Issue link: https://www.e-digitaleditions.com/i/1211868
10 BioPharm International eBook February 2020 www.biopharminternational.com ket access, and physician and patient information and awareness. ADDRESSING THE ISSUES BioPharm: How can these challenges be addressed? Lakelin (TrakCel): Within the context of manufacturing, more and more investment is being made into man- ufacturing technologies, particularly the aspect of automation, in an effort to drive efficiencies and lower cost of goods. Automation can help to lower cost of goods by reducing the amount of manual labor required while main- taining GMP. Manufacturing tech- nologies are certainly moving toward this direction, bringing the benefit of reduced labor but also fewer 'open steps' in manufacturing, leading to a reduction in time from starting mate- rial collection to product administra- tion. With regards to addressing the needs for CoI and CoC in the supply cycle, more and more developers are choosing digital, cloud-based system to provide visibility and compliance in the delivery of their product. Forte (Bone Therapeutics): These chal- lenges are being addressed individu- ally by the different organizations or generally throughout the field under the guidance of leadership organiza- tions that aim at promoting the devel- opment of new CGT products for the benefit of patients with unmet medi- cal needs. Within the role of individual orga- nizations, an important consideration to enable success is the selection of an outsourcing partner. Through anal- ysis of the required capabilities and competencies is the first step since the availability of 'hard skills' is obviously a must. The cultural fit and the assess- ment of the outsourcing organization 'soft skills' is also an absolute must. The selection process should be thor- ough and documented even before financial aspects are considered. The challenge of scarcity of talent, both within product developing orga- nizations as well as within CDMOs, is one that with the clear expan- sion of the field represents a signif- icant challenge. Correct search and attractive projects will help ensure adequate staffing of outsourcing partners. Leading organizations in the field of CGT are actively contrib- uting to the training and networking of emerging talent. It should also be pointed that in the face of growing evidence of sig- nificant and long-term value, CGT products are delivering to patients, the general challenges regarding the full chain of value from innovation to market access are being addressed by multiple stakeholders and regulators are becoming more familiar with this field and more willing to take risks in favor of the value these products are delivering to patients. Nyamay'antu (Polyplus-transfection): Developers are dependent on manu- facturers who are themselves depen- dent on suppliers of raw materials. The selection of raw material suppliers by developers and manufacturers is important to anticipate future needs during scaling up and commercial- ization. Raw materials will need to be GMP-compliant for the drug product to reach commercialization, and their supply should be secured. LACKING CAPACITY? BioPharm: Do you have any experi- ences of the issue of a lack in manu- facturing capacity for CGT? Forte (Bone Therapeutics): It is clear that with the growth of the field with multiple products in development and an expanding number of organiza- tions involved in CGT product devel- opment, the demand for outsourcing partnerships is increasing and the availability is somewhat limited. Some areas represent a bigger challenge than others, specifically gene editing, viral vectors, or manufacturing, while availability is bigger in other areas, such as clinical research organizations and clinical development, where the challenge is to select an adequate and relevant partner for your project. It is critical to anticipate needs as part of well-controlled project man- agement approach for the develop- ment of a product. Anticipating when the outsourcing needs are going to be required allows for adequate selection and availability programming and, to a certain extent, absorb any poten- tial waiting times in a parallel project management approach. At the same time, and in view of the success of the field again deliv- ering value to patients and expand- ing business opportunities, industry is also witnessing an expansion in the availability of outsourcing part- ners, with more and more flexible and competent CDMOs and other pro- vider organizations being created, which can offer support and availabil- ity for outsourcing partnerships. Lakelin (TrakCel): Due to the rapid growth and potential of the person- alized medicine market over the past decade, there have been a number of factors that have arisen regarding the capacities of outsourcing part- ners. Sourcing, harvesting, and trans- porting materials through the supply chain can be a real challenge, and Partnerships for Outsourcing Development "It is clear that with the growth of the field … the demand for outsourcing partnerships is increasing and the availability is somewhat limited." —Miguel Forte, Bone Therapeutics