If you are considering whether to take the time in advance of your investigational new drug (IND) application submission to meet with FDA for feedback on your development program, here are some thoughts to ponder and reasons not to pass up this valuable opportunity.
Dr. Kenneth Burhop is the chief scientific officer of Sangart Inc., a biopharmaceutical company that engages in the research, development, and commercialization of oxygen therapeutics. He joined Sangart in January 2011, after serving as the global scientific lead/CSO for Baxter Healthcare’s Medication Delivery division and VP of R&D for Baxter's Biopharmaceutical Technologies business, including the company’s second generation recombinant hemoglobin program. He has authored over forty publications, more than seventy abstracts, several book chapters, and has been invited to speak at various international meetings and symposia, and is a recognized international expert in the field of hemoglobin therapeutics. Burhop shares his opinions on clinical outsourcing.
In 2010, the International Conference on Harmonization (ICH) rolled out its E2F Development Safety Update Report (DSUR) guideline. The DSUR is similar to the US’s Investigational New Drug Annual Report (IND-AR) and the EU’s Annual Safety Report (ASR) in that its purpose is to provide a brief overview of safety for a project on an annual basis. By Malarkodi S. Moorthy, M.Sc., M.Phil., Medical Writer
The cost of new drug discovery has skyrocketed in recent years, and is something that should have everyone in the drug discovery industry concerned. Sergei Varshavsky, M.D., Ph.D., and senior VP of global strategy for contract research firm Synergy Research Group (SynRG), notes it was not always this way. Some of the greatest medicinal discoveries in the history of mankind were inexpensive to develop and test. “There was the discovery of the smallpox vaccine in 1796, ether anesthesia in 1846, and insulin and penicillin in the early 20th century,” he says. “None of them cost much. In fact, the patent for insulin was sold to the University of Toronto for a half-dollar. Despite the low cost, these drugs have saved billions of lives.” Unfortunately today’s medical community is no longer able to accomplish similar feats for such a low cost.
Biopharmaceutical companies’ marketing applications must present the history of their unique development programs and provide renewed hope for patients seeking safe and effective therapies. PRA Health Sciences has the necessary experience to deliver comprehensive marketing applications (NDA, BLA, MAA, etc) across all therapeutic areas and in all regions.
The EU Clinical Trials Directive (CTD) has been fully implemented in the Netherlands.
An international pharmaceutical company approached Camargo Pharmaceutical Services to help navigate the Food and Drug Administration (FDA) 505(b)(2) approval pathway for a promising drug under development designated for patients with cardiovascular disease. Product X is a prodrug that is converted in one metabolism-dependent step to produce the active metabolite of an approved drug.
Sponsors and CROs want to ensure that the processes and workflows they use in their electronic Trial Master Files (eTMF) comply with all regulatory requirements, resulting in a robust system that will produce complete documentation able to withstand an agency audit. To provide a solid basis for decision-making, we’ve researched both the regulatory basis for signatures and the technology implications around how to collect signatures. Since the goal of any eTMF system is to streamline processes and increase compliance, implementing valid signature processes in the least cumbersome manner is always of concern.
Assume a generic drug company, let’s call them AB Generics, Inc., always targets the introduction of its generic drugs when the reference product comes off patent. AB’s executive team has looked ahead and seen the generic cliff — few products coming off patent after 2016 — and is looking for alternative revenue sources.
Taking new products successfully through clinical development, submission and approval can be a difficult, expensive and lengthy process. SynteractHCR’s medical regulatory affairs group offers a wide range of services that spans the full range of product development, including training, performed by senior regulatory professionals with experience in pharmaceutical, diagnostic, device and biotechnology industries. Our medical regulatory affairs team is here to deliver on aggressive timelines and control costs, while ensuring compliance and patient safety.
As an international, full-service clinical contract research organization, SynteractHCR strives to deliver actionable results for your clinical trial needs. Our medical writing group consists of qualified Ph.D., M.D., and other experts, and our European medical writers are all members of the European Medical Writers Association. Our translation team consists of native speakers with many years of experience in translating all documents necessary for the performance of clinical studies. Our medical writers are committed to delivering a well-designed clinical program that will meet your study’s ultimate goals.
