Speaker Biographies

Prof. Dr. Annemieke Aartsma-Rus is a professor of Translational Genetics at the Department of Human Genetics of the Leiden University Medical Center. She played an important role in the development of the antisense mediated exon skipping therapy for Duchenne muscular dystrophy during her PhD research (2000-2004) at the Leiden University Medical Center (the Netherlands). As of December 2007 she became leader of the “DMD exon skip group”. Since 2013 she has a visiting professorship at the Institute of Genetic Medicine of Newcastle University (UK). She is President of the Oligonucleotide Therapeutics Society (2019-2020) and vice-chair of COST Action CA17103 (Delivery of antisense RNA therapies). In 2013 she was elected a member of the junior section of the Dutch Royal Academy of Sciences (DJA), which consists of what are considered the top 50 scientists in the Netherlands under 45. In 2018, she was one of the founding members of Young Academy Leiden (YAL), the local Leiden counterpart of the DJA. She has been selected as most influential scientist in Duchenne muscular dystrophy in the past 10 years by Expertscape based on contributions to the understanding and treatment of Duchenne muscular dystrophy four times in a row (2015-now).

Phil Baran was born in 1977 in Denville, New Jersey. He received his BS in Chemistry from NYU in 1997, his PhD at the Scripps Research Institute in 2001, and from 2001-2003, he was an NIH postdoctoral fellow at Harvard. His independent career began at Scripps in the summer of 2003. He currently holds the Darlene Shiley Chair in Chemistry. Phil has published over 200 scientific articles and has been the recipient of several ACS awards, such as the Corey (2015), Pure Chemistry (2010), Fresenius (2006), and Nobel Laureate Signature (2003), and several international distinctions, such as the Hirata Gold Medal and Mukaiyama Prize (Japan), the RSC award in Synthesis (UK), and the Sackler Prize (Israel). In 2013, he was named a MacArthur Foundation Fellow; in 2015, he was elected to the American Academy of Arts and Sciences; in 2016, he was awarded the Blavatnik National Award; and in 2017, he was elected to the National Academy of Sciences, USA. He has delivered hundreds of lectures around the world and consults for numerous companies, such as Bristol-Myers Squibb (since late 2005), Boehringer-Ingelheim, AstraZeneca, DuPont and TEVA, and is a scientific advisory board member for Eisai, Abide, and AsymChem. In 2016, he was appointed as an Associate Editor for the Journal of the American Chemical Society. He co-founded Sirenas Marine Discovery (2012) and Vividion Therapeutics (2016) and, in 2013, he co-authored The Portable Chemist’s Consultant, an interactive book published on the iBooks store along with his graduate class in Heterocyclic Chemistry (viewable for free by anyone on iTunes University). Outside of the lab, Phil enjoys spending time with his wife, Ana, and three young children, Lucia, Leah, and Manuel.

Vera Brinks is director pharmaceutics at ProQR Therapeutics, where she is responsible for formulation development and supports DP manufacturing process development. She has over 15 years’ experience in the (bio) pharmaceutical field, with a focus on formulation-related quality attributes of oligonucleotides and biologicals. Vera received her PhD in the field of biopharmaceutics at the Leiden University (The Netherlands), after which she has been postdoctoral fellow at the Utrecht University (the Netherlands) and at the FDA (CDER, DTP, US), before joining ProQR in 2014.

Professor Marvin H. Caruthers research includes nucleic acids chemistry and biochemistry. Approximately 35 years ago, the methodologies that are used today for chemically synthesizing DNA and RNA were developed in his laboratory. His laboratory has also pioneered the synthesis of many new nucleic acid analogs that have found applications in the nucleic acid diagnostic and therapeutic areas. He is the recipient of the National Academy of Sciences Award for Chemistry in Service to Society, the Prelog Medal, the Economists Award in Biotechnology, and the US National Medal of Science. He is also the recipient of The National Academy of Science Award in the Chemical Sciences, The American Chemical Society Award for Creative Invention, The Frantisek Sorm Medal-The Academy of Sciences of the Czech Republic and The Life Time Achievement Award of the Oligonucleotide Therapeutic Society. Dr. Caruthers is an elected member of The US National Academy of Sciences, The American Academy of Arts & Sciences, The National Inventors Hall of Fame, The National Academy of Inventors, and a Corresponding Member of the German Academy of Science Gottingen. One of the co-founders of Amgen and Applied Biosystems, Dr. Caruthers remains active in the Biotechnology arena – most recently as a co-founder of Array BioPharma and miRagen Therapeutics.

