Technological innovation, the coronavirus pandemic and a changing regulatory landscape are among the most important topics for the new chief of compliance of the pharmaceutical company Eli Lilly & Co., Alonzo Weems.
Mr. Weems succeeded Melissa Stapleton Barnes, who retired from the Indianapolis-based company in June after approximately nine years as its chief ethics and compliance officer.
As an employee of Eli Lilly since 1997, Mr. Weems is deeply familiar with the core businesses of the company. Among his previous roles, he served as an oncology clinical research support attorney and as director of global workforce diversity. Most recently, he was Assistant General Counsel.
The pharmaceutical industry is heavily regulated and Mr. Weems begins his new role as the Covid-19 pandemic intensifies attention in the sector. The company produces several Covid-19 drugs, including two monoclonal antibody treatments. US regulators halted distribution of the drugs last month because data shows they are not effective against variants of the virus.
In his new role, Mr. Weems will work to ensure, for example, that interactions between the company’s sales and marketing representatives and healthcare professionals comply with regulatory standards.
It will also help the company respond to potential regulatory changes. Amid mounting public consternation over high drug prices, US lawmakers have discussed proposals that could limit drug companies in the way they price their products. President Biden this month issued an executive order aimed at lowering prescription drug prices, including by allowing states to import drugs from Canada.
In an interview with Risk & Compliance Journal, Weems spoke about how compliance is changing for Eli Lilly in light of the coronavirus pandemic and the changing regulatory environment. Below are edited excerpts.
WSJ: Upon reaching this position, what are your priorities? Are there any changes you want to make?
Mr. Weems: We have to be doing [compliance] in ways that are easier for our colleagues to understand. We need to think about how it can be easier to get the information as we enable, partner, and help our colleagues do their jobs. That is not sexy. But it is very, very important to offer a program that meets the needs of the business.
We have to make sure we have the right capabilities, that our risk assessment and monitoring are correct. And that we are doing it in the best way. That we are executing our business risk management program in the best way possible. That we are optimizing our training and communication resources.
WSJ: Has the way you monitor and track your compliance with your various regulatory obligations at Eli Lilly evolved in recent years?
Mr. Weems: Yes, it is evolving. It is about trying to move from a much more manual, individual and predominant approach to observation. [approach]…to [one] where there are many data feeds.
The challenge is: How do we connect all this data to get a more holistic picture and information? How do we use machine learning to display outliers, because it can do so much more efficiently than we can?
Now I have had two conversations and a deeper dive with the new leader of our digital solutions and information group. [Diogo Rau]as we think about the partnership between that group and our global ethics and compliance and business risk management function.
He was as excited as I was during the conversation. So I see it as a really strong partnership. But you know, you are moving data from different systems, from different platforms. The details are not insignificant and the journey is not easy. But that’s the future of doing even better monitoring work.
WSJ: What do you consider to be the biggest compliance risks or challenges facing the pharmaceutical industry right now?
Mr. Weems: A big problem in the industry is cyber threats. I believe that we will continue to view cyber and information security as a significant risk that companies are working hard to mitigate.
Not surprisingly, as a pharmaceutical company, we continue to pay close attention to the pricing and access environment. What Covid reminded us all of is the important role the pharmaceutical and biotech industry plays in providing answers to challenging health and medical problems. But we know that there are significant access challenges that we still face, nationally and internationally. That is a risk during the pandemic, especially since we are increasing vaccines and antibodies.
There is a greater regulatory focus on quality issues. That is a conversation that is also important to us, to which we pay a lot of attention.
The last one I would mention [are the risks posed by] corruption, bribery and transfers of value. We are always thinking and working hard to avoid any kind of material compliance failures. We want to be very diligent in executing our programs and in making the right decisions.
WSJ: Is there a way that the company has adapted to meet compliance during the pandemic that you believe turned out to be positive and will continue?
Mr. Weems: In short, we never fail to deliver. Yes, you didn’t have to travel. But we continued to have communications and conversations with health professionals. Making sure we were doing that right and being accurate and monitoring those communications didn’t stop.
Probably like many [other companies], some of the audits became more virtual. We had to find out, “How do we do world class audits and even some monitoring in a virtual world?” Really knowing the essence of what you needed to find, what you were looking for, became even more important.
I think what we learned is that we can do it well and effectively. And we also learned that it is valuable to be present, to be in the place.
WSJ: In the future, will there be some kind of hybrid situation where in some cases you will continue to do things virtually, but in other cases where it is of higher value, you will do things in person?
Mr. Weems: I think we will continue to do so.
We have learned that there are many things that we can achieve virtually. Communications in some way, around the world, probably improved. At least the frequency of communications improved.
Working virtually can allow us to further stretch our resources. But at the end of the day, we have to make sure that we are getting the high level of quality that we want.
WSJ: He has experience working on diversity issues in the company. Is diversity, fairness and inclusion something that you think compliance plays a role in?
Mr. Weems: This is where I think there are common ground: Leaders who drive diversity, equity and inclusion, and leaders who drive ethics and compliance, we are all in the business of culture.
Diversity, equity and inclusion are not rooted in a legal standard. Rather, it is about saying, “Do we have the processes that consistently ensure that we are identifying, rewarding, recognizing and promoting talent across the organization and doing so broadly?” And observe the processes that give us some assurance that we are doing it well.
We all have a stake in making sure we are doing well, regardless of your role as a leader or as an employee.
Write to Dylan Tokar at [email protected]
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