Navigating FDA Type B Meetings with CBER: A Comprehensive Guide
MF BIOTECH has supported the preparation and conduct of various FDA Type B meetings and scientific advices, and there are even more considerations than what we could summarize in this guide. MF BIOTECH is happy to support you in making your agency meeting a success.
Navigating the regulatory landscape for biologics and biotechnology products requires careful planning and communication with regulatory agencies like the U.S. Food and Drug Administration (FDA). For developers of biologics seeking guidance and clarification on regulatory requirements, FDA Type B meetings with the Center for Biologics Evaluation and Research (CBER) are crucial. These meetings provide an opportunity for sponsors to discuss specific issues related to product development, clinical trials, and regulatory pathways. In this article, we'll delve into the steps involved in preparing for and conducting a successful FDA Type B meeting with CBER, which is also summarized in Exhibit 1.
EXHIBIT 1 | Step-by-step guide for FDA Type B meetings
Step 1: Determine the Need for a Type B Meeting
The first step in the process is to assess whether a Type B meeting with CBER is suitable for your product development program or whether other FDA meeting types or interactions could be more adequate depending on the meeting objectives and discussion topics.
FDA Type B meetings are typically requested to discuss specific issues or questions related to preclinical or clinical development, manufacturing, or regulatory strategy. Common reasons for requesting include Pre-IND meetings prior to filing of an IND, seeking advice on study design, endpoints, patient population, or clarification on regulatory requirements.
Step 2: Prepare Meeting Request
Once the need for a Type B meeting is identified, sponsors must prepare a meeting request to be submitted to CBER.
The meeting request should include an overview of the product, its development status and specific questions or topics for discussion. It's essential to provide sufficient background information to enable CBER to understand the purpose and scope of the meeting so that the appropriate CBER staff can be identified for participation in the meeting.
As the meeting request contains the list of questions for discussion and objectives of the meeting, the overall strategy for the meeting should be thoroughly prepared in advance.
The meeting requests contains a proposal for meeting dates, the format (in-person, teleconference, or videoconference), and the participant list.
Step 3: Submit Meeting Request to CBER
Meeting requests should be submitted to CBER through FDA's electronic submission gateway or other designated portals, following the agency's guidance on meeting request submissions in compliance with the eCTD format.
It's important to adhere to the specified timelines and content requirements outlined by CBER to ensure timely processing of the meeting request.
Step 4: Pre-Meeting Communication and Planning
CBER typcially responds to meeting requests within 21 days after receipt.
If the meeting requests is granted, CBER will provide all meeting details. As per FDA’s meeting guidance, the meeting should be scheduled within 60 days, however, later dates are common depending on the availability of CBER staff. If needed, sponsors may engage in pre-meeting communication with CBER to discuss logistical details, such as scheduling, format (in-person, teleconference, or videoconference), and participant list.
If the meeting is denied or for other reasons, sponsors may have the opportunity to address any questions or concerns raised by CBER regarding the meeting request or provide clarification on submitted documents.
Step 5: Submit Meeting Package
The preparation of the meeting package typically starts at the time the meeting request has been submitted (Step 3) or earlier.
Besides the meeting information, the meeting package must contain data summaries for each question to support the discussion. The content of the meeting package should be closely aligned with the information provided in the meeting request, in particular the list of questions.
The meeting package must be submitted to CBER and received at least 30 days prior to the agreed meeting date.
Step 6: Preliminary Responses from FDA
The sponsor receives FDA’s preliminary responses to the meeting package at least 2 days prior to the meeting. This time should be blocked for all sponsor team members who participate in the meeting or contribute to its preparation.
The sponsor team should thoroughly review the responses and selects those topics that should be discussed with the agency during the meeting. As best practice, the sponsor prepares presentation slides to support the discussion and submits them to FDA prior to the meeting.
In addition, the sponsor anticipates critical discussion points of the meeting and aligns potential response and backup strategies before the meeting.
Step 7: Conduct the Type B Meeting
On the scheduled meeting date, sponsors, along with relevant stakeholders such as key team members, experts, and key opinion leaders, participate in the Type B meeting with CBER representatives.
During the meeting, sponsors present the previously selected questions or topics for discussion (Step 6).
Step 8: Final Meeting Minutes
Following the Type B meeting, FDA issues the final meeting minutes within 30 days after the meeting. The preliminary responses provided by FDA (Step 6) are the basis for the meeting minutes.
