Anna Frostegård, MD, PhD, is the Co-Founder and Chief Scientific & Medical Officer of Annexin Pharmaceuticals.
Can you tell us about your background?
I come from a family with several inventors and have grown up in an international entrepreneurial environment. This meant that I hardly had any choice, but to be involved in all aspects of entrepreneurship from childhood. I learned early on the importance of going your own way, being patient, building long-term values and that success is a result of hard work.
When the time came to make decisions about “what I would become,” it was difficult to choose between medicine, journalism or law. In the end, the fascination with the human body and the idea that medical research can affect our lives won. At the time, I dreamt of being able to discover nothing less than some groundbreaking treatment that would be there if loved ones were to get sick. So I trained as a physician but also as an academic researcher, all while the entrepreneurial spirit has remained a part of me.
While working on my PhD at Karolinska Institutet in Stockholm, I played my part in a discovery that became the scientific basis of Annexin Pharmaceuticals. Clearly, a scientific promise does not necessarily translate into business. But here I am eighteen years later in a privileged role as CSO/CMO at Annexin Pharmaceuticals where I have followed the path from the very moment of invention at the lab bench up to the clinical stage.
Can you tell us about your role as Co-Founder and Chief Medical and Scientific Officer with Annexin Pharmaceuticals?
As a co-founder, and an inventor, the transition from being a clinical doctor and academic researcher into the founding, financing and becoming CSO and than CMO and running a drug development company has been quite a ride. In the past seven years we incorporated the company, built the team and went through many challenges in preclinical and clinical paths, as well as an IPO.
Annexin Pharmaceuticals is a listed biotech focusing on a narrow program with a single drug. We have only four full-time core team senior level executives and one part-time employee. We are in a clinical stage with one clinical trial ongoing and two more expected to start by the end of the year.
The role of CMO is easy to misunderstand as tasks can differ in different companies. In a tiny biotech such as Annexin, I as a CMO have a first and foremost strategic role where I contribute from a medical point of view which can affect development and business critical decisions. This requires me to continuously evaluate scientific, clinical and ethical aspects of our decisions in the light of the regulatory and competitive landscapes. This also requires very close interactions with the CEO. Also, as a CMO in small biotech, I am exposed into a level of detail that would not happen in bigger companies. For example, in the preclinical stage I am familiar with every single data file, be it a rat or non-human primate.
How do you make your decisions around what companies to outsource with?
Successful outsourcing, access to external global talent and efficient execution in this complex environment are the basis of our lean operational model. We are dependent on CROs to run our non-clinical work and clinical trials, as well as to manufacture our drug product. In addition, almost everything else from bookkeeping, legal and intellectual property council, as well as regulatory has to be outsourced and managed.
Prior to COVID, we put quite some effort into meeting as many global providers in person as possible. Providers now make quite an effort to speak with tiny biotech companies. They have changed the ways of looking into semi-virtual setups. In the past, these companies wouldn’t look at you because it wasn’t enough business for them but now they make you feel like you’re one of their most valuable customers because there are more and more companies like us coming to service providers. They also understand more and more the reality of small biotech operational realities and financing so they don’t have expectations that we will be the same types of customers as the pharma giants.
When we meet providers, we insist on not only meeting the sales pitch business development team but also the team expected to do the work for us, those who are to be accountable on a day-to-day basis. We try to determine the culture fit; we have a list of questions as to how they handle different situations and interactions and how dynamic they are. We also try to share our passion for the project with the providers as we expect them to participate in our decision-making. We want them to know that they are a real partner and to feel like an integral part of our team.
In terms of clinical trials and manufacturing, our personal approach has made a huge difference for us now during COVID. We were able to leverage digital interactions to choose multiple providers that satisfied our initial in- person interviews.
"We try to determine the culture fit; we have a list of questions as to how they handle different situations and interactions and how dynamic they are. We also try to share our passion for the project with the providers as we expect them to participate in our decision-making."
How has your outsourcing strategy evolved from founding through team building, IPO and now COVID?
As we have matured, we found ourselves spending more time, human and financial resources on deciding which service provider to take in. In the beginning we would ask friends and family for recommendations. This is a big no-no. We would never do that now. We also have expanded our outreach from sending RFPs to only three outsourcing providers, as we did early on, to up to ten outsourcing providers. You would be amazed at how different the proposals to the same RFP look when they come back to us. We also make sure to tell our potential partners how many other providers we are meeting with and try to be transparent in our interactions.
After choosing a service provider, how do you communicate effectively and ensure success?
This takes a lot of effort. To us, it’s about building human relationships with the external teams and the people working on our project on a day-to-day basis. It is also about being very clear with the leadership of the providers, that regardless of how tiny we are, we are to hold the provider accountable for their performance. Importantly, we want to be assured as much as possible that there will be maximum effort made to keep the same team on our project. We don’t want to build a relationship with one team and have someone else handling the project on a daily basis.
In terms of communication, I realize that we have a lot of ad-hoc meetings. Sometimes all it takes is a ten- minute call rather than a biweekly scheduled meeting.
The providers we work with give us a lot of flexibility in terms of how we interact. Another key for us has been having a very experienced and driven COO in house. Our COO, having worked previously at multiple CROs, understands providers and knows how to make them both comfortable working with us while delivering what we need on time.
"No matter how tiny you are, you need to maintain a high level of professionalism when making outsourcing decisions. In each and every outsourcing situation, you are making decisions that will have long- term consequences for the company."
What are some mistakes you’ve learned from?
Every day, our team at Annexin strives to do the right things at the right time, find cost-effective solutions to challenges, communicate to the market in a relevant and accurate way and at the same time maintain shareholder trust in the company. It’s not a simple equation. Certainly, we have done our share of what, now in retrospect, I would call mistakes.
One is, as I mentioned before, taking shortcuts while outsourcing, such as relying on family and friends’ recommendations. No matter how tiny you are, you need to maintain a high level of professionalism when making outsourcing decisions. In each and every outsourcing situation, you are making decisions that will have long- term consequences for the company.
Another one I would like to highlight is under-budgeting for outsourcing activities. You should be prepared to allocate sufficient time and have an option to take in an external second and potentially third opinion while evaluating proposals.
A third mistake would be taking too long to challenge relationships with service providers that either do not fit culturally or do not deliver. In the early days and being such a small company, we didn’t dare to do a transfer from a key CRO even when it was an obviously poor match. We were concerned that we already invested heavily in that relationship and that the time and costs associated with a transfer in the middle of a project would be prohibitive to us. Once we had gone through the transfer, the only regret we had was not taking that step earlier.
It doesn’t matter how experienced in outsourcing you are or how much prep work you’ve done. Each and every relationship may turn sour. It is important to remain careful and alert even after choosing an outsourcing partner. If you see any telltale signs that things are not working the way you expect them to, don’t wait. Address the issues and be very open about why you think it doesn’t work and ask for a change.
Is there anything else that you wanted to share?
When building a team from the ground up in a tiny company, make sure your team shares the same vision.
