Life Science Today 017 – Covance, IQVIA, ThermoFisher, Convalescent Plasma, Remdesivir
Originally Published as The Niche Podcast
Introduction
Welcome to The Niche Podcast – Your weekly 5-minute rundown of the biotech, clinical research, and applied science industries. I’m your host, Dr. Noah Goodson. This week, site-less with vision, IQVIA back on track, 36%, convalescent plasma, and Remdesivir approved.
Covance Siteless with Vision
Contract Research Organizations (CROs) are the ultimate middle-man. Their role is to facilitate the clinical testing of drugs, devices, and therapeutics. This positions CROs between the sponsors that want approval and pay them, the regulatory agencies they are answerable to, the doctors and front line organizations where research is executed, and the individuals who volunteer to participate in clinical research. Even the simplest clinical study will involve no less than five stakeholders including sponsor, regulators, site, investigator, and participant. The greatest challenge in clinical research is not designing creative studies or interpreting data: It is in navigating this unique and complex ecosystem.
Covance, one of the largest CROs in the world has a vision for how to streamline the process for the 21st century: go siteless. Sites are the location at which clinical research occurs. This could be a small medical office, but more often it is at large research hospitals. As one of the stakeholders, sites provide input, preferences, and an added level of regulation to process. Any research study will identify a number of sites where one or more investigators exist and can recruit participants into the study. In pre-digital era, sites were absolutely essential to identifying a patient population, recruiting them, and maintaining local data records. The primary role of sites has been to provide a location and the population to be studied. With the decentralization of our society and increased digital freedom, there is more ability than ever for companies to directly communicate with pools of potential participants. In part, that is why there are deals that see CROs signing partnerships with disease specific organizations. This gives them access to directly engage with potential participants, removing the need for sites. This also removes the cumbersome need for participants to commute to a location for the frequent re-testing involved in many clinical trials.
Sites are always going to be critical for certain therapies, like IV chemotherapy. However, for most drugs and therapeutics, home-based follow-up is more possible than ever. Imagine a combination of in-home testing kits, at home visits, mobile clinics, and virtual conversations. Medicine is moving in that direction. Society is moving in that direction. Research too must go that way.
Decentralized clinical research has been a hot-topic issue for years, but Covance is the first major player to commit to site-less clinical research stating that the majority of trials will be in this new model by the end of 2021. If cost is partially a function of number of stakeholders, then Covance has just taken 20% of them off the table.
IQVIA Q3 Guidance Update
Staying with CRO news, IQVIA updated their guidance for the 3rd time in 2020. They started the year expecting to be at between $11.7 and $12 billion in revenue. They then dropped this significantly in Q1, raised it in Q2, and have raised it again in Q3 to $11.1-11.25 billion. Beyond that, forecasting into 2021, IQVIA thinks they will be at $12.3-12.6 billion. Basically, back on track for their historic growth trends. No one really knows what bumps could be down the pipeline as COVID19 continues to progress around the world. However, most companies across the biotech and pharmaceutical space have weathered the storm and many came out thriving.
Sponsor
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ThermoFisher Hits 36%
In other news, ThermoFisher, the scientific supply company posted 36% year-over-year earning for Q3. As a major supplier of diagnostic testing kits and laboratory supplies, portions of their sales were weakened early in the year by the pandemic. Those have bounced back, and COVID19 related sales brought in $2 billion from Q3 alone. These will likely remain high through the coming 3 or 4 quarters.
Convalescent Plasma Failure
A phase 2 clinical trial for convalescent plasma has failed to meet the primary end point. 464 adults were admitted to the hospital with moderate COVID-19. About half were given convalescent plasma, half were not. 19% of those on the therapy died compared to just 18% off the therapy. There was no difference in survival between the groups. In short, convalescent plasma does not increase your chance of survival from COVID19.
Remdesivir (Veklury): Approved
The antiviral therapy, Remdesivir was approved by the FDA for the treatment of COVID19. Now being sold by Gilead as Veklury, the therapy showed generally good results through trials. It was given emergency use authorization in May, the guidance was further relaxed this fall, and after being used to treat patients as significant as President Trump, the Therapy has received full authorization. This makes it the standard of care in hospitals as the only fully approved COVID19 therapeutic. Since many global regulatory agencies follow FDA standards, this puts Veklury in a strong position for robust sales globally across the next year.
For best outcomes, the antiviral should be given early on during the infection. If you suspect you may have COVID19, get tested as early as possible since rapid intervention could be critical to effectively mitigating outcomes.
Closing Credits
Thanks for joining me on The Niche Podcast; your weekly 5-minute summary of top news in the biotech, clinical trials, and applied science industries. You can find us on your favorite podcast app. Like, comment, subscribe, and most of all share with your friends. If you like what you hear, please rate and review, it really helps us. Once again, I’m Dr. Noah Goodson, I’ll see you next week.
Sponsors
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Story References
https://www.bmj.com/content/371/bmj.m3939
https://www.nejm.org/doi/full/10.1056/NEJMoa2007764
Music by Luke Goodson