A Snapshot of the Webinar “Development of a Cell-Based Assay”
Cell-based assays are usually used to represent the mechanism of action (MoA) of the administered drug. Throughout various stages of drug development, they may be used for different purposes. These include detecting the presence of neutralizing antibodies (NAbs) and evaluating a drug’s potency. In Altasciences’ webinar, “Development of a Cell-Based Assay,” Dr.
Medical Writing Expertise Is at the Heart of Your Submission
Collaboration and communication means quality documentation for your drug development program. Our Medical Writing teams collaborate constantly with our experts and yours, ensuring that very scientific document required for your study is accurate, complete, and-compliant with regulatory guidance. From initial protocol to the final clinical study report, we deliver rapidly, without compromise.
As a stand-alone solution, or part of an Altasciences study program, our Medical Writing team is ready to support you. You can work in unison with us on a Full-time equivalent (FTE)basis, or project by project, the choice is yours.
Development of a Surrogate Cerebrospinal Fluid Matrix for Quantitative Analysis of Antisense Oligonucleotides by Hybridization LC-MS/MS
A Novel Method for Performing Linearity Assessments in Whole Blood Prepared Using a Lyse/No Wash Procedure
September 2022
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Our Altascientists are hard at work, whether it’s on your drug development projects or producing insightful scientific resources to share their knowledge with you. Catch up on what you may have missed, or revisit some highlights from the last three months. |
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A Message from Our CEO to You News: Hoth Therapeutics Chooses Altasciences to Manufacture HT-TBI Award Announcement: Altasciences named finalist for Scrip Awards 2022 Audiobook Series: Listen to all issues of your favorite scientific journal, The Altascientist Scientific Journal: Issue 27—Complexities of Early Phase Ophthalmic Drug Development News: A Conversation with Chris Perkin, a Forward Thinker in the Research Space! |
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On-Demand Webinar: Animal Disease Models and Overcoming Technical Challenges—Experimentally Induced Hemophilia Type A Audiobook: Altasciences’ Nonclinical Safety Testing Guide |
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Blog: Five Reasons to Place Early Phase Clinical Research in Canada Quick Chat: The Makings of a CNS Center of Excellence (with Dr. Milovan) Scientific Journal: Issue 25—Flexibility in Phase I Study Timing |
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Quick Chat: Complex and Customized Formulation Development (with Andrew Buis) News: Altasciences Continues Manufacturing Expansion in Philadelphia with a Client-Dedicated Building Project On-Demand Webinar: Advantages of Terminal Sterilization Over Aseptic Manufacturing |
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Podcast: Microsampling—When Small Steps Lead to Big Outcomes Blog: Five Lesser-Known Uses for PCR |
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Scientific Journal: Issue 26—CDISC Data Standards |
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CASE STUDY—How Data Standardization Shortens Drug Approval Times
CDISC and SEND Simplify and Expedite Study Data Interpretation
Read The Altascientist and see how CDISC and SEND standards simplify and speed up analysis of your data, facilitating regulatory review and increasing your access to the power of big data. Includes two illustrative case studies and comprehensive FAQs.
Speak with an expert to learn more about our service offering.
Have five minutes? Take a look at these:
- Fact Sheet: Comprehensive Research Support Offering
- eBook: One Integrated Solution for Meeting Your Preclinical to Clinical Drug Development Needs
- Webpages:
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services.
Start Your Driving Trial Quickly—Simulators on Site
Driving simulator studies are a safe, efficient, and effective alternative to on-the-road driving trials for CNS-active drugs. The Altascientist dives into the requirements and technicalities of driving studies, and explains how driving simulation offers…
Faster study startup • Lower cost • No risk of property damage • No risk of injuries
… including a case study whose results were described as “reassuring” by the FDA.
Altasciences has conducted over 13,000 simulated drives in support of drug development.
Download as a PDF or listen to the audiobook, the choice is yours.
You may also be interested in the following:
Still Using Tablets in Your Clinical Trials? Consider Changing to a Better Option.
Accelerate Your Clinical Trials With This Dosage Form
With tablets presenting numerous drawbacks, liquid-filled capsules (LFCs) are becoming the optimal choice for clinical trials. Their benefits include:
- Ease of scalability from preclinical to clinical to commercial volumes
- Quick dose adjustments
- Faster dissolution and absorption
- Less required stability studies
LFCs are most suitable for drugs with complex formulations, low-dose requirements, poor solubility, or highly potent active pharmaceutical ingredients (APIs). Clients with such drug profiles substantially accelerated their drug development process using LFCs for early phase clinical trials, resulting in reduced costs.
Where Do We Come In?
