Risks and Rewards in GMP Process Automation [Will Moss]
Yan Kugel is joined by Will Moss founder and CEO of Seal, to talk about the critical need for automation in GXP processes. Will shares his expertise on balancing automation […]
play_arrow
Agility in Pharma: Transforming Challenges into Opportunities [Elizabeth Hickman]
Yan Kugel is joined by Elizabeth Hickman, the Chief Business Officer at AustinPx. With over a decade of experience in the biotech and pharmaceutical sectors, Elizabeth shares her insights on drug development, innovative manufacturing solutions, and the pressing need for sustainability in pharma.
In the dynamic landscape of the pharmaceutical industry, agility is more than just a buzzword; it is a necessity. The ability to adapt swiftly to changing circumstances, regulatory demands, and technological advancements is crucial for staying competitive. In this article, we draw insights from a recent episode of the Qualitalks Podcast featuring Elizabeth Hickman, Chief Business Officer at AustinPx, who shared her journey and perspectives on fostering agility within pharma.
Table of Contents
A Personal Journey in Pharma
Elizabeth Hickman’s career reflects a deep commitment to the pharmaceutical sector, predominantly in the Contract Development and Manufacturing Organization (CDMO) space. With over a decade of experience, she articulated how her diverse exposure to various drug development programs has shaped her passion for the industry. Unlike traditional pharmaceutical companies where professionals might focus on single programs throughout their careers, the CDMO model offers a broader view of the challenges and innovations across multiple projects.
Elizabeth’s move to AustinPx was driven by three core motivations:
- Identifying Industry Gaps: She recognized a growing need for agile early-phase development partners due to the consolidation of CDMOs in the industry. This insight led her to see AustinPx as an ideal solution.
- People-Centric Approach: The talent and expertise within Austin’s team stood out. The company’s previous model as a specialty pharma organization endowed its professionals with unique skills that facilitate tailored client services.
- Innovative Technology: Elizabeth highlighted Kinetisol technology as a game-changer in the amorphous dispersion industry, which promises to enhance drug delivery while addressing regulatory challenges.
Leadership and Mentorship
Elizabeth’s ascent in the pharmaceutical sector underscores the importance of mentorship and supportive leadership. She credited her success to influential mentors such as Tim Scott and Aileen Ruff, who encouraged her to expand her capabilities and pursue new challenges. Their guidance helped her cultivate a client-centric approach that remains central to her philosophy at AustinPx.
As she prepares to transition to the role of CEO, Elizabeth emphasizes the foundational work laid over the past two and a half years to ensure sustainable growth. Her vision includes investing in people as key drivers of success, recognizing that high-quality service stems from well-supported and empowered teams.
High Science, High Touch
At AustinPx, agility is embodied in their “high science, high touch” model. This approach merges rigorous scientific methodologies with personalized client service. Elizabeth elaborates on how empowering scientists with the right resources leads to innovative solutions that meet clients’ complex needs.
This model not only enhances communication and collaboration among teams but also streamlines processes for quicker project turnaround. By fostering a culture where scientists can make informed decisions, AustinPx positions itself as a trusted partner in drug development.
Sustainability in Pharma
As sustainability becomes a paramount concern across industries, Elizabeth discussed how AustinPx is addressing environmental impacts through innovative practices. The Kinetisol technology is pivotal in this regard, offering a non-solvent based process that minimizes environmental harm while improving operational efficiency.
By streamlining manufacturing processes and reducing reliance on toxic solvents, AustinPx not only enhances sustainability but also delivers cost savings to clients—demonstrating that ecological responsibility can align with business objectives.
Future Trends and Challenges
Looking ahead, Elizabeth is keenly aware of emerging trends that will shape the pharmaceutical landscape. The Inflation Reduction Act of 2022 has significant implications for small molecule development, prompting companies to seek agile solutions that reduce manufacturing costs without compromising quality.
AustinPx aims to leverage these shifts by continually adapting its strategies and enhancing its capabilities to serve clients effectively.
Conclusion
The pharmaceutical industry is navigating an era defined by rapid change and complex challenges. Leaders like Elizabeth Hickman exemplify how adopting an agile mindset can transform obstacles into opportunities. By focusing on innovative solutions, empowering teams, and prioritizing sustainability, companies can not only thrive in today’s environment but also contribute meaningfully to the future of healthcare.
