Pharma World Magazine continues its journey around the world of Technology Transfer and now it makes a stop in Milan to discover TTFactor, a great and important example not only domestically but also internationally.
Pharma World Magazine meets Daniela Bellomo, founder and Managing Director of TTFactor, in order to know more about this Italian private Company and understand how technology transfer can be a winning strategy for the future of Biotech.
Mrs. Bellomo, could you tell us what TTFactor is?
TTFactor is a private Company that deals with the technology transfer of research projects, at the time, of 3 structures, the European Institute of Oncology (IEO), the FIRC Institute of Molecular Oncology (IFOM) and the Monzino Cardiology Centre (CCM). I say “currently” because one of our aims is to expand our portfolio by entering into agreements with other research facilities.
Our mission is to help researchers and clinicians in the evaluation of the commercial potential of their research and promote the relationship with Industry to foster the development of their inventions. In a few words TTFactor can be considered as a motor to transform a worthy idea in a product accessible to the patient, whether it is a diagnostic or a therapeutic. Currently only 38% of Phase III oncological drugs manages to reach approval. The failure rate is too high and reasons are many. The TTFactor challenge is to select research projects as soon as possible, trying to identify ideas that can really have an important meaning and application.
What does it mean for a research Center to rely on a private facility for technology transfer?
Regarding our case, TTFactor is the exclusive licensee of all intellectual property of IEO and IFOM, who are the founders institutions. We also manage the intellectual property of the Monzino Center on an exclusive consulting arrangements with annual renewal. Our job is the evaluation of projects, scouting into laboratories, the filing patents, stipulating enhancement agreements with industry and venture capital. Processes are streamlined. The agreements are signed jointly with research Center without the need for further and approvals steps between different offices. Our model “one-stop shop” is well established and is the result of several years experience.
How do you select a winning project?
Skills and experience are the most important things. The expertise in biotech and pharmaceutical items is certainly fundamental, but not sufficient to ensure a technological transfer of worth. That is why our team includes people with mixed background, academic and industrial, PhD or science graduates who have acquired master’s degree in Economics or Law and who are skilled and know what factors are important to recognize a potential new drug. The team is then also completed by skilled lawyers in intellectual property, contracts, patents, licensing and management. The team may also relies on the skills of managers used to working with healthcare and italian finance, international professors and experts in technology transfer and venture capital representatives.
All these skills put together create a “filter” very narrow allowing you to select the most deserving research projects from the commercial point of view and give credibility and visibility at international level. Thanks to this filter, we evaluated 137 inventions but we have filed only 30 patents.
What does it mean to support the project along its business development?
Technology transfer should include the complete development chain of a drug or a diagnostic, and take into account the high risk of the steps, such as pre-clinical research and clinical trials on humans, until the post-marketing time with the surveillance of side effects (pharmacovigilance). As we have already said, Phase III oncological drugs have a very high rate of failure. This problem may be due to a poor selection of the products at the beginning, or also in a disconnection between the development of the drug and the study of the target on which it should act. With the introduction of biotech, mass medicine has given way to the customized/personalized medicine and this is crucial, while a drug is on development, continue to check and validate the target. Only in this way, we can get to Phase II trials with an idea as accurate as possible of patients who will respond to therapy we have been studying. Technology transfer is therefore the key to creating an integrated system of research, clinical and industry to optimize the final result, and reach the principle goal, which is to bring a benefit to the patient.
Why choose a structure specialized in technology transfer?
Many have tried on their own to carry out a research project from the idea to the market, but in most cases the efforts have not come to an end and the process has not generated value, because if not structured properly the relationships between research and industry and venture capital, are random, usually very difficult and especially not always advantageous for University or research facility. Researchers do not always have the skills to understand if the financial terms of their contracts are correct and lined with international standards or if they provide the right guarantees to the Institute. These are issues that we know rather well, thanks to our affiliation to the European and American associations of technology transfer. By the way, I am director of EU-LIFE to which refer 13 Technology-Transfer institutions in many European countries with the aim of identifying and establishing best practices for technology transfer at Community level.
I think it is also important underline that as Italian we have to deal with a very complicated regulatory system that does not stimulate the generation of value, and above all does not protect the intellectual property. That’s is just the opposite compared to the US where forty years ago Bayh-Dole Act or Patent and Trademark Law Amendments Act (Pub. L. 96-517, 12 December 1980) was adopted. Thanks to this law the US government recognizes the intellectual property of researchers who finances as long as the research institutes to organize and structure the technology transfer processes, giving licensed products preferentially to American companies. This law has given a significant boost to the creation of new SMEs and momentum investors, who felt protected by the government. In this way the United States built the biotech industry, but not only. Thanks to the protection of intellectual property, hospitals, even the size of our Italian, now can boast massive return of royalties and therefore can continue to finance their research. In this scenario, you can easily understand how the technology transfer is not a cost, but an investment.
In Italy the situation is quite different, as we have said, there is no legal protection of intellectual property. In this scenario, then a structure that deals with technology transfer becomes a value only when it aims to create a process similar to that stimulated by the United States, for the researchers and the University an economic return when the invention will become product. Only in this way the search will continue to finance itself.
When can you define “finished” the work of technology transfer?
Generally the technology transfer work ends with the licensing contract or patent license, which are made with the companies. Specifically, we have contracts only with companies that guarantee us to commit to develop the product. Our contracts indeed provide the guarantee for its development under penalty of restitution of the project when the company, for whatever reason, is not able to carry it forward. It’s a very important point, because in this way we can avoid that investors acquire the license of some projects only to block them and thus avoid competition on the market.
The process of technology transfer also protects basic research, or threatens to collapse?
Basic research is fundamental to any applied research; to protect it we always specify in our contracts that companies can not in any way affect or influence the activities of researchers, however, it guaranteed them the right to acquire the patents and insert it into their development plan if the project becomes interesting from a commercial point of view.
What stages of the research deals with the transfer of technology?
Obviously it depends on the structure. In our case, we have recently signed an agreement with the first accelerator of the Italian biotech, which will allow access to selected projects in the funding allocated to the early stages of preclinical development of a project, those at higher risk, on which large companies usually they are little interested in investing. We did not include any form of exclusivity to the accelerator that I like to describe it as one more weapon to facilitate the creation of value around the most promising projects of the institutions we represent.
Maria Luisa Nolli presents Daniela Bellomo
Daniela Bellomo is a colleague for many years now; I have been collaborating with her in the business associations since the early 2000s, when the transfer of technology was still in its infancy in Italy and she, at San Raffaele Hospital, was trying to explain how a collaborative relationship between University and Industry could enhance the research projects.
She is a founder of TTFactor that is the first private enterprise in Italy to deal with tech transfer, and has very unique features like that to be inside one of the most important Italian research centers, to have a scientific board including international experts and to have a unique focus and expertise in intellectual property.
Daniela seems determined to continue this work began with determination and that is bringing significant results in the scenario of tech transfer not only italian but also international.
She is a member of the Women & Technologies, the association created by Gianna Martinengo to enhance the female talent through technologies. We organized together two events as part of the prize “Women & Technology”. In 2010 she received Camuna Rose award for innovative women’s entrepreneurship.