In the middle of a day filled with dealmaking and valuation of biotech assets, participants of BIO-Europe Spring® were treated to a refreshing hour of pure academia, including a half-hour lecture on the history of oncology.
Ahead of the workshop session on “Collaborative models for early clinical studies between innovative biotechs and academics,” the moderator Jean-Pierre Armand, MD, carved out a moment to offer a refresher course for business development executives on the first-in-human Phase I trial.
In cancer drug development this critical step for biotechs needs to be organized from the earliest stages of discovery moments, he suggested, emphasizing that Phase I should be led by the same people who advanced the candidate drug through discovery, then formulation and pharmacotoxicology.
Rather than moving to a conclusion, Dr. Armand instead provided a bridge from academic discourse to more mercenary interests by promoting the virtues of the Gustave Roussy Institute in Paris as a collaborator for early stage clinical programs in oncology. Formerly the director of the Institute, he now leads the Phase I Unit that he founded, and which currently has some 60 first-in-human clinical studies underway.
“My job is to work with small biotech companies,” he explained as he moved into his closing point. “At Institut Gustave Roussy, we have many more targets than we have drugs on hand, and this is the reason I have come to a biotech meeting, because I do need additional drugs to enrich the spectrum we have from six major pharmaceutical companies. We will work with small, one-drug companies when the drug is very original, because what we need is to hit these targets. Even where a drug is original but very risky, we will take the risk, and develop the drug.”
After a return to his role as moderator for the workshop, Dr. Armand introduced leaders from other institutions seeking collaborations on early stage oncology drug development.
Øyvind Arnesen is the CEO for Ultimovacs, a spin-off company from the the Norwegian Radium Hospital that is bringing forward a therapeutic cancer vaccine directed against human telomerase. In the form of a candid SWOT analysis, Arnesen promoted for biotechs seeking early stage collaboration the capabilities and opportunities of the Oslo Cancer Cluster.
Filippo de Braud is the Head of the Department of Medical Oncology with the National Tumor Institute in Milan, Italy, affiliated with the academic hospital. Biotech projects are handled capably and crisply, he said, offering two service models, the first where “we decide what we will do and the biotech pays, or else a cooperation where the biotech pays part and we take a percentage of the patent.”
Vicenç Tur is the CEO at Lipopharma, a clinical-stage biopharmaceutical company advancing Minerval for the treatment of glioma and other solid tumors using a novel approach called membrane-lipid therapy for the modulation of tumor membranes. He encouraged other biotechs to consider the advantages of collaborating with his main academic partner, the University of the Balearic Islands, for very early stage work such as the discovery, elucidation of mechanisms of actions and development of biomarkers.
Esteban Cvitkovic, MD, the founder and CSO of OncoEthix, a Swiss-based biotechnology company that was acquired by Merck, Sharp & Dohme for USD 375 million in December, 2014.
A self-described well-paid iconoclast, Cvitkovic has steered 20 drug candidates through Phase I, and offered to participants that “80% to 90% of what you need to know you will find out from the first 100 patients in your Phase I trial. You can increase this to 95% with the next 100 patients.”
Other well-practiced and quotable quotes he offered included :
“If you can cure a mouse and can not get your drug to an IND, it is your fault.”
“Seventy percent of data about curing mice is not reproducible.”
“Data is the only reason for value. The rest is bullshit.”
And he offered this wisdom as one of Steve’s Tenets : “Forcing or accelerating development phases increases dramatically the lead failure rate.”
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