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Kopczynski C.,Aerie Pharmaceuticals | Novack G.D.,PharmaLogic Development Inc. | Swearingen D.,Celerion | Van Haarlem T.,Aerie Pharmaceuticals
British Journal of Ophthalmology | Year: 2013

Background/aims To evaluate the ocular hypotensive efficacy, ocular and systemic safety, and systemic exposure of two formulations of 0.5% AR-12286 Ophthalmic Solution. Methods This was a double-masked, single-centre, crossover study in 18 normal adult volunteers. Volunteers were randomised to one of two dosing sequences: Formulation A once daily, both eyes (OU) for 8 days, a 7-day minimum washout, and then Formulation B, or the reverse. The main outcome measures were ocular tolerability, intraocular pressure (IOP) and blood levels of AR-12286 and its metabolites. Results Systemic absorption was low, with a majority of subjects showing no measurable drug concentration in plasma (<1 ng/ml) at any time point with either formulation. The most frequent ocular adverse events were conjunctival hyperaemia, eye irritation, instillation site reaction, increased lacrimation, and blurred vision which were relatively short-lived and judged as not clinically significant. Both formulations of AR-12286 produced substantial reductions from baseline IOP ranging from 3 to 7 mm Hg (p<0.0001). Conclusions No differences were noted in ocular safety between formulations of AR-12286 0.5%, dosed once daily in the morning for 8 days. AR-12286 produced little systemic exposure to the parent compound or two known metabolites. Clinically and statistically significant reductions in IOP were seen in these normotensive subjects.


Buda J.J.,RTI Health Solutions | Carroll F.I.,Rti International | Kosten T.R.,Baylor College of Medicine | Swearingen D.,Celerion | Walters B.B.,Rti International
Neuropsychopharmacology | Year: 2015

Animal studies suggest that kappa opioid receptor antagonists (KORAn) potentially could treat a wide variety of addictive and depressive disorders. We assessed the KORAn JDTic for safety, tolerability, and pharmacokinetics in a double-blind, placebo-controlled, randomized trial evaluating single oral doses in healthy adult males. Predose and postdose safety assessments included orthostatic vital signs; 6-lead continuous telemetry monitoring (approximately 16 h predose to 24 h postdose); 12-lead electrocardiograms (ECGs); clinical chemistry, hematology, coagulation, and urinalysis; psychomotor functioning (using the Wayne Saccadic Fixator (WSF)); and adverse events. As a potential indicator of JDTic effects on affect, the POMS Standard instrument was administered predose and daily postdose Days 1-6. At 1 mg, 2 of the 6 JDTic (and 0/6 placebo) subjects experienced a single, asymptomatic event of multiple beats of nonsustained ventricular tachycardia (NSVT). Their events were temporally similar with respect to time postdose (and the postdose timing of an NSVT event in a monkey). These events triggered a study stopping rule. No differences were observed between the placebo and JDTic subjects with respect to clinical chemistry, hematology, coagulation, urinalysis, orthostatic vital signs, WSF, or 12-lead ECG parameters. Plasma JDTic levels were below the lower limit of quantitation (0.1 nM) in all subjects. There were no significant differences in POMS scores between the placebo and JDTic groups. Although the evidence is circumstantial, it suggests that NSVT is a potential JDTic toxicity in humans. Given the therapeutic potential of KORAn, further investigation is needed to determine whether a significant JDTic human cardiac effect indeed exists, and if so, whether it is specific to JDTic or represents a KORAn class effect. © 2015 American College of Neuropsychopharmacology. All rights reserved.


Islam R.,Celerion
Bioanalysis | Year: 2014

Biologics such as monoclonal antibodies and recombinant proteins represent a significant portion of the pharmaceutical market. With many of the first generation biologics' patents expiring, an increasing number of biosimilars will be submitted for approval in the near future. The successful development of a biosimilar requires the demonstration of biosimilarity in terms of efficacy, safety and purity to an innovator-approved product. While regulatory frameworks have been established for the approval of biosimilars in several countries, there is not an established guidance for bioanalytical testing of biosimilars. Although there are regulatory guidances and White Papers on testing requirements for biologics in general, there is a need to address the bioanalytical challenges and solutions that apply specifically to the analysis of biosimilars in biological samples. This paper will focus on components of the PK and immunogenicity assays that are critical to biosimilar drug development. © 2014 Future Science Ltd.


