The biopharma community met at Munich in Germany for BIO-Europe 2023, where attendees from across the world took part in networking events to foster collaboration, last month. With a turnout of nearly 6000 participants and more than 150 exhibitors, the event hosted a number of panel discussions.
In collaboration with our parent company, life science technology solutions provider Inpart, here are the highlights from BIO-Europe 2023.
Table of contents
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The impact of R&D pipelines on pharma deal making priorities
In the fast-paced and ever-evolving world of pharmaceuticals, the need to generate a return on investment for medicines is crucial. As blockbuster drugs lose market exclusivity, pharma companies face the challenge of replacing lost revenues to sustain themselves and drive growth. While some companies develop new medicines in-house, an increasing number of top-tier pharma companies are sourcing their products from external partners. This trend highlights the importance of understanding how R&D pipelines influence deal making priorities and the freedom to explore new areas beyond traditional franchises.
During Bio-Europe 2023, John Copeland, head of Commercial BD&L at MSD International, emphasizes the importance of following innovation across the complete spectrum. Merck’s focus extends from early-stage ventures to late-stage assets. With approximately 80 transactions in 2022, Merck remains committed to exploring partnerships in various therapeutic areas, including oncology, immunology, and more.
Nisha Nanda, Group Vice President of Business Development at Eli Lilly & Company, highlights Lilly’s engagement with the biotech ecosystem. Their venture funds, incubators, and services provide avenues to explore new science outside their current focus areas. Lilly’s approach is therapeutic area agnostic, with a focus on platforms and new science that may contribute to their future endeavors.
Vincent Ruland, head of R&D Strategy, Portfolio, and Operations at Bayer Pharmaceuticals, takes an internal perspective on portfolio decision-making. While augmenting in-market assets may be a short-term priority, Bayer also seeks breakthrough opportunities beyond specific therapeutic areas. Striking a balance between depth and breadth is key for Bayer, as they aim to create strategic synergies while avoiding spreading themselves too thin.
Natalie Ter Wengel, a leader in Pfizer’s business development team, sheds light on Pfizer’s five core areas of focus: oncology, vaccines, immunology and inflammation, internal medicine, and anti-infectives. Pfizer’s partnering opportunities span various stages, from early investments to traditional licensing deals and service agreements. Their decision-making is primarily driven by their pipeline needs and the continuous evaluation of commercial assets.
In the dynamic landscape of pharmaceuticals, R&D pipelines play a pivotal role in dictating deal making priorities. While companies like Merck, Lilly, Bayer, and Pfizer have their specific approaches, they all share a common goal of finding strategic partnerships that align with their pipeline needs and drive future growth. The ability to balance their current assets and explore new therapeutic areas is vital for sustained success in an ever-evolving industry. As the pharma landscape continues to evolve, it will be intriguing to see how these companies adapt their deal making strategies to stay at the forefront of innovation and deliver transformative medicines to patients worldwide.
The impact of AI on drug discovery and development
AI is revolutionizing the pharmaceutical industry, particularly in the areas of drug discovery and development. The integration of AI technologies has brought about significant advancements, leading to more efficient and innovative approaches in the pharmaceutical sector. In the context of this increasing influence of AI, it becomes important to understand the current landscape, its potential for future advancements, and the impact on different parts of the industry.
The application of AI in drug discovery has significantly accelerated the process of identifying potential drug targets and developing new compounds. AI algorithms and machine learning techniques have enabled biopharmaceutical companies to analyze complex biological and chemical data, leading to the identification of novel drug targets and the design of optimized drug candidates. This has resulted in the development of promising clinical stage assets, demonstrating the effectiveness of AI in driving innovation in drug discovery.
In the realm of clinical development, AI has played a crucial role in enhancing patient stratification, predicting treatment responses, and optimizing clinical trial operations. By leveraging AI-based algorithms and real-world data, pharmaceutical companies can identify specific patient populations, streamline trial recruitment, and improve the overall efficiency of clinical trials. The use of AI in risk stratification and trial operations has led to improved patient outcomes, reduced trial failure rates, and accelerated the development of new medicines.
