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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Growth Hormone Research Society perspective on the development of
long-acting growth hormone preparations</title><author><name sortKey="Christiansen, Jens Sandahl" sort="Christiansen, Jens Sandahl" uniqKey="Christiansen J" first="Jens Sandahl" last="Christiansen">Jens Sandahl Christiansen</name><affiliation><nlm:aff id="aff1"><institution>Aarhus University</institution><addr-line>Aarhus, Denmark</addr-line></nlm:aff></affiliation></author><author><name sortKey="Backeljauw, Philippe F" sort="Backeljauw, Philippe F" uniqKey="Backeljauw P" first="Philippe F" last="Backeljauw">Philippe F. Backeljauw</name><affiliation><nlm:aff id="aff2"><institution>Cincinnati Children’s Hospital</institution><addr-line>Cincinnati, Ohio, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Bidlingmaier, Martin" sort="Bidlingmaier, Martin" uniqKey="Bidlingmaier M" first="Martin" last="Bidlingmaier">Martin Bidlingmaier</name><affiliation><nlm:aff id="aff3"><institution>Klinikum der Universität München</institution><addr-line>Munich, Germany</addr-line></nlm:aff></affiliation></author><author><name sortKey="Biller, Beverly M K" sort="Biller, Beverly M K" uniqKey="Biller B" first="Beverly M K" last="Biller">Beverly M K. Biller</name><affiliation><nlm:aff id="aff4"><institution>Massachusetts General Hospital</institution><addr-line>Boston, Massachusetts, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Boguszewski, Margaret C S" sort="Boguszewski, Margaret C S" uniqKey="Boguszewski M" first="Margaret C S" last="Boguszewski">Margaret C S. Boguszewski</name><affiliation><nlm:aff id="aff5"><institution>Federal University of Parana</institution><addr-line>Curitiba, Brazil</addr-line></nlm:aff></affiliation></author><author><name sortKey="Casanueva, Felipe F" sort="Casanueva, Felipe F" uniqKey="Casanueva F" first="Felipe F" last="Casanueva">Felipe F. Casanueva</name><affiliation><nlm:aff id="aff6"><institution>Santiago de Compostela University</institution><addr-line>Santiago de Compostela, Spain</addr-line></nlm:aff></affiliation></author><author><name sortKey="Chanson, Philippe" sort="Chanson, Philippe" uniqKey="Chanson P" first="Philippe" last="Chanson">Philippe Chanson</name><affiliation><nlm:aff id="aff7"><institution>Université Paris Saclay</institution><addr-line>Le Kremlin-BicϪtre, France</addr-line></nlm:aff></affiliation></author><author><name sortKey="Chatelain, Pierre" sort="Chatelain, Pierre" uniqKey="Chatelain P" first="Pierre" last="Chatelain">Pierre Chatelain</name><affiliation><nlm:aff id="aff8"><institution>University Claude Bernard</institution><addr-line>Lyon, France</addr-line></nlm:aff></affiliation></author><author><name sortKey="Choong, Catherine S" sort="Choong, Catherine S" uniqKey="Choong C" first="Catherine S" last="Choong">Catherine S. Choong</name><affiliation><nlm:aff id="aff9"><institution>University of Western Australia</institution><addr-line>Subiaco, Western Australia, Australia</addr-line></nlm:aff></affiliation></author><author><name sortKey="Clemmons, David R" sort="Clemmons, David R" uniqKey="Clemmons D" first="David R" last="Clemmons">David R. Clemmons</name><affiliation><nlm:aff id="aff10"><institution>University of North Carolina</institution><addr-line>Chapel Hill, North Carolina, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Cohen, Laurie E" sort="Cohen, Laurie E" uniqKey="Cohen L" first="Laurie E" last="Cohen">Laurie E. Cohen</name><affiliation><nlm:aff id="aff11"><institution>Boston Children’s Hospital</institution><addr-line>Boston, Massachusetts, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Cohen, Pinchas" sort="Cohen, Pinchas" uniqKey="Cohen P" first="Pinchas" last="Cohen">Pinchas Cohen</name><affiliation><nlm:aff id="aff12"><institution>University of Southern California</institution><addr-line>Los Angeles, California, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Frystyk, Jan" sort="Frystyk, Jan" uniqKey="Frystyk J" first="Jan" last="Frystyk">Jan Frystyk</name><affiliation><nlm:aff id="aff1"><institution>Aarhus University</institution><addr-line>Aarhus, Denmark</addr-line></nlm:aff></affiliation></author><author><name sortKey="Grimberg, Adda" sort="Grimberg, Adda" uniqKey="Grimberg A" first="Adda" last="Grimberg">Adda Grimberg</name><affiliation><nlm:aff id="aff13"><institution>Children’s Hospital of Philadelphia</institution><addr-line>Philadelphia, Pennsylvania, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Hasegawa, Yukihiro" sort="Hasegawa, Yukihiro" uniqKey="Hasegawa Y" first="Yukihiro" last="Hasegawa">Yukihiro Hasegawa</name><affiliation><nlm:aff id="aff14"><institution>Tokyo Metropolitan Children’s Medical Center</institution><addr-line>Tokyo, Japan</addr-line></nlm:aff></affiliation></author><author><name sortKey="Haymond, Morey W" sort="Haymond, Morey W" uniqKey="Haymond M" first="Morey W" last="Haymond">Morey W. Haymond</name><affiliation><nlm:aff id="aff15"><institution>Baylor College of Medicine</institution><addr-line>Houston, Texas, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Ho, Ken" sort="Ho, Ken" uniqKey="Ho K" first="Ken" last="Ho">Ken Ho</name><affiliation><nlm:aff id="aff16"><institution>University of Queensland</institution><addr-line>Brisbane, Queensland, Australia</addr-line></nlm:aff></affiliation></author><author><name sortKey="Hoffman, Andrew R" sort="Hoffman, Andrew R" uniqKey="Hoffman A" first="Andrew R" last="Hoffman">Andrew R. Hoffman</name><affiliation><nlm:aff id="aff17"><institution>VA Palo Alto Health Care System and Stanford University</institution><addr-line>Palo Alto, California, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Holly, Jeff M P" sort="Holly, Jeff M P" uniqKey="Holly J" first="Jeff M P" last="Holly">Jeff M P. Holly</name><affiliation><nlm:aff id="aff18"><institution>University of Bristol</institution><addr-line>Bristol, UK</addr-line></nlm:aff></affiliation></author><author><name sortKey="Horikawa, Reiko" sort="Horikawa, Reiko" uniqKey="Horikawa R" first="Reiko" last="Horikawa">Reiko Horikawa</name><affiliation><nlm:aff id="aff19"><institution>National Center for Child Health and Development</institution><addr-line>Tokyo, Japan</addr-line></nlm:aff></affiliation></author><author><name sortKey="Hoybye, Charlotte" sort="Hoybye, Charlotte" uniqKey="Hoybye C" first="Charlotte" last="Höybye">Charlotte Höybye</name><affiliation><nlm:aff id="aff20"><institution>Karolinska University Hospital</institution><addr-line>Stockholm, Sweden</addr-line></nlm:aff></affiliation></author><author><name sortKey="Jorgensen, Jens Otto L" sort="Jorgensen, Jens Otto L" uniqKey="Jorgensen J" first="Jens Otto L" last="Jorgensen">Jens Otto L. Jorgensen</name><affiliation><nlm:aff id="aff1"><institution>Aarhus University</institution><addr-line>Aarhus, Denmark</addr-line></nlm:aff></affiliation></author><author><name sortKey="Johannsson, Gudmundur" sort="Johannsson, Gudmundur" uniqKey="Johannsson G" first="Gudmundur" last="Johannsson">Gudmundur Johannsson</name><affiliation><nlm:aff id="aff21"><institution>University of Gothenburg</institution><addr-line>Gothenburg, Sweden</addr-line></nlm:aff></affiliation></author><author><name sortKey="Juul, Anders" sort="Juul, Anders" uniqKey="Juul A" first="Anders" last="Juul">Anders Juul</name><affiliation><nlm:aff id="aff22"><institution>Rigshospitalet</institution><addr-line>University of Copenhagen, Copenhagen, Denmark</addr-line></nlm:aff></affiliation></author><author><name sortKey="Katznelson, Laurence" sort="Katznelson, Laurence" uniqKey="Katznelson L" first="Laurence" last="Katznelson">Laurence Katznelson</name><affiliation><nlm:aff id="aff23"><institution>Stanford University</institution><addr-line>Stanford, California, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Kopchick, John J" sort="Kopchick, John J" uniqKey="Kopchick J" first="John J" last="Kopchick">John J. Kopchick</name><affiliation><nlm:aff id="aff24"><institution>Ohio University</institution><addr-line>Athens, Ohio, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Lee, K O" sort="Lee, K O" uniqKey="Lee K" first="K O" last="Lee">K O Lee</name><affiliation><nlm:aff id="aff25"><institution>National University of Singapore</institution><addr-line>Singapore, Singapore</addr-line></nlm:aff></affiliation></author><author><name sortKey="Lee, Kuk Wha" sort="Lee, Kuk Wha" uniqKey="Lee K" first="Kuk-Wha" last="Lee">Kuk-Wha Lee</name><affiliation><nlm:aff id="aff26"><institution>UCLA School of Medicine</institution><addr-line>Los Angeles, California, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Luo, Xiaoping" sort="Luo, Xiaoping" uniqKey="Luo X" first="Xiaoping" last="Luo">Xiaoping Luo</name><affiliation><nlm:aff id="aff27"><institution>Tongji Hospital</institution><addr-line>Wuhan, China</addr-line></nlm:aff></affiliation></author><author><name sortKey="Melmed, Shlomo" sort="Melmed, Shlomo" uniqKey="Melmed S" first="Shlomo" last="Melmed">Shlomo Melmed</name><affiliation><nlm:aff id="aff28"><institution>Cedars-Sinai Medical