Flagship @ BIO 2025

After many years of research, AI-supported molecules have started entering clinical trials and the 2024 Nobel Prize in Chemistry recognized the impact of computational biology on reenvisioning the drug discovery process.  This opening session will discuss where AI applications are already showing the most utility in biopharma development and how executives should prepare for the next wave of applications for better developing therapies and cures for patients.

Speakers:
Molly Gibson, Origination Partner, Flagship Pioneering

Luba Greenwood, Executive in Residence, PureTech Health; Chief Executive Officer, Gallop Oncology

Iya Khalil, Vice President and Head of Data, A.I. & Genome Sciences, Merck

Mary Rozenman, CFO/CBO, insitro

Moderator: Ricardo Vilanova, Partner, AI and Intelligent Automation, Ernst & Young 

The COVID-19 pandemic taught us many lessons, but we have yet to fully implement our collective learnings. As the virus hit, vaccines were developed at speed, yet societies across the world still lacked therapeutic tools that could be rapidly and sustainably scaled at a global level. Small molecule antivirals are essential in order to beat the next pandemic, reducing morbidity and mortality and slowing the development and transmission of new variants escaping vaccines and neutralizing antibodies. In support of the G7’s recommended 100 Days Mission and the International Pandemic Preparedness Secretariat (IPPS), the INTREPID Alliance this year began publishing quarterly global landscape assessments of antiviral compound R&D. These reports seek to aid in the identification of clinical (e.g., Phase 2/3 ready) and preclinical antivirals aligned with the 100 Days Mission and highlight gaps in the pipeline, to support the goal of developing at least two ‘Phase 2 ready’ therapeutic candidates against the identified viral pathogen families of greatest pandemic potential. In this session we seek to bring together voices from across the global public and private R&D and funding ecosystem to identify the barriers to success. What can be done from within the biotech ecosystem today, to ensure that we aren’t left unprepared to treat the next pandemic tomorrow.

Speakers:
Raj Panjabi, Senior Partner, Flagship Pioneering

Ruxandra Draghia-Akli, Executive Vice President and Head of R&D, Novavax; Chair, Scientific Advisory Board, INTREPID Alliance

Dawn O'Connell, Former Asst. Secretary for Preparedness and Response (ASPR), U.S. Department of Health and Human Services

John Pottage, Lead Scientific Consultant, INTREPID Alliance

Bryan Shuy, Former Chief of Staff to House Appropriations Agriculture & FDA Subcommittee Chairman, Former Deputy Assistant Secretary and Chief of Staff to the Assistant Secretary for Preparedness and Response ; Senior Vice President, The Conafay Group

Moderator: Susan Dentzer, President and CEO, America’s Physician Group

siRNA, mRNA, pick-your-favorite-RNA, CRISPR, ADCs, PROTACs, molecular glues, precision-meds, CAR-T, epigenetic and allosteric modulators, AI/ML-everything, tissue-selective nanoparticles, AAV delivery systems, etc. These are all novel drug or delivery modalities with potential to significantly impact patients’ lives and global health (some have already succeeded), but with various degrees of “validation,” whether preclinically, clinically, or commercially.

Join this panel for an exciting conversation with a panel of biotech entrepreneurs, business development and R&D industry leaders as they explore topics around platform build, modality value drivers, what does modality “validation” mean to pharma, how do patients in need of innovative medicines factor in, what’s partnerable and what’s not, what is the desired data package to catalyze partnering discussions, macro considerations that impact deal terms and process, and when should pharma take a leap-of-faith decision to partner early/pre-validation vs. wait for key in vivo data.

Speakers:
Svetlana Lucas, Chief Business Officer, Scribe Therapeutics

Barbara Lueckel, Global Health of Research Technologies, Roche

Michael Palladinetti, Global Head of Business Development and Licensing, Sanofi

Caroline Stark Beer, former Chief Business Officer, Jnana Therapeutics

Moderator: Amanda Kay, Senior Partner and Chief Business Development Officer, Flagship Pioneering

Mirai Bio is revolutionizing the field of genetic medicine by serving as a comprehensive solutions provider for genetic medicine development, focusing on ML-enabled nucleic acid design, delivery, and manufacturing. Mirai's proprietary library of ionizable lipids includes ML-inspired components that demonstrate higher in vivo potency than leading commercial options for liver, with translation to non-human primates. By leveraging novel in-house barcoding methods, Mirai can rapidly assess multiple lipid nanoparticles (LNPs), reducing time and costs. The company’s innovative approach also includes a modular targeting LNP platform, facilitating selective extrahepatic delivery to novel tissues utilizing conjugation capabilities. The company’s unique open-platform partnership model applies Mirai’s expertise across diverse therapeutic approaches and modalities, supporting drug development of the most innovative cargos.

