January 1, 1981
Genetic Engineering News Founded
Publisher Mary Ann Liebert begins publishing Genetic Engineering News.
November 5, 1981
Laboratories of Elizabeth Lacy and Frank Constantini (Oxford) and Frank Ruddle (Yale) report successful nuclear integration and germ-line transmission of foreign DNA into laboratory mice.
March 1, 1982
Augenlicht and Kobrin develop DNA microarray for differential screening of genes expressed in healthy and cancerous mouse colon cells.
October 28, 1982
First Recombinant Drug
FDA/CDER approves recombinant human insulin (Humulin-R), developed by Eli Lilly and Genentech. It is the first medicine (drug or biological) to be produced using genetic engineering.
August 1, 1983
Groups from Monsanto and the University of Ghent independently report the first expression in plants of foreign genes transferred via the Ti plasmid of Agrobacterium tumifaciens.
November 13, 1984
HIV Characterized (if not finally named)
At the 15th Princess Takamatsu Symposium, competing research groups from Institut Pasteur (Luc Montagnier) and NIH (Robert Gallo) present papers identifying the virus that causes AIDS.
January 1, 1984
OTA’s “Commercial Biotechnology”
U.S. Office of Technology Assessment publishes “Commercial Biotechnology: An International Analysis,” which forms the basis for much succeeding discussion of economic and regulatory development.
January 22, 1985
NIH Gene Therapy Guidelines
NIH publishes first draft of its points to consider in proposing experiments in human somatic cell gene therapy. Germ-line cell experiments remain off-limits.
March 7, 1985
The University of Leicester lab of Alec Jeffreys publishes “Hypervariable ‘minisatellite’ regions in human DNA,” laying out the theory and practice of DNA fingerprinting.
December 20, 1985
Kary Mullis and colleagues at Cetus publish “Enzymatic amplification of beta-globin genomic sequences and restriction site analysis for diagnosis of sickle cell anemia,” which describes the method for polymerase chain reaction gene amplification.
July 23, 1986
Recombinant Hepatitis B Vaccine
FDA grants a BLA to Merck & Co. for Recombivax HB, the first recombinant vaccine for hepatitis B.
Automated DNA Sequencing
Leroy Hood, Lloyd Smith, and colleagues at the California Institute of Technology describe “Fluorescence detection in automated DNA sequence analysis,” a milestone in the development of gene-sequencing machines.
June 26, 1986
White House Office of Science and Technology Policy publishes “Coordinated Framework for Regulation of Biotechnology” establishing regulatory jurisdiction and principles for USDA, EPA, FDA, NIH, NSF, and OSHA.
April 26, 1987
In the first authorized outdoor tests of a recombinant bacterium, Advanced Genetic Sciences’ FrostBan, a nonice- nucleating strain of Pseudomonas syringae, intended to delay frost damage to crops, is applied to a strawberry field.
November 25, 1987
Transgenic Plants in the Field
U.S. Dept. of Agriculture authorizes its first field tests: Calgene’s bromoxynil-resistant tobacco.
April 30, 1988
Human Genome Organization (HUGO) founded, with Johns Hopkins’ Victor McKusick as president.
U.S. Funds Genome
U.S. Congress appropriates first funds for sequencing the human genome for F/Y 1988. The precursor of the Human Genome Project starts life with $10.7 million from the DOE and $17.2 million from NIH.
April 12, 1988
USPTO grants patent 4,736,866 to Harvard College for Philip Leder and Timothy A. Stewart’s invention, “a transgenic nonhuman mammal whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said mammal…”
Ismael Hidalgo (co-founder of Absorption Systems) pioneers the characterization and development of Caco-2, an in vitro model to predict human intestinal absorption.
April 1, 1989
OTA’s “New Developments in Biotechnology: Patenting Life”
U.S. Office of Technology Assessment publishes “New Developments in Biotechnology: Patenting Life—Special Report,” outlining the scientific issues associated with intellectual property in genetic information, and outlining the legal arguments for and against.
December 21, 1990
A team from the laboratory of Mary-Claire King (UC Berkeley) identifies the link between a housekeeping gene, BRCA1, and an inherited predisposition to breast cancer.
February 1, 1990
NIH, DOE Pitch Human Genome Project
A joint working group of the U.S. DOE and the NIH presents “Understanding Our Genetic Inheritance, The U.S. Human Genome Project: The First Five Years (from 1991 to 1995)” to Congress.
October 1, 1991
OTA’s "Biotechnology in a Global Economy"
U.S. Office of Technology Assessment publishes “Biotechnology in a Global Economy,” focusing on America’s ability to compete in the increasingly worldwide enterprise of biotechnology.
