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1rem

Accurately targeted immunotherapies through reliable neoantigen recognition enable personalized medicine development.

Research into Cold Cancers Heating Up

Activation and expansion are essential for success in both autologous and allogeneic therapies.

Development of Gamma-Delta T-Cell Therapies

Continuous manufacturing and a quality-by-design development approach are a natural fit.

QbD for Small-Molecule Continuous Process Development

Podcast will explore the technical aspects and advantages of messenger RNA (mRNA) as the basis for therapeutics in cancer treatment as well as vaccines. Based off the success of the mRNA-based COVID-19 vaccines, the biopharma industry is responding with enthusiasm and intense focus on the development of mRNA-based therapeutics for diseases. An area of particular challenge is the delivery of the mRNA therapeutic in vivo. Formulation solutions, such as encapsulating the mRNA within a lipid nanoparticle (LNP) structure, has proven effective. Here, Stefaan De Koker, vice-president of Technology and Innovation, etherna, goes into more detail about the benefits and challenges of developing mRNA-based therapeutics for oncology and vaccines, and discusses the practical application of LNPs toward that goal.

Stefaan De Koker, Vice-President Technology and Innovation, etherna

Stefaan De Koker holds a master in Bioengineering and obtained his PhD at the lab for Molecular Immunology at Ghent University. Throughout his career, he has had a keen interest in understanding how activation of the innate immune system shapes the adaptive immune system and in translating this knowledge into improved vaccines and immunotherapies. De Koker became involved early in the messenger RNA (mRNA) therapeutics field and published seminal papers on the mode-of-action of mRNA vaccines, on the usage of mRNA for intratumoral immunomodulation, and on the development of novel delivery vehicles for mRNA therapeutics. In September 2016, De Kokerjoined ethernawhere he leads the Technology and Innovation team. His focus is currently on the design of customized mRNA lipid-based nanoparticles (cLNPs) for extrahepatic delivery, immunomodulation, and gene editing. De Koker has authored more than 60 publications and is co-inventor on more than 15 patent applications.

 presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

Podcasts

In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.

Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines

Podcast will give an overview of the latest analytical tools and their applications in the drug development market, covering topics such as the current implementation of capillary electrophoresis, the impact of emerging therapies on innovation, and the ethical and regulatory considerations in ongoing drug development.

Dr. Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina.

Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina, boasts over 20 years of experience in the biopharmaceutical field, with notable tenures at Pfizer, Hospira, Centre for Marine Bioproducts Development, Stellenbosch University, and the Queensland University of Technology. With a background enriched by a Ph.D. from Stellenbosch University and an MBA from the University of New South Wales, Jan tailors programs spanning pre-clinical to commercial manufacturing phases, enhancing BioCina's business development through his comprehensive industry insight and technical expertise.

In this episode of the Drug Solutions Podcast, Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina, discusses the latest analytical tools and their applications in the drug development market.

Drug Solutions Podcast: Applying Appropriate Analytics to Drug Development

In this episode of the Drug Solutions podcast, Jill Murphy, Editor, speaks with Dr. Graziella Piras, senior director of Strategic Marketing at 908 Devices, about drug development, specifically related to monitoring bioprocess parameters and other important technologies important to moving the process forward.

Graziella has over 15 years of experience in developing products, applications, and solutions for upstream bioprocessing. Before joining 908 Devices, she held various positions in marketing and R&D at Thermo Fisher Scientific, leading projects to support the Cell Culture and Cell Therapy business.

Graziella obtained her Ph.D. in Biochemistry & Molecular Biology in Belgium. She did her postdoc studying the role of epigenetic regulation on cancer and development at the National Cancer Institutes in Maryland.

Drug Solutions Podcast: Breaking Through the Barriers of Drug Development

In this episode of the Drug Solutions podcast, Felicity Thomas, European/Senior Editor, talks to David Tisi, technical director at Senopsys LLC, and Reenal Gandhi, global business development director for the Prescription Division of 

. In the first segment of the episode, David chats about some of the key challenges impacting oral dosage forms and the approaches and solutions available that are helping developers overcome these hurdles. After, Reenal details the intricacies of intranasal drug dosage forms, such as the convenience and the growth of this route of administration, challenges of development, and the possibilities of repositioning drug products.

