Clearing the Runway for Successful Specialty Drug Launch and Commercialization

The increased complexities of the specialty drug landscape can seem overwhelming to even the most experienced in-house marketing teams at pharmaceutical and biotechnology companies worldwide. When failure is not an option for introducing a new therapy or repositioning an existing specialty product, a growing number of manufacturers are choosing AscellaHealth as a trusted partner with proven end-to-end solutions powered by a team of experts that ensure success.

AscellaHealth enables partners to successfully commercialize therapies for complex, chronic conditions. A comprehensive suite of services guides clients through every stage of the process, from clinical trials through approval, pre-commercialization support and ultimately transitioning patients on to therapy.

With global expertise in specialty fulfillment, data analytics, and patient support/HUB services, AscellaHealth streamlines product launch, provides an ecosystem of financial solutions to its partners and ensures patients have access to therapies they need for better outcomes.

Key Points of Navigation: Don’t Go at It Alone

While there is a wealth of opportunity for manufacturers to introduce breakthrough treatments, the ability to execute in the post-pandemic environment requires disciplined execution every step of the way.

“The issues can be daunting and make it even more important for companies to align early-on in the commercialization process with a trusted partner that has the know-how to surmount these challenges,” says AscellaHealth CEO Dea Belazi, PharmD, MPH, “This is no time for trial and error.”

Attracting Capital Investment

Despite some optimistic financial reports, funding remains tight and many biotech manufacturers, especially early-stage companies in their pre-revenue phase, still struggle to raise enough capital to proceed down the pathway to commercialization.

“Financing challenges certainly complicate an already complex marketplace,” says Mario Patone, CFO, AscellaHealth. “But the good news is that AscellaHealth is positioned to help its partners cultivate investment in a constricted financial marketplace.”

Market Access Strategy and Pre-Commercialization Planning

AscellaHealth builds a successful go-to-market launch complete with key launch milestones including:

• Clinical Trial Support
• Commercial Team Design
• Patient Journey Mapping
• Market Access and Payer Strategy
• Specialty Pharmacy Fulfillment and Distribution
• Data and Analytics for Program Optimization

“By accessing the right clinical data during R&D and during Phase II-III clinical trials, companies gain early visibility into the total health system costs related to a particular disease – including safety, efficacy, epidemiology and outcomes,” says Belazi. “This is critical because the disease burden is often not quantified for certain populations or sub-populations indicated for high-cost specialty drugs.”

AscellaHealth empowers pharmaceutical manufacturers with data analytics to inform later-stage decisions, demonstrate long-term outcomes and provide real-world evidence (RWE) that supports market strategy, pricing, and product differentiation.

Seamlessly Transition Clinical Trial Patients to Commercial Product

AscellaHealth maximizes its resources to ensure a seamless transition from clinical trial to paid product. The AscellaHealth payer team utilizes its deep, longstanding relationships throughout the payer community to rapidly secure product reimbursement. Manufacturers also rely upon AscellaHealth’s customized and personalized patient engagement programs and the dedicated attention of Patient Care Coordinators to improve patient adherence to therapy and create long standing relationships throughout the clinical trial through commercial launch. Through these resources, AscellaHealth has seen 96% of clinical trial patients transition to paid products within 30 days of commercial launch.

Ease Financial Burdens

AscellaHealth’s customized copay assistance programs and innovative financial and technology solutions ease the economic burdens for patients to pay for prescribed therapies and concurrently support payer initiatives to include these drugs in their benefit packages.

“These financial platforms raise the confidence level of manufacturers that their products will be adopted by patients and reimbursed by payers,” emphasizes Patone. “As a result, companies are more enthusiastic about dedicating resources to research and development of innovative, novel products and investors have a greater appetite to fund more projects.”

Ensure Worldwide Distribution, On-time Product Delivery

There are often distinct requirements for the transportation, warehousing/storage, and handling of specialty pharmaceuticals. Manufacturers now recognize the importance of partnering with AscellaHealth’s exclusive distribution services for expert planning, tracking and delivering product to reach patients whenever and wherever needed. Solutions also include technology-based patient engagement tools which capture real-time prescription data and analytics, providing a holistic picture of data to optimize programs.

A Pathway to Growth in 2024

Reuters reported that in 2023, the FDA saw nearly a 50% increase in the approval of new drugs, signaling promising trends for the future. With 55 novel therapies, this significant increase contrasts sharply with the 37 approvals seen in 2022 and falls more in line with the historical average of approximately 45 to 50 new drug approvals annually.

“With this positive indication of market growth, we project that there will be an even greater number of biotech companies seeking market approval of a specialty drug amid increased competition for market share,” concludes Belazi. “Clearly, the scope and breadth of services needed to ensure success go well beyond the resources of most manufacturers who turn to AscellaHealth as a trusted resource. Every day, our team gets critical healthcare products from manufacturers to patients while ensuring an efficient flow of funds between payers and pharma.”