CoreRx

Welcome to this episode of Drug Digest, a tech talk with the 

 editors, who discuss with experts the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products. In this episode, the editors dive into innovations driving the discovery and development of new and emerging therapies.

This episode of Drug Digest is sponsored by:

Steven Lynn, Executive Vice President, Pharmaceuticals for Regulatory Compliance Associates (RCA)

Alexander Natz, Secretary-General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)

Key challenges to emerging therapy development and manufacturing

Market positioning of small-molecule drugs vs. large-molecule drugs

Future direction of industry development of both small-molecule and large-molecule drugs

CMOs, CDMOs, scientists, developers, and other technical experts working with emerging therapies

Companies who are seeking regulatory information on emerging therapies

Companies from US looking to work in Europe or vice-versa in the emerging therapies field

Steven Lynn
Executive Vice President, Pharmaceuticals
Regulatory Compliance Associates (RCA)


Steve has over twenty-three (24) years of quality and regulatory compliance related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma and tissue industries. He served in executive leadership roles with global accountability in both the private sector, as well as at the US FDA. Steve is an expert in Current Good Manufacturing Practices compliance related matters and has significant experience with other GxP quality compliance and regulatory issues. Steve is currently the Executive Vice President, Pharmaceuticals for Regulatory Compliance Associates. Prior to RCA he was the principal consultant/owner for Lynn Consulting, LLC, which provided expert GxP consulting services to the life sciences industry.

Alexander Natz
Secretary-General
European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)


Alexander Natz is the Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and advises innovative pharmaceutical and biotech companies, including start-ups, in regulatory and pricing & reimbursement matters from the EU law and German law perspective. From 2008 to 2013, he was Head of the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. (BPI). Before, he worked as a lawyer at Sträter Law Firm in Germany with a special focus on managed entry agreements and licensing of pharmaceuticals. Alex has also worked in the field of competition law with the European Commission and in the pharmaceutical industry. As a research assistant at Duke University (USA) he has dealt with international pharmaceutical law.

Webcasts

Thursday April 28, 2022 at 11am ET | 10am CT | 8am PT
 In this new video series, Drug Digest, the Pharmaceutical Technology editors examine the topic of emerging therapies in more detail, covering subjects such as the challenges of scale, the potential benefits of drug delivery innovation, importance of early analytical studies, the evolution of the regulatory landscape, and differences between regional regulatory requirements. Join the editors as they speak with experts from Regulatory Compliance Associates (RCA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), and others.



Drug Digest: Emerging Therapies In all Shapes and Sizes

Podcasts

Drug development timelines are shortened by the corporate and clinical strategies of biotech and pharmaceutical companies to achieve proof-of-concept or to rapidly get to the market.  For new drug entities entering clinical trials, selecting the right drug product depends on many factors, including the corporate and clinical strategy, and the physiochemical properties of the drug substance.  This episode will consider time and cost for developing and compounding or manufacturing the different types of oral drug products dosed in early clinical trials.

Oral Drug Product Strategies and Considerations for Quick to Clinic and Quick to Market

Articles

Cationic Adsorbent Gel Raft formulation for use in proton pump inhibited stomach.   Concept proven with fiberoptic UV probes eliminating the need for HPLC analysis. 

Delayed Binding of Bile Salts by Matrix Bound Cationic Adsorbents Dispersed in Alginate Rafts

The bioavailability of insoluble compounds remains one of the biggest challenges to drug delivery. While there are strategies that can be applied at lower dosage levels, it is particularly difficult to formulate for improved bioavailability at high dosage levels.  Improving bioavailability can be crucial to creating a dosage form that is easy to use and meets requirements for patient compliance.

CoreRx tackles bioavailability challenges for molecules by leveraging our membrane flux in vitro technology.  Today, we will discuss how using this technology enabled CoreRx to discern which factors were most important for bioavailability of a model Class IV compound, and led to development of a formulation with ~70% increase in bioavailability.


Screening Permeability as a Tool in Formulation Selection 

Bioavailability of insoluble compounds is one of the biggest challenges to drug delivery. 
Improving bioavailability is crucial to creating dosage forms that are easy to use and meet demands for patient compliance. 