Chapter Highlights
- Introduction to Agility in Pharma (00:02 – 01:14)
- Elizabeth’s Career Journey (01:14 – 02:38)
- Joining AustinPx (02:38 – 04:15)
- Mentorship and Leadership Insights (06:19 – 11:52)
- Role as Chief Business Officer (11:52 – 12:30)
- Agility in Early Phase Development (15:06 – 17:39)
- Client Satisfaction and Business Growth (18:18 – 19:24)
- Sustainability Initiatives (23:09 – 25:44)
- High Science, High Touch Concept (26:15 – 27:00)
- Awards and Recognition (27:05 – 28:25)
- Future Trends in Pharma (31:05 – 32:06)
By embracing agility, pharmaceutical companies can navigate uncertainties while driving innovation and enhancing patient outcomes.
Podcast transcript:
Please be advised that this is an AI generated transcript and may contain errors.
00:27 – 01:14
Yan Kugel: Welcome to the Quality Talks podcast where we dive deep into the world of pharmaceuticals. I’m Yan Kugel, your host, and in today’s episode, we are excited to have Elizabeth Hickman, the Chief Business Officer at AustinPx joining us. With over a decade of experience in the biotech and pharmaceutical sectors, Elizabeth has a wealth of knowledge and expertise in drug development, marketing strategy, and innovative manufacturing solutions. We’ll explore her personal journey in the industry, her current role at AustinPx and the exciting concept of high touch high science. We’ll also discuss the vital role of sustainability in pharma manufacturing and delve into advanced drug delivery technologies and uncover the industry trends that shaping our future. So Elizabeth, welcome. It’s a pleasure to have you on the show and having this chat with you.
01:31 – 01:34
Elizabeth Hickman: Yeah, thank you, Jan. It’s great to be on. I appreciate that.
01:36 – 01:55
Yan Kugel: So you had quite an interesting career and can you share your personal journey that led you to your current position in AustinPx and maybe even tell us what initially attracted you to this industry?
01:57 – 02:38
Elizabeth Hickman: Yeah sure, great question, thank you. I have spent most of my career in the CDMO industry and most of that was with oral drug development. I have a true love of this industry. I really appreciate the exposure to the many different drug development programs and being a part of helping clients solve complex drug delivery problems. That’s very different from being in a pharma company where you might just be exposed to 1 program over the life of your career there. So, you know, in the CDMO industry, you get to work with multiple companies and multiple different campaigns.
02:38 – 03:06
Elizabeth Hickman: So it’s really great to have that exposure. And you know, the feeling that you get when you help a client overcome a challenge and seeing them get that drug either to the clinic or to the market is just a really great experience and what fuels my passion for being in this industry. Do you want me to talk about why I joined AustinPx?
03:07 – 03:26
Yan Kugel: Yeah, so feel free to share that as well. So I think it was an additional pivot in your career and with your experience you had multiple choices where to invest your energy and challenges. So why exactly there?
03:29 – 04:15
Elizabeth Hickman: Yeah, so I joined AustinPx really for 3 key reasons. The first being that I saw a real need in the industry for a more agile and focused early phase development partner. You know, after many, many years of CDMO, M&A, consolidation of smaller CDMOs, I saw that there was really a gap and a growing need in demand for smaller, agile, early phase CDMOs. And I saw a real solution for that with AustinPx. Second was the people that worked here. They’re very intelligent and capable pharmaceutical development professionals. And you know, I say that because their earlier business model before we changed it to a straight CDMO model of being a specialty pharma company really helped them develop specific skill sets and bring that to the table for our clients that you don’t really see in the CDMO industry. The team has a lot of experience and understanding of preclinical and clinical testing, and that’s really highly beneficial for our clients when you’re trying to deliver highly empathetic and tailored services for our clients. And then the last reason is the technology that the company has in kinetisol. Kinetisol is really a differentiating technology that has the potential to dramatically disrupt the morphous dispersion industry and help a lot of pharmaceutical innovators bring new and improved treatments to the market.
04:17 – 06:19
Yan Kugel: So Before we dive more into your role there as Chief Business Officer, you are a leader in the industry. Luckily, I think that in the pharmaceutical industry, we do have female leaders who are in such position, and I have felt it throughout my career as well. I think it’s an amazing place that gives a lot of opportunities for this equality. And You had a long career and it’s interesting for me to learn more about your experiences, your pivotal experiences that paved your road to your current position. Maybe you can share with us also some of the challenges that you faced throughout your early career that brought you to the position of a leader where you’re at right now.
