Ensuring quality and compliance for combination products and advanced device platform technologies is a complex process that frequently evolves with new technologies and shifting regulations. Creating effective methodologies – or ’playbooks’ – can save time, reduce error and increase the rate of product approval, according to James Wabby.
Wabby is AbbVie’s executive director, regulatory affairs – emerging technologies/combination products, with over 19 years of experience in regulatory affairs, quality compliance and quality operations within the GxP regulated environment. Specifically, he develops regulatory strategies on advanced device platform technologies including digital therapeutics and digital medicine. On the combination product side, this includes the regulatory strategies for complex medical devices and CMC device aspects to deliver medicinal products.
Here, Wabby discusses his processes for ensuring compliance in product development at AbbVie, the value of a playbook, and the success of the model in the case of combination ocular drug delivery system Durysta.
Melissa Porter: How do you make sure AbbVie is in line with the latest regulations and what can you do to expedite product development in clinical trials?
James Wabby: First, I need to confirm the company vision from a global perspective and work with commercial to discuss what is next on the horizon while ensuring regulatory compliance with global regulations. This includes looking at the corporation and figuring out what steps are needed to build the infrastructure to sustain product development and manufacturing to execute clinical trials.
The infrastructure planning includes the strategy from a clinical trial perspective, a quality system perspective, investigational product perspective and a safety perspective. So, for example, if we’re moving into either an emerging or a disruptive technology platform, what do the steps and strategy look like, and can it be done within the current structure? It is critical to work with top-level executive management to provide education in the form of a playbook which outlines the strategy.
MP: How does a playbook provide value in product development?
JW: A playbook provides a repeatable, scalable process that saves time, reduces error, and provides us with the best chance of gaining product approval. It’s a global strategy that answers questions for each product, such as ‘What is the regulatory framework for the combination product?’, and ‘What type of infrastructure will we need to maintain compliance?’
The playbook will outline the approach when implementing a quality system for different types of combination products. Remember: your regulatory submissions are only as good as your quality system. Therefore, the infrastructure is key.
“Your regulatory submissions are only as good as your quality system. Therefore, the infrastructure is key.”
When we finally confirm the combination product type, the next question is, what about digital health? What about digital therapeutics? What about emerging technologies? What about digital medicine? How do we do that? We use the same footprint in terms of understanding infrastructure, communication, strategy and education, and develop the skill set as well as the quality management system internally.
MP: Is there a particular product where you saw the most success from a playbook you created at AbbVie?
JW: Durysta, the first and only FDA-approved dissolvable ocular implant to reduce eye pressure in patients with open angle glaucoma or high eye pressure. It is a single-entity combination product; an applicator that delivers a small molecule. The product went through the playbook and executed the various quality system procedures to ensure compliance. Currently, we are strategising to expand into the global market space.
Because we had the playbook in place and a quality system established, everything worked the way it should. The quality system was strong, the regulatory submission was strong, and we were successful; we received FDA approval for the product.
MP: Where did you learn how to create the best possible playbook for AbbVie?
JW: The regulatory affairs playbook development and methodology originated from my graduate school thesis, which is pretty unusual. My thesis was on HIPAA [US Health Insurance Portability and Accountability Act, a US federal law that created national standards for consent around sensitive patient health information] when it was established on 21 August 1996. The HIPAA handbook which was part of my thesis, incorporated the introduction of privacy and security standards which were established on 14 April 2003.
I have used this model to develop the visionary aspect of the combination product and digital health playbooks because they all have the same footprint, which is to ensure regulatory compliance. The first thing I had to figure out in developing one of these playbooks is, what are the standards and what are the regulations? You are going to train people on it, so you must be able to translate from a regulatory, legal perspective into basic layman’s terms, present on it, and then be able to help people understand the concepts and provide education on the vision of where we are going.
“The quality system was strong, the regulatory submission was strong, and we were successful; we received FDA approval for [Durysta].”
When I had the HIPAA training handbook within my thesis, it was the same footprint. I took the regulations, put them in layman’s terms, figured out how to train healthcare staff on it, educated others, and then showed them the blueprint for where we were headed.
I took that methodology and applied it to the playbooks I use now, and that is how it came alive. But the key here is, you must understand the regulatory framework to communicate it effectively to various teams and executive leadership. If you don’t, the regulatory affairs playbooks will be of no worth to anyone.
By Melissa Porter
James Wabby will be presenting a case study entitled ‘Developing a Digital Playbook for Designing Combination Products and Digital Medicine Studies’ at Outsourcing in Clinical Trials Southern California on December 7th-8th at the San Diego Marriott La Jolla, in San Diego, California.
This in-person, highly anticipated conference will cover the future of clinical trials including the latest innovation, technology and outsourcing strategies. Interested in attending? Places are limited but you can still register here.