PharmaPendium. The definitive source of best-in-class drug information

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1 Please contact us for more information Americas E-Customer Service 360 Park Avenue South New York, NY USA Tel: ( , if calling from outside the USA and Canada) Fax: Europe, Middle East and Africa E-Customer Service Theodor-Heuss-Allee Frankfurt/Main, Germany Tel: Fax: Asia Pacific E-Customer Service Higashi-Azabu Minato-ku, Tokyo Japan Tel: Fax: jpinfo@pharmapendium.com The definitive source of integrated preclinical, clinical and post-marketing drug information for: Preclinical and Clinical Safety Assessment Toxicology, Adverse Events Delivery Pharmacokinetics, Exposure Data Efficacy Biomarkers, Experimental Design, Primary & Secondary Endpoints Regulatory Affairs Precedents from Entire Library of FDA Approval Documents PharmaPendium The definitive source of best-in-class drug information Save time and operational costs Gain actionable data Plan intelligently Act smartly PharmaPendium is a trademark of Elsevier Inc. RTECS is a registered trademark of the U.S. Public Health Service in the United States. MedDRA is a registered trademark of the International Federation of Pharmaceutical Manufacturers Associations in the United States. Separate license to MedDRA required. All other names are or may be trademarks or registered trademarks of their respective owners. *Separate license to MedDRA required. pp_br_1108

2 Insightful Content Plus Powerful Functionality Now you can search, view and compare documents from the world s two major regulatory agencies the FDA & EMEA at the same time, on a single site, with a single search. PharmaPendium enables pharmaceutical researchers in preclinical and clinical drug development to finally be able to... PharmaPendium meets the critical needs of a variety of users within the biopharmaceutical industry including: Preclinical Safety Assessment Teams Toxicologists Pharmacokineticists Safety Pharmacologists Regulatory Affairs Staff Pharmacoepidemiologists Clinical Researchers Information Specialists Save valuable time PharmaPendium saves weeks to months typically spent during the drug development process on finding drug safety and approval data through document delivery services or the FDA. PharmaPendium provides searchable access to more than 850,000 pages of safety information in seconds so there is no need to spend weeks reading and skimming to find comparable data for safety profiles (animal, human and post-marketing data) for drugs similar to your candidate. Reduce strategic or opportunity costs PharmaPendium gives you a clear strategic advantage by providing new (mostly unpublished) relevant comparative data before making a decision or assessment. Avoid the submission mistakes made by competitors: Eliminate the risk of repeating costly regulatory cycles by searching historic FDA approval documents for previously unacceptable submissions. Save the cost of re-submission and the opportunity cost on your patent. Compare preclinical and clinical safety data of approved drugs to better predict animal model to human translation from the toxicity/adverse effect perspective. Reduce drug development cost by identifying safety risks earlier. Learn from approved drugs by viewing their integrated post-marketing safety data with toxicity/adverse effect data obtained in preclinical and clinical studies. Avoid re-inventing the wheel Using the globally-searchable PharmaPendium, researchers can find and cite previously run preclinical experiments they did not know even existed, possibly eliminating the need for planned studies that would have taken years to accomplish. Leverage the best historic data in a meaningful way PharmaPendium makes the entire FDA library of Freedom of Information (FOI) documents on the approval of drugs and their efficacy, safety, pharmacokinetics and pharmacodynamics detailed experimental data searchable and accessible for the first time. Prevent repeating the mistakes of the past PharmaPendium is the best tool available to avoid Regulatory Recycling by carefully examining data, statistics and experimental designs that were rejected in the past within your Drug Class or by your Reviewer. Respond quickly under pressure (the urgency factor) Have searchable documents at your fingertips in minutes when, for example, you are responding to FDA inquiries. When your patent clock is ticking, response time and fast access to precedents are critical. the only integrated and text-searchable source of FDA (back to first approved drug) and EMEA documents Pharmacokinetics Researchers: Make sure you have the Complete Picture PharmaPendium contains volumes of preclinical AND clinical exposure data at all parameters (cmax, tmax, AUC,Vss, CL, etc.) and all study groups (Healthy, Disease state, Concomitant Drugs) the vast majority of which are not published in the literature and so available nowhere else. This level of detail now available to drug delivery experts as a means of comparison or to draw inferences is a true breakthrough.

