In honor of National Hispanic Heritage Month, AHLA has partnered with the Hispanic National Bar Association to present this three-part series highlighting the career journeys of Latino/Latina health law leaders. In the first episode, Gelvina Rodriguez Stevenson, Vice President, General Counsel, The Wistar Institute, and Esteban Rodriguez, Counsel, O’Melveny & Myers LLP, speak with Sarina Rivera, Assistant General Counsel, Genentech. In her role, Sarina has provided strategic health care and FDA regulatory counseling to global and U.S. R&D organizations, and she currently supports Genentech’s pharmaceutical technical group and is active in the organization’s diversity and inclusion initiatives.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
In honor of National Hispanic Heritage Month, AHLA has partnered with the Hispanic National Bar Association to present this three-part series highlighting the career journeys of Latino/Latina health law leaders. In the first episode, Gelvina Rodriguez Stevenson, Vice President, General Counsel, The Wistar Institute, and Esteban Rodriguez, Counsel, O’Melveny & Myers LLP, speak with Sarina Rivera, Assistant General Counsel, Genentech. In her role, Sarina has provided strategic health care and FDA regulatory counseling to global and U.S. R&D organizations, and she currently supports Genentech’s pharmaceutical technical group and is active in the organization’s diversity and inclusion initiatives.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
This episode of ala Speaking of Health Law is brought to you by HLA members and donors like you. For more information, visit american health law.org.
Speaker 2:Welcome everyone. Vitos. Thank you for joining us. This podcast is part of the Latino Latina Health Law Leaders podcast series being presented by the American Health Law Association in conjunction with the Hispanic National Bar Association in recognition of Hispanic Heritage Month. So for those of you who don't know, Hispanic heritage month spans two months. It begins on September 15th in recognition of the date when five Latin American countries, that was El Salvador, Honduras, Costa Gu, and Nicaragua gained their independence from Spain in 1821 and then Mexico. Chile and Belize earned their independence later that month as well. And while this started originally as Hispanic Heritage Week in 1968, it has expanded to a month long time to honor the history, culture, and achievements of the Latino and Latina community. My name is Galvin Stevenson. I will be your cohost. And I serve on the board of Directors of the American Health Law Association and as co-chair of the Hispanic National Bar Association's Health and Life Sciences section. And I'm thrilled to co-host this with, uh, Esteban Rodriguez, um, who will be facilitating as well. Our aim in this podcast is to celebrate Latino Latina leaders in the health and life sciences legal field. Over the course of the series, we're gonna talk with Hispanic attorneys and legal professionals who are working on cutting edge issues in the health and life sciences space. These are people who are trailblazers in, in the legal profession and in the Hispanic community as well. We'll hear about their backgrounds, their journeys, their amazing work, and the challenges and highlights they've faced in their careers. With that said, Esteban, I will turn it over to you to introduce our fantastic guest today.
Speaker 3:Hi Galvin. Thank you so much for that introduction. As Galvin mentioned, my name is Stevan Rodriguez. I'm one of your co-host. I'm a council with Omel Albany and Myers and it's Los Angeles office. We're, my practice focuses on litigation in the firm's product liability, masstorts and life sciences industry groups. I'm also a member of both the ALA and the H B A. I'm really excited to welcome our guests for today's podcast, Serena Rivera, Assistant General Counsel at Genentech. Serena, it's great to connect with you. Thank you for taking the time to be with us today. We'll spend the first part of the podcast learning more about your background, the second part, focusing on your work and a substantive topic or two in the healthcare space. And then we'll wrap up with some key takeaways. But let me start by introducing you as an assistant GC at Genentech. Serena has provided strategic healthcare and FDA regulatory counseling to global and US r and d organizations for the last 14 years. Her counseling spans preclinical discovery through phase three, and she has guided life cycle teams across multiple therapeutic areas, including oncology, neurology, central nervous system, metabolic, and infectious disease. Serena currently supports her organization's pharma technical group on GMP Quality Matters and conducts training sessions on legal and compliance issues, including emerging privacy and data sharing laws. A proud daughter of Puerto Rican parents. Serena is also active in Genentech's diversity and inclusion initiatives. Born and raised in New Jersey. Serena received her JD from Seaton Hall University School of Law, and her ba Summa CU Laude from New Jersey City University. Serena's accomplishments outside of Genentech are just as impressive. She's an army veteran who served in the National Guard after high school. Thank you for your service, Serena. And she's also a mother of four. So, Serena, I'd like to start by talking a bit about the early stages of your journey. Can you tell us about, uh, your family and how you ended up in law school?