October 11, 1991
NIH Files cDNA Patents
First reports that the NIH has filed patents on cDNA sequences discovered by then-NINDS researcher J. Craig Venter set off a firestorm. Partially lost in the exchange is NIH’s explanation that it was seeking the patents to establish prior art and forestall later applications by private parties.
May 26, 1992
FDA Biotech Food Policy
In its “Statement of Policy: Foods Derived from New Plant Varieties” FDA says it is “not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way,” indicating that it will not regulate bioengineered foods unilaterally.
April 1, 1992
Despite early enthusiasm for Centoxin, Centocor’s intended monoclonal blockbuster for treating toxic shock syndrome, FDA declines to approve the drug, saying data failed to show efficacy.
December 30, 1993
rDNase Approved for CF
U.S. FDA approves recombinant deoxyribonuclease I—or DNase I (generic name dornase alfa, tradename Pulmozyme)—to treat cystic fibrosis.
November 1, 1993
FDA approves Monsanto’s recombinant bovine somatotropin.
October 14, 1993
FDA & Gene Therapy
FDA publishes “Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products” establishing its role in regulating commercialization of these products.
May 17, 1994
In okaying sale of Calgene's recombinant FlavrSavr tomato, FDA concludes that it is as safe as conventional tomatoes, and that "the use of aminoglycoside 3'-phosphotransferase II is safe for use as a processing aid in the development of new varieties of tomato, oilseed rape, and cotton intended for food use."
July 28, 1995
First Bacterial Genome
A team from The Institute for Genomic Research (TIGR) publishes the 1.8 Mbp genome of the Gram-negative bacillus Haemophilus influenzae, the first cellular organism to be fully decoded.
November 10, 1995
FDA Lifts Special Restrictions on Biotech Drugs
Health and Human Services Secretary Donna Shalala announces that FDA will eliminate a host of special restrictions on biotechnology companies and their products, bringing them into the mainstream of drug regulation.
July 5, 1996
Ian Wilmut and colleagues from the Roslin Institute and PPL Therapeutics deliver the first mammal cloned from an adult somatic cell. She will live until 2003.
April 3, 1996
Biotech Crops in U.K.
First weed- and insect-resistant biotech crops commercialized: U.K. authorities call Roundup Ready soybeans "as safe as conventional soybeans."
Absorption Systems Founded
Absorption Systems, a preclinical ADMET contract research organization, is founded by Patrick Dentinger and Ismael Hidalgo in Exton, PA.
PDUFA Boosts Approvals
Additional resources paid for by the U.S. Prescription Drug User Fee Act (PDUFA passed in 1992) help FDA to break the backlog of drug and biologic applications, reducing review times and producing an all-time record number of New Drug Approvals and Biologic License Applications for New Molecular Entities.
November 6, 1998
Human Embryonic Stem Cells
James Thomson, Jeffrey Jones, and co-workers report isolating five human embryonic stem cell lines from human blastocysts, noting "These cell lines should be useful in human developmental biology, drug discovery, and transplantation medicine."
December 11, 1998
C. elegans Sequenced
The C. elegans Sequencing Consortium (based at Washington University and the Sanger Center) reports the full 97 Mbp genome of Caenorhabditis elegans, revealing more than 19,000 genes.
June 4, 1998
Preliminary Human Genome Map
The “rough draft” map of the human genome will “speed up the process of getting very useful sequences in the hands of people who want it,” says NHGRI director Francis Collins.
July 1, 1999
Vijay Singh, then head of largescale cell culture at Schering-Plough, describes a “disposable bioreactor for cell culture using wave-induced agitation,” inaugurating a significant trend in the manufacture of biologicals.
September 17, 1999
The death of 18-year-old Jesse Gelsinger in a University of Pennsylvania gene-therapy trial prompts an agonizing, industry-wide reappraisal.
December 14, 2000
Four articles lay out the genome of Arabidopsis thaliana, the first plant to be sequenced. The analysis covers 115.4 Mbp of the 125 Mbp genome, and 25,498 genes encoding proteins from 11,000 families.
June 26, 2000
Genome Sequenced (But It’s a Draft)
President Bill Clinton and Prime Minister Tony Blair, flanked by J. Craig Venter of Celera Genomics and Francis Collins of NHGRI, proclaim "the completion of the first survey of the entire human genome."
FDA publishes Biopharmaceutics Classification System (BCS) guidance; Absorption Systems’ novel Caco-2 testing leads to optimized standards for permeability assessment.
February 16, 2001
Human Genome, End of the Beginning?
A consortium including scientists from Celera Genomics and 13 other organizations publishes first consensus sequence of human genome: 2.91-billion bp generated by whole-genome shotgun sequencing. Findings: 26,588 v-encoding transcripts, plus about 12,000 possible (but weakly supported) genes, "separated by large tracts of apparently noncoding sequence. Only 1.1% of the genome is spanned by exons, whereas 24% is in introns, with 75% of the genome being intergenic DNA."