Center</institution><addr-line>Los Angeles, California, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Miller, Bradley S" sort="Miller, Bradley S" uniqKey="Miller B" first="Bradley S" last="Miller">Bradley S. Miller</name><affiliation><nlm:aff id="aff29"><institution>Masonic Children’s Hospital</institution><addr-line>Minneapolis, Minnesota, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Misra, Madhusmita" sort="Misra, Madhusmita" uniqKey="Misra M" first="Madhusmita" last="Misra">Madhusmita Misra</name><affiliation><nlm:aff id="aff4"><institution>Massachusetts General Hospital</institution><addr-line>Boston, Massachusetts, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Popovic, Vera" sort="Popovic, Vera" uniqKey="Popovic V" first="Vera" last="Popovic">Vera Popovic</name><affiliation><nlm:aff id="aff30"><institution>University of Belgrade</institution><addr-line>Belgrade, Serbia</addr-line></nlm:aff></affiliation></author><author><name sortKey="Rosenfeld, Ron G" sort="Rosenfeld, Ron G" uniqKey="Rosenfeld R" first="Ron G" last="Rosenfeld">Ron G. Rosenfeld</name><affiliation><nlm:aff id="aff31"><institution>Stat5 Consulting</institution><addr-line>Los Altos, California, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Ross, Judith" sort="Ross, Judith" uniqKey="Ross J" first="Judith" last="Ross">Judith Ross</name><affiliation><nlm:aff id="aff32"><institution>Jefferson Medical College</institution><addr-line>Philadelphia, Pennsylvania, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Ross, Richard J" sort="Ross, Richard J" uniqKey="Ross R" first="Richard J" last="Ross">Richard J. Ross</name><affiliation><nlm:aff id="aff33"><institution>University of Sheffield</institution><addr-line>Sheffield, UK</addr-line></nlm:aff></affiliation></author><author><name sortKey="Saenger, Paul" sort="Saenger, Paul" uniqKey="Saenger P" first="Paul" last="Saenger">Paul Saenger</name><affiliation><nlm:aff id="aff34"><institution>SUNY</institution><addr-line>Stony Brook, New York, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Strasburger, Christian J" sort="Strasburger, Christian J" uniqKey="Strasburger C" first="Christian J" last="Strasburger">Christian J. Strasburger</name><affiliation><nlm:aff id="aff35"><institution>Charite-Universitätsmedizin</institution><addr-line>Berlin, Germany</addr-line></nlm:aff></affiliation></author><author><name sortKey="Thorner, Michael O" sort="Thorner, Michael O" uniqKey="Thorner M" first="Michael O" last="Thorner">Michael O. Thorner</name><affiliation><nlm:aff id="aff36"><institution>University of Virginia</institution><addr-line>Charlottesville, Virginia, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Werner, Haim" sort="Werner, Haim" uniqKey="Werner H" first="Haim" last="Werner">Haim Werner</name><affiliation><nlm:aff id="aff37"><institution>Tel Aviv University</institution><addr-line>Tel Aviv, Israel</addr-line></nlm:aff></affiliation></author><author><name sortKey="Yuen, Kevin" sort="Yuen, Kevin" uniqKey="Yuen K" first="Kevin" last="Yuen">Kevin Yuen</name><affiliation><nlm:aff id="aff38"><institution>Swedish Neuroscience Institute</institution><addr-line>Seattle, Washington, USA</addr-line></nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">27009113</idno><idno type="pmc">5081743</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5081743</idno><idno type="RBID">PMC:5081743</idno><idno type="doi">10.1530/EJE-16-0111</idno><date when="2016">2016</date><idno type="wicri:Area/Pmc/Corpus">001189</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001189</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Growth Hormone Research Society perspective on the development of
long-acting growth hormone preparations</title><author><name sortKey="Christiansen, Jens Sandahl" sort="Christiansen, Jens Sandahl" uniqKey="Christiansen J" first="Jens Sandahl" last="Christiansen">Jens Sandahl Christiansen</name><affiliation><nlm:aff id="aff1"><institution>Aarhus University</institution><addr-line>Aarhus, Denmark</addr-line></nlm:aff></affiliation></author><author><name sortKey="Backeljauw, Philippe F" sort="Backeljauw, Philippe F" uniqKey="Backeljauw P" first="Philippe F" last="Backeljauw">Philippe F. Backeljauw</name><affiliation><nlm:aff id="aff2"><institution>Cincinnati Children’s Hospital</institution><addr-line>Cincinnati, Ohio, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Bidlingmaier, Martin" sort="Bidlingmaier, Martin" uniqKey="Bidlingmaier M" first="Martin" last="Bidlingmaier">Martin Bidlingmaier</name><affiliation><nlm:aff id="aff3"><institution>Klinikum der Universität München</institution><addr-line>Munich, Germany</addr-line></nlm:aff></affiliation></author><author><name sortKey="Biller, Beverly M K" sort="Biller, Beverly M K" uniqKey="Biller B" first="Beverly M K" last="Biller">Beverly M K. Biller</name><affiliation><nlm:aff id="aff4"><institution>Massachusetts General Hospital</institution><addr-line>Boston, Massachusetts, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Boguszewski, Margaret C S" sort="Boguszewski, Margaret C S" uniqKey="Boguszewski M" first="Margaret C S" last="Boguszewski">Margaret C S. Boguszewski</name><affiliation><nlm:aff id="aff5"><institution>Federal University of Parana</institution><addr-line>Curitiba, Brazil</addr-line></nlm:aff></affiliation></author><author><name sortKey="Casanueva, Felipe F" sort="Casanueva, Felipe F" uniqKey="Casanueva F" first="Felipe F" last="Casanueva">Felipe F. Casanueva</name><affiliation><nlm:aff id="aff6"><institution>Santiago de Compostela University</institution><addr-line>Santiago de Compostela, Spain</addr-line></nlm:aff></affiliation></author><author><name sortKey="Chanson, Philippe" sort="Chanson, Philippe" uniqKey="Chanson P" first="Philippe" last="Chanson">Philippe Chanson</name><affiliation><nlm:aff id="aff7"><institution>Université Paris Saclay</institution><addr-line>Le Kremlin-BicϪtre, France</addr-line></nlm:aff></affiliation></author><author><name sortKey="Chatelain, Pierre" sort="Chatelain, Pierre" uniqKey="Chatelain P" first="Pierre" last="Chatelain">Pierre Chatelain</name><affiliation><nlm:aff id="aff8"><institution>University Claude Bernard</institution><addr-line>Lyon, France</addr-line></nlm:aff></affiliation></author><author><name sortKey="Choong, Catherine S" sort="Choong, Catherine S" uniqKey="Choong C" first="Catherine S" last="Choong">Catherine S. Choong</name><affiliation><nlm:aff id="aff9"><institution>University of Western Australia</institution><addr-line>Subiaco, Western Australia, Australia</addr-line></nlm:aff></affiliation></author><author><name sortKey="Clemmons, David R" sort="Clemmons, David R" uniqKey="Clemmons D" first="David R" last="Clemmons">David R. Clemmons</name><affiliation><nlm:aff id="aff10"><institution>University of North Carolina</institution><addr-line>Chapel Hill, North Carolina, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Cohen, Laurie E" sort="Cohen, Laurie E" uniqKey="Cohen L" first="Laurie E" last="Cohen">Laurie E. Cohen</name><affiliation><nlm:aff id="aff11"><institution>Boston Children’s Hospital</institution><addr-line>Boston, Massachusetts, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Cohen, Pinchas" sort="Cohen, Pinchas" uniqKey="Cohen P" first="Pinchas" last="Cohen">Pinchas Cohen</name><affiliation><nlm:aff id="aff12"><institution>University of Southern California</institution><addr-line>Los Angeles, California, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Frystyk, Jan" sort="Frystyk, Jan" uniqKey="Frystyk J" first="Jan" last="Frystyk">Jan Frystyk</name><affiliation><nlm:aff id="aff1"><institution>Aarhus University</institution><addr-line>Aarhus, Denmark</addr-line></nlm:aff></affiliation></author><author><name sortKey="Grimberg, Adda" sort="Grimberg, Adda" uniqKey="Grimberg A" first="Adda" last="Grimberg">Adda Grimberg</name><affiliation><nlm:aff id="aff13"><institution>Children’s Hospital of Philadelphia</institution><addr-line>Philadelphia, Pennsylvania, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Hasegawa, Yukihiro" sort="Hasegawa, Yukihiro" uniqKey="Hasegawa Y" first="Yukihiro" last="Hasegawa">Yukihiro Hasegawa</name><affiliation><nlm:aff id="aff14"><institution>Tokyo Metropolitan Children’s Medical Center</institution><addr-line>Tokyo, Japan</addr-line></nlm:aff></affiliation></author><author><name sortKey="Haymond, Morey W" sort="Haymond, Morey W" uniqKey="Haymond M" first="Morey W" last="Haymond">Morey W. Haymond</name><affiliation><nlm:aff id="aff15"><institution>Baylor College of Medicine</institution><addr-line>Houston, Texas, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Ho, Ken" sort="Ho, Ken" uniqKey="Ho K" first="Ken" last="Ho">Ken Ho</name><affiliation><nlm:aff id="aff16"><institution>University of Queensland</institution><addr-line>Brisbane, Queensland, Australia</addr-line></nlm:aff></affiliation></author><author><name sortKey="Hoffman, Andrew R" sort="Hoffman, Andrew R" uniqKey="Hoffman A" first="Andrew R" last="Hoffman">Andrew R. Hoffman</name><affiliation><nlm:aff id="aff17"><institution>VA Palo Alto Health Care System