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Oligonucleotide-Based Therapeutics Conference

DIA Your Way! Join us live in-person or later from the comfort of your home/office at your own pace. This event offers two learning avenues depending on your schedule!


Speakers

  • Benjamin  Stevens, PhD, MPH

    Benjamin Stevens, PhD, MPH

    • Director CMC Policy and Advocacy
    • GlaxoSmithKline, United States

    Ben Stevens is an Associate Director of Regulatory Affairs, CMC at Alnylam and has nearly 13 years of drug discovery experience. Prior to Alnylam, Ben was a Principal Consultant at PAREXEL and also spent nearly 4 years in the Office of New Drug Products (ONDP) at the US FDA where he was an Acting Branch Chief. Before FDA, Ben spent seven years in pharmaceutical R&D at Pfizer and Merck. Ben received a Ph. D. in Chemistry from the University of Pittsburgh, a M.P.H. from the Johns Hopkins and is a co-author of over 20 publications and patents.

  • Scott  Henry, PhD

    Scott Henry, PhD

    • Vice President, Nonclinical Development
    • Ionis Pharmaceuticals, Inc., United States

    Dr. Henry received a PhD in Biochemistry form North Dakota State University. He was a post-doc fellow at Parke Davis, Ann Arbor MI, depart. of toxicology. He joined Isis Pharmaceuticals, Inc. as a Sr Scientist in toxicology. He helped characterized and studied mechanisms of various toxicities e.g. the effects of oligonucleotide treatment on clotting time prolongation, alternative complement pathway activation, proinflammatory effects in rodents, platelet alterations and the effects related to the accumulation of oligonucleotide in kidney. As VP of Non-Clinical Development he has participated in the development of ~8 different phosphorothioate oligodeoxynucleotides and 30+ different 2’-MOE modified phosphorothioate oligonucleotides.

  • Ronald L. Wange, PhD

    Ronald L. Wange, PhD

    • Associate Director for Pharm/Tox ODE3, CDER
    • FDA, Office of New Drugs, United States

    Dr. Wange is a Supervisory Pharmacology/Toxicology Reviewer within the Office of New Drugs in CDER at the FDA, and has over 12 years of experience reviewing small molecule drugs, biotherapeutic proteins and oligonucleotide-based therapeutics. He is a founding member of OND’s Pharmacology/Toxicology Oligonucleotide Subcommittee, which considers issues specifically related to the safety review of oligonucleotide-based therapeutics. Dr. Wange has a bachelor’s degree in Biochemistry from the University of California, and a Ph.D. in Pharmacology from Vanderbilt University. Prior to joining the FDA, Dr. Wange headed the T-Lymphocyte Signaling Unit at the National Institute on Aging at the NIH.

  • Louis  O'Dea, MD

    Louis O'Dea, MD

    • Executive Vice President, Chief Medical Officer and Head, Regulatory Affairs
    • Akcea Therapeutics, United States

  • Hobart  Rogers, PharmD, PhD

    Hobart Rogers, PharmD, PhD

    • Pharmacologist
    • FDA, United States

    Dr. Bart Rogers is a reviewer in the Genomics and Targeted Therapy Group in the Office of Clinical Pharmacology (OCP) at the FDA. Dr. Rogers also serves as an active duty officer with the United States Public Health Service. He serves as the lead for OCPs review of all synthetic oligonucleotides. His research interests are focused on the pharmacology of synthetic oligonucleotides, orphan disease drug development, and pharmacogenomics. Dr. Rogers completed his Pharm.D. degree from the University of Maryland, School of Pharmacy in 2004. He went on to obtain his Ph.D. in Clinical Pharmaceutical Sciences with a focus on cardiovascular pharmacogenomics from the same institution.

  • Laura  Sepp-Lorenzino, PhD

    Laura Sepp-Lorenzino, PhD

    • Chief Scientific Officer
    • Intellia Therapeutics, Inc., United States

  • Andrew  Slugg, MBA, MS

    Andrew Slugg, MBA, MS

    • VP, Regulatory Affairs
    • Alnylam Pharmaceuticals, United States

  • Barry  Ticho, DrMed, PhD

    Barry Ticho, DrMed, PhD

    • Chief Medical Officer
    • Stoke Therapeutics, United States

  • Daniel  Capaldi, PhD

    Daniel Capaldi, PhD

    • Vice President, Analytical and Process Development
    • Ionis Pharmaceuticals, Inc., United States

    Daniel received a B.Sc in chemistry and biology and a Ph. D in chemistry from King’s College, London. In March 1996, Daniel joined Ionis Pharmaceuticals, Inc. as a process chemist where he spent four years working on process improvements in large-scale oligonucleotide synthesis. In his current position as Vice President, Analytical and Process Development, Daniel is contributing to the development of antisense therapeutics and has responsibility for a variety of process chemistry and CMC functions including supply chain improvements and process optimization, analytical method development and validation, release and stability testing and impurity characterization

  • Monica  Cooper

    Monica Cooper

    • Review Chemist
    • FDA, United States

  • Kim  Tyndall

    Kim Tyndall

    • President
    • CMC Tyndall Consultant LLC, United States

    Kim is a Director of CMC Regulatory Affairs at GlaxoSmithKline (GSK). She has been at GSK since 1981 in a variety of chemistry and CMC Regulatory roles. Her primary responsibilities include CMC Regulatory oversight of the oligonucleotide platforms and alliances, as well as due diligence on oligonucleotide opportunities. Kim has held multiple positions in Analytical Development and CMC Regulatory Affairs including Post Approval and Biopharm Regulatory Affairs. Kim received a BA in Biology from East Carolina University in 1981.

