With her large experience in the pharmaceutical industry, Helen Blanco currently serves as Chief Operating Officer at Node Pharma, a preclinical radiopharmaceutical company based in Norway. We recently spoke with Helen about the key criteria when selecting an imaging vendor and exciting upcoming innovations in the oncology space. The following is the first excerpt from our conversation.
Can you share a little about your career in the pharmaceutical industry with us?
By education I have a diploma in engineering, Biophysics and Medical Technology, in addition, I have a Master of Business Administration and in total, I have about 24 years’ experience in the pharmaceutical industry. I started working for AstraZeneca in Sydney, Australia and after a while, I got to participate in the trainee programme they had at their headquarters in Gothenburg. I got to work in Data Management, Clinical Project Management and then in the early phase group as a Study Manager. After seven years I then moved from Sweden to Switzerland and worked as a study manager for Celgene in the lymphoma group, working on a non-Hodgkin’s lymphoma phase II basket trial and various haematology studies. This led to Revlimid coming to the market for mantle cell lymphoma in the US and later in the EU as well. I was the first employee hired by Celgene in the clinical department at their international headquarters in Neuchatel, Switzerland.
My next company was Mylan Biologics, Mylan was and is one of the largest generic companies. I was responsible for their preclinical and clinical trials for the Herceptin biosimilar, which later also entered the market.
But then life moved on. I married, we had a son and we realised that we wanted to go back to my home country of Norway. Norway doesn't have a lot of pharmaceutical companies especially if you've been in clinical development. So that led me into the world of CRO business where I worked for a small CRO called Smerud, and I also ended up working for Covance (now Fortrea) for three years. Covance gave me the opportunity to work with a radioligand called Xofigo which came on the market for prostate cancer with metastatic disease to bone.
Thereby, I moved into the radiopharmaceutical space of Norway, which is quite extensive today, where I worked for Nordic Nanovector, and then ended up as Head of Clinical Operations at OncoInvent for three years where I built up the department, hired people, selected CROs, all the same things I've been doing at Mylan and Celgene. The two last companies I worked for have been in the immune therapy space, in Lund and Bergen.
I was also part of developing a national action plan for clinical studies, that came out in 2021 and is part of the Health Directorate of Norway. I'm also a subject matter expert for the Norwegian Research Council taking part in the committee for evaluating all the funding applications. It gives a good overview of all the upcoming innovations that we have in the country.
When selecting an imaging vendor to support your studies what are the key criteria?
The experience is an important factor. We will check the experience in the same indication and a similar study because it means that they have the possibility to provide similar settings. If we are conducting a large phase III study, we will look at the providers’ experience in late-phase trials and the size of the previous clinical trials they worked on. The experience of our team is also important. If we have someone within the team who has previously worked with the specific vendor, we of course ask for feedback from them regarding the imaging vendor.
Other criteria would be to focus on key performance indicators, for example by checking if they were delivering their services on time. We also pay attention to their assigned team members (Project Managers, Business Developers, Readers, etc) and their potential previous collaborations. You can have clauses related to turnaround for study team members. When the bid defence meeting arrives, we pay attention to the demonstration, their skills and knowledge, and the lessons learned from their past trials can influence the decision as well.
The eagerness of the provider to work with us, how willingness is the other party to negotiate the contract, and how quickly the vendor is responding are also key criteria. I think that providers should reply in a reasonable time, but of course, we understand that you cannot prepare a proposal in 10 minutes. The flexibility of the vendor regarding the study setup or the budget is also a factor, as many biotech companies have budget restrictions. Vendors need to understand and customise the study as much as possible when there are budget limitations. Their financial set-up or the willingness to meet on a milestone payment can influence the decision.
I think it can be difficult for early biotech companies that very often lack the skills to select the right CRO or the imaging vendor or vendors in general. In the selection of vendors, it can be challenging to differentiate when a vendor has the knowledge or not, if the internal team lacks experience in CRO and vendor selection. Even though it is an additional cost, it could be a good alternative to require consultant expertise and knowledge for the vendor selection. Independent consultants do not always have the same interest in selecting providers for instance when it comes to financial aspects. So, I think it's crucial for biotech companies to have somebody who understands specialities like manufacturing or medical imaging.
What innovation are you most excited about in the oncology space?
I do believe in the radiopharmaceutical space. For example, Node Pharma has a nanoparticle to which they have attached a Radium 223 isotope. It's a platform technology where you can attach an antibody to it, and you can thereby pinpoint different solid tumours. They are in their early stage, but I do believe in that field. Radiation is known to kill tumour cells, it's not something that you need to prove. There's been a long debate about whether it is beta radiation or alpha radiation that we should go with. For beta, you have longer wavelengths so you can get more systemic effects, but with alpha radiation, the wavelength is really, really short and systemic side effects become a very small risk. Well, I think this is a good project, but they are in the early stages.
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