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April 2010
Aclairo is pleased to announce that Dr. Robert Osterberg has been elected as chairman of the U.S.P.'s Council of Experts Toxicology Committee for a period of 5 years (2010-2015)
May 29, 2009
Aclairo is pleased to announce that it has achieved WBENC certification as a women-owned business enterprise. WBENC (The Women's Business Enterprise National Council, www.wbenc.org ) is the nation's largest third-party certifier of women-owned businesses that works to encourage the utilization and expansion of supplier/vendor diversity programs.
May 21, 2009
Aclairo is pleased to announce its membership in Virginia Biotechnology Association: http://www.vabio.org/new-member-spotlight-aclairo-pharmaceutical-development-group-inc/
November 10, 2008
Aclairo® is pleased to welcome Gary Wolfe, Ph.D., D.A.B.T, to our team of toxicology consultants. Dr. Wolfe brings an expertise in the FDA-regulated preclinical development and direction of GLP studies. Dr. Wolfe will direct our Scientific Services Group, which prepares regulatory submissions, and monitors and manages nonclinical studies.
October 21, 2008
Aclairo's senior consultant, Dr. Robert Osterberg, has become the 1st recipient of the Marshall Steinberg Memorial Prize awarded by the International Pharmaceutical Excipients Council Foundation (IPEC). This prize recognizes Dr. Osterberg's contribution in the field of excipient safety, including his role in the promulgation of the FDA Guidance for Industry: Non-clinical Studies for the Safety Evaluation of Pharmaceutical Excipients, and more recently, his work with IPEC-Americas and the New Excipient Evaluation Program.
October 6, 2008
Aclairo® welcomes Debra Barrett, D.V.M., Ph.D, a board-certified toxicologist, to our team of senior consultants. Dr. Barrett brings 20 years of experience in early drug discovery and nonclinical drug safety evaluation.
September 24, 2008
Aclairo® is co-sponsoring the American College of Toxicology Symposium X, titled: "Considerations for Nonclinical Drug and Biologic Development in Europe". This symposium will be held Tuesday, November 11, 2008 during the 29th Annual Meeting of the American College of Toxicology in Tucson, Arizona.
June 2, 2008
Aclairo® is co-sponsoring December 4-5, 2008 SOT Contemporary Concepts in Toxicology Workshop on "Hemangiosarcoma in Rodents: Mode-of-Action Evaluation and Human Relevance"in Arlington, VA.Other co-sponsors include the HESI PPAR Agonist Project Committee, AstraZeneca, Daiichi-Sankyo, GlaxoSmithKline, Merck Research Laboratories, Pfizer, Sanofi-Aventis, the SOT Regulatory and Safety Evaluation Specialty Section, and Takeda Pharmaceutical Company. To register, view the workshop program, or submit abstracts, go to http://www.toxicology.org/ai/meet/hr-COF_meeting.asp. The early registration deadline is July 31, 2008. The purpose of the workshop is to explore the modes of action and human relevance of hemangiosarcoma induction in rodents by various classes of compounds.
March 2008
Aclairo® is attending 2008 SOT (Society of Toxicology) Annual Meeting in Seattle, Washington.
Dr. Robert Osterberg will introduce and chair a workshop entitled "Dermal Toxicological Assessment of Nanomaterials and Nanodevices". He will also engage in a Great Debate regarding the Maximum Tolerated Dose in all toxicology studies, and conduct a presentation on "Toxicological Considerations for the Use of Excipients in Topical Drug Products and FDA's Excipients Guidance".
Aside from attending sessions and meeting with clients, Dr. Susan Wilson will be interviewing candidates for senior consultant positions and Karen Walthall will be interviewing qualified research fellow candidates. Dr. Hilary Sheevers will be attending sessions and assisting with the interview process. If you are interested in Aclairo® employment, please contact us. We look forward to seeing you in Seattle at SOT!
December 12, 2007
Aclairo's offices will be closed for holidays between December 25, 2007 and January 1, 2008. We will resume operations Wednesday, January 2, 2008.
October 18, 2007
Aclairo® has moved its offices on October 18, 2007! Our new address is 1950 Old Gallows Road, Suite 300, Vienna, VA 22182
October 8-12, 2007, University of California, San Francisco, CA
Aclairo's senior regulatory toxicologist and former FDA reviewer, Dr. Hilary Sheevers, will be giving a talk on "How much animal data are required to move onto clinical testing?" at the 2nd CTSI Regulatory Education Seminar focusing on preclinical aspects of drug development.
