Mediconomics cuts a path through “jungle of regulation”

October 10, 2014 ctheodoropulos

The Managing Director at Mediconomics, Uwe Albrecht, MD, may be the busiest man at BIO-Europe® 2014 in Frankfurt in November.  In one hand he will be carrying the portfolio for the well-established contract research organization he founded and manages. In his other hand this year he is carrying a portfolio of assets he hopes to out-license to potential partners.

Uwe Albrecht, Managing Director, Mediconomics

Uwe Albrecht, Managing Director, Mediconomics

“You could say we have inherited some ideas, patents and products from the German branch of a worldwide organization, and some others from an English company that was holding some interesting intellectual properties,” said Albrecht. “There is a great deal of potential, but it will require building up the story with some good partners who have more marketing experience than myself, and who are ready to invest in developing the opportunities.”

One product that is ready for marketing is a medical device for weight management and control, he said, while another product in development for the past two years is a treatment for herpes labialis, or cold sores.

“It is an effective treatment, we have clinical proofs and now we are looking for a partner to go through the final phases, register the product, and specifically to market it,” he said.

In a more traditional role, he will be representing the services of Mediconomics as he has since 1999.

“Our main focus is in clinical research across the full range from Phase I to Phase IV, along with the associated tasks such as data management and quality assurance. What distinguishes us is that we are more willing than most other companies to overcome hurdles, to drive things forward. And we have both the experience and the expertise to get things done that need to be done,” he said.

Recent experiences include successfully completing a Phase I study for a peptide in the treatment of HIV that generated “solid data for a drug that is a promising candidate for patients,” according to Albrecht.

He said he is also proud of his group for handling an unusual and difficult task of passing through regulatory affairs medical-grade gases, “which can be a real pain regulatory-wise because the smallest volume, the smallest package unit, if you like, is one truckload.”

Looking back over the past 10 years, he notes that in the ongoing process of international harmonization the regulatory agencies have become much more stringent.

“As a result, more and more companies can become lost in the jungle of regulations, guidelines and all the requirements for data to fulfill obligations,” he said, adding that one area of particular concern is pharmacovigilance.

“This was once a task more or less overlooked by companies that has now become a primary focus with requirements for ongoing safety reporting. We have developed a service in this area for clients to assure the timely supply of all the data compilations needed,” he said.

In Germany, the recent changes to the German Drug Law in conjunction with complex requirements for drug safety monitoring has resulted in regulations “far more complicated than similar regulation in other countries,” he said. “We have nonetheless been successful in looking into it and understanding the requirements, such that I believe we know what is being asked for and I would say this certainly gives us an advantage.”

The specific strengths for Mediconomics in German-speaking regions creates unique opportunities for the firm’s clients, such as an entry strategy where companies may first win approval in Switzerland and then move more easily into extra-European geographies.

Mediconomics offers an expertise in dealing with two of the most important regulatory authorities in Europe, according to Albrecht, the German authority, which he acknowledged can be difficult to work with, as well as good relations with the European Medical Agency.

“We enjoy close links with England Medicines and Healthcare Products Regulatory Agency, and putting all this together places us at the center of an important network for companies interested in entering the European market,” he said.

At BIO-Europe, Albrecht said he will also be seeking potential partners interested in extending their portfolio. “We do quite a bit of extension guidance work, having some 30 years experience in this area.”

 

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