Operations as an Integrated Function for Medicine Development
Episode

Shailah Yazdani, Director of Operations at the Center for Breakthrough Medicines (CMB) at Discovery Labs

Operations as an Integrated Function for Medicine Development

LabOps is both a driver and an influencer within a CDMO.

 

In this episode, Shailah Yazdani, Director of Operations at the Center for Breakthrough Medicines (CMB) at Discovery Labs, talks about her journey into LabOps, the multiple facets and capabilities CBM has as a Contract Development and Manufacturing Organization (CDMO), and the role LabOps play there. Shailah started working in the travel industry, an entirely different space from where she is now, but she learned to find similarities between both. Engaging with people, generating and analyzing data, and working with automation were transferable skills. She explains how at the Center for Breakthrough Medicines, she works in operations to support clients and patients by accelerating the speed at which they take the therapeutic assets they need from discovery to commercialization. Shailah discusses how operations provide an infrastructure for different work streams within a CDMO and why good communication is key.

 

Tune in and learn about what Shailah shares on LabOps within CBM!

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Operations as an Integrated Function for Medicine Development

About Shailah Yazdani:

Passionate about driving the next generation of provider and patient care offerings, Shaila Yazdani has dedicated more than 15 years to creating and modernizing organizational systems and delivering best-in-class healthcare solutions. Focusing on the company vision and mission, Shailah works with industry leaders to solve multi-layered challenges, designing innovative systems to create value and ignite enterprise growth. 

Throughout her career, Shailah has honed a skillset that blends critical thinking and problem-solving to create progressive and effective change. As Director of Operations for the Center for Breakthrough Medicines (CBM) since 2021, a cutting-edge cell and gene therapy company, Shailah successfully launched their analytical development labs and piloted the rollout of GMP testing. By readily identifying the root cause of complex interdepartmental issues, Shailah generates solutions that reduce or eliminate operational inefficiencies, delivering comprehensive and dynamic operational systems. In her previous role as Head of Lab Operations for Testing Centers of America (TCA), Shailah designed and launched both brick-and-mortar and mobile COVID-19 testing labs from the ground up, serving a critical need during the height of the COVID-19 pandemic. Results-driven by nature, Shailah embraces her role as an integrator, outlining and disseminating objectives to empower multidisciplined groups and individuals to work together towards common goals. 

Equipped with an MBA from the Fox School of Business at Temple University and a Lean Six Sigma Black Belt certification in Healthcare, Shailah champions continuous change and operational excellence by reducing waste and delivering scalable systems, on-time, and on budget. She began her career working as an Operations Manager for Asina Travel & Tours Inc, before joining Parkway Clinical Laboratories (PCL) in 2009. Starting as an Operations Assistant and Manager, Shailah continuously drove improvements, and moved up the organization, reaching Chief Operating Officer before becoming President and Head of Financial Operations for the MENA region. In 2019, as an independent healthcare consultant, Shailah worked with healthcare providers to both establish and improve their financial operating systems.

Named Honoree for Philadelphia Business Journal’s ‘Diversity Leaders in Business Award (2021).”, Shailah has developed not only a distinct and strategic sense of where the clinical and biotech industry is headed, but she also knows what it takes to bring the right people together to make the future of healthcare a reality.

 

LabOps_Shailah Yazdani: Audio automatically transcribed by Sonix

LabOps_Shailah Yazdani: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

Kerri Anderson:
By building a platform to share challenges, thoughts from leaders, and network together, the LabOps Leadership Podcast is elevating LabOps professionals as well as the industry as a whole.

Samantha Black:
With the intent of unlocking the power of LabOps, we deliver unique insights to execute the mission at hand, to standardize LabOps, and empower LabOps leaders.

Kerri Anderson:
I’m Kerrie Anderson.

Samantha Black:
And I’m Samantha Black. Welcome to the LabOps Leadership Podcast.

Samantha Black:
We are so excited today to be joined by Shailah Yazdani, who is Director of operations at the Center for Breakthrough Medicines. Thanks for joining us today, Shailah.

Shailah Yazdani:
Thanks, Sam, it’s so good to be here and I appreciate you having me. Happy New Year.

Samantha Black:
Happy New Year. We’re so excited to have you on the show today and you have a ton of great experience. Can you just start off by telling us a little bit how you got to where you are today?