and Stanford University</institution><addr-line>Palo Alto, California, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Holly, Jeff M P" sort="Holly, Jeff M P" uniqKey="Holly J" first="Jeff M P" last="Holly">Jeff M P. Holly</name><affiliation><nlm:aff id="aff18"><institution>University of Bristol</institution><addr-line>Bristol, UK</addr-line></nlm:aff></affiliation></author><author><name sortKey="Horikawa, Reiko" sort="Horikawa, Reiko" uniqKey="Horikawa R" first="Reiko" last="Horikawa">Reiko Horikawa</name><affiliation><nlm:aff id="aff19"><institution>National Center for Child Health and Development</institution><addr-line>Tokyo, Japan</addr-line></nlm:aff></affiliation></author><author><name sortKey="Hoybye, Charlotte" sort="Hoybye, Charlotte" uniqKey="Hoybye C" first="Charlotte" last="Höybye">Charlotte Höybye</name><affiliation><nlm:aff id="aff20"><institution>Karolinska University Hospital</institution><addr-line>Stockholm, Sweden</addr-line></nlm:aff></affiliation></author><author><name sortKey="Jorgensen, Jens Otto L" sort="Jorgensen, Jens Otto L" uniqKey="Jorgensen J" first="Jens Otto L" last="Jorgensen">Jens Otto L. Jorgensen</name><affiliation><nlm:aff id="aff1"><institution>Aarhus University</institution><addr-line>Aarhus, Denmark</addr-line></nlm:aff></affiliation></author><author><name sortKey="Johannsson, Gudmundur" sort="Johannsson, Gudmundur" uniqKey="Johannsson G" first="Gudmundur" last="Johannsson">Gudmundur Johannsson</name><affiliation><nlm:aff id="aff21"><institution>University of Gothenburg</institution><addr-line>Gothenburg, Sweden</addr-line></nlm:aff></affiliation></author><author><name sortKey="Juul, Anders" sort="Juul, Anders" uniqKey="Juul A" first="Anders" last="Juul">Anders Juul</name><affiliation><nlm:aff id="aff22"><institution>Rigshospitalet</institution><addr-line>University of Copenhagen, Copenhagen, Denmark</addr-line></nlm:aff></affiliation></author><author><name sortKey="Katznelson, Laurence" sort="Katznelson, Laurence" uniqKey="Katznelson L" first="Laurence" last="Katznelson">Laurence Katznelson</name><affiliation><nlm:aff id="aff23"><institution>Stanford University</institution><addr-line>Stanford, California, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Kopchick, John J" sort="Kopchick, John J" uniqKey="Kopchick J" first="John J" last="Kopchick">John J. Kopchick</name><affiliation><nlm:aff id="aff24"><institution>Ohio University</institution><addr-line>Athens, Ohio, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Lee, K O" sort="Lee, K O" uniqKey="Lee K" first="K O" last="Lee">K O Lee</name><affiliation><nlm:aff id="aff25"><institution>National University of Singapore</institution><addr-line>Singapore, Singapore</addr-line></nlm:aff></affiliation></author><author><name sortKey="Lee, Kuk Wha" sort="Lee, Kuk Wha" uniqKey="Lee K" first="Kuk-Wha" last="Lee">Kuk-Wha Lee</name><affiliation><nlm:aff id="aff26"><institution>UCLA School of Medicine</institution><addr-line>Los Angeles, California, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Luo, Xiaoping" sort="Luo, Xiaoping" uniqKey="Luo X" first="Xiaoping" last="Luo">Xiaoping Luo</name><affiliation><nlm:aff id="aff27"><institution>Tongji Hospital</institution><addr-line>Wuhan, China</addr-line></nlm:aff></affiliation></author><author><name sortKey="Melmed, Shlomo" sort="Melmed, Shlomo" uniqKey="Melmed S" first="Shlomo" last="Melmed">Shlomo Melmed</name><affiliation><nlm:aff id="aff28"><institution>Cedars-Sinai Medical Center</institution><addr-line>Los Angeles, California, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Miller, Bradley S" sort="Miller, Bradley S" uniqKey="Miller B" first="Bradley S" last="Miller">Bradley S. Miller</name><affiliation><nlm:aff id="aff29"><institution>Masonic Children’s Hospital</institution><addr-line>Minneapolis, Minnesota, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Misra, Madhusmita" sort="Misra, Madhusmita" uniqKey="Misra M" first="Madhusmita" last="Misra">Madhusmita Misra</name><affiliation><nlm:aff id="aff4"><institution>Massachusetts General Hospital</institution><addr-line>Boston, Massachusetts, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Popovic, Vera" sort="Popovic, Vera" uniqKey="Popovic V" first="Vera" last="Popovic">Vera Popovic</name><affiliation><nlm:aff id="aff30"><institution>University of Belgrade</institution><addr-line>Belgrade, Serbia</addr-line></nlm:aff></affiliation></author><author><name sortKey="Rosenfeld, Ron G" sort="Rosenfeld, Ron G" uniqKey="Rosenfeld R" first="Ron G" last="Rosenfeld">Ron G. Rosenfeld</name><affiliation><nlm:aff id="aff31"><institution>Stat5 Consulting</institution><addr-line>Los Altos, California, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Ross, Judith" sort="Ross, Judith" uniqKey="Ross J" first="Judith" last="Ross">Judith Ross</name><affiliation><nlm:aff id="aff32"><institution>Jefferson Medical College</institution><addr-line>Philadelphia, Pennsylvania, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Ross, Richard J" sort="Ross, Richard J" uniqKey="Ross R" first="Richard J" last="Ross">Richard J. Ross</name><affiliation><nlm:aff id="aff33"><institution>University of Sheffield</institution><addr-line>Sheffield, UK</addr-line></nlm:aff></affiliation></author><author><name sortKey="Saenger, Paul" sort="Saenger, Paul" uniqKey="Saenger P" first="Paul" last="Saenger">Paul Saenger</name><affiliation><nlm:aff id="aff34"><institution>SUNY</institution><addr-line>Stony Brook, New York, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Strasburger, Christian J" sort="Strasburger, Christian J" uniqKey="Strasburger C" first="Christian J" last="Strasburger">Christian J. Strasburger</name><affiliation><nlm:aff id="aff35"><institution>Charite-Universitätsmedizin</institution><addr-line>Berlin, Germany</addr-line></nlm:aff></affiliation></author><author><name sortKey="Thorner, Michael O" sort="Thorner, Michael O" uniqKey="Thorner M" first="Michael O" last="Thorner">Michael O. Thorner</name><affiliation><nlm:aff id="aff36"><institution>University of Virginia</institution><addr-line>Charlottesville, Virginia, USA</addr-line></nlm:aff></affiliation></author><author><name sortKey="Werner, Haim" sort="Werner, Haim" uniqKey="Werner H" first="Haim" last="Werner">Haim Werner</name><affiliation><nlm:aff id="aff37"><institution>Tel Aviv University</institution><addr-line>Tel Aviv, Israel</addr-line></nlm:aff></affiliation></author><author><name sortKey="Yuen, Kevin" sort="Yuen, Kevin" uniqKey="Yuen K" first="Kevin" last="Yuen">Kevin Yuen</name><affiliation><nlm:aff id="aff38"><institution>Swedish Neuroscience Institute</institution><addr-line>Seattle, Washington, USA</addr-line></nlm:aff></affiliation></author></analytic><series><title level="j">European Journal of Endocrinology</title><idno type="ISSN">0804-4643</idno><idno type="eISSN">1479-683X</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Objective</title><p>The Growth Hormone (GH) Research Society (GRS) convened a workshop to address
important issues regarding trial design, efficacy, and safety of long-acting
growth hormone preparations (LAGH).</p></sec><sec><title>Participants</title><p>A closed meeting of 55 international scientists with expertise in GH, including
pediatric and adult endocrinologists, basic scientists, regulatory scientists, and
participants from the pharmaceutical industry.</p></sec><sec><title>Evidence</title><p>Current literature was reviewed for gaps in knowledge. Expert opinion was used to
suggest studies required to address potential safety and efficacy issues.</p></sec><sec><title>Consensus process</title><p>Following plenary presentations summarizing the literature, breakout groups
discussed questions framed by the planning committee. Attendees reconvened after
each breakout session to share group reports. A writing team compiled the breakout
session reports into a draft document that was discussed and revised in an open
forum on the concluding day. This was edited further and then circulated to
attendees from academic institutions for review after the meeting. Participants
from pharmaceutical companies did not participate in the planning, writing, or in
the discussions and text revision on the final day of the workshop. Scientists
from industry and regulatory agencies reviewed the manuscript to identify any
factual errors.</p></sec><sec><title>Conclusions</title><p>LAGH compounds may represent an advance over daily GH injections because of
increased convenience and differing phamacodynamic properties, providing the
potential for improved adherence and outcomes. Better methods to assess adherence
must be developed and validated. Long-term surveillance registries that include
assessment of efficacy, cost-benefit, disease burden, quality of life, and safety
are essential for understanding the impact of sustained exposure to LAGH
