Listen hard to ideas around you then be decisive: Our clinical program AMO-06, in development for treatment of combat related PTSD, is a highly unusual and difficult disease target, but listening to our chief scientific and chief medical executives, whose knowledge of the area is extensive, made it seem like a no brainer that we should pursue it.
Ibraheem Mahmood is Co-founder and CEO at AMO Pharma. He has an extensive life science and finance background that spans 25 years. His experience includes previous roles in Lifescience M&A and Fundraising at Nomura, Lifescience Equity Research at Investec and Business Development and Corporate Venture Capital at Shire Pharmaceuticals. He was Co-founder, President and CEO of the clinical operations services company DrugDev, in which he raised over 50m dollars in financing and he sold the business to IQVIA in 2017. Ibraheem studied medicine at University of Oxford.
Thank you so much for your time! I know that you are a very busy person. Our readers would love to “get to know you” a bit better. Can you tell us a bit about your ‘backstory’ and how you got started?
I was born in the UK, a child to Indian/Pakistani immigrants, and studied medicine at the University of Oxford. I started my career in Big Consulting but did not really start to enjoy myself until I entered the field of life science finance, which involved negotiating deals and raising capital for life sciences companies. After several years, I co-founded DrugDev, a software company in the business of automating clinical trials. The context for DrugDev is that the cost of conducting clinical trials of medicines has grown 1000% in the last 30 years. This is unsustainable. It is also heartbreaking as many life changing medicines are not tested simply because it costs too much to test them. This problem is more acute than ever, as the cost of trials is as high as it has ever been whilst at the same time the last 20 years has yielded more drugs worthy of clinical testing than in all human history before that. The costs are so high partly because many clinical trial operations are hesitant to adopt new technology that make running clinical trials more efficient — the mission for DrugDev was to address this issue by driving large scale adoption of technology in the clinical trials world.
To achieve this was all about managing risk. Firstly, we spent a lot of time working with our customers to help them manage any risks that they perceived with using new technology. Secondly, we engaged with their customers — clinical trial physicians — around the world and provided them technology that helped them more easily find a clinical trial to be involved with, taking the risk out of the process. Thirdly, we raised capital to acquire trusted niche providers already in the clinical trial space but who were perceived as being risky because they were too small — being part of DrugDev hopefully giving them the scale to be de-risked. The platform was very successful — we ultimately raised more than 50 million dollars and were acquired by IQVIA, the largest outsourced provider to the pharmaceutical industry, and today many of our systems (such as payments for clinical trials) are the most used technology in the clinical world. Most importantly, I think we put a significant dent in the cost of conducting clinical trials.
After the success of DrugDev, I thought it was time to develop some of our own drugs rather than help other companies advance theirs. In 2015, I co-founded AMO Pharma with Dr. Michael Snape. Following my experience at DrugDev, it may be unsurprising to learn that the primary philosophy behind AMO Pharma was about managing risk.
Can you share a story about the funniest mistake you made when you were first starting? Can you tell us what lessons or ‘take aways’ you learned from that?
My co-founder at DrugDev won the award for “Most Outstanding Woman in Pharma” and was unable to collect the award as she was heavily pregnant. I offered to go in her place and enjoyed the energy of being in a room with so many driven and successful woman leaders, although I was somewhat feeling the pressure as many specifically applauded me — as the only man at the event — for supporting women in the pharmaceutical industry. Nevertheless, it was a great evening and my assumption was that all I needed to do was go up and collect the award once I was called as a pre-recorded video of my colleague making her acceptance speech was played. When the moment came the MC said, to my horror, “And to accept her award is Ibs Mahmood, who will say a few words about what it means to be a successful woman”… What do you say — as a man — to a room full of ‘alpha females’ about being a successful woman in Pharma? It was terrifying at the time and hilarious afterwards. In the end, my epiphany was to talk about my mother who pulled herself up by her bootstraps as a young academic in the 1960s in a rather race intolerant England, to become a successful life sciences researcher and who, in truth, is the reason I am so driven. Equally, I am able to tell my three daughters that they can be whatever they want to be because their mother, a smart life scientist herself, has found the time for them!
What did I learn? You are always ON as a leader, and so you always need to do the prep work!
None of us are able to achieve success without some help along the way. Is there a particular person who you are grateful towards who helped get you to where you are? Can you share a story?
Dr. Hugo Stephenson, my co-founder at DrugDev. He went with his gut and gave a rookie CEO a shot! I met him via an introduction from a mutual investor and pitched him what I thought was an outstanding idea for an easy-to-use drug delivery system. Hugo was kind enough to be polite when he told me he thought it was a terrible idea and then promptly said he wanted to start another business together which turned in to DrugDev.
Extensive research suggests that “purpose driven businesses” are more successful in many areas. When your company started, what was its vision, what was its purpose?
As mentioned earlier, when I co-founded AMO Pharma our primary business philosophy was managing risk, coupled with the commitment to address areas of significant unmet need in global health. The ultimate goal for pharmaceutical companies is to develop medicines that can help improve the health and quality of life of patients worldwide. To help manage risk along the way, AMO Pharma has a three-pronged approach.