Dr. Corey graduated with a BA from Harvard in 1985 and a PhD from UC Berkeley under the direction of Dr. Peter Schultz in 1990. He has had his own laboratory at UT Southwestern since 1992 and is currently the Rusty Kelley Professor of Biomedical Science in the Department of Pharmacology.

John Davis is presently Vice President, Head of Preclinical Development at Dyne Therapeutics, a genetic medicine company located in Waltham, MA, and is responsible for developing preclinical strategies necessary for underwriting clinical trials from First In Human through Phase III. John has close to 20 years of experience in a global biopharmaceutical setting with expertise in managing both exploratory and GLP nonclinical toxicology studies; utilizing both internal and external resources. John’s breadth of portfolio support includes antisense oligonucleotide, small molecule and biologic programs. Prior to joining Dyne, John was Vice President of Preclinical Development at Wave Life Sciences where he established toxicology as a core discipline including leading cross-functional teams aimed at developing and implementing early safety screening strategies. Prior to Wave, John held positions of increasing responsibility at first Schering-Plough and then Pfizer. While at Pfizer, John was a recognized leader in developing mechanism-based human risk assessment projects and led highly effective cross-discipline teams utilizing demanding novel approaches. John has co-authored more than 20 peer-reviewed publications and reviews and has given numerous invited seminars at both scientific meetings as well as academic institutions. John has co-chaired multiple continuing education courses, symposia and workshops at both annual Society of Toxicology (SOT) and American College of Toxicology (ACT) meetings, and is a founding/charter member of the Drug Discovery Toxicology Specialty Section of SOT where he has served as the secretary/treasurer and president and was a member of the SOT Congressional Task Force. He has also participated in multiple industry-wide consortiums including the nephrotoxicity working group of the ILSI-HESI toxicogenomics group and the Critical Path Initiative’s nephrotoxicity biomarkers working group. John recently completed a 6-year term as an Associate Editor for the journal Toxicology and Applied Pharmacology and is a charter and current member of the University of Wisconsin Undergraduate Pharm/Tox External Advisory Board.

Jesse Faber is a Senior Process Engineer in the Process Engineering and Manufacturing group at Biogen and is responsible for the operation of an ASO clinical and commercial manufacturing facility. Jesse has twenty years of experience in the pharmaceutical industry in drug substance and drug product manufacturing for companies including Merck and GlaxoSmithKline. He has been at Biogen for the past four years where he has helped to lead the startup of Biogen’s first internal ASO manufacturing facility and the subsequent process validation of their first ASO molecule. Jesse holds a Bachelor’s degree in Chemical Engineering from Clemson University.

Elena Feinstein MD, PhD is a Chief Scientific Officer for Quark Pharmaceuticals, Inc. She received her MD degree (with honors) from the Russian State Medical University (former 2nd Moscow State Medical School) and PhD degree (with honors) in Molecular and Cellular Biology from the Weizmann Institute of Science in Israel. Since joining Quark, she has been holding increasingly senior positions, first leading the high throughput functional gene discovery programs in numerous disease areas and then taking the lead in establishment of Quark’s siRNA therapeutics platform, drug discovery and early development. Prior to joining to Quark, Dr. Feinstein conducted academic research in the fields of apoptosis and cancer in the Weizmann Institute of Science. She is a principle or senior author of dozens of publications in the high impact peer-reviewed journals and an inventor on numerous awarded patents and patent applications.

