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

http://promo.mjhlifesciences.com/biopharmacongress/

The COVID-19 pandemic has disrupted the routine of in-person events, the need for sharing information and building key supplier connections for bio/pharmaceutical development and manufacturing has never been greater.

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Adare, Aizon, BASF, Beckman Coulter, Catalent, DocuSign, Honeywell, Lighthouse, Lonza Pharma and Biotech, LSNE, Mikart, Nelson Labs, Qualicaps, Shimadzu, suez and VAI

Wednesday, November 11, 2020 | 8:30 AM EDT – 4:00 PM EDT

On demand available after airing until Nov. 11, 2021.

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