Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Felicity Thomas

In this exclusive Drug Digest video interview John McQuaid from Almac Pharma Services and Sridevi Khambhampaty from Shilpa Biologics delve into the evolution of the bio/pharma outsourcing market and look at how service-providers’ strategies have adapted to meet demand. 

Strategic Partnerships 

In this exclusive Drug Digest video interview, Felicity Thomas, Associate Editorial Director, 

Group, interviews experts about strategic partnerships in the bio/pharma industry. During the discussion, various experts will detail how the bio/pharma outsourcing market has evolved, how service providers have adapted to meet the shifting industry demands, the benefit of ‘integrated services’ and the potential challenge to providing such services while also being flexible, and potential trends that may shape the outsourcing market in the coming years.

John McQuaid, President & Managing Director, Almac Pharma Services

John first joined Almac Group in 1994 and has held a number of management roles during his tenure. In 2011 he was appointed to Vice President of Technical Operations within Almac Pharma Services where he was responsible for overseeing the strategic growth and development of the Pharmaceutical Development & Manufacturing service offering.

John, who holds a BSc Honours degree, was promoted to President and Managing Director, Almac Pharma Services, in 2022 and is responsible for the strategic, financial and operational leadership of global business. He has extensive product development, quality assurance and validation experience with direct experience of hosting product pre-approval inspections by multiple regulatory authorities.nt. Dr. Kane received his Bachelors, Masters and PhD degrees from the Bombay College of Pharmacy, University of Bombay, India, and served as a post-doctoral fellow at the School of Pharmacy, University of Cincinnati, Ohio. He has also earned an executive MBA from Richard Ivey School of Business, University of Western Ontario, Canada. Dr. Kane is a member of various international pharmaceutical professional organizations and is often asked to speak about scientific topics on formulation, technology and other technical aspects at major industry events. He has also published many articles in international journals and delivered many talks at meetings and conferences across the globe.

Sridevi Khambhampaty, CEO at Shilpa Biologics

Dr. Sridevi Khambhampaty is presently the CEO of Shilpa Biologics. She has an impressive 20 plus-year career in the biopharmaceutical and biotechnology sector. Dr. Sridevi has a PhD from NCBS-TIFR Bangalore, and after completing a postdoctoral fellowship at Stanford University, California, she has served in various leadership roles in at Syngene International, Intas Pharmaceuticals and Dr. Reddy’s Laboratories, prior to her present assignment at Shilpa Biologics.

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.

Innovations in Biopharmaceutical Development

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Drug Digest: Strategic Partnerships 

Ask the Expert: Product Inspection, Part Two

In this episode of Ask the Expert, Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, addresses the benefits of automating visual inspection, which include increased efficiency and accuracy, and what goes into the cost versus benefit of automating inspection of small batches.

“[T] he decision to continue manual inspection for small batch sizes involves several considerations,” says Margosch. “So, costs versus benefit, automated inspection systems can still have high upfront costs for small batch sizes. The return on investment maps may still not justify the expenses if the volume does not vary in automation. [One should] evaluate the cost effectiveness of automating small batches versus manual inspection, [and] if possible, conduct a pilot test for automated inspection on the product to evaluate its principal effectiveness and efficiency before fully committing to automation.”

In this episode, Margosch also discusses how cold chain requirements can be maintained during visual inspection. “Maintaining the cold chain for parameters is critical to ensure product stability, especially when visual inspections [that are] typically performed at room temperature,” says Margosch. “Several strategies are available to assure that the cold chain is maintained during inspection, so [one should] develop comprehensive standard operation procedures that outline the processes for handling, storing, transport, and visual inspection that all require cold chain management, include specific protocols for the transfer of products from cold storage to room temperature. [One should] ensure that these procedures are followed and documented. [One should] consistently implement a robust temperature monitoring and alert system for the entire cold chain, that means for both refrigerated transport and cold storage itself, but ensure also a temperature-controlled and monitored transport from cold storage to room temperature all the way … inside the inspection rooms and back, and very important, limit the duration that products are exposed to room temperature during the inspection processes.”

Click the video above to watch Dr. Margosch answer the following questions:

“My company is looking to move from a manual to a fully automated final product inspection method. However, although we manufacture mostly large batch sizes of product, some of our clients require small batch size production for some of their products. Should we continue to inspect those products manually?”

