Enteris BioPharma to Host Webinar on Strategies for Initiating Phase 1 Clinical Development with Limited API

Rhea-AI Summary

Enteris BioPharma, a subsidiary of SWK Holdings (Nasdaq: SWKH), announced a webinar on January 19, 2021, titled "Strategies for Entering Phase 1 Clinical Development with Limited API Quantities." Co-hosted by Thomas Daggs and Angelo Consalvo, the webinar will focus on CMC strategies for pharmaceutical companies managing limited access to active pharmaceutical ingredients (API). CEO Rajiv Khosla highlighted the challenges faced by emerging biotech firms in drug development.

Enteris is advancing various clinical products, including Ovarest® and Tobrate™.

Positive

• Enteris is advancing its product pipeline, including Ovarest® for endocrine disorders and Tobrate™ for urinary tract infections.
• The webinar aims to share strategies for overcoming challenges in Phase 1 clinical development.

Negative

• Limited access to APIs may pose challenges for advancement in clinical trials.
• -

BOONTON, N.J., Jan. 12, 2021 /PRNewswire/ -- Enteris BioPharma, Inc., a biotechnology company developing innovative drug products built around its proprietary delivery technologies and a wholly-owned subsidiary of SWK Holdings Corporation (Nasdaq: SWKH), announced that the company will host a webinar, titled "Strategies for Entering Phase 1 Clinical Development with Limited API Quantities."  The event is scheduled for Tuesday, January 19, 2021 at 1:30 p.m., ET, and will be co-hosted by Thomas Daggs, MBA, Enteris' Senior Director Product Development and Quality Control, and Angelo Consalvo, Enteris' Director Manufacturing.

During the webinar, Mr. Daggs and Mr. Consalvo will discuss their expertise in developing CMC approaches for advancing pharmaceutical companies into Phase 1 clinical development, while managing limited access to active pharmaceutical ingredients, also known as API.  

"The earliest stages of drug development can be the most daunting, particularly for emerging pharmaceutical and biotechnology companies, which often must contend with limited resources, including access to API," said Rajiv Khosla, Ph.D., Chief Executive Officer of Enteris. "At Enteris, we have encountered this situation with our development partners, and our manufacturing team has been able to devise strategies for developing CMC approaches that can be applied to a wide range of Phase 1 trial demands.  This webinar, which is the second in a series of virtual events that Enteris is hosting, is designed to share our knowledge and expertise with those who desire novel strategies for initiating clinical programs with limited API quantities."

Details of the webinar are as follows:

Title: Strategies for Entering Phase 1 Clinical Development with Limited API Quantities
Date: Tuesday, January 19, 2020
Time: 1:30 p.m. ET
Webinar Link: https://zoom.us/webinar/register/WN_RWaEgsjSSHCVUcBwVv2Wpg

About Thomas Daggs, MBA
As Senior Director Product Development and Quality Control at Enteris, Mr. Daggs is responsible for the Analytical and Quality Control groups as well as CMC project management.  With more than 15 years of pharma, biotech and diagnostics experience, Mr. Daggs possesses broad knowledge of all aspects of pharmaceutical development with technical strengths in analytical methodology/controls.

About Angelo Consalvo
As Director of Manufacturing at Enteris, Mr. Consalvo is responsible for cGMP manufacturing and pre-formulation characterization studies.  Mr. Consavlo has more than 34 years of biopharma experience in process development and manufacturing. Throughout his career, he has led the successful development and transfer of numerous commercial manufacturing processes and built an expertise in working with small molecule and peptide/protein APIs, both recombinant and synthetic.

About Enteris BioPharma
Enteris BioPharma, Inc. is a wholly-owned subsidiary of SWK Holdings Corporation (Nasdaq: SWKH) offering innovative formulation solutions utilizing its proprietary drug delivery technologies, Peptelligence^® and ProPerma™. The technologies have been the subject of numerous feasibility studies and active development programs, several of which are in late-stage clinical development. Additionally, Enteris BioPharma is advancing an internal product pipeline of oral tablet reformulations of drug products that address significant treatment opportunities for which there is no oral delivery option. Enteris BioPharma's most advanced internal product candidate, Ovarest^® (oral leuprolide tablet), is an oral peptide being developed for the treatment of endocrine disorders. Tobrate^TM (oral tobramycin tablet) is also being developed by Enteris BioPharma for the treatment of uncomplicated urinary tract infection (uUTI).  A third internal compound, octreotide, is currently in preclinical development. For more information on Enteris BioPharma and its proprietary oral delivery technology, please visit http://www.EnterisBioPharma.com.

 

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SOURCE Enteris BioPharma, Inc.

FAQ

What is the purpose of the Enteris BioPharma webinar on January 19, 2021?

The webinar aims to discuss strategies for entering Phase 1 clinical development with limited API quantities.

Who is hosting the Enteris BioPharma webinar?

The webinar is co-hosted by Thomas Daggs and Angelo Consalvo, both of Enteris BioPharma.

What products is Enteris BioPharma developing?

Enteris is developing Ovarest® for endocrine disorders and Tobrate™ for urinary tract infections, among others.

When is the Enteris BioPharma webinar scheduled?

The webinar is scheduled for January 19, 2021, at 1:30 p.m. ET.

What challenges do emerging pharmaceutical companies face according to Enteris BioPharma?

Emerging pharmaceutical companies often struggle with limited resources, especially access to active pharmaceutical ingredients (APIs).