preparations.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Bang, P" uniqKey="Bang P">P Bang</name></author><author><name sortKey="Bjerknes, R" uniqKey="Bjerknes R">R Bjerknes</name></author><author><name sortKey="Dahlgren, J" uniqKey="Dahlgren J">J Dahlgren</name></author><author><name sortKey="Dunkel, L" uniqKey="Dunkel L">L Dunkel</name></author><author><name sortKey="Gustafsson, J" uniqKey="Gustafsson J">J Gustafsson</name></author><author><name sortKey="Juul, A" uniqKey="Juul A">A Juul</name></author><author><name sortKey="Kristrom, B" uniqKey="Kristrom B">B Kriström</name></author><author><name sortKey="Tapanainen, P" uniqKey="Tapanainen P">P Tapanainen</name></author><author><name sortKey="Aberg, V" uniqKey="Aberg V">V. 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Eur J Endocrinol</journal-id><journal-id journal-id-type="iso-abbrev">Eur. J. Endocrinol</journal-id><journal-id journal-id-type="hwp">EJE</journal-id><journal-title-group><journal-title>European Journal of Endocrinology</journal-title></journal-title-group><issn pub-type="ppub">0804-4643</issn><issn pub-type="epub">1479-683X</issn><publisher><publisher-name>Bioscientifica Ltd</publisher-name><publisher-loc>Bristol</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">27009113</article-id><article-id pub-id-type="pmc">5081743</article-id><article-id pub-id-type="doi">10.1530/EJE-16-0111</article-id><article-id pub-id-type="publisher-id">EJE160111</article-id><article-categories><subj-group subj-group-type="heading"><subject>Commentary</subject></subj-group></article-categories><title-group><article-title>Growth Hormone Research Society perspective on the development of
long-acting growth hormone preparations</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Christiansen</surname><given-names>Jens Sandahl</given-names></name><xref ref-type="aff" rid="aff1">1</xref><xref ref-type="author-notes" rid="fn1">*</xref><xref ref-type="author-notes" rid="fn2">†</xref></contrib><contrib contrib-type="author"><name><surname>Backeljauw</surname><given-names>Philippe F</given-names></name><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Bidlingmaier</surname><given-names>Martin</given-names></name><xref ref-type="aff" rid="aff3">3</xref><xref ref-type="author-notes" rid="fn1">*</xref></contrib><contrib contrib-type="author"><name><surname>Biller</surname><given-names>Beverly M K</given-names></name><xref ref-type="aff" rid="aff4">4</xref><xref ref-type="author-notes" rid="fn1">*</xref></contrib><contrib contrib-type="author"><name><surname>Boguszewski</surname><given-names>Margaret C S</given-names></name><xref ref-type="aff" rid="aff5">5</xref></contrib><contrib contrib-type="author"><name><surname>Casanueva</surname><given-names>Felipe F</given-names></name><xref ref-type="aff" rid="aff6">6</xref></contrib><contrib contrib-type="author"><name><surname>Chanson</surname><given-names>Philippe</given-names></name><xref ref-type="aff" rid="aff7">7</xref></contrib><contrib contrib-type="author"><name><surname>Chatelain</surname><given-names>Pierre</given-names></name><xref ref-type="aff" rid="aff8">8</xref></contrib><contrib contrib-type="author"><name><surname>Choong</surname><given-names>Catherine S</given-names></name><xref ref-type="aff" rid="aff9">9</xref></contrib><contrib contrib-type="author"><name><surname>Clemmons</surname><given-names>David R</given-names></name><xref ref-type="aff" rid="aff10">10</xref></contrib><contrib contrib-type="author"><name><surname>Cohen</surname><given-names>Laurie E</given-names></name><xref ref-type="aff" rid="aff11">11</xref></contrib><contrib contrib-type="author"><name><surname>Cohen</surname><given-names>Pinchas</given-names></name><xref ref-type="aff" rid="aff12">12</xref><xref ref-type="author-notes" rid="fn1">*</xref></contrib><contrib contrib-type="author"><name><surname>Frystyk</surname><given-names>Jan</given-names></name><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Grimberg</surname><given-names>Adda</given-names></name><xref ref-type="aff" rid="aff13">13</xref></contrib><contrib contrib-type="author"><name><surname>Hasegawa</surname><given-names>Yukihiro</given-names></name><xref ref-type="aff" rid="aff14">14</xref></contrib><contrib contrib-type="author"><name><surname>Haymond</surname><given-names>Morey W</given-names></name><xref ref-type="aff" rid="aff15">15</xref></contrib><contrib contrib-type="author"><name><surname>Ho</surname><given-names>Ken</given-names></name><xref ref-type="aff" rid="aff16">16</xref></contrib><contrib contrib-type="author" corresp="yes"><name><surname>Hoffman</surname><given-names>Andrew R</given-names></name><xref ref-type="aff" rid="aff17">17</xref><xref ref-type="author-notes" rid="fn1">*</xref><xref ref-type="corresp" rid="cor1"></xref></contrib><contrib contrib-type="author"><name><surname>Holly</surname><given-names>Jeff M P</given-names></name><xref ref-type="aff" rid="aff18">18</xref></contrib><contrib contrib-type="author"><name><surname>Horikawa</surname><given-names>Reiko</given-names></name><xref ref-type="aff" rid="aff19">19</xref></contrib><contrib contrib-type="author"><name><surname>Höybye</surname><given-names>Charlotte</given-names></name><xref ref-type="aff" rid="aff20">20</xref></contrib><contrib contrib-type="author"><name><surname>Jorgensen</surname><given-names>Jens Otto L</given-names></name><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Johannsson</surname><given-names>Gudmundur</given-names></name><xref ref-type="aff" rid="aff21">21</xref></contrib><contrib contrib-type="author"><name><surname>Juul</surname><given-names>Anders</given-names></name><xref ref-type="aff" rid="aff22">22</xref></contrib><contrib contrib-type="author"><name><surname>Katznelson</surname><given-names>Laurence</given-names></name><xref ref-type="aff" rid="aff23">23</xref></contrib><contrib contrib-type="author"><name><surname>Kopchick</surname><given-names>John J</given-names></name><xref ref-type="aff" rid="aff24">24</xref></contrib><contrib contrib-type="author"><name><surname>Lee</surname><given-names>K O</given-names></name><xref ref-type="aff" rid="aff25">25</xref></contrib><contrib contrib-type="author"><name><surname>Lee</surname><given-names>Kuk-Wha</given-names></name><xref ref-type="aff" rid="aff26">26</xref></contrib><contrib contrib-type="author"><name><surname>Luo</surname><given-names>Xiaoping</given-names></name><xref ref-type="aff" rid="aff27">27</xref></contrib><contrib contrib-type="author"><name><surname>Melmed</surname><given-names>Shlomo</given-names></name><xref ref-type="aff" rid="aff28">28</xref></contrib><contrib contrib-type="author"><name><surname>Miller</surname><given-names>Bradley S</given-names></name><xref ref-type="aff" rid="aff29">29</xref></contrib><contrib contrib-type="author"><name><surname>Misra</surname><given-names>Madhusmita</given-names></name><xref ref-type="aff" rid="aff4">4</xref></contrib><contrib contrib-type="author"><name><surname>Popovic</surname><given-names>Vera</given-names></name><xref ref-type="aff" rid="aff30">30</xref></contrib><contrib contrib-type="author"><name><surname>Rosenfeld</surname><given-names>Ron G</given-names></name><xref ref-type="aff" rid="aff31">31</xref></contrib><contrib contrib-type="author"><name><surname>Ross</surname><given-names>Judith</given-names></name><xref ref-type="aff" rid="aff32">32</xref></contrib><contrib contrib-type="author"><name><surname>Ross</surname><given-names>Richard J</given-names></name><xref ref-type="aff" rid="aff33">33</xref></contrib><contrib contrib-type="author"><name><surname>Saenger</surname><given-names>Paul</given-names></name><xref ref-type="aff" rid="aff34">34</xref></contrib><contrib contrib-type="author"><name><surname>Strasburger</surname><given-names>Christian J</given-names></name><xref ref-type="aff" rid="aff35">35</xref><xref ref-type="author-notes" rid="fn1">*</xref></contrib><contrib contrib-type="author"><name><surname>Thorner</surname><given-names>Michael O</given-names></name><xref ref-type="aff" rid="aff36">36</xref></contrib><contrib contrib-type="author"><name><surname>Werner</surname><given-names>Haim</given-names></name><xref ref-type="aff" rid="aff37">37</xref></contrib><contrib contrib-type="author"><name><surname>Yuen</surname><given-names>Kevin</given-names></name><xref ref-type="aff" rid="aff38">38</xref></contrib><aff id="aff1"><label>1</label><institution>Aarhus University</institution><addr-line>Aarhus, Denmark</addr-line></aff><aff id="aff2"><label>2</label><institution>Cincinnati Children’s Hospital</institution><addr-line>Cincinnati, Ohio, USA</addr-line></aff><aff id="aff3"><label>3</label><institution>Klinikum der Universität München</institution><addr-line>Munich, Germany</addr-line></aff><aff id="aff4"><label>4</label><institution>Massachusetts General Hospital</institution><addr-line>Boston, Massachusetts, USA</addr-line></aff><aff id="aff5"><label>5</label><institution>Federal University of Parana</institution><addr-line>Curitiba, Brazil</addr-line></aff><aff id="aff6"><label>6</label><institution>Santiago de Compostela University</institution><addr-line>Santiago de Compostela, Spain</addr-line></aff><aff id="aff7"><label>7</label><institution>Université Paris Saclay</institution><addr-line>Le Kremlin-BicϪtre, France</addr-line></aff><aff