Moreover, AI has paved the way for the emergence of precision medicine, where AI-driven diagnostic tools and predictive modeling enable personalized treatment approaches. The integration of AI in clinical decision-making has led to early disease detection, accurate patient stratification, and the identification of optimal treatment regimens. This has not only improved patient care but also revolutionized the traditional approach to clinical trial design and patient management.
In the context of business development and partnerships, the pharmaceutical industry has witnessed a surge in collaborations with AI companies. These strategic partnerships have enabled pharmaceutical companies to gain access to advanced AI technologies, expertise, and innovative solutions for drug discovery, development, and commercialization. The partnerships have facilitated the integration of AI capabilities into existing drug discovery pipelines, driving advancements in target identification, lead optimization, and clinical validation.
The regulatory landscape has evolved to accommodate the growing influence of AI in pharmaceutical research and development. Regulatory agencies have issued guidance and frameworks for the use of AI in drug discovery and development, providing a roadmap for the adoption of AI technologies while ensuring compliance with regulatory standards. The collaboration between pharmaceutical companies and regulatory bodies has been instrumental in shaping the regulatory approach to AI integration, fostering a supportive environment for innovation and technological advancements.
Looking ahead, the future of AI in drug discovery and development holds immense potential for further advancements. The continued integration of AI technologies and the convergence of data-driven approaches are expected to drive transformative changes in the pharmaceutical industry. As AI continues to evolve, it will play a pivotal role in accelerating the development of new medicines, optimizing clinical outcomes, and shaping the future of precision medicine.
Overall, then, the integration of AI in drug discovery and development has revolutionized the pharmaceutical industry, driving innovation, efficiency, and personalized approaches to patient care. The strategic partnerships, regulatory support, and technological advancements in AI have positioned the industry for a future that embraces data-driven solutions and transformative advancements in drug development.
As the pharmaceutical sector continues to embrace AI technologies, it is poised to unlock new opportunities and address critical healthcare challenges, ultimately leading to improved patient outcomes and the development of groundbreaking therapies.
The evolving role of data in rare disease and personalized medicine
In the ever-evolving field of rare disease and personalized medicine, the role of data has become increasingly pivotal. The utilization of data has become essential in enabling better diagnosis, treatment, and care for individuals with rare conditions. This has led to discussions on key questions that still need to be answered, such as data accessibility, ethical considerations, biomarker use, and how to move forward to maximize the potential of data in this field.
During Bio-Europe 2023, experts from various domains have contributed valuable insights on the importance of data in rare disease and personalized medicine. Christopher Klein, director of the Care-for-Rare Foundation, emphasized the significance of genomic data in understanding rare diseases, highlighting the potential of children with rare diseases as pioneers of precision medicine. Eric Mertz, SVP and Head of International Business Development at Centogene, stressed the role of AI and machine learning in leveraging the full potential of rare disease data, citing the use of synthetic data to amplify statistical significance in small patient cohorts. Lori Badura, head of Global Partnering Rare Disease and Neuroscience at Ipsen, emphasized the need to look beyond genomics and consider other markers such as epigenetics, especially in the context of the heterogeneity and difficulty in diagnosing rare diseases.
The panelists discussed the challenges and opportunities in data quality, accuracy, and completeness when dealing with rare diseases. Eric highlighted the heterogeneity of existing data and the importance of embracing the FAIR (Findable, Accessible, Interoperable, and Reusable) data principles. Klein pointed out the challenge of data silos and emphasized the need for sharing data to expedite the discovery of cures for rare diseases. Badura highlighted the importance of collaboration in developing large databases that can aid in understanding diseases and identifying potential biomarkers.
Patient privacy and ethical concerns were also addressed, with emphasis on the need to balance data sharing with patient privacy. The stringent regulatory rules, such as General Data Protection Regulation (GDPR), and the importance of anonymizing data were discussed as essential factors in ensuring ethical data handling. In the context of clinical trials, the panelists discussed the potential of data-driven approaches in optimizing trial protocols, patient stratification, and endpoint selection. The discussion focused on leveraging AI to understand disease progression, monitor treatment response, and identify biomarkers for patient selection. The economic implications of data-driven approaches were also highlighted, with a focus on the cost-effectiveness of leveraging existing data for market access and commercial purposes. It was emphasized that the economic impact of AI in rare diseases goes beyond monetary considerations and encompasses fairness, equity, and hope for patients.