Altasciences’ state-of-the-art cGMP manufacturing and analytical facility in Philadelphia has a team of experienced scientists to support you through your entire drug development process, from pre-formulation to clinical trials and beyond. Our advanced equipment includes cutting-edge liquid-filling, binding, and sealing machines, ensuring an impressive 97% right-first-time (RFT) batch release success rate.
Consult our resources for further details on how you can benefit from using LFCs in your clinical trials.
| eBooklet (PDF) | Infographic (PDF) | Quick Chat (Video) | Client Case Study (PDF) |
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Ready to accelerate your drug development? Speak with one of our experts.
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
Hoth Therapeutics Announces the Selection of Altasciences for Manufacturing HT-TBI for Traumatic Brain Injury and Stroke
RELEASED AND WRITTEN BY HOTH THERAPEUTICS, INC.
NEW YORK, Sept. 20, 2022 /PRNewswire/ — Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced it has signed an agreement with Altasciences, a fully integrated early phase CRO/CDMO, to develop and manufacture the HT-TBI drug product formulation. HT-TBI is being developed as a novel, point-of-care therapy for the treatment and/or prevention of secondary brain injury (e.g., brain edema and inflammation) resulting from ischemic stroke and traumatic brain injury ("TBI"). HT-TBI will be developed as a ready-to-use drug-device combination product for use in non-healthcare settings by patients and caregivers at risk for stroke/TBI, emergency healthcare professionals, and military personnel.
"We are pleased to have been selected by Hoth Therapeutics, Inc. to support their important goal of developing a ready-to-use drug-device combination product for the treatment and/or prevention of secondary brain injury. Altasciences' purpose is to help companies like Hoth Therapeutics research and develop potentially life-saving therapeutics—as safely and as fast as possible," stated Ben Reed, General Manager, CDMO Services at Altasciences.
"Hoth is excited to announce this partnership and next milestone in our development of HT-TBI," stated Dr. Stefanie Johns, Chief Scientific Officer. "We are leveraging Altasciences' expertise to develop and manufacture novel parenteral formulations to achieve a formulation that requires no preparation or special storage requirements to ensure HT-TBI can be used anywhere in the field at the time a head injury or stroke occurs."
The HT-TBI formulation development and manufacturing work by Altasciences will be used to support a future Investigational New Drug (IND) Application to initiate clinical trials.
About Hoth Therapeutics, Inc.
Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to developing innovative, impactful, and ground-breaking treatments with a goal to improve patient quality of life. We are a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing. Utilizing a patient-centric approach, we collaborate and partner with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options. To learn more, please visit https://ir.hoththerapeutics.com/.
About Altasciences
Altasciences is an integrated drug development company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, cGMP manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences' integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, cGMP manufacturing for clinical and commercial, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
Forward-Looking Statement
This press release includes forward-looking statements based upon Hoth's current expectations which may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, and are subject to substantial risks, uncertainties and assumptions. These statements concern Hoth's business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates and any other product candidates Hoth may develop, and the labeling under any approval Hoth may obtain; the timing and costs of clinical trials, the timing and costs of other expenses; market acceptance of Hoth's products; the ultimate impact of the current Coronavirus pandemic, or any other health epidemic, on Hoth's business, its clinical trials, its research programs, healthcare systems or the global economy as a whole; Hoth's intellectual property; Hoth's reliance on third party organizations; Hoth's competitive position; Hoth's industry environment; Hoth's anticipated financial and operating results, including anticipated sources of revenues; Hoth's assumptions regarding the size of the available market, benefits of Hoth's products, product pricing, timing of product launches; management's expectation with respect to future acquisitions; statements regarding Hoth's goals, intentions, plans and expectations, including the introduction of new products and markets; and Hoth's cash needs and financing plans. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. You should not place undue reliance on these forward-looking statements, which include words such as "could," "believe," "anticipate," "intend," "estimate," "expect," "may," "continue," "predict," "potential," "project" or similar terms, variations of such terms or the negative of those terms. Although Hoth believes that the expectations reflected in the forward-looking statements are reasonable, Hoth cannot guarantee such outcomes. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described in the section entitled "Risk Factors" in Hoth's most recent Annual Report on Form 10-K and Hoth's other filings made with the U.S. Securities and Exchange Commission. All such statements speak only as of the date of this press release. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates, and beliefs. Hoth cannot guarantee future results, events, levels of activity, performance or achievements. Hoth does not undertake and specifically declines any obligation to update or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law.
Investor Contact:
LR Advisors LLC
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
Phone: (678) 570-6791
- Xiong Y, Mahmood A, ChoppM. Current understanding of neuroinflammation after traumatic brain injury and cell-based therapeutic opportunities. Chin J Traumatol. 2018;21(3):137-151. doi:10.1016/j.cjtee.2018.0
SOURCE Hoth Therapeutics, Inc.