In this episode of the Drug Solutions podcast, Felicity Thomas, European/Senior Editor, talks to Rhonda Henry, President of Emmes’ BioPharma Group, and Adam Mendizabal, VP and Director of Emmes’ Cell and Gene Therapy Center, about the role contract research organizations (CROs) play in cell and gene therapy development. Rhonda and Adam will discuss the key factors and solutions driving growth in the CRO market with a particular emphasis on cell and gene therapies entering development pipelines, and will address some of the challenges facing the industry and best practices to ensure these limitations are overcome. SPONSOR: Baxter BioPharma Solutions

In this episode of the Drug Solutions podcast, Felicity Thomas, European/Senior Editor, catches up with Ana Ladino, Ashland’s Global Director—Regulatory Affairs, about the acceptance of a novel excipient onto CDER’s pilot review program, the next steps involved in progressing an excipient through the review program, and the change in industry’s mindset toward review programs in general.

In this episode of the Drug Solutions podcast, Jill Murphy, Editor, talks to Normand Blais, senior director of Development and Innovation in Biologics at BIOVECTRA, and Jessica Madigan, director of Business Development in Biologics at BIOVECTRA, about multiple topics under the vaccine umbrella. Blais and Madigan discuss the importance of advancements in the pipeline after COVID-19, challenges in the industry, and CDMOs differentiating themselves as vaccine leaders.

Jill Murphy, editor, and Grant Playter, associate editor, discuss the results from Pharmaceutical Technology’s latest employment survey. This survey, which polled approximately 300 members of the pharmaceutical industry, is designed to gather insights on topics like the broader state of pharmaceutical employment, trends going on in the industry, and predictions for its future. In this episode, Jill and Grant take a deep dive into these statistics and discuss what underlying factors might be at the root of it all.

PR agencies perspectives lightening round: buy/hold/sell on mRNA beyond Vaccines, Organ on a chip, Artificial Intelligence (AI) and Machine learning (ML), Viral Vector Yield Improvements, Quality Management Maturity (QMM), Near Patient Manufacturing. The role of a PR agency: are you a coach, a resource, a creative inspiration, a connector, a battering ram, secret sauce, an authoritative stakeholder, experienced guide? How has getting a message out has changed in the last 5 -10 years for pharmaceutical companies. What pharma industry trends do you see as important and want to emphasize, or are simply excited by? SPONSOR: Societal CDMO

How can organizations determine when to outsource vs. insource? What factors can (or should) be considered? The right outsourcing strategy has the potential to limit unnecessary costs, maintain output and turnaround times, and enable continued flexibility. In part two of this outsourcing series, Meg Rivers and Jeff Henderson, key account manager of Vetter, discuss: 1) what the biopharma industry currently tends to outsource, 2) outsourcing strategies the biopharma industry should be utilizing, 3) internal tasks the biopharma industry should consider outsourcing more in development and manufacturing, 4) what the biopharma industry should reconsider outsourcing and instead perform in-house, and 5) what organizations are choosing not to outsource and why.

FDA mentioned QMM in its 2019 report, Drug Shortages: Root Causes and Potential Solutions, which pointed to a lack of manufacturer incentives to improve their quality management beyond the minimum required for current good manufacturing practice (CGMP) compliance. In this podcast learn what QMM is, and how far beyond GMP functions QMM will drill into, and what accountability senior management bears for sustaining a corporate quality management culture, from an interview with executives at Shabas Solutions LLC, who ran the overseas pilot program.

A look back at challenge and innovation highlights in 2022 for oral solid dosage forms, this podcast episode will review industry experts’ takes on factors driving the evolution of OSD forms as well as innovations in APIs, technology, and methodology. Highlights include commentary from experts at LGM Pharma, Hovione, Syntegon, and Colorcon. SPONSOR: Lonza Recipharm

In this episode of the Drug Solutions Podcast, Alivia Leon, assistant editor, speaks with Christian Dunne, director of global corporate business development, Chargepoint Technology, about current and future processing equipment trends. Christian shares his expertise on trends such as automation, cost, and sustainability, and highlights how these aspects can affect processing equipment and the bio/pharma industry. SPONSOR: Lonza

In this episode of the Drug Solutions podcast, Felicity Thomas, European/Senior Editor, talks to Ana Ladino, Ashland’s Global Director—Regulatory Affairs, about the role of novel excipients in drug development. Ana highlights the importance of novel excipients in the advancing drug development pipeline, gives an overview of CDER’s pilot review program, discusses potential changes to regulatory approaches in other regions, and provides an overview of best practices for companies to follow when dealing with novel excipients. SPONSOR: JRS Pharma