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  • Academy eBriefings

  • eBriefing

    Equivalence of Complex Drug Products

    Scientific and Regulatory Challenges

    Organizers: Melanie Brickman Borchard (The New York Academy of Sciences), Alison Carley (The New York Academy of Sciences), Daan J.A. Crommelin (Utrecht University), Wenlei Jiang (US Food and Drug Administration), Scott McNeil (Nanotechnology Characterization Laboratory), Vinod Shah (Non Biological Complex Drugs Working Group), and Jon de Vlieger (Lygature)

    This eBriefing looks at approaches for complex drug development and regulation, outstanding challenges in the assessment of complex drug equivalence, consequences for product interchangeability, and comparisons of biological and non-biological complex drug families.

    In this eBriefing

    • Regulatory pathways for generics and biosimilars
    • Scientific considerations to approaching complex generics
    • Issues with iron carbohydrate similars
  • Recent eBriefings 

    April 3, 2017

    Alzheimer's Disease as a Neurovascular Inflammatory Disorder

    Keynote Speaker: Costantino Iadecola (Weill Cornell Medicine)

    Alzheimer's disease has long been framed as a neurological disorder. Recently, however, an appreciation and understanding of how vascular dysfunction contributes to its disease pathology is growing, and inflammatory contributors are currently under intense investigation. This eBriefing covers the basic research and clinical science elucidating such mechanisms that underlie the contribution of inflammatory pathways to vascular cognitive impairment and dementia.

    March 22, 2017

    What International Scientists Should Know about Immigration and Travel

    Featuring: Liqin Ban (Liqin Ban PLLC) and Yelena Bernadskaya (NYC Postdoc Coalition)

    This eBriefing features a discussion on the implications of the White House's executive order on immigration.

    March 16, 2017

    The 2016 Blavatnik Science Symposium

    Keynote Speakers: Chris Chang (University of California, Berkeley) and Edward Chang (University of California, San Francisco)

    On July 18–19, 2016, the New York Academy of Sciences hosted the third annual Blavatnik Science Symposium, a gathering of 54 laureates, finalists, and alumnae of the Blavatnik Awards for Young Scientists. What began in 2007 as a regional program granting unrestricted funds to a small cohort of extraordinary young scientists has grown into a robust community nearly 200 strong.

    March 15, 2017

    Microbial Influences in Cardio–Metabolic Diseases

    Featuring: Henrik Bjørn Nielsen (Clinical-Microbiomics A/S), Martin J. Blaser (New York University Langone Medical Center), Patrice D. Cani (Universite Catholique de Louvain, LDRI), Rachel Carmody (Harvard University), Stanley L. Hazen (Cleveland Clinic), Gerald I. Shulman (Yale University School of Medicine), Marion Soto (Joslin Diabetes Center, Harvard Medical School), and Dan Winer (University of Toronto)

    The microbiome is emerging as an important regulator of health and disease well beyond the digestive tract. This eBriefing surveys highlights from recent research innovations and therapeutic applications from the microbiome with a focus on metabolic disease.

    March 2, 2017

    Understanding Autophagy to Enhance Clinical Discovery: The 2016 Dr. Paul Janssen Award Symposium

    Featuring: Yoshinori Ohsumi (Tokyo Institute of Technology)

    In 2016, Yoshinori Ohsumi won the Nobel Prize for his ground-breaking research on autophagy, which demonstrated the crucial process it serves in maintaining cellular homeostasis, as well as established its role in human health. This eBriefing covers Ohsumi's presentation, in which he reflected on his initial work on the key players in autophagy and shared his vision for future advancements in the field. Following his award lecture, fellow prominent scientists at the forefront of autophagy research discussed emerging concepts and technologies, which are included as well.

    February 28, 2017

    Equivalence of Complex Drug Products: Scientific and Regulatory Challenges

    Organizers: Melanie Brickman Borchard (The New York Academy of Sciences), Alison Carley (The New York Academy of Sciences), Daan J.A. Crommelin (Utrecht University), Wenlei Jiang (US Food and Drug Administration), Scott McNeil (Nanotechnology Characterization Laboratory), Vinod Shah (Non Biological Complex Drugs Working Group), and Jon de Vlieger (Lygature)

    This eBriefing looks at approaches for complex drug development and regulation, outstanding challenges in the assessment of complex drug equivalence, consequences for product interchangeability, and comparisons of biological and non-biological complex drug families.