Shailah Yazdani:
Sure, so I like to say that I’m Indian by heritage, Zambian by birth, and American by choice, and what that means is that I’ve had a rich and diverse set of experiences throughout my life that have shaped my approach to life itself, to problem-solving and to engaging with people, and being both a part of a team as well as leading a team. So I’ve had an interesting journey to where I am today. I started off post-high school just working a summer job at a travel agency just to sort of get some cash in my pocket and pay for extra expenses and then also support myself through college, and that eventually led to my mom and I starting off our own travel agency, snd we started this actually a few months before 9/11. So that was a very interesting time period for travel and just through hard work and staying the course, we actually survived that rough time period, and that eventually led me to meeting or actually opening the door to my next adventure. So once I felt that I hit the ceiling with the travel agency and was looking for the next chapter of my life, the doors opened for me to actually join a clinical diagnostic lab here in Philadelphia. So I moved from Chicago, which is where I was living out here for this particular role, and started entry-level at this clinical lab. And then over the course of 12 years, moved up into a leadership position and the operations role was a heavy focus of mine, so I moved from client service into a financial and billing role and then into operations, and that was probably the, where I like to say I grew up, and it was just eye-opening to see how we can take a small community-based lab and with strategic planning and execution and a solid leadership team, take that to be a global organization, first nationwide and then global. And true to form, when I was done with that adventure, I looked outside to see where else I could spread my wings, and the Center for Breakthrough Medicines actually was a great opportunity for me to step into. It also was a startup environment, and that’s where I’d cut my teeth, so to speak, and so have been here since 2021, 2020, actually, correct.

Samantha Black:
Yeah, what an interesting time to join.

Shailah Yazdani:
Yeah, so I was not completely in the loop on cell and gene therapy back in 2019, and so for these doors to open and for me to understand the possibilities and the hope these advanced therapies provide patients was I mean, it was just there was no way that I couldn’t step into it. My dad had a neurodegenerative disorder, and that’s what he had passed away from in 2009. And so the possibilities of what these therapies offer is just something that I could really stand with and stand behind and really want to be a part of moving forward.

Samantha Black:
That’s incredible, and I feel like 2019 was really when things started ramping up, like it was the moment in time where everybody was like, I think this can actually happen, you know? So what an exciting time to join the organization and be on the forefront of such exciting science. So can you just tell us a little bit about what the Center for Breakthrough Medicines is doing?

Shailah Yazdani:
Yeah, sure, so we are a single-site CDMO, and we have built capabilities that encompass process development, cell therapies, viral vector manufacturing, testing and analytical services, research and development, all under one roof, so we can support our clients and their patients to take their therapeutic assets all the way from discovery through commercialization. So it’s exciting that we’re doing this and that we’ve taken this approach. We can definitely provide our clients and these patients economies of scale and time savings as well in terms of getting these therapies to market. So that is what our mission is, is to improve the speed to market for these therapeutic assets, very exciting.

Samantha Black:
So what are you guys doing that’s maybe a little bit different or unique than other CDMOs out there?

Shailah Yazdani:
Sure, it’s a good question. So I think because we are single site warehousing, all these capabilities under one roof, there is a smoother transition from one cycle to the next cycle and so on and so forth. And with analytics under the same roof, we no longer have to outsource the analytics that’s required for these therapies to move to the next step and to the next development cycle, it’s all in one under one roof. All the data is housed under one roof as well, so there’s opportunities for consolidation of those analytics and that data and trending and just providing a more robust package of information for our clients and the patient itself. So I keep mentioning patients because they’re at the forefront of everything that we do. I think sometimes we get lost in the nitty-gritty of the day-to-day and we forget the impact that we are actually having and the hope that we’re providing them, and so I always like to focus on that aspect. When you’re having a rough day or, and something’s not quite going as well as you’d like it to, keeping that in mind that there’s a patient at the end of the cycle is so important and so valuable for us to stay motivated and passionate about what we’re doing and what we’re achieving.

Kerri Anderson:
Yeah, I think that’s so great to always remember the why of what you’re doing for something.

Shailah Yazdani:
Yes, for sure.

Kerri Anderson:
So I’m curious, your journey from how you got to where you are today is incredibly fascinating. What was it like transitioning from travel agency and then working in the lab because you didn’t have science background, correct?

Shailah Yazdani:
No, I didn’t.

Kerri Anderson:
I’m sure that was a challenge.

