The pharmaceutical industry is at the forefront of the European Union’s efforts to drive innovation and technological leadership. A staggering 25% of pharmaceutical startups emerge from technological transfer, the process of transforming cutting-edge research into commercially viable products and services. By bridging academia and industry, tech transfer catalyzes economic growth, job creation, and groundbreaking deep-tech solutions, accounting for over 60% of economic growth in developed countries.

The EU’s substantial funding initiatives, like Horizon Europe’s €95.5 billion budget, feature specific calls supporting various tech transfer stages. Research and Innovation Actions (RIAs) target lower Technology Readiness Levels (TRLs) 3-5, focusing on early-stage research and proof-of-concept. In contrast, Innovation Actions (IAs) target higher TRLs 6-8, concentrating on product/service development and commercialization.

One notable opportunity is the EIC Transition program under Horizon Europe’s European Innovation Council (EIC). Offering grants up to €2.5 million, it empowers startups to validate technologies, build prototypes, and prepare for market entry – bridging the dreaded “valley of death.” Companies like Anaviri, a Spanish biotech firm, received €2.3 million to develop a novel HIV vaccine through this program.

Pharma-Focused Funding Bonanza

For pharma startups and tech transfer offices (TTOs), the EU’s funding landscape is ripe with potential. From 2021-2027, €8.2 billion is allocated for health research and innovation – underscoring pharma’s pivotal role in advancing healthcare and economic growth.

The “Tackling Diseases” call, with a €1.3 billion budget, supports innovative disease prevention, diagnosis, and treatment solutions. Projects like INNODIA, which received €27 million to develop better diabetes treatments, exemplify the transformative impact of such funding.

Collaboration: Synergy for Success

The EU actively encourages academia-industry partnerships, recognising their synergistic power. TTOs play a crucial role, in bridging cutting-edge research and commercial applications. By leveraging expertise and networks, TTOs help startups identify and acquire promising technologies while navigating IP and commercialisation complexities.

Having witnessed the tangible impacts of these programs, I can attest to their ability to foster a conducive ecosystem for tech transfer and innovation. This firsthand experience guides entities through the EU funding maze, enhancing prospects for success.

Upcoming opportunities include the EIC Pathfinder Open and Challenge calls, fostering cutting-edge, high-risk/high-impact research and deep-tech breakthroughs. With a budget of €624 million in 2023, these calls present exciting avenues for pharma innovators.

As the world grapples with healthcare challenges, the EU’s commitment to fostering tech transfer and supporting pharma innovation is vital. By seizing these opportunities and forging strategic partnerships, startups and TTOs can unlock groundbreaking research’s full potential, shaping a brighter, healthier future.

The WHO guidelines define technology transfer as a logical procedure that controls the transfer of products, processes, and knowledge, together with their documentation and professional expertise, within a facility or between facilities. It may involve development, manufacturing, and testing sites. The transfer may occur during a product’s development phases or after obtaining marketing authorization.

The WHO guidelines, as well as ICH Q10 and ICH Q12, consider the transfer of technology part of a pharmaceutical product’s lifecycle.

When the transfer is between different companies, in addition to regulatory and quality implications, it may also have legal and economic implications that need to be considered and addressed when planning the technology transfer.

The goal of a Technology Transfer

Depending on the development phase, the goal of the technology transfer is to transfer product and process knowledge between development and manufacturing, between small-scale manufacturing lines to large-scale manufacturing lines, or between manufacturing sites to achieve product realization.

The knowledge transferred forms the basis for establishing the manufacturing process, control strategy, process and methods validation approach, and ongoing continuous improvement.

What does the Technology Transfer project include?

• Documented project plan covering the different aspects of the project, relevant responsibilities, and timelines.
• Detailed description of the process steps and analytical methods.
• Detailed quality risk management plan.
• Comprehensive gap analysis to assess the capabilities of the receiving unit (RU) and the sending unit (SU) in terms of facilities, equipment, QC laboratories, quality, and regulatory aspects. This may be achieved by way of thorough due diligence.

The success of a technology transfer process depends heavily on the communication, transparency, and goodwill of both the SU and the RU.

Comparability between the original process to the transferred process

Whether it is during the development phases or post-approval, a comparability exercise to support the technology transfer should be executed. Based on the project step, the complexity and number of changes will define the extent of comparability to be conducted.  ICH, FDA, and EMA guidelines on comparability should be consulted.

Guidelines about post-approval changes should be considered to understand how to manage the change and the reporting requirements.

Meeting with regulatory authorities prior to initiation of the technology transfer

It is important to consult with the relevant regulatory authorities prior to the initiation of the technology transfer. If it is a product in the development phase with an active IND, ensure you provide the FDA with the technology transfer plans, including the comparability protocol, before engaging in the process. This will allow the FDA to provide you with timely comments. For an approved product, it is even more important and relevant to provide the regulatory authority with your plans for future changes to avoid risking your commercial supply.

