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Our key approach is to focus on quality

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Chris Henshall, Senior Director, Strategic Marketing – Biologics, West Pharmaceutical Services, in an interaction with Usha Sharma, talks about the latest trends of biologics drug delivery system and the company’s innovative products

Tell us about the latest global trends of biologics drug delivery system and how closely has this trend evolved in India?

Chris Henshall

First, I think it’s important to talk about a trend within the biopharmaceutical industry, which is an overall shift away from primary care toward speciality care, patient-centric and precision-based medicine. With this as a driver, increased competition and the healthcare industry’s focus on costs and quality-based metrics are spurring drug companies to engineer better patient experiences into their treatments. This means companies are refining the design of the product in the earlier  stage of the drug development process. The focus on the patient has helped increase the interest in biologics.

Five major trends include:

  • From less expensive, one-size-fits-all drugs to higher-priced targeted medicines (driven by scientific advancements)
  • From provider as decision maker to patient as decision maker (driven by better access to information, payer formulary, copay and benefit tiers)
  • From point-in-time, non-integrated medical/ patient data to continuous and integrated medical/ patient data (driven by payers/ physicians/ hospitals/ regulatory)
  • From open patient access (US) to limited patient access (driven by healthcare cost control through payers)
  • From limited patient access (developing nations) to increased patient access (driven by lower cost medicines and biosimilars)

As more biologics and biosimilars come onto the market—including those used for the diseases such as rheumatoid arthritis, multiple sclerosis and psoriasis—patients in India and around the world are offered new hope in the management of their chronic conditions. However, despite the promise for patients, maintaining the safety and efficacy of these cutting-edge therapies can present unique challenges around packaging, containment and delivery for pharmaceutical manufacturers.

Pharma manufacturers are now making packaging and delivery systems an integral component of drug development and research. Increasingly, pharma and biopharmaceutical companies are moving toward polymers, not glass, for containment. Additionally, they are adopting innovative approaches to drug delivery that strike the needed balance between high-quality drug containment and user-friendly design.

The NovaPure brand addresses growing need for high-quality packaging solutions for pre-fillable syringe systems. Tell us more about the product and how relevant it is in today’s time.

The market for pre-fillable systems is growing. In fact, two-thirds of the world’s blockbuster drugs are now delivered via a pre-filled syringe system or auto-injector, and auto-injectors are one of the fastest growing delivery segments. To ensure effective delivery and patient safety, manufacturers need high-quality components that are designed and manufactured to reduce particulates, ensure consistency of delivery and that fit the changing needs of higher-volume delivery systems.

West’s NovaPure plungers are manufactured using Quality by Design (QbD) principles to help ensure superior quality. The QbD approach for NovaPure plungers has resulted in lower part-to-part variability, low particulate levels, and a more consistent injection rate when used as part of an injection system. The NovaPure brand is incredibly relevant in today’s global market, which continues to see an increased focus on quality. One of the biggest challenges we hear from customers is meeting regulatory standards for quality. Driven by concerns for patient safety, regulatory agencies are asking drug and packaging manufacturers to build quality into their products from the start to ensure consistent quality throughout a drug product’s lifecycle.

Biosimilars are one of the fastest growing segments in India. What are the challenges and opportunities that exist in this segment?

Biosimilar manufacturers are looking for delivery system companies that incorporate innovative design features such as ease of use, versatility and adaptability to address emerging challenges and incorporate forward-thinking innovation. This presents significant opportunity for packaging and delivery system manufacturers to design innovative, integrated delivery systems that not only function effectively, but are also designed to be easy and intuitive for patients to use. As patents continue to expire on marketed biologics, there is a huge opportunity for biosimilar manufacturers to capitalise on market opportunities and bring more affordable medicines to the market. This means being ready to file first, and that requires having a plan to bring the biosimilar to the market, and to the patient, quickly and efficiently with high quality supporting data.

How will the latest trends in biosimilars impact pharma manufactures in strategising pharma packaging?