    February 22, 2017

    Grantsmanship for Graduate Students and Postdocs: F30, F31, F32

    Featuring: Jaime S. Rubin (Columbia University)

    In this eBriefing, graduate students and postdocs can learn tips for concise and persuasive writing, a skill not only vital in academia, but essential for any career path.

    February 10, 2017

    Advances in the Neurobiology of Mental Illness

    Speakers: Tyrone D. Cannon (Yale University), K. Ranga Rama Krishnan (Rush Medical College), Husseini Manji (Janssen Research & Development, LLC), Vaibhav Narayan (Janssen Research & Development, LLC), Daniel Pine (National Institute of Mental Health, US National Institutes of Mental Health), and B. Timothy Walsh (New York State Psychiatric Institute, Columbia University)

    Mental health disorders can cause debilitating consequences on quality of life for individuals, families, and society. The World Health Organization has reported that mental illnesses are the leading causes of disability worldwide. Depression alone accounts for one third of this disability.
     
    At this symposium, scientists, physicians, clinicians, other allied healthcare providers, policy makers, and patients across a range of scientific, clinical, industry, and government sectors explored new scientific understanding of the neurobiology (including genetics, neurocircuitry, and neuroimmune mechanisms) of a range of mental illnesses.

    February 7, 2017

    Aging and Nutrition: Novel Approaches and Techniques

    Speakers: Jan van Deursen (The Mayo Clinic), Vadim Gladyshev (Harvard University), Matt Kaeberlein (University of Washington), Vera Gorbunova (University of Rochester), Nicholas Stroustrup (Harvard University), and Arlan Richardson (University of Oklahoma)

    This eBriefing documents how prominent researchers in the field came together to explore the interplay between aging, nutrition, and metabolism, as well as the important role that novel technologies will play in current and future studies.

    January 26, 2017

    Big Data, Consumer Technology, and the Obesity Epidemic: Emerging Science and Ethical Considerations

    Organizers: Jason Block (Harvard Medical School), Matthew Harding (University of California Irvine), John G. Kral (SUNY Downstate Medical Center), Kristina H. Lewis (Wake Forest School of Medicine), Satchidananda Panda (SALK Institute), Gilles Bergeron (New York Academy of Sciences), and Mireille Mclean (New York Academy of Sciences)

    Researchers, health professionals, and a growing wellness-conscious public use technology to monitor health status. Big Data harnessed from this technology have created a foundation for focused research targeting obesity, but at what cost?

    January 18, 2017

    Antibiotics in Food: Can Less Do More?

    Organizers: Gary R. Acuff (Texas A&M University), Robert Brackett, (Illinois Institute of Technology), Sarah Marie Cahill (Food and Agriculture Organization of the United Nations), Bruce Cogill (Consultant), Jeffrey Farber (University of Guelph), Gilles Bergeron (The Sackler Institute for Nutrition Science), and Mireille Mclean (The Sackler Institute for Nutrition Science)

    Antibiotics have been used to prevent disease and accelerate growth in animal-rearing. Driven by concerns about antibiotic resistance, reduction in antibiotic use has changed the dynamics between food supply, food safety and public health. Concurrently, scientific advances offer alternative options such as probiotics and bacteriophages. This one-day conference reviewed the implications of antibiotic use in the food system from veterinary health, human health, food safety, and food system economic perspectives, addressing questions about how agricultural use contributes to antibiotic resistance in both humans and animals, the global landscape of antibiotic use in the food system, and viable alternatives.

    January 13, 2017

    Multiple Sclerosis: Diagnostic and Treatment Frontiers

    Keynote Speakers: Barry G. Arnason, MD (University of Chicago) and Giancarlo Comi, MD (Università Vita-Salute San Raffaele)

    Multiple sclerosis (MS) is a disease of the central nervous system that disrupts nerve impulses. Given the widespread prevalence and the disabling effects of this neurological condition, it is critical that diagnostics and treatments for MS continue to improve. This one-day, translational conference brought together academic and clinical researchers with industry leaders to discuss current therapeutics; diagnostic, prognostic, and predictive biomarkers; MRI usage in diagnosis and monitoring, and novel and emerging treatments.

