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Bethesda North Marriott Hotel and Conference Center

25 oct 2017 7:00 a.m. - 27 oct 2017 3:00 p.m.

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

DIA/FDA Oligonucleotide-Based Therapeutics Conference

Convening industry and health authorities to inform, educate, and share advancements in oligonucleotide-based therapeutic product development.

Session 4C: Clinical Advances in Oligonucleotide-Based Therapies for Neuromuscular Diseases

Session Chair(s)

Saraswathy V. Nochur, PhD, MSc

Saraswathy V. Nochur, PhD, MSc

Chief Regulatory Officer

Alnylam Pharmaceuticals, United States

Several oligonucleotide-based therapeutic candidates have been evaluated in the clinic for the treatment of neuromuscular diseases, including two for rare diseases. This session will explore the development of 3 different molecules, one about to enter the clinic, another getting ready for NDA, and a third that has been approved by FDA and EMA. While each of the disease states for these agents are distinct, there are similarities in the clinical development strategies and the challenges faced. Clinical data will be shared.

Learning Objective :
  • Appreciate key aspects of development of oligo-therapeutics in this space, including antisense oligonucleotides (ASOs) and small interfering RNAs (siRNAs)
  • Recognize the challenges faced in terms of neurologic endpoints, their clinical meaningfulness, and evaluation in trials
  • Prepare for unique aspects in the development of drugs for rare diseases, including role of natural history data, learnings from previous failed or successful clinical trials, etc.
  • Speaker(s)

    Lois  Freed, PhD

    Session Co-Chair

    Lois Freed, PhD

    FDA, United States

    Director, Division of Pharmacology/Toxicology-Neuroscience (DPT-N), CDER

    Wildon  Farwell, MD

    Development and Approval of Nusinersen for Spinal Muscular Atrophy: Challenges and Successful Strategies

    Wildon Farwell, MD

    Biogen , United States

    Senior Director, Clinical Development

    John L. Berk, MD

    Hereditary ATTR Amyloidosis: Long-Term Clinical Experience with Patisiran, an Ivestigational RNAi Therapeutic, in an Open Label Study

    John L. Berk, MD

    Boston University, United States

    Associate Professor of Medicine, School of Medicine

    Laurence  Mignon, PhD

    Development of Ionis-MAPTRx, the First Tau-Lowering Antisense Oligonucleotide, in Patients with Mild AD

    Laurence Mignon, PhD

    Ionis Pharmaceuticals, Inc., United States

    Director, Clinical Development

      Panel Discussion

    Panel Discussion

    All Session Speakers, United States

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