Throughout the panel, the experts highlighted the golden opportunity presented by the current momentum in rare disease and personalized medicine. The positive shift in mentality, the willingness to collaborate, and the potential of AI as a tool for understanding disease markers and indicators were underscored. Education and communication with patient groups and families are crucial in demystifying AI and its role in advancing rare disease and personalized medicine. The evolving role of data in rare disease and personalized medicine presents a transformative opportunity to revolutionize the diagnosis, treatment, and care of individuals with rare conditions. The insights shared by the panelists underscore the potential of data-driven approaches, the importance of collaboration, and the need for ethical, patient-centric handling of data in this critical field.
Navigating the changing landscape of pharmaceutical deal making
The pharmaceutical industry is currently witnessing a period of significant transformation, particularly in the realm of deal making. The financial markets have been challenging, causing a shift in the dynamics of funding and investment. This has led to a re-evaluation of strategies and a focus on innovative approaches to drive growth and success in the industry.
One of the key trends impacting pharmaceutical deal making is the availability of funding. While there is money in the market, it is tightly controlled and the pressure to deploy it is increasing. Venture capitalists and other funders are seeking opportunities to invest, but they are being more cautious and selective in their choices. This has created a challenging environment for companies seeking funding for their programs and initiatives.
Another significant force driving change in deal making is the market access and pricing environment. There is a growing emphasis on delivering innovative solutions that address unmet medical needs and provide significant value to patients and healthcare systems. This shift has prompted pharmaceutical companies to focus on first-in-class innovation and breakthrough designations to unlock the potential for rapid approval and successful clinical development.
Furthermore, the public markets have also played a crucial role in shaping the landscape of pharmaceutical deal making. The volatility and uncertainty in the markets have impacted the availability of liquidity events for venture capitalists. This in turn has led to a reevaluation of the types of deals being pursued, with a focus on smaller, mid-sized M&A transactions and partnerships that provide the right funding and support for innovative programs.
In response to these challenges, pharmaceutical companies are redefining their deal structures and investment strategies. There is a growing emphasis on equity investments in early-stage companies, strategic alliances, and diverse deal structures that allow for risk-sharing and long-term partnerships. These approaches aim to leverage the expertise and resources of both parties to drive successful clinical development and commercialization of innovative programs.
Amidst these pressures and challenges, the pharmaceutical industry continues to demonstrate resilience and adaptability. Companies are committed to overcoming these obstacles by fostering a culture of innovation, collaboration, and strategic decision-making. The industry is optimistic about the potential for continued success, driven by a shared vision to prioritize patient impact and deliver groundbreaking solutions to address critical healthcare needs. By embracing innovation, strategic partnerships, and a focus on value-driven solutions, the industry is poised to navigate these changes and drive sustainable growth and success in the evolving pharmaceutical landscape.
Exploring trends and collaborations in the biotech industry
The biotech industry continues to be a hotbed of innovation and investment, with a diverse range of players contributing to its vibrancy. In this Bio-Europe 2023 panel discussion, industry leaders shared insights into their strategies, collaborations, and the emerging trends in the biotech landscape. The conversation highlighted the critical role of partnerships, the impact of regional dynamics, and the focus on precision and innovation in therapeutic development.
One of the key takeaways from the discussion during this Bio-Europe 2023 congress was the emphasis on collaboration and the convergence of different expertise to support biotech companies in their growth and development. The panelists emphasized the importance of coming together to assist biotech partners, especially in the current challenging funding environment. They underscored the need for a collective effort to ensure that companies are working towards the right value inflection points and delivering the right data to attract investment and drive future success.
While European companies are increasingly gaining attention for their focus on efficient trial designs and quick data evaluation, the presence of transatlantic companies is a testament to the interconnectedness of the industry. The role of establishing bridges to facilitate access to funding and investor networks, particularly in the U.S., emerged as a critical aspect of fostering growth for European companies.