id="aff8"><label>8</label><institution>University Claude Bernard</institution><addr-line>Lyon, France</addr-line></aff><aff id="aff9"><label>9</label><institution>University of Western Australia</institution><addr-line>Subiaco, Western Australia, Australia</addr-line></aff><aff id="aff10"><label>10</label><institution>University of North Carolina</institution><addr-line>Chapel Hill, North Carolina, USA</addr-line></aff><aff id="aff11"><label>11</label><institution>Boston Children’s Hospital</institution><addr-line>Boston, Massachusetts, USA</addr-line></aff><aff id="aff12"><label>12</label><institution>University of Southern California</institution><addr-line>Los Angeles, California, USA</addr-line></aff><aff id="aff13"><label>13</label><institution>Children’s Hospital of Philadelphia</institution><addr-line>Philadelphia, Pennsylvania, USA</addr-line></aff><aff id="aff14"><label>14</label><institution>Tokyo Metropolitan Children’s Medical Center</institution><addr-line>Tokyo, Japan</addr-line></aff><aff id="aff15"><label>15</label><institution>Baylor College of Medicine</institution><addr-line>Houston, Texas, USA</addr-line></aff><aff id="aff16"><label>16</label><institution>University of Queensland</institution><addr-line>Brisbane, Queensland, Australia</addr-line></aff><aff id="aff17"><label>17</label><institution>VA Palo Alto Health Care System and Stanford University</institution><addr-line>Palo Alto, California, USA</addr-line></aff><aff id="aff18"><label>18</label><institution>University of Bristol</institution><addr-line>Bristol, UK</addr-line></aff><aff id="aff19"><label>19</label><institution>National Center for Child Health and Development</institution><addr-line>Tokyo, Japan</addr-line></aff><aff id="aff20"><label>20</label><institution>Karolinska University Hospital</institution><addr-line>Stockholm, Sweden</addr-line></aff><aff id="aff21"><label>21</label><institution>University of Gothenburg</institution><addr-line>Gothenburg, Sweden</addr-line></aff><aff id="aff22"><label>22</label><institution>Rigshospitalet</institution><addr-line>University of Copenhagen, Copenhagen, Denmark</addr-line></aff><aff id="aff23"><label>23</label><institution>Stanford University</institution><addr-line>Stanford, California, USA</addr-line></aff><aff id="aff24"><label>24</label><institution>Ohio University</institution><addr-line>Athens, Ohio, USA</addr-line></aff><aff id="aff25"><label>25</label><institution>National University of Singapore</institution><addr-line>Singapore, Singapore</addr-line></aff><aff id="aff26"><label>26</label><institution>UCLA School of Medicine</institution><addr-line>Los Angeles, California, USA</addr-line></aff><aff id="aff27"><label>27</label><institution>Tongji Hospital</institution><addr-line>Wuhan, China</addr-line></aff><aff id="aff28"><label>28</label><institution>Cedars-Sinai Medical Center</institution><addr-line>Los Angeles, California, USA</addr-line></aff><aff id="aff29"><label>29</label><institution>Masonic Children’s Hospital</institution><addr-line>Minneapolis, Minnesota, USA</addr-line></aff><aff id="aff30"><label>30</label><institution>University of Belgrade</institution><addr-line>Belgrade, Serbia</addr-line></aff><aff id="aff31"><label>31</label><institution>Stat5 Consulting</institution><addr-line>Los Altos, California, USA</addr-line></aff><aff id="aff32"><label>32</label><institution>Jefferson Medical College</institution><addr-line>Philadelphia, Pennsylvania, USA</addr-line></aff><aff id="aff33"><label>33</label><institution>University of Sheffield</institution><addr-line>Sheffield, UK</addr-line></aff><aff id="aff34"><label>34</label><institution>SUNY</institution><addr-line>Stony Brook, New York, USA</addr-line></aff><aff id="aff35"><label>35</label><institution>Charite-Universitätsmedizin</institution><addr-line>Berlin, Germany</addr-line></aff><aff id="aff36"><label>36</label><institution>University of Virginia</institution><addr-line>Charlottesville, Virginia, USA</addr-line></aff><aff id="aff37"><label>37</label><institution>Tel Aviv University</institution><addr-line>Tel Aviv, Israel</addr-line></aff><aff id="aff38"><label>38</label><institution>Swedish Neuroscience Institute</institution><addr-line>Seattle, Washington, USA</addr-line></aff></contrib-group><author-notes><corresp id="cor1">Correspondence should be addressed to A R Hoffman; Email:
<email>arhoffman@stanford.edu</email></corresp><fn id="fn1"><label>*</label><p>(Member of the Planning Committee)</p></fn><fn id="fn2"><label>†</label><p>(Deceased)</p></fn></author-notes><pub-date pub-type="ppub"><month>6</month><year>2016</year></pub-date><pub-date pub-type="epub"><month>6</month><year>2016</year></pub-date><volume>174</volume><issue>6</issue><fpage>C1</fpage><lpage>C8</lpage><history><date date-type="received"><day>6</day><month>2</month><year>2016</year></date><date date-type="rev-recd"><day>16</day><month>3</month><year>2016</year></date><date date-type="accepted"><day>23</day><month>3</month><year>2016</year></date></history><permissions><copyright-statement>© 2016 The authors</copyright-statement><copyright-year>2016</copyright-year><copyright-holder>The authors</copyright-holder><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by/3.0/deed.en_GB"><license-p><inline-graphic xlink:href="88x31.jpg"></inline-graphic>This
work is licensed under a <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/3.0/deed.en_GB">Creative
Commons Attribution 3.0 Unported License</ext-link>.</license-p></license></permissions><self-uri content-type="pdf" xlink:type="simple" xlink:href="eje-174-C1.pdf"></self-uri><abstract><sec><title>Objective</title><p>The Growth Hormone (GH) Research Society (GRS) convened a workshop to address
important issues regarding trial design, efficacy, and safety of long-acting
growth hormone preparations (LAGH).</p></sec><sec><title>Participants</title><p>A closed meeting of 55 international scientists with expertise in GH, including
pediatric and adult endocrinologists, basic scientists, regulatory scientists, and
participants from the pharmaceutical industry.</p></sec><sec><title>Evidence</title><p>Current literature was reviewed for gaps in knowledge. Expert opinion was used to
suggest studies required to address potential safety and efficacy issues.</p></sec><sec><title>Consensus process</title><p>Following plenary presentations summarizing the literature, breakout groups
discussed questions framed by the planning committee. Attendees reconvened after
each breakout session to share group reports. A writing team compiled the breakout
session reports into a draft document that was discussed and revised in an open
forum on the concluding day. This was edited further and then circulated to
attendees from academic institutions for review after the meeting. Participants
from pharmaceutical companies did not participate in the planning, writing, or in
the discussions and text revision on the final day of the workshop. Scientists
from industry and regulatory agencies reviewed the manuscript to identify any
factual errors.</p></sec><sec><title>Conclusions</title><p>LAGH compounds may represent an advance over daily GH injections because of
increased convenience and differing phamacodynamic properties, providing the
potential for improved adherence and outcomes. Better methods to assess adherence
must be developed and validated. Long-term surveillance registries that include
assessment of efficacy, cost-benefit, disease burden, quality of life, and safety
are essential for understanding the impact of sustained exposure to LAGH
preparations.</p></sec></abstract></article-meta></front><body><sec><title>Background</title><p>The long-term safety and efficacy of daily recombinant human growth hormone (rhGH) have
been well documented since its approval by the United States Food and Drug
Administration (FDA) in 1985 and by the European Medicines Agency (EMA) in 1987.
However, daily GH injections can be burdensome for some patients and caregivers.
Furthermore, variability in clinical outcomes is well recognized in clinical practice,
and may reflect differences in adherence to prescribed therapy (<xref rid="bib1" ref-type="bibr">1</xref>). Published data and clinical experience indicate that
nonadherence to daily rhGH therapy increases over time (<xref rid="bib2" ref-type="bibr">2</xref>, <xref rid="bib3" ref-type="bibr">3</xref>, <xref rid="bib4" ref-type="bibr">4</xref>, <xref rid="bib5" ref-type="bibr">5</xref>, <xref rid="bib6" ref-type="bibr">6</xref>, <xref rid="bib7" ref-type="bibr">7</xref>, <xref rid="bib8" ref-type="bibr">8</xref>) and impairs therapeutic responses. Many life circumstances can
interfere with adherence to daily injections, thus compromising therapeutic outcomes. By
decreasing injection frequency, long-acting GH (LAGH) formulations may improve adherence
and thereby potentially maximize clinical efficacy. Consequently, there are currently
several LAGH preparations in various stages of preclinical development, with some
already approved for clinical use (<xref ref-type="table" rid="tbl1">Table 1</xref>).