While biologic drug manufacturers may have the resources to collaborate with a drug delivery manufacturer to design a custom-made device, biosimilar manufacturers—due to the rush to file first once the original patent expires and smaller budgets—are often not afforded that luxury. Instead, biosimilars must be delivered in ready-made delivery systems. The good news for drug makers is that these offerings are being created based on previous designs and data utilised for original biologics drugs. The challenge biosimilar manufacturers face is knowing which delivery system is best for their drug and how quickly their partner can assist them in getting the offering to market. To this end, biosimilar manufacturers will likely look for a trusted partner in the drug delivery device manufacturer space to guide them as they choose the appropriate system to deliver their drug.

Why are pharma companies demanding drug containment and delivery systems solutions? How can integrated containment and delivery solutions help improve patient outcomes?

Most patients are not trained medical practitioners; therefore, they need delivery systems to be intuitive. Ensuring a self-injection system is easy to hold and deploy, as well as limiting the number of steps that a patient has to manage through administration, will greatly increase their satisfaction with the injection system and help promote greater adherence. To this end, collaborating with a delivery system manufacturer that is knowledgeable and focussed on providing quality solutions to ensure that all four key elements of an integrated design— the drug, the primary container, the delivery system and the end use—can be very beneficial to the drug manufacturer. Together, device and drug manufacturers can work seamlessly as partners to provide innovative solutions that help mitigate risk, encourage patient adherence and enhance value through unique integrated delivery combinations.

What key factors need to be considered while selecting a containment and delivery system?

More and more, drugs are coming to market as combination products, meaning the drug is paired with a delivery device. This is especially true for chronic conditions such as rheumatoid arthritis and diabetes. As a result, pharma companies are paying closer attention to the design, function and efficacy of integrated delivery systems. This, coupled with a broader trend in the market toward patient-centric design and increased home-based administration, means that it behoves drug manufacturers to care about the delivery device for their drug. Perhaps the biggest benefit is the delivery system’s impact on the likelihood of medication adherence. A drug can only truly have the desired patient benefit if it is taken as prescribed, delivered effectively and maintains performance over time. However, it is hard for patients to alter their lifestyle and routines; making an easy-to-use, integrated delivery system essential for improving patient outcomes.

How can West Pharmaceutical’s focus on quality and innovative drug packaging and delivery systems help biosimilars and generics makers  to differentiate their products from others?

At West, we understand the biosimilars and generics boom intimately. We know the complexity of these drugs and their need to be delivered through an integrated system that is safe, reliable and patient-centric. We also know that generic and biosimilar manufacturers feel immense pressure to file first, and we have a comprehensive portfolio of offerings to help them to get their products to market quickly. A key part of our approach is a focus on quality. Regulators and drug manufacturers alike place significant emphasis on quality standards. No longer just an innovative suggestion, QbD has become a non-negotiable aspect of drug delivery technology development. Applying a data-driven, design control process and QbD approach to the design and development of packaging components and delivery systems can help ensure a delivery system that consistently functions as expected. The use of clean, injectable systems with high-quality injectable drug components can also lower the risk of particulates and leachables, helping to reduce patient risk and ensure the drug and its packaging meet strict standards for quality set by regulatory agencies.

Tell us more about West’s Biopharma Week 2017.

From May 29 – June 2, 2017, we participated in educational seminars and activities focussed on trends and best practices in biologic drug delivery throughout India. One of the highlights of West’s Biopharma Week 2017 was a presentation on best practices for improving patient outcomes through integrated containment and delivery systems at the 6th Annual InnoPack Pharma Confex in Mumbai. Other activities included scientific seminars in Bengaluru and Hyderabad, and in-house educational workshops with pharmaceutical and biotechnology customers in Ahmedabad. Throughout the week, West experts in integrated containment and delivery systems shared market insights and discussed industry trends, challenges and solutions for the safe and effective containment and delivery of injectable biologics and biosimilars with local pharmaceutical and biotechnology professionals. We also showcased several innovative drug delivery system and packaging component technologies.

  • SmartDose platform
  • SelfDose patient-controlled injector
  • A range of administration systems
  • NovaPure components
  • Daikyo Crystal Zenith® cyclic olefin polymer

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