Chantal Ferguson is a graduate of Wesleyan University with a BA in Neuroscience. At Wesleyan, she perfumed research in Dr. Stephen Devoto’s neuromuscular development lab, studying the genetic regulatory network involved in zebrafish neuromuscular development. After graduating college, Chantal performed research in the Breast Cancer Center at Massachusetts General Hospital, focusing on treatment related complications, outcomes, and patient care. As she embarked on her MD/PhD at UMass Medical School (UMMS), Chantal's passion for studying neurological diseases combined with her interest in RNA interference led her to Dr. Anastasia Khvorova’s lab in the RNA Therapeutics Institute. The Khvorova lab develops and chemically optimizes short interfering RNAs (siRNAs) for CNS delivery. Chantal’s thesis project focuses on developing and using siRNAs to understand the relationship between Apolipoprotein E and neurodegeneration. Chantal’s clinical interests include neurology and interventional radiology.

CMC consultant specializing in CMC, Reg CMC and QA of oligonucleotides. 25 years of experience in the field of oligonucleotides with a range of academic, industry and contract manufacturing experience. Kevin has been working in the oligonucleotides area since starting his Ph.D. at the University of London in 1995. Subsequently he worked for Avecia Biotechnology, now Nitto Denko Avecia for 8 years across both their original Scottish site at Grangemouth and then Milford, Massachusetts. Since 2009 he has held positions as Head of CMC at RXi Pharmaceuticals, Galena Biopharma and Dicerna Pharmaceuticals. In 2016 Kevin founded FTS Pharma Consulting, LLC to primarily assist early-phase oligonucleotide clients with their Technical, Regulatory CMC and Quality Assurance challenges.

Jeff Foy is the Executive Director of Toxicology at Dicerna Pharmaceuticals a wholly owned subsidiary of Novo Nordisk located in Lexington Massachusetts. He is responsible for the design and conduct of toxicology studies and authoring of nonclinical regulatory submissions for Dicerna’s platform of compounds which are predominantly GalNAc-conjugated double-stranded siRNAs. He also manages the nonclinical writing group at Dicerna. Prior to joining Dicerna, Jeff worked at Celgene where he worked on small molecules and biologics for oncology and severe inflammatory diseases. He received his PhD in toxicology from Northeastern University in Boston. Jeff also chairs the oligonucleotide safety working group (OSWG).

Dr. Xiao Shelley Hu is a seasoned pharmaceutical scientist with over 20 years of experience driving innovation across multiple therapeutic areas. She earned her Ph.D. and M.S. in Pharmaceutics from The Ohio State University, an M.S. in Environmental Chemistry from the Chinese Academy of Sciences, and a B.S. in Pharmacy from Peking University. As the President and Founder of Translational Consulting LLC, Dr. Hu provides specialized expertise in DMPK, clinical pharmacology, pharmacometrics, and translational strategies to pharmaceutical and biotech companies. Her leadership experience includes serving as Vice President and Head of DMPK and Clinical Pharmacology at Wave Life Sciences, where she spearheaded regulatory filings and advanced global programs involving antisense oligonucleotides, siRNA, and A-to-I editors. Previously, at Akebia Therapeutics, she led Clinical Pharmacology and Bioanalytical Science Department, overseeing registrational studies leading to the approval for VAFSEO. During her tenure at Biogen, she played a pivotal role in the approval of PLEGRIDY and contributed to TECFIDERA world-wide approval. A published author and sought-after speaker, Dr. Hu is committed to leveraging her deep expertise to champion data-driven approaches and shape the future of personalized medicine.

Ms. Hong Jiang received her Master’s degree in 1999 from University of Texas at Austin where she conducted research in the mechanism of phage Mu transposition under the direction of Prof. Rasika M. Harshey. She has accumulated two decades of experience in drug discovery and development while working at Wyeth BioPharma, Novartis Institutes for BioMedical Research, and currently Biogen. At Biogen Hong is the leader of the analytical development group supporting oligonucleotide development. Her experience before joining Biogen includes analytical method development for small molecule, biologics and mRNA programs with a focus on mass spectrometry, drug metabolism, and protein drug formulation.