It is formally not required that sponsors prepare meeting minutes, however, some sponsors provide their meeting minutes to FDA to facilitate alignment of their understanding about the key discussion points, decisions, and action items agreed upon during the meeting.
Step 9: Follow-Up and Implementation
After the Type B meeting, sponsors should promptly address any action items or follow-up tasks identified during the meeting.
This may include revising study protocols, updating regulatory submissions, or addressing specific concerns raised by CBER. Effective communication and collaboration with CBER throughout the follow-up process are critical to ensuring alignment with regulatory expectations and advancing the product development program.
Conclusion
Navigating FDA Type B meetings with CBER requires careful planning, preparation, and collaboration between sponsors and regulatory authorities. By following the steps outlined in this guide, sponsors can maximize the value of these meetings and obtain valuable feedback and guidance to support the development and regulatory approval of biologics and biotechnology products. Effective communication and engagement with CBER are essential for achieving regulatory success and bringing innovative therapies to patients in need.
The Investigational Medicinal Product Dossier (IMPD): Essential CTA Document and Guide for Your Biopharmaceutical Development Program
MF BIOTECH has a proven track record in writing IMPDs that enabled a smooth CTA review process across all development stages, especially for complex biopharmaceuticals.
The Investigational Medicinal Product Dossier (IMPD) is one of the essential documents for a clinical trial application (CTA) in the EU. Especially prior to initiating clinical development, the preparation of an IMPD may take some effort because it is typically the first time that all development data generated to date are summarized in a comprehensive manner for the review by competent authorities. The IMPD may also serve as critical documentation during due diligences with potential investors and cooperation partners.
IMPD STRUCTURE
The IMPD consists of four parts: quality, pre-clinical, clinical data, and the assessment of overall risk benefit. It is possible to cross-reference to the Investigator’s Brochure (IB) if the information is already included there.
The structure of each IMPD part is closely aligned with the headings of the Common Technical Document (CTD) which also is the structure of dossiers for marketing authorization applications. Therefore, the IMPD sets the very early basis of the future dossier.
In the case of complex biopharmaceuticals, the IMPD structure and the allocation of available data must be accurately planned out so that the information can be easily located and presented in a clear manner (e.g. cell and gene therapies without a defined drug substance).
CONNECTING IMPD WRITING AND DEVELOPMENT STRATEGY
The IMPD summarizes and organizes available development data including key conclusions and provides reference and context to applicable regulatory guidelines and other scientific aspects taken into account during development. Overall, the development strategy is concisely reflected in the storyline of the IMPD.
When writing and compiling the IMPD, it is common that additional development questions may arise requiring further justification or mitigation strategies, for example if data are incomplete or deviations from regulatory guidelines occurred. IMPD writing facilitates to address these issues by:
Clear presentation of available data and information
Accurate and appropriate language for reviewers
Making best use of the available regulatory framework
Providing scientific-technical considerations and justifications, as needed
Cross-functional collaboration
Proactively anticipating questions from regulators avoiding delays during the CTA review
Augmenting and refining strategic considerations of the development program.
Accelerate Your Cell and Gene Therapy Development Through Regulatory Expedited Programs - PRIME, RMAT, ILAP & Co.
MF BIOTECH supports you with your requests for PRIME, RMAT, ILAP and other expedited programs and beyond the designation.
Cell and gene therapies are at the forefront of today’s medicine. Their development is complex and requires significant investment, resources and expert knowledge over a substantial period of time. Additionally, innovative medicinal products carry inherent risks due to their novelty in multiple areas. Some of the challenges during development include setting up a manufacturing process suitable for clinical trials and commercialization, generation of non-clinical data packages taking into account the mode of action and specific nature of the product, demonstration of clinical safety and efficacy in patients, and ensuring market access and acceptable pricing.
TAILORED DEVELOPMENT STRATEGIES & CONTINUOUS REGULATORY INTERACTIONS
Regulatory agencies of all major markets have recognized that innovative therapies such as cell and gene therapies require a tailored approach for successful development. Expedited programs by regulatory agencies offer several tools to address this need. The most important benefit is continuous interaction between the authority and the applicant to align the development strategy and requirements towards clinical development and marketing authorization. Expedited programs include, for example:
EMA: PRIME
FDA: RMAT
UK: ILAP
To enter an expedited program, the development candidate must meet strict criteria in terms of unmet medical need of the target disease as well as scientific evidence of its potential to address this unmet medical need. Therefore, the designation for an expedited program also acknowledges the therapeutic value of the product and increases the product value and attractiveness of the company and platform technology.