In 1901, the first Nobel Prize was awarded to recognize those who “have conferred the greatest benefit to humankind.” Often the work that goes into winning this prestigious award occurs over decades and uncovers the fundamental and “basic” nature of the universe. But after a scientific advancement has been recognized by the Nobel committee, will it ever deliver on its promise to confer a true benefit to humanity? During this panel, hear from scientists and company executives across different stages of drug development on how they are moving beyond just a laboratory experiment to bring “Nobel Prize-winning science” into human applications to shape the future of treatment for some of the most pressing health challenges today.

Speakers:
John Lepore, CEO-Partner, Flagship Pioneering & CEO, ProFound Therapeutics

Michael Severino, CEO-Partner, Flagship Pioneering & CEO, Tessera Therapeutics

Eamonn Hobbs, President and Chief Executive Officer, Syncromune

Sharon Rosenzweig-Lipson, Chief Scientific Officer, Life Biosciences

Moderator: Barbara Cheifet, Chief Editor, Nature Biotechnology 

As biological threats evolve, traditional stockpiling strategies need to adapt to ensure both readiness and flexibility. This session will delve into dual-use models that serve commercial and public health needs, enhancing resource optimization and resilience. By also linking low-demand public health items with higher-demand commercial products, these dual-use models can drive commercial sustainability while expanding access to unmet medical needs. Participants will gain insights into how these models can create growth in reaching underserved medical areas, foster resilience, and support rapid, coordinated responses to biosecurity challenges, ultimately strengthening global health security.

Speakers:
Hamilton Bennett, Executive Director, Global Health Security, R&D and Partnerships, Moderna

Derrick Sim, Interim Chief Vaccine Programs and Markets Officer, GAVI The Vaccine Alliance

Lynda Stuart, President and Chief Executive Officer, Fund for Science and Technology Washington

Rajinder Kumar Suri, CEO, Developing Countries Vaccine Manufacturers Network (DCVMN) International

Moderator: Emma Wheatley, Executive Director Access and Business Development, CEPI

R&D is often the most cost-intensive and risky step in a new drug's life cycle yet often dictates the speed and adaptability of the innovation ecosystem. The time and capital required for biotech to translate a new concept or target into a clinical asset is substantial, and in the age of platform companies, the potential targets are vast. How do you know what targets to prioritize? Partnerships between biotech and pharma in early-stage R&D have become more common and often crucial for advancing target discovery. This panel will spotlight successful R&D collaborations leveraging innovative bioplatforms that integrate cutting-edge technologies like genomics, proteomics, and AI-driven analytics to identify novel therapeutic targets more efficiently. Pharma leaders will share insights on what they are looking to get out of biotech partnerships and how to attract a partner for early R&D success. Early-stage partnerships enhance pharma pipelines and reduce time-to-market for new therapies, a winning solution for biotech, pharma, and, ultimately, patients.

Speakers:
Paul Biondi, Managing Partner, Flagship Pioneering; President, Pioneering Medicines

Lovisa Afzelius, General Partner, Flagship Pioneering 

Ram Aiyar, Chief Executive Officer and President, Korro Bio

Uli Stilz, Head of the Bio Innovation Hub, Novo Nordisk

Moderator: Hannah Green, Life Sciences Reporter, Boston Business Journal

The cancer therapeutics landscape is constantly evolving as breakthroughs across modalities drive toward the shared goal of providing accessible and life-saving treatments to patients. Companies are addressing the urgent unmet needs of patients with targeted therapies tailored to patients’ specific cancer profile and improving quality of life while undergoing treatment with therapies that have better efficacy and fewer side effects. Despite setbacks, we are witnessing differentiated and innovative approaches designed to address both common and rare cancers. This panel of thought leaders will investigate the latest breakthroughs in oncology, offering a comparative analysis of these advancements, from next-generation ADCs to cutting-edge in vivo immunotherapies and combination approaches, while examining the potential these modalities hold to outsmart the disease at its core.