06:28 – 07:22
Elizabeth Hickman: Yeah, sure. I’ve always been on the sales and marketing side of things during my career in CDMO industry. And I started with a small early phase company out in California called Pharmatech. And we had a lot of expertise there to help clients really achieve tight timelines and tight budgets. That’s really where I learned and developed my love for the CDMO industry, but also the type of skills and service that the industry needs to be successful. We had a very client-centric approach at Pharmatech, And I carried that through my career within the CDMO industry and adding that to how we developed the team here at AustinPx of really being focused on the needs of the client and bringing what we like to call a high science, high touch service to those clients. After I left PharmaTech, I had some experience with a couple of other CDMOs, which really expanded my experience in other dosage forms and other formulation technologies, specifically hot melt extrusion and lipid formulation development with soft gel. And then I returned to PharmaTech for a couple of years, and we brought on spray drying, which was very impactful for the growth of the company, but also adding to my understanding of amorphous dispersion development technologies. So I had been exposed to hot melt extrusion and lipids and then I added the capability of spray drying. And that led to the acquisition of Pharmatech by Catalint. And following the Catalint acquisition of Pharmatech, I stayed on with Catalan and that’s really where I got to develop and expand my skills and expertise within business operations, really diving into strategy and growth. And while I was there, I was able to participate in M&A aspects of acquiring other companies and technologies and bringing that in and that was actually my first exposure to AustinPx and the Kanata Sol technology.
09:03 – 09:49
Yan Kugel: So that’s quite an impressive journey. And Elizabeth, did you have mentors that you would say helped you throughout this career or how one achieves such advancements or chases such interesting positions? So one could say you can do a lot of work yourself and just pave the road yourself, But I think a lot of the opportunities come by working with the right people, having the right mentors, being there in the right place at the right time. Would you say it was something like this for you? How did it happen for you?
09:50 – 10:40
Elizabeth Hickman: Yeah, timing is everything, right? But being there when opportunities open up a bit, I have certainly had the privilege of having some fantastic mentors and advocates for my career throughout my time in the CDMO industry and you know just to point out a few of those 1 was Tim Scott who is the current CEO here at AustinPx. He was also the president of PharmaTech. And he really helped to grow my capabilities and challenge me to expand beyond what I was currently doing and learn new things. But, you know, he was a key part of my growth. Another person is Aileen Ruff, who was my supervisor when I was at Catalan. She also really challenged me to do more and she trusted me which helped really develop my belief in myself and my expanding and asking for more responsibility and helping me build those skills to get me to where I am today. So, what’s that saying that you stand on the shoulders of giants in order to grow and develop.
11:21 – 11:52
Yan Kugel: Yeah, that sounds good. So as you said, it’s important to have the right people believe in you and support in you. So I’m glad to hear that you had this opportunity to have those people around you. Right now, you’re the Chief Business Officer at AustinPx. What does it mean? What are your core responsibilities there and what impact do they have on the business of the company?
11:52 – 12:15
Elizabeth Hickman: Sure, okay. Yeah, so currently I’m the Chief Business Officer for AustinPx. I oversee business development, project management, strategy, and human resources for the company. So really business operations for the company. However, I’ll be transitioning to the role of CEO in January of next year.
12:17 – 12:30
Yan Kugel: Nice. Okay. Congratulations on that. So do you have any specific visions that you already have in mind that you want to implement once you step in those big shoes?
12:31 – 13:14
Elizabeth Hickman: Yeah. So we’ve really established a really strong foundation for AustinPx. We’ve been laying that out over the last 2 and a half years to make sure that we’re ready for continued growth and sustainable growth as we bring on more projects and more clients. So, you know, my goal is to really make sure that we’re continuing addressing our ability to grow and support more clients. You know, 1 of the things that we try to invest in is our people. The CMO industry, while you have to have the facilities and the equipment and the space to do things, it’s really the people that our clients come to work with, right? It’s the people who execute those projects. So developing our scientists and our technicians and the different people that interact with our clients is a key part of what we wanna do going forward. We felt that really contributes to our high touch, high science method of serving our clients and bringing a really client-centric service to what we do.
13:51 – 14:02
Yan Kugel: Right. So AustinPx is a mid-size CDMO, right? We would say right around 200 employees, something like this.
14:02 – 14:05
Elizabeth Hickman: No, actually I’d say we are a small company. We have about 50 people here.
14:06 – 15:04
Yan Kugel: So it’s smaller. So it’s developing. So what is the dynamic in working in such an environment of a smaller CDMO, which is probably more innovation focused? And you mentioned that you wanted to bring more agility to pharmaceutical manufacturing which we know is something that is not very common because of all the regulations. So usually for most of the companies especially big ones agile work is a scary word or even unfamiliar word for them. So you mentioned that you wanted to come there because you felt you can implement it there. So how do you do it in such a company that manufactures pharmaceuticals according to regulations and strict procedures?