Speaker 4:Sure. Um, and thank you so much for that wonderful introduction. It's an absolute pleasure to be here speaking with you both today. Um, so I was, uh, born and raised in Hudson County, New Jersey. Uh, I grew up with my mom and dad who, um, were both, uh, born and raised in Puerto Rico and arrived in this country when they were about 16 years old. I grew up in this, in, in my household. Um, I had a younger sister. It was about 16 months younger than myself. Um, and, uh, I was, um, a proud product of the Hudson County School System. And, uh, graduated high school in about 1999, if I remember correctly. Cause it was, you know, the, the music playing at that at our senior, uh mm-hmm.<affirmative> senior prom was Prince's party. Like it's 1999, and you kind of never forget that. Um, there you go. There you go. Right. And I knew, I knew when I graduated college that I wanted, uh, graduated high school, that I, I wanted to go to college. Right. Uh, but I also knew that there wasn't really going to be a, a good way to pay for that. Um, and so I decided, uh, pretty early on that I was going to enlist in the Army National Guard, um, because, uh, you know, they offered the GI bill and it seemed to me a very good way to both serve my country and get college paid for. Uh, so I enlisted, uh, right after high school and spent, you know, six, uh, three months in, in basic training. And then another three months after my first year of college at New Jersey City University, uh, learning to be a medic. Um, and so from there, uh, you know, I had to make a decision, right? Once I was in, uh, college, it, it time was ticking. And I think I was in my third year of college where I had to make a really important decision. What did I want to be when I grew up? And, uh, I was in the, um, recruiter of the, the office, the guidance office, and there was a pamphlet there that said things, you know, you can do with an English degree. So I was an English major at the time, and one of the items on that list said lawyer. And it was like a light bulb went off in my head at that time because I hadn't actually ever considered that as a, as a possibility. You know, In fact, I remember sitting in the guidance office of my high school when I was about, uh, junior year or so, we were talking in that meeting about, you know, what did I wanna be? Right? And I think at that time, I was very interested in science, and I had mentioned something along the lines of wanting to maybe go into science. And, you know, sadly, the interaction with that guidance counselor did not, was, was, did not go well. You know, I was essentially told, eh, maybe, you know, that's not for you. You need to, you have to think about something else that's not for you. Right? And so that was my first experience of kind of feeling like, hmm, like, do I have, you know, kind of questioning do I have what it takes to maybe, you know, enter into one of these professions? Um, um, but I knew by the time I got to college that I, that I could, you know, it was, it, um, you know, I had more confidence in my ability. And so when that light bulb went off, when I saw that pamphlet, it was done. I was going to go to law school.
Speaker 3:That's great. That's great. Uh, very glad that that pamphlet was there for you,<laugh>. Uh, and we're here today because of it. Um, so you mentioned your time in the Army. Did, did your military experience, uh, shape who you've become as a professional?
Speaker 4:Absolutely. I have carried essentially the, the core Army values with me all these years. And I've always had, uh, instances in my life where I've been able to call on those values. You know, that the values include honor, honor, integrity, um, you know, ensuring that you, you, um, have, you know, fortitude. And, and so I've had many instances in my life where I've had to pull on those, and those have been a tremendous benefit to me overall as a person and as a professional to be able to kind of take a step back and see the, the broader picture and work towards a common goal. Because being in the army is always about working towards that common goal. Uh, and so, you know, I learned those lessons very early on in the military, and I've carried them forward ever since.
Speaker 3:That's great. So go to the Army, decided to go to law school. Uh, can you tell us what ultimately led you to pursue, pursue a career in health law, and what has kept you interested in it?