November 2007
As an invited speaker at the international DIA meeting in Amsterdam, Netherlands, Dr. Forbes will be giving a lecture on photocarcinogenesis. This meeting is organized by the DIA and is intended to support a joint effort by the government and industry to update the European Photosafety regulatory guidance document
June 27 - 30, 2007
Aclairo's senior consultant, Jeri El-Hage, will be the invited speaker at a Covance-sponsored symposium held in conjunction with the 34th Annual Meeting of the Japanese Society of Toxicology, Tokyo, Japan. The title of her talk is “Toxicity and Carcinogenicity Profiles of the Peroxisome Proliferator-Activated Receptor Agonists (PPAR) and U.S. FDA Regulatory Recommendationsâ€.
11/16/07
Dr. Susan Wilson will co-chair a session at the ACT in Palm Springs, California on the non-clinical requirements for route of administration changes for pharmaceutical drug products.
7/25/06
Aclairo' Senior Consultant Jeri El-Hage will be presenting a talk at the National Institute of General Medical Sciences/NIH sponsored meeting on Predictivity of Animal Models for Drug Safety Assessment on August 15 , 2006.
Dr El-Hage will give a presentation entitled " Preclinical Safety Testing of Peroxisome Proliferator-Activated Receptor (PPAR) Agonists: Predictivity for Human Safety." The meeting will be held August 15-16, 2006 at the Lister Hill Auditorium on the NIH campus in Bethesda, MD. For further information contact the NIH website at http://pub.nigms.nih.gov/generic_meeting/index.cfm?id=26
7/10/06
Aclairo® is pleased to announce the expansion of our preclinical services. Aclairo® welcomes Jeri El-Hage, Ph.D, a recognized expert in FDA-regulated preclinical drug development, to our team of senior consultants.
Dr. El-Hage joins the consultants at Aclairo®, bringing 18 years of preclinical regulatory experience, and allowing Aclairo® to offer more expertise in preclinical drug development than ever before. Leadership positions held in the Center for Drug Evaluation and Research at FDA include 6 years as supervisory pharmacologist in the Division of Metabolism and Endocrinology Products (DMEP), and 2 years as the Associate Director of Pharm/Tox for the Office of Drug Evaluation I. Her career in CDER also included 8 years as a pharmacology/toxicology reviewer in DMEP and 4 years as a reviewer in the Division of Reproductive and Urology Products.
Needless to say, Aclairo® is delighted to welcome Dr. El-Hage to our consulting group, and to offer her expertise to aid our clients.
Dr. El-Hage's most recent special projects and committee work within the FDA include:
- Carcinogenicity Assessment Committee member
- Pharmacokinetics/Toxicokinetics Subcommittee, co-chair. This committee recently published the draft guidance entitiled "Safety Testing of Drug Metabolites" in June, 2005.
- Recognized expert on the preclinical development and toxicity of Peroxisome Proliferator-Activated Receptor (PPAR) Agonists.
- Follow-on growth hormones and insulins
Dr. El-Hage has extensive preclinical experience with drugs indicated for diabetes, obesity, and dyslipidemia and peptide and protein hormone biologics.
Please contact Dr. El-Hage at: mailto:jelhage@aclairo.com or 703-506-6760 X 310
6/22/06
Aclairo's Vice President and Chief Scientific Officer Susan Wilson will co-chair a symposium at the American College of Toxicology annual meeting.
The symposium is titled "Challenges in the Safety Assessment of Topical Drug Development - Special Considerations for Known Entities (non-NCE's) and Route of Administration Changes" The ACT annual meeting will be held November 5 to 8, 2006 at Renaissance Esmeralda Resort & Spa in Indian Wells (Palm Springs Area), CA. To find out more we encourage you to visit the ACT at:http://www.actox.org/
6/13/06
Aclairo's President and CEO, Hilary Sheevers, PhD will present a section at the PERI course on Clinical Development of Drugs for Asthma and COPD on Monday, July 24th.
Dr. Sheevers will speak on Toxicology Considerations in Drug Development for Asthma and COPD. Her presentation will cover pharmaceutical toxicology considerations and focus on inhaled drugs. The Pharmaceutical Education & Research Institute, Inc. course on Clinical Development of Drugs for Asthma and COPD will be held July 24 -26, 2006 at the Hyatt Regency Baltimore in Baltimore, MD. For more information we encourage you to visit the PERI website.