Dr. Kandasamy has over 10 years of experience in oligonucleotide research and development. He worked on siRNA delivery technologies for 5 years at Alnylam prior to joining the Medicinal Chemistry group at Wave in 2016. He earned a Ph.D. in synthetic carbohydrate chemistry focused on discovering new methods for stereospecific anomeric C-O and C-C bond formation related to GalNAc sugars from the Indian Institute of Technology Kanpur (India) before completing postdoctoral work on glycopeptides at the University of Konstanz (Germany) with Professor Richard R. Schmidt and worked on aminoglycosides antibiotics at University of Montreal (Canada) with Professor Stephan Hanessian.

Dr. Steven Kates is Vice President of Regulatory Affairs at Dicerna Pharmaceuticals a wholly owned subsidiary of Novo Nordisk located in Lexington Massachusetts. He is a highly experienced pharmaceutical executive with over thirty years in R & D for both human therapeutics and life science products and has advanced several compounds through drug development from early pre-clinical to early clinical development and approval. He has held senior positions at Takeda, Lakewood Amedex, Ischemix, Citius Pharmaceuticals, Surface Logix, Consensus and Millipore Corporation. Dr. Kates is a world-leading chemist and industry expert in peptide design and manufacture. He has written or co-authored more than 100 articles, reviews, and patents. Dr. Kates has served as editor of two books entitled Solid-Phase Synthesis: A Practical Guide and ADMET for Medicinal Chemists, A Practical Guide; guest editor of Biopolymers; and as a member of the Editorial Board of International Journal of Peptide Research and Therapeutics. A Part-Time Assistant Professor at Northeastern University College of Professional Studies in Regulatory Affairs and Visiting Professor of Chemistry at Brandeis University, Dr. Kates earned his B.S. in chemistry from Bates College, Ph.D. in Synthetic Organic Chemistry from Brandeis University and conducted post-doctoral studies at The Massachusetts Institute of Technology.

Ed Kaye, a pediatric neurologist, is the chief executive officer and a director of Stoke Therapeutics. Ed previously served as CEO of Sarepta Therapeutics, where he led the successful push to win FDA approval of Exondys 51, a pioneering drug for Duchenne muscular dystrophy. Before taking on the CEO role at Sarepta, he served as the company’s chief medical officer for six years, leading the drive to develop Exondys 51. He also served on Sarepta’s board of directors. Earlier in his career, Ed spent 10 years at Genzyme Corporation, most recently as group vice president of clinical development, where he supervised clinical research in programs focused on lysosomal storage disease and genetic neurological disorders. At Genzyme, Ed also held various roles, including vice president of medical affairs for lysosomal storage diseases, vice president of clinical research and interim head of PGH global medical affairs. Ed currently serves as a member of the boards of directors at Cytokinetics, Inc. and the Massachusetts Biotechnology Council. Prior to entering the biotech industry, Ed trained in pediatrics, pediatric neurology and biochemical genetics. He was on the research staff at Massachusetts General Hospital and Tufts University Medical Center and was the chief of biochemical genetics at the Children’s Hospital of Philadelphia. He remains on the pediatric neurology staff at Boston Children’s Hospital. Ed earned his B.S. in biology from Loyola University and earned his M.D. at the Loyola University Stritch School of Medicine.

Dr. Leberer received his Ph.D. in Biology at the University of Konstanz, Germany (1986), and conducted post-doctoral training in molecular biology at the Banting and Best Institute of the University of Toronto, Canada. He then obtained the Habilitation for Professor of Biochemistry at the University of Konstanz, Germany (1992). From 1989-1998, he served as Senior Research Officer in genetics and genomics at the Biotechnology Research Institute, National Research Council of Canada, Montreal. He was also Adjunct Professor at McGill University, Montreal. Since joining the pharmaceutical industry in 1998, Dr. Leberer carried out various managing roles in Hoechst Marion Roussel, Aventis and Sanofi, including responsibilities in functional genomics, biological sciences, alliance management and external innovation for oligonucleotide-based therapeutics. In addition, from 2012-2018, he has been the Scientific Managing Director of the Innovative Medicines Initiative COMPACT Consortium on the delivery of biopharmaceuticals across biological barriers and cellular membranes, Brussels. Since March 2021, Dr. Leberer is Senior Life Sciences Consultant at ELBIOCON (www.elbiocon.com). He serves as a member in Scientific Advisory Boards of several biotechnology companies, and he is the Head of the Supervisory Board of BioM, Munich. His research has focused on the molecular mechanisms of signal transduction and the role of signalling molecules in human diseases. He is the co-discoverer of the p21 activated protein kinase (PAK) family of cell signalling proteins and of novel virulence-inducing genes in pathogenic fungi. He is co-author of more than 60 publications in prestigious peer-reviewed journals including Nature and Science.

