INDIANAPOLIS, Jan. 11, 2016 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (NASDAQ:ASMB), a biotechnology company developing curative treatments for infectious diseases including hepatitis B virus (HBV) and C. difficile (CDI) infections, today announced several new senior level hires across the organization. The added team members include Richard Colonno, PhD, as Chief Scientific Officer; Thomas Rollins as Chief Development Officer and Head of the Microbiome Program; Elizabeth Haber Lacy as General Counsel and Vice President of Legal Operations; Wayne Herber, PhD, as Vice President, Biological Manufacturing and Quality; Hongmei Huang, PhD, as Vice President, Information Technology and Informatics; Leping Li, PhD, as Vice President, Discovery; Micah Mackison as Vice President, Corporate Development and Strategy; Eric Ruby as Vice President, Regulatory Affairs and Quality Assurance and Simon Haydar, PhD, as Senior Director, Discovery.
“The exceptional quality of these incoming senior managers adds significant depth and experience to the innovative science and technical approaches we are pursuing at Assembly to cure HBV and leverage the microbiome to treat infectious diseases,” said Assembly Chief Executive Officer Derek Small. “With our team largely complete and cash reserves on hand projected to fund our progress for two years, we anticipate initiating clinical trials in the second half of 2016 with our microbiome therapy for recurrent CDI and our lead CpAM antiviral compound for the treatment of HBV.”
Chief Scientific Officer Richard Colonno, PhD, is an internationally recognized expert with over 30 years of experience in antiviral drug discovery and development. He joins Assembly from Presidio Pharmaceuticals, where he served as CSO and directed the company’s hepatitis C (HCV) antiviral programs, including the discovery and development of the HCV NS5A inhibitor ravidasvir. Prior to Presidio, Dr. Colonno was Vice President, Infectious Diseases Drug Discovery at Bristol-Myers Squibb, where he played a pivotal role in building the company’s existing antiviral franchise, including the discovery, development and approval of entecavir (Baraclude®) for HBV and atazanavir (Reyataz®) for HIV. Earlier, he was Senior Director of Antiviral Research at Merck Research Labs following research positions at DuPont’s Experimental Station and the Roche Institute of Molecular Biology. Dr. Colonno received a PhD in Microbiology from the University of Kansas and has co-authored more than 160 scientific articles.
Chief Development Officer and Head of the Microbiome Program Thomas Rollins joins Assembly from anti-infective drug developer Cubist Pharmaceuticals, where he was Senior Vice President and Global Head, Program and Portfolio Management, chairing the team overseeing global product development. During his tenure, Mr. Rollins oversaw the global development and commercialization of the anti-bacterial drugs Sivestro® and Zerbaxa®, and helped transform Cubist into a multi-program, multi-product company. Previously, Mr. Rollins was Senior Vice President, Program Management at Sunovion Pharmaceuticals. At Sepracor, as Senior Vice President of Development, Mr. Rollins established an efficient and productive semi-virtual drug development organization that advanced Lunesta® from IND through NDA submission in just 42 months. Earlier in his career, Mr. Rollins served as a researcher before moving to Project Management at Merck, where he was co-team leader for a number of major global products, including Crixivan®, the first HIV protease inhibitor, and the pioneering osteoporosis drug Fosamax®. Mr. Rollins received an MBA from Rutgers University and BS and MS degrees from Michigan State University.
General Counsel and Vice President of Legal Operations Elizabeth Haber Lacy was formerly a partner in the Indianapolis office of law firm Barnes & Thornburg, specializing in corporate and entrepreneurial services, venture and corporate financings and corporate transactions. Previously, she was a partner in the corporate practice at Indianapolis legal firm Leagre, Chandler & Millard. Earlier in her career, Ms. Lacy worked at Chicago law firms Kirkland & Ellis and Jones, Day, Reavis & Pogue. Ms. Lacy is a member of the Indiana and Illinois state bars. She received an AB in public policy from Duke University and a JD from the Case Western Reserve University School of Law, where she graduated summa cum laude and was elected to the Order of the Coif. Ms. Lacy was selected for inclusion in The Best Lawyers in America® in 2011-2015 and was named "Lawyer of the Year" in 2013 in the area of venture capital law.
Vice President, Biological Manufacturing & Quality Wayne Herber, PhD, is a microbiologist with almost 30 years of experience in the scale-up and manufacture of a wide range of vaccines and other biologics, as well as antibiotics and secondary metabolites. Prior to Assembly, Dr. Herber was Senior Director, Manufacturing Science & Technology at AstraZeneca Biologics. Previously, Dr. Herber was Vice President, Process and Product Development at Auxilium Pharmaceuticals. For more than 20 years, Dr. Herber held positions of increasing responsibility at Merck, starting as Senior Research Microbiologist and progressing to Senior Director for Bioprocess R&D, Fermentation & Cell Culture, and ultimately Director/Distinguished Scientist for Vaccine Process Development. He received a BS from the University of Delaware and a PhD in microbiology from Rutgers University. Dr. Herber completed post-doctoral studies at Georgetown University School of Medicine.
Vice President, Information Technology and Informatics Hongmei Huang, PhD, was most recently Senior Director and Global Head of Research IT/Informatics at Janssen (Johnson & Johnson), where she oversaw scientific data management and IT services. Previously, Dr. Huang was Director and Site Head, Novartis Research IT, where she was responsible for the development and delivery of informatics systems, infrastructure and client solutions for the Infectious Disease and Oncology units. As Associate Director, R&D Informatics at Exelixis, Dr. Huang spearheaded informatics support for clinical development activities. As Associate Director/Site Area Head, Global Research Informatics at Roche, Dr. Huang provided strategic informatics services for discovery and preclinical safety. At Array BioPharma, Dr. Huang established a fully integrated research informatics platform. She received a BS at Beijing University, an MS from the University of Michigan and a PhD in organic chemistry at the Scripps Research Institute.