6/04/06
Aclairo's Senior Consultants Paul Donald Forbes and Robert Osterberg will be presenting seminars on regulatory phototoxicology at the American Society for Photobiology annual meeting.
Don Forbes and Robert Osterberg will be presenters in the PPS course on Photostability. Additionally, Don will chair the Phototoxicity 2 seminar. The ASP annual meeting will be held July 8 to 12, 2006 at the Westin Rio Mar Beach Resort in Puerto Rico. To find out more we encourage you to visit the ASP website at: http://www.kumc.edu/POL/ASP_Home/asp_meet.html
5/15/06
Aclairo's Vice President and Chief Scientific Officer Susan Wilson has contributed two chapters to a new book published by FDA News.
Susan Wilson coauthored chapter 8: "Common Technical Document Summaries" and authored chapter 9: "Detailed Safety Section of the CTD" in the book PREPARING THE NEW DRUG APPLICATION: Managing Submissions Amid Changing Global Requirements. This new book will bring you up to speed on recent changes to the NDA process - including the change from paper to electronic format - and guide you step-by-step through the application process. Whether you're an industry veteran or newcomer, this book will help ensure that your new drug does indeed make it to the marketplace. Published March 2006, 307 pages, $295
Link to FDA News bookstore: http://www.fdanews.com/wbi/bookstore/2129-1.html
4/28/06
Aclairo's Senior Consultant Robert Osterberg has coauthored a chapter in a new book published by Taylor and Francis Group.
Robert Osterberg coauthored Chapter is 14 entitled: "Drug Safety Toxicology" in the new book: BIOLOGICAL CONCEPTS AND TECHNIQUES IN TOXICOLOGY, An Integrated Approach edited by Jim E. Riviere. published by Taylor and Francis Group. Highlighting the latest advances in molecular biology, mathematical modeling, quantitative risk assessment, and biopharmaceutical development, this reference presents how current scientific applications and methods impact and revolutionize mainstream toxicological research.
Link to Taylor and Francis online: http://www.crcpress.com/
1/31/06
Aclairo® is pleased to announce the expansion of our preclinical services. Aclairo® welcomes Robert E. Osterberg, R.Ph., Ph.D, a recognized expert in FDA-regulated preclinical drug development, to our team of senior consultants.
Robert E. Osterberg, R.Ph., Ph.D.
Fellow, Academy of Toxicological Sciences
Dr. Osterberg joins the consultants at Aclairo® , bringing his many years of academic and preclinical regulatory experience, and allowing Aclairo® to offer more expertise in preclinical regulatory drug development than ever before. Previously, Dr. Osterberg held numerous positions in CDER at FDA. His leadership positions in FDA included supervisory/team leader activities in the Divisions of Anti-Infective; Special Pathogen; and Anti-Inflammatory, Analgesic, and Ophthalmic Drug Products. Dr. Osterberg also held acting positions as the Associate Director of Pharm/Tox for CDER, and began his career in CDER as Deputy Director in the Anti-Viral Division. Dr. Osterberg also has experience in the Centers across FDA, including Veterinary Medicine, Foods, and experience in the US Consumer Product Safety Commission.
He assisted in the development of acute, subchronic, and chronic toxicology testing protocols for the Interagency Regulatory Liaison Group (IRLG), OECD and the Bureau of Foods' Red Book.
Needless to say, Aclairo® is delighted to welcome Dr. Osterberg to our consulting group, and to offer his expertise to aid our clients.
Dr. Osterberg's most recent special projects and committee work within the FDA include:
- Carcinogenicity Assessment Committee member
- Inactive Ingredients Subcommittee co-chair (excipients, extractables and leachables and other impurity types)
- Genetic Toxicology Subcommittee co-chair
- ICH-CTD Format for CDER pharm-tox reviewers leader
- Photobiology Subcommittee contributor
- CDER safety coordinator for numerous ICH Safety Guidances and the ICH Q3 A, B and C guidances
Dr. Osterberg has extensive experience with anti-infective, ophthalmological, topical dermal and systemic pharmaceuticals, including antibiotics, anti-fungal, and anti-parasitic drug products. He continues to be one of the central figures in expanding the pharmaceutical industry's understanding of FDA/CDER guidances, preclinical testing, and pharm/tox policies.
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