Prof. Dong-ki Lee received B. S. in Chemistry from Korea Advanced Institute of Science and Technology (KAIST) in 1993, and Ph. D. in Biochemistry from Cornell University in 1999. After post-doctoral training in Pohang University of Science and Technology (POSTECH), Toolgen Inc., and KAIST, he joined POSTECH as an assistant professor in 2004. In 2008, He moved to Sungkyunkwan University and is a full professor of Chemistry since 2012. In 2008, Prof. Lee was selected as the principal investigator of the Global Research Laboratory program, funded by Korean government, to develop novel RNAi medicine. He is currently serving as the Asian editor of “Nucleic Acid Therapeutics” and a editorial board member of "Molecular Therapy: Nucleic Acids". His work on novel siRNA structures, nucleic acid aptamers, and eukaryotic gene regulation has been published as over 80 papers including prestigious journals such as Nature, Cell, PNAS, and Molecular Therapy. In 2010, he founded OliX Pharmaceuticals, a publicly traded RNAi therapeutics company, and serves as Chief Executive Officer.

Marc Lemaître holds a degree in Organic Chemistry and a PhD in Biochemistry from the University of Liège, Belgium. Since 1985, Marc’s professional interests have been the study of the Nucleic Acids and therapeutics as well as diagnostic applications. Based in the USA since 2006 he worked for Glen Research, as CEO of Girindus America, a CMO with a focus on the cGMP manufacture of oligonucleotides for therapeutic applications. Marc is now working as consultant since 2013, working mostly on CMC with start-up and Pharma companies developing therapeutic oligonucleotides and peptides.

Patrick Y. Lu, Ph.D, Founder & Honorary CSO, Inc., Chairman of Suzhou Sirnaomics and Guangzhou Nanotides. Dr. Lu started his biopharmaceutical industry career in 1993 as a lab head in Novartis and was the co-founder and Executive VP of Intradigm Corporation (2001-2006). Patrick has authored more than 50 scientific papers, review articles and book chapters, and is an inventor for more than 50 issued and pending patents. He has been an invited speaker in many international conferences throughout the world and received a number of Government grants. Under his leadership, Sirnaomics has raised more than US$70 million dollars and has developed a series of “first-in-class” siRNA therapeutic candidates at different phases of clinical studies, in both USA and China. The company’s therapeutic programs are focused on anticancer and antifibrotic indications. Recent development of the company’s leading drug product in combination with immune checkpoint inhibitor (mAb) for treatment of hepatocellular carcinoma has demonstrated a strong therapeutic benefit with a syngeneic mouse model.

Dr. Madsen is currently Associate Director, Analytical Development and Quality Control at Ionis Pharmaceuticals, Inc., Carlsbad, California. Prior to joining Ionis in 2013 he worked in the analytical development groups at CovX Research and Biogen. Dr. Madsen has +14 years’ experience working in the pharmaceutical industry and has expertise in a variety of methodologies, including HPLC, mass spectrometry, and ICP-MS analysis. In his current role, Dr. Madsen is responsible for supporting a broad spectrum of activities to support oligonucleotide clinical programs, such as testing and release of manufacturing intermediates, drug substance, and drug product, plus authoring manufacturing intermediate specifications, drug substance specifications, and relevant CMC sections for regulatory filings.

