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Capital in the brain: support and advice in drug approval processes

In his profession, age and experience are decisive advantages: Dr. Mohamed Baccouche (57) consults pharmaceutical companies worldwide on the development and approval of new drug substances. “I have been involved in the approval of numerous medications,” said Baccouche. This knowledge is his capital - knowledge which Baccouche has stored in his brain rather than on the bookshelf. And that is why his Constance office is remarkably tidy.

Consults pharmaceutical companies worldwide on the development and approval of new drug substances: Mohamed Baccouche (Photo: Frank van Bebber)
The centrepiece of his office is his computer, which the expert uses to connect to the Internet and update himself on the latest international pharmaceutical laws and directives. He has a dense network of partners and many contacts with companies, researchers and public authorities. “I know them and they know me – such a relationship cannot be built in a few days,” said Baccouche adding that broad practical experience is necessary for his job as well as theoretical knowledge. There is more than enough work for Baccouche and his colleagues.

"Up until the end of 2011, research-based pharmaceutical companies can obtain authorisation for marketing 358 new drugs or new indications for existing medications,” estimates the Association of Research-Based Pharmaceutical Companies representing 45 German companies.

Approval failure – a nightmare

The drugs will potentially benefit patients suffering from more than 100 different diseases. Drug development projects focus mainly on drugs for the treatment of cancer (26 per cent of all projects), cardiovascular diseases (18 per cent) and infections. According to the Association, Germany plays a central role in the development of new drugs.

Which directive is currently under development, which paragraph has to be taken into consideration? Pharmaceutical companies frequently invest one billion euros and ten years into the development of a new drug. The delay of or even failure to obtain marketing authorisation is a nightmare. That is why companies turn to Baccouche for help and advice. The chemist has been working in the pharmaceutical industry for more than 30 years. He worked at Altana Pharma (formerly Byk Gulden) for 28 years, including 19 years as the head of International Regulatory Affairs. He was also involved in establishing a master’s course in regulatory affairs at the University of Bonn and has lectured on regulatory affairs for ten years. Baccouche was also involved in founding the German Society of Regulatory Affairs (DGRA). Following the acquisition of Altana Pharma by Nycomed in Spring 2007, Baccouche decided to set up his own business.
The Océ Business Park in Constance offers entrepreneurs like Mohamed Baccouche space and service. (Photo: Frank van Bebber)
Now, Baccouche runs his own Institute for Regulatory Affairs and Pharmaceutical Services (IPMB) in which he works closely with freelance consultants in other cities. The highly specialised expert did not have to advertise his services. When it became known that he had started his own business it did not take very long for the first clients to become aware of this. He is now hopping back and forth between Europe and the USA serving clients all over the world. “No matter where they are, it is a virtual company,” said Baccouche who has Lake Constance on his doorstep as well as the international airport in Zurich.

Finding the right strategy

He is in contact with different experts and departments at each client, including research and development experts as well as marketing professionals. The approval of drugs must not fail just because the necessary studies and analyses are missing. “It is crucial to define the correct development and approval strategy right from the start,” said Baccouche. “Those who do not take the regulatory environment into consideration are at risk of making a bad investment.” Baccouche puts companies on the right track; he provides advice on strategy as well as operational support in the preparation of documents. He might strengthen a team or act as independent expert who poses critical questions before the regulatory authorities’ assessor arrives.

“My goal is to have strategic partners and long-term contacts,” said Baccouche adding that, “top quality is the motto of IPMB.” And that is also what he tells his clients: “It is always important to do the right thing.”

fvb – 21.12.2007
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