Training for those making the journey of bringing an asset from R&D through to commercial
By popular demand, CBE brings our third Uplift Program: Translation Uplift
CBE’s Translation Uplift program is designed to give you the tools and technical knowledge to understand what translation is all about. The key elements that support translating an asset from R&D into the clinic and then ultimately to a commercial product.
Assembling a team of technical experts, we asked them to bring their experiences into each short course to create an online learning program that allows participants to get up to speed on the areas involved in product realisation. Translation Uplift covers the fundamentals of successful translation of R&D assets from the bench to the clinic and then into commercial supply in a flexible and convenient format, that can fit around your job.
Explore the many facets of the translation process, covering product development, scaling-up processes from the bench, technology transfer from R&D into production, elements of process validation ready for commercial production, managing the complex supply chains that support the process and applying phase appropriate GMPs.
TRANSLATION UPLIFT
OVERVIEW
Translation Uplift Program Outline
CBE’s Translation Uplift program is designed to uplift participants knowledge in product realisation: and covers the fundamentals of successful translation of R&D assets under GLP through to a validated, GMP compliant commercial product. Designed by the CBE team to provide an industry relevant learning experience, including practical case studies, examples and guests who have been through the process before to help debunk some of the common myths and share their experiences to avoid common pitfalls. By elevating their understanding of the overall process, participants can design in with confidence GMP, quality by design and the necessary documentation to ensure their asset is translated efficiently and effectively. This program creates a shared understanding of the process, a common language and through relevant examples, an experiential learning around ‘why’ and ‘how’ put it into practice.
| Translation Short Courses | |
|---|---|
Product Development | The umbrella course. Breakdown how defining what the product is and understanding how it will compete in the marketplace is the cornerstone of product development. Taking the many facets of product development, build out the different disciplines required to bring it from the bench, to the clinic and then on to be registered. Understanding project management as key to unlocking cross functional inputs across process development, regulatory and clinical development. Topics: Product Proposition / TPP / Project Planning / Regulatory Considerations / Process Development / Clinical Development |
Process Scale-Up | Learn how to plan for process scale-up success. We unpack the learnings for scaling your process from the lab to pilot scale, then engineering runs and exhibit batches. Process scale-up has the potential to delay products to market. With many technical aspects, teams often embark without an understanding of the different elements to be considered. Through case examples we put the concepts into practice, showing elements at each step in the scale. Topics: Scale-Up Pre-requisites / Value of Scale-Up Studies / Designing Pilot Scale Operations / Regulatory Considerations / Full Scale Production |
Technology Transfer and GMP Readiness | All products have a technology transfer at some point, whether its from the research lab to the CDMO or to a different manufacturing site. Understanding what it takes and how to do it effectively can save time, resources and money. We set you up to achieve the goal of technology transfer activities, transferring product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization. Appreciation of this knowledge forming the basis for the manufacturing process, control strategy, process validation approach, and ongoing continual improvement. Topics: Fundamentals of Technology Transfer / Knowledge Requirements / Regulatory Considerations / Risk Management / Execution & Measuring Success |
Phase Appropriate GMPs | Phase appropriate GMPs is a critical success factor to the development program. Gain clarity in what GMPs to apply at what phase of development. The transition from drug discovery through to commercialisation is a long and complex journey taking many years, with exponentially increasing compliance and regulation. Overreach of GMPs and compliance programs can lead to delays in innovation and rapid development. Under control can cause delays in product registration a significant GMP non-compliance which can create barriers to market entry. In a nuanced regulatory world, understand the secrets to phasing GMPs with the product development journey. Topics: Global Regulation / Phase Appropriate Change Management / Analytical QC Phases / Quality Systems / Process Development Documentation / Qualification and Validation Phases |
Managing Complex Supply Chains | A key to successful product development and commercialization is a robust supply chain. Unlock how quality begins with suppliers, understand supply chain risks and how to manage them. Supply chains can be highly complex. While traditional companies manage starting materials and outward logistics, many now outsource operations, rely on technology providers, or operate as fully "virtual" organizations. Learn how qualifying and managing suppliers, determining timing and methods, and using risk assessments to optimize supply chain management is critical. Topics: Challenges / Risk Management / Controlling the Supply Chain / Stewardship, Management & Monitoring / Virtual Companies & Outsourcing |
Process Validation | Learn how to plan for a successful process validation. We breakdown the phases of process validation and build out an understanding of the critical success factors for each phase. Process validation is the final step in the translation journey and a major milestone to launch, having the potential to delay products to market. Getting validation right, needs rigorous understanding, planning and management, before execution. We break down the jargon and make it clear what and how the Control Strategy, CQAs, CPPs, MAs, Qualification and Validation all relate. Ensuring you are clear on the validation deliverables and knowledge needed to manage validation programmes and documentation aligned with the GMPs. Topics: Regulatory thinking / CPPs and CQAs / Pre-requisites for PV and Engineering batches / PV Protocols and Sampling / Supporting Validation Programs |
Delivered in a virtual, online environment, ideal for busy professionals. Theoretical concepts will be translated to the real world environment and be supported with Guest lectures, self directed learning, Q&A facilitated sessions and case work. .
There is an online Welcome and Information Session, then each online Short Course will entail:
- Two to three hours of theory, practical application and guest lectures (self paced learning)
- One hour of facilitated Case Study and Q&A Webinar with a CBE expert
- Case study work
- An online Assessment
Each Short Course will have an assessment and at completion of the Translation Uplift Program participants will receive a Certificate and Digital Credential.
Translation Uplift Program Schedule
The schedule for the 2025 Translation Program is now available.
2025 Schedule
| Cohort | Course Opens & Welcome Information Session | T01 Product Development Webinar & Case Study | A02 Process Scale-Up Webinar & Case Study | A03 Technology Transfer and GMP Readiness Webinar & Case Study | A04 Phase Appropriate GMPs Webinar & Case Study | A05 Managing Complex Supply Chains Webinar & Case Study | A06 Process Validation Webinar & Case Study | Status |
Q2 2025 | 18 Mar 2025 | 25 Mar 2025 | 1 Apr 2025 | 8 Apr 2025 | 15 Apr 2025 | 29 Apr 2025 | 6 May 2025 | Enrolments open, filling now |
Q3 2025 | 5 Aug 2025 | 12 Aug 2025 | 19 Aug 2025 | 26 Aug 2025 | 2 Sep 2025 | 9 Sep 2025 | 16 Sep 2025 | Enrol |
Click here to register for a place in the GMP Uplift Program
Places per cohort are limited, so register your interest today to secure a place or email gmpuplift@cbe-ap.com.au with any queries or for company group registration.