“My company is looking to develop a product that needs to be stored at a cool temperature. How can we assure the regulators that the cold chain is maintained during visual inspection?”

Dirk Margosch is Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG. Since joining Vetter in 2008 as head of automated visual inspection, Margosch has promoted to managing the visual inspection department and, from 2021, overseeing all non-aseptic production, including assembly and secondary packaging.

Margosch joined Vetter in 2008 as head of production overseeing process implementation, product-specific qualification and operation of automated visual inspection systems, until he was given the opportunity to manage the entire visual inspection department including both, manual and automated visual inspection. Since 2021, he has been responsible for non-aseptic production, which encompasses automated and manual visual inspection, assembly, and secondary packaging.

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This new video series will expand on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to 

, and it may appear in a future episode or print column.

Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, provides advice on final product inspection for small batch sizes. He also discusses how to maintain cold chain during visual inspection. 

Ask the Expert: Product Inspection, Part Two; Automated Product Inspection and Cold Chain Considerations

In an interview with Pharmaceutical Technology®, Michelle Bridenbaker from Unbiased Science discusses her thoughts on the key industry from 2024 and those she anticipates will impact the industry in 2025 and beyond.

Industry Outlook 2025: Continuing Innovation 

Looking at 2024, Michelle Bridenbaker, COO of Unbiased Science—a health science communications company—believes the most noteworthy trend shaping the bio/pharma industry has been the level of innovation that has been seen. “The first area that I really see that has been consequential has been the advances we’ve made in kind of personalizing medicine,” she says. “So, this is everything from our ability to do DNA sequencing, to RNA technology, CRISPR [clustered regularly interspaced short palindromic repeats], even things that are more lab and bench work in organoids.”

Of course, adding to this trend is artificial intelligence (AI), Bridenbaker continues, which is allowing for greater analysis of data. “There’s no question that AI is also impacting [personalized medicine], because we’re catching patients [that we previously missed],” she asserts. “I work in the rare disease space, and we missed patients before, but now, we can use AI to look at data that already exists and pick out that one patient that we may not have caught before, that needle in the haystack.”

Moving into 2025 and beyond, Bridenbaker anticipates a continuation in innovation and use of AI. “In 2025 and beyond, I really feel that we are going to have to spend a lot of time educating and upskilling our workforce,” she stresses. “And I think this is sometimes underestimated. It's like, the technology is great and it's wonderful, we're implementing it, but I think as well, we have to make sure we have the requisite skills to be able to keep up with the technology.”

Michelle Bridenbaker, BSN, MBA, MS, COO of Unbiased Science.

Michelle Bridenbaker, BSN, MBA, MS, is COO of Unbiased Science—a health science communications company. She is also the Vice-President of the Medical Information Leaders in Europe, and she heads up the Global Medical Information and Communications function at Recordati Rare Diseases. Michelle has approximately 20 years’ experience within industry, working across a variety of roles. Most recently, she has been involved in trying to help shape the future and strategy for the pharmaceutical industry to be more effective communicators.

Pharmaceutical Technology® sits down with Henny Zijlstra from Adragos Pharma to chat about the trends affecting the outsourcing market, various strategies being employed by service providers, and the value of end-to-end services.

DCAT Week 2025: Gaining End-to-End Clarity

Looking at the outsourcing market more from the customer side, Henny Zijlstra, chief commercial officer for Adragos Pharma, specifies that a key trend is onshoring. European companies are shying away from Asia and India more so and are preferentially looking for goods and services based with Europe instead, she explains. In addition to onshoring, the geopolitical situation is high on the agenda, leading to more companies looking at outsourcing manufacturing in Europe versus the United States, she adds.

“I don't believe that [customer] demands have [necessarily] increased or changed,” Zijlstra continues. “I think it's more the service levels that [customers are] looking for which are different.” For service-providers, being customer focused is key, she remarks, making sure the customer is prioritized and have full transparency during their development project.

“In general, we've seen that it's not only Big Pharma looking for outsourcing [partners anymore],” Zijlstra says. “The biotechs [also] need these service levels, and they need the help to make sure that they actually get to the next phase of their development, to either secure their funding or to actually get to the patients faster. So, from that perspective, an end-to-end service, gives you the clarity.”