Speaker 4:Yeah, sure. So it's, it's kinda interesting because I think it kind of, I think the practice of health law sort of found me. You know, I, I was, uh, a first year in law school and there was, there was this, um, opportunity to participate in, um, a fellowship. It was the Justice Clifford Fellowship, and I applied to it on a whim and, you know, didn't think I would get it right. I was like, Oh, maybe not right. There were many people competing for that fellowship. And to my surprise and great joy, I, I got the fellowship and it was at a law firm in New Jersey called Pio, Broberg and Newman, which happens to specialize at that time anyway in pharmaceutical defense. So, uh, for me, no brainer, I would summer at this law firm, and I, you know, I came back actually my second year, um, to summer as well. And then, you know, there, you know, thankfully there was an offer waiting for me upon graduation. And so that is, you know, it happened, right? That, that was the firm that I'd had experience with up until that point. And so I was quickly immersed in the world of, um, supporting pharmaceutical companies.
Speaker 3:That's great. And in describing your background, it's, um, quite obvious that, and from our conversations that you consider yourself to be a generalist at, at Genentech, uh, and your time there, you've worked in a lot of different sectors in the life sciences industry. Can you tell us, uh, a bit about what you're, uh, doing nowadays and looking back on your time, which component has been of most interest to you?
Speaker 4:Yeah, so I, I like to say it's, you know,<laugh>. I say I'm, I'm a jack of all trades. That's how I kind of refer to myself. And I say that with pride, right? Because I think the next part of that saying is master of none. But I feel like I, I, I, I've also been able to master the, the areas that I've, um, worked in. Right? Um, the other thing I like to say jokingly is I've done everything at genetic except clean, the clean, the bathrooms like that, you know, because I have just, you know, had so many opportunities there, which I've been incredibly grateful for. Um, you know, I have had, um, the ability to participate in supporting our company from basically from cradle to grief, you know, so I, I, I've worked on, um, uh, preclinical, uh, on the preclinical side, uh, supporting, uh, the very early science. I've had an opportunity to support the actual clinical development. So once the drugs actually actually, you know, get into the clinic or intervene, um, used on, on subjects, I've had an opportunity to counsel there on the commercial side, you know, the entire first bit of my career was spent supporting commercial operations. And then more recently on, uh, I'm providing legal support to our pharma manufacturing organization. And, and PT is sort of the engine of the pharmaceutical company. And I've had a, a really great experience getting to know that. And then a smattering of privacy work, you know, healthcare compliance work, uh, you know, it's been, it's been pretty extraordinary. I've never felt pigeonholed, I've never felt constrained in terms of what I could learn. Uh, and, you know, I'm very grateful that I work for a company that fosters those opportunities.
Speaker 3:Yeah. I was actually about to ask you that. If, if those opportunities, are those things you sought out, it just kind of happened to be the case that you've worked in these various areas. How, how did that come to be?
Speaker 4:Yeah, so some of it is, uh, was a consequence of, um, various situations, right, that were happening at the company. So we were, very early on in my career, we acquired Gene, uh, Roche required Genentech, um, which required a shift to the legal support. So I had started out, uh, primarily on the commercial side. And then once that shift occurred, my, my work kind of moved over onto the development side. Um, so some of it has been as a result of circumstances, others have been, you know, areas of interest. So the, the, the privacy work that I've been able to kind of dabble in on the side, on the data sharing side, um, that has been, uh, has occurred as a result of my direct interest. Some of the compliance work I've done has also happened as a result of, of just direct interest. And then, you know, and then, and then I've had various assignments. And so I think the manufacturing piece that I'm doing now, that was an assignment and a, and a growth opportunity for me, which I actually really appreciate.
Speaker 3:Great. So now on the manufacturing side, uh, can you tell us, uh, about any trends that you're seeing nowadays, um, and the kind of work that you're doing?