Patrick J.,New Haven Pharmaceuticals | Dillaha L.,New Haven Pharmaceuticals | Armas D.,Celerion | Sessa W.C.,Yale University
Postgraduate Medicine | Year: 2015

Aims. Low-dose acetylsalicylic acid (ASA; aspirin) for secondary prevention reduces cardiovascular disease mortality risk. ASA acetylates cyclooxygenase in the portal circulation and is rapidly (halflife, 20 min) hydrolyzed. Certain patients with cardiovascular disease may exhibit high on-therapy platelet reactivity as a result of high platelet turnover, a process whereby platelets are produced and are active beyond the duration of antiplatelet coverage provided by once-daily immediaterelease (IR) ASA. A once-daily, extended-release (ER) ASA formulation using ER microcapsule technology was developed to release ASA over the 24-h dosing interval and reduce maximal plasma concentrations to spare peripheral endogenous endothelial prostacyclin production. Methods. Healthy adults (n = 50) were randomized in a crossover study to receive two different ER-ASA single doses (up to 325 mg) and two different IR-ASA single doses (up to 81 mg) in four periods, each separated by ‡14 days. Pharmacodynamics was assessed by measuring serum thromboxane B2 (TXB2), urine 11-dehydro-TXB2, and arachidonic acid-induced platelet aggregation. Pharmacokinetics was determined for ASA and salicylic acid (SA). Results: Both formulations produced dose-dependent inhibition on all pharmacodynamic parameters. Marked inhibition of TXB2 and 11-dehydro-TXB2 was maintained over the 24-h dosing interval after a dose of ‡81 mg ER-ASA or ‡40 mg IR-ASA. The dose required to achieve 50% of maximum TXB2 inhibition with ER-ASA was 49.9 mg versus 29.6 mg for IR-ASA, for a similar maximum pharmacodynamic effect (98.9% TXB2 inhibition). This suggests that an approximately twofold greater ER-ASA dose (162.5 mg) is necessary to obtain the same response as that of IR-ASA 81 mg. Peak ASA concentrations were lower and Tmax was longer with ER-ASA versus IR-ASA. Administration of IR-ASA resulted in a dosenormalized mean Cmax of ASA that was approximately sixfold higher than that for ER-ASA and a Cmax of SA approximately two- to threefold higher than that for ER-ASA. Conclusion. Both ASA formulations showed dose-dependent antiplatelet activity. Compared with the IR-ASA, ER-ASA released active drug more slowly, resulting in prolonged absorption and lower systemic drug concentrations, which is expected for an ER (24-h) formulation. © 2015 Informa UK Ltd.


The purpose of this article is to articulate the fundamental issues of archiving electronic GLP data in a CRO environment. CROs struggle to address the absolute requirement of archiving GLP studies electronically. The difficulty of adhering to this is partly due to the wide variety of systems and types of electronic data. Often the end solution to this complicated issue is printing the data at the end of the study and in turn archiving the paper data, foregoing or ignoring the fact that scientific decisions were made while reviewing electronic data. Paper data and electronic data can be different. For example, chromatographic resolution or being able to focus in on detailed integration of chromatograms can significantly change the perspective of the data. While the core goal of archiving according to GLP principles are met, the reality is much different. Businesses purchasing CRO capabilities and regulatory agencies have been quite clear that when it comes to auditing the data that the electronic record is the preferred and often required source of the information for auditing and review purposes. The fact is that paper data do not always provide the flexibility, sensitivity and complete data context that an electronic record can provide. The ability to adhere to compliance standards due to the electronic data cannot be undervalued and by printing the data after all the acquisition, decisions, scientific judgments and review, do a complete disservice to the multidimensional (such as colors for deactivated or changed data, audit trails, 'zooming-in functionality', direct data links and snapshots) data in an electronic system. © 2011 Future Science Ltd.


Offman E.,Celerion | Messina J.,OptiNose | Carothers J.,OptiNose | Djupesland P.G.,OptiNose | Mahmoud R.A.,OptiNose
Headache | Year: 2013

