INTRODUCTION from Shahin Gharakhanian, MD, DPH. Soheila Gharakhanian. October. 2020

The 4^th edition of the transatlantic Boston Biotechnology Summit originally intended to focus or re-focus on the essential “raison d’être” of the biotechnology industry. The central theme was therefore Obtaining Approval for Novel Treatments to Serve Patients In Need. In 2016, the co-founders of the Boston Biotechnology Summit® started their journey to create an essential event. They decided that their mission was to create an exclusive Trans-Atlantic Bridge designed to foster innovative synergies between biotech and pharma companies, healthcare-focused cities and regional clusters, and institutional, philanthropic and strategic investors. Their intent was to spark projects, their financing and strategic deals in order to solve unmet medical needs and globally improve the lives of patients. Over the past three years in Paris (France), Boston MA and Philadelphia PA, over 80 Leaders and Experts have discussed their views and presented their work to over 700 professionals from the biotechnology community, representing close to 300 organizations from nearly thirty countries or US states. The central theme of the first edition was an introduction to the biotechnology ecosystems in Boston and Paris, which were also highlighted in terms of innovation and leadership. The Summit’s framework for its 2^nd edition was “From the promise of raising capital to the reality of clinical trials” and featured speakers from the academic, biotech, investor, legal/regulatory and pharma worlds. Collaboration is an increasingly important component in the next stage of biotechnology’s evolution, for at least three fundamental reasons:

• First, no single technology is likely to generate all the drug innovations required to treat the complex range of diseases that constitute unmet medical needs in our societies.
• Second, no single company or entity can possibly possess all the answers,
• Third, the risky nature of the economics of biotechnology is such that no single region can achieve results on its own.

By choosing Collaboration as its central theme, the third Summit further ensured that it could offer an efficient and cost-effective forum that would add value for the professionals and organizations in attendance. We have found confirmatory inspiration in David Epstein’s #1 New York Times Bestseller, Why Generalists Triumph in a Specialized World. The Boston Biotechnology Summit offers a hand-crafted, generalist forum for professionals from the biotechnology and health industry.

On 30 December 2019 a ProMed email from the International Society of Infectious Diseases (IDSA) contained information on <Undiagnosed pneumonia in China>, thus alerting the world to what was to become the worst health crisis in 100 years. On 24 January 2020, the New England Journal of Medicine (2020, 382: 727-733) published a brief report from the China Novel Coronavirus Investigating and Research Team: “In December 2019, a cluster of patients with pneumonia of unknown cause was linked to a seafood wholesale market in Wuhan, China. A previously unknown betacoronavirus was discovered through the use of unbiased sequencing in samples from patients with pneumonia. Human airway epithelial cells were used to isolate a novel coronavirus, named 2019-nCoV, which formed a clade within the subgenus sarbecovirus, Orthocoronavirinae subfamily. Different from both MERS-CoV and SARS-CoV, 2019-nCoV is the seventh member of the family of coronaviruses that infect humans. Enhanced surveillance and further investigation are ongoing”. That same day The Lancet (2020, 395:497-506) published the clinical features of patients in Wuhan “The 2019-nCoV infection caused clusters of severe respiratory illness similar to severe acute respiratory syndrome coronavirus and was associated with ICU admission and high mortality. Major gaps in our knowledge of the origin, epidemiology, duration of human transmission, and clinical spectrum of the disease need fulfilment by future studies”. The pandemic that followed has been compared to major events in human history and has had profound economic, political, psychological and sociological effects (please refer to references). On 31 May, the Boston Globe reproduced an article first reported in the New York Times <In Geneva – one of the world’s richest cities – a mile-long line for free food” A formidable challenge was thus posed to Public Research Institutions and the Biotechnology and Pharmaceutical Industries in particular. The Boston Business Journal has since reported that some 30 companies in MA are focused on Covid-19, and clinicaltrial.gov accessed in August 2020 listed over 3000 studies. In October 2020, we will be approaching the first anniversary of the Covid-19 pandemic. The Summit Organizers & Program Committee have decided to combine the central themes of the 3^rd Summit <Collaboration> and the planned theme of the 4^th Summit <Obtain approval for Novel Treatments to Serve Patients in Need: Roadmap from IND to NDA> in order to focus on a Special Virtual 4^th Summit on Covid-19: State-of-the Art.