“The 4 Pillars of a Successful Cell and Gene Therapy Launch”

January 09, 2020

Q&A with Kevin Cast & Paul Furgal of Archbow Consulting

The 12th 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:

  • What are your goals and expectations for the patient experience? That can define logistics and patient engagement requirements.
  • Who are the trustworthy partners that share your vision for the patient and product journey? How will you work together to foster greater speed, reliability, traceability, and temperature-controlled transport that are required for the efficacy and safety of CGT treatment?
  • How can you plan for flexibility and customization? Because these products are customized per-patient, there will likely be more exceptional circumstances than found with a traditional product.
  • What are the needs of your customers? That might mean transportation and housing support for patients, delivery protocols for dewars for hospitals, and integrated ordering systems for HCPs.

Mishra: How does the emerging industry achieve a successful transition from Clinical to Commercial while ensuring compliance with GMP, GCP and GDP standards?

Kevin Cast: The reality is that there are distinct differences between the licensing and certifications required for the distribution of clinical product vs. distribution and sale of commercial product. The list of standards above is just one element of ensuring a successful commercial launch. Many CGT manufacturers are comfortable delivering and managing clinical products to clinical trial sites; however, making a smooth transition into a commercial organization takes time and a different skill set.  Companies need to think beyond the innovative science to the practical nature of commercialization and even on to shareholders.

Mishra: What are the challenges for Third Party Logistics (3PL) companies in Cell & Gene Therapy industry and how will they be met?

Paul Furgal: We need to rethink the applicability of a 3PL as it relates to CGT.  For these therapies, fewer, but more refined, services are needed.  Third-Party Logistic providers need to excel where they provide value: customer service, data reporting, contracts and chargebacks, state licensure, order to cash, and product returns.

With CGT products, certain areas may need to be enhanced, including serialization services, import/export expertise, and coordination with manufacturer ordering platforms.

Mishra: In this context, what makes a good 3PL Partner? 

Paul Furgal: In addition to the core competencies of a 3PL, we advise our manufacturer clients to look for the following when choosing a 3PL partner:

  • Proper Accreditations – for example, cGMP and SOC-1
  • Array of affiliated services – partners that have the ability and commitment to grow in the CGT space and provide additional services
  • Account Management within/across all stakeholders – flexibility in how each account is serviced is vital
  • Account Management to the manufacturer partner – trust in day-to-day interactions
  • Familiarity in the space – a deep understanding of each stakeholder and how to solve issues in a timely manner
  • Value – fair pricing and terms for the level of service needed

Mishra: Archbow Consulting delivered the “Flash Title Flow Model” at the 12th Annual Conference of BSMA in Burlingame on the 15th of October. Would you elaborate on this subject and point out the intrinsic challenges faced?

Paul Furgal: In a Flash Title model, the product ships directly to the customer (in CGT, usually a hospital) from the manufacturer.  When the product arrives at the hospital, the title transfers from the manufacturer to the distributor.  The distributor sells the product to the hospital and collects payment.  Essentially, the distributor only owns the product for a flash of time in-between the manufacturer and hospital having ownership. This differs from the traditional model where the 3PL buys and houses inventory because CGT products are produced and delivered on-demand from the manufacturing site.

The Flash Title model works well when designed and implemented properly, but manufacturers need to be mindful of:

  • The design and implementation of the program
  • Ensuring all stakeholders are engaged and committed
  • Hospital training on the actual designed process specific to the product
  • Hospital’s capacity to execute against the designed process
  • Hospital contracting relationships with distributors

To mitigate the potential issues, manufacturers should begin designing models 18 months in advance of their expected launch date.

Mishra: Specialty Pharmacies appear to be coming forward to enhance the supply chain of CGT. What is your assessment of their role and how the pharmacy industry must reconfigure itself?

Kevin Cast: The very nature of the CGT lifecycle conflicts with the Specialty Pharmacy model in ways that are yet to be fully reconciled.  However, with other service providers meeting the high touch needs of these patients in new ways, SPs are actively pursuing solutions to show their value and relevance in this space.

SPs can leverage their expertise with complex disease states and patient management. They are unique in their ability to provide pre- and post-treatment support to patients. Since they are able to communicate directly with patients, they can be a valuable source of RWE. Innovations like placing pharmacists inside manufacturers’ facilities might open some interesting new opportunities for SPs.

SP’s are also experts at securing payer contracts, and thus realizing reimbursement. Many of the largest payers across the U.S. have their own SP.  These large, payer-owned SPs can realize efficiencies and greatly facilitate product delivery and patient monitoring. Some of the leading independent SPs also have capabilities to handle these products.

SPs present some challenges in coordination with the end sites of care (typically, a hospital.)  Some state pharmacy laws prevent one pharmacy from dispensing to another pharmacy and that pharmacy dispensing to a patient. SP distribution can also deviate from the standard hospital workflow. Today, with a handful of products, it’s manageable, but with so many new products on the horizon, this could become problematic.

It will be vital to continue considering SPs as product tolerability improves and treatment is possible at different sites of care.

Mishra: Finally, how do you envision Archbow Consulting serving the Life Sciences industry to address the challenges of commercialization of CGT supply chain?

Kevin Cast: At Archbow, we have been working in this space ever since CGTs came to light, helping clients create the best commercialization strategies, including supply chain solutions and patient support services.  Through collaborative industry groups, like BSMA and the Alliance for Regenerative Medicine (ARM), we’ve built an extensive network of vendors, KOLs, and sites of care, to give our clients the ability to navigate the unique needs of the space.  Our true strength comes from the deep, real-world experience of our team members, spanning all touchpoints in the product’s commercial journey.

With no roadmap for CGT, it can feel overwhelming to stay up to speed.  We continue to learn, to expand our network of people and organizations, and leverage this accumulated expertise to provide the best guidance possible for our customers.  That allows our manufacturer customers to focus on what they do best – bringing these amazing, life-changing therapies to patients.

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