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1rem

Contract service providers must step up their game to stay competitive in increasingly complex bio/pharma market.

Pharmaceutical Outsourcing Present and Future

The need for preclinical testing expertise is growing as molecular complexity increases.

Navigating the Preclinical CRO Outsourcing Process

A look at the newest innovations offers a deeper understanding of affinity ligands and their role in the future of downstream processing.

A Closer Look at Affinity Ligands

In this episode of the Drug Solutions podcast, Felicity Thomas, European/Senior Editor, chats with Sergey Vlasenko, associate vice-president, Pharma/Biopharma, Agilent, about trends impacting bio/pharmaceutical manufacturing. Sergey provides an overview of some of the key trends and then focuses on a novel modality—oligonucleotides—highlighting the specific challenges related to the manufacture of these exciting therapeutics.

Sergey Vlasenko, associate vice-president, Pharma/Biopharma, Agilent

Vlasenko joined Agilent in 2018 through its acquisition of the privately owned company ProZyme, a developer and manufacturer of glycan reagents, kits, and standards, required for biotherapeutic protein characterization. Prior to ProZyme, Vlasenko managed the R&D and marketing teams developing and commercializing innovative products for the Pharma and Biopharma industry.

 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, Sergey Vlasenko from Agilent chats about bio/pharmaceutical manufacturing trends, with a particular focus on oligonucleotides.

Drug Solutions Podcast: Unlocking the Latest Manufacturing Trends

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

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, 

® spoke with Gil Roth, president of the Pharma & Biopharma Outsourcing Association (PBOA), and Tara Dougal, content director, Pharma portfolio, Informa Markets, on the current challenges facing the outsourcing industry today as well how contract service providers are tackling sustainability and other big trends in the industry.

 is the founder and president of the Pharma & Biopharma Outsourcing Association (PBOA), a non-profit trade group advocating for the regulatory, legislative, and general business interests of the contract manufacturing organization/contract development and manufacturing organization (CMO/CDMO) sector. He was the founding editor of 

 is content director for the Pharma portfolio at Informa Markets, where she oversees development of in-person, hybrid, and digital content for the CPHI Europe, CPHI North America, and Pharmapack Europe exhibitions and for CPHI Online.

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 dynamically different. 

Drug Solutions Podcast: Challenges, Sustainability, and Big Trends in Outsourcing Today

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

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

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.

, Senior Associate, Shabbas Solutions LLC

, Senior Consultant, Shabbas Solutions LLC

, Advisor, Quality and Corporate Compliance, Shabbas Solutions LLC

Shabas Solutions provides Bio-Medical Scientific and Technical Services, Management Advisory Services, Medical Logistics and Supply Chain Management Support, Financial Management Support, Technology Integration, and Training, and Communication and Outreach to Federal Government Agencies. We are recognized for successfully leading large scale, departmental level mission-support operations through our expertise in policy, operations, and systems. As a scientific services provider we offer pharmaceutical consulting across the full lifecycle – drug discovery and development (small molecules and biologics), pharmaceutical manufacturing quality management maturity (QMM), pharmaceutical products storage and distribution, and regulatory affairs. As a responsible contractor, we maintain an ISO 9001:2015 certified quality management system and a DCAA-approved accounting system.

In this episode of the Drug Solutions Podcast, Chris Spivey interviews executives at Shabas Solutions LLC, who ran the overseas QMM pilot project.

Drug Solutions Podcast: FDA Quality Management Maturity (QMM) Overseas Pilot Program Findings: Going Beyond the Regulations

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. In part one of this outsourcing series, Meg Rivers, senior editor, and John Koleng, VP of product development and manufacturing for TFF Pharmaceuticals, discuss:

Curia is a global contract research, development, and manufacturing organization offering products and services across the drug development spectrum to help their partners turn ideas into real-world impact—from curiosity to cure.

John Koleng, PhD, VP of Product Development and Manufacturing, TFF Pharmaceuticals:

 Koleng has co-founded several life sciences development and industrialization consultancies focused on product development, manufacturing, scale up, commercialization, and supply chain management. He has more than 20 years of experience in the pharmaceutical industry, including more than 10 years as a consultant. Koleng has been a founding member of three drug development companies that are actively developing new products. He has a diverse range of drug development experience from formulation to route of administration. He has published numerous scientific research articles and is an inventor on 16 issued US patents and pending patent applications. Koleng has worked with TFF Pharmaceuticals as a consultant and is an inventor on several provisional patent applications filed on behalf of TFF. Prior to his consulting career, Koleng was a founding member and served in various roles at PharmaForm before the company was sold to Akela Pharma, Inc. in 2007. John Koleng, Ph.D., R.Ph., VP of Product Development and Manufacturing at TFF Pharmaceuticals has a BS degree in Pharmacy (1994), and a PhD in Pharmaceutics (2002), both from the University of Texas at Austin where he currently holds an adjunct assistant professor of pharmaceutics appointment and serves on the UT College of Pharmacy Dean’s Advisory Council. He is a registered pharmacist.

In this episode of the Drug Solutions Podcast, John Koleng, VP of product development and manufacturing for TFF Pharmaceuticals shares outsourcing strategies in biopharma.

Drug Solutions Podcast: Outsourcing vs. Insourcing in Biopharma: Determining the Best Strategy: Part 1

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, and much more.

 is the Vice President of Digital Innovation at Dot Compliance, a quality management software provider designing solutions specifically for the life science industry. A senior executive with more than 20 years of experience focused on digital transformation within highly regulated industries, Beasley helps companies maximize their investment in enterprise cloud solutions.