Paul F. Manley, has accumulated 30+ years of business and senior management experience in regulatory affairs, compliance and overall drug development, across a range of therapeutic areas within the pharmaceutical, biologic and consumer products industries. Mr. Manley’s corporate career encompassed senior management and technical leadership positions within the US and Europe in both large corporations (VP, Global Regulatory Affairs – Oncology, J&J) and start-up-like entities (VP, Regulatory Affairs and Compliance, Genta Incorporated). In 2007 Mr. Manley established Orvieto Consulting, LLC, providing strategic advice to numerous companies across a wide range of scientific disciplines and through all phases of development through to post-marketing.

Muthiah Manoharan, PhD. Dr. Muthiah (Mano) Manoharan serves as a Senior Vice President of Drug Innovation, a Scientific Advisory Board Member, and a Distinguished Research Scientist at Alnylam Pharmaceuticals, Cambridge, Massachusetts, USA. In 2003, he was the first chemist hired at Alnylam. He and his team pioneered the discovery and development of the chemical modifications, GalNAc conjugation chemistry, and LNP delivery platform that make RNA interference-based human therapeutics possible. This work led to the approval of four RNAi therapeutics: ONPATTRO® (patisiran, 2018), GIVLAARI® (givosiran, 2019), OXLUMO® (lumasiran, 2020) and Lequio® (inclisiran, 2020). Dr. Manoharan has had a distinguished career as a world-leading chemist in the field of oligonucleotides. He is an author of more than 225 publications (nearly 50,000 Google Scholar citations with an h-index of 101 and an i10-index of 399) and over 400 abstracts, as well as an inventor of over 250 issued U.S. patents. Prior to Alnylam, Dr. Manoharan worked in the field of antisense oligonucleotide therapeutics at Ionis (formerly Isis) Pharmaceuticals and LifeCodes Corporation (1988-1990) . Dr. Manoharan received his B.Sc. and M.Sc. degrees in chemistry at the American College, Madurai, India. He earned his Ph.D. in chemistry (with Professor Ernest L. Eliel) at the University of North Carolina, Chapel Hill and carried out post-doctoral research (with Professor John A.Gerlt) in the field of oligonucleotide chemistry at Yale University and at the University of Maryland. Dr. Manoharan is the winner of the Lifetime Achievement Award of the Oligonucleotide Therapeutics Society (2019), the M. L. Wolfrom Award from the American Chemical Society (2007) and D. Horton Industrial Carbohydrate Chemistry Award from the American Chemical Society (2021).

Dr. Monia is the chief executive officer and a founding member of Ionis Pharmaceuticals. His contributions at Ionis include research into the medicinal chemistry and mechanisms of action of RNA-targeting modalities to treat human diseases, most notably antisense-based therapeutic strategies. Dr. Monia has extensive experience across a range of therapeutic areas, including oncology, metabolic disease, inflammation, neurological disease and cardiovascular disease, which have resulted in a broad range of successful clinical achievements and in marketing approvals for new medicines. Dr. Monia has published more than 200 primary research manuscripts, reviews and book chapters, and is an inventor on more than 100 issued patents. He serves as a senior editor for the journal Nucleic Acid Therapeutics, is on the board of directors for Dynacure, and has served as president of the Oligonucleotide Therapeutics Society (OTS). Dr. Monia is also an adjunct professor of biology at San Diego State University where he lectures at the graduate level on pharmacology. Dr. Monia received his Ph.D. in Pharmacology from the University of Pennsylvania and B.S. degrees in Molecular Biology and Analytical Chemistry from Stockton University in Pomona, New Jersey.

I am an Analytical Scientist with GMP and research experience in pharmaceutical research and development organizations. Following an MS degree from Kent State University, I have been working in the Pharmaceutical industry since 2003 starting with small molecules and have been working with oligonucleotides for the past 11 years, specifically PEGylated aptamers and siRNA oligonucleotides.