<table-wrap id="tbl1" position="float"><label>Table 1</label><caption><p>Long-acting GH preparations.</p></caption><table frame="hsides" rules="groups"><thead><tr><th align="left" rowspan="1" colspan="1"></th><th align="left" rowspan="1" colspan="1"><bold>Company</bold></th><th align="left" rowspan="1" colspan="1"><bold>Product</bold></th><th align="left" rowspan="1" colspan="1"><bold>Modification to the GH molecule</bold></th><th align="left" rowspan="1" colspan="1"><bold>Frequency of administration</bold></th><th align="left" rowspan="1" colspan="1"><bold>Current status</bold></th></tr></thead><tbody><tr><td align="left" colspan="3" rowspan="1"><bold>Depot chemical</bold></td><td align="left" colspan="3" rowspan="1"><bold>Depot formulations</bold></td></tr><tr><td align="left" rowspan="1" colspan="1"></td><td align="left" rowspan="1" colspan="1">Genentech</td><td align="left" rowspan="1" colspan="1">Nutropin Depot</td><td align="left" rowspan="1" colspan="1"> Encapsulated in biocompatible, biodegradable,
polylactide-coglycolide polymer microspheres</td><td align="left" rowspan="1" colspan="1">14 days</td><td align="left" rowspan="1" colspan="1">Removed from the market</td></tr><tr><td align="left" rowspan="1" colspan="1"></td><td align="left" rowspan="1" colspan="1">LG Life Sciences, Ltd.</td><td align="left" rowspan="1" colspan="1">LB3002</td><td align="left" rowspan="1" colspan="1"> Microparticles containing GH incorporated into
sodium hyaluronate and dispersed in an oil base of medium-chain
triglycerides</td><td align="left" rowspan="1" colspan="1">7 days</td><td align="left" rowspan="1" colspan="1">Marketed in Korea for childhood GHD Approved in Europe, but
not marketed in the EU</td></tr><tr><td align="left" rowspan="1" colspan="1"></td><td align="left" rowspan="1" colspan="1">Altus Pharmaceuticals</td><td align="left" rowspan="1" colspan="1">ALTU-238</td><td align="left" rowspan="1" colspan="1"> Protein crystallization technology</td><td align="left" rowspan="1" colspan="1">7 days</td><td align="left" rowspan="1" colspan="1">No longer being developed</td></tr><tr><td align="left" rowspan="1" colspan="1"></td><td align="left" rowspan="1" colspan="1">Critical Pharmaceuticals</td><td align="left" rowspan="1" colspan="1">CP016</td><td align="left" rowspan="1" colspan="1"> Supercritical carbon dioxide, formed when
CO<sub>2</sub> exceeds its thermodynamic critical point, used to
create the depot</td><td align="left" rowspan="1" colspan="1">2 weeks (planned)</td><td align="left" rowspan="1" colspan="1">Preclinical studies</td></tr><tr><td align="left" colspan="3" rowspan="1"><bold>PEGylated formulations</bold></td><td align="left" colspan="3" rowspan="1"><bold>PEGylation</bold></td></tr><tr><td align="left" rowspan="1" colspan="1"></td><td align="left" rowspan="1" colspan="1">Ambrx</td><td align="left" rowspan="1" colspan="1">ARX201</td><td align="left" rowspan="1" colspan="1"> 30-kDa PEG added to unnatural amino acid
incorporated into GH</td><td align="left" rowspan="1" colspan="1">7 days</td><td align="left" rowspan="1" colspan="1">No longer being developed</td></tr><tr><td align="left" rowspan="1" colspan="1"></td><td align="left" rowspan="1" colspan="1">Novo Nordisk A/S</td><td align="left" rowspan="1" colspan="1">NNCI126-0083</td><td align="left" rowspan="1" colspan="1"> 43-kDa PEG residue attached to glutamine 141 </td><td align="left" rowspan="1" colspan="1">7 days</td><td align="left" rowspan="1" colspan="1">No longer being developed</td></tr><tr><td align="left" rowspan="1" colspan="1"></td><td align="left" rowspan="1" colspan="1">Pfizer</td><td align="left" rowspan="1" colspan="1">PEG-GH PHA-794428</td><td align="left" rowspan="1" colspan="1"> Branched 40-kDa PEG on N terminus of GH</td><td align="left" rowspan="1" colspan="1">7 days</td><td align="left" rowspan="1" colspan="1">No longer being developed</td></tr><tr><td align="left" rowspan="1" colspan="1"></td><td align="left" rowspan="1" colspan="1">Bolder BioTechnology</td><td align="left" rowspan="1" colspan="1">BBT-031</td><td align="left" rowspan="1" colspan="1"> Site-specific PEGylated GH analog</td><td align="left" rowspan="1" colspan="1">7 days (planned)</td><td align="left" rowspan="1" colspan="1">Preclinical studies</td></tr><tr><td align="left" rowspan="1" colspan="1"></td><td align="left" rowspan="1" colspan="1">GeneScience Pharmaceuticals Co., Ltd.</td><td align="left" rowspan="1" colspan="1">Jintrolong</td><td align="left" rowspan="1" colspan="1"> 40-kDa PEG attached to GH</td><td align="left" rowspan="1" colspan="1">7 days</td><td align="left" rowspan="1" colspan="1">Marketed in China for childhood GHD</td></tr><tr><td align="left" colspan="3" rowspan="1"><bold>Prodrug formulations</bold></td><td align="left" colspan="3" rowspan="1"><bold>Mechanism of conversion to active
drug</bold></td></tr><tr><td align="left" rowspan="1" colspan="1"></td><td align="left" rowspan="1" colspan="1">Ascendis Pharma A/S</td><td align="left" rowspan="1" colspan="1">TransCon PEG GH (ACP-001)</td><td align="left" rowspan="1" colspan="1"> hGH transiently bound to a PEG carrier molecule via
a self-cleaving linker. The released GH is unmodified</td><td align="left" rowspan="1" colspan="1">7 days</td><td align="left" rowspan="1" colspan="1">Phase II studies in children and adults</td></tr><tr><td align="left" colspan="3" rowspan="1"><bold>Noncovalent albumin binding GH
compound(s)</bold></td><td align="left" colspan="3" rowspan="1"><bold>Albumin binding</bold></td></tr><tr><td align="left" rowspan="1" colspan="1"></td><td align="left" rowspan="1" colspan="1">Novo Nordisk</td><td align="left" rowspan="1" colspan="1">NNbib195-0092</td><td align="left" rowspan="1" colspan="1"> Single-point mutation in GH, with albumin binding
moiety attached (noncovalent albumin-binding properties)</td><td align="left" rowspan="1" colspan="1">7 days</td><td align="left" rowspan="1" colspan="1">Phase II studies in children and Phase III studies in
adults</td></tr><tr><td align="left" colspan="3" rowspan="1"><bold>GH-fusion proteins</bold></td><td align="left" colspan="3" rowspan="1"><bold>Protein fused with GH</bold></td></tr><tr><td align="left" rowspan="1" colspan="1"></td><td align="left" rowspan="1" colspan="1">Asterion</td><td align="left" rowspan="1" colspan="1">ProFuse GH</td><td align="left" rowspan="1" colspan="1"> GH binding protein</td><td align="left" rowspan="1" colspan="1">1 month (planned)</td><td align="left" rowspan="1" colspan="1">Preclinical studies</td></tr><tr><td align="left" rowspan="1" colspan="1"></td><td align="left" rowspan="1" colspan="1">Genexine and Handok</td><td align="left" rowspan="1" colspan="1">GX-H9</td><td align="left" rowspan="1" colspan="1"> Hybridization of noncytolytic immunoglobulin Fc
portions of IgD and IgG4</td><td align="left" rowspan="1" colspan="1">7–14 days</td><td align="left" rowspan="1" colspan="1">Phase II studies in adults</td></tr><tr><td align="left" rowspan="1" colspan="1"></td><td align="left" rowspan="1" colspan="1">Hanmi Pharmaceutical Co. </td><td align="left" rowspan="1" colspan="1">LAPSrhGH/HM10560A</td><td align="left" rowspan="1" colspan="1"> Homodimeric aglycosylated lgG4 Fc fragment</td><td align="left" rowspan="1" colspan="1">7–14 days</td><td align="left" rowspan="1" colspan="1">Phase II in adults</td></tr><tr><td align="left" rowspan="1" colspan="1"></td><td align="left" rowspan="1" colspan="1">OPKO Biologics and Pfizer</td><td align="left" rowspan="1" colspan="1">MOD-4023</td><td align="left" rowspan="1" colspan="1"> Carboxyl-terminal peptide (CTP) of hCG
β-Subunit</td><td align="left" rowspan="1" colspan="1">7 days</td><td align="left" rowspan="1" colspan="1">Phase II studies in children and Phase III studies in
adults</td></tr><tr><td align="left" rowspan="1" colspan="1"></td><td align="left" rowspan="1" colspan="1">Teva</td><td align="left" rowspan="1" colspan="1">TV-1106</td><td align="left" rowspan="1" colspan="1"> Albumin</td><td align="left" rowspan="1" colspan="1">7 days</td><td align="left" rowspan="1" colspan="1">Trials have been discontinued</td></tr><tr><td align="left" rowspan="1" colspan="1"></td><td align="left" rowspan="1" colspan="1">Versartis</td><td align="left" rowspan="1" colspan="1">VRS-317</td><td align="left" rowspan="1" colspan="1"> XTEN sequence: naturally occurring hydrophilic
amino acids </td><td align="left" rowspan="1" colspan="1">7–14 days</td><td align="left" rowspan="1" colspan="1">Phase III studies in children and Phase II studies in
adults</td></tr></tbody></table></table-wrap></p><p>In light of the interest generated by these new formulations, the Growth Hormone
Research Society (GRS) convened a workshop in Asilomar, CA, USA on 4–7 November
2015. The purpose of the workshop was to review the current state of the field and
address key issues regarding trial design, efficacy, and safety of LAGH
preparations.</p></sec><sec><title>Methods</title><p>Fifty-five invited international leaders from 14 countries across 5 continents with
expertise in the field of GH attended the meeting. These included pediatric and adult
endocrinologists, basic scientists, regulatory scientists from the FDA and EMA, and
scientists from the pharmaceutical industry. A review of the current status of LAGH
development was published before the meeting (<xref rid="bib9" ref-type="bibr">9</xref>). A planning committee of the GRS comprising adult and pediatric
endocrinologists from academic institutions determined the agenda, selected speakers to
summarize key relevant topics, and formulated the questions for discussion at this
workshop.</p><p>Following presentations that summarized the literature, four breakout groups addressed
each topic in more detail by discussing the list of questions formulated by the planning
committee and subsequently agreed upon by all participants. All attendees reconvened
after each of the breakout sessions to share reports from the groups. At the end of days
1 and 2, a writing team compiled the breakout group reports into a final document that
was reviewed and revised in its entirety by participants on the concluding day in an
open forum. When there was no clear agreement by most participants, consensus was
reached by voting. This draft document was edited further for formatting and references,
and then recirculated to the academic attendees for final review after the meeting.