David Tisi, technical director at Senopsys LLC

David is founding member of the scientific team at Senopsys LLC, a specialty services firm dedicated to the development of palatable drug products. He has over 15 years of experience in taste assessment and taste masking novel drug formulations for children and adults, leveraging his background in sensory science and food chemistry. David received his Masters in Food Science from Cornell University and began his career in product innovation at PepsiCo and Nestle.

Reenal Gandhi, global business development director for the Prescription Division of 

Reenal has more than 15 years’ experience within the drug delivery and pharmaceutical industries, involved in the development and commercialization of wide-ranging drug delivery solutions. Over the course of her career, Reenal has actively worked on business development related to nasal and injectable devices, such as prefilled syringes and autoinjectors. Since December 2020, Reenal has been working for Aptar Pharma, driving the assessment of new opportunities and focusing on new technologies in particular.

In this episode, David Tisi and Reenal Gandhi provide expert insights into advances and innovations changing the drug dosage form landscape.

Drug Solutions Podcast: Innovations and Advances in Drug Dosage Forms

In this episode of the Drug Solutions Podcast, Grant Playter, associate editor, speaks with Jeff Fischer, co-founder and president of Longhorn Vaccines and Diagnostics, on the history and ongoing development of both protein- and mRNA-based vaccines. Topics of discussion include recent vaccine approvals, the broader state of the vaccine industry, and ideal use cases for both vaccine formulations.

Jeff Fischer, co-founder and president, Longhorn Vaccines and Diagnostics

Jeff Fischer, MBA, is the President of Longhorn and is responsible for oversight of all non-scientific aspects of the organization to include regulatory affairs. Jeff co-founded the company and has served as its Chief Financial Officer from 2007-2017. From 1998-2005, Jeff served as an executive vice president and CFO in the biotechnology industry. He is a former infantry officer in the United States Marine Corps and holds an MBA from the University of Texas at Austin.

Jeff Fischer, co-founder and president of Longhorn Vaccines and Diagnostics, discusses the history and ongoing development of both protein- and mRNA-based vaccines.

Drug Solutions Podcast: Evaluating the Vaccine Marketplace

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—a contract development and manufacturing organization dedicated to human-centric and sustainable pharmaceutical development—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 to overcome these challenges and focus on the issue of sustainability within this sphere. Finally, they touch upon some of the other potentially important future trends that will impact biologic drug development and manufacturing.

Hanns-Christian Mahler is Chief Enablement Officer (CEO) & Board Member, ten23 health

. Mahler’s previous roles include the head of Drug Product Services at Lonza, head of Pharmaceutical Development and Supplies at Roche, and principal scientist of Pharmaceutical Development and CMC Project Manager Erbitux for Merck KGaA. He holds a PhD in Toxicology from the Institute of Pharmacy at the University of Mainz and is an adjunct faculty member and lecturer at the universities of Frankfurt and Basel. He obtained his venia legendi (German Habilitation) from the University of Frankfurt/M. in 2011. Mahler also serves on the boards of Bionter and KriyaBio, and is an editor for several pharmaceutical journals.

Andrea Allmendinger, PhD, Chief Scientific Officer at ten23 health.

 Dr Allmendinger is also Adjunct Professor and Group Leader at the University of Freiburg (Baden-Württemberg, Germany), researching novel parenteral drug formulations and device solutions to improve stability, usability and cost of goods. Between 2010 and 2021, she was Principal Scientist, Pharmaceutical Development at Roche, working on, inter alia, manufacturability and injectability of high-concentration protein formulations, formulation and process development of freeze dried formulations, syringe and high volume drug/device combination products, particulates and surfactant strategy. Dr Allmendinger studied Pharmacy at the University of Heidelberg, Germany, and University College London, UK, and holds a PhD in Pharmaceutical Sciences from the University of Basel, Switzerland. She obtained the venia legendi (German Habilitation) from the University of Freiburg in 2021, and serves as Editor-In-Chief for the AAPS Open Journal.