Speakers:
Kyle Holen, Head of Development, Therapeutics, and Oncology, Moderna

Jodi Bass, Senior Director, Precision Medicine, Johnson & Johnson

Chris LeMasters, CEO, XinThera, a Gilead Company

Mollie Leoni, Chief Medical Officer, Kura Oncology

Moderator: Alex P. Philippidis, Senior Business Editor, Genetic Engineering & Biotechnology

This panel will explore the vital role of patients and their families in driving innovation in rare disease therapies. By sharing personal experiences and expert insights, panelists will highlight how grassroots advocacy, research collaborations, and breakthrough technologies are transforming the landscape of drug development in rare disease. Attendees will gain a deeper understanding of the power of patient voices and actions in shaping and accelerating new rare disease treatments. Panelists will address challenges faced by rare disease communities, including access to treatments, funding hurdles, and gaps in research. Through interactive discussions and firsthand narratives, attendees will leave with practical insights into how they can engage in advocacy efforts, build meaningful partnerships with researchers and industry leaders, and contribute to the advancement of therapies that address unmet medical needs.

Speakers:
Michelle Werner, CEO-Partner, Flagship Pioneering & CEO, Alltrna

Jill Chertow, Founder and President, Propionic Acidemia Foundation

Wendy Erler, SVP Patient Affairs, Sarepta Therapeutics

Karin Knobe, Global Head of Rare Diseases Clinical Development, Sanofi

Julia Vitarello, Co-Founder, EveryONE Medicines

Moderator: Lei Lei Wu, Reporter, Endpoints

Co-discovery and co-development partnerships have become a cornerstone of the biopharma industry. These partnerships can unlock the potential for groundbreaking medicines, yet their scientific complexity and multifaceted nature present unique challenges. This panel explores the intricacies of these collaborations, delving into the business structures, motivations, and decision-making processes that are crucial for success and optimal performance. From aligning research objectives and intellectual property strategies to establishing clear governance structures and communication channels, partners must navigate a myriad of considerations to foster a productive and sustainable collaboration. Attendees will gain valuable insights into fostering alignment, maximizing partnership value, and ultimately delivering transformative therapies to patients.

Speakers:
Jeremy Ahouse, VP of Alliance Management for Pioneering Medicines, Flagship Pioneering

Wanda Rutledge-Gordon, Associate Vice President, Chief Alliance Officer, Eli Lilly

Peggy Scherle, Chief Scientific Officer, Prelude Therapeutics

Risa Shapiro, Head of Alliance Management for Platforms & Early R&D, Novartis  

Moderator: Jake Beverage, VP, Alliance Management, AbCellera

According to the most recently available figures, more than 2,000 new oncology clinical trials have begun since 2023, demonstrating the continued need for innovative and effective cancer therapies. While many well-known targets have already yielded first-in-class biotherapeutics, the future of precision medicine depends on identifying novel targets and demonstrating - in the clinic - that they can be successfully drugged. This session explores strategies and successes of companies pioneering novel targets and modalities in solid tumors in the clinic. Participants will gain insights into how these candidates were selected and progressed, and the decision-making process involved in evaluating novel agents as monotherapies or as combinations.

Speakers:
Steven Bellon, Chief Scientific Officer, Foghorn Therapeutics

Scott A. Armstrong, Senior Vice President for Drug Discovery & Chief Research Strategy Officer, Dana-Farber Cancer Institute

Angela Cacace, Chief Scientific Officer, Arvinas

William R. Sellers, Core Institute Member and Cancer Program Director, Broad Institute; Professor of Medicine, Dana-Farber Cancer Institute and Harvard Medical School

Jeevan Virk, Therapeutic Area Strategy Head, Novartis

Moderator: Selina Koch, Executive Editor, Head of Intelligence & Research, BioCentury Inc.

The BIO Storytelling Stage is a showcase of the heart of BIO's priorities—sharing the stories of the biotechnology industry that show who we are, who we serve, what we do, and why we do it. You'll hear inspiring stories from researchers on the newest biotech advancements, perspectives from patients and caregivers on how biotech has affected their lives, and insights from company founders on their relentless pursuit to make the world a better place.

Speakers:
Monica Fay, VP, Global Medical Affairs, Rare Disease and Therapeutics, Moderna

Natalie Kuldell, Executive Director, BioBuilder Educational Foundation

Rob Perez, Founder and Chairman, Life Sciences Cares

Robyn Riseberg, Founder, Boston Community Pediatrics

Silvia Taylor, Executive Vice President, Chief Corporate Affairs & Advocacy Officer, Novavax

Moderator: Susan Roberts, Founder, Roberts Communications

America's biotechnology firms are struggling to attract capital due to political and economic headwinds that threaten to slow the pace of innovation. To address this, the National Security Commission on Emerging Biotechnology recommends at least $15 billion in federal investment over five years that would unlock tens of billions in additional private funding. Smart reforms can reduce investor risk, accelerate commercialization, and strengthen the entire biotechnology ecosystem. This session will examine how targeted tools—like seed-stage funds—can spur private investment and scale up U.S. biotechnology.

