North American pitviper antivenom: selected venom proteins, fab and affinity pure: past, present, future (1973-2003), and (2003-2023)
Straight, Richard C.
BTG International Inc.
Salt Lake City, Utah USA
1. Bridging the gaps from “genomics/venomics/proteomics/toxinomics/antivenomics” to medical envenomation therapy(s) and outcomes.
2. Antivenom type: The path to an optimally safe and effective antivenom drug for envenomation therapy is long, multistep and challenging. Consider:
a) Is the proposed antivenom (antibody or non-antibody) rational?
b) Can effectiveness be demonstrated in laboratory studies?
c) Can safety and effectiveness be demonstrated in well-designed clinical studies?
d) Is the proposed antivenom drug commercially viable?
e) Can the drug after well designed Clinical Trials receive regulatory approval?
f) Be prepared to spend 5-20 years from concept to approved commercial product.
3. Envenomations and therapies are complex, often uncontrollable multi-factor processes. Consider:
a) Snake: species/venom proteins/geographic/habitat/ecology/climate/behavior/circumstances.
b) Patient: age and health status.
c) Envenomation: bite site/dose of venom/ time-to-treatment (premedical & medical)/major venom protein toxins/ protein toxin biochemistry and direct and induced pathology(s)/antibody drug-purified (IgG-Fab2-Fab), and non-antibody drug used (dose and dose schedule).
d) Treatment(s) outcomes.
4. Historical example: North American pitviper antivenom: selected venom proteins, fab and affinity pure: past, present, future (1973-2003), and (2003-2023).
Richard Straight, Ph.D.
BTG Specialty Pharmaceuticals
615 Arapeen Drive, Suite #105
Salt Lake City, UT, 84108 USA
D: +1 801 583 8077 x1 | C: +1 801 913 4799 | F: +1 801 583 8076