Shailah Yazdani:
Yeah, it was in the beginning. I think what has to be or what has to remain a focus is finding the similarities in what you have done as you do a career shift, particularly if it’s from one industry to another. So what I’ve found is sometimes best practices can come, in one industry can actually come from a completely different industry, right? And you’ll find similarities or similar threads in unexpected ways. So I think the one thing that I learned from the travel industry that translated really well into the clinical diagnostics industry is engaging with people and how to interact with them, how to get them comfortable, and a focus on data and information. So tools to collect that information, those are also very similar in between the two industries, it would never have thought that, but the tools that I was using in the travel industry came in very handy, clinical diagnostics, particularly since I entered in the client services role at the lab that I was at. And then what I found in terms of similarity between the clinical lab diagnostics industry and the pharma industry specifically for testing is this is a very up-and-coming area. So economies of scale is something that we’re trying to achieve, whereas clinical diagnostics is a mature industry. And so there are best practices across sample management and testing and data generation and analytics that transfer really well into setting up our infrastructure here. And so those are the lens with which being a startup, I actually had the opportunity to influence some of that decision-making, and so I was very grateful for that opportunity at CBM, but some of those best practices I’m finding are actually fitting quite well here at CBM and setting up our framework and our infrastructure here. So automation is another key piece where I’m finding, in clinical diagnostics it’s part and parcel of what you do. Since it’s high volume testing, high throughput testing, you have to have automation to achieve efficiency. So again, it’s a matter of transferring that knowledge set and that understanding here to see how we could achieve the same similar efficiencies of scale here in testing and analytics.

Kerri Anderson:
Yeah, absolutely. I mean, I couldn’t agree more. I think data is an important part of where this industry is going and it’s something we’re seeing people think about more and more.

Shailah Yazdani:
Yeah, specifically for a CDMO, analytics are a key driver of the progression of a therapeutic asset, right? So you can’t move forward unless you have your critical quality attributes identified and you have information about them. So with the understanding that the actual service and the product that we offer under the Testing and Analytical Services department, it’s data and it’s not just data, it’s actually insightful and meaningful data. That is our service, it’s our product. And so if we focus on how to optimize and deliver that information in a manner that’s effective and useful, it makes us that much more powerful in delivering these therapies and improving that speed to market and achieving our mission.

Samantha Black:
That’s super interesting that you view it that way because I feel like that’s a shift, right, from the way that it was done even ten years ago. You know, everybody thought that the product, the medicine at the end was the goal, and it still is, but the data at the center and how you got there, like that’s so much more of a big deal nowadays than it was even five years ago, you know? And so I think you, what you said about transfering your knowledge and your skill sets over from different industries, that’s really fascinating to me because I think a tool is a tool, right? And as a LabOps manager and working in LabOps, right, it’s all about the tools that you use to help the team, right? And so I think being in a support role where you use those tools and having that perspective can be really important for pushing the whole entire team forward. Do you feel like in your role that you’re kind of pushing the team by using some of these tools and these, the skills and having like a focus on the data? Do you feel like that’s helping the entire team move forward, not just, you know, your direct reports?

Shailah Yazdani:
Sure, that’s actually a great question, and I’ve thought about this quite a bit. So what testing and analytical services provides is analytics. That’s what our service and product is. The CDMO’s service or product is actually the therapeutic asset, so just want to make sure I distinguish between the two. So operations in my perspective is both a driver and an influencer. We’re very much an integrated function. We don’t, or we shouldn’t exist in a silo. I think when we exist in a silo, there’s a lack of cohesion that I find that the team operates under, exists under, and so you’ll have multiple parallel or divergent work streams, but they’re not brought together unless operations is providing that infrastructure to do so, and that could be using tools like communication. It could be simply identifying similarities of each workstream and then building scale behind those similarities. It could be identifying process gaps and designing solutions to fill those measuring and then filling that gap with a solution and then ensuring its sustainability. So operations does all of that in a multi-faceted role, and it’s not just the individuals on the operations team. We influence the decision-making of other team members based on the data that we provide or the key performance indicators that we’re measuring or understanding what the strategic vision is and then tying it to the actual execution against that strategy and saying, hey, does our execution or does our tactical activities support what the vision of the mission is? So I’ve heard, and I’ve actually said many times, that operations wears multiple hats, but I think what I would restate that as, is that we both drive and we both influence decision-making, and direction provide focus as well. So it’s not just limited to the operations team, it’s actually expanded out to the broader technical team as well.

Samantha Black:
Amazing.

Kerri Anderson:
I love that.

Shailah Yazdani:
Thank you.

Samantha Black:
So I guess one other question I have on that same vein is, as an operations team and influencing decision-making, what are some of the most important parts of your job besides the data? Like, are you, I guess because you’re at a higher level, right, so you have a team under you. So on a day to day, what do you think? Some are the most impactful things that your team is doing on a day-to-day basis, like tactically, besides providing the data? Like what are some things that you have seen make a big difference in the organization?