Vice President, Discovery Leping Li, PhD, has more than 20 years of experience in drug discovery and early development, leading project teams and advancing multiple programs from early lead identification to advanced clinical development in infectious diseases, cancer and metabolic disorders. Dr. Li joins Assembly from antiviral drug developer Presidio Pharmaceuticals, where he was Vice President of Chemistry and inventor of the HCV NS5A inhibitor ravidasvir. Previously, he was Scientific Director in Medicinal Chemistry at Amgen, where he received the 2004 Robert A. Swanson Distinguished Employee Award. Before Amgen, Dr. Li served as a Research Investigator at Abbott Laboratories. Dr. Li obtained a BS degree from Shandong University in China. He earned a PhD in organic chemistry at Rice University and conducted postdoctoral research at Stanford University.
Vice President, Corporate Development and Strategy Micah Mackison has over 15 years of pharmaceutical and life sciences experience in corporate development and strategy, mergers and acquisitions and finance. Prior to Assembly, he was Senior Director, Corporate Investment–Life Sciences for Jabil, where he was responsible for healthcare M&A and venture investments. Previously, Mr. Mackison founded and served as Managing Director of Oakridge Bioventures, a pharmaceutical strategy and M&A advisory firm, where he advised and co-founded startup companies. Previously, Mr. Mackison served as Divisional Director of Corporate Strategy and Senior Director, New Ventures at Lundbeck in Copenhagen. Prior to Lundbeck, Mr. Mackison was Director, Corporate Development and M&A with Ovation Pharmaceuticals, which was acquired by Lundbeck in 2009. Earlier in his career, Mr. Mackison held positions of increasing responsibility in finance at Pfizer and Eli Lilly. He earned a BS in finance from Indiana University.
Vice President, Regulatory Affairs and Quality Assurance Eric Ruby has more than 20 years of experience in managing regulatory strategy and the regulatory review process at leading biotechnology companies, where he has had responsibility for more than 15 drug development programs. Prior to Assembly, Mr. Ruby was Vice President of Regulatory Affairs at Presidio Pharmaceuticals, where he oversaw regulatory strategies for the company’s HCV development programs. Previously, he was Senior Director, Regulatory Affairs at Alnylam Pharmaceuticals and at Vertex Pharmaceuticals. At Vertex, Mr. Ruby led global regulatory activities for the HCV drug Incivek™ up to Phase III. Earlier in his career, Mr. Ruby was a chemistry reviewer and manager for drug metabolism and pharmacokinetic reviews at the US Food and Drug Administration. Mr. Ruby earned a BA from Harvard University and an MS degree from the University of California, Berkeley.
Senior Director, Discovery, Simon Haydar, PhD, has broad experience in the operational and strategic management of early stage drug research. Dr. Haydar joins Assembly from Eli Lilly & Co., where he was a Senior Research Advisor before serving as Director, then Senior Director of External Innovation R&D Emerging Markets unit. Prior to Lilly, Dr. Haydar was Chief Scientist for HIV Infectious Diseases at GlaxoSmithKline. Earlier in his career he was a medicinal chemistry Group Leader at Wyeth Pharmaceuticals and a Senior Research Scientist at Albany Molecular Research. Dr. Haydar is the co-author of many patents, as well as numerous scientific publications and presentations. He earned a PhD in organic chemistry at the University of Vermont and completed a postdoctoral fellowship at Florida State University.
About Assembly Biosciences
Assembly Biosciences, Inc. is a public biotechnology company developing novel oral therapies for the cure of intractable infectious diseases, currently focusing on hepatitis B virus (HBV) and C. difficile infections (CDI). Assembly’s HBV-Cure research team is discovering and developing multiple drug candidates that address both upstream and downstream targets in the HBV lifecycle for possible use in combination therapy. The goal is to eradicate, rather than just treat, HBV infection with an orally-administered regimen. Assembly has built a senior scientific team that has over 30 years of combined experience working on HBV. The company’s CDI program is focused on the targeted delivery of microbiome-based therapies in a novel oral formulation to treat recurrent CDI patients. Assembly has a proprietary delivery system, GemicelTM, which allows for targeted delivery of selected GMP-manufactured bacteria to the lower gastrointestinal tract, and it has built a team of world-class microbiome scientists from academia and industry to help advance this innovative program. For more information visit assemblybio.com.
Cautionary Note Regarding Forward-Looking Statements
The information provided herein contains estimates and other forward-looking statements regarding future events, including statements about the therapeutic potential of our HBV and CDI programs, timing of the initiation of our planned clinical trials in each of these programs and projections regarding adequacy of capital. Such statements, which we intend to be covered by the safe harbor provisions contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: our ability to retain necessary employees and to staff our operations appropriately; the components, timing, cost and results of clinical trials and other development activities involving our product candidates; the unpredictability of the preclinical and clinical development of our product candidates and of the duration and results of regulatory review of those candidates by the FDA and foreign regulatory authorities; our anticipated capital expenditures, our estimates regarding our capital requirements, and our need for future capital; and the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties. These and other potential risks and uncertainties that could cause actual results to differ from the results predicted are more fully detailed under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2014, and other reports filed with the Securities and Exchange Commission. It is not possible for Assembly management to predict all risks nor can Assembly assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements Assembly may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
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