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In the pharmaceutical world, Technology transfer (TT) is part of the product’s lifecycle. TT refers to the process of transferring knowledge, technologies, and methodologies from one institute or facility to another. This broad definition encompasses various activities, from moving academic discoveries to the commercial sector to sharing innovations between different companies or research facilities.
In this issue of The Biotech Startup Standard, we cover several key aspects of technology transfer:
Our articles provide snapshots of these essential topics, offering insights and practical advice for biotech startups. Dive into this issue to uncover detailed discussions, expert opinions, and success stories that will equip you with the knowledge and tools needed to navigate the complexities of technology transfer.
With over 35 years in biopharmaceutics and biotechnology, Ms. Zaibel has led an impressive number of multidisciplinary projects, supports startups globally, and has secured FDA and EMA approvals for recombinant proteins, vaccines, and medical devices. In 2019-2020, Ms. Zaibel joined the Weizmann Institute of Science SPARK project as a mentor and also became a member of the advisory board and lecturer for a new Master's degree in Regulatory and Drug Development at TAU. In 2022, the ADRES team led by Ms. Zaibel joined the BIODESIGN ISRAEL Rambam healthcare campus program as mentors. In 2023, Rivka was accepted as a mentor by EIT Health.
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Welcome to the inaugural issue of The Biotech Startup Standard, your premier source for insights and guidance in the development of new medicinal products. The idea for this magazine came to me during a brainstorming session between us at ADRES and a few industry colleagues over coffee. We realized there was a gap in accessible, practical information for biotech startups navigating the complex journey from concept to market. I reached out to several writers and experts in the field, and to my delight, they were enthusiastic about contributing their knowledge and experiences. Their cooperation has been invaluable in bringing this magazine to life.
The Biotech Startup Standard is dedicated to addressing these challenges head-on. Our quarterly issues, each dedicated to a specific topic, will provide biotech startups with the latest trends, expert advice, and success stories from the world of medical innovation.
Join us as we embark on this journey to transform innovative ideas into life-saving solutions!
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From my experience as a biotech startup founder, the technology transfer (TT) process involves due diligence and relationship building with the principal investigator (PI) and lab members, the Tech Transfer Office (TTO), Or an incubator’s management team. Most times, things don’t go as smoothly as expected, and this article will focus on what can be done in advance to avoid or minimize the gaps. Remember: Both sides of the tech transfer share the same goal of drug/therapy/product development at best! The main pillars for a successful TT are:
Technology Transfer (TT) is done after a deal or agreement is set. The process can be divided into three main parts:
The goal is to evaluate gaps, raise questions, and look for data inconsistencies or contradictions in the literature. Prepare thoroughly based on literature, the web, AI tools, and the licensing agreement.
Approach the Principal Investigator while CCing the TT representative, legal representative, and one board member of the company. Write an engaging intro email and set up an intro meeting. Tailor the TT visit agenda, map the topics and relevant people to meet, and build the schedule with the Principal Investigator or Lab research associate. Allocate time for your presentation and self-introduction, the first cornerstone of building trust. Don’t come alone. Bring a team member, consultant, or an unbiased person proficient in TT. Here is the agenda I prepared for the TT from UCLA lab.
Visit:
Goal: Build trust and rewrite the strategy and development plan based on the tech transfer.
Now that the visit agenda is ready, get super prepared and navigate the schedule professionally while applying the following pillars: Documentation and organization, transparency, and trust.
Building trust with power skills: Respect the work done, the findings, and the efforts behind them. Come humbly, ask questions, listen, and remember that this interaction is for the long-term, and relationship building is essential. Avoid “educating” the lab members. Process what can be done and what can’t, and to what extent.
It is essential to list the responsibilities of each party and prepare an agenda for the visit in advance. Talk with those who practically did the work. Ask for every detail.
Communicate mainly about what didn’t work since this precious knowledge is hidden and can save you time and effort in your development endeavors.
Document every piece of data that needs to be sorted out further. Create a “live” document of the topics covered, gaps, and things to fill.
Zoom out and re-evaluate your development plan, strategy, and milestones. If major gaps are found–rewrite the strategy and development plan, find creative solutions, and adapt the budget plan for needed tasks. Prepare a summary document or presentation and communicate it with the Board of Directors.
You are ready to go!
Goal: joined collaboration for fruitful processes–take proactive actions to keep the interaction alive:
In summary, successful technology transfer requires thorough preparation, a respectful attitude, critical thinking, and humility. By evaluating gaps, raising questions, and building trust through transparency and effective communication, founders can bridge the gap between academia and industry. The key is maintaining an ongoing relationship, sharing insights, considering collaborative opportunities, and remembering that both parties aim to advance drug, therapy, or product development.
Dorit Cohen Carmon is a proficient biotech leader experienced in establishing and managing companies in various therapeutic areas. She brings Strategic vision, planning, and execution for integrating R&D, legal, and BD aspects. She received her Ph.D. from WIS and was awarded a Teva Post-Doctorate fellowship. Dorit's motivation is to translate scientific technologies into therapies and connect people for value creation.
