New technology adoption

\
\
\
\
\
\
\
\
\

Use the wheel above to find out more about New Technology Adoption.

 Click on the graphic to find out the current debates and questions being asked in the industry. As we delve deeper into the answers over the next few months and years, we will be building on this knowledge and sharing even more resources such as downloads, case studies and links to member-only content in our technology development portfolio.

Do you know where your company is in the cycle of new technology adoption?
Do you have a good story to tell or best practice ideas to share?

Please get in touch at info@biophorum.com and do come back and visit this site as we collaborate on the industry view.

The biopharmaceutical industry is playing an ever increasing and pivotal role in addressing lack of or poor treatment options for both widespread and rare diseases, and lack of innovation keeps the costs of new medicines high. There are multiple barriers to implementing new technologies- the aim of this best practice resource is to enable new technologies to be adopted more effectively within companies and across the biomanufacturing industry. This resource is a high-level toolbox and guidance for R&D, technology discovery, sponsors, risk managers and regulatory teams.

Click on the graphic to find out the current debates and questions being asked in the industry. As we delve deeper into the answers over the next few months and years, we will be building on this knowledge and sharing even more resources such as downloads, case studies and links to member-only content in our technology development portfolio.
The downloadable pdf is a fully navigable high-level toolbox and guidance for R&D, technology discovery, sponsors, risk managers and regulatory teams.

Clear objectives

What the technology adoption seeks to achieve in terms of cost, quality, speed in bringing lifesaving medicines to the market and/or continued delivery and any gaps it addresses.  Early understanding of the maturity and readiness of the technology and implementation risks should be considered while setting the objectives for the adoption.  If the technology is part of an overarching strategy, clear definition of how it fits in the bigger picture should also be considered.

  • What is it?
  • What is the scope of the problem / opportunity​?
    • How pervasive is it?
    • What is its impact (new to us, new to industry, new to world)?
  • What kind of priority does / should this have?
  • What option(s) are we pursuing?

  • How does it help our patients / customers (external or internal)?
  • How does it align with our corporate strategy?
  • What is the size of the opportunity?
  • Does it make us more competitive?
  • Are there published results that indicate this problem / opportunity can be addressed?

  • What is the best option we should pursue to solve / address this problem / opportunity?
  • What value does to this option deliver?
  • What are the key milestones for the development plan?
    • Proof of concept points
    • Spending milestones
    • Resource plans

  • What is the best site to start?
  • What will need to be changed at the selected site?
  • Demonstrate the value this option delivers
  • What are the key milestones for the implementation plan?
    • Spending milestones
    • Resource plans
    • Start-up

  • What are the key milestones for the implementation plan?
    • Spending milestones
    • Resource plans
    • Start-up timelines
  • What success do we expect to see as deployment expands?

*Technology readiness level

The downloadable pdf is a fully navigable high-level toolbox and guidance for R&D, technology discovery, sponsors, risk managers and regulatory teams.

Robust business case

This is crucial, as they are highly scrutinized, especially visionary technologies.  Alignment/clarity of need and  early value realization paves the way for adoption.

  • What is the size of the opportunity?
  • What is the potential size of the investment we will need to make?
  • How do we fund?
  • What is the potential duration of the investment program?
  • What other investments is this competing with?

  • What are the available options and do any work?
  • How much time and effort are needed to reach our first decision point?
  • How comprehensive are the estimates?
    • Does it cover all areas?
    • Does it include all organizational impacts?
    • How accurate are the estimates?
  • What impact does what we now know have on the overall business case?

  • How much time and effort are needed to reach our next decision point?
  • Who is updating the details for the business estimates?
    • Does it cover all areas?
    • Does it include all organizational impacts?
    • How accurate are the estimates?
  • What impact does what we now know have on the overall business case?

  • Has funding been budgeted / approved for initial deployment?
  • What are the performance metrics?

  • Has funding been budgeted / approved for full deployment?
  • What are the performance metrics?
*Technology readiness level

The downloadable pdf is a fully navigable high-level toolbox and guidance for R&D, technology discovery, sponsors, risk managers and regulatory teams.

Technology development and proofs of concepts (PoC)

Developing a PoC to support where you are in the development  process allows the business to evaluate the feasibility of the technology and is a key enabler for endorsement.  It could help identify unforeseen risks. There is guidance on technology development levels, which can be used to evaluate the progress of the technology stage.