The discussion also shed light on the evolving trends in therapeutic development, with a particular focus on specific therapeutic areas that are driving significant interest and investment. The emergence of anti-inflammatory treatments, innovative approaches in oncology and advances in precision oncology, and the rise of radiopharmaceuticals were cited as areas of high interest and potential growth. Additionally, the increasing focus on precision and targeted therapies, such as gene editing and gene therapy, highlighted the industry’s dedication to advancing novel modalities for addressing complex diseases.
The panelists at this Bio–Europe 2023 session also shared success stories and examples of strategic collaborations that have led to breakthroughs in therapeutic development. These stories highlighted the impact of strategic partnerships in enabling the development of novel treatments, leveraging expertise across different domains, and driving innovations that have the potential to transform patient care.
The panelists emphasized the need for early engagement and collaboration to support companies in designing efficacious trials, patient selection, and budgeting, crucial elements that significantly impact the success of biotech ventures. The shared experiences and success stories underscored the critical role of strategic partnerships in driving innovation and supporting the growth of biotech companies. As the industry continues to evolve, the focus on precision, innovation, and global collaborations will remain pivotal in shaping the future of biotech.
Understanding the challenges and opportunities of European HTA harmonization
The European healthcare landscape has long been characterized by its complexity, particularly in the realm of health technology assessment (HTA) and reimbursement. The recent introduction of legislation aimed at harmonizing the HTA process across Europe has sparked both hope and skepticism within the pharmaceutical and biotech industry.
One of the fundamental goals of European HTA harmonization is to streamline the process of market access for pharmaceutical and biotech products. Previously, companies seeking to commercialize their products in Europe faced the daunting task of navigating individual member states’ pricing, reimbursement, and HTA requirements. This resulted in a fragmented and labor-intensive process, with the same data being analyzed in varying ways across different member states. The new legislation sets out a phased approach, with the harmonization of HTA procedures slated to take effect over several years, starting with ATMP and oncology drugs in 2025, followed by orphans in 2028, and all other centralized drugs in 2030. The envisioned process involves the submission of HTA data centrally to the EU, alongside a joint clinical assessment, which will inform member states’ pricing and reimbursement decisions.
However, despite the potential benefits of harmonization, industry experts have raised concerns about the practical implications of the new legislation. One key challenge lies in the duplication of efforts, as companies are still required to comply with both European and national HTA requirements, leading to additional resource demands and complexities in trial planning and data generation.
For emerging biotech firms, the European HTA harmonization poses a particularly daunting task, as they usually lack the resources and infrastructure of larger pharmaceutical companies. The new process demands early involvement in trial planning and close collaboration across regulatory, clinical development, and market access functions, placing a significant strain on internal resources.
Moreover, uncertainties around the availability of advisory mechanisms and the binding nature of HTA advice have compounded the challenges faced by industry stakeholders. The limited availability of slots for joint scientific consultations and the non-binding nature of the advice further exacerbate the complexities of navigating the harmonized HTA process.
Overall, while the European HTA harmonization holds promise for simplifying market access and fostering broader patient access, it also presents formidable challenges for industry stakeholders. The need for early and proactive engagement, resource optimization, and adaptation to evolving regulatory landscapes will be paramount in navigating the complexities of European HTA harmonization. As the industry prepares for the phased implementation of the legislation, collaborative efforts and ongoing dialogue with regulatory authorities will be crucial in ensuring a smooth transition and maximizing the potential benefits of harmonization.
The future of the biotech industry in Japan
The biotech industry in Japan is currently undergoing a significant transformation, driven by a new government strategy to accelerate growth and innovation in this sector. In this Bio-Europe 2023 panel session, Kozo Saiki, director general of the Japan Machinery Center for Trade and Investment, presented the government policies aimed at promoting startups and prioritizing biotech as a critical technology area for economic growth. With a budget of over 8 billion euros allocated for promoting the industry, Japan is making a bold commitment to fostering innovation and collaboration in the biotech sector.
One of the key focus areas of the Japanese government’s strategy is the support and promotion of pharmaceutical biotech startups. Saiki highlighted the challenges in the Japanese ecosystem, such as the limited availability of venture capital for investment in the preclinical and clinical testing stages. To address this issue, the government has launched a project with more than 2 billion euros to incentivize collaboration with venture capitalists. Through this initiative, the government aims to encourage more investment in pharmaceutical startups and facilitate their global market expansion.