First, we are focused on developing drugs that treat rare and ultra-rare diseases, for which regulatory agencies including the U.S. Food and Drug Administration (FDA) have established specific protocols and guidelines to try to accelerate and incentivize innovation. Second, our company is focused on drugs that have available clinical data from testing in humans. A major reason that many drugs fail is safety issues, meaning they cause side effects that make them impractical to administer to patients. Our company identifies drugs that have previously been tested in clinical trials for another disease state and that have available safety data, but for whatever reason were ultimately not pursued further. Once we identify promising de-risked drugs with available clinical data, we acquire them and jumpstart development for a different disease state.
The third phase of our approach is developing drugs for treatment of central nervous system (CNS) and psychiatric diseases. This may seem an unusual approach to managing risk, but our viewpoint is that if you have a team of CNS experts you can manage the risk of clinical trial execution. In other words, if you design a clinical trial well in CNS and psychiatric disorders then it will be easier to determine if a drug is really working and maximize the chances of achieving a successful clinical trial result. In one example, we are developing AMO-01 for treatment of Phelan-McDermid syndrome, a rare genetic condition caused by a chromosomal deletion. The most common characteristics found in these patients are intellectual disability of varying degrees, delayed or absent speech, symptoms of autism spectrum disorder, low muscle tone, motor delays and epilepsy. Rather than measuring just one of these symptoms following treatment, we are working to measure the disease as a whole. Our team has extensive experience in diseases affecting the CNS including developmental disorders and have collaborated closely with the FDA to develop composite endpoints that consider the disease symptoms overall. This way, we can hopefully bring patients a drug that will truly have a positive impact on their lives. Together, these three elements help us effectively manage risk and we have applied this philosophy to our work at AMO Pharma since its inception.
Thank you for all that. Let’s now turn to the main focus of our discussion. Can you share with our readers a story from your own experience about how you lead your team during uncertain or difficult times?
The COVID-19 pandemic has presented challenges for people in any industry. In the pharmaceutical industry, it has caused disruption in clinical research for almost every drug developer around the world. Companies including AMO Pharma started to search for more patient centric approaches to clinical research that would facilitate continued participation. And given the diseases we are targeting (rare developmental disorders), it was even more essential to keep patients safe — these patients have difficulty thinking and problem solving, with speech, hearing and vision, weakened muscles and mobility issues that make participating in clinical trials challenging to start. They often must be brought into a clinical trial by a caregiver.
Telehealth solutions and virtual doctor’s visits have emerged as solutions during the pandemic, but they still present challenges for assessing patients with CNS and developmental disorders. Our team at AMO Pharma worked diligently with third-party organizations and the FDA to develop a solution that is acceptable to all sites participating in our pivotal REACH-CDM clinical trial, which initiated back in December 2020 and is currently enrolling patients living with congenital myotonic dystrophy, a rare and severe genetic disease that causes progressive muscle loss and developmental impairment. This collaborative effort positions us to provide regulators with a clear assessment of patient outcomes. It was not an easy undertaking to come up with a solution, but the hard work and dedication of our team, coupled with the flexibility and responsiveness of the partners we worked with, made it possible to move this clinical trial forward as quickly as possible during the pandemic.
Moreover, there is no right answer to running trials during a pandemic. What was key here was doing our homework, making a decision, and then following through. It sounds simple, but the challenge here is to keep the faith when other companies are taking different approaches. The key to maintaining conviction is to surround yourself with a team of experts who really care about what you are doing.
Did you ever consider giving up? Where did you get the motivation to continue through your challenges? What sustains your drive?
Giving up is not an option for our team. The patients we are aiming to treat suffer from serious and debilitating diseases including rare disorders that impact children and that have limited or no treatment options. Many of these diseases are also potentially fatal. Patients and their families are desperate and anxiously waiting for any approved treatments. AMO Pharma is dedicated to making a positive difference for these patients and bringing them drugs that can reduce disease burden, slow disease progression or reduce many or all symptoms of a disease. We keep this goal in mind in everything that we do, and the challenges presented by the COVID-19 pandemic motivated us that much more to find a solution to advance our drugs in development as quickly as possible. Our passion for drug development is also strengthened and inspired by the many personal connections me and others on the team have to the rare disease community. We are also encouraged by the resilience and perseverance of the patient communities and advocates we work with. Given that these are small patient populations, you really get to know these families personally and understand the challenges they face on a daily basis.
The problem with truly innovative treatments is you do not fit in to the cookie-cutter approach for investors — and so the closest we ever come to giving up is when investors keep saying no. However, for the reasons above we kept knocking on doors until we were able to successfully fund our clinical programs.
What would you say is the most critical role of a leader during challenging times?
Clear and frequent communication is an essential part of being a leader, especially during challenging times. In the pharmaceutical industry, this includes communication with key stakeholders such as regulators, patient advocacy groups, patients and their families, and employees. Active discussions with these groups to keep them updated on clinical research progress and business developments shows that you are engaged, collaborative, transparent and care about their voices. Their perspectives may also help a leader to develop a more comprehensive understanding of an issue and better create potential solutions. In challenging times, people often need information and to feel that their concerns and feelings are valued.
