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Translational Medicine Molecular Imaging Driving Development Sridhar Nadamuni Pharmacoimaging combines traditional pharmacology with broad imaging capabilities, enabling better decision making, improved clinical trial design, and more confdent lead candidate selection. Imaging technologies are also being used for drug safety assessment, both to screen drugs in the discovery stage and to provide supporting data later on. Increasingly, imaging will be incorporated into preclinical and clinical studies to interrogate and quantify both drug effcacy and safety in the same animals or patients, according to presentations given at World Pharma Congress' recent "Molecular Imaging Conference in Drug Discovery and Development." "The uniqueness of our approach is to focus more on the drug target and disease biology up front, as we develop a picture of whether and how in vivo imaging can enhance intended decision making," says Patrick McConville, Ph.D., CSO and COO at Molecular Imaging. "Our approach drives successful pharmacoimaging by ensuring inherent relevance of the data output to the intended biological or molecular question, and how this relates to the clinical path and related decision making," Dr. McConville explained. In vivo imaging facilitates access to in- formation that is more directly relevant to drug mechanism or that cannot be obtained through other means. Further, imaging biomarkers are being used to provide readout of a broad range of relevant physiological and functional parameters, including metabolism, cellularity, proliferation, hypoxia, and infammation. Such data enables measurement of disease progression and response to targeted therapies, at a mechanistic level. Imaging has become a standard tool for characterizing biologic molecule targeting and biodistribution using isotopes for PET, SPECT, and fuorophores. Labeling of antibodies, antibody-drug conjugates, proteins and peptides, and nanoparticles for imagebased detection, is a powerful approach to drug discovery and development. New imaging modalities including photoacoustic technology and clinical fuorescence will provide powerful approaches to translational medicine. High-Throughput Toxicity Screening The CMOS-based microelectrode array Targeted small molecules linked to chemotherapy drugs are used in conjunction with a companion imaging agent. Vintafolide consists of a small molecule targeting the folate receptor that is linked to a potent chemotherapy drug. The companion imaging agent, etarfolatide, consists of the same small molecule that targets the folate receptor, but is instead conjugated to a 99mTc-based imaging group. Endocyte (MEA) system combines the advantages of both MEA systems and patch clamp systems, enabling noninvasive recording from complete cellular monolayers. It can record intracellular action potentials. With more than 16,000 sensor sites that can be addressed individually, the chip increases data output at single-cell resolution. The new silicon microelectrode array platform developed by Dries Braeken, Ph.D., R&D; team leader, and his colleagues at the NEWS Molecular Diagnostics > Seegene Taps Eidia to Bring its Molecular Diagnostics to Japan Molecular diagnostic developer Seegene is working with Eidia—Eisai's in vitro diagnostics arm—to bring its portfolio of TOCE™ technology-based multiplexed molecular diagnostic tests to the Japanese market. Under the terms of the agreement, Seegene will supply a range of these tests, which Eidia will exclusively market and distribute across the country. Seegene notes that Japan is the thirdlargest diagnostics market in the global $52 billion industry, behind North America and Europe. > Corgenix Makes Contract Manufacturing Agreement with EDP Biotech Diagnostic developer and marketer Corgenix Medical has entered into a 10year contract manufacturing agreement with EDP Biotech, a frm focused on the development and commercialization of immunodiagnostic tests. Under the terms of the agreement, Corgenix will manufacture and supply ColoMarker™, a blood test developed to detect the early stages of colon cancer. > MDxHealth, Summit Pharmaceuticals International Ink Japanese Distribution Deal MDxHealth has tapped Summit Pharmaceuticals International to gain access to the Japanese market for its PharmacoMDx epigenetic technologies and products. MDxHealth said that through this partnership, Summit will provide "the necessarily leverage and expertise to penetrate the Japanese market." > Mylan, Zyomyx Enter Exclusive Distribution Agreement for HIV/AIDS POC Dx Mylan and Zyomyx have entered into an exclusive agreement related to distribution rights for the latter's point-of-care (POC) CD4 T-cell count test—which is in the fnal stages of development and is expected to launch next year—in the developing world. Physicians often refer to patients' CD4 count for diagnostic purposes in cases of HIV/AIDS. Under the terms of the agreement, Mylan has also made an undisclosed equity investment in Zyomyx. Further, to complement this agreement, Mylan has inked a global access commitment with the Bill & Melinda Gates Foundation. The frm said it has committed to ensuring the Zyomyx CD4 test is made available at a reasonable price in high-burden HIV countries. n Interuniversitair Micro-Electronica Centrum (IMEC) in Belgium, is equipped with thousands of sensors on a single silicon chip, to target single cells growing on the surface. The standard silicon technology integrating all amplifers, flters, stimulation and impedance circuitry into the chip, facilitates massive parallelization and increasingly effcient and cheaper systems. Additional ultra-small electrodes enable recording and stimulation of single cells. As Dr. Braeken explained, "We developed a new assay to record signals that are much larger in amplitude than extracellular signals—up to 20 mV versus one to two mV." These signals closely resemble intracellular signals recorded with patch clamp techniques. The assay makes use of the integrated stimulation circuitry to create transient nanopores by electroporation of the membrane patch. This creates a low-resistance path to the intracellular milieu, enabling observation of the full shape of the action potential. The intracellular signals are available from a single cell over fve consecutive days. For example, cardiac cellular signals recorded by this chip allowed for the accurate measurement of cardiac action potential duration, upstroke velocity, and different phases of the downstroke. The CMOS MEA system is poised for a multiwell format, allowing ultra-high throughput without compromising signal quality. Software design and automation should enable extraction of specifc ion channel parameters for drug screening. The technology can be integrated in organ-on-a-chip systems for more advanced predictive toxicology screening of cardiac or neuronal cells. See Molecular Imaging on page 36 34 | August 2013 | GENengnews.com | Genetic Engineering & Biotechnology News