STEP-BY-STEP GUIDE TO PREPARE AND ENTER AN EXPEDITED PROGRAM
Select the expedited program that is right for your development program
Check if you meet the eligibility criteria (take note of potential gaps and challenges)
Consider your regulatory strategy in terms of regulatory interactions and target markets for commercialization
Align activities related to the expedited program with overall development program and strategy
Timing for preparation and submission of request as well as subsequent actions to implement expedited program
Resources for preparation of request as well as management of expedited program
Obtain preliminary feedback from Agency (if offered)
Validate your eligibility for the designation and obtain specific points for consideration for the request
Prepare full request including content and evidence to meet specific criteria
Be ready to answer additional questions during the assessment of your request
Designation granted
Make best use of the expedited program to accelerate your development program
Drug Repurposing: Opportunities for Developing Drugs Faster, Safer, Cheaper in New Therapeutic Areas
Drug discovery and the translation of research findings into new therapies require significant investments and resources by biopharmaceutical companies. Analyses across all therapeutic areas indicate that the development of a new medicine, from target identification through marketing authorization, takes over 12 years and often much longer (DiMasi 2010).
An attractive alternate development strategy is the repurposing of known drugs. The basic idea works as follows: Marketed drugs are approved for certain uses and have been tested in humans, so detailed information is available on their pharmacology, formulation and potential toxicity. The repurposing builds on these available data and previous research and development efforts, which facilitates the identification, design and development of new therapies and which can speed up the review by agencies and, if approved, the integration of the product into the healthcare system.
A comparison between conventional development strategies (i.e. for novel drugs and generics) and the repurposing development approach is presented in Exhibit 1. A more detailed view on the development process for novel and repurposed drugs is shown in Exhibit 2. In the literature, the estimated benefits of the repurposing development strategy slightly differ depending on the product type and target indication, however, it is obvious that drug repurposing is less risky, cheaper and faster than the development of novel drugs.
EXHIBIT 1 | Positioning of development strategies of biopharmaceutical companies.
EXHIBIT 2 | Comparison of drug development process for (a) novel drugs and for (b) repurposed drugs (Ashburn 2004).
Repurposing of established drugs can be defined as “studying drugs that are already approved to treat one disease or condition to see if they are safe and effective for treating other diseases” (National Center for Advancing Translational Sciences).
All repurposing programs contain two key elements:
taking existing scientific or medical knowledge and technology that is “approved” for human use in one disease or condition; and
applying this knowledge and technology to another disease or condition.
Exhibit 3 summarizes various examples of repurposed drugs for small molecules and biologicals. The opportunities of drug repurposing have been also discovered for the creation of totally new treatment regimens, e.g. combination therapies in oncology (Exhibit 4, Bertolini 2015).
EXHIBIT 3 | Examples of drugs repurposed for orphan indications in the US.
EXHIBIT 4 | Repurposing of drugs used in the development of new combination therapies for cancer treatment (Bertolini 2015).
The concept of drug repurposing is known to regulators, and applicable regulatory frameworks have been defined in the EU and the US (Exhibit 5). As for the development and registration of new molecule entities (NMEs), similar incentives exist for repurposed drugs, e.g. for orphan drugs or pediatric development programs. Combining the advantages of the drug repurposing approach with a sound development and regulatory strategy (avoiding pitfalls) provides enormous opportunities for biopharmaceutical companies.
EXHIBIT 5 | Overview of relevant regulatory frameworks for drug repurposing in the EU and in the US (Papakrivos 2011).
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DiMasi J.A., Feldman L., Seckler A., Wilson A. (2010): Trends in risks associated with new drug development: success rates for investigational drugs. Clin Pharmacol Ther. 87, 272–277.
Ashburn et al. (2004): Nat Rev Drug Disc 3 , 673-683
Bertolini F., Sukhatme V.P., Bouche G. (2015): Drug repurposing in oncology - patient and health systems opportunities. Nat Rev Clin Once 12, 732–742.
Papakrivos J. (2011): Regulatory Strategy for the Development of Known Drugs in New Therapeutic Areas, Rheinische Friedrich-Wilhelms-Universität Bonn
MF BIOTECH is experienced in the preparation and execution of customized development strategies for repurposed drugs.
