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In this episode of the Drug Solutions podcast, Felicity Thomas, Associate Editorial Director, chats with Hanns-Christian Mahler, CEO and board member of ten23 health, about the growing demand for fill/finish services, technological advances and novel approaches helping to advance fill/finish, sustainable and green practices, the impact of smaller batch sizes, and regulatory guidance updates in the space.

 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 previously worked for Lonza, Roche, and Merck, and currently serves on the boards of Bionter and KriyaBio. Hanns-Christian is also an editor for several pharmaceutical journals.

 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, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

Drug Solutions Podcast: Growth and Advancements in Fill/Finish 

 podcast, Felicity Thomas, European/Senior Editor, chats with Alexander Natz, Secretary-General of EUCOPE, about the European Health Data Space (EHDS), which was formally adopted by the European Parliament in April 2024. The EHDS aims to improve individual’s the access to and control of their own health data and also to allow for the secondary use of health data in research, innovation, policy-making, and regulatory activities.

 is Secretary-General of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE). As Secretary-General, Alex advises innovative pharmaceutical and biotech companies, including start-ups, in regulatory and pricing and reimbursement matters from the European Union 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.

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Podcast will give an overview of the biosimilars market. Industry experts will discuss regulatory controls, pricing pressure, the state of the healthcare industry, and other factors affecting the uptake of biosimilars in the market. Manufacturing challenges as well as current and future needs will also be discussed. Experts will also highlight technological innovations, such as digitalization technologies, and their role in facilitating analytical characterization and manufacturing controls for biosimilars.

Zara Bukhari, PhD student, Biochemistry, University of the Pacific, Stockton, California

Zara Bukhari completed a master’s degree in engineering at Birla Institute of Technology and Sciences, India, with an internship at Biocon Biologics, focusing on Semglee (insulin glargine-yfgn). This experience sparked Bukhari’s interest in the pharmaceutical industry. Subsequently, she worked as a bioprocess engineer at Biocon Biologics for six years, contributing to the design of purification platforms for biosimilars and innovator biologics. Notably, she was involved in a validation study leading to the successful biologics license application filing of Ogivri (trastuzumab-dkst), a biosimilar to Herceptin (trastuzumab), offering her insights into regulatory requirements and the biosimilars market. Bukhari is currently pursuing a PhD in biochemistry, specializing in ubiquitin biology at the University of the Pacific, Stockton, Calif. Through her PhD, Bukhari aspires to contribute valuable insights into the role of ubiquitination in regulating the cellular proteome and its broader implications in diseases to advance scientific understanding and potentially aid the scientific community in identifying novel drug targets.

John Gabrielson, Senior Vice-President, Biosimilars, and Head of Business, JSR Life Sciences

John Gabrielson is senior vice-president, Biosimilars, and head of Business for JSR Life Sciences. He is a seasoned executive, company builder, and strategist with nearly 20 years of experience developing biologics. With experience at large and small biotech companies and most recently a leading contract development and manufacturing organization, Gabrielson is now focused on accelerating biosimilar adoption across the industry.

In this episode of the Drug Solutions Podcast, industry experts give an overview of the biosimilars market and discuss factors affecting not only their manufacture, but their upstake in the market as well.

Drug Solutions Podcast: The Biosimilars Landscape

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, 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.

, is the Director, Science Staff in the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research at the FDA. Dr. Fisher focuses on engaging FDA stakeholders and supporting advanced pharmaceutical manufacturing technologies. At the FDA, he has served as a primary and secondary reviewer of Abbreviated New Drug Applications (generics) and Drug Master Files, a Team Lead, a subject matter expert on complex drug substances and advanced biomanufacturing, and a liaison to the United States Pharmacopeia BIO1 Expert Committee. He joined the FDA in 2014 as a chemical engineer with expertise in the synthesis of biomolecules. Dr. Fisher’s work prior to joining the FDA focused on the microbial production of proteins and glycoproteins. Dr. Fisher was the co-founder and Chief Science Officer of a startup company focused on microbial technologies for the production of glycoproteins. He earned his B.S. degree at the University of Maryland College Park (Chemical Engineering) and his Ph.D. at Cornell University (Chemical & Biomolecular Engineering).

Adam C. Fisher, PhD, director of Science Staff and Immediate Office/Office of Pharmaceutical Quality at the Center for Drug Evaluation and Research/FDA, discusses point of care and patient manufacturing with Pharmaceutical Technology editor Jill Murphy. 

Drug Solutions Podcast: FDA Speaks About Near Patient and Continuous Manufacturing 

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


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.

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.

In this episode, Ana Ladino provides expert insight into novel excipients in the current and future drug development landscape.

