Articles

A primer for understanding these remarkable therapies and their impacts in clinical trials.

Lessons in Cell and Gene Therapies

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

Videos

Cell and gene therapies continue to expand rapidly, with an anticipated exponential growth over the next five years. This rapid growth has left an urgent need for industry scientists to gather and share lessons learned concerning bioanalytical, biomarker and regulatory strategies. This series provides insight from PPD Laboratories’ experts into a variety of cell and gene therapy (CGT) modalities in the bioanalytical community, with detailed discussions that leverage their experience with technologies and modalities within this CGT sphere.


Tech Talks: Cell & Gene Therapy Series

Tech Talks: Extractables & Leachables Series

Join us for a live virtual grand opening event that will share a first look at PPD Laboratories’ new multi-functional lab in Suzhou, China. This significant expansion will enhance PPD’s bioanalytical, biomarker and vaccine service offerings to support global clinical trials for both China-based and global pharma and biotech customers. The event will include introductory remarks from key laboratory leaders, a virtual tour of the new lab, highlights from the in-person event in China earlier this month, and a live Q&A.

Attendees will learn about the service offerings of PPD Laboratories’ new multi-functional lab in Suzhou, China.

Attendees will learn about PPD Laboratories’ strategies and goals for growth in China.

Attendees will learn about PPD’s commitment to global drug and vaccine development and how our lab in Suzhou, China supports these goals.

Wednesday, June 9, 2021 at 9am EDT| 3pm GMT

Wednesday, June 9, 2021 at 12pm EDT| 9am PDT

*Two Live Airings: Wednesday, June 9, 2021 at 9am EDT| 3pm GMT & Wednesday, June 9, 2021 at 12pm EDT| 9am PDT* Join us for a hybrid/virtual event to celebrate the opening of PPD Laboratories’ newest lab in Suzhou, China. Hear from PPD Laboratories leaders, take a virtual tour, and participate in a live Q&A. *On Demand Until June 9, 2022*