In this episode, Hanns-Christian Mahler and Andrea Allmendinger from ten23 health will discuss some key aspects of biologic drug development and manufacturing.

Drug Solutions Podcast: Considering Biologic Drug Development and Manufacturing Holistically

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.

Rhonda Henry is the President of Emmes’ BioPharma Group

. She holds a B.S. in nursing from the University of North Carolina, Wilmington. Rhonda joined Emmes with 30 years of clinical research experience holding a number of leadership positions in clinical operations, patient centricity and strategic partnerships at PPD.Before her entry into clinical research, Henry served as a nurse at New Hanover Regional Medical Center. In 2020, she was named to the PharmaVOICE 100 list of most inspiring people working in the life-sciences industry. She has been active in a number of non-profit organizations, including her current position as chair of the board of directors for The Carousel Center, a nationally accredited child advocacy center serving New Hanover, Brunswick, and Pender counties.

Adam Mendizabal, PhD is the VP and Director of Emmes’ Cell and Gene Therapy Center

. He joined Emmes in 2002 and has progressively increased responsibilities from a Biostatistician and Sr Investigator to his current role leading the expansion and of the cell and gene therapy clinical trial portfolio at Emmes. During his time at Emmes, Adam has co-authored publications across different therapeutic areas that have focused on cell and gene therapies. He received his Bachelor’s degree in Biological Sciences from Rutgers College in 2000, a Master’s degree in Statistics from Rutgers University in 2002, and a PhD in Epidemiology from The George Washington University in 2014.

In this episode, Rhonda Henry and Adam Mendizabal from Emmes discuss the role CROs play in cell and gene therapies undergoing clinical trials at all stages.

Drug Solutions Podcast: How CROs Adapt Themselves in the Ever-Changing Landscape of Cell and Gene Therapies

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.

Ana L. Ladino is Ashland’s Global Director-Regulatory Affairs

. As senior leader of the regulatory affairs function, she manages strategic direction and operational oversight for the regulatory activities for all Ashland’s Life Sciences products: excipients and other oral solid dosage ingredients and coatings, injectables, nutrition, nutraceuticals, agrochemicals, and medical devices. She oversees all FDA and other global regulatory authority interactions for Ashland’s products while ensuring a high level of integrity in regulatory and quality compliance. With 25 years of experience in the healthcare industry, she has extensive experience in drugs, combination products, medical devices, excipients, and API regulatory requirements. She has been involved in industry organizations such as RAPS, IPEC, AAM, ISO, NEMA, authored many global regulatory-related papers, and presents worldwide on various regulatory topics. She served on the Healthcare Businesswomen’s Association (HBA)—West Chester Board.

Ana holds a bachelor’s degree in electrical engineering and a master’s degree in biomedical engineering from Autonomous University of the West (UAO), in Cali, Colombia. In the past, she has worked for West Pharmaceuticals, Accellent, Siemens, GE Medical, and as a university professor.

In this episode, Ana Ladino provides an update on the acceptance of a novel excipient onto CDER’s pilot program.

Drug Solutions Podcast: Progressing Excipients Through Review

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 dissected: 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?

Debra Harrsch, President and CEO, Brandwidth Solutions

Brandwidth Solutions’ holistic approach to scalable, science-focused, and customized marketing starts with in-depth industry knowledge and the full scope of services that enable you to get where you need to go. We speak science®.

Beth Willers, Principal, White Matter Communications

WMC was built to deliver a different type of agency experience to the B2B Life Sciences mark.et. Our focus is on developing quality content while building good habits across the PESO spectrum and making deeper connections both internally and externally to sustain a healthy brand evolution.