Drug Solutions Podcast: Novel Excipients in Drug Development

Quality will forever be a topic of discussion for the pharmaceutical industry, and who better to share their insight than FDA? Director of FDA’s Office of Pharmaceutical Quality, Michael Kopcha,deputy director of science, Sau Lee, anddeputy director of operations, Cindy Buhse, join Chris Spivey, editorial director, for a discussion about:

The framework for regulatory advanced manufacturing evaluation (FRAME)

Quality as a co-dependent variable of economic outcome

Advanced versus traditional manufacturing

Pandemic pressures and improved communication

Keeping up with biotech and emerging therapies

Re-shoring drug manufacturing to the United States

What manufacturers need to understand about advancing pharmaceutical science


, PhD, R.Ph., is the director of FDA’s Office of Pharmaceutical Quality (OPQ). This office has more than 1,300 staff responsible for assuring the availability of quality medicines for the American public through assessment, inspection, surveillance, research, and policy. OPQ contributes to the assessment of nearly every type of human drug marketing application including new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), including 351(k) applications (i.e., biosimilars). OPQ also performs the quality assessment of investigational new drug applications (INDs) and establishes quality standards for over-the-counter drug products and facilities. Dr. Kopcha earned his doctorate and master’s degrees in pharmaceutical science and a bachelor’s degree in pharmacy from Rutgers University. He served as an adjunct assistant professor in the Department of Pharmaceutics at Ernest Mario School of Pharmacy at Rutgers.

, PhD, is the deputy super office director of science in the Office of Pharmaceutical Quality. He directs the activities of staff members in OPQ sub-offices responsible for the quality assessment of regulatory submissions (OBP, OLDP, ONDP, and OPMA). He represents OPQ in programs and activities that impact quality assessments by coordinating with OPQ, the Center of Drug Evaluation and Research (CDER), and ORA. He also serves as the point person for the pharmaceutical industry and scientific/academic groups in developing programs to support science- and risk-based application assessment and approval. Prior to joining FDA, Dr. Lee received a bachelor of science degree in chemical engineering from the University of Virginia with a minor in materials science and a PhD in chemical engineering from Princeton University.

is currently the acting senior advisor for scientific operations in the OPQ in the CDER in the FDA. Dr. Buhse joined FDA in 2001 in OPQ’s office of testing and research. She was the director of the office of testing and research from 2013 to 2017 and the director for the office of quality surveillance (OQS) from 2017 to 2019. Before joining FDA, Dr. Buhse worked in management positions in production, validation, and analytical services at Sigma Aldrich Corporation and as a senior research scientist for Rohm and Haas Company. Dr. Buhse received a B.A. in chemistry from Grinnell College and a PhD in physical chemistry from the University of California, Berkeley. OQS assures that quality medicines are available through signal detection, data analysis, review of the state of quality, and proactive stakeholder engagement.

In this episode of the Drug Solutions Podcast, Chris Spivey, editorial director, interviews Michael Kopcha, Sau Lee, and Cindy Buhse of FDA about not being afraid to try new approaches and how they invite fresh ideas and abundant communication.

Drug Solutions Podcast: FDA Weighs in on Advancing the Science of Pharmaceutical Manufacturing

Counterfeit pharmaceutical products are a global issue that impacts all stakeholders in the pharma industry and poses a potentially lethal threat to patients. Globally, measures have been put in place to help tackle the problems posed by counterfeit medicines; however, as the United Kingdom is now no longer a part of the European Union, concerns have been raised that the country could be left exposed to an increased prevalence of counterfeit medicines infiltrating the market.

Anti-counterfeiting measures are expected to become stricter in the future to ensure patients are protected and with the rising levels of data that will be required to be managed and processed, blockchain could offer a suitable solution to industry. To learn more about the issue of counterfeit medicines and the potential benefits that can be gained from using blockchain as an infrastructure technology, 

 spoke with Raja Sharif, CEO and founder of FarmaTrust—a provider of blockchain and artificial intelligence (AI) provenance systems for the pharmaceutical and healthcare sectors.

Pharmaceutical Technology discussed the potential increased risk of counterfeit medicines in the UK post-Brexit and how blockchain could be a useful tool to tackle the issue.

Tackling Counterfeit Medicines

Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.

A Novel, Enhanced, and Sustainable Approach to Audit Trail Review

The warning letters deal with a range of violations involving items from personal hygienic products to mismarketed analgesics.

FDA Posts Slate of Seven Warning Letters Following Company Inspections

A Phase III trial demonstrated mNEXSPIKE’s non-inferior efficacy compared with Moderna’s original COVID vaccine, Spikevax.

FDA Approves New Moderna COVID-19 Vaccine mNEXSPIKE

The concerns of industry experts expressed at INTERPHEX in April 2025 are still pertinent in an uncertain global political climate.

Geopolitical Shifts Change Nature of Pharma Partnerships

Bempikibart (ADX-914) is a human anti-IL-7Rα antibody that blocks the IL-7 and TSLP pathways, which have been implicated in driving T cell-mediated pathological processes in autoimmune diseases.

FDA Grants Fast Track Designation to Q32 Bio Treatment for Alopecia Areata

INTERPHEX Tariff Roundup

® Group was busy networking with industry leaders at INTERPHEX 2025 in New York City on April 2, United States President Donald Trump scheduled the announcement of what he called “Liberation Day” with a 10% baseline tariff on imported goods from most other countries in the world, effective April 5 (1).

