Altasciences Expands Strategic Support for Early Drug Development in Europe and Adds Key Employees to Its Preclinical Team in North America
Laval, Québec, October 14, 2022 – Altasciences hired two expert advisors to support its strategic growth in Europe, while its preclinical team continues to expand with the addition of two key employees.
Providing strategic input into steering Altasciences’ drug development solutions direction in Europe, Peter Varney joins the company as Pharma Development and Strategy Advisor. Peter brings 40 years of experience in commercial development, strategic alliances, and relationship management at Covance/Labcorp to his new position. Hazel Clay, with over 30 years of experience in supporting the development of innovator pharmaceutical assets at Covance/Labcorp, plays a key role as Drug Development Advisor in Altasciences’ European expansion. Both Peter and Hazel are based out of Altasciences’ offices in Harrogate, UK.
"With their extensive experience and keen strategic vision, Peter and Hazel are important assets to Altasciences’ expansion into the European market. We wanted to provide our European clients access to in-depth knowledge on early phase drug development to help them get better drugs to market faster," stated Chris Perkin, Altasciences’ Chief Executive Officer.
In addition, Dr. Lisa Biegel joins Altasciences as Senior Scientific Director, Preclinical Services, and will be based at the Columbia, MO, facility. With over 30 years of industry experience in regulatory toxicology at Covance/Labcorp, Lisa will provide leadership and oversight, as well as strategic scientific input, to the study direction and reporting teams.
Furthermore, Annette Kenser joins Altasciences as Senior Director of Quality Assurance, Preclinical Research. Annette has extensive experience as a scientific quality assurance auditor, and will focus on identifying areas of improvement while aligning quality assurance activities throughout the organization.
"We are pleased to welcome Lisa and Annette to Altasciences, and look forward to benefitting from their talents and contributions in the preclinical space," said Andy Brown, Site Director at Altasciences’ Columbia preclinical facility.
About Altasciences
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, 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, 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.
Julie-Ann Cabana
Altasciences
+1 514 601-9763
jcabana@altasciences.com
Immunogenicity Target Interference: A Novel Blocking Approach
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.
ISSUE NO. 28 — Applications of Liquid-Filled Hard-Shell Capsules in Drug Development
Liquid-filled hard-shell capsules (LFHCs) are a popular formulation for oral solid delivery of chemical drugs and nutraceuticals. Often selected for drugs with poor solubility/bioavailability, LFHCs also have applications in a number of other situations, including specific benefits during early-phase clinical development.
In Issue 28 of The Altascientist, you will find:
• Applications of LFHCs
• The production process
• The role of excipients
• Other advantages of LFHCs
• A case study
• How Altasciences can help
Applications for Liquid-Filled Hard-Shell Capsules in Your Drug Development Program
The use of modern drug discovery approaches, such as combinatorial chemistry and high-throughput screening, as well as structural understanding of drug-target binding by X-ray diffraction and molecular modelling, has resulted in an increasing percentage of highly potent lead compounds.
The majority of these compounds have high-melting points and poor aqueous solubility, which directly impact their dissolution and bioavailability. In an LFHC, readily metabolized lipid-based solutions are used as liquid carriers, providing for optimized absorption of the active pharmaceutical ingredient (API).
LFHCs offer several advantages for handling these challenging APIs, including:
• improved safety in processing and administration of potent drugs
• ease of administration
• flexible application
• abuse-resistant formulations
How Altasciences Can Help With Your Liquid-Filled Hard-Shell Capsule Formulations and Manufacturing
Altasciences has a proven track record and thorough expertise with LFHCs, having completed numerous projects over the years, for a wide range of clients. Our highly knowledgeable experts will assist you in determining the most appropriate and efficient program parameters, from batch size to excipient selection and capsule composition, color, and banding options. Our skilled operators use state-of-the-art machinery for every step of the process. We perform comprehensive process validation prior to manufacture, identifying and correcting any potential issue before it becomes a problem. We provide 100% manual inspection of the finished capsules and take pride in doing the job right the first time, every time.
Explore all issues of The Altascientist in our Resource Center. And don’t forget to subscribe to “The Altascientist: Audiobooks” on Spotify, Apple Podcasts, or wherever you get your audio content.
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
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.
Altasciences' Proactive Drug Development Solution: Small Molecules
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