Shailah Yazdani:
I think communication is the most important tool in an organization, both from bottom up and then top down. So understanding that what our vision and our mission is not just a statement, but how it translates into what we do day to day, and then receiving that feedback from those who are actually in the lab and understanding what their challenges are, providing a feedback loop and then closing those feedback loops. That’s how we continue to move the needle, I would say, in achieving what our goals and our objectives are and then engaging our team, keeping them passionate about what they’re doing, reminding them that science is still at the forefront of everything that we do, and that is actually what is solving these larger problems for these patients and providing them with that hope. It’s not the operations team that’s doing that. All we do is really provide the ecosystem in which the scientist and the technical aspect gets to shine. So I think keeping that communication alive and in front of them and again, reminding them on a day to day what it is that they’re helping achieve is actually vital. So for me, communication is the most important thing that an organization can really embrace, facilitate and engage in on a day-to-day basis, and that drives all other activities. So as long as you have a robust communication system, I think it just lends to inherent success of an organization.

Kerri Anderson:
It sounds like you’re doing incredible work there and you’re really building a great team. I’m sure, during that time, you’ve learned a lot of lessons. What’s some advice you could offer to our listeners?

Shailah Yazdani:
Oh gosh, now that requires some reflection. I think it goes back to reminding ourselves on a day-to-day basis of the impact we’re having. You know, startups are admittedly an intense environment. I have spent my career in startups, and what I always walk away with is don’t lose that passion, don’t lose that interest, and not just yourself, but ensure that your team and those that are on other teams continue to feel that excitement about what you’re doing. And so I think the focus on who we’re helping, what we’re doing, and why we’re doing it, I think is important and something that we should never lose sight of. And the days that we do, there should be other team members who step up and say, this is why we’re doing this, remember? To keep us moving forward. And so I think, again, that lends itself also to the inherent success of an organization. So there’s no one clear path to success, right? It’s like multiple workstreams, it’s multiple pathways that all converge and ultimately achieve that goal, that objective, and keep the focus on the patient and who we’re trying to help, and why we’re trying to help them. We all have stories, we all have family members who’ve experienced some health issue and there have been moments where you’re like, oh gosh, can it get any worse, right? Well, I think what we’re doing is a reminder that, no, actually, it can’t get any worse, this is it. It’s not going to get any worse than this, it’s only going to get better. And I think that’s the lesson that I hope I always walk away with every day, and also my team and those that I interact with as well.

Samantha Black:
That’s such a great perspective. I think you’re very lucky to, I know that you work very hard, I can tell that you work very hard to keep that perspective, but I’ve heard with maybe other pharma leaders or other individuals, they don’t have that same perspective. So I love keeping that patient at the forefront and making that the center of everything that you do. That’s really an incredible perspective in my personal opinion.

Kerri Anderson:
Yeah, I think that’s what makes an amazing leader.

Shailah Yazdani:
I appreciate it. Thank you.

Samantha Black:
Well, I think for the last question we have, you know, you’re an incredible leader and obviously, you have a fantastic work environment and you’re doing a lot of great work at the center. And so if people want to find you or connect with you and learn more about what you’re doing, how might they do that?

Shailah Yazdani:
So I can be found on LinkedIn and you’re more than welcome to share my email address. I would be happy to connect with anyone with additional questions. I can share that with you after the podcast, or however you see fit, but happy to do so.

Samantha Black:
Awesome, yeah, no, I think that’s incredible and we will post that in the show notes for everybody. So if you are interested, you can just click the link in the show notes and reach out. So I think that’s all we have today. Thank you so much for joining us. This has been incredible. I’ve really enjoyed speaking with you and thank you for sharing your experiences.

Shailah Yazdani:
Yeah, thank you so much for having me. I’ve enjoyed speaking with both of you and thank you for actually doing this and pulling together lab operation leaders, appreciate it.

Samantha Black:
Great, thank you.

Shailah Yazdani:
Have a good day.

Kerri Anderson:
Thank you for tuning in to this episode of the LabOps Leadership Podcast. We hope you enjoyed today’s guest.

Samantha Black:
For show notes, resources, and more information about LabOps Unite. Please visit us at LabOps.Community/Podcast. This show is powered by Elemental Machines.

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Things You’ll Learn:

  • One can take a community-based lab to a global organization with strategic planning and execution, and a solid leadership team.
  • CBM has built capabilities encompassing process development, cell therapies, viral vector manufacturing, testing, analytical services, and research and development, all under one roof.
  • For a CDMO, analytics are a key driver of the progression of a therapeutic asset, and providing insightful data is very valuable for clients and patients.
  • IF Lab Operations are siloed, that will create a lack of cohesion in the multiple works streams a pharma company might have.
  • Communication is the most essential tool in an organization as it is key to keeping everyone on board with their vision and mission, finding value in provided feedback, and reminding the impact and importance of everyone’s tasks.

Resources:

  • Connect with and follow Shailah Yazdani on LinkedIn.
  • Follow the Center for Breakthrough Medicines on LinkedIn.
  • Discover the Center for Breakthrough Medicines Website!
  • Reach out to Shailah at [email protected]
  • Connect with and follow co-host Kerri Anderson on LinkedIn.