Erudio Glossary Inventory

Prepared by Sunghee Yun (Co-Founder & CTO) · personal study notes

Erudio Glossary Inventory

Working inventory of terms from biologics, binding kinetics, and US biodefense and regulatory policy. Short descriptions only; full explanations are built separately. Last updated 2026-10-17.

1. Glossary

Sorted case-insensitively. CDC appears twice on purpose — two different terms that share an acronym.

#	Term	Stands for / one-liner	Note
1	510(k)	FDA premarket notification pathway for devices substantially equivalent to an existing one
2	adalimumab	molecule in Humira; anti-TNF-α IgG
3	ADCC	antibody-dependent cellular cytotoxicity — NK cell grabs Fc, kills the target cell
4	AFM	atomic force microscopy
5	analyte	the molecule being measured (in SPR/BLI, the one in solution)
6	ARPA-H	Advanced Research Projects Agency for Health
7	ASPR	Administration for Strategic Preparedness and Response (HHS; owns the SNS since 2018)
8	B cell	lymphocyte that makes antibodies
9	BAA	Broad Agency Announcement — open call for research proposals
10	BLI	bio-layer interferometry
11	CBRN	chemical, biological, radiological, nuclear
12	CBRND	Chemical, Biological, Radiological, Nuclear Defense
13	CDC (agency)	Centers for Disease Control and Prevention
14	CDC (immunology)	complement-dependent cytotoxicity — C1q binds clustered Fc, cascade punches a pore
15	CHO	Chinese hamster ovary (cells) — the default factory for antibody drugs
16	CPE	Capability Program Executive — DoD/DoW acquisition role and office named by the portfolio it manages; see CPE CBRND
17	CPE CBRND	Capability Program Executive for Chemical, Biological, Radiological and Nuclear Defense — manages DoW’s CBRN defense equipment and medical countermeasures for the Joint Force; formerly JPEO-CBRND
18	Crohn’s disease	autoimmune inflammation of the gut; treated with anti-TNF
19	cytokine	small immune-signaling protein (TNF-α, IL-6, …)
20	DFS	dynamic force spectroscopy
21	DoW	Department of War
22	DTRA	Defense Threat Reduction Agency
23	ELISA	enzyme-linked immunosorbent assay
24	EMA	European Medicines Agency
25	Fab	fragment, antigen-binding — the two arms of the Y
26	Fc	fragment, crystallizable — the stem of the Y that talks to the immune system
27	FDA	Food and Drug Administration
28	FFRDC	Federally Funded Research and Development Center (e.g., Johns Hopkins APL)
29	Genesis Mission	DOE AI-for-science initiative (Executive Order, Nov 24 2025)
30	globulin	globular blood proteins; antibodies are the gamma fraction
31	glycosylation	sugar chains attached to a protein after synthesis; process-dependent, not in the gene
32	HCP	host-cell protein — CHO proteins that must be purified out
33	HELP	Senate Health, Education, Labor, and Pensions committee
34	Herceptin	trastuzumab (Genentech/Roche); anti-HER2
35	HHS	Department of Health and Human Services
36	homeostasis	the body’s self-regulation toward a stable internal state
37	Humira	AbbVie’s brand of adalimumab	full story: AbbVie, adalimumab, 2023 US biosimilar entry, PBM rebates
38	IgG	immunoglobulin G — the main antibody class in blood and the class nearly all antibody drugs belong to
39	immunoglobulin	formal name for antibody (Ig)
40	IND	Investigational New Drug (application) — FDA permission to dose humans
41	INN	International Nonproprietary Name — the generic drug name (e.g., adalimumab)
42	junk DNA	the ~98% of the genome that doesn’t code for protein
43	K_D	equilibrium dissociation constant — k_off / k_on
44	k_off	dissociation rate constant
45	k_on	association rate constant
46	Keytruda	pembrolizumab (Merck); anti-PD-1 checkpoint inhibitor
47	ligand	(biochemistry) molecule that binds a target; (SPR/BLI) the molecule immobilized on the sensor	both senses
48	metagenomics	sequencing all genetic material in a sample at once
49	monoclonal antibody	one identical antibody made by one cell clone
50	NCATS	National Center for Advancing Translational Sciences
51	NCI	National Cancer Institute
52	NIH	National Institutes of Health
53	NK cell	natural killer cell — the executioner in ADCC
54	OCET	FDA Office of Counterterrorism and Emerging Threats	inside FDA’s Office of the Chief Scientist; home of MCM / CBRN / stockpile work
55	oligo	oligonucleotide — short synthetic DNA/RNA strand
56	ONC	Office of the National Coordinator for Health IT
57	Operation TrialBlazer	HHS initiative (June 22 2026) to speed trials/INDs; applications Sept 15–Oct 30 2026
58	OPHPR	Office of Public Health Preparedness and Response	under CDC, not FDA
59	OTA	Other Transaction Authority — flexible federal contracting outside the FAR
60	PBM	pharmacy benefit manager — negotiates drug prices and rebates for insurers
61	psoriasis	autoimmune skin disease; treated with anti-TNF
62	QRI	Qualified Research Institution — FDA Expedited IND Pilot term
63	residual DNA	leftover host-cell DNA in the drug product; limited by regulators
64	RFI	Request for Information — questions only, no money
65	RFP	Request for Proposals — a deliverable to bid on
66	SBIR	Small Business Innovation Research (grants)
67	SLEP	Shelf-Life Extension Program
68	SPR	surface plasmon resonance
69	Strategic National Stockpile	SNS — federal reserve of medical countermeasures, run by ASPR
70	T cell	lymphocyte that kills infected cells or directs other immune cells
71	VSA	Versatile Smart Assay (Erudio’s platform)

