Genetic Engineering & Biotechnology News

SEP15 2017

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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28 | SEPTEMBER 15, 2017 | | Genetic Engineering & Biotechnology News ogy, so is our practice; what the pathologist thinks today, the physician does tomorrow." Transitioning to Diagnostics The transition from research to the clinic is a long and winding road for diagnostic platforms. "There are many challenges that must be overcome," explains Michael Mon- talto, Ph.D., executive director and head of translational pathology and biomarker tech- nologies, translational medicine, Bristol-My- ers Squibb. New diagnostic platforms usu- ally emerge from the exploratory research setting. In the case of digital pathology-based tests, there are signs of progress. Dr. Montal- to points to immune checkpoint modulators as a driving force. "These are rapidly altering the way physicians treat cancer." Although these tests are helpful, there are also challenges of introducing new immu- nohistochemistry (IHC) tests. "When IHC slides are examined, often there is reader-to- reader variability," says Dr. Montalto. "Also, we are learning that quantifying specific types of immune cells may be more relevant than others, and it's nearly impossible to dif- ferentiate them under a microscope. Digital pathology and computer vision will certainly help in such cases. In the past decade, this technology has made rapid progress in the automated quantitation of positive cells, providing more robust and repeatable data in clinical trials." Another example of progress from re- search to the clinic occurred this past spring. The FDA approved marketing of Philips' In- telliSite Pathology Solution, the first whole- slide imaging system, for the primary review and interpretation of digital surgical pathol- ogy slides. The system enables pathologists to read tissue slides digitally, instead of using a microscope, to make a diagnosis. "This is a significant step forward for digital pathol- ogy," observes Dr. Montalto. "It paves the way for automated image analysis of com- panion and complementary IHC diagnostic tests to enter the clinic." Because exploratory research in immuno- oncology continues to expand, Dr. Montalto believes the market will continue to see more of this approach. Another future improve- ment will include multiplexing that assesses many proteins, not just one, which is critical for immunophenotyping in the context of the tumor microenvironment. "We are already using it extensively on the research side of things, but the model al- lowing it to move into diagnostics has not yet arrived," states Dr. Montalto. "Current- ly, challenges include regulatory hurdles, re- imbursement, and cost. One doesn't just use a $10,000 microscope for this sort of thing. Multiplexing also needs to be simplified. It is still very technically challenging, and must be better automated for a non-Ph.D. opera- tor. However, these are all standard market limitations for transitioning from the re- search to the diagnostic market." It's just a matter of time until these chal- lenges are surmounted, according to Dr. Montalto: "Multiplexed image analysis and a host of other technologies such as next- generation sequencing, gene-expression pro- filing, and liquid biopsies are on the horizon. All are progressing rapidly and improving to ultimately allow everyday incorporation into the diagnostic arena. This will also greatly improve patient stratification and enhance precision medicine." Into the Future With the rise of digital pathology, pa- thologists are beginning to perform the most of their diagnostic reviews using computer workstations instead of microscopes. "Most of the initial hurdles of these new technolo- gies have now been overcome, and this opens up new possibilities," notes Jesper Molin, se- nior research scientist, Sectra. "For example, it is now possible to review multiple slides side by side, to store and collect key images, and to search for diagnostic information in the contrast data of the image. These are all novel tools that will make pathologists smarter in the future." Does that mean we may soon no longer need the eyes and intuition of pathologists? Not at all. "Machine learning will be very important within the pathology domain as many researchers and companies work on systems to automate part of the work that pathologists perform," explains Molin. Protein & Antibody Engineering Summit 13 – 17 November 2017 | EPIC SANA Lisboa Hotel | Lisbon, Portugal Ninth Annual Plenary Keynotes Safety Considerations for Development of Immune Agonist and Immune Antagonist Biotherapeutics Rakesh Dixit, Ph.D., DABT, Vice President, R&D, and Global Head, Biologics Safety Assessment, MedImmune (A member of AstraZeneca Group) Learning What Works from Successful Tumour Infiltrating Lymphocyte Therapy Andrew Sewell, Ph.D., Professor, Division of Infection and Immunity, Cardiff University School of Medicine Widening the Therapeutic Index: The Next Generation of Antibody-Drug Conjugates (ADCs) John M. Lambert, Ph.D., Executive Vice President Emeritus and Distinguished Research Fellow, ImmunoGen, Inc. A Division of Cambridge Innovation Institute The best biologics technology meeting in Europe: a must-attend conference for novel biologics. One of the best antibody conferences I've been to. The presentations were of superb quality. PEGS Europe is a gem for protein engineers with depth and breadth in a stimulating and engaging environment! REGISTER BY 6 OCTOBER AND SAVE! Tissue Samples Continued from page 27 Translational Medicine

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