Speaker 4:Yeah, so, uh, so the, the client group that I represent on the manufacturing side is, is the quality organization. So this is the organization responsible for ensuring that we're complying with a good manufacturing practices or GMPs. And so what I'm seeing, um, recently there's a, a, a, a uptick in terms of FDA inspections happening at sites. I think with covid, some of that has slowed down a bit, obviously, because, you know, the, the practicalities of bringing people on site, I think there was, there was a lot more, uh, constraint around that. What, with things opening up now, I'm seeing a kind of a flood of FDA inspection requests, uh, both announced and unannounced, um, for pre-approval purposes and for general GMP purposes. Um, so I'm seeing a flurry of activity happening around the inspection side, which of course requires us as companies to be prepared and to, to always be prepared because you don't often know when these inspections are going to happen.
Speaker 3:Right, right. So you also, uh, worked on the r and d side of things at Genentech, as you mentioned. Uh, as I'm sure you've seen, the FDA has recently made a push to encourage drug sponsors to increase diverse participation in clinical trials. I'd love to get your views on that push, whether you see it as important and whether you've seen progress in this area.
Speaker 4:Yeah, that's a great question, and I think, um, I have seen, uh, I, I appreciate this push towards ensuring more diversity in our clinical studies, because the data that we derive from our clinical studies is really only as good as the patient populations that we have participating in those clinical studies, right? It's not often apples to apples and oranges to oranges when you're looking at the way a drug interacts with the body. And so it's critically important that there is a representative cross section of people participating in the studies. Um, and often like the, the practical reality is that there are many barriers to, uh, participation in clinical trials for some people. And Genentech in particular, I'm very proud of this, um, has initiated, um, an advancing inclusive research initiative at the company, really designed to get to the heart of where those barriers lie. And, and to do what we can to help eliminate those barriers. So for example, setting up clinical trials where the people are, right. Bring the clinical trials to the people, right? And because often travel and the expense associated with that is prohibitive for a lot of folks. So let's bring it to them. Let's partner with, um, large clinical trial sites in these urban areas, right? So that we can be able to, uh, better provide access and, and allow us to really, um, research and, and, uh, be able to, to get a better sense of, of what those, what the part, the participants' pain points are around participation, and then hopefully alleviate those. So I think it's an incredibly important and vital initiative, and it's only going to re result in, um, our products, um, you know, servicing, um, more people and, um, being even more effective.
Speaker 2:Yeah. And Serena, that it's just, it's so impressive. You've had such a breadth of experience working on all of these different, you know, topics and areas, um, at your company. You've been on the r and d side, the commercial side, um, the manufacturing side. So you have a really great perspective, and I know in as Seban, you know, mentioned in your introduction that you're also doing a lot of work and are very active in your company's diversity, equity, and inclusion initiatives. Can you tell us a little bit about what those are and whether you've seen them have an impact, you know, over, over time?
Speaker 4:Yeah, sure, sure. That's, So this is a, a topic that is so near and dear to my heart. Um, and I think Genentech in particular has done a really great job of, of focusing on DEI initiatives as, as a, as an enterprise, right? So it's not even just sort of limited to different groups and disparate positions being taken. No, it's straight from the top that this is critically important. Um, and some of the groups that I've participated in have been the, the, um, the legal department's, d e I group, um, which I'm very proud to have participated in, in a number of initiatives that that group has put forth, including, um, trainings around implicit bias, which I think is something that, um, you know, we all benefit from being sensitized to, because we all hold implicit biases, right? And being able to recognize that and accept that, I think is, you know, allows us to, to be one step closer to ensuring, uh, you know, healthy, um, safe work environment for all. So that's one initiative. The other initiative that I'm also very passionate about is the mental health initiative that exists at Genentech. I think that, um, for too long there's been too much stigma around, um, the discussion of mental health. Um, I think our profession in particular, uh, suffers from very, very high, you know, rates of drug abuse, alcoholism, depression, you know, and I don't, I, you know, I, I, I don't know that we're talking about that piece enough at our companies. And the only way you can destigmatize these com, you know, these conversations is by actually having them. Um, and the more people that have, you know, the kind of the courage to be vulnerable and express their struggles, the more people you know, will in turn feel that they are safe to share that and seek help. So I think that's, uh, a huge piece of what Genentech is doing, uh, right now, and I'm, I'm very pleased to be a part of that.