Objectives. - The purpose of this study was to directly compare the pharmacokinetic (PK) profile of 22-mg sumatriptan powder delivered intranasally with a novel Breath Powered™ device (11 mg in each nostril) vs a 20-mg sumatriptan liquid nasal spray, a 100-mg oral tablet, and a 6-mg subcutaneous injection. Background. - A prior PK study found that low doses of sumatriptan powder delivered intranasally with a Breath Powered device were efficiently and rapidly absorbed. An early phase clinical trial with the same device and doses found excellent tolerability with high response rates and rapid onset of pain relief, approaching the benefits of injection despite significantly lower predicted drug levels. Methods. - An open-label, cross-over, comparative bioavailability study was conducted in 20 healthy subjects at a single center in the USA. Following randomization, fasted subjects received a single dose of each of the 4 treatments separated by a 7-day washout. Blood samples were taken pre-dose and serially over 14 hours post-dose for PK analysis. Results. - Quantitative measurement of residuals in used Breath Powered devices demonstrated that the devices delivered 8 ± 0.9 mg (mean ± standard deviation) of sumatriptan powder in each nostril (total dose 16 mg). Although the extent of systemic exposure over 14 hours was similar following Breath Powered delivery of 16-mg sumatriptan powder and 20-mg liquid nasal spray (area under the curve [AUC]0-∞ 64.9 nghour/mL vs 61.1 nghour/mL), sumatriptan powder, despite a 20% lower dose, produced 27% higher peak exposure (Cmax 20.8 ng/mL vs 16.4 ng/mL) and 61% higher exposure in the first 30 minutes compared with the nasal spray (AUC0-30 minutes 5.8 nghour/mL vs 3.6 nghour/mL). The magnitude of difference is larger on a per-milligram basis. The absorption profile following standard nasal spray demonstrated bimodal peaks, consistent with lower early followed by higher later absorptions. In contrast, the profile following Breath Powered delivery showed higher early and lower late absorptions. Relative to the 100-mg oral tablet (Cmax 70.2 ng/mL, AUC0-∞, 308.8 nghour/mL) and 6-mg injection (Cmax 111.6 ng/mL, AUC0-∞ 128.2 nghour/mL), the peak and overall exposure following Breath Powered intranasal delivery of sumatriptan powder was substantially lower. Conclusions. - Breath Powered intranasal delivery of sumatriptan powder is a more efficient form of drug delivery, producing a higher peak and earlier exposure with a lower delivered dose than nasal spray and faster absorption than either nasal spray or oral administration. It also produces a significantly lower peak and total systemic exposure than oral tablet or subcutaneous injection. © 2013 OptiNose AS. Headache published by Wiley on behalf of the American Headache Society.


Jamieson B.D.,Cempra | Ciric S.,Celerion | Fernandes P.,Cempra
Antimicrobial Agents and Chemotherapy | Year: 2015

Solithromycin, a new macrolide and the first fluoroketolide, is in late-stage clinical development and, like older macrolides, is primarily metabolized and excreted through liver-dependent mechanisms. This study evaluated the safety and pharmacokinetics of solithromycin in patients with chronic liver disease. This open-label, multiple-dose study in subjects with hepatic impairment and in healthy control subjects (matched for age, weight, and sex) enrolled 8 Child-Pugh class A (mild), 8 class B (moderate), and 8 class C (severe) patients and 9 healthy controls. Subjects (n = 33) received one 800-mg dose on day 1 followed by once-daily doses of 400 mg on days 2 through 5. The most commonly reported adverse events were mild diarrhea and mild headache, and no significant differences were noted between hepatically impaired subjects and healthy controls. The pharmacokinetics of plasma solithromycin in subjects with mild and moderate impairment was similar to that in control subjects. In subjects with severe impairment, total exposure to solithromycin at steady state (area under the plasma concentration-time curve [AUC0-tau]) was decreased compared to that in control subjects, which may have been related to the higher body mass index of individuals in this group. No greater accumulation was noted in any hepatically impaired cohort on day 5 compared to that in control subjects. No decrease in dosage is therefore needed when administering solithromycin to patients with mild, moderate, or severe hepatic impairment. Solithromycin was well tolerated in this patient population, and no significant differences in safety, compared to healthy controls, were noted. Copyright © 2015, American Society for Microbiology. All Rights Reserved.