  • Ramin  Darvari, PhD, MS

    Ramin Darvari, PhD, MS

    • Associate Research Fellow
    • Pfizer Inc., United States

  • Ramesh  Raghavachari, PhD

    Ramesh Raghavachari, PhD

    • Chief, Branch I, DPMA1, OLDP, OPQ, CDER
    • FDA, United States

    Ph.D - Temple University, Philadelphia, PA Currently a Chemist at FDA/CDER, has been with FDA since 2003.

  • Susan  Srivasta, PhD

    Susan Srivasta, PhD

    • President
    • ElixinPharma, United States

  • René  Thürmer, PhD

    René Thürmer, PhD

    • Deputy Head of the Unit Pharmaceutical Biotechnology BfArM
    • Federal Institute for Drugs and Medical Devices, Germany

    Dr. René Thürmer received his diploma in chemistry and his Ph.D. in biochemistry from the University of Tübingen. He joined the BfArM (Federal Institute for Drugs and Medical Devices, Bonn, Germany) in 2000. He currently serves as a CMC reviewer and is Deputy Head of the Unit Pharmaceutical Biotechnology. His experience is in the field of formulation, manufacture and control of medicinal products, in particular in the field of peptides, proteins, liposomes, sustained release polymer drug products, depot formulations, polymer-conjugated drug products, natural and synthetic surfactants, nanomedicine and others. His special focus lies on oligonucleotide preparations.

  • Patrik  Andersson, PhD

    Patrik Andersson, PhD

    • Principal Scientist, Discovery Safety Specialist
    • AstraZeneca R&D, Sweden

    I received my PhD in toxicology from Karolinska Institutet, Stockholm in 2003. Joined AstraZeneca R&D in Gothenburg in 2004 as a toxicologist supporting Cardiovascular and Metabolic drug projects in the Discovery phase. Since 2012 focusing on nucleotide drugs, including oligonucleotides and mRNA therapeutics. Currently leading the preclinical safety activities for oligonucleotides and targeted drug delivery in the AstraZeneca strategic collaboration with Ionis Pharmaceuticals in the Cardiovascular and Metabolic therapeutic area.

  • Elena  Braithwaite, PhD

    Elena Braithwaite, PhD

    • Toxicologist
    • FDA, United States

    Dr. Elena Braithwaite is a toxicologist at the US Food and Drug Administration and a Diplomate of the American Board of Toxicology. She has a broad background in various aspects of basic research including DNA repair, mutagenesis and signal transduction.

  • Xuan  Chi, MD, PhD

    Xuan Chi, MD, PhD

    • Pharmacologist/Acting Team Leader
    • CDER, FDA, United States

    Dr. Chi is a Pharmacology/Toxicology reviewer in the Division of Cardiovascular and Renal Products at the Office of New Drugs, CDER FDA. Prior to that, she was a clinical analyst and SME in the Federal Healthcare Practice at Deloitte Consulting LLP and her projects were focused on post-marketing drug safety and review modernization effort at OGD. She had also worked as a staff fellow at Office of Blood Review and Research, CBER FDA. She is specialized in analyzing data from toxicological, pharmacological and clinical studies of original NDAs, BLAs, INDs, and 510(k)s. She had Ph.D. in genetics and had postdoctoral training in molecular genetics and pathology.

  • David  Corey, PhD

    David Corey, PhD

    • Professor
    • UT Southwestern Medical Center at Dallas, United States

  • Jeffrey  Foy

    Jeffrey Foy

    • Senior Director of Toxicology
    • Dicerna Pharmaceuticals, United States

  • Aimee L. Jackson, PhD

    Aimee L. Jackson, PhD

    • Chief Scientific Officer
    • Atalanta Therapeutics, United States

    Aimee has been working in the field of RNA interference and microRNAs for >15 years and has authored/co-authored >20 publications. She received her PhD from Univ of Colorado Health Science Cntr and performed post-doc research at Univ of Washington. Aimee joined Rosetta Inpharmatics/Merck, where she established the use of RNAi combined with expression profiling technologies for target identification, target validation, elucidation of drug mechanism-of-action, and patient stratification. She investigated the therapeutic application of siRNAs. Aimee leads the discovery/development of new therapeutic targets in diverse disease indications, pioneering the implementation of translational biomarkers for mechanistic proof-of-concept in patients.

  • Arthur A. Levin, PhD

    Arthur A. Levin, PhD

    • Executive Vice President, Research and Development
    • Avidity Biosciences , United States

  • Emily J. Place, PhD, MPH

    Emily J. Place, PhD, MPH

    • Pharmacologist, Office of New Drugs, CDER
    • FDA, United States

    Emily is a co-chair of FDA’s Pharmacology/Tox Oligonucleotide Subcommittee. She received a BS in Biology from State Univ of New York in 01’, a PhD in Cell Biology from Univ of Connecticut in 06’. She joined the Research Enhancement Award Program as an Assoc Investigator at San Francisco VA Medical Cntr where her research focused on miRNA dysregulation in prostate cancer. In 08’ she joined the Depart of Hematology at Stanford Univ School of Medicine as a postdoc fellow. In 2012 she completed her MPH in Epidemiology from Univ of California at Berkeley. Emily completed a fellowship at NCI/NIH in the Laboratory of Human Carcinogenesis. Research involved examining the role of extracellular plant small RNA communication in human carcinogenesis.