Speaker 2:Yeah. And have you seen the, um, kind of the, the impact of those types of programs? Like, is there more of an openness, um, more just availability of resources?
Speaker 4:I think so, right. I think I, I've seen it within our own group mm-hmm.<affirmative>, um, you know, I, our events we do put on programming as part of both, you know, the diversity inclusion, the traditional diversity inclusion and the mental health initiative. We see a ton of participation in, in this programming. People are really engaged. Um, you know, they, there's a lot of buy-in, right? And the importance of these initiatives, and I think it, it has shaped how people, uh, communicate with each other and, you know, has shed a light on, you know, um, the different styles that people have and how to best respond to those. So I think in sort of like, in little ways, it's chipping away as some of the things that may have previously divided us. And, and I think that's, that's wonderful.
Speaker 2:Yeah. Well, that's great. And tell us a little bit more about your experience as a, as a Latina lawyer in this space, in life sciences. They're not, you know, a bazillion of you<laugh>. Um, what is, what has that been, you know, how, how do you think that's impacted your career trajectory? And, and yeah, just tell us more about that.
Speaker 4:Yeah, so, so I've always thought of myself as a bit of a unicorn. I, I use that, that, that, um, designation very proudly. Um, you know, in, in, in many settings, I do feel like I am, you know, this bright sparkly pink unicorn kind of sitting in the room. And, you know, I take great pride in that, right? Um, although I wish there were more, right? I wish there were more of us, but until they're, until there are, I am happy to, um, to be, uh, a, a representative and, you know, an example of what can be, right? Um, and so, you know, from very early on in my career, I was often the only one in the room. The only, uh, uh, Latina, the only sometimes the only, sometimes the only woman, right? Um, and, and so I was very sens. I was very, um, you know, kind of became a little desensitized to that cause that was sort of the norm, right? Um, but what I'm seeing more and more as time has gone on, especially in the last three, four years, is a real push towards, um, opening those doors wider and, and fostering, uh, more diversity in the workplace, which I've, I'm, uh, so excited about. Um, the statistics are still abysmal, though. I remember looking at the statistics, you know, probably five, six years ago, and I'm like, Oh, well, you know, 4% of attorneys in the United States are Latino, and of that 2% are female. And whoa. And that's still the statistic, you know, It doesn't, it hasn't changed, you know, so like, why isn't it changing, right? We're doing all this really good work. So why isn't that overall statistic changing? Yeah, you see it in different corners, right? In my organization, I see the shift, which I think is wonderful. Um, but for me personally, I've always taken the position of bringing my authentic self to my work. Um, in the early days of my career, I, I would, you can't see me folks, but I have very curly hair. Um, but in the early days of my career, I was out adamant about straightening that hair, you know, I wanted to, as I felt like that looked more professional, right? Um, nowadays, forget it, this is, is curly hair, don't care. Um, I'm, you know, going to present myself as I am and I'm going to, you know, voice my opinions and, you know, and, and hopefully people appreciate that.
Speaker 2:Yeah, no, that, yeah, that, that's great. Serena and I, this is a great segue, uh, into our, our final three questions, um, uh, to, to wrap up the podcast. And, uh, you know, you talked about, thank you for, for, for providing the stats of, of, you know, 4% of, um, lawyers in the US or Latino. Only 2% are, are women in your right. It hasn't changed in, in, in the past, in, in a long time. So there's still more that needs to get be done. Um, what, what do you, what, what are the, what do you think are things that we can all do as members of the health law bar or health law professionals? What can we be doing to increase diversity in life sciences and and health and health law?