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Technology transfer companies play a crucial role in translating groundbreaking research into practical solutions that benefit society. They serve as bridges between academia and industry, facilitating the transformation of theoretical discoveries into marketable products and services.
Ramot, established in 1973a subsidiary of Tel Aviv University Ltd. is the Tech-Transfer company of Tel Aviv University, responsible for commercializing the inventions and patents of the university’s researchers. It manages all the university’s commercialization activities, from protecting the intellectual property of researchers’ inventions to licensing them to relevant industrial entities. The company fosters and creates new business opportunities at the university, such as establishing startups, licensing technology to existing companies – both Israeli and multinational – and creating collaborations with these entities.
Since its inception, Ramot has filed over 5,000 patent applications and maintains a portfolio of approximately 1,600 patent applications and patents. Ramot signs dozens of commercial agreements each year and is involved in the establishment of approximately 100 startups.
Startup establishment is a central strategy employed by Ramot to promote technologies. When a technology requires further development, Ramot facilitates fundraising, identifies suitable entrepreneurs, and collaborates with venture capital funds, incubators, and other organizations that support entrepreneurs. This collaboration equips entrepreneurs with the tools and support they need for startup success. For instance, Ramot has successfully nurtured two notable startups:
Alpha Tau: Established in 2015, based on the technology of Prof. Yona Keisari and Prof. Itzhak Kelson. Alpha Tau is a clinical-stage oncology company developing a novel radiotherapy technology for treating solid tumors. The company’s technology aims to address the limitations of conventional radiation therapy by minimizing side effects and improving treatment efficacy. In 2022, Alpha Tau merged with SPAC at a valuation of approximately $1 billion and began trading on the Nasdaq. The company recently conducted its first clinical trial in prostate cancer patients.
Imagindairy: Founded in 2020, Imagindairy is a biotechnology company based on Prof. Tamir Tuller’s technology. It is developing a sustainable and scalable process for producing cultivated dairy products using precision fermentation. Leveraging artificial intelligence and systems biology, Imagindairy’s technology utilizes microorganisms to create milk proteins identical to those found in cow’s milk. As of 2022, the company has raised approximately $28 million in funding.
At the heart of Ramot’s success in nurturing tech transfer startups lies its close collaboration with researchers. Ramot actively engages with researchers throughout the innovation cycle, from ideation to commercialization. This deep understanding of the research landscape and the challenges faced by researchers enables Ramot to identify promising technologies with commercial potential and provide tailored support to transform them into viable startups.
The company’s collaborative approach extends to identifying and attracting talented entrepreneurs. Ramot works closely with researchers to identify individuals with the technical expertise, business acumen, and leadership skills necessary to successfully lead tech transfer startups. By fostering strong relationships with both researchers and entrepreneurs, Ramot creates an environment conducive to innovation and startup growth.
To navigate the ever-changing technological landscape, Ramot adopts innovative strategies. It allocates resources to identify emerging technological trends and participates in international conferences and events. These activities enable Ramot to recognize new opportunities for technology transfer and establish international partnerships.
In conclusion, Ramot plays a pivotal role in commercializing groundbreaking research from Tel Aviv University. By supporting researchers, establishing startups, collaborating with venture funds, incubators, accelerators, and entrepreneurs, and fostering a culture of close collaboration with researchers, Ramot contributes to Israel’s economy and enhances our lives through novel technologies.
You can find more information on the Ramot: www.ramot.org
Dr. Tali Aloya is a seasoned Life science executive with over 20 years of experience, including roles as CEO of BioRap Technologies and IP director at High Jump Pharma. She currently leads the Life Sciences Business Development at Ramot, Tel Aviv University, and holds a PhD in Biological Chemistry from The Hebrew University of Jerusalem
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In the ever-evolving field of healthcare, bringing a new idea to fruition involves a meticulous understanding of the market need. Whether it’s a new drug, a revolutionary medical device, a healthcare app, or a unique service model, the success of such innovation hinges on its relevance and demand within the healthcare market. Here’s a structured approach for assessing the market need for a new idea in healthcare:
Begin by clearly defining the value of your healthcare innovation:
If your idea can be used to treat several conditions, choose the one that is of utmost need. Establish clear objectives for the design of your idea, based on the defined unmet needs.
Healthcare market research is a systematic process that involves ongoing collection, analysis, and interpretation of data related to the healthcare industry. It helps in understanding market dynamics, consumer behavior, and competitive landscape. Remember, since it takes a long time to reach the market, market research should be updated regularly.
Understanding the size and growth rate of the healthcare market, including specific segments relevant to your idea, is crucial. It is also important to learn how the market is structured: who are the critical players, who controls what segment (including HMOs, government, etc.).This analysis helps identify the potential and scalability of your innovation.
Gaining insights into consumer behavior, preferences, and needs is essential. This involves collecting data on patient demographics, healthcare personnel approach to the idea, healthcare utilization patterns, to assist in the development of patient-centric solutions.
Search for competitor or existing solutions, even if they are not similar. Assessing your competitors’ products, pricing, distribution channels, and marketing strategies provides a benchmark and helps you plan your offering effectively in the market.