The readiness levels describe what is needed to progress through each stage. The type of PoC and the linked development of technology is dependent on stage.  It enables organizational readiness.

  • Does technology exist to address this problem / opportunity or are we developing something new?
  • Could we apply / adapt technology to this problem?
  • Is it something we can manufacture?
  • Is this something we can utilize in manufacturing?

  • Is there reliable evidence this technology / product will perform as required??
  • What problems were encountered generating this evidence / how were they overcome? ​
  • Are all the components of this solution tested and available such that it can be reliably made?
  • Are there strong references for the concept of this technology?
  • Where has this been done?

  • What scale are we using?
    • Benchtop
    • Commercial
  • What are the key proof of concept point?
    • Key technology elements work
    • We can apply in our manufacturing process
  • We are identifying organizational impacts?

  • Have we had successful PoC at desired scale?
  • Does it work at desired scale?

*Technology readiness level

The downloadable pdf is a fully navigable high-level toolbox and guidance for R&D, technology discovery, sponsors, risk managers and regulatory teams.

Senior sponsorship

Identifying a primary sponsor for the technology adoption is critical to the success and delivery of the outcome.  The sponsor will serve as the primary decision maker through all the stages, enable the adoption process and mitigate organizational roadblocks.  Having the sponsorship defined early will help enable including sponsor’s input on building a strong business case and aligning the adoption to organizational vision and business initiatives.

  • What level of senior sponsorship is required for this potential investment?
    • Will it only apply to a small part of the business?
    • How pervasive could it become?
    • How well does this fit into our existing organization?
    • Who is the best person to start?

  • What Officer(s) are engaged?
  • Where does this fall on their priority list?
  • Can they articulate the “story”?
  • How much stakeholder involvement has there been to date?

  • What scale are we using?
    • Benchtop
    • Commercial
  • What are the key proof of concept point?
    • Key technology elements work
    • We can apply in our manufacturing process
  • We are identifying organizational impacts?

  • How visible is our sponsor?
  • Are we getting the resources needed?
  • Are there organizational roadblocks that need to be addressed?

  • How visible is key leadership about communicating this approach?
  • How have they been engaging the key people / sites where this approach will be deployed?
  • Who will follow-up once the initial senior sponsor moves on?
*Technology readiness level

The downloadable pdf is a fully navigable high-level toolbox and guidance for R&D, technology discovery, sponsors, risk managers and regulatory teams.

Stakeholder identity and management

Identifying and managing the right stakeholders at the right time, with clear accountabilities is key to the success of a new technology adoption.

  • What mix of organizations and people are needed now?
    • Will it only apply to a small part of the business?
    • How pervasive could it become?
  • What organizations and people will this potentially impact?

  • Who are the key stakeholders? Difference between informing the stakeholders vs. when should they be involved?
  • What are their interests?
  • According to them, how well are their interests met by this technology?
  • How much stakeholder involvement has there been to date?

  • Do we have a balanced team of stakeholders / sites to implement this?
  • Is there a development plan / timeline with accountable people committed?
  • What are the reporting / update methods?

  • Who are the key people at the initial site?
  • How much engagement have we had with them to date?
  • How is this approach in their best interest?
  • What resources / skills are missing?

  • How do we scale out key resources / skills?
  • What stories are being circulated about this approach?
  • Who are the key advocates across the organziation?
  • How are we dealing with rejection of this approach by a given site?

*Technology readiness level

The downloadable pdf is a fully navigable high-level toolbox and guidance for R&D, technology discovery, sponsors, risk managers and regulatory teams.

Risk management

Using an agile/fast fail risk management methodology, including proofs of concepts, business risk, technology risk and regulatory risk.

  • What is the potential chance of success knowing what we know now?
  • What other problems / opportunities could be addressed if we don’t pursue this one?
  • What are the key decision points during development of solutions to this problem / opportunity?

  • What is the technology readiness?
  • What is the manufacturing readiness?
  • What is the organizational / human readiness?
  • What happens if we don’t do this?

  • What is the development portfolio impact?
  • What is the commercial product portfolio impact?
  • How likely is it that all remaining gaps will be filled before the technology ceases to be of value to the organization?

