 2007.

Michal was a project manager, with the major impact on the producer improvement process in years 2004-2007.

GMP Implementation and QP Activity for the Batch Release for EU from India

A CEE drug distributor, located in the Czech Republichad the duty to build up the batch release function after Czech republic entered the EU in 2004. The products were imported form India.

The project was prepared and run in the last quarter of 2003. In March 2004, the distributor was the first certified batch release organization in the Czech Republic. The project covered also numerous audits at the manufacturing places in India and interaction with the site quality management system.

Xenia participated in this project as the contracted Qualified Person and Project Leader. Xenia performed as QP for the distributor during 2004-2007 and she made about 1000 batches releases without any claims from the market or regulatory authorities.