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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
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
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 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
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 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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