At the same time, Japan is actively working to strengthen its capabilities in cell and gene therapy. Reina Kodera, deputy director at the Ministry of Economy, Trade, and Industry, emphasized the government’s efforts to enhance drug discovery functions, develop manufacturing technology, and support reverse translational research in cell and gene therapy. With substantial subsidies totaling about $2.3 billion, Japan is encouraging capital investment by CMOs, CDMOs, and departmental material manufacturers to advance these cutting-edge technologies within the country.
In addition to government initiatives, Japanese biotech startups are also making significant strides in innovation and drug discovery. For example, Cognano, a hybrid biotech and IT company, is leveraging AI and big data to revolutionize immune monitoring systems and drug discovery for untreated cancers. Another notable company, Molcure, is pioneering AI-driven drug discovery, partnering with pharmaceutical companies to find new drugs, especially in the field of antibodies and peptides. Their success in finding high-affinity antibodies and designing new antibodies using generative AI demonstrates the immense potential of AI in biotech innovation. Moreover, Japan is at the forefront of allogeneic cell therapy with companies like Rebirthel leading the way in developing off-the-shelf universal T cell therapy. Their patented technologies and focus on expanding global collaborations and partnerships position them as key players in the evolving landscape of cell therapy.
Overall, the panelists at this Bio-Europe 2023 session agreed that the biotech industry in Japan seems poised for significant growth and innovation, fueled by government support, technological advancements, and the pioneering efforts of biotech startups. Japan is paving the way for transformative developments in the global biotech landscape and, as the industry continues to evolve, partnerships and collaborations with Japanese biotech startups offer promising opportunities for international stakeholders to engage in the burgeoning biotech ecosystem of Japan.
Navigating open innovation: strategies for successful partnering
In today’s rapidly evolving landscape of innovation, the importance of strategic partnering cannot be overstated. As organizations seek to leverage external expertise, resources, and technologies, establishing successful partnerships has become a critical factor in driving innovation and advancing scientific endeavors.
The process of navigating open innovation begins with a clear understanding of the challenges and opportunities inherent in building partnerships. As experts in the field warn, it is essential to acknowledge the asymmetry between companies, particularly when small biotech firms engage with large pharma companies. The complexities of large organizations, including diverse responsibilities, accountabilities, and decision-making processes, can create challenges for smaller entities. Understanding this asymmetry and proactively managing the cadence and expectations of interactions is crucial for successful collaboration.
In the context of open innovation, the timing of partnership discussions remains important. While it is generally advisable to initiate discussions early in the process, it is essential for smaller organizations to assess the readiness of their assets and technologies before engaging with potential partners. Early engagement should be focused on establishing a common understanding of the science, articulating the potential impact, and finding the right sponsor within the larger organization. By aligning the timing of discussions with the stage of the opportunity and the needs of the partnering organization, smaller entities can enhance the effectiveness of their engagement strategies.
Soft skills play a pivotal role in influencing initial discussions and accelerating the path of partnering. The ability to communicate a compelling story, demonstrate transparency, and actively listen to the needs and feedback of potential partners are critical soft skills for successful engagement. Establishing a common vocabulary and understanding the context of academic partners’ priorities are also vital for fostering effective collaborations with academia.
In the realm of open innovation, it is also important to recognize that a “no” does not necessarily equate to a definitive rejection. Rather, it may signify a temporary pause, a need for additional data, or a shift in organizational priorities. Maintaining frequent and meaningful reconnections, based on substantive progress and data-driven insights, can help overcome initial setbacks and rekindle interest in potential partnerships.
Looking ahead, the future trends in open innovation point towards an increased focus on smaller initial collaborations, derisking deals, and the integration of data sciences, digital platforms, and advanced therapies. The evolving landscape presents opportunities for organizations to leverage strategic partnerships as a means to access complementary expertise and technologies, thereby accelerating innovation and driving scientific advancements. By embracing strategic engagement, effective communication, and proactive relationship management, experts in the field can position themselves for success in the dynamic landscape of open innovation.