Kevin McCarthy, Senior Consultant, Orientation Marketing

Orientation Marketing is a life science and pharmaceutical marketing agency operating within specialist B2B scientific sectors. We help drug, ingredients, packaging, medical technology, contract manufacturing, development and research organisations uncover marketing opportunities to become visible, increase engagement and generate more leads.

Public relations agencies dissect pharmaceutical trends: Brandwidth Solutions, Orientation Marketing and White Matter Communications

Drug Solutions Podcast: Pharma Trends Dissected by 3 PR Agency Luminaries

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:

What the biopharma industry currently tends to outsource

Outsourcing strategies the biopharma industry should be utilizing

Internal tasks the biopharma industry should consider outsourcing more in development and manufacturing

What the biopharma industry should reconsider outsourcing and instead perform in-house

What organizations are choosing not to outsource and why

Jeff Henderson, key account manager, Vetter:

 Henderson has served in a variety of positions as an engineer, consultant, and business development professional over the span of his 25-year career. He began his engineering and consulting role with Barry-Wehmiller Design Group in St. Louis, designing, installing, and validating filling and packaging lines for the food, beverage, and pharma industries before earning his MBA at Pepperdine University in Malibu, CA. After that, Henderson worked at Amgen where he was initially responsible for managing contract manufacturing operations at various packaging and sterile fill/finish sites in the United States. He later moved into a more strategic role in developing manufacturing strategies for clinical and commercial products in Amgen’s pipeline. In 2007, he moved to Seattle to focus on downstream efforts in automated warehousing and material handling before returning to a biotech engineering role at Medimmune’s pilot plant in Gaithersburg, MD. Following his position at MedImmune, he joined Vetter as a key account manager in 2010 and has been growing a solid business footprint over the past 12 years.

Listen to part one of this outsourcing series.

In this episode of the Drug Solutions Podcast, Meg Rivers discusses outsourcing strategies in biopharma with Jeff Henderson, key account manager of Vetter.

Drug Solutions Podcast: Outsourcing vs. Insourcing in Biopharma: Determining the Best Strategy: Part 2

Vitrakvi (larotrectinib) was first granted accelerated approval by FDA in November 2018.

Bayer Announces FDA’s First Full Approval of NTRK Inhibitor

The company has plans to invest $23 billion during the next five years to expand manufacturing and R&D in the US, which will include seven new facilities.

Novartis to Expand US-Based R&D and Manufacturing

Lack of skills in the AI realm was a distant second among those surveyed about the biggest barrier to innovation while using the technology.

Agentic AI Growth Predicted, but More Than Half of Pharma Still Resisting Change: Report

Advancement of emerging therapies faces hurdles across all aspects and phases of drug development and manufacturing.


Navigating the Complexities of Emerging Therapy Development

Advanced solutions are improving drug dissolution, absorption, and overall therapeutic performance.

Enhancing Solubility and Bioavailability with Nanotechnology

Alexander Seyf, CEO and Co-Founder of Autolomous

Alexander Seyf, CEO and co-founder of Autolomous, sees the advancement of artificial intelligence (AI) and machine learning (ML) as tools to support pharmaceutical scientists and manufacturers in their work.

“AI and ML can help us to do the leg work, but the main work is going to need to be done by our own brain, but by human being,” Seyf insists. “I think it will be more segregation of mechanical work rather than intellectual work. And for identifying the progression of biology and the discovering the different solutions for different diseases, you've seen an amazing trend today. There are companies in the United States that we're looking at using off-the-shelf drugs for different indications that it was not intended from beginning. And I believe that's a huge, huge progression in the right direction. And for drug discovery, we're going to look at cross fertilization, of what we have already enhanced for the solution to the diseases that we don't have any treatment for. So, we will see examples of that practically, ML and AI can help us to progress the pharma and other industries, for that matter, more in the right direction.”

Click the video above to watch the full interview.

Alexander Seyf is CEO and Co-Founder of Autolomous.

Pharmaceutical Technology® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about the use of artificial intelligence and machine learning in pharmaceutical development and manufacturing.

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