Guiding Principles for the Development of Highly Innovative Biopharmaceuticals – an Overview from Program Management Perspective
From the very beginning of the Covid-19 pandemic, biopharmaceutical development companies have been at the forefront of developing effective therapies to prevent and treat SARS-CoV-2 infections. The development and approval of vaccines against the SARS-CoV-2 virus was of critical importance supported by global and national initiatives including substantial public funding. As a result, also innovative therapeutic approaches entered into clinical development – with great success – in particular the application of mRNA technology in the field of vaccines.
SARS-COV-2 MRNA VACCINES – AN EXAMPLE FOR HIGHLY INNOVATIVE BIOPHARMACEUTICALS
In close alignment with regulators, vaccine development for SARS-CoV-2 could follow an accelerated timeline (Figure 1, Krammer 2020). Because of knowledge gained from the initial development of vaccines for SARS-CoV and MERS-CoV, the discovery phase was omitted. Existing processes were adopted, and Phase 1/2 trials were started. Phase 3 trials were initiated after the interim analysis of Phase 1/2 results, with several clinical trial stages running in parallel. In the meantime, vaccine producers could start the large-scale production of vaccine candidates, at risk.
EXHIBIT 1 | Traditional and accelerated vaccine-development pipelines.
PRODUCT APPROVALS IN RECORD TIME
As of August 2022, in total 6 SARS-CoV-2 vaccines have been approved in the EU. 4 out of these 6 vaccines could be developed and approved in approximately 10-13 months (Figure 2). In contrast to other development programs, these extremely fast development timelines raise basic questions:
What are the success factors of these biopharmaceutical development companies to develop products in record time?
What are the key learnings for biopharmaceutical development programs to accelerate the development and approval?
What are major impediments within an organization or from the outside that could slow down or even make a development program fail?
EXHIBIT 2 | Overview of approved SARS-CoV-2 vaccines in the EU and estimated timelines till approval.
CHARACTERISTICS AND CHALLENGES OF INNOVATION MANAGEMENT
In general, innovations significantly differ from other projects which involve repetitive routine decisions. Innovations specifically raise novel challenges for their management and confront a company with several barriers throughout the innovation process. Consequently, innovations require another type of management in comparison to repetitive routine decisions (Hauschildt, 2010).
Innovations are related to a high degree of novelty and uncertainty.
Innovations are based on knowledge which has to be complemented by new knowledge in order to decrease their complexity and risk of failure.
Due to their newness, innovations have to be established within a market for commercialization as well as in the company during the innovation process.
Especially innovations with a high degree of newness, such as radical innovations, impose these managerial challenges on innovation management (Leifer, 2000).
PROGRAM MANAGEMENT AS FACILITATOR FOR HIGHLY INNOVATIVE BIOPHARMACEUTICALS
The development of innovative biopharmaceuticals pose unique challenges to development companies and teams working on such a program. Each company, technology and product have specific features that influence the path of the development program such as maturity of technology, funding or resources assigned to the program. But, there are several guiding principles that teams developing innovative therapies can follow right from the program start:
Assemble and develop a high-performing and committed program team that embraces change.
Prepare an integrated development strategy that fundamentally reflects the science of the product and of all required development activities (to be discussed with regulatory authorities).
Prepare a robust program plan that is aligned within the organization and that includes agile planning elements.
Set up a clear and lean program governance and decision making process.
Continuously assess and manage risks and handle issues - be prepared for surprises.
Empower the program team to keep the program on track and to remove roadblocks.
Use effective program management tools that provide clear guidance to the program team and that transparently report relevant information to all stakeholders.
In summary, successful development of innovative medicines requires a company culture and organizational framework that enables program teams to effectively drive innovative development programs. Besides the support from the company’s Senior Management, Program Management plays a pivotal role as facilitator of innovative biopharmaceutical development programs and to deliver critical program goals.
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EMA (2022): Authorised COVID-19 vaccines, retrieved from website in Aug 2022.
Firgens, M. (2012): The Management of Ideas in the Front End of Innovation – a Case Study About the Creation of Innovation in the Pharmaceutical Industry, Master Thesis - Master of Business Administration in General Management.
Hauschildt, J.; Salomo, S. (2010): Innovationsmanagement, 5th edition, München.
Krammer, F. (2020): SARS-CoV-2 vaccines in development. Nature 586, 516–527.
Leifer, R. (2000): Radical Innovation: How Mature Companies Can Outsmart Upstarts, 1st edition, Boston.
