John J Jordan Letter to Thomas O. Barnett July 23

John J Jordan Letter to Thomas O. Barnett
July 23, 2020
Page 4
conditions. Some of the Requesting Parties compete with each other to provide biologics for the
same condition, such as asthma, cervical cancer, and leukemia.12
The Requesting Parties are currently independently developing monoclonal antibody
agents that may be used to treat COVID-19 and planning for mass production of safe and
effective mAb therapeutics.
13 The extraordinary circumstances of the COVID-19 pandemic have
necessitated that the Requesting Parties ramp-up their production capacity much earlier in the
research and development process.14 The Requesting Parties point out that one recent article
noted, “n a pandemic, [manufacturers] can’t wait to start making [their] investment in the
manufacturing until [they’re] sure [they] have a product. . . . To be ready to make large volumes
of the products, companies must begin preparing their plants now. They need to secure supply
chains for key ingredients[,] install new equipment, and find contract manufacturers who can
help.”15
Additionally, the demand for whichever mAb treatments ultimately prove effective will
likely dwarf the capacity available to any one manufacturer. One recent report estimated that in
2019 “approximately 53 million standard units (i.e., doses) of mAbs were sold . . . in the United
States, many of which treat severe illnesses that address otherwise unmet medical needs.”16 The
report then estimates that the “lower bound for . . . the true demand” for a COVID-19 mAb
treatment is over 25 million doses, in other words, nearly half of all mAb treatments
administered annually in the nation.17 Even if a pharmaceutical company chose to devote all of
its capacity to COVID-19 mAB treatments, this lower bound estimate of demand is still more
than any one manufacturer could produce.
Given the need for expedited production of any approved COVID-19 mAb treatments
and capacity constraints facing the industry, the Requesting Parties propose to exchange
information regarding “manufacturing facilities, raw materials, and supplies that could be used to
produce COVID-19 mAb treatments, specifically global capacity that has been reserved
internally or through third parties for the potential production of COVID-19 mAb treatments.