August 9, 2001
Stem Cell Restrictions
After months of lobbying from both sides and tense internal White House debate, President George W. Bush limits work on embryonic stem cells and bans creation of new eSC lines.
September 22, 2001
NAS Stem Cell Report
National Academy of Sciences publishes "Stem Cells and the Future of Regenerative Medicine."
October 3, 2002
Teams from TIGR and the Sanger Center report the 23 Mbp, AT-rich genomic sequence of Plasmodium falciparum, the malaria parasite, which carries some 5,300 genes. The same week, Celera Genomics researchers publish their genome of malaria’s Anopheles mosquito vector.
July 11, 2002
Researchers at the State University of New York report the creation of a full-genome cDNA from published sequences of poliovirus, and its reverse transcription into viral RNA.
November 21, 2002
University of Washington researchers show that vaccines can reduce incidence of infection by human papilloma virus, an established cause of cervical cancer.
April 14, 2003
Human Genome Map Project Complete
NHGRI and DOE announce completion of the Human Genome Project, two years ahead of schedule and at a cost of $2.7 billion. The completed sequence covers nearly 99% of human genome’s regions and has a 99.99% accuracy.
October 16, 2003
China Approves World’s First Gene-Therapy Product
The China State Food and Drug Administration approves the world’s first commercial genetherapy product—Gendicine, from Shenzhen SiBiono GeneTech, which delivers the p53 gene via an adenovirus vector as a therapy for squamous cell head and neck cancer.
July 28, 2004
NAS: Engineered Foods Are Safe
National Academy of Sciences study of engineered foods concludes that, "To date, no adverse health effects attributed to genetic engineering have been documented in the human population."
December 23, 2004
DNA Microarray Diagnostic Device
The FDA approves Roche AmpliChip Cytochrome P450 Genotyping Test, the first DNA microarray system okayed for clinical applications.
April 1, 2004
Lab Rat Genome
Rattus norvegicus becomes the third mammal (after humans and mice) to have its genome sequenced, in a project led by Baylor’s Richard Gibbs.
September 1, 2005
The broadly based Chimpanzee Sequencing and Analysis Consortium publishes its draft sequence for what may be our closest living relative, along with a “largely complete catalog” of about 40 million genetic changes that have arisen since the species diverged, casting a long-range light on human evolution.
August 11, 2005
Rice Genome Mapped
The International Rice Genome Sequencing Project publishes its “Map-based sequence of the rice genome,” covering 95% of the genome of the world’s most important staple crop.
August 25, 2005
Reprogrammed Stem Cells
Harvard scientists report fusing adult skin cells with embryonic stem cells to reset the culture so that the cells behave like embryonic stem cells.
January 31, 2006
Though Dow AgroSciences receives regulatory approval for a plant-made vaccine (from USDA’s Center for Veterinary Biologics, for a vaccine against Newcastle disease in poultry), the product is not marketed. It is nonetheless the first plant-pharmed vaccine to win approval.
June 14, 2007
Genome as Complex System
The NHGRI’s ENCODE consortium report “Decoding the Blueprint,” portrays the human genome as a complex informational network of genes, regulatory elements, and other factors yet to be discovered. Then NHGRI director Francis Collins predicts, "The scientific community will need to rethink some long-held views about what genes are and what they do, as well as how the genome’s functional elements have evolved."
April 3, 2008
Some RNAi Therapy Questions
A study by University of Kentucky researcher Jayakrishna Ambati and co-workers suggests that some RNAi drugs work by activating the immune system rather than by silencing genes.
Transporter Assays Take a Leap Forward Due to Increased Funding
FDA funds over $1M in research to Absorption Systems’ CellPort Technologies® to develop cellbased transporter assays.
November 20, 2009
A consortium based at Iowa State University-Ames publishes a draft sequence of the 2.3 Gbp maize genome. They predict the genome will contain 32,000 genes.
March 30, 2010
Court Voids Gene Patents
In Association for Molecular Pathology, et al. v United States Patent and Trademark Office, et al., U.S. District Court invalidates Myriad Genetics/ University of Utah Research Foundation patents on the BRCA1 and BRCA2 genes, accepting the argument that genes are products of nature and cannot be patented. Decision was partially reversed on July 29.
Successful System for Drug Transporters Introduced
Absorption Systems introduces its patented, Caco-2 based CellPort Technologies® as the most definitive test system for drug transporters.
April 29, 2011
Appeals Court OKs Stem Cell Funding
U.S. Court of Appeals for the District of Columbia lifted a lower-court injunction. The ruling opens the door for resumed federal funding of research on embryonic stem cells.