Conclusion

Technology transfer of a manufacturing process is a key and complex activity in the pharmaceutical industry. It requires careful planning and execution, as well as consideration of which development stage it is recommended to encompass in such a process. Stakeholders from different expertise should be consulted, and regulatory expectations should be taken into consideration, all to ensure a successful transfer and continuation of product development or commercialization.

List of guidelines:

1. WHO guidelines on transfer of technology in pharmaceutical manufacturing, 2011
2. New Version on WHO Guidelines on Process Transfer, 2021
3. ICH Q10 Pharmaceutical Quality System
4. ICH Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management

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In the pharmaceutical industry, technology transfer is critical to ensuring that knowledge about product development and manufacturing processes is shared effectively across different phases and sites. Technology transfer aims to facilitate product realization by transferring essential process knowledge and control strategies between development and manufacturing teams and across manufacturing sites.

Collaborative Foundations for Success

The process begins with robust collaboration across multiple functions, including research and development, manufacturing, quality assurance, regulatory bodies, and commercial teams. From early development, it’s vital to assess unit operations at a commercial scale, identify Critical Quality Attributes (CQAs) and critical Process Parameters (CPPs), and establish a control strategy. This foundational work ensures that both the originating (sending) and recipient (receiving) units are equipped with a clear understanding of the product, process knowledge, and plans for mitigating risks.

Role Clarity and Relationship Management

Key to a smooth technology transfer is defining roles and responsibilities early, particularly between the sending and receiving units. Maintaining solid relationships within the transfer team is crucial for navigating the complexities of technology transfer, especially when it spans different cultural contexts.

Effective Team and Governance Structures

A formal technology transfer team should include leaders from both sending and receiving sites and Subject Matter Experts (SMEs) from areas such as Analytical Sciences, Engineering, Manufacturing, Quality, supply chain, and Regulatory Affairs. This team ensures comprehensive oversight and expert input essential for a successful transfer.

For governance, project leads and stakeholders must outline a clear framework encompassing the transfer’s scope, timelines, resources, budget, and success criteria. This framework should also include robust change and risk management strategies and a structured decision-making process.

Minimizing Changes Through Strategic Gap Analysis

Upon receiving the technology transfer package, the receiving unit conducts a gap analysis to compare existing and planned operational processes. This step helps identify knowledge gaps, process adaptations, and facility modifications. To ensure success, it’s critical to minimize changes. Keeping materials and manufacturing processes as consistent as possible with the original site helps maintain drug quality and integrity.

Effective technology transfer in pharmaceutical manufacturing is a strategic, structured process that extends beyond merely moving technology from point A to B. It involves detailed planning, skilled teamwork, and stringent management to ensure that every drug production phase meets the highest quality and efficacy standards. By adhering to these guidelines, pharmaceutical companies can achieve seamless technology transitions, ensuring consistent drug quality and availability in the market.

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In the pharmaceutical industry, analytical technology transfer (ATT) is a crucial process that involves moving validated analytical methods from one laboratory to another. This is typically done between different locations within the same company or between different companies. The transfer ensures that the recipient laboratory can perform the analytical method reliably and consistently, producing results that are comparable to those obtained by the transferring laboratory.

Importance of ATT

The primary aim of analytical technology transfer is to verify that the receiving lab not only understands and can implement the method but also generates accurate and reliable results. This process is vital for maintaining the integrity of drug development and manufacturing and ensuring that quality control is consistent across different sites.

Regulatory Guidelines

Different regulatory agencies have outlined expectations for ATT. For example, USP 1224, ‘transfer of analytical procedures’, includes detailed instructions that address how to carry out the transfer, how to train personnel at the receiving site, and how to verify that the transferred analytical method performs as expected. Several types of transfers are considered: comparative testing, co-validation between two or more laboratories, revalidation, and even transfer waiver.

Despite the existence of these guidelines, there is often room for interpretation, which can lead to variations in how ATT is executed.

Steps in ATT

A typical analytical technology transfer includes:

• Preparing a detailed transfer protocol.
• Sharing scientific documentation related to the method, including detailed analytical procedures.
• Providing reference samples.
• Executing the required study(ies) at the receiving site to validate the transfer.
• Assessing the results to confirm that the method performs adequately in the new setting.

Challenges and Considerations

Despite its routine nature, ATT can be complex and challenging. Differences in equipment, reagents, personnel, and even environmental conditions between sites can affect the outcome of the transfer. Therefore, a risk analysis is often performed as part of the transfer protocol to identify and mitigate potential issues.

