Get to Know Advanced Therapy Management

Learning Objectives

After completing this unit, you’ll be able to:

Define reactive, proactive, and coactive treatments.
Explain what advanced therapy is.
List the advantages of using advanced therapies.
Describe the main stages and features of Advanced Therapy Management.

Before You Start

Before you start this module, make sure you complete the following content. The work you do here builds on the concepts and work you do in that content.

Coactive Support

If you completed the Care Programs module, you learned how healthcare has moved from being reactive in the 1960s to proactive in the 2000s, and finally, coactive in present times. Here’s a brief recap.

In reactive healthcare systems, patients passively receive care. Treatment is often a standardized, one-size-fits-all approach. When a primary care physician (PCP) prescribes medication, factors such as insurance coverage sometimes outweigh the drug's effectiveness for that specific patient. If it doesn’t work, the PCP tries another, and so on. This trial-and-error approach can inflate costs for chronic conditions, lead to poor health outcomes, and leave patients dissatisfied.

In coactive healthcare, patients are active participants in their own health. Instead of generalized treatment, pharma companies use biomarkers to develop personalized medicines. The result is precision care: fewer adverse effects, less need for high-risk invasive testing, and lower overall costs.

One such coactive treatment is advanced therapy.

It’s in Your Genes

While modern medicine has made remarkable progress in treating life-threatening diseases and complex disorders, the treatment journey can still be long, arduous, and uncertain. Healthcare professionals struggle with providing the optimal treatment at the correct time, while patients face the anxiety of an uncertain treatment process, its effectiveness, and the road to recovery.

Advanced therapy represents the next frontier in healthcare, harnessing the power of genetics to address the challenges of lengthy and complex treatments. This emerging field, also known as personalized medicine, cell and gene therapy, or chimeric antigen receptor (CAR) T-cell therapy, uses biomarker information for disease prevention, diagnosis, and treatment. With this information, life sciences organizations can design and deliver tailored treatment plans and proactive outcome monitoring based on individual susceptibility to side effects.

Advanced therapy is administered in two ways: in-vivo and ex-vivo. In-vivo therapy involves delivering the medicine directly to the patient, while ex-vivo therapy involves manufacturing the medicine from living cells outside the body before reintroducing it to the patient. This module focuses exclusively on ex-vivo personalized medicine, also known as regenerative therapy.

At the heart of ex-vivo personalized medicine lies gene and cell-based therapy. This treatment involves manufacturing medicine from the living cells of the patient, which is known as autologous therapy, or a donor, which is known as allogeneic therapy. After it is introduced into the patient’s cells, the new genetic material targets and neutralizes mutated genes responsible for causing illnesses.

A typical autologous workflow, such as CAR T-cell therapy, consists of five key steps. Here’s an illustration of those steps and the workflow.

The advanced therapy steps including enrollment, scheduling, apheresis, manufacturing, and infusion.

Intake: Healthcare professionals enroll the patient and prepare them for therapy by obtaining consent, verifying insurance coverage, and placing initial cell orders.
Scheduling: Scheduling coordinators coordinate a series of appointments to encompass the entire therapeutic journey.
Apheresis: Medical technicians collect a biosample from the patient’s or donor's living cells. In CAR T-cell therapy, they collect T-cells or lymphocytes from the patient's blood.
Manufacturing: Laboratory scientists isolate the cells, engineer with the CAR or T-cell receptor (TCR) gene, and grow them.
Infusion: Healthcare providers reintroduce the manufactured biosample into the patient's body. In CAR T-cell therapy, they infuse the engineered T-cells back into the patient's bloodstream.

Why Advanced Therapy?

Advanced therapy is gaining momentum in healthcare because it:

Consists of a one-off treatment, as opposed to traditional treatments that entail a lifetime of managed care.
Makes the physician-patient engagement more patient-centric.
Leads to better health outcomes and improved adherence due to its proactive, preventive approach, as opposed to the traditional reactive approach.
Provides precision care that reduces adverse drug reactions (ADRs).
Reduces the reliance on high-risk and invasive testing procedures.
Lowers overall medical costs as compared to traditional treatments where ADR hospitalizations, trial-and-error dosages, and late-stage diagnosis can drive up costs. Also, gene sequencing costs are low and take less time than most of the existing treatments.
Helps an aging population that is prone to genetic diseases.

Advanced Therapy Management Basics

Advanced therapy is a rapidly evolving field that demands innovative workflows and rapid turnaround times—from patient to manufacturer and back to the patient. The development and delivery of personalized medicine involve numerous complex steps and a diverse array of stakeholders, including pharmaceutical companies, manufacturers, insurance payers, and providers.

Advanced Therapy Management streamlines the complexities of the end-to-end journey for advanced therapies—from order intake to infusion and observation. It offers flexible and intuitive scheduling capabilities, coupled with optimized supply chain visibility. Together, these features enable pharmaceutical companies to scale their operations across geographies and implement sophisticated scheduling logic.

With Advanced Therapy Management, you can:

Streamline the delivery of advanced therapies to improve patients’ accessibility and health outcomes.
Configure multiple therapies on one platform.
Book apheresis, manufacturing, and infusion appointments, respecting lead times and available capacity.
Maintain full visibility of custody chains in line with local protocols and regulations, from sampling through administration.
Activate an intelligent command center that unifies systems across partners, patients, and procedures.

In this unit, you learned about advanced therapy, its key processes, and its benefits to patients and pharmaceutical companies. Next, explore the Therapy Orchestration framework, including the objects and workflows that drive it.

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