Meeting participants from pharmaceutical companies were not part of the planning
committee or writing team and were not present during the discussion and text revision
on the final day. However, scientists from industry and regulatory agencies were shown
the manuscript before submission in order to identify factual errors, but they were not
involved in the writing. This report is a concise chronicle of the workshop and is not
intended to be an exhaustive review of the literature on the topic. The contents of this
manuscript were derived from: (i) the content of the speaker presentations, (ii) the
combined comments of the breakout groups to the specific questions discussed, (iii) the
collective remarks of the entire group during report-back sessions, and (iv) the current
peer-reviewed literature in the GH field.</p></sec><sec><title>The clinical need for a LAGH preparation in pediatric and adult
endocrinology</title><p>Large interindividual variability in the growth response to daily GH injections in
GH-deficient children and adults reflects numerous inherent biological factors,
including dosing and dose frequency and varying sensitivity to both exogenous GH and
endogenous insulin-like growth factor 1 (IGF1) (<xref rid="bib10" ref-type="bibr">10</xref>, <xref rid="bib11" ref-type="bibr">11</xref>). In addition, reduced
adherence to daily injections likely compromises response to treatment. The requirement
for daily injections may also represent a barrier to initiating and maintaining therapy
in both pediatric and adult patients. Many scenarios were discussed in which LAGH would
represent a significant innovation in the delivery of clinical care for patients
deficient in GH. All participants recognized the need for LAGH.</p></sec><sec><title>Development of LAGH preparations</title><p>As described in the review prepared for this workshop (<xref rid="bib8" ref-type="bibr">9</xref>), several technologies are being used to prolong GH exposure. These
include: (i) depot formulations, (ii) pegylation, (iii) prodrugs, (iv) noncovalent
albumin binding GH compound(s), and (v) GH-fusion proteins (<xref ref-type="table" rid="tbl1">Table 1</xref>). These preparations are currently in various stages of
development, with some already approved in Europe and Asia.</p></sec><sec><title>Endocrine features of LAGH</title><p>There was overall consensus that currently available data do not allow determination of
whether the effects of LAGH will differ from those of daily GH. In addition, it is not
clear whether the physiological GH pulsatility and diurnal secretory pattern seen in
normal subjects are important for attaining optimal injected GH effects (<xref rid="bib12" ref-type="bibr">12</xref>). It has been emphasized that many currently
prescribed hormone replacement therapies, including daily GH, glucocorticoids, and
various formulations of sex steroids, do not replicate normal physiologic pattern of
secretion of the endogenous hormones in terms of pulsatility and diurnal variation. The
LAGH preparations that were used in clinical trials, as well as continuous infusions of
GH, did not result in tachyphylaxis or substantial differences in clinical effects when
compared with daily injections of GH (<xref rid="bib13" ref-type="bibr">13</xref>, <xref rid="bib14" ref-type="bibr">14</xref>, <xref rid="bib15" ref-type="bibr">15</xref>,
<xref rid="bib16" ref-type="bibr">16</xref>).</p></sec><sec><title>Safety considerations unique to LAGH</title><p>LAGH products exhibit different pharmacokinetics and pharmacodynamics compared with
daily GH and, therefore, safety considerations may be specific to these formulations. In
particular, the mechanism whereby each product prolongs the action of GH differs; such
additional moieties or properties may have an impact on safety distinct from
considerations about GH or IGF1 levels. Therefore, the safety of each individual LAGH
product should be assessed. Also, there is a need to consider the pharmacodynamic impact
of each LAGH product. Care should be taken to avoid overtreatment, and therefore safety
monitoring is critically important. Potential issues include: (i) supraphysiological
elevations of GH and/or IGF1, (ii) trough GH concentrations above normal physiological
levels, (iii) fluctuating IGF1 levels, (iv) elevated IGF1 in the absence of GH
bioactivity, (v) nonphysiological tissue distribution due to distinct biological
features of the products, and (vi) the specific chemical composition of each LAGH
product may confer unique safety issues.</p><p>The impact on safety of longer exposure to GH and/or IGF1 with the LAGH preparations is
unclear. Serum IGF1 levels are generally higher immediately following an injection and
lower before the next injection. It will be important to associate IGF1 levels with side
effects.</p><p>In children and adolescents, rare side effects of daily GH replacement include
intracranial hypertension, slipped capital femoral epiphyses, and hyperglycemia in those
at risk for diabetes (<xref rid="bib17" ref-type="bibr">17</xref>). Whether LAGH will
exacerbate these risks is unknown. The safety issues need to take into account specific
factors including age, pubertal stage, and populations at risk for diabetes
(particularly certain GH therapeutic indications such as small for gestational age (SGA)
and Turner syndrome). In patients who develop the rare and serious side effect of benign
intracranial hypertension, daily GH therapy is suspended until the condition resolves.
One theoretical (and important) concern with LAGH is that the long duration of action
does not allow immediate reversibility of exogenous GH exposure. In young children with
congenital, severe GH deficiency, hypoglycemia may occur when the drug effect wanes. In
such patients, prospective studies would need to include monitoring blood glucose levels
at the end of the LAGH dosing interval, when serum GH levels may be at their lowest.</p><p>In children and adults, it is unclear whether carbohydrate or lipid metabolism (<xref rid="bib18" ref-type="bibr">18</xref>) will differ between LAGH and daily GH-treated
patients. Glucose metabolism should be monitored in patients on LAGH because of concerns
related to the possibility of prolonged GH bioactivity (<xref rid="bib19" ref-type="bibr">19</xref>).</p><p>The theoretical concerns regarding whether there is an effect of GH treatment on
neoplasia were addressed in recently published position papers (<xref rid="bib20" ref-type="bibr">20</xref>, <xref rid="bib21" ref-type="bibr">21</xref>, <xref rid="bib22" ref-type="bibr">22</xref>). These concerns may also apply to LAGH. The
impact of possible supraphysiological and sustained GH and IGF1 levels after an
injection and the altered balance between GH and IGF1 with LAGH on potential long-term
cancer risk is unknown. Childhood cancer survivors should be monitored for possible
development of secondary neoplasms, especially those who received cranial
irradiation.</p><p>Daily administration of GH results in a consistent day-to-day hormonal and metabolic
response (<xref rid="bib23" ref-type="bibr">23</xref>). In contrast, LAGH administration
may result in different patterns on each day within the dosing interval, and the
long-term consequences of this pattern are unknown. It is important to emphasize that
neither daily GH nor LAGH products recapitulate normal physiologic secretion.</p><p>LAGH preparations may result in injection site pain, skin irritation, allergic
reactions, and lipoatrophy (<xref rid="bib24" ref-type="bibr">24</xref>). These effects,
which were reported in some early LAGH studies, vary among preparations (<xref rid="bib25" ref-type="bibr">25</xref>). The incidence of local skin reactions for
each preparation should be explored further.</p></sec><sec><title>IGF1 measurements during LAGH administration</title><p>Unlike the experience with daily GH, both the appropriate timing of blood sampling and
the interpretation of the IGF1 standard deviation score (SDS) in LAGH-treated patients
are controversial. LAGH preparations differ in the kinetics of serum GH and IGF1 that
they induce. Studies need to take into account the pharmacokinetics and pharmacodynamics
of each product in order to gauge the optimal timing of IGF1 measurement. The goal is to
maintain serum IGF1 concentrations within the normal age-appropriate range for a
majority of the treatment period.</p></sec><sec><title>The role of antibody measurements</title><p>Antibody measurements are used to assess potential immunogenicity that may impact both
efficacy and safety. Because the impact of these antibodies on clinical outcomes is
unclear, the interpretation of such results and the assimilation into study design need
to be considered. Specifically, it is clinically important to determine whether there
are neutralizing antibodies that could inhibit the intended drug effects.
Discontinuation of LAGH in the face of rising antibody titers may be considered if there
is a clinically significant reduction in IGF1 response or growth velocity or coexistence
of a severe allergic reaction. However, there are challenges in interpreting these
results due to the marked variability of antibody assays.</p></sec><sec><title>Pediatric trial design</title><p>The goals of pediatric GH therapy are to maximize adult height and to bring children
into the normal height range as soon as possible. Primary outcomes include first year
height velocity and delta height SDS (<xref rid="bib26" ref-type="bibr">26</xref>);
however, the most practical endpoint to measure in a Phase 3 pediatric clinical trial is
height velocity. In addition, secondary outcomes include height velocity SDS, delta
height velocity, bone age advancement, predicted adult height, and delta IGF1 SDS.
Nongrowth outcomes should also be measured, including body composition, metabolic
indices, and percentage of children entering puberty. Additional patient-related
outcomes to be monitored include adherence, quality of life (QoL), and patient
satisfaction. Models to assess burden of disease and therapy should be developed.</p><p>A trial duration of 1 year in prepubertal, treatment-naïve children was
considered appropriate to assess efficacy using a carefully matched control group.
Longer treatment duration is required to assess the safety profiles of the LAGH
preparations. Weight-based fixed dosing was advised for pediatric Phase 3 trials, with
downward dose titration performed for elevated serum IGF1 levels demonstrated on at
least two consecutive measurements. It is important to establish the appropriate time
between injections for IGF1 measurement. Opinions differ on the utility of peak, mean,
and trough IGF1 concentrations as tools to monitor and guide therapy. Phase 2 results
for each product should provide information to determine which IGF1 measurement time
point is clinically useful.</p><p>It is important to ensure matched study populations when comparing LAGH with daily GH.
