Cell And Gene Therapies: Driving Innovation For Logistical Solutions

By Layne Martin

This article originally appeared in Life Science Leader magazine.

Cell and gene therapies are making waves in the healthcare industry. The role that these therapies are playing is revolutionizing medicine as we know it and, in turn, transforming both the product and patient journey across the entire healthcare continuum. With over 950 cell and gene therapy clinical trials currently in the pipeline and four therapy approvals as of Jan. 1, the momentum for regenerative medicine is moving at an exponential pace.

Human cell and gene therapy can be broadly defined as the process of introducing genetic material to modify or manipulate the expression of a gene product or to alter the biological properties of living cells for therapeutic use. Contemporary examples of these therapies include replacing a disease-causing gene with a healthy copy of the cell, effectively deactivating the disease- causing gene, or by introducing a new or modified gene into the body to help treat disease.

Due to the nature of how cell and gene therapies need to be handled through the drug life cycle, it’s important for us to share insights into how biopharma and life sciences companies can think through managing the payer and provider landscape, create standards to help minimize risks, and scale their business as well as orchestrate logistics with these highly sophisticated therapies.

Aside from the clinical opportunity that these products present, they do introduce tremendous complexity into both the manufacturing and commercial processes. (See the March 2018 issue’s article “Intricate Supply Chain Complicates Gene Therapy Manufacturing.”) To be successful, biopharma companies need to be committed to putting the patient at the center of the cell and gene ecosystem. A focus on the patient — patient safety, patient outcomes, and patient access — ensures the best outcome for all stakeholders in the value chain.

REMEMBER THESE 3 POINTS BEFORE DEVELOPING YOUR GENE THERAPY PLAN
The following three considerations are important for any biopharma company that plans to develop a cell and gene therapy commercialization strategy:

1. CONSIDER THE FAIL POINTS — Incumbent (and often disparate) systems are not organized to support cell and gene therapy. They lack the ability to capture funding fl ows, adapt to complex logistics models, and, most importantly, meet patient safety metrics. Consider who and how each constituent in this complex process will be held accountable each step of the way.
2. FRONT-END PLANNING WILL PROVIDE GREATEST SUCCESS IN LONG-TERM OUTCOMES — The investment required to bring cell and gene therapies to the market can be immense for any biopharma company. It is critical for biopharma companies to share best practices to help align processes for greatest success. It’s not only important to dive deep into the logistical solutions to ensure the protection of these products so they are handled with the utmost care; it is also critical to prioritize risk management, patient access, and patient monitoring solutions.
3. THINK THROUGH STRATEGIC PARTNERSHIPS — Ensure strong business health by finding a partner who can remove the financial burden from the day-to-day operations and most importantly provide solutions for patients to manage financial barriers and variable reimbursement schema.

As personalized medicine continues to evolve, it’s important for biopharma companies to be on the front lines to meet those needs of complex specialty products across the supply chain. When biopharma and life sciences partners work closely together with manufacturing partners, they improve the lives of the patients served.

LAYNE MARTIN is the VP and general manager for supply chain solutions at McKesson Specialty Health. He is responsible for core distribution services, title 3PL, and nontitle 3PL services.