Henny Zijlstra, Chief Commercial Officer of Adragos Pharma

Henny Zijlstra, Chief Commercial Officer (CCO) of Adragos Pharma, is a strategic and customer-focused leader with a Master’s in Business and a robust background in International Business. With nearly 18 years of experience in the pharmaceutical industry, she began her career in business development, sales, and product management before rising to management and more commercially focused roles.
Her career includes significant roles in sales, product management, and global business development at renowned companies such as DSM, Lonza, and Hetero Europe. Passionate about challenging conventions, Henny consistently pushes boundaries to develop forward-thinking strategies that drive growth and transformation.
As CCO, Henny leads with a compelling vision, instilling a customer-centric mindset across the organization. Her commitment to excellence and industry progress fuels Adragos Pharma’s mission to deliver impactful innovations.

In an interview with Pharmaceutical Technology®, Tore Bergsteiner from MAIN5 details his predictions for how the mega trends will shape the bio/pharma industry in 2025 and beyond.

Industry Outlook 2025: A Busy Time Ahead

According to Tore Bergsteiner, managing partner at MAIN5, a European consulting firm specializing in digitally enabled change for life sciences R&D organizations, the mega trends from 2024, such as the digital transformation, supply chain globalization, and regulatory reforms, will continue to keep the industry busy in 2025. Industry hasn’t quite matured enough yet, he stresses, and is still getting to grips with how each of the mega trends will have an impact in the future.

“Breaking it down into operations, AI [artificial intelligence]-driven drug discovery or development will be tremendously accelerated and [enable the] identification of potential new drug candidates by analyzing vast amount of data sets, predicting drug efficacy, and optimizing clinical trial designs,” Bergsteiner says. “This approach [will] reduce time and costs associated with traditional drug development.”

There have already been successes with AI-approaches seen in the field of personalized drugs, Bergsteiner adds. “The human metabolism is so different between patients,” he explains, “but AI enables us to develop treatments tailored to individual genetic profiles, improving therapeutic efficiency, efficacy, [and] reducing adverse reactions.”

Tore Bergsteiner, Managing Partner at MAIN5

Tore Bergsteiner is Managing Partner at MAIN5, a European consulting firm specializing in digitally enabled change for life sciences R&D organizations. Tore has approximately 30 years of experience in industry and has been a pioneering influence in the field of electronic regulatory submissions and within the management and publishing servicing industry. He previously worked for EXTEDO GmbH, a leading international product vendor of electronic approval systems for publicly owned and private pharmaceutical industry, and IABG GmbH, a major German technology and operating company. Tore graduated in Computer Sciences in 1996 and studied at the University of Bremen, Germany, the University of Texas, Austin, USA, and the Julius Maximilian University of Würzburg, Germany.

Pharmaceutical Technology® discusses the quality and compliance issues surrounding the use of animal-derived ingredients in the bio/pharma industry with Roger Viney, chief commercial officer of ICE Pharma.

DCAT Week 2025: Quality and Compliance for Animal-derived Products

“There are two main differences in terms of quality and compliance that you have to take into account when you're handling animal-derived products,” explains Roger Viney, chief commercial officer of ICE Pharma. “The first is to have steps in your process that ensure biological inactivation, whether it's of course, removal of bacteria, denaturing of DNA, and particularly viral inactivation.”

Secondly, Viney adds that traceability is important: Knowing the exact origin of the animal-derived material means that should there be any issues in a particular country or with a particular disease, it is easy to identify and segregate the material that will be affected, he remarks.

Looking at regulatory requirements, Viney points out that harmonization is critical and allows for increased security of supply. Furthermore, offering fully integrated services is an added benefit for customers as it provides them with the confidence in traceability of the products, he specifies.

 spoke with Viney about the utility of bile acids as excipients to help improve solubility and bioavailability. The interview can be viewed by following the link below:

https://www.pharmtech.com/view/improving-solubility-and-bioavailability-with-bile-acids

Roger Viney, PhD, is the chief commercial officer for ICE Pharma and is responsible for the global commercial functions. Roger has a 30-year career, starting in R&D and then moving across to sales, marketing, key account management, and business and product management for the pharma market.

Felicity Thomas

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