Biopharmaceutical companies’ marketing applications must present the history of their unique development programs and provide renewed hope for patients seeking safe and effective therapies. PRA Health Sciences has the necessary experience to deliver comprehensive marketing applications (NDA, BLA, MAA, etc) across all therapeutic areas and in all regions.
Given the complex nature of medicines and the associated unpredictability of adverse events, pharmacovigilance activities play a critical role in managing the risks posed to the general population.
Omeros Corporation (NASDAQ: OMER) today announced that its Investigational New Drug Application (IND) to evaluate OMS824 in Huntington's disease has been cleared by the U.S.
Eli Lilly and Company (NYSE: LLY) announced today Phase III clinical trial results from enzastaurin's PRELUDE study, which explored the molecule as a monotherapy in the prevention of relapse in patients with diffuse large B-cell lymphoma (DLBCL).
Telormedix, a clinical stage biopharmaceutical company focusing on toll-like receptor 7 (TLR7) small molecules in the treatment of cancer and inflammatory diseases, recently announced that it has recruited the first patient in a Phase II trial of its lead product TMX-101, a TLR-7 agonist, in carcinoma in situ (CIS) in the bladder.
Recipharm and PledPharma announce FDA approval of an IND application for Phase IIb clinical trial with PledOx, PLIANT, in the U.S.The material for PLIANT has been manufactured by Recipharm Pharmaceutical Development.
Mesoblast Limited (ASX:MSB) (OTC ADR:MBLTY) today announced that United States Food and Drug Administration (FDA) is in agreement for Mesoblast to supply its proprietary Mesenchymal Precursor Cells (MPCs) for clinical trials in the United States under Investigational New Drug (IND) protocols, from Lonza's contract manufacturing facility in Singapore, in addition to its United States facility.
Ability Pharmaceuticals, a privately held biopharmaceutical company, announced recently that it was awarded a 36 month 1.2 Million Euros grant under the INNPACTO-2012 Collaborative Program from the Ministry of Economy and Competitiveness of the Government of Spain.
Savant HWP, Inc. today announced the receipt of a three-year grant to support the development of 18-MC (18-methoxycoronaridine) as a potential orally active treatment for drug addiction, obesity and other forms of compulsive behavior.
Immunovative, Inc. ("IMUN" or the "Company") (OTCQB: IMUN) announces today that Immunovative Therapies, Ltd. ("ITL") has been granted regulatory clearance from Thailand authorities to advance its lead AlloStim™ immunotherapy product candidate to the Phase II/III clinical development stage in advanced metastatic breast cancer.
Bio-Matrix Scientific Group, Inc. (OTCQB: BMSN) announced today that its wholly owned subsidiary, Regen BioPharma, Inc., has contracted Cascade Life Sciences, Inc. to research the safety and efficacy of Regen's HemaXellerate™ product using mice models for testing
ViaCyte, Inc., a leading regenerative medicine company developing a transformative cell therapy for treatment of diabetes, announced today that it has received a $10.1 million Strategic Partnership Award from the California Institute for Regenerative Medicine (CIRM).
Eli Lilly and Company (NYSE: LLY) today announced positive top-line results of three completed Phase III AWARD trials for dulaglutide, an investigational, long-acting glucagon-like peptide 1 (GLP-1) analog being studied as a once-weekly treatment for type 2 diabetes.
Researchers have launched a clinical trial to evaluate the drug candidate DEX-M74 as a treatment for a rare degenerative muscle disease, hereditary inclusion body myopathy (HIBM). National Institutes of Health scientists from the National Center for Advancing Translational Sciences (NCATS) and the National Human Genome Research Institute (NHGRI) will conduct the clinical trial at the NIH Clinical Center.
Eli Lilly and Company (NYSE: LLY) announced today the decision to stop ongoing clinical studies investigating pomaglumetad methionil, also known as mGlu2/3, for the treatment of patients suffering from schizophrenia.