3 Best-in-Class, Trusted Content Sources Extracted data sets and the only product to provide longitudinal data views PharmaPendium provides access via a single point to searchable and trusted drug safety information covering over 3,000 approved drugs, with integrated preclinical, clinical and post-marketing safety data. US FDA Drug Approval Package Database (Reviews: post 1991) New! FDA Classic Collection all FDA drug approval documents on all drugs from 1992 back to the first approval files The combination of these two databases creates an entire searchable library of documents written by the FDA on the approval of drugs, pharmacokinetics, efficacy and safety New! European Medicines Agency (EMEA) European Public Assessment Reports (EPAR) Approval Documents Database (Drugs or indications approved in Europe with manually extracted preclinical, clinical toxicity and adverse effects data contains drugs not approved in the US) Meyler s Side Effects of Drugs, 15th edition Adverse Event Reporting System (AERS) Database Target information and target-drug relationships from multiple sources The PharmaPendium Drug Safety Database -- Pre-clinical and clinical toxicity data manually extracted from all FDA Approval Packages Toxicity information for approved drugs extracted from literature Metabolite and metabolic transformation information for PharmaPendium drugs extracted from literature Intuitive user interface with searchable access to all content Searchable FDA Drug Approval Document Usability and Efficiency That Simplify Research PharmaPendium is designed to help you develop safer drugs with increased efficiency, reduced risks and lowered cost. Dynamic interface streamlines the research process Previously FDA Freedom of Information documents and EMEA EPARs were only available in unsearchable formats like microfiche (order paper copy from FDA FOI), paper or a static PDF containing an unsearchable image. Now PharmaPendium finally solves this problem by delivering fully searchable, electronic FDA and EMEA documents. All FDA and EMEA documents on PharmaPendium are globally searchable and filterable by: Effect Targets Drugs Drug Classes Chemistry Sophisticated functionality saves you time PharmaPendium users have discovered that tasks that used to take several people weeks or even months are now easily done in minutes. Customizable searching yields results that help you make the right decisions Perhaps even more importantly, PharmaPendium allows such research and searches to find key decision-support information that would previously have been missed. Preclinical and clinical assessments and prioritization can now be done with the full complement of comparable data. Our features enable you to: Conduct research using four pathway options: drug class, adverse effects/toxicity, targets, and chemical compound Search using standardized terminology Medical Dictionary for Regulatory Activities (MedDRA *) Search text by keyword Filter search results by drugs/drug classes, adverse effects/toxicity, data sources, and/or other criteria Search by molecular structure or substructure and export results Gain searchable access to relevant sections within an FDA package by document type Export valuable safety information

4 Preclinical/Clinical Development Assessment Which competitors drugs have the same combination of adverse effects as my drug candidate? Show me the relevant preclinical and clinical studies. Show all antipsychotics that have exhibited Electrocardiogram (ECG) anomalies in preclinical experiments, clinical trials or post-marketing reports. Pharmacokinetics/Drug Delivery Assessment Find preclinical and clinical pharmacokinetics exposure parameters for the drugs in my drug class (Cmax, Tmax,Vss, etc.). See screenshot below.

5 Regulatory Affairs What can I learn from the history of regulatory cycling within my drug class in order to make this New Drug Application (NDA) proceed more quickly to approval? Searching on DNDP s requests (Division of Neuropharmacological Drug Products). Clinical Development What are the primary and secondary endpoints that have been described, used and approved within my drug class? See screenshot below.

6 Timely, trusted content combined with powerful functionality The only searchable database of ALL FDA Drug Approval Packages Important content beyond FDA documents now including EMEA EPAR Approval Documents Relevant information with an intuitive user interface and search tools that allow researchers to identify and collect the right information quickly Built for efficiency data sets, data views, and other features that enhance research productivity and yield results in minutes rather than days Stay on the safe side Identify safety risks earlier Reduce the drag of non-returning investments Make better predictions on animal model to human translation Use toxicity studies on excipients already reported by others Make the correct pipeline prioritization decisions Use precedents to make the best regulatory argument as quickly as possible Avoid regulatory recycling Discover the PharmaPendium advantage at info.pharmapendium.com IP licensing Web seminars Interactive video demonstrations Visit our website today