MF BIOTECH is your partner for program management in the development of innovative biopharmaceuticals with hands-on experience on various product types, indications, company sizes and team settings.
Preparation of integrated development strategies and definition of key development milestones for CMC, non-clinical, clinical, regulatory (Europe, USA)
Full planning and execution of highly innovative and complex development programs including project planning and tracking of timelines, quality, costs
Lead and develop emerging high-performing program teams consisting of SMEs, project managers, or functional leaders from different technical disciplines.
Rare Diseases: Accelerate Your Product Development Through Orphan Designation
The number of rare diseases for which no treatment is currently available is estimated to be between 4,000 and 5,000 worldwide. Each disease affects only a small proportion of the population, often starting at birth or during infancy. In Europe, these diseases in sum affect 25 to 30 million people.
Mostly due to economic reasons, the development of therapies for rare diseases has been unattractive for pharmaceutical companies. Accordingly, these medicines are also commonly referred to as “orphans”.
USE THE BENEFITS …
Therefore, most countries put incentives in place to encourage the development of therapies for rare diseases. Incentives comprise financial benefits, programs to accelerate development and market access, and market exclusivity. To be eligible, the drug or device under development must obtain orphan designation issued by the respective regulatory authority.
… BUT A TAILORED DEVELOPMENT STRATEGY IS KEY
Although the criteria for orphan designation appear similar between countries, the product development strategy and application for orphan designation must take into account product- and country-specific aspects.
For example, orphan drugs intended for rare pediatric disease can benefit from additional incentives or regulatory pathways to accelerate market approval. To meet the prevalence criterion for orphan designation, the applicant must collect country specific prevalence or incidence data. Only limited experimental data from preclinical and clinical studies may be available, and appropriate justifications must be provided in the application for orphan designation.
The following overview summarizes incentives and requirements for orphan drug designations:
MF BIOTECH has obtained orphan designation for drugs and devices worldwide including the EU and US – in one go.
Preparation and evaluation of strategies and scenarios for orphan designation (globally or nationally)
Preparation and conduct of pre-submission meetings and hearings for orphan designation
Preparation and filing of application for orphan designation worldwide including EMA and FDA
Development of integrated development strategy plans for accelerated product development of biopharmaceuticals
Benefit from EMA’s Innovation Support and Incentives for Small Biotech and Pharma Businesses
The European Medicines Agency (EMA) supports micro-, small- and medium-sized enterprises (SMEs) that develop human or veterinary medicinal products with the goal to promote innovation and development of new medicines. To achieve this, incentives are provided to help SMEs overcome the main financial and administrative hurdles associated with pre-marketing procedures, particularly scientific advice, marketing authorization application and inspection procedures. The initiative also introduced incentives for post-authorization procedures.
THE INCENTIVES - WHAT ARE THE BENEFITS FOR SMEs?
Once the SME status has been granted, companies are eligible for the following incentives provided by EMA:
Regulatory, administrative and procedural assistance from the Agency’s SME office including SME briefing meetings;
Fee incentives, which are further detailed in Exhibit 1;
Certification of quality/ non-clinical data for advanced therapy medicinal products (ATMPs) intended for human use;
Translations of the product information documents submitted in the application for marketing authorization;
Waiver of the MedDRA licensing fee when registering with EudraVigilance. This is only available for micro- or small enterprises, not for medium-sized enterprises;
Inclusion in the SME public register.
Especially, fee reductions can be significant incentives for SMEs. Example: for a multidisciplinary EMA scientific advice procedure, SMEs pay a fee of around 8,000 Euro instead of 80,000 Euro for non-SMEs. To benefit from any fee incentives, the SME status has to be assigned by EMA’s SME Office before a regulatory submission. Therefore, it is recommended to consider the registration as SME early during the development.
EXHIBIT 1 | Fee incentives and financial benefits provided by EMA for SMEs.
THE CRITERIA – IS YOUR COMPANY AN SME?
The main criteria determining whether an enterprise is an SME are:
The company must be established in the European Economic Area (EEA);
Staff headcount less than 250 employees;
Either annual turnover of not more than 50 million Euro or annual balance sheet total of not more than 43 million euro.
The above defined thresholds apply for individual firms only. If a firm is part of a larger group, headcount and financial data of the linked enterprises or partners need to be taken into account.
NON-EEA SMEs - CAN COMPANIES OUTSIDE OF THE EU BENEFIT?