The current landscape of biotech deal making
The biotech industry is constantly evolving, presenting new challenges and opportunities for companies, investors, and dealmakers. In recent times, the industry has witnessed significant shifts in the way deals are structured, the focus on innovation, and the impact of external factors such as market conditions and funding availability. As players navigate this dynamic landscape, it is crucial they understand the current trends, anticipate future developments, and adapt strategies accordingly.
A key dealmaking trend remains the delicate balance between an emphasis on innovation and the need to de-risk investments. While innovation remains crucial for value creation, there is also a growing focus on de-risked opportunities. Companies and investors are seeking assets with strong potential for near-term commercialization and clear paths to market. This shift reflects a more cautious approach to risk management and a desire for shorter timelines to value realization.
The process of structuring biotech deals has become more intricate, particularly in the context of evaluating platforms versus assets. While platforms offer the potential for multiple product developments, the focus on specific assets and their potential for commercial success has led to a reassessment of deal structuring strategies. This has necessitated a deeper understanding of the strategic fit of platforms and assets within the broader industry landscape, as well as a more nuanced approach to evaluating and prioritizing opportunities.
The biotech market as a whole has experienced fluctuations, impacting deal making and funding availability. The recent market volatility has led to a reevaluation of investment strategies, with a focus on fiscal responsibility and capital conservation. As companies seek funding and investors assess opportunities, the need for strategic alignment and risk mitigation has become paramount. This requires a careful analysis of market conditions, regulatory dynamics, and the competitive landscape to ensure effective decision-making in a volatile environment.
This evolving nature of biotech deal making has also influenced deal timelines and expectations. The pressure to expedite deals, coupled with the complexities of due diligence and negotiation, has presented challenges for both parties involved in the deal. Dealmakers are striving to strike a balance between speed and thoroughness, recognizing the need for efficient processes without compromising the integrity of the transactions. Establishing clear communication and managing expectations are critical in mitigating challenges related to deal timelines.
The biotech deal making landscape is undergoing a period of transformation, characterized by a shift in focus, challenges in deal structuring, market volatility, and evolving deal timelines. As industry experts and stakeholders, it is imperative to stay abreast of these developments, anticipate future trends, and adapt strategies to align with the changing dynamics. By leveraging insights and foresight, the biotech industry can navigate through these challenges and capitalize on emerging opportunities, driving continued innovation and value creation in the years to come.
Maximizing value through pharma-startup partnerships
In the rapidly evolving landscape of pharmaceuticals and biotech, the potential for successful collaborations between pharma companies and startups has become increasingly clear. Such partnerships have the potential to drive innovation, bring new therapies to market, and ultimately benefit patients. However, navigating these partnerships requires a delicate balance of aligning interests, managing differences, and fostering a collaborative mindset.
One of the key considerations in forming successful partnerships between pharma companies and startups is the careful selection of assets to be offered for partnering. Startups must decide early on which assets to offer for partnering and which to develop internally. Additionally, determining the stage at which to initiate partnering discussions is crucial. While inbound interest from pharma companies is ideal, startups must also be prepared to proactively seek out partnerships when the time is right.
Moreover, commitment is essential from both the startup and the pharma company in order to foster a successful partnership. This includes a commitment to the asset, its development, and the resources required to drive the collaboration forward. Furthermore, maintaining open communication, building trust, and aligning on shared goals are critical components for a successful partnership.
When it comes to structuring deals, it is important that startups are realistic about the business case and the potential outcomes. While milestones and licensing deals may offer valuable incentives, it is essential to carefully evaluate and negotiate these terms to ensure that they align with the long-term objectives of the partnership. It is important to minimize the collaboration tax – the increased efforts and resources required for effective collaboration – while maximizing the value creation from the partnership.
In a rapidly evolving industry, the timing of engaging in partnerships with pharma companies is a final and crucial consideration for startups. While partnering earlier may present opportunities to secure funding and drive innovation, it is also essential to preserve the nimbleness and entrepreneurial spirit of the startup. Additionally, maintaining a clear understanding of what is being offered, and effectively managing differences and expectations is vital for the success of the partnership.
Partnering 2030: The Biotech Perspective 2023