For Immediate Release
Media Contact:
Devendra Mishra
Executive Director & Co-Founder
Phone: 818-224-1552
Email address: dmishramnd@gmail.com
“The 4 Pillars of a Successful
Cell and Gene Therapy Launch”
Q&A with Kevin Cast & Paul Furgal of Archbow Consulting
Calabasas, January 9, 2020: The 1 2 th Annual Conference of BSMA in Burlingame, CA, on October 15, brought together over 170 executives discussing Commercialization of the embryonic industry of Cell and Gene Therapy. Subsequently, Devendra Mishra , Executive Director, of BSMA had the opportunity to interview Kevin Cast (Partner) and Paul Furgal (Vice President) of Archbow Consulting on the subject of “The 4 Pillars of a Successful Cell and Gene Therapy Launch” . Their comprehensive answers to my questions provide significant insights into how the traditional distribution must be transformed to meet the challenges of the revolutionary therapy.

Archbow, with offices in Orlando, FL and Zug, Switzerland, is a strategic consulting practice for the pharma & biotech industry. Founded by industry veterans who leverage their intrinsic, diverse and deep connections across the industry, their consulting team provides actionable strategic guidance to help pharma and biotech brands realize commercial success. 
Kevin Cast 's career in the pharmaceutical and biotech industries spans three decades. He's held sales and trade positions at Ciba-Geigy and Serono, and managed specialty pharmacy accounts, distribution, and HUB business development at Express Scripts.
He holds a Bachelor of Liberal Arts in Biology from Illinois Wesleyan University and a Master’s Degree in Botany from Oklahoma State University.
Paul Furgal has over 25 years experience in specialty pharmacy and distribution contracting, Cell and Gene Therapies, reimbursement HUB development, and biologic product launches. Prior to joining Archbow, Paul worked at McKesson Specialty Health for 16 years where he built McKesson’s 3PL service offering and was responsible for SCM Solutions/Managed Distribution. He also pioneered McKesson’s go-to-market Cell and Gene Therapy solution for manufacturers. Before McKesson, Paul held a variety of roles of increasing responsibility with EMD Serono and Abbvie.   
Here are the highlights of the conversation:
Mishra How well do Cell & Gene Therapies fit in the traditional biopharma supply chain?
Paul Furgal: Cell and Gene Therapies (CGTs) work well with the traditional supply chain in some ways and not-so-well in others. Traditional supply chain products are manufactured, the inventory is stored awaiting shipment, and then end-users purchase the product. But in some CGT supply chains, the process is initiated by patients when blood/tissue is collected, sent to a new type of manufacturing facility, and then returned to the patient upon completion. Because of this, CGT is a “demand chain” than a supply chain. Where a traditional supply chain is linear, a CGT demand chain is more circular – originating and ending with the patient.

The distribution ecosystem doesn’t have to be reinvented for CGT; it just needs to be adjusted. For example, CGT products are not being stocked at wholesalers or distributors. Because they are often patient-specific, the products are manufactured in a batch of one and packed and shipped directly from the manufacturing site to the site of administration. Extreme temperature requirements may also present additional logistical complexities.

Moving from a traditional supply chain to a CGT demand chain model could impact many processes, including ordering, delivery, invoicing, the hospital contractual relationships, the approved vendor process, etc.  
Mishra : Knowing FDA’s forecast of the huge pipeline of such CGT therapies, what are some key commercial considerations for planning a successful Cell and Gene Therapy product launch?
Paul Furgal: Delivering care for CGT products takes a significant amount of coordination across multiple stakeholders in the healthcare ecosystem before, during, and after treatment. Because these products are new and questions about optimal commercialization are still being answered, allowing more time for planning than you would with a typical biotech product is essential. 

Commercial considerations are even more dependent on patient experience than ever before. Since the demand chain starts with patients, companies have to think about engaging with patients well before they actually get treated. Further, manufacturers may need to stay engaged with the patients well after treatment to collect real-world evidence (RWE). Therefore, it is important to align around these key considerations....
To learn what these considerations are and for the complete interview...
About BSMA ~ Driving Innovation in the Life Sciences Supply Chain
Since its inception in 2007, BSMA is a global organization that fosters Innovation and Adoption of disruptive technologies within the end-to-end supply chain of the Life Sciences industry. With offices in California (USA), Brussels (Belgium) and Mumbai (India), BSMA promotes collaboration and networking between professionals of the biotech, pharmaceutical, academic and medical diagnostics enterprises. The Alliance partners with industry, academia, foundations, suppliers, technology enablers, research institutions, trade organizations and the government to improve productivity, quality, product and service integrity, risk mitigation, managerial talent development and patient care globally. It is also the home of start-up companies engaged in business development and scale up.