  • What are the remaining risks to adoption and how might they be mitigated?
    • Properly resourced
    • Appropriate timelines
    • Good location fit
    • Local organizational readiness
  • Do we have the initial site “ready for success”?

  • What are the remaining risks to adoption and how might they be mitigated?
    • Properly resourced
    • Appropriate timelines
    • Modifications to local sites understood
    • Local organizational readiness
*Technology readiness level

The downloadable pdf is a fully navigable high-level toolbox and guidance for R&D, technology discovery, sponsors, risk managers and regulatory teams.

Regulatory approval

Regulatory awareness and engagement is needed at each stage gate. Awareness of the regulatory implications and risks associated with the technology with the expectation that regulatory acceptance is very likely.

  • What are the potential regulatory implications of addressing this problem / opportunity?

  • Are there published test results that indicate this technology can perform as needed?
  • Are there any early adopters already approaching regulatory groups?
  • How / where should we approach starting regulatory discussions?

  • Are all the components of a product tested and available such that it can be reliably made?
  • Is there reliable evidence that this technology / product will perform in the relevant operational environment?
  • What problems were encountered when this evidence was generated and how were those problems overcome?

  • Where are we deploying this first?
  • What is the regulatory environment for this type of approach at that location?
  • What regulatory engagement has been employed to date?

  • Where in total are we deploying this approach?
  • What regulatory differences are there between the first site and any subsequent locations?
  • What regulatory engagement has been employed to date?
  • How are we leveraging previous successful regulatory engagements?
*Technology readiness level

The downloadable pdf is a fully navigable high-level toolbox and guidance for R&D, technology discovery, sponsors, risk managers and regulatory teams.

Good manufacturing practice (GMP) readiness

Even in the earliest stages of technology development, line-of-sight to GMP readiness is critical. By considering process control, validation, regulatory compliance, and supply chain requirements from the outset, expensive pitfalls can be avoided late in the adoption process.

  • Will this solution impact GMP operations at any facilities?

  • Have the technologies under consideration been scored in terms of GMP ease of implementation?
  • Have GMP functional area representatives provided feedback on potential challenges?

  • What components of the technology have a history of GMP compliance?
  • What risk mitigations are needed for components with a limited track record?
  • What supply chains need to be created/modified to support regular use?
  • Will modifications to enable GMP compliance impact the final technology’s KPIs?

  • Will the technology be implemented at a pilot site?
  • What changes will be needed to site policies, procedures, and training?
  • What change control activities are needed for active drug programs?
  • What end-points are needed to support global roll-out?

  • Are we deploying this approach consistently?
  • What change control activities are needed for global deployment?
  • What is the timeline for overall deployment?
*Technology readiness level

The downloadable pdf is a fully navigable high-level toolbox and guidance for R&D, technology discovery, sponsors, risk managers and regulatory teams.

Operational readiness

  • Human readiness- sharing implementation strategy and getting people ready for implementation
  • Procedures, process, training and getting buy-in
  • Physical facility is ready, including support functions and 3rd parties
  • Technology proved sustainable including support
  • Commercial contracts in place
  • Maintenance plan and supply chain in place

  • Receiving site operational, technical quality and regulatory risks identified?
  • Have you Identified the QMS, automation anddigital needs for implementation?

  • Have you identified the landing site?
  • Is the vendor quality and site approved and audited?
  • Does this require changes to site QMS, automation and/or digital infrastructure?
  • Have you addressed any potential IP issues?

  • Do you have a preliminary validation masterplan for GMP implementation?
  • Agreed on the landing site and made plans to upskill the operator on the new tech?
  • Ensured all quality audits and regulatory approvals are granted?
  • Formally initiated the change management system?
  • Completed the IQ/OQ plans?
  • Is dual sourcing required and feasible?

  • Completed the validation and PQ plans?
  • Got the network strategy finalized for the new tech,  including any supply commitments and chain of custody needs?
  • Are the impacted workforce fully trained on the new technology?
  • Finalized all MES, QMS and automation aspects of this technology?

  • Reviewed key learning from the implementation phase and addressed any deviations?
  • Completed a formal AAR?
  • Initiated the evaluation to further adopt the technology in the remaining network?
*Technology readiness level

The downloadable pdf is a fully navigable high-level toolbox and guidance for R&D, technology discovery, sponsors, risk managers and regulatory teams.

Share This