Analytical technology transfer is a key activity in the pharmaceutical industry that supports the safe and effective production of medications. While it is governed by regulatory expectations, the specific practices can vary, requiring careful planning and execution to ensure success.

The Virtual-Tangible Fine Line

Drafting a technology license agreement is a complex professional matter, typically handled by lawyers specializing exclusively in the field. Surprisingly, the principles and rules of an apartment rental agreement, a topic familiar to many, can assist in navigating and understanding the concepts of IP licensing.

Below, we will review the overlapping points between these two agreements – different yet surprisingly similar – which will greatly facilitate our ability to recognize and navigate technology licensing agreements.

In the example before us, we will talk about licensing a patent for drug manufacturing versus renting an apartment.

Let’s start with the agreement terms that define and limit the subject of the transaction and the scope of the license or the rental:

1. The subject of the rental – an apartment– is registered in the Land Registry in the name of the owner/lessor, indicating ownership of the entire apartment without the ability to split ownership of specific rooms. Similarly, The subject of the license – a patent is registered in the Patent Office in the name of its owner/licensor, denoting ownership of the entire patent without the ability to split it.

2. The rental period – Example: 5 years with an option for extension. The license period – Example: For the duration of the patent’s validity, or, for a fixed period with an option for extension.

3. The permitted use of the apartment – Example: For residential purposes only. The permitted use of the patent – Example: For producing a topical drug only but not for producing an ingestion drug.

4. Subleasing—Example: The tenant is allowed to sublease. Sub-licensing—Example: The licensee is allowed to grant a sub-license.

5. The scope of use of the apartment – Example: Renting the living and bedrooms, except for the storage room. The scope of use of the patent – Example: A license limited to part of the technology covered by the patent or some of the patent claims.

6. Regulatory compliance – Example: The tenant undertakes to comply with all laws applicable to a resident, and the licensee undertakes to comply with the relevant regulations for the exploitation of the patent, the production of the drug, its marketing, etc.

While acknowledging the great similarity between the aforementioned types of transactions, it is also possible at this stage to discern the advantages and greater flexibility in technology (intellectual property) licensing transactions over the rental of a physical asset.

For example, while a physical asset’s rental is limited to a defined tenant(s), an intellectual asset can be licensed to multiple users/licensees or a single user/licensee if the license is defined as exclusive. Moreover, in technology licensing, it is possible to stipulate that the license is granted and limited to exploitation in a particular country/territory, while in another country/territory, the license will be granted to another licensee. Furthermore, it is also possible to determine many commercial segmentations – such as: one licensee will obtain a license for production only, while another licensee will be granted a license – for the same patent – for marketing and distribution only.

For the sake of ‘the sacred balance,’ let us note that renting an apartment (and physical assets in general) has its own advantages: In case of a breach of the rental contract terms, the lessor can take physical steps to restore the asset to its possession, for example, by eviction, replacing the locks, taking actual possession, fencing, etc. In contrast, due to the virtual nature of intellectual property licensing, there is no possibility to literally ‘lay hands’ on the intellectual asset in a situation where the licensee violates the license terms. Complex legal enforcement actions must be taken to prevent the exploitation of the license by the violator.

Now, let’s go back and compare yet another aspect of the above transactions – so different in nature yet so similar in the framework of their terms – this time, we’ll address certain aspects of the Transactions Consideration:

1.1 Apartment Rental Consideration—Example: The rent is calculated based on the property’s space. Patent licensing Consideration—Example: Royalties are calculated as a percentage of revenues derived by the licensee from the exploitation of the license.

1.2 A greater similarity can often be seen in the rental of commercial property (for example, a store in a mall), where it is customary for the consideration paid by the tenant to be partly composed of royalties on the store’s revenues in addition to lump-sum payments made in advance, or during the rental period. Similarly, in licensing, it is customary that, in addition to royalties, the licensee will make lump-sum payments that are not dependent on the revenues derived from exploiting the license. These fixed payments are usually paid both as a one-time payment upon the license coming into effect as well as periodic payments that are not income-dependent.

2. We have referred above to subleasing versus sublicensing. Indeed, in the context of the consideration, there is much similarity: In subleasing, the primary tenant will pay the lessor all or part of the sublease rent she received from the subtenant. Similarly, in sublicensing, the primary licensee will pay the licensor the agreed portion of the sublicense royalties derived from the sublicensee.

In summary, the great similarity, which does not always receive due attention, between transactions in tangible assets and transactions in virtual assets demonstrates the ‘tangibility’ of intellectual assets and the ‘virtuality’ aspects in transactions of tangible assets. Realizing and understanding said similarity could meaningfully facilitate the structuring and execution of Tech transfer transactions.