1992 - 1998: Finding Our Way

Because of the increasing complexity of regulatory compliances and lack of approved therapeutic biological products, the focus of SBT Annual Meetings are often preclinical work and phase I and II trials, as opposed to phase III trials or optimizing the use of approved biologics in anti-cancer therapy. The focus of SBT narrows and the field becomes more challenging for researchers.

Benchmarks:

  • Interleukin-2 is granted regulatory approval by FDA for renal cell cancer in May of 1992 and for melanoma in 1998
  • In November of 1993, the FDA announces that all biologicals, including patient-specific products that involve modification of the tissue, require an Investigational New Drug (IND) approval; this limits the ability to conduct trials with patient specific products
  • Former SBT president, Michael Hawkins, MD and the SBT Board of Directors declare the focus of the society to be at the translational level of preclinical and phase I trials
  • Lippincott becomes the new publisher of the Journal of Immunotherapy; David Parkinson, MD is named editor of the Journal in 1995
  • No new therapeutic biological products are approved by the FDA between May of 1992 and November of 1997
  • Former president, Richard V. Smalley, MD steps forward to administer the society as treasurer from 1994 - 1998 because of increased restrictions and the uncertainty of administrative support from the NCI or industry; he also registers SBT as a not-for-profit corporation in the state of Wisconsin
  • SBT member, Antonio J. Grillo-Lopez, MD is the project clinician in the development of Rituxan™; the FDA's approval of rituximab (Rituxan™) in 1997 drives the profitability in the following years for monoclonal antibody treatment which in turn further establishes biological cancer treatments in the field of cancer research