Advancing Products for Multiple Indications and Presentations
How to address the complexity of multiple scenarios of products being studied for multiple indications and delivery options.
Dave Powell, Vice President, Business Development, Grand River Aseptic Manufacturing03.01.23
frequently, injectable drug products are undergoing clinical trials for
multiple indications while also being developed for multiple delivery
presentations and routes of administration. What may have been
considered post-launch product life-cycle activities in the past, has
been accelerated to ensure product launch in the ideal drug delivery
presentation or system. An increasingly competitive landscape, along
with the uncertainty of treatment reimbursement for patients, has made
the development of multiple drug delivery presentations before
commercialization the new norm. This challenges product development,
manufacturing, and supply chain professionals, as well as
component/delivery system suppliers and CDMOs. How do you address the
complexity of products being studied for multiple indications in
multiple drug delivery options concurrently?
Prepare for the multiple scenarios of the product being studied.
Early on, start examining the potential life cycle of the product. With a
renewed focus on patient care, what is the best delivery method for the
patient? Will it be self-administered, in a physician’s office, or
administered in a hospital setting? It is important to think of what the
product looks like from the start and what it should look like in the
future for the best patient experience. A product may start with one
presentation and end in an entirely different presentation because that
is what is determined to be the best experience for the patient.
Considering all the different material and component options with
component suppliers and your manufacturer at the beginning also help.
For example, do your suppliers have long-lead times, and can they
provide flexibility if you need to pivot as studies progress and your
needs change? Does your manufacturer have vial, syringe, and cartridge
capabilities, and do they have the equipment to scale up as studies
progress? Is there a potential that the patient could self-administer
the medication or even utilize an on-body system? Discussing with
suppliers and manufacturers early on helps see the full picture of
what’s available in the timeframe required to meet your product
Understand regulatory requirements for each indication and drug delivery platform.
Regulatory pathways continue to evolve as the pharma industry moves
towards drug-device combination products to give patients a better
experience. It is important to understand the regulatory pathway to
approval and commercialization at the start of the project. Outside
consultants should be considered for their regulatory expertise in
combination products, as it is becoming increasingly more complicated to
understand regulatory expectations. Regulatory experts can also help
develop a strategy for each phase of product development.
Sharing knowledge and experiences while openly communicating potential
drug delivery scenarios amongst all your suppliers, manufacturers, and
consultants is necessary to ensure drug products safely and effectively
impact patients. Be transparent throughout product development to ensure
your partners have recent regulatory experience, especially with
Investigate multiple CDMOs and consider their external partnerships.
Working with CDMOs and their partners that have a range of experiences
is immensely helpful in ensuring your product successfully navigates
from clinical development to commercial manufacturing. Equipment
capabilities can impact primary packaging component selection, and it is
important your CDMO’s capabilities align with all your product
development scenarios and can support scale-up and distribution. CDMOs
that have invested in newer facilities will have the latest innovative
technology, which is especially important with sterile filling and
finishing to ensure the highest quality. Experience, capabilities,
equipment, quality record, and partnerships are all key considerations when deciding who to trust to manufacture your drug product.
CDMOs that have strong partnerships with equipment manufacturers receive
responses quickly and work together easily to come up with solutions
for your product as it evolves during development and commercialization.
Strong relationships aid in product discussions to confirm you have the
right drug container for your product and avoid issues during
production. Established supplier partnerships also help get components
when needed or provide alternate options based on availability and
Consider modular sterile filling technology to provide flexibility.
To address the potential for multiple drug delivery scenarios during
product development, consider modular sterile filling technology.
Modular filling technology’s innovative design supports manufacturing in
multiple formats using the same filling line, all with state-of-the-art
isolator technology. As you need to go from a vial to a syringe or a
cartridge, modular technology is set up to seamlessly assist with that
Modular filling equipment is beneficial for product development and the
manufacture of clinical materials because of its ability to run small
batches in one container, then switch modules to a different
component. Another great benefit of modular technology is the
flexibility to scale up during commercialization when the final drug
delivery and component selection are still in question. This is
especially important with biologics, as modular technology can make it
easier when looking for the best way to deliver the therapeutic to the
Plan for success and stay launch ready with Grand River Aseptic
Manufacturing (GRAM). GRAM has three sterile filling lines, with a
fourth on the way, all with Bausch+Ströbel filling equipment and SKAN
isolator technology. All of GRAM’s sterile filling lines utilize
identical filling and isolator technology, which provides clients with
the ultimate versatility and flexibility to seamlessly scale their
products as needed to succeed in the marketplace. Specifically related
to modular technology, GRAM’s equipment includes the VarioSys. GRAM,
Bausch+Ströbel, and SKAN partnered up on a video series called VarioSys World that showcases key attributes and benefits of modular technology.
Dave Powell brings over 30 years of experience in the
pharmaceutical and biotech industries to his executive role at Grand
River Aseptic Manufacturing (GRAM).
Hospira, and most recently, Pfizer. As Pfizer’s Senior Director,
Development Services and Commercial Accounts, Dave headed the global
Development Services and Commercial Accounts organizations of the
CentreOne contract development and manufacturing business, including
accountability for customer management. Over his career, Dave led
personnel in Europe, India, Japan, and Australia. He is highly skilled
in portfolio management, quality assurance, problem solving, and
University of Wisconsin-Madison and MBA in Business from Marquette