Speaker 4:Yeah, it's a fantastic question. I was thinking a lot about this in the lead up to this podcast, and I think, well, there's a couple of things, right? It's, I think representation is incredibly important. I think, um, for me, I'm the first lawyer in my family, so I didn't see other lawyers. Um, it didn't seem like a, necessarily when I was young, like a, a viable pathway for me. And so I think, um, providing more visibility, right? Um, getting out there and letting people see, you know, that this is, this is something that's possible, um, interacting with young people to the extent that, you know, there are volunteer opportunities at schools or chances to talk and relate your experience, I think that goes a long way towards planting the seed that this is, that this is a possibility for you. And whenever I can, I do take those opportunities to do that. Cause I think it's, I think the representation and the visibility piece is incredibly important. Um, and then the other bit, right, I think the, the, probably the, one of the bigger, um, impediments is, is access. Um, you know, law school is a luxury, you know, it can be a real luxury for a lot of people. And, um, you know, finding ways to maybe even steer people towards programs where they can, you know, receive appropriate assistance to be able to make that dream a reality, um, I think, you know, could go a long way towards, um, increasing, increasing the numbers. Yeah,
Speaker 2:No, that, that's, that, that's, those are great pieces of concrete advice. And, and like you said, the mentorship is, is key. Um, what about, what advice would you give to COR attorneys who are just thinking about a career in, in health law and just sort of starting out any tidbits and how to, um, navigate that, How to, you know, get to where you wanna be?
Speaker 4:Yeah, so I think my best piece of advice is to be open minded, right? I think sometimes we go into this thinking, this is what I'm going to be and this is what I'm going to do, and nothing's gonna, and maybe, maybe that's correct, but I think you maybe lose some opportunities to branch out and into other areas when you're a little too focused and maybe not willing to, to take a chance on something different. I mean, that's sort of been the hallmark of my career, is taking a chance and, you know, kind of going with the flow and seeing where it leads, because sometimes it leads somewhere really exciting and really rewarding. Um, so I would say be open in your early careers, especially to other opportunities. Look for chances to cross train in different spaces. Sometimes that's really tough to do in the law firm. If you're starting in from in the law firm, you kind of get put in one practice group and, and that's might be where you stay, right? Um, look for, look for chances to, to work in other groups and see other aspects of the law. I think that's especially important for, for life sciences.
Speaker 2:Yeah, that's great advice. And um, you know, and as you said, there's so many different components, uh, in health law and life sciences. You can be doing so many different things that you may not even know about when you're just going in. Okay. Last question. This one's gonna be hard cuz you have so many wonderful things to say, but in three words,<laugh> or so, uh, how would you describe your experience as a Latina life sciences attorney?
Speaker 4:<laugh>. Okay. All right. Here we go. Three words. Mm-hmm.<affirmative>. Um, so the first is rewarding, right? Uh, so for me, the, the practice of law has been incredibly rewarding, um, in that I think, um, it's allowed me to really grow as a human. Um, and it has afforded me the ability to really take care of my family. Um, like that can't be understated. It's, it's, it's really kind of changed my family tree in a lot of ways. And, and so, um, you know, I'm super grateful for that two challenging<laugh> cause I can't leave that out. Um, the practice of law is inherently challenging. Um, the practice of law as a Latina is inherently challenging. Um, and, uh, you know, but I think, I think it's how, how we rise to those challenges that defines us more so than anything. Um, so it's okay to struggle. It's okay to have the, the, you know, the upsets. Um, but you know, it's, it's, it's, it's important to be able to, to come back, right? And rise up from those things and not let those challenges define you. Um, and so, and third and final trailblazing, I'll use the word trailblazing, um, because, um, you know, as I mentioned, I am the first in my family. Um, I, you know, take a lot of pride in being able to be, uh, a role model and a mentor to other, um, young Latinas, you know, out there who, you know, maybe might look at me and say, Hey, you know, maybe I could, they won't need a, a pamphlet in their guidance office to spark the idea. They can actually see it in practice and think that, you know, I can do that too.
Speaker 2:That's great. That's great. Okay. Thank you. Thank you, Serena. I'll turn it over to you. List
Speaker 3:Devon. Yeah, I, I was just gonna say, I'm sure many, many who are listening are having that reaction right now. Uh, so Serena on behalf of ALA and the hm b Galvin, and I want to thank you again for taking the time to be with us and for the amazing conversation that we just had. Your words of wisdom leadership and, and commitment are truly inspiring. So thank you.
Speaker 4:Thank you.
Speaker 1:Thank you for listening. If you enjoyed this episode, be sure to subscribe to ALA speaking of Health Law wherever you get your podcasts. To learn more about ALA and the educational resources available to the health law community, visit American health law.org.