Good Day BIO: Who invents new drugs? (Spoiler: We do.)
December 6, 2022
A new study provides new insight into who develops new drugs—and no surprise, small biotechs in the U.S. play a starring role. Plus, news from USTR on the IP waiver expansion and a new report highlighting the role for biotech in transforming food systems. (754 words, 3…
The only newsletter at the intersection of biotech, politics, and policy
December 6, 2022
A new study provides new insight into who develops new drugs—and no surprise, small biotechs in the U.S. play a starring role. Plus, news from USTR on the IP waiver expansion and a new report highlighting the role for biotech in transforming food systems. (754 words, 3 minutes, 46 seconds)
P.S. Today, BIO’s John Murphy will join a free virtual event hosted by The Hill, Reimagining the Pharma Supply Chain—you can watch here at 1 PM ET.
Who invents new drugs? (Spoiler: U.S. small biotechs)
Small biopharmas lead the way: 55% of all therapies the U.S. originated were developed by small biopharmaceutical companies with less than $500 million in annual revenue, and 45% were fully discovered by small biopharmas on their own without an academic or government transfer of IP.
Partnerships go both ways: 1/3 of therapies originating in large firms are later sublicensed to small firms for production, especially for rare-disease treatments serving smaller patient cohorts.
The private sector does most drug development. NIH’s Cooperative Research and Development Agreements and intermural grants produced four of the 363 new drugs developed between 2011 and 2020, while “U.S. academic institutions created 10% of all indigenously originated IP.”
But U.S. dominance is being challenged by competitors around the world. Data shows venture-backed biopharmaceutical startups in Asia—predominantly driven by China—now equal the annual total of the U.S., with 93 startups. Europe was relatively flat, with 44 biopharma startups.
BIO’s take: The study shows “remarkable overall R&D productivity of U.S.-based biopharmaceutical enterprises” and “interdependence of the various large and small, public, and private actors that contribute to this flexible ecosystem,” says Hans Sauer, BIO’s VP for IP. “We shouldn’t take such successes for granted. It is critical that we maintain rational policies” that enable successful research, development, and market entry of new medicines.
USTR: U.S. to support extension of deadline on WTO TRIPS Ministerial Decision; requests USITC investigation to provide more data on COVID-19 diagnostics and therapeutics “Over the past five months, USTR officials held robust and constructive consultations with Congress, government experts, a wide range of stakeholders, multilateral institutions, and WTO Members,” said Ambassador Katherine Tai. “Real questions remain on a range of issues, and the additional time, coupled with information from the USITC, will help the world make a more informed decision on whether extending the Ministerial Decision to COVID-19 therapeutics and diagnostics would result in increased access to those products. Transparency is critical and USTR will continue to consult with Congress, stakeholders, and others as we continue working to end the pandemic and support the global economic recovery.”
Biopharma Dive: With new data, Nkarta builds case for ‘natural killer’ cell therapy “Seven of 10 patients with non-Hodgkin lymphoma who received a medium or high dose of Nkarta’s treatment, dubbed NKX019, had a complete response, meaning their cancer was put into remission, according to a Monday statement. One of four on the lowest dose had a complete response, while no responses were observed in five study participants with leukemia.”
The Washington Post: COVID hospitalizations rising post-Thanksgiving after an autumn lull “COVID hospitalizations last week reached their highest level in three months, with more than 35,000 patients being treated, according to Washington Post data tracking.”
Feeding the world requires big changes, including biotech advances, U.N. says
Status quo won’t work: We’re not meeting the U.N. Sustainable Development Goals and will not have enough food for the anticipated global population of 10 billion by 2050 “without broader socioeconomic and environmental change,” FAO says.
What will work: shifting to sustainable, more-productive approaches that are accessible worldwide. This can be achieved with “triggers of transformation” including improved governance, informed consumers, better income and wealth distribution, and innovative technologies and approaches.
Biotechnology is crucial—including developments like gene editing, microbes, synthetic biology, and use of bioreactors for lab-produced foods, says the report, which calls for means to ensure “the more vulnerable producers are granted access” to them.
Societal change and sacrifice are required—but “if governments, consumers, businesses, academia, and the international community act now, it is still possible to bring about long-term sustainable change,” the report concludes.