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Best Practices for CMO/Board Interactions

Dr Julie Hambleton shares what she learned in her career journey from big pharma to small biotech advancing from CMO, board member and CEO.

March 2, 2021
Best Practices for CMO/Board Interactions

Julie Hambleton, MD, is the Interim President and CEO of Arch Oncology, and serves as a Director for Accent Therapeutics, Arch Oncology, IGM Biosciences and SpringWorks Therapeutics.

Can you tell us about your experience in the biotech industry?

I am a hematologist/oncologist by training. I started on the faculty at UCSF and first entered “Industry” in 2003 at Genentech. I was there for 7 years & stayed for about a year after the Roche acquisition. By then I was running a large global group largely for breast and ovarian cancers. In 2010, I moved from an ~ 80,000 person company to becoming the 15th employee at a startup – Clovis Oncology. There, I was part of the team to in-license two molecules, one of which is now approved (rucaparib). After two and a half years with Clovis, I was recruited to Five Prime Therapeutics as Chief Medical Officer, where I remained for three years. In that time, we put a couple of molecules into the clinic and the Company went public. I was part of the roadshow team for the IPO and participated in two follow-on financings as well. In addition to clinical development, which includes clinicians, clinical scientists, clinical operations, and regulatory, I also oversaw pharmacology and CMC.

From Five Prime, after a major licensing deal with BMS, I went to BMS for a year and a half as VP, Head of US Medical Affairs, overseeing both oncology and non-oncology from the medical affairs perspective. I then returned to the Bay Area and joined IDEAYA Biosciences as CMO, joining before the company had any molecules in the clinic. While at IDEAYA, we did an IPO and I was part of the IPO roadshow team. We also in-licensed a molecule that is now in clinical trials.

I stepped away from my operational role in April of last year. I had been on the board of IGM Biosciences and joined the boards of SpringWorks Therapeutics, Arch Oncology and Accent Therapeutics. At Arch, there was a change in leadership and I was asked to step in as interim CEO.

How does your perspective change between the role of CMO, CEO and board member?

As a board member, your role is more as advisor, although there’s a remit to oversee and endorse critical corporate activities, with a responsibility to Investors or shareholders and fiduciary responsibility to the company, but you aren’t there doing the work. Through a Development lens, it’s about helping build the company as it evolves, providing guidance and helping with clinical plan concepts, strategies and execution as the clinical programs advance. Perhaps now that I have had a brief CEO experience, I may be able to provide some guidance to CEOs as a board member in terms of considerations and financing when the company is in its early phase, or at least have an improved appreciation of their focus.

As CEO, my ultimate role is to speak or partner with potential and existing investors and raise money so that the employees can do the work they want and need to do, whether an experiment in the lab or a clinical trial. As CEO, you oversee multiple different functions and manage functions you’ve likely never done yourself, such as, for me, finance. This is true of many senior roles, in which you manage functions outside your direct expertise. You need to learn enough about that function so that you can ask good questions, and depend on the content experts working beneath you. You need to think about whether you have the right people around you and the right leaders whom you can depend on and delegate to.

Also, whenever you move up the ladder and have people under you taking over the roles you just exited, you must remember that you aren’t there to do their job. I may ask my CMO questions because I know her area but I certainly don’t want to step in and do what she’s doing; I want to empower her in her role. My role needs to be something else.

"As a board member, your role is more as advisor, although there’s a remit to oversee and endorse critical corporate activities, with a responsibility to Investors or shareholders and fiduciary responsibility to the company, but you aren’t there doing the work."

How can a CMO best support a CEO? Is it different when the CEO has CMO or medical experience?

Having worked with CEOs who don’t have clinical development experience or much exposure, I think the advantages are that you understand the activities and the timelines that it takes to do a clinical trial, for example. It takes quite a number of months to write a protocol, find trial sites, choose a CRO, and do all the logistics needed for trial initiation and execution. Manufacturing also takes a long time, particularly for biologics. A CEO who came up through the ranks on the commercial or business development side may not have that same level of experience or understanding.

The CEO is oftentimes more of the salesperson because they are trying to bring in money to pay salaries and benefits let alone run the clinical trials and experiments. The investors often look to the CMO to double check the CEO. The most important thing is that the CEO and CMO are aligned, particularly when they get out in public, presenting to investors and bankers. A lot of credibility lies on the CMO’s shoulders to talk about how things are progressing.

