Drug Solutions

In this episode of the Drug Solutions podcast, Felicity Thomas, European/Senior Editor, talks to Hanns-Christian Mahler, CEO and board member, and Andrea Allmendinger, chief scientific officer, both at ten23 health about some of the hurdles facing developers and manufacturers of biological therapies. Hanns-Christian and Andrea take a closer look at some of the solutions being used within industry...

Following disruption in the bio/pharmaceutical supply chain as a result of the COVID pandemic, the outsourcing industry has learned to adapt and push forward in a climate that is dyamically different. In this Drug Solutions podcast episode, Pharmaceutical Technology® spoke with Gil Roth, president of the Pharma & Biopharma Outsourcing Association (PBOA), and Tara Dougal, content director, Pharma p...

In this episode of the Drug Solutions podcast, Jill Murphy, Editor, talks to Lon Johnson, VP of Sales and Marketing at Colbert Packaging Corporation, about drug packaging solutions, sustainable options for companies to move towards, EPR laws, and the challenges of transitioning to more renewable packaging options. Sponsor: Colbert Packaging

In this episode of the Drug Solutions podcast, Jill Murphy, Editor, talks to Adam C. Fisher, PhD, director of Science Staff and Immediate Office/Office of Pharmaceutical Quality at the Center for Drug Evaluation and Research/FDA, about point of care, patient manufacturing, and new innovative technologies in the industry.

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 t...

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 t...

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, Jil...

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 stakeholde...

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 c...

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 bear...

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/...

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 app...

Drug delivery has grown in leaps and bounds in recent decades, including growth in administration methods, therapeutic formulation, and delivery systems. David Bunka, chief technical officer, Aptamer Group, joins Meg Rivers, senior editor, for a deep dive into Optimers (optimized aptamers). Bunka discusses some of the key differences between Optimer drug conjugates and antibody-drug conjugates (AD...

Cell therapies are a hot topic in the bio/pharma industry today. In this episode, Meg Rivers, senior editor, Andrew Scharenberg, CEO, Umoja Biopharma, and Ryan Crisman, co-founder and chief technical officer, Umoja Biopharma, discuss 1) the greatest advancements in cell therapy to date; 2) where there’s room for improvement; 3) the biggest trends in cell therapy development; 4) the pros and cons o...

Through research collaborations, consortia, licensing, investments, and acquisitions, the emerging science and innovation team at Pfizer seeks to harness external, cutting-edge preclinical assets and novel technologies in emerging therapies. Increasingly, the focus is on true first-in-class mechanisms, if not only in-class programs, that would allow real breakthroughs for patients. Chris Spivey, e...

In what instances should organizations outsource vs. insource? Determining the right outsourcing strategy is key to limit unnecessary costs, maintain output and turnaround times, and enable continued flexibility. Meg Rivers, senior editor for Pharmaceutical Technology, and John Koleng, VP of product development and manufacturing for TFF Pharmaceuticals, will discuss: 1) what the biopharma industry...

In this episode of the Drug Solutions podcast, Felicity Thomas, European/Senior Editor, talks to Fernando Muzzio, Distinguished Professor, Chemical and Biochemical Engineering, Rutgers University, about a novel approach to improving drug solubility—continuous melt coating. Fernando talks about the technique in some detail, a little about some of the results that have been achieved in research, and...

In this episode of the Drug Solutions podcast, Grant Playter, Assistant Editor, talks with Rosalind Beasley, Vice President, Digital Innovation, Dot Compliance, on the current landscape surrounding compliance and validation. Topics of discussion include frequently overlooked factors in the validation process, under-the-radar innovations, the evolving role of the cloud in quality management systems...

In this episode of the Drug Solutions podcast, Felicity Thomas, European Editor, talks to a couple of experts on drug packaging advances that have been impactful in recent years and those that may have an impact in the future. Some talking points include sustainable packaging, tailored and patient-centric packaging options, the packaging challenges that arise when dealing with biologics, technolog...

Oral solid dosage forms are a dynamic, ever-changing landscape, driven primarily by more highly potent new chemical entities (NCEs) that require particularly specific formulations. In this Drug Solutions Podcast episode, Deepak Thassu, vice-president R&D and Regulatory Submission, LGM Pharma, and Marco Gil, senior vice-president of Sales & Marketing, Hovione, discuss how, in addition to NCEs, olde...

Just how important is training for aseptic processing? Human error is one of the biggest pitfalls for contamination in aseptic processing, and the proper training of staff continues to be of the utmost importance. In this Drug Solutions Podcast episode, Patrick Nieuwenhuizen, director senior consultant, PharmaLex, shares how important training is for aseptic processing along with environmental con...

Quality will forever be a topic of discussion for the pharmaceutical industry, and who better to share their insight than FDA? Three representatives from FDA—Michael Kopcha, Sau Lee, and Cindy Buhse—join Chris Spivey, editorial director, for a discussion about 1) emerging technology programs; 2) the framework for regulatory advanced manufacturing evaluation; 3) quality management maturity ratings;...

In this episode of the Drug Solutions Podcast, Feliza Mirasol, Pharmaceutical Technology’s science editor, discusses technologies enabling biologics and emerging therapies manufacturing and development with Barry Holtz, PhD, chief scientific officer of Phylloceuticals, and Professor Yaakov Nahmias, founder and chief scientific officer, Tissue Dynamics and founder and president, Future Meat Technol...