In these communications it is critical to show empathy by feeling empathy. Level with people, even on occasions show vulnerability, and they will go the extra mile to help you, especially if what you are doing is worthy.
When the future seems so uncertain, what is the best way to boost morale? What can a leader do to inspire, motivate and engage their team?
Confidence in a leader is essential during times of uncertainty. The solution to a given problem may not be clear by a leader or his/her team, but employees must believe that their leader will find a path forward and execute their goal. It is also important to identify small wins that the team can achieve quickly and easily. These wins need to be meaningful and celebrated to help boost confidence, increase morale and build momentum within a company. And as I said above, it is important to level with people and to show empathy by feeling empathy.
What is the best way to communicate difficult news to one’s team and customers?
It is important to be straightforward and honest when communicating difficult news. Leaders should tell employees and customers what they know or do not know and try to provide timelines, where applicable, as best as possible to try to reduce any stress or uncertainty. It is also best to communicate any plans or strategies in decision-making to show that you are thinking proactively about how to address a specific challenge. But before any of this, it is important to build a long-term relationship of trust.
How can a leader make plans when the future is so unpredictable?
The goal should be to keep moving forward and at the best pace possible, not just sticking to a plan. In an unpredictable environment, a leader cannot and should not expect everything to go according to plan. As leaders we are not expected to have all the answers or ideas, but we are expected to identify the best plan based on all available information and keep an open mind.
Is there a “number one principle” that can help guide a company through the ups and downs of turbulent times?
One of the biggest takeaways from our journey and business strategy has been the need to be flexible and consider innovative new approaches in clinical research. While our business philosophy is to manage risk as much as possible, it is essential to be able to adapt and evolve business strategies to address any challenges or unexpected circumstances. No one could predict the global COVID-19 pandemic but many companies in the pharmaceutical industry including AMO Pharma have worked tirelessly to overcome challenges and move their clinical research and drug development programs forward as quickly as possible, understanding that there are patients who cannot afford to wait until after a pandemic for potentially lifesaving treatments.
Can you share 3 or 4 of the most common mistakes you have seen other businesses make during difficult times? What should one keep in mind to avoid that?
The customer is NOT always right. Stick to your guns (within reason). For example, despite what a lot of pharmaceutical stakeholders might say, it is possible to create new therapeutic areas as long as you have the right team and have a LOT of meetings with the FDA to establish how you are going to run your clinical trials.
Always save money (apart from on staff). You do not need to spend the maximum to get the best clinical trial result. Smaller smart trials are often better, especially in orphan indications.
As Gandhi said, “I want the culture of all lands to be blown about my house as freely as possible. But I refuse to be blown off my feet by any.”In other words, listen hard to advice on how to deal with the turbulence but do not jump to any conclusions or panic.
Generating new business, increasing your profits, or at least maintaining your financial stability can be challenging during good times, even more so during turbulent times. Can you share some of the strategies you use to keep forging ahead and not lose growth traction during a difficult economy?
The key stakeholders of investors and major drug company partners are just as active during the pandemic as they were previously, and in many cases, more active due to the funds flow into the global economy to support it at this perilous time. So financial stability in our industry has fortunately not been a challenge at this time.
Here is the primary question of our discussion. Based on your experience and success, what are the five most important things a business leader should do to lead effectively during uncertain and turbulent times? Please share a story or an example for each.
Surround yourself by experts who love what they do: When the pandemic hit, I said to the AMO Pharma team, “We have 35m dollars to run our Phase III pivotal clinical trial, please do not assume we will get more money if we screw it up due to the pandemic — with that in mind, what are we going to do?” Many people on our team have extensive experience at large pharmaceutical companies where there are often significant cash offers — they had not been asked a question like this before. But because of their deep expertise they were nevertheless able to comprehensively redesign our pivotal trial to ‘COVID-19 proof’ it.
Own it: In the above situation, we were in uncharted territory. While my team was confident in their solution they also needed to know that I stood behind them with the board of directors and our investors.
Build trust, by showing empathy and willingness to show vulnerability: When the COVID-19 pandemic hit I knew that we needed to do something to address the challenges but openly admitted that I was not sure what — that helped build a lot of trust among my team.
Listen hard to ideas around you then be decisive: Our clinical program AMO-06, in development for treatment of combat related PTSD, is a highly unusual and difficult disease target, but listening to our chief scientific and chief medical executives, whose knowledge of the area is extensive, made it seem like a no brainer that we should pursue it.
Be willing to act: The above clinical program, because it is highly novel, took more than a year to fund but our continued persistence ultimately led to our success in generating funding.
Can you please give us your favorite “Life Lesson Quote”? Can you share how that was relevant to you in your life?
As above:
“I do not want my house to be walled in on all sides and my windows to be stuffed. I want the culture of all lands to be blown about my house as freely as possible. But I refuse to be blown off my feet by any.”
