“Digitalization Opportunities for Cell and Gene Therapy”

January 06, 2020

Q&A with Mandar Paralkar, Senior Director of SAP Systems

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 Mandar Paralkar, Senior Director and Digital Innovation Advisor of Life Sciences at SAP, who had made the presentation, “Leveraging the Digital Supply Chain to Deliver Personalized Patient Solution“, at the conference. Mandar’s comprehensive answers to the questions provide significant insights into the potential for accelerated advancement of the revolutionary therapy. SAP, a $29 Billion global company leading the market in enterprise application software, has been committed to “improving patient outcomes, safety, and quality of care by enabling collaboration across the digital health sciences” through software solutions.

Mandar Paralkar is the Senior Director of the Life Sciences Industry at SAP and Advisor for Digital Innovation. He engages with Pharmaceutical, Biotech and Medical Device segments to understand trends and challenges in the industry and advise IT solution to resolve the business pain points in the value chain. Mandar Paralkar holds MBA from St. Joseph University, Philadelphia, PA, USA and B.S (Mechanical Engineering) from VJTI, Mumbai University, India.

Here are the highlights of the conversation:

MISHRA: Leveraging the Digital Supply Chain for delivery of personalized patient solutions in case of Cell and Gene Therapy is more urgent and stringent than it is for traditional bio-pharma. What do you think?

PARALKAR: Large pharmaceutical companies are acquiring biologics and therapy companies to grow their businesses and diversify their portfolios. Time constraints for personalized patient treatments with typical delivery timeframes within a month make the situation urgent and the cold chain nature of these costly drugs with temperature monitoring, and time in/out of refrigeration makes requirements more stringent for traceability of the chain of identity (the patient) along with chain of custody (status of drug) for the therapy or drug through-out the supply chain. SAP Digital Supply Chain covers planning, sourcing, process manufacturing and distribution along with analytics and can provide transparency and visibility across the Health Sciences value chain.

MISHRA: What are the uniquely differentiating characteristics of the value chain of personalized patient solutions which have to be addressed by technology enablers?

PARALKAR: Traditional drug manufacturing involves a make-to-stock strategy and has a demand-driven supply chain involving buffer inventory with stock managed over period of several months or years. Rough-cut demand plans come from sales depots, matching demand with supply from sites. Heuristics determine supply network plans, which tighten the production plan for manufacturing and detailed scheduling for resources and machines on the packaging line. Billing is traditionally simple with invoicing of prescription/over-the-counter drugs sold via wholesalers thru retail pharmacies.

Conversely, the cell and gene therapy supply chain require a make-to-order manufacturing strategy with a batch size of one per patient lot and the time period is less than a month from blood sample collection to drug infusion. However, the patient enrollment /dropout rate at the hospital can change over period and communication to the manufacturing site is critical as changes directly impact available capacity to manage demand planning accuracy and patient appointment slotting on the calendar. Additional factors like patient parameters need to be captured such as cell count, weight, etc., that will trigger appropriate adjustments during the biologic manufacturing process to supply medicine at the right place and at the right time. Billing must be more agile with a focus on outcome-based reimbursements based on the recovery of a patient’s health status after consuming the medicine.

MISHRA: How can digital technology enable delivery of personalized patient solutions at scale and as a service?

PARALKAR: Digital technology is comprised of three components. First, a scalable business process platform and a flexible orchestration platform for Life Sciences drug manufacturers. Second, a robust business network that can support business process data collaboration across various value chain entities like hospitals, contract development and manufacturing organizations. Third, a user-friendly application suite across various lines of business-like planning, procurement, production, and commercialization for offering value-added services in cell and gene therapy-based business model. Cloud-based analytics play a vital role in orchestrating services as data from ERP systems like SAP will be combined with data non-SAP systems like transportation and patient administration at hospitals for monitoring entire the life cycle of patient’s journey. The SAP S/4HANA Intelligent Enterprise offers the three components narrated above as necessary to meet the needs of Bio-pharma companies in cell and gene therapy for clinical and commercial areas.

MISHRA: How intelligent does the enterprise have to be to meet the unique objectives of Cell and Gene Therapy – CGT?

PARALKAR: Intelligence is part of the application platform where experience management can improve brand performance, leading to improved market share. Conversational Artificial intelligence can improve communication, while working with business partners outside the four walls of the enterprise. The Internet of Things – IoT plays a key role to capture sensor parameters for cold chain offerings with near real time data, whereas predictive analytics can play an important role for proactive monitoring of business intelligence data to prevent batch quality issues and avoid non-conformances while working with sub-contractors. Financials can manage condition-based contracts to offer milestone-based payments as manufacturers negotiate service levels with hospitals, who in turn work closely with patient’s health insurance companies for accounts receivables. Machine Learning with improved cash applications and invoice clearing can add a lot of value whereas robotics process automation can clearly reduce manual intervention for certain repetitive tasks in the supply chain.

MISHRA: What does that framework look like which integrates Patient/Donor with medical treatment and post-treatment services?

PARALKAR: Customers are evaluating front-end tools to capture donor information for plasma therapy or patient information for CAR-T therapy from hospitals/private clinics. This data needs to be routed through networks or blockchain type technologies from hospitals to manufacturers, ensuring trust and transparency. On-boarding these new types of business partners like blood-plasma collection centers will require proper training and audit procedures in place by manufacturers. Hospitals will lead medical treatments and post treatment services, but Life Sciences manufacturers will offer the right tools like mobile apps and web forms to improve service levels for patient satisfaction.

MISHRA: How do Information Systems rewire the traditional supply chain of made-to-order batch size of 1 in terms of suppliers, the business and customers?

PARALKAR: Instead of managing one supply chain for traditional drug products/substances now, the complexity is increasing several-fold and it will be like consecutively managing a separate supply chain per patient. As regulatory approvals are received by manufacturers from new countries for commercial distribution, collaboration with local business partners like blood-plasma and apheresis collection centers will take a new turn with streamlined collaboration of data and information to make existing supply chains more efficient and cost conscious.

MISHRA: We believe that in the embryonic evolution of CGT, we must collaborate to compete. Can you enable the creation of a CGT Market Place or Platform/Network with tools and process to federate, aggregate, anonymize, curate and broker clinical and financial data that serves the Life Sciences industry?

PARALKAR: Inter-operability will be key for various IT vendors in the open eco-system to exchange data. Customers will ensure they select the right IT players that have the necessary technology to deliver innovation in the market place. For example, SAP has partnered with Mercy Health to deliver Real World Evidence Insights as a service used by medical device manufacturers. Mercy anonymizes and curates the patient’s clinical data to help build better medical products that improve care for patients everywhere.

The opinions expressed by Mandar Paralkar are solely his and may not express the views or opinions of SAP.

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