Speakers:
Tom DiLenge, Senior Partner, Global Public Policy, Regulatory & Governmental Strategy, Flagship Pioneering

Luciana Borio, Venture Partner, ARCH Venture Partners

Joe Buccina, Policy and Research Director, National Security Commission on Emerging Biotechnology (NSCEB)

David Schaffer, Hubbard Howe Jr. Distinguished Professor of Chemical and Biomolecular Engineering, Bioengineering, Molecular and Cell Biology, University of California at Berkeley

Moderator: Kelly Seagraves, Vice President, National Security & International Affairs, BIO

Recent data reveals that less than 10% of CEOs in the biopharma industry are women, while female representation in leadership teams stands at 25%. However, the momentum for change is undeniable. A growing number of female leaders are driving innovation and shaping the future of healthcare, demonstrating the powerful impact of women at the forefront of the industry. This panel will spotlight glass shattering female CEOs who are not just leading biotech companies - they are reshaping the future of healthcare. These leaders are leveraging their unique perspectives to foster innovation, develop patient-focused solutions, and push their companies forward in an increasingly competitive industry. Attendees will gain firsthand insights into the pivotal moments and bold decisions that have propelled these leaders to the forefront of biopharma. From startup funding to empowering women in life sciences and tackling gender disparities in research and healthcare, this panel will explore how female-led innovation is transforming healthcare and setting new standards for excellence.

Speakers:

Angela Hwang, CEO-Partner, Flagship Pioneering & CEO, Metaphore

Judy Chou, President and CEO, AltruBio

Elizabeth Jeffords, President & CEO, Iolyx Therapeutics

Sabrina M. Johnson, President and CEO, Daré Bioscience

Daisy Robinton, Co-Founder & CEO, Oviva Therapeutics

Moderator: Nicole DeFeudis, Editor, Endpoints News 

Breakthroughs in biomanufacturing, biochemical modeling, and AI-enabled drug discovery and development could dramatically boost industry-wide productivity—but they require massive early-stage investments that are currently too risky for many private firms to undertake alone. The NSCEB urges the U.S. government to launch a national research agenda and seed funding effort to tackle "grand challenges" like these.

Speakers:
Gevorg Grigoryan, Co-Founder & Chief Technology Officer, Generate:Biomedicines

Rhys Dubin, Policy Advisor, Office of the Special Envoy for Critical and Emerging Technology (S/TECH), U.S. Department of State

Steven Moss, Senior Policy Advisor, National Security Commission on Emerging Biotechnology (NSCEB)

Computational methods including AI/machine learning have the potential to be transformational in biopharma by accelerating and enhancing many aspects of drug discovery to bring better drug candidates with a higher likelihood of success to the clinic. Robust data sets are often cited as the limiting factor for this technology. However, less discussed but crucial to the success of computational drug discovery is fostering a new generation of drug hunters with multi-disciplinary training needed to make the best use of these advancements. There may be a shortage of computational chemists and molecular modelers needed to explore the vast array of opportunities that can benefit from computational drug discovery. Hear from a panel of academic and industry leaders that are developing this next-generation, what is most important for them and what our broader ecosystem can do to help fill in the pipeline gaps and ensure we have the people in place to match the technology. This session will focus on the benefits of computational methods, including AI/machine learning, to advance drug discovery, as well as the importance of fostering the next generation of scientists leveraging these vast datasets.

Speakers:
Mickey Atwal, Chief Data and AI Officer, Pioneering Intelligence

Wade Davis, Senior Vice President, Head of Digital for Business, Moderna

Jennifer Chambers, Senior Director of Education, Schrödinger

Rebecca Swett, Director, Computational Chemistry, X-Chem

Anna Marie Wagner, Biotech investor, advisor, board member

Moderator: Alex P. Philippidis, Senior Business Editor, GEN

Are the nationalist trends toward investment, trade and national security policies going to divide the world into different spheres of R&D and access to health care products? What impact will they have on global research, cross-border collaboration, and access to healthcare products and public health? The Balkanization of science, knowledge and discovery may have profound impacts on what has traditionally been a collective, global effort.

Speakers:
Michael Nally, CEO-Partner, Flagship Pioneering & CEO, Generate:Biomedicines

Bibhash Mukhopadhyay, Venture Capital Investor

Jennifer Sheng, Head of Healthcare Equity Capital Markets, Citi

Erika Smith, CEO, EpiTET Therapeutics

Moderator: Joseph Damond, Chair, International Trade Policy & Global Life Sciences, Crowell Global Advisors