Issue:April 2021

EXECUTIVE INTERVIEW – Celanese: Better Therapeutic Outcomes From Better Drug Delivery

In the evolving world of medicine, long-acting dosage forms are becoming more prevalent in the drug development pipeline. These forms are ideal for providing targeted drug release with continuous drug administration, ensuring patient adherence, which is of particular importance when compliance is crucial to treatment response. In addition, these dosage forms contribute to improved safety and efficacy through better dosing. Celanese Corporation’s pharmaceutical business works closely with its customers to create innovative drug-eluting implants, inserts, and transdermal films delivering biologics and small molecules to meet the goals of patient-centric therapies, improved medicine, and better healthcare economics. Drug Development & Delivery recently spoke with Laura Brand, Vice President of Celanese’s Medical & Pharmaceutical Business about it drug delivery platform and the value it brings to the industry.

Q: You recently joined Celanese as the new leader for Medical & Pharmaceuticals. Can you tell us about your background and area of expertise?

A: My area of expertise is primarily in the large molecule oncology space encompassing drug product differentiation for new molecular entities and for biosimilars. I started developing my expertise at the Boston Consulting Group (BCG) predominantly in the healthcare business, and I worked with a wide variety of clients to support launch strategies, post-merger integrations, and measuring the effectiveness of launch spend. After 10 years at BCG, I moved to Amgen, where I held a variety of roles. However, the majority of my time was spent on the commercial side of the oncology business developing a strong understanding of the full spectrum of challenges of growing specific oncology drugs. From clinical trials though regulatory and reimbursement hurdles ending with product differentiation and both physician and patient education, I was able to establish a strong knowledge of both innovative and biosimilar oncology assets. Now with Celanese, I am using my experience to drive a stronger understanding of these challenges, enabling Celanese to be a true partner in our customer’s drug pipeline development.

Q: We don’t often see a move like yours from a Pharma company to a Specialty Materials company. What drew you to the Celanese organization?

A: Celanese is much more than just a materials company. When I was introduced to the company, I was amazed to see how broadly Celanese’s materials were used. What I saw was the POTENTIAL. Our business is in a lot of interesting spaces from inhalation and injection devices as well as more complex orthopedic implants and glucose monitors. Even more complex is the drug-eluting platform for implants and inserts and the significant impact they can have on the improvement of healthcare, in patient therapeutics, and ultimately on patient’s lives due to improved efficacy through better dosing and a more targeted therapeutic approach. Patient adherence is such an important aspect of a medicine’s efficacy. Oftentimes, you will see great results in a clinical trial, but they are not replicated in the real world because the patient doesn’t take his/her dose on time or misses it for various reasons. The idea of taking this issue out of the equation and having an implant or insert that can release the drug over time is fascinating. Whether the delivery form is used in the eye, contraceptives, oncology, or various other applications, it just has great potential.

In addition, Celanese’s vision to “improve the world and everyday life through our people, chemistry, and innovation” is strongly supported through its emphasis on sustainability and diversity with strong environmental, social, and governance initiatives, making it a leading company to be at the forefront of positive change, and that is a type of company I am happy to be associated with.

Q: Could you please tell us more about Celanese’s healthcare business as well as your drug-eluting platform?

A: What’s interesting about Celanese’s Health Care business is how well diversified it is within the medical and pharmaceutical industries. Our materials are used in essentially every type of medical device you can think of, from drug delivery and administration (eg, auto-injectors and inhalers), to interventional and surgical devices, to pharmaceuticals. Two key application area highlights include: (1) Patients’ self-administration, such as wearable infusion pumps in which Celanese’s technology enables smaller and more reliable devices that are more cost-effective to produce, and (2) Drug delivery in the form of drug-eluting durable implants or insert. This second focus area is an area for disruption that is very important. Our durable drug-eluting implants allow our customers and innovation partners to rethink how many medications are currently delivered and open the door to opportunities to enhance the drug’s impact on patient outcomes. We strive to create value of a drug product through improved quality of a therapeutic via more safe and efficacious delivery as well as lower the total net costs of healthcare.

Getting a pharmaceutical company to incorporate a new technology is viewed as high risk. They see a new technology can lead to additional time-to-market. However, with a proven technology demonstrating that our delivery platform works in existing drugs, we can provide peace of mind for customers to incorporate these delivery concepts into their drug development process. Moreover, we expect our durable delivery platform will drive better patient adherence, which will then drive better outcomes. This improvement in outcomes is due to the patient having the right dosage continuously, which should in turn drive a positive outcome from a reimbursement perspective and ultimately, can be a strong path for pharmaceutical companies to extend the lifecycles of their products.

Q: What are some of the advantages of Celanese’s Long-Acting Dosage durable delivery platform versus other controlled-release mechanisms?

A: Let me first address the value of durable implants. With a durable implant, you can better control the release of the drug at a more stable rate. It provides the ability to deliver controlled dosing over a long duration especially when continuous dosing is critical to achieve the expected outcome. Because of its biostable and durable nature, our platform allows clinicians to reliably interrupt the therapy due to such issues as toxicity, side effects, or life changes. In addition, the need to remove the implant or insert ensures dosing clarity when it comes to subsequent dosing.

With a biodegradable system, you don’t have as much control over the release, and removing the device is often not possible. Both have their benefits and drawbacks as you don’t want to have to explant something unnecessarily. However, we believe our delivery platform is complementary and better suited for many indications and situations.

Celanese’s VitalDose® EVA copolymer is a delivery platform that has a long clinical history of use and is used in a number of products undergoing clinical trials as well as marketed products. The drug delivery platform is very flexible making it compatible with both biologics and small molecule APIs for local or systemic drug administration. It also allows for very high drug loading (~75% max) and is ideal for treatment durations from months to years. We don’t just supply the material. We work closely with our customers in a development partnership.

Q: You mentioned you don’t just “supply material.” Can you elaborate on the partnerships you established with your customers?

A: In a typical supplier-customer relationship, a customer calls a supplier up and asks for a material because they already know what they want. However, Celanese works directly with its customers to understand what the true needs are and customize the materials to fit those needs. We support our customers from early feasibility through development so we can help their drug successfully reach commercialization. Once commercialized, we provide customers with quality material tailored for their application.

We are committed to providing our customers with extensive development support as can be seen by our recent investment in our technical resources. Earlier this year, we opened our new pharmaceutical lab in Kentucky, which has been designed to support our customers with early stage feasibility work. We are equipped to create functional API-loaded prototypes, the ability to characterize and measure in vitro drug release, as well as to provide technical transfer support to our customers and their partners. In addition, Celanese is committed to providing strong regulatory support. Backed by years of experience working with global regulatory bodies, we provide customers with relevant certifications and documentation needed throughout various stages of their drug development and approval process.

With our breadth and depth of experience in polymer technology, Celanese continues to make it a high priority to apply that expertise in servicing our customers in the pharmaceutical and medical industry now and in the future.

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