Francis Ring is currently an Assistant Director at Ionis Pharmaceuticals in Carlsbad and has worked in oligonucleotide manufacturing for 12 years. Prior to Ionis, he completed a B.S. in Chemical Engineering at Stanford University. At Ionis, he leads the design and implementation of automated equipment, including oligonucleotide synthesizers, chromatography skids, and the building automation. He is also the primary architect of all manufacturing trending programs at Ionis, including developing custom validated scripts for data collection purposes.

Dmitry Samarsky, PhD, has been at the inception of RNAi technology and drug development—starting in 2001 as Director of Technology Development at Sequitur (acquired by Invitrogen) and (in 2005) as Director of Technology Development at Dharmacon (now part of GE). He then served as VP of Technology Development at RXi Pharmaceuticals, USA (2007-2011), SVP of Technology and International Business Development at RiboBio, China (2011-2016) and, most recently, as Chief Scientific Officer at Silence Therapeutics, Germany/UK (2016-2018) and Ceif Technology Officer at Sirnaomics, US. He is currently a Founding Scientist, CSO and Board Member at ARNAgen Therapeutics, US. Dr. Samarsky has authored more than 40 scientific papers, articles, book chapters, patents and patent applications. He has been an invited speaker at more than 100 international conferences, and currently serves on the Scientific Advisory Boards for the OTS (Oligonucleotide Therapeutics Society). Dr. Samarsky received his doctorate in biochemistry and molecular biology from University of Massachusetts, Amherst (1998), followed by a postdoctoral position as an H. Arthur Smith Fellow for Cancer Research in Michael Green's lab at University of Massachusetts Medical School (1998-2001).

Tara Scherder has over 20 years of experience in the pharmaceutical and biopharmaceutical industries as a statistician, engineer, and master black belt. Her passion is the powerful combination of science and statistics to increase knowledge, optimize both manufacturing and business processes, and reduce risk. She combines statistical expertise with extensive knowledge of manufacturing platforms and analytical sciences, in conjunction with business and regulatory acumen to achieve goals. She has functioned as both an in-house and external statistical consultant to drug substance and drug product teams from product development through commercial supply for the spectrum of product platforms. She frequently speaks at industry forums and publishes on the practical incorporation of statistical methods for Lifecycle Process Validation. Tara earned a BS degree in Chemical Engineering from the University of Pittsburgh and a MS degree in Statistics from Carnegie Mellon University. As partner at SynoloStats, she passionately collaborates with teams to leverage statistical methods to accelerate timelines, design and develop robust processes, and assure ongoing quality to patients and consumers.

In 2009, Dr. David Tabatadze cofounded ZATA in partnership with Dr. Paul Zamecnik (1912-2009) where he has served as the President and CEO. Dr. Tabatadze has led the development of novel nucleic acid platform technology enabling the synthesis of next generation oligonucleotides (ON) with custom-designed properties based on the incorporation of various branched chemical groups on the internucleoside phosphates. ZATA’s ONs (ZONs) are applicable to all currently known oligotherapy-based approaches including antisense and CRISPR. Dr. Tabatadze has significant experiencing in consulting medical device companies in the development and FDA clearance of commercially available light-based medical devices. His thirty-plus years of R&D experience includes developing novel drug candidates and diagnostic probes, business development and management, execution of IP portfolio and regulatory submission. Dr. Tabatadze possesses a MS in organic chemistry, a PhD in bioorganic chemistry, and has received post-doctoral training in nucleic acid chemistry at the Worcester Foundation for BioMedical Research (Shrewsbury, MA). He has also co-authored over three dozen peer-reviewed papers, patent applications, and patents. At ZATA, Dr. Tabatadze has established business and collaborative relationships with several biotech and academic institutions locally and internationally.

Dr. W. Brad Wan is a Principal Scientist in the Department of Medicinal Chemistry at Ionis Pharmaceuticals located in Carlsbad, CA. Dr. Wan has been with Ionis pharmaceuticals since 2007 focusing on the synthesis of novel nucleoside monomers and oligonucleotide conjugates to improve potency and uptake in various tissues. His most recent work has been to evaluate the significance of controlling the stereochemistry of the phosphorothioate linkages that comprise the backbone of antisense oligonucleotide therapeutics.