News Article | October 27, 2016
Site: globenewswire.com

FORT LAUDERDALE, Fla., Oct. 27, 2016 (GLOBE NEWSWIRE) -- OmniComm Systems, Inc. (OmniComm) (OTCQX:OMCM), a global leading provider of clinical data management technology, recognizes excellence in innovation at OmniComm’s 6th annual Innovation Forum customer summit.  Attendance increased more than 20% year-over-year, with participation from 42 life science companies and partners.  Attendees heard from over 19 different OmniComm customer and partner speakers, each of whom achieved significant gains in clinical trial productivity, clinic automation, clinical data quality, operational efficiency and compliance using OmniComm’s suite of eClinical products. “Every year I am impressed with the increasing diversity of our client base,” said Kuno van der Post, SVP of business development at OmniComm.  “We had representatives from pharmaceutical, biotechnology, medical device, academic research, and contract research (CRO) organizations, including delegates from four of the top five global CROs.  This broad spectrum of clients is a testament to our continued market growth.  We are on pace for a record sales year with almost half our business coming from new clients.  The scalability and flexibility of our technology and our specialization in EDC is a significant contributor to that growth.” Attendees also participated in product workshops prior to the start of the event.  These half-day workshops offered users free training and skills enhancement with TrialMaster® EDC and TrialOne®. “As the EDC specialist, we strive to be the pioneer in EDC technology, but the true pioneers are our customers.  Seeing the amazing value each and every customer has generated from our solutions is a moment of pride and fulfillment for our entire team,” said Cornelis Wit, CEO of OmniComm.  “The success of this conference is the result of the open sharing of customer experiences, successes and networking.  Maybe more importantly, the true measure of the user group success is the relationships that were developed which will extend the benefits for all of our users throughout the year and into the future.” OmniComm’s commitment to its customers extends to honoring organizations that share the passion for progress, creativity, collaboration, and advancement in life sciences.  The Excellence in Innovation Award recognizes life sciences organizations that have designed and implemented significant innovation using OmniComm’s technology and services, resulting in improved organizational operational efficiencies, best practices and business outcomes specifically for: This year’s Excellence in Innovation Award recipients are Celerion, TFS and WCCT Global. About OmniComm Systems, Inc. OmniComm Systems, Inc. is a leading strategic software solutions provider to the life sciences industry. OmniComm is dedicated to helping the world’s pharmaceutical, biotechnology, contract research organizations, diagnostic and device firms, and academic medical centers maximize the value of their clinical research investments. Through the use of innovative and progressive technologies these organizations drive efficiency in clinical development, better manage their risks, ensure regulatory compliance and manage their clinical operations performance.  OmniComm provides comprehensive solutions for clinical research with an extensive global experience from over 5,000 clinical trials. For more information, visit www.omnicomm.com. Trademarks OmniComm, TrialMaster, TrialOne and Promasys are registered trademarks of OmniComm Systems, Inc. Other names may be trademarks of their respective owners.


News Article | November 17, 2016
Site: www.prnewswire.com

LINCOLN, Neb., Nov. 17, 2016 /PRNewswire/ -- Celerion is pleased to announce a key technology addition to its early clinical development capabilities, Celexus®. Celexus® offers clients a first look at their early clinical research data in real-time, as it is collected in the clinics...


News Article | February 22, 2017
Site: www.businesswire.com

LINCOLN, Neb.--(BUSINESS WIRE)--Celerion continues to grow in response to the evolving needs of early clinical research. With the increasing focus on evaluating drug effects in relevant patient populations earlier in development, Celerion is pleased to announce that Dr. Marc Hoffman has joined the company as Chief Medical Officer. Dr. Hoffman will have responsibility for leading the global medical staff and providing medical oversight and expertise to support early clinical research studies. Dr. Hoffman joins Celerion from Patient iP where he served as Chief Medical Officer, providing clinical leadership around Patient iP’s innovative platform, customer programs and related medical affairs activities. Prior to joining Patient iP, he held the roles of Chief Medical Officer and Senior Vice President and General Manager over the Biopharmaceutical Business at Theorem Clinical Research, leading the development of drugs and biologics. Previously in his career, Dr. Hoffman held positions of increasing responsibility in Medical and Scientific Affairs at Baxter, Hospira and Covance, providing senior-level strategic direction for Phase II-IV programs. Dr. Hoffman brings over 28 years of knowledge and experience as a physician in the pharmaceutical, device, and CRO industries to this role. He is experienced in global drug development, medical affairs, pharmacovigilance and regulatory affairs, and has a proven track record in building, managing and globalizing medical teams. “We are pleased to have Marc join our executive leadership team during this exciting period of growth in our company,” said Susan Thornton PhD, President and CEO. “His depth of experience in managing all aspects of global drug development in multiple therapeutic areas will not only make him a valuable asset for our organization but also for our clients.” Translating science into medicine, Celerion is a premier provider of early clinical research and translational clinical pharmacology sciences from their global locations in North America, Europe and Asia. Celerion conducts First-in-Human, clinical Proof-of-Concept and patient dose response studies, cardiovascular safety and clinical pharmacology research supporting product labeling. With purpose built clinic and laboratory facilities and highly automated technology, Celerion provides full study services including clinical study conduct, data management and biometrics, PK/PD analysis, bioanalytical services, medical writing, and regulatory and drug development program management. For more information please visit www.celerion.com.

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