What have you learned that you wish you knew as a novice CMO?

Early on, as a CMO at Five Prime starting outreach with investors, it took a lot of energy to keep telling our story. But it was necessary because we needed to raise money to do the work we wanted to do. It’s like being a lab investigator who needs to write grants.

As a CMO, you can get lost in the details of the development world and clinical trials. Over time you learn what investors need to know and what they are looking for and how to give them what they need. Investors want to know time to proof of concept, data read-out, time to drug approval, disease settings etc, or if you can collaborate or make a deal with a pharma partner. They need a return on investment so they can continue to build their funds and invest in the next company. As a CEO, you need to think about funding strategies, whereas the CMO is there to deliver on the clinical trials and generate key data. The focus of the CMO and CEO are aligned but slightly different.

Do you have any horror stories or success stories of CMO board interactions?

My personal interactions have been very positive; the boards have been generally very supportive. I had one experience in which a board member asked about if it would be faster and more cost effective to go into healthy volunteers rather than patients for a first-in-human oncology trial. It wasn’t the board member telling me one way or another but asking me. While I had an opinion, I stepped back and did some more research before getting back to him.

My first time presenting to the board was as a VP. The CMO asked myself and my companion diagnostic translational colleague to present on a program. We were very science detail oriented with lots of slides. We were probably one-quarter into our presentation when the CEO stopped us. This particular business-oriented board didn’t really want a deep dive into the science. The CEO could read the room and shortened the discussion. Other boards want to know all of the science details. That was an eye-opener in terms of “knowing your audience” – what your board or investors want to hear versus what someone who has been in R&D is used to talking about with colleagues.

What excites you about a company that makes you want to participate on their board?

For me personally, it’s usually about the science and trying to help advance exciting new therapeutics for patients. I am very oncology-focused. I have been approached about being on public boards for very mature companies but I don’t want to sit on boards just to sit on boards. I tend to like the smaller and earlier stage companies that are going to build. I like the evolution of starting with a VC-oriented board and then, as the company gets closer to both going public and getting into the clinic, the composition of the board changes – maybe adding individuals with finance, commercial and/or development person.

Your classic startup is focused on new research so there are a lot of PhD scientists. As the program moves towards the clinic, the Company starts hiring clinical people. Often, the budget changes asymptotically because clinical trials are so expensive compared with what happens in research, and clinical people tend to have higher salaries. Sometimes it’s great to have people like myself on the board who have been through this to council the CEO about what to anticipate as the company advances. Similarly, as a molecule moves towards approval, the Company will start hiring commercial people and that brings yet another dynamic change. I enjoy helping companies go through the evolution of these stages.

How can we improve gender equity at the executive and board level?

People should expect that they deserve these opportunities and should look for them. This is largely through networking and being open-minded. Some of my board and other job opportunities came through recruiters. For one board opportunity, at first glance I thought I wouldn’t be interested but decided to look into it and learn. I had my first introductory call with the CEO and was convinced that I needed to be with the company. I was pleasantly surprised. Not everything is that positive but you need to be open-minded to try.

I recently had a call with a colleague from a bank that supported one of my companies during an IPO. She now sits on boards, and we discussed companies that need board members and which women we knew who could fill those roles. She’s a business-oriented board member but, through me, she has development people she can recommend for boards. I can’t stress enough how important it is to network and have good exposure and good experiences – with men as well as women. For one of my boards, I was recommended by a male colleague who was on the board. You need to keep those relationships positive.

Is there anything else that you want to add?

For CMOs who become CEOs, I encourage you to learn what you’re good at and what you really enjoy. I know a CMO who had a stint as a CEO and it was a really painful experience - the clinical trials and data weren’t panning out, making it difficult to raise money. Everybody thinks that the CEO is the top of the pyramid, but everything rests on your shoulders. It’s great fun when the data are compelling and you can raise money hand over fist, but for those of us with deep experience in drug development, we know that many drugs or programs actually don’t pan out.

Lastly, as a CMO, you have one boss – the CEO. As CEO, you have multiple bosses because the board is your boss, oftentimes beyond just the board Chairperson. People don’t realize that CEOs have bosses too! It’s a different dynamic that many CMOs aren’t aware of.

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