Yes, non-EEA companies, i.e. companies outside of the EU, can register as SME and take advantage of the SME incentives under one of the following conditions:
Companies have established a subsidiary in the EEA
Indirectly benefit from the SME incentives through an EU established SME regulatory consultancy.
Therefore, also SMEs that are based outside of the EU (e.g. Switzerland, USA, India or China) can benefit from EMA’s SME incentives. In the context of Brexit, UK-based SMEs need to submit a new SME application under the options for non-EEA SMEs above.
THE PROCESS - WHAT IS THE SME OFFICE? HOW TO OBTAIN SME STATUS?
The SME Office has been established at EMA to offer assistance to SMEs including providing contact with relevant scientific and regulatory staff within the Agency to help address any questions early during product development.
For registration as SME, companies need to complete the form “Declaration on the qualification of an enterprise as micro-, small or medium-sized enterprise (SME)” and submit it to the SME Office. Annual accounts, information on ownership and proof of establishment in the EEA should be included as additional documentation.
MF BIOTECH is registered as SME at EMA and can support your SME registration including companies based outside of the EU.
Check if SME requirements are met
Assistance during the SME registration process
Preparation of the application package
Maintenance of the SME status
How to Tackle Tech Transfer Projects for Biopharmaceuticals
The transfer of manufacturing processes and analytical procedures between facilities or laboratories is an essential technical activity during the lifecycle of a drug, as outlined in ICH Q10. These “technology transfers” - or simply “tech transfers” - take the outputs of process and method development activities and transfer the knowledge (sending unit) to a different location where the process or analytical procedure should be operated in the future (receiving unit).
Technology transfers require substantial resources, technical know-how and organizational skills in both sending und receiving units. Each tech transfer project has its unique risks and challenges inherent to the product and technology as well as related to the project organization.
TECH TRANSFERS ARE ESSENTIAL FOR PRODUCT DEVELOPMENT AND COMMERCIALIZATION
Technology transfers are frequently conducted throughout the product lifecycle for all types of biopharmaceuticals and can be triggered by a variety of reasons taking into account business and regulatory rationales:
Product life cycle management from R&D through scale-up to routine manufacturing
Post-approval changes to implement new process versions
Need for additional manufacturing capacity driven by increased demand or risk mitigation
Strategic requirements to relocate manufacturing sites for rationalization or economic advantages in different regions of the world
THE TECH TRANSFER PROCESS IN 5 STEPS
The technology transfer process typically consists of 5 main steps which are further outlined in Exhibit 1:
Assessment of the feasibility for the tech transfer project
The technical preparation of the technology transfer for analytical methods and manufacturing process
Implementation of analytical methods and manufacturing process up to technical batch scale at the receiving unit
Compilation of comprehensive documentation of the tech transfer
Obtain approval by regulatory authorities
Certain tech transfer activities may run in parallel, and cross-functional collaboration is required during each process step. Investing sufficient time and resources initially for planning of the tech transfer project will pay off at subsequent project stages. This includes a well prepared transfer plan, tech transfer package as well as a gap and risk analysis in the beginning of the project.
EXHIBIT 1 | The technology transfer process explained in 5 steps.
EXPECT RISKS, GAPS AND CHALLENGES
Technology transfers are complex projects, and each step of the tech transfer process requires consideration to address the project specific risks. These risks can be categorized into two main groups
Technical and development risks
Project management and organizational risks
A selection of risks and challenges commonly encountered during tech transfer projects are summarized in Exhibit 2. Of note, there are always technical risks or gaps specific to the project and technology which are typically identified and mitigated during an initial high-level risk and gap analysis.
For example, the exact production equipment of the sending unit may not always be available at the receiving manufacturing site, which likely requires adjustments to the manufacturing process when transferring it to the receiving unit. Consequently, the manufacturing process must be optimized for the available equipment at the receiving unit to maximize product yield and to minimize impurity levels.
EXHIBIT 2 | Examples of commonly encountered tech transfer risks, which in sum can have a huge impact on the project.
Most of the tech transfer risks may be categorized as moderate risks. However, in sum, they can have a huge impact on the quality, timelines, costs and resource needs of the tech transfer. Companies that successfully manage tech transfers continuously analyze and reduce the risks to an acceptable level throughout the technology transfer process.
We can support your technology transfer projects.
Comprehensive project management and targeted support of the transfer team
Development of integrated technology transfer plans and strategies
Compilation of technology transfer packages and document preparation for regulatory submission
Creation of customized and streamlined processes and operating procedures for technology transfers in your organization