15:06 – 16:09
Elizabeth Hickman: Yeah. So, you know first off quality has it is the standard. You can’t be successful within this industry unless you have quality and can meet the regulatory requirements that are put upon our clients. Right? However there’s different things that we can do to make sure that we are able to serve our clients in the early phases when they do need more flexibility and agility within their CDMO partners. You know at AustinPx we call this our high science high touch concept. And this model is about combining cutting edge scientific rigor with personalized client centric service. We do this to ensure that we can effectively support our clients in an increasingly complex and competitive market right? It starts with innovation within our science and making sure that we are empowering our scientists to be able to make good decisions for their clients empowering them with the tools and resources to do that really good science.
16:09 – 16:57
Elizabeth Hickman: And then letting them help their clients in the best way to solve their challenges. And then as they move into manufacturing making sure we’re putting systems in place that while they meet regulatory requirements it allows flexibility and scheduling and moving products through the system. And then having a really good QC and QA team behind that to ensure quality get product out the door. So you know that requires a team that really works very closely together teamwork is essential to what we’re doing making sure that we break down any kind of boundaries between groups so that communication as we’re developing that product there’s input from manufacturing about scale up there’s input from QC about what those methods should look like to enable faster turnaround of projects and planning as we move into manufacturing release.
17:44 – 18:17
Yan Kugel: So Would you say that after you came to the company and started implementing those ideas so do you see tangible results in how things are happening in terms of how quickly you finalize projects maybe even turnover of company how more effective you are at manufacturing batches? Where do you see exactly those impacts?
18:18 – 18:56
Elizabeth Hickman: Yeah so you can certainly see impacts in programs that we’re managing for clients right? Being able to meet these very challenging rapid timelines to help get them to clinic as well as overcoming some of challenges they see formulation development we’re definitely seeing that one of ways we know it’s working is not only meeting those milestones they’re asking us but also return business rate feedback we get from our clients we get a lot feedback from clients about how agile we are how high communication is at company how much they trust us repeat business kind cements us plus reputation we’re getting within industry referrals really helps us understand where things are working so client satisfaction is really where we confirm what we’re doing is helping them.
19:26 – 19:42
Yan Kugel: So basically this helps you move quickly within project do relevant changes much more efficiently quicker so you can bring product market quicker right?
19:43 – 20:23
Elizabeth Hickman: Right yeah so you know there are so many people involved getting drug developed then manufactured for clinic those groups have be very integrated each other requires lot teamwork communication right assess risk come up opportunities for making timelines shorter or reducing risk then making sure team has tools resources get done as well as empowering them make those decisions for client where they think they can make improvements.
20:24 – 20:45
Yan Kugel: And do you think this can be also applicable commercial drug manufacturers or do think it’s applicable only first stages development but once it’s already commercialized completely validated then there is no way use same methods what do think?
20:46 – 21:30
Elizabeth Hickman: Yeah so you know as move into commercial things have get far more structured right? There are validation requirements have meet make sure you’re doing so as move into phase 3 commercial ability be little more agile does go down however we have belief if can build some agility into product help accelerate once does get into commercial adds lot value whether it’s making sure formulation strategy manufacturing process design into campaign drug product itself streamlined are picking simplest form getting product produced or over complicating maybe technologies drug doesn’t necessarily need so really thinking end very beginning can help accelerate things as get into commercial so reducing delays because there’s additional steps built or potential errors could happen commercial because complexity process.
22:17 – 23:07
Yan Kugel: Right so I agree on that. And so when I was at CPHI Milan it was visible all over so many companies are concentrating sustainability so all over where look see buzzword somewhere on flyers. And What are your thoughts on this? So how does sustainability come together pharma manufacturing? Does it is it important what but know benefits might it hold opinion following sustainability best practices?
23:09 – 24:05
Elizabeth Hickman: Yeah so you know 1 way we’re driving sustainability improvements is through innovation with amorphous solid dispersion development And you know demand amorphous solid dispersions certainly growing especially percent new small molecules coming into development pipeline have bioavailability solubility issues so we’re really looking ways improve sustainability there so Amorphous solid dispersions essential improving bioavailability poorly soluble drugs You know traditional approaches include spray drying hot melt extrusion spray drying specifically leading amorphous dispersion technology out there utilizes organic solvents part environmental impact drug product development so from commercial standpoint spray-dry products whole probably represent around 8 thousand metric tons solvent per year which has negative effects environment.
24:06 – 25:05
Elizabeth Hickman: And as molecules become more poorly soluble they’re also exhibiting increased challenges solvent solubility so looking ways solve bioavailability challenge but use different approaches is 1 way AustinPx doing that And that’s with our kinetosol technology which is non-solvent based process but also brings additional benefits like operational footprint And all these things also lead cost improvements client right? So from sustainability standpoint not just environmental impact it’s operational impact well leads savings client down road as well improvements manufacturability.