In this episode, Grant Playter, assistant editor, sits down with Rosalind Beasley, vice president, Digital Innovation, Dot Compliance, to discuss the current state of the compliance and validation industry.

Drug Solutions Podcast: The Current State of Compliance and Validation

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, technological advances making packaging more convenient, and some interesting insights from events. The experts involved in this discussion were Aurelio Arias, who is part of the EMEA thought-leadership group at IQVIA, and Josh Brooks, the marketing and community director for a new event called Connect in Pharma.

Aurelio Arias, engagement manager, European Thought Leadership, IQVIA

Aurelio creates topical and forward-looking strategic content relevant to pharma executives and publishes articles, blogs and white papers on a regular basis. He is involved in numerous projects related to increasing access to medicine as well as the interface between healthcare and digital technology. He is considered a subject matter expert in these areas and speaks at numerous conferences worldwide, presents at board-level meetings and engages with consulting projects.

Prior to IQVIA, Aurelio has worked in R&D and in various strategy consulting roles. He holds an MSci in Chemistry from Imperial College London.

Josh Brooks, marketing & community director, Packaging at Easyfairs

Josh heads marketing and communication activities across an international portfolio of agenda-setting packaging events in the UK, France, Switzerland and Italy. He joined Easyfairs in 2018 after an early career in business journalism and publishing, where he covered a wide range of sectors including packaging, printing, construction, property and electronics.

In this episode, experts share their insights into important drug packaging advances of the past, present, and future.  

Drug Solutions Podcast: Drug Packaging Advances

Survey responses indicate that bio/pharma faces tariff-driven rising costs and supply strain, with firms aiming to boost compliance and diversification and seeking stable trade and R&D support.

Bio/Pharma's Tariff Response: Key Insights from Industry Survey Results

The company will highlight how its GMP services combine engineering, consulting, equipment qualification, and facility validation to better integrate its services during Farmaforum, which is being held in Madrid from Sept. 17–18, 2025.

Telstar to Showcase Integrated GMP Services at Farmaforum

Experts from LGM Pharma and Rockwell Automation share their thoughts on what makes tech transfer effective, where processes could be improved, and why certain development and manufacturing decisions are so crucially important.

Emerging Tools, Integrated Controls Impact Tech Transfer

The investment will expand the company’s manufacturing and packaging capabilities at its Maple Grove, Minn. site, which Bora acquired in 2024 with its acquisition of Upsher-Smith Laboratories.

Bora Pharmaceuticals to Expand Midwest Manufacturing Site

The acquisition expands the CDMO’s small-molecule API development and manufacturing services in the US.

ESTEVE CDMO Acquires Regis Technologies

This episode of Drug Digest will discuss strategies for accelerating early-stage development, approaches to speeding up timelines for complex formats, and maintaining a flexible CMC process that ensures quality.

Speed, Flexibility Top Large-Molecule Manufacturing Trends

In this exclusive Drug Digest video interview, Patrick Lavery, Editor, 

® Group, interviews industry experts about large-molecule manufacturing trends. During the discussion, the experts will detail what those trends are, what are currently some approaches to speeding up development timelines without sacrificing quality, how manufacturers are strategizing to accelerate the earliest stages of development, and what the future holds in terms of next-gen advancements.

Deepak Bahl, Global Head of Applied Sciences, Pharma, Roquette

Deepak Bahl currently serves as Global Head of Applied Sciences, Pharma, at Roquette. His experience spans the development of conventional and enabled dosage forms of small molecules, liquids, parenterals, and peptides. He has held positions of increased responsibilities at Bristol Myers Squibb, Celgene, Merck and Co., Catalent Pharma Solutions, and Ranbaxy Research Laboratories.

Deepak has a PhD in Pharmaceutical Sciences from the University of Connecticut and Masters in Pharmacy (MPharm) from the College of Pharmacy, New Delhi. His work has led to the approval of four NDAs & MAAs, five ANDAs, three 505(B)(2)s, one BLA, and several patents/publications. His expertise includes design and scale-up of complex formulations such as gastroretentive systems, controlled release, multilayer tablets including bilayer and trilayer tablets, Zydis orally disintegrating tablets, multi-unit dosage units, and reverse engineering for development of generic bioequivalent pharmaceutical products. Deepak has held several leadership positions at the American Association of Pharmaceutical Scientists and currently serves as the chair of the AAPS Preformulation & Formulation Design/Development Community.

Jagruti Patel, Senior Director of Commercial Development, Lonza

Jagruti Patel is a senior professional with decades of experience in the biopharmaceutical industry and at Lonza. She plays a pivotal role in bridging operations and commercial teams to drive innovative biologics partnerships. Starting her career at Lonza in Slough as an entry-level R&D scientist, Jagruti has held diverse roles across the global network, including program management, key member of site leadership team, and commercial strategy in locations such as Singapore, Portsmouth, and California. Known for her collaborative leadership and strategic insight, she has been instrumental in shaping customer-centric solutions and fostering a culture of appreciation and growth. Jagruti’s journey at Lonza is not only a testament to her professional achievements but also to the strong community and lifelong relationships she has built along the way.

Drug Digest is a tech talk video series with the 

® editors, who interview industry experts to discuss 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.

 Developments in Small Molecule APIs, Excipients, and Ingredients

Editor's note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

In this exclusive Drug Digest video, Deepak Bahl from Roquette and Jagruti Patel from Lonza look at strategies for accelerating early-stage development while reducing risk, approaches to speeding up timelines for complex formats without sacrificing quality, and maintaining a flexible CMC process that ensures quality.

Outsourcing

Latest News

Pharmaceutical Outsourcing Present and Future