Healthcare is heavily regulated. Staying informed about regulatory changes and ensuring compliance is vital when developing and introducing new healthcare products or services. Follow the regulatory agencies of the markets you wish to reach regularly. Learn about their approval of products for the same intended uses.
Before a full-scale launch, testing your idea through pilot studies or focus groups can provide valuable feedback on market acceptance and potential areas for improvement. Clinical trials are compulsory for some products, like drugs and high-risk medical devices. Some products can get approval without clinical trials, but marketing and commercializing will almost always require them in healthcare. Learn the process and seek expert advice.
Assess the feasibility of entering new markets or expanding operations. This includes understanding local healthcare systems, reimbursement mechanisms, and customer preferences.
Conclusion
Assessing the market need for a new healthcare idea is a complex but critical process. It requires a deep dive into market research, consumer understanding, and competitive analysis. By following these steps, healthcare innovators can significantly increase the chances of their idea’s success in the market.
Dr. Michal (Micki) Roll is an experienced healthcare and business development professional. She holds an MBA, PhD in Medical Sciences (Pharmacology) with a Post Doctorate in Neurobiology and training in IP protection.
Micki was the Deputy Director General of R&D at Tel Aviv Medical Center (TASMC) and CEO of its tech. transfer R&D co. She had previously served as the Director of the Research Department of Hadassah Medical Organization.
Micki is co- director of the MSc program: “Therapeutics development and Regulatory Science” the Faculty of Medical & Health Sciences, Tel Aviv University and consultant to the Ministry of Health
Micki is a member of the 8400 health network.
michalroll@gmail.com +972-524266006
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There are many considerations to account for, both prior to and during the development of any new healthcare solution or innovation. Proactive steps such as performing market research, assessing competitors, and developing a strategy to comply with country-specific regulatory requirements are very important and well-established. If the strategic plans for your offering include making your innovation available in the United States market, it is critical to assess and define a cohesive and complementary market access strategy to maximize your chances of successful market entry and adoption.
The US healthcare system continues to undergo rapid transformation. The number of impactful innovations coming to market continues to grow at an accelerated pace. Competition is fierce, raising capital is challenging, and those who don’t account for market access considerations early in the development process are more likely to struggle. US market access can be defined as the intersection three score, interdependent categories:
Is there (what is) a viable reimbursement pathway to payment for your solutions from Medicare and private health insurance plans? Is there a code I will need for payment from insurers? Will I need a new code, or can I use an existing code? What are the requirements to obtain a new code? What is the value (clinical, economic, quality of life improvements) your solution can bring to patients, physicians, and insurance companies in the US versus competitors and/or standard care? How does your innovation improve patient outcomes, change physician treatment protocol? Is your solution cost-effective? What is the budget impact on payers? (How) does it improve patient experience? Which payers should you target? What do payer Medical Directors think are the most important areas for which to define and illustrate value for your specific innovation? What is your evidence and publication strategy to illustrate this value to various stake holders in the US healthcare ecosystem? Can you (how can you) incorporate various endpoints into your clinical trial design? What other studies will you need? What other tools will be necessary to show value? How will you price and justify the pricing for your solution in the US?
Whether your innovation is a diagnostic test, medical device, digital platform, SaaS or a therapeutic, assessing and establishing market access pathways early in the development process, combined with thorough market research and a well-defined regulatory approach (when applicable) will maximize the opportunity to drive successful market entry and adoption for your innovation. The author is a visionary market access leader with extensive experience in health technology reimbursement, value creation, and payer access.
The author is a visionary market access leader with extensive experience in health technology reimbursement, value creation, and payer access. Darron, who recently emigrated to Israel, is co-founder and managing partner of Dream Big Health. www.dreambighealth.org
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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.
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.
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.
TWINNOVATION - a consultancy specializing in non-dilutive funding for startup companies and research grants, with extensive experience in securing grants from the European Union, building consortia, and project management
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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.
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.
The success of a technology transfer process depends heavily on the communication, transparency, and goodwill of both the SU and the RU.
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.
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:
With over 35 years in biopharmaceutics and biotechnology, Ms. Zaibel has led an impressive number of multidisciplinary projects, supports startups globally, and has secured FDA and EMA approvals for recombinant proteins, vaccines, and medical devices. In 2019-2020, Ms. Zaibel joined the Weizmann Institute of Science SPARK project as a mentor and also became a member of the advisory board and lecturer for a new Master's degree in Regulatory and Drug Development at TAU. In 2022, the ADRES team led by Ms. Zaibel joined the BIODESIGN ISRAEL Rambam healthcare campus program as mentors. In 2023, Rivka was accepted as a mentor by EIT Health.
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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.
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.
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.
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.
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.
www.scinai.com
Mr. Elad Mark served as Scinai Head of CDMO and COO, He is an executive leader and principal process engineer with over 15 consecutive years of biotechnology industry experience Including various technology transfer and scale up of biological product, green field facilities and aseptic processes design including cGMP manufacturing. Prior to joining Scinai, Mr. Mark led a technology transfer for Novartis’s $800 million investment in a biologics facility in Singapore, designed to support both clinical and commercial production of potential new products that include monoclonal antibodies
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