Variables to consider should include age, gender, midparental target height, onset of
puberty, ethnicity, severity of growth hormone deficiency (GHD), and BMI-SDS. It will be
essential to define selective benefits and risks of LAGH in randomized controlled trials
in pediatric populations other than GHD, such as Turner syndrome, chronic renal failure,
Prader–Willi syndrome, Noonan syndrome, short children born SGA, and idiopathic
short stature. It should not be assumed that the effects and safety profile of LAGH in
these other conditions will be similar to those seen with LAGH therapy in GHD.</p><p>In clinical trials, safety monitoring should be performed after 1 and 3 months, and then
every 3 months thereafter. This should include assessment of glucose regulation with
hemoglobin A1c, fasting glucose, and insulin levels. Hepatic, thyroid, and adrenal
function should also be monitored. However, in formal surveillance programs and clinical
practice, these safety parameters should be considered annually.</p></sec><sec><title>Adult trial design</title><p>Daily GH replacement therapy for adult GHD was approved by the United States FDA in
1996, using changes in body composition as the primary outcome. Additional outcome
measures that could be evaluated in LAGH trials include patient-recorded outcomes such
as QoL, exercise capacity, and work productivity. A trial duration of 6 months is
considered appropriate to assess efficacy. As in the pediatric trials, it is important
to include carefully matched control groups. Attention should also be paid to the many
variables previously described including age, gender, severity of GHD, and BMI when
comparing LAGH with daily GH therapy. Safety of LAGH in adults can only be determined
after a long treatment duration, and therefore extension studies may be required after
completion of the controlled trials.</p><p>Truncal or visceral fat reduction at 6 months is recommended as the primary end point in
adult trials. Secondary end points (some of which would require longer treatment
duration) include IGF1, QoL, lipid profiles, exercise capacity, cardiovascular risk
factors, and bone mineral density. The initial dose should take into account age,
gender, and oral estrogen use in women. Study design in adults should include a dose
titration to achieve a mean serum IGF1 in the normal age-appropriate range, with the
timing of the IGF1 measurement based on pharmacodynamic findings for each compound.</p><p>Safety monitoring with laboratory tests, similar to those described above for the
pediatric trials, should be performed at 1, 3, and 6 months on treatment and then at
regular intervals (sooner if clinically indicated) in clinical trial extensions, formal
surveillance programs, and in clinical practice. Brain MRI should be performed before
the start of LAGH and as clinically indicated thereafter in patients with GHD due to
hypothalamic–pituitary tumors.</p></sec><sec><title>Adherence</title><p>Adherence to therapy is an extremely important variable that is difficult to assess
reliably. Clinical trials select for motivated participants and the infrastructure of
these studies enhance adherence. Methods to monitor adherence include vial count,
electronic devices, web-based entry, and patient diaries. Serum IGF1 may be a surrogate
marker of compliance. Measurement of LAGH by product-specific assays may be useful.
Adherence may also be affected by ease of use of the delivery device, but little data
are available to assess this supposition (<xref rid="bib27" ref-type="bibr">27</xref>,
<xref rid="bib28" ref-type="bibr">28</xref>).</p></sec><sec><title>Conclusion</title><p>LAGH compounds are a novel approach to the therapy of GHD and other growth disorders.
LAGH may represent an advance over daily GH injections because of the potential for
improved adherence and outcomes. LAGH may offer patients and families therapeutic
alternatives and flexibility. Better methods to assess adherence need to be developed
and validated. Long-term surveillance registries that include assessment of long-term
efficacy, cost-effectiveness, disease burden, QoL, and safety measures are essential for
understanding the impact of chronic exposure to all preparations of LAGH.</p></sec><sec><title>Declaration of interest</title><p>J S C: consultant for Ascendis Pharma A/S, Novo Nordisk, and Teva. P F B: consulted for
Ipsen, Novo Nordisk, EMD Serono, Versartis, and Sandoz, and currently receives grant
support from Versartis. M B: consults for Genexine, OKPO, Sandoz, Teva, and Versartis,
and has previously consulted for Biopartners. B M K B: PI, research grants to
Massachusetts General Hospital from OPKO Biologics, Novo Nordisk, Versartis. Consultant
to: Novo Nordisk, Pfizer, and Versartis. M C S B: consulted for Pfizer; lecture fees
from Pfizer, Merck Serono. F F C: research grants, lecture, or consulting fees from
Pfizer. PhC: research and educational grants from Ipsen, Novo Nordisk, and has served as
investigator for clinical trials funded by Pfizer, Ipsen, Prolor Biotech. Member of
Advisory Boards from Ipsen, Eli Lilly. Gave lectures for Ipsen and Pfizer. All the fees
and honoraria were paid to his institution. PierreC: consulted for, principal
investigator of a clinical trial, and speaker or chair in meetings promoted by Merck
Serono and Ascendis Pharma A/S. C S C: research support from Merck Serono. D R C:
consulted for Pfizer and Novo Nordisk. L E C: honorarium from Scherer Clinical
Communications. PinchasC: consults for Ascendis Pharma A/S, OPKO Biologics, Teva, and
Versartis. J F: nothing to disclose. A G: consults for the Pfizer International Growth
Study database. Y H: nothing to disclose. M W H: nothing to disclose. K H: receives
lecture fees from Ipsen and consults for Versartis and Pfizer. A R H: consults for Teva,
Ascendis Pharma A/S, Versartis, and Genexine. J H: nothing to disclose. R H: nothing to
disclose. C H: investigator for Novo Nordisk, Teva, Ascendis Pharma A/S, Versatis, and
Handok-Genexine and has consulted for Novo Nordisk and Teva. J O L J: lecture fees and
grant support from Pfizer and Novo Nordisk. G J: lecture fees from Novo Nordisk, Pfizer,
and Merck Serono and has received grant support (2010–2015) from Novo Nordisk,
Pfizer, and Sandoz. A J: lecture fees from Ipsen, Novo Nordisk, Ferring, and Sandoz;
principal investigator on a multicenter trial, which received unrestricted grant support
from Novo Nordisk. L K: nothing to disclose. J J K: consults for Teva and EMD Serono;
lecture fees from Pfizer; inventor of Growth Hormone Antagonists (US Patent #
5,350,836). K O L: nothing to disclose. K W L: nothing to disclose. X L: consults for
Gensci, Ipsen, Merck Serono, Novo Nordisk. S M: research grant support from Versartis. B
S M: consults for Alexion, BioMarin, Endo Pharmaceuticals, Genentech, Ipsen, Novo
Nordisk, Sandoz, and Versartis and has received research support from Alexion, Abbvie,
Eli Lilly, Debiopharm, Endo Pharmaceuticals, Genentech, Ipsen, Novo Nordisk, Pfizer,
Sandoz, and Versartis. M M: consulted for Genentech. V P: PI in clinical research
studies for LG Life Science, OPKO Biologics, Versartis, Hanmi, and Teva. R G R: consults
for Ascendis Pharma A/S, OPKO Biologics, Versartis, Teva, Genexine, Novo Nordisk, and
Sandoz. J R: research support from Eli Lilly, Novo Nordisk, and Versartis and consults
for and serves on an advisory board for Novo Nordisk. R J R: equity interests in Diurnal
Ltd and Asterion Ltd. P S: consults for Ascendis Pharma A/S, Teva, OPKO Biologics.
Speaker bureau Novo Nordisk. C J S: consults for Prolor, Versartis, Novo Nordisk, Merck
Serono, Pfizer, and Genexine. M O T: Founder and CSO Ammonett Pharma, which is
developing a ghrelin mimetic. H W: nothing to disclose. K Y: research grant support from
Pfizer, Novo Nordisk, Eli Lilly, OPKO Biologics, Teva, and Versartis, and has served on
the advisory boards for Pfizer, Novo Nordisk, Sandoz, and Versartis.</p></sec><sec><title>Funding</title><p>This work was supported by the Growth Hormone Research Society.</p></sec></body><back><ack><title>Acknowledgment</title><p>The GRS and all the authors of this report would like to thank the following individuals
for their participation in the workshop and their invaluable comments and
perspectives:</p><p><italic>Regulatory scientists</italic>:</p><p>United States FDA: Smita Abraham, Jean-Marc Guettier, and Marina Zemskova; EMA: Thorsten
Vetter</p><p><italic>Industry observers</italic>:</p><p>Michael Beckert (Ascendis Pharma A/S), George Bright (Versartis), Jose Cara (Pfizer),
Susan K Durham (Immunodiagnostic Systems), Gili Hart (OPKO Biologics), Michael
Højby (Novo Nordisk), Lein Jin (GeneSci), Udo Mueller (Teva), Markus Zabransky
(Sandoz), and Tony Mason (Ferring).</p></ack><sec><title>Dedication</title><p>The authors dedicate this paper to our late colleague and friend, Jens Sandahl
Christiansen, a consummate clinical investigator and a kind and devoted physician.</p></sec><ref-list><title>References</title><ref id="bib1"><label>1</label><mixed-citation publication-type="journal"><person-group person-group-type="author"><name><surname>Bang</surname><given-names>P</given-names></name><name><surname>Bjerknes</surname><given-names>R</given-names></name><name><surname>Dahlgren</surname><given-names>J</given-names></name><name><surname>Dunkel</surname><given-names>L</given-names></name><name><surname>Gustafsson</surname><given-names>J</given-names></name><name><surname>Juul</surname><given-names>A</given-names></name><name><surname>Kriström</surname><given-names>B</given-names></name><name><surname>Tapanainen</surname><given-names>P</given-names></name><name><surname>Aberg</surname><given-names>V.</given-names></name></person-group><article-title>A comparison of different definitions of growth response in short
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