    December 13, 2016

    The Addicted Brain: New Treatment Frontiers: Sixth Annual Aspen Brain Forum

    Keynote Speakers: The Honorable Patrick J. Kennedy (Former United States Representative, Rhode Island; Co-Founder, One Mind; and Founder, Kennedy Forum), George F. Koob (National Institute on Alcohol Abuse and Alcoholism, U.S. National Institutes of Health), and Nora D. Volkow (National Institute on Drug Abuse, U.S. National Institutes of Health)

    Leading experts, including NIAAA and NIDA directors, discuss the latest on neurobiology of addiction; susceptibility of the teen brain; new treatment strategies; and social, economic, political, and legislative aspects of this disease.

    December 12, 2016

    MicroRNAs: A Gene Silencing Mechanism with Therapeutic Implications

    Keynote Speaker: David Bartel (Whitehead Institute for Biomedical Research, Howard Hughes Medical Institute, MIT)

    MicroRNAs (miRNA) play critical roles in regulating gene expression. This symposium presented up-to-date basic, translational, and clinical research addressing the biology of miRNA and their promise as a therapeutic target.

    November 21, 2016

    Surgery and Cognition: Delirium, Cognitive Decline, and Opportunities to Protect the Brain

    Featuring: Sharon Inouye (Harvard Medical School)

    Surgery helps millions of Americans overcome illness to live longer, healthier lives. Yet surgery can lead to delirium, cognitive decline, and perhaps even a higher long-term risk of dementia for many patients, a risk that is poorly understood and often under-recognized in the clinic. With numerous factors—including age—contributing to each patient's level of risk, what are the challenges and opportunities to creating biomarkers and therapeutics for those who are most vulnerable?

    October 18, 2016

    HIV 2016: HIV and Non-Communicable Diseases

    Featured Speaker: Peter Godfrey-Faussett (UNAIDS)

    Participants gathered at the New York Academy of Sciences to discuss one of the next frontiers in the HIV field: how NCDs and HIV interact, how they should be treated, and how policy needs to adapt to facilitate effective treatment for people living with NCDs.

    October 3, 2016

    The Physics of Everything

    Is there a limit to human knowledge? Where do philosophy and physics intersect? Are we alone in the universe? Answering these and other questions, this six-part series united some of our most vibrant public intellectuals and communicators for explorations that reflect on the current state of modern physical sciences, its greatest mysteries and future endeavors, and its philosophical significance for our understanding of reality and the spiritual dimension of human existence.

    August 10, 2016

    Food–Microbiome Interaction: Implications for Health and Disease

    Keynote Speakers: John Bienenstock (McMaster University, Canada) and Jeffrey Gordon (Washington University in St. Louis)

    This eBriefing discusses the links between gut microbiota, diet, and health. It covers topics including the microbiome in development; microbiome interactions outside the gut; and the therapeutic potential of targeting the microbiome.

    July 8, 2016

    Sohn Conference: Pediatric Cancer in a Post-genomic World

    Keynote Speakers: Richard Gilbertson (Cambridge Cancer Centre, University of Cambridge, UK) and Craig B. Thompson (Memorial Sloan Kettering Cancer Center)

    This eBriefing covers the latest research on pediatric cancers, including topics such as etiological differences between pediatric and adult cancers, epigenetics, mechanisms of metastasis and disease recurrence, risk factors, diagnostics, and novel treatment approaches.

    July 7, 2016

    Epigenetics: Cancer and Beyond

    Organizers: Donald McCaffery (Resverlogix Corp.), Norman Wong (Resverlogix Corp.), Sarah Zapotichny (Resverlogix Corp.), George Zavoico (Jones Trading Institutional Services), Sonya Dougal (The New York Academy of Sciences), and Caitlin McOmish (The New York Academy of Sciences)
    Keynote Speaker: Craig B. Thompson (Memorial Sloan Kettering Cancer Center)

    Epigenetic abnormalities contribute to tumorigenesis and various diseases beyond cancer. This eBriefing describes recent progress in validating the therapeutic potential of small molecule inhibitors targeting epigenetic marks.