25:48 – 26:13
Yan Kugel: Right so thanks for elaborating on that And before spoke mentioned high touch high science concept So can elaborate bit on what does mean context pharmaceutical manufacturing how does it connect clients serve?
26:15 – 27:00
Elizabeth Hickman: Yeah so high science high touch has do with our client-centric culture how serve clients best way It’s really building empathy well strong communication skills how we do that but also making sure we’re thinking innovatively our clients arming scientists tools technologies able address these challenges help get next phase their development So we have empower create Ritz-Carlton type approach our services giving team autonomy support go above beyond our clients.
27:05 – 27:32
Yan Kugel: Right So you mentioned being innovative right? And also talked lot about KinetiZoll right? So I do believe also received innovation prize CPHI reward being innovative this approach right?
27:33 – 28:25
Elizabeth Hickman: Yeah yeah And we had pleasure accepting Advanced Innovation Award most recent CPHI Worldwide Conference And prior that also got Interfax Award Advanced Innovation as well And you know I think that’s because they recognize significant advancement meeting demand alternative sustainable solutions amorphous dispersion And by eliminating need solvents while reducing operational footprint streamlining manufacturing processes technology like Kinetisol can reduce costs improve sustainability without compromising performance We felt really great industry recognizing rewarding us for it.
28:29 – 28:38
Yan Kugel: So what is main difference between this technology traditional methods like spray drying?
28:39 – 29:38
Elizabeth Hickman: Yeah so there’s 3 things 1 is performance Now there’s not one-size-fits-all technology out there for any drug but many cases we’ve shown kinetosol can work poorly soluble compounds So from performance standpoint we have seen kinetosol generate greater performance within bioavailability with know anything from 2-6 times improved bio availability exposure molecule compared other formulation strategies It also generates better particle amorphous dispersion particle improved flow compressibility which has downstream benefits reducing challenges go into tableting It’s also more sustainable it does not use any solvent generate amorphous dispersion It also has much smaller footprint than say commercial scale spray drying Our commercial unit can fit traditional pilot scale size manufacturing plant opposed commercial spray dryer can be large as 4-5 story building with lot utilities ancillary requirements rounded from solvent handling nitrogen requirements utilities.
30:24 – 30:24
Yan Kugel: So that
30:24 – 30:46
Elizabeth Hickman: really contributes sustainability And then last scalability equipment itself has very high throughput can really handle from very small large demand forecasts commercial needs can stick same piece equipment your product grows.
30:47 – 31:04
Yan Kugel: So now that will be stepping CEO what current trends industry feel are most interesting for follow especially talking new technology legislation supply chain so what do feel about it?
31:05 – 31:53
Elizabeth Hickman: Yeah you know increased interest sustainability certainly something we’re watching making sure we’re working clients help them do Another thing is 2022 Inflation Reduction Act its significant impact having small molecule development making sure we’re positioning ourselves growing capabilities expertise be able help our clients see impact IRA their small molecule drug development continuing be agile helping them reduce cost manufacturing small molecule drugs so they can overcome some challenges act.
31:57 – 32:06
Yan Kugel: Excellent Thank you for this insight Elizabeth So is there anything else would like add didn’t touch?
32:08 – 32:32
Elizabeth Hickman: No not specifically I’m very excited about future AustinPx where it’s going lead us We’ve seen lot success thus far utilization both conical capabilities non-conical services over last 18 months looking forward continuing journey this amazing team we have.
32:33 – 32:52
Yan Kugel: Excellent So I wish best luck success upcoming role I’m sure it will be wonderful journey hope next year afterwards see each other CPHA again when will be getting another award hopefully then.
32:52 – 32:59
Elizabeth Hickman: Yeah thank you Yeah too bad missed each other last Let’s make sure see each other next year Frankfurt.
33:00 – 33:04
Yan Kugel: 100% So thank you Elizabeth best luck to you.
33:04 – 33:07
Elizabeth Hickman: Yeah thanks invitation This was fun.
Guest
Elizabeth Hickman
Elizabeth Hickman serves as Chief Business Officer and incoming CEO at AustinPx, a leading contract development and manufacturing organization (CDMO) specializing in bioavailability enhancement of orally delivered small molecule drug candidates. Elizabeth brings over two decades of expertise in the biotech and pharmaceutical sectors, formerly serving in leadership positions for West Pharmaceutical Services, Catalent, and Pii. Elizabeth holds a BA in Microbiology from The University of Texas at Austin and an MBA in Marketing from San Diego State University.
Post comments (0)