One week later, in the early morning hours of April 9, Trump went ahead with levying reciprocal taxes on countries the president had felt engaged in unfair trading practices, 

 (1). Those tariffs were what, later that day, Trump then selected for a 90-day pause that briefly sent a boomerang through US and worldwide stock markets, which were sent reeling.

With news breaking in the middle of the three-day INTERPHEX conference, a prompt posed by PharmTech Group to several of its interviewees at the conference ran the risk of becoming quickly obsolete: If this may apply to your company, give us your thoughts on the current tariffs being enacted by the US and the reshoring expectations relative to this change in policy, and how you believe this may impact you or the industry.

While some of the interview subjects politely declined the question, several attacked it head-on and laid out their companies’ plans for both the short and long term.

Click the video above to view a compilation of those responses.

 for complete coverage of INTERPHEX 2025.

1. Wiseman, P. and Rugaber, C. Another U-Turn: Trump Reverses Tariffs That Caused Market Meltdown, But Companies Remain Bewildered. 

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Even with, or perhaps because of, the rapidity with which changes in United States policy are developing, many in the bio/pharmaceutical industry are taking a longer view.

PharmTech News

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Tariff Pause Reinforces Uncertainty Among Biopharma Professionals

INTERPHEX Interview with Todd Andrews

When single-use technologies began to be adopted, the attitude in the bio/pharmaceutical industry was a “wild wild West,” says Todd Andrews, global director of Applications and Business Development for CPC’s Biopharma business. Andrews spoke exclusively with 

® Group at INTERPHEX 2025 in New York City.

Andrews is also secretary of the executive board of directors of the Bio-Process Systems Alliance, and in that capacity, he said one current priority is keeping abreast of new and changing regulations regarding single-use technologies, which are evolving in a similar fashion to those concerning per- and polyfluoroalkyl substances, or PFAS.

Being able to customize services and offerings for individual customers is another important touchstone, according to Andrews.

“What we're seeing now is a lot of forward-thinking end users trying to break up—we call it ‘break up the octopus’,” Andrews says in the interview. “Instead of this giant tubing assembly, how do you break it up into the common subassemblies? And you almost can treat it like a Lego, where you may have a ‘T’ or a cross and you can basically customize at the point of use, instead of customizing with the OEM [original equipment manufacturer]. And if you're an OEM supplying this, this adds a lot more efficiency, because now, instead of making lower volumes of multiple part numbers, you can make higher volumes of lower part numbers.”

The 2025 edition of INTERPHEX took place from April 1–3, 2025 in New York City.

Click the video above to watch the full interview.

Todd Andrews, Global Director, Applications and Business Development, CPC

Todd Andrews is global director—Applications and Business Development for CPC's Biopharma business. For more than 20 years, he has focused on single-use connection technology development and integration into the bioprocessing industry, in addition to the emerging cell and gene therapy markets. With a Bachelor of Science degree in plastics engineering and a Master of Business Administration, Andrews has held roles in design engineering, product management, business development, and sales. Andrews also currently serves as secretary on the Bio-Process Systems Alliance (BPSA) executive board of directors.

As single use becomes more prevalent, end users are looking for more customization, and regulators are refining their rules, says Todd Andrews of CPC in an interview with Pharmaceutical Technology® Group.

INTERPHEX 2025: ‘Breaking Up the Octopus’ of Single-Use Systems

Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments, in an interview with Pharmaceutical Technology®.

Industry Outlook 2025: US Political Motivations and Legislative Discussions

According to Miguel Forte, president of International Society for Cell & Gene Therapy (ISCT), board member of Alliance for Regenerative Medicine, and CEO of Kiji Therapeutics, there are two aspects to consider when assessing the potential impact on industry of the new administration in the United States. “One is a conservative attitude to business, which I think might have some potential positive impact. That's good [because it] will support the economy and give a certain confidence to investment,” he says.

Additionally, Forte specifies that the leadership must impact business positively while also managing to make careful decisions around technological aspects of the industry, allowing organizations, such as FDA, the ability to perform their jobs. “I would also want to see that public health and product considerations are done the right way,” he adds.

A legislative change in the US that will more than likely have an impact on the bio/pharma industry is the introduction of the BIOSECURE Act, which was passed in September 2024. “I can understand some political motivations on how to manage the flow of the data [in relation to the BIOSECURE Act],” Forte says. “Some companies may get impacted, not only the ones that are directly targeted by the BIOSECURE Act, but also the ones that had deals and partnerships and collaborations with those companies, they will have to readjust their businesses again.”

Looking at industry regulations in more detail, Forte specifies that FDA has been keen on engaging in discussions about cell and gene therapy and becoming more comfortable with these novel modalities. “I believe that regulators [are] in a much better position today to make the right decisions and support the field in terms of the development [of cell and gene therapies], and that will translate in legislation, for sure, as well,” he adds. “I think, from a new technology point of view, we saw some good decisions in terms of reimbursement into the US recently, which I think is a good signal to the field.”

Regulatory Oversight and Compliance

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