ageneo life science experts gmbh

ageneo life science experts gmbh

The Role of Ageneo Life Science Experts GmbH in Advancing Biotechnology

1. Introduction to Ageneo Life Science Experts GmbH

Ageneo Life Science Experts GmbH (ALSE) is a specialist life science consultancy focusing exclusively on developing business and regulatory strategies for biotechnology-oriented companies marketing and developing products containing biotechnological new active substances, with specific expertise in recombinant (micro)organisms and biotechnologically derived products. The company’s services include providing strategic advice and practical assistance in producing expert reports, Value Dossiers (qualification and quantification of benefit and risk according to the clinical and pre-clinical area, respectively), and clinical trial applications at the European level for human and product-specific issues when marketing products containing biotechnological new active substances (including recombinant (micro)organisms).

ALSE is operated by a team of consultants who have been closely involved in the development of the EMA/FAGG regulations and guidance or have been active as (national) experts in the assessment of recombinant (micro)organisms, cell culture, and viral vector-based products for many years, while also working with regulatory agencies such as the EMA/CHMP and having established close contacts with the EMA Fees and Werkgroep Besluitvorming and EMA/CHMP/VEG.

2. Key Services and Expertise Offered by Ageneo

In June 2020, Ageneo Life Science Experts was founded as an independent consultancy firm in Germany. Their team of professionals possesses comprehensive global experience in all the key areas of pharmaceutical development and the business management of biotechnology companies, including strategic and operational functions. Ageneo Life Science Experts have combined that expertise under one roof. As a result, this makes it possible for clients not only to directly access specialized advice, but also get intra-specialized perspectives spanning the entire value chain. The range of operations of Ageneo includes support in non-clinical and clinical trial development, pharmaceutical preparation, regulatory affairs, data safety monitoring board implementation, discussions with regulatory authorities, as well as post-approval lifecycle challenges, and market access. Moreover, Ageneo can provide advice in the development of biosimilars. A supply chain strategy, business development, and investor engagement can also be supported by Ageneo.

The Ageneo team has exceptional regulatory expertise stemming from years of experience working for health authorities, such as the German Federal Institute for Drugs and Medical Devices (BfArM), the German Paul-Ehrlich-Institute (PEI) and the European Medicines Agency (EMA). This background, with the added experience of both development and marketing approval, expertly equips the team for a spectrum of time-sensitive missions in the support of pharmaceutical developers, which can involve conducting targeted internal audits, gap analyses, or complete mock inspections. Last but not least, trustfully collaborating with health authorities is also an integral part of their service. Ageneo executes high precision work in the areas of marketing and commercialization strategies of specialized products, whether they are hospital products or diagnostics. Everyone on the Ageneo team has years of experience in these favored areas of commercial projects and has demonstrated great success in their previous work.

3. Collaborations and Partnerships in the Biotechnology Industry

Main partnerships taking place in the biotechnology industry rely on discovery, research, and initial preclinical development, where new platform technologies, research teams, and unique methodologies often combine from various development teams. In translational development, small companies carrying out preclinical development might be supportive in combining existing clinical funds with proof-of-concept projects and promote cooperation with medical teams all over the world. With access to the newly developed pharmaceutical products, the clinical development can be easily opened up to larger biotechnology companies, pharmaceutical companies, contract research organizations, and regulatory affairs experts. At present, CROs appear as excellent gateways towards large biotechnology companies in translational and clinical development of early-stage products, as many larger biotechs focus on later stages of development such as phase II/III clinical development and are not alike concentrating on the phase zero and early phase I programs.

The role of Ageno Life Science Experts GmbH with this business model is to fill a gap within the medical needs for pharmaceutical products. As business specialists, Ageno starts partnerships and develops small development businesses that focus on an essential medical need in a certain indication with a promising, established preclinical product. The company’s team members as human biomaterial experts ensure the right validation, safety, and biomaterial support from their specialized biomaterial facilities, and finally, Ageno offers an operation model for such partnerships that save up to 50% in direct costs.

4. Case Studies and Success Stories

4.1 How computer simulations can predict complex protein interactions

Biotechnology is a multidisciplinary field combining natural sciences and engineering. Predicting how proteins or genes will interact with each other is a crucial task. While modern molecular biological methods quickly find numerous interactions, new generation computers allow simulations on how a possible protein-protein complex would look and work. Ageneo completed a large project on predicting protein-protein interaction for the company AB Lyons. Resources and staff from three companies were involved: AB Lyon, Harlequin, and Ageneo. The outcome was very satisfying as it considerably advanced the capabilities of the customer in searching for difficult targets. The cooperation agreement was beneficial for each of the partners involved. Archive software which had been developed was tailored for other customers.

4.2 Molecular archaeology – Mass spectrometry based analysis of mummy paper fragments

Ageneo Life Science Experts GmbH has been founded to exclusively concentrate on and bundle the wealth of scientific expertise available in the AgenoLife network. The impressive weight of freely available scientific knowledge is homogeneously balanced by cutting-edge technologies like crystallography or intelligent computer programs. Using and enhancing such tools is our daily duty and predominant strength so that organizational support and administration can be minimized. Along the edge of our scientific activities, we have regularly presented cutting-edge ideas to clients and in scientific publications. These case studies touch several of the services presented by Ageneo and are supposed to give an impression about what is currently unthought, but feasible for clients from the biotech and pharma area.

5. Future Innovations and Trends in Biotechnology

Efficiency and cost-effective production in the area of white biotechnology particularly becomes more and more enabled by systems biology. This scientific discipline approaches the inherent complexity and network structure of biological systems mainly by identifying components of these systems, as well as their interactions and dependencies, in a comprehensive and hierarchical manner. In this way, it will be possible for bioprocesses of metabolic engineering to attain levels of efficiency recently unthinkable and for storages of molecular farming to possess higher capacity and robustness, allowing efficient production on industrial scales. Besides recombinant cells as factories for the synthesis of a great variety of substances of interest – such as solvents, fuels, chemicals, materials, food, health management products, molecular drugs, etc. – the relevance of pharma plants, providing additional plant-specific substances, is extraordinary, not only due to present rapid growth rates.

Concerning diseases, relevant biotechnological challenges to be addressed can be summarized by the following list: develop vaccines for important diseases; prevent and control diseases by immunomodulation; diagnose diseases; cure and treat diseases; combat microbial resistance; use food to improve health; reconstruct tissues; prevent aging and decline in function; augment human capabilities. For these and further consumption-related aspects (about 50% of total costs of the health system), the most advanced methods of molecular biology must be used by building on and extending emerging capabilities. These will include comprehensive and quantitative models of molecular steps in pathways controlling immune function, likely to be involved in both immediate and delayed protective immunity. Within these profiles, Ageneo Life Science Experts GmbH is supporting a variety of biotechnology companies and institutions in scientific and technological infrastructure by taking a consultancy role in project planning, developing R&D profiles (in vitro and in vivo biology, strain improvement, molecular biology, metabolic engineering, bioinformatics), assembling and managing multi-disciplinary teams, setting up and running laboratory tasks, evaluating R&D work (quality assurance), designing businesses and developing markets, financing, and issues of capital stock.