Bio International Convention 2022: Program highlights

The 2022 BIO International Convention will feature 100+ interactive sessions across 4 days covering a variety of therapeutic areas, business development, digital health, patient advocacy, public policy, and next-generation biotherapeutics, and the latest updates from industry experts on COVID-19. 

The program will be delivered in person at the convention (June 13-16) in San Diageo.

Wednesday Keynote: Venus Williams and Erin Andrews​

Seven-time Grand Slam singles champion, four-time Olympic gold medalist and entrepreneur Venus Williams will discuss her groundbreaking career, business success, and health journey in a conversation with Emmy-nominated sports reporter Erin Andrews in the keynote address on Wednesday, June 15.​

Williams will discuss her experience as a patient advocate, having been diagnosed with Sjögren’s syndrome, an autoimmune disease that causes fatigue and muscle and joint pain.

Meanwhile, Andrews is also an advocate for women in sports and cervical cancer awareness, as a survivor herself. 

The future of flu protection: Novel influenza technologies​

This panel​ will explore how novel vaccine, therapeutic, and diagnostic technologies are being applied to improve our ability to protect against seasonal influenza, with the conversation framed within the context of ongoing efforts as part of the US Government’s National Influenza Vaccine Modernization Strategy (NIVMS).

Panelists from companies and health agencies (including Genentech and Seqirus) will discuss how these novel technologies address the unique aspects of the influenza virus, avoid the problem of egg adaptation, and will highlight the regulatory and market challenges for advancing new influenza products. Panelists will also discuss the interface between seasonal flu and pandemic flu and how these platforms may be used for rapid response to the next flu pandemic. 

Gene and cell therapies: a regulatory update​

The number of cell and gene therapies entering clinical trials is growing at an increased rate. With FDA providing new guidance on AAV-based gene therapies, early engagements with a strong regulatory strategist can help navigate the complexities of an evolving regulatory environment and give insights to the different ways to enhance the efficiency of CGT development programs. This session​ will cover FDA Guidance documents, including PDUFA VII Commitment letter and their implications on CGT programs. 

How RNA will advance precision medicine and accessibility​

Following the success of RNA in creating COVID-19 vaccines, stakeholders are looking closely into how the tech can be leveraged and targeted to treat a multitude of diseases beyond infectious diseases. This panel of RNA experts​ will discuss how the next generation of therapies using RNA-based technologies and methods to identify novel RNA targets will transform the industry by improving precision medicine and increasing patient accessibility.

Artificial intelligence and machine learning: case studies in rare disease drug development​

Drug development remains a field ‘defined by failure’, with roughly 90% of products entering clinical trials shelved after companies spend countless hours and millions of dollars testing them only to discover worrying safety signals or lack of efficacy in the intended patient population. 

By analyzing large complex biological and clinical datasets, AI/ML algorithms can help researchers optimize drug design and biomarker identification by uncovering patterns previously invisible to the human mind – improving our ability to predict what is likely to succeed (or fail) in clinical trials with greater confidence. 

Experts on this panel​ will explore specific use cases for AI/ML in drug discovery, including biomarker identification and clinical trial design, and discuss challenges that need to be overcome for the field to accelerate the adoption of best practices for training/validating algorithms; detect bias that could undermine patient equity and safety; and ensure that regulators, clinicians, and patients have confidence in the performance of AI tools to improve real world patient outcomes.

Fireside chat with the Commissioner of Food and Drugs, Dr. Robert M. Califf​

Robert M. Califf, M.D., is Commissioner of Food and Drugs. President Joe Biden nominated Dr. Califf to head the U.S. Food and Drug Administration and Dr. Califf was sworn in on February 17, 2022. Previously, Dr. Califf served as Commissioner of Food and Drugs from February 2016 to January 2017.

As the top official of the FDA, Dr. Califf is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public health. Dr. Califf served as the FDA’s Deputy Commissioner for Medical Products and Tobacco from February 2015 until his first appointment as Commissioner in February 2016.
Prior to rejoining the FDA, Dr. Califf was head of medical strategy and Senior Advisor at Alphabet Inc., contributing to strategy and policy for its health subsidiaries Verily Life Sciences and Google Health. He joined Alphabet in 2019, after serving as a professor of medicine and vice chancellor for clinical and translational research at Duke University. He also served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute. A nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, health care quality, and clinical research, Dr. Califf has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,300 publications in the peer-reviewed literature.

Dr. Califf will be at BIO on Thursday June 16.​

USG Investments manufacturing and supply chain​

The COVID-19 pandemic demonstrated the need for readily available manufacturing surge capacity in times of emergency, and the demand for long-term investment expanding the US’ industrial base. ASPR/BARDA are working to take these lessons learned and invest in manufacturing and the medical supply chain through programs such as their Industrial Base Expansion (IBx) and proposed Biopharmaceutical Manufacturing Consortium (BioMaC). This two-part panel starts on Monday, June 13.​

Overcoming non-price barriers to patient access​

Many life sciences companies offer programs to help patients afford their medications. But how can they help patients get medications when the challenges are not financial?

Johnson & Johnson and Sanofi will be among the leading life sciences companies who will share examples of their initiatives​ to help patients overcome non-price barriers to treatment access, such as launching a program to deliver much-needed HIV drugs by drone in remote locations, and a program that has increased vaccination rates by as much as 30% among underserved communities.

Best practices for building an inclusive biotech company​

For the third year, BIO, in partnership with Coqual, is launching the Measuring Diversity and Inclusion in Biotech report. This session will present the latest data​ while leaders will discuss how to implement best practices.

Spurring biotech innovation across the globe​

Biotechnology continues to become more and more globalized, with research and commercialization efforts reaching new corners of the world. Governments across the world are focusing more intently on the growth of national biotechnology sectors in response to the COVID-19 pandemic and as a means to ensure future preparedness for global health challenges. While governments are taking different approaches to strengthening local sectors, it has become clear to all that bolstering global collaboration between public and private stakeholders is critical. This panel will discuss the issues on Monday June 13.​