2. Biophysics Intuitions

The same quantity seen from several angles — several important readings, not an exhaustive list.

Term	Ways to read it
K_D	(1) Balance equation: k_on [A][B] = k_off [AB] — count × frequency on each side. (2) [B]_free = K_D × [AB]/[A]_free — K_D is the price per unit of bound-to-free odds. (3) Net binding rate: d[AB]/dt = k_on ([A][B] − K_D [AB]) — K_D is the zero-crossing, k_on sets the speed. (4) Fraction bound = [drug]/([drug] + K_D) — unit-free; [drug] ≈ total drug when drug is in excess (favorite).

3. The six biosimilar bills

Four Senate bills plus two House companions, all in the 119th Congress (Jan 2025 – Jan 2027; anything not passed by then dies and must be reintroduced). “S.” = Senate bill, “H.R.” = House bill; a bill must pass both chambers in identical form, which is why companion bills are introduced in parallel. Health bills go through the Senate HELP committee (House: Energy and Commerce); the antitrust bill went to Judiciary instead. Statuses as of July 2026 — re-verify before citing.

Bill	Name	Sponsors	What it does	Status	Relevance to VSA
S.1414 / H.R. 9661	Expedited Access to Biosimilars Act	Senate: Paul (R-KY), Lee (R-UT), Hassan (D-NH). House (introduced July 15, 2026): Langworthy (R-NY), Schrier (D-WA)	Removes the default requirement that a biosimilar applicant run a comparative clinical efficacy study; FDA keeps the authority to require one case by case	Ordered reported by HELP, July 22, 2026	The one that creates VSA’s market. If clinical trials are no longer the default, analytical proof of equivalence becomes the whole case — the gap VSA claims to fill (testing burden)
S.1954 / H.R. 5526	Biosimilar Red Tape Elimination Act	Senate: Lee (R-UT), Luján (D-NM), Paul, Hassan, Schmitt, Ossoff. House (Sept 2025): Pfluger (R-TX), Landsman (D-OH)	Deems every FDA-licensed biosimilar interchangeable with its reference product, so pharmacists can substitute automatically; no more switching studies. Preserves exclusivity already earned by first interchangeables	Introduced in three consecutive Congresses; this time ordered reported favorably by HELP June 17, 2026 and placed on the Senate calendar July 27	Attacks substitution friction (the Humira-era barrier), not testing. Raises the stakes on equivalence: if every approved biosimilar can be auto-swapped, “are these two truly the same?” becomes a patient-level question — a stronger argument for a rigorous functional test
S.1096	Preserve Access to Affordable Generics and Biosimilars Act	Klobuchar (D-MN), Grassley (R-IA) + eight cosponsors (5 D, 3 R)	Bans pay-for-delay: any settlement in which the brand gives a generic/biosimilar maker anything of value (cash, or a promise not to launch an authorized generic) in exchange for delaying entry is presumed anticompetitive; FTC enforces	Ordered reported by Judiciary, April 3, 2025 — earliest to clear committee; earlier versions passed the Senate and died in the House	Antitrust, not science — VSA does not address it. Explains part of why Humira biosimilars were held off until 2023 (AbbVie settled every challenger on a 2023 date). Part of the “system is rigged, Congress is unrigging it” story, not the VSA pitch
S.3510	Biosimilar Inspection Modernization Act of 2025	Budd (R-NC), Hassan (D-NH)	Expands remote regulatory assessments, convenes a meeting on mutual recognition agreements with foreign regulators, requires an FDA plan on domestic inspections	Has not moved	Manufacturing-inspection logistics; peripheral to VSA

One line to hold onto: the bills attack three different things — testing burden (S.1414), substitution friction (S.1954), anticompetitive deals (S.1096) — plus inspections (S.3510). Only the first is VSA’s tailwind directly; the others raise demand for biosimilars, which raises demand for a fast equivalence test. Often cited alongside them, but not bills: FDA’s Oct 29, 2025 announcement on dropping clinical efficacy studies for some biosimilars, the Langworthy/Schrier press release, and David Lim’s Politico piece (July 21, 2026) on Hill momentum.