Behind the Scenes of Pharma: People, Culture & Partnerships
Galenisys Newsletter : January 2026
Table of Contents
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TALES FROM FARAWAY PHARMA
India & an Unqualified Success
By Steve Biddulph -
SUCCESSFUL PARTNERING WITH ASIAN COMPANIES
Plenty of due diligence necessary
By Richard van Duyse -
PHARMA FASHION
Where will the GLP 1s take us
By The Editor -
THE FAMILY ENVIRONMENT
Christmas in the WFI system
By Steve Biddulph
INDIA & AN UNQUALIFIED SUCCESS
by Steve Biddulph
Fellow of Royal Society of Biology. Board level pharma experience. QSM and Aseptic Manufacturing & Control Expertise. Galenisys Managing Director.
Continuing Tales from Faraway Pharma Steve remembers ... the Indian Seminar
Many years ago, we decided that instead of bringing everyone to headquarters to present the annual objectives for Quality and Compliance, we would organise Quality Seminars around the world in various locations so that people would not spend too much time travelling. We had these week long seminars in Latin America, Europe and Asia.
The one in Asia was held in India and the Indian affiliate did a great job in getting it organised and ensuring that people were picked up from the local airport and transported to the hotel where the seminar was to take place.
On the first morning, local TV cameras were in place and members of our company’s team were being interviewed on the seminar’s objectives and organisation. Before the seminar began there was a ceremony in which the members of the Seminar Committee were asked to light one of the candles that surrounded the figure of Ganesh (the chap in the picture) to ensure the success of the seminar. This was all unexpected and we the visitors had not been briefed on the process in advance.
Each person solemnly lit his candle and handed the lighted taper to the next person. All was going well until one visitor, unfortunately a guy from process development, tried to light his candle. But the taper went out, so he tried to relight it from the previous burning candle but unfortunately extinguished that one also. He then tried again to light it from three other candles but only succeeded in putting them out as well.
Before he could put out a fifth candle, our Indian hosts intervened and provided a new lighted taper. Given the evident lack of technology transfer, they then lit all of the remaining candles themselves.
Despite the candle issue, Ganesh smiled on the seminar, and it was an Unqualified success.
HAPPY NEW YEAR !
SUCCESSFUL PARTNERING WITH ASIAN COMPANIES
Plenty of due diligence
By Richard van Duyse
Experienced international vaccine industry consultant. Specialized in project & operational management, facility design, start-ups, & technology transfers. Bachelor of Applied Science (B.Sc.).
In this article I’m looking at how to be successful when working with Asian pharmaceutical partners. Such collaboration offers significant opportunities.
When partnering with Asian companies these are 5 key requirements for success:
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Regulatory alignment: Ensure there is compliance with both international, and local regulations. This includes GMP standards, validation requirements, and documentation practices. Check audit preparedness.
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Quality and reliability: Clients expect consistent product quality, robust quality systems, and reliable supply performance, even after changes & post approval variations, & regardless of geographic distance. Iron out problems arising from variations in quality culture and risk tolerance in advance.
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Communication and coordination: Clear, structured communication across time zones and cultures is essential. This includes regular meetings including skilled language staff, well-defined escalation paths, and transparent reporting.
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Supply chain and logistics management: Look for management resources & experience regarding lead times, cold-chain requirements, import/export regulations, and risk mitigation to ensure uninterrupted supply.
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Cultural and business understanding: The client needs awareness of cultural norms, decision-making styles, and business expectations. This builds essential long-term partnerships and avoids misunderstandings.
In my experience working with vaccine companies or Technology Transfer (“TT”) partners in China, India, and Japan requires a country specific rather than a one-size-fits-all approach. Particular challenges in each territory are:
China
• Regulatory complexity and change: China’s regulatory environment evolves rapidly. Requirements, timelines, data integrity and interpretations may change with limited notice.
• Documentation and data expectations: Detailed data packages are required but limited, & often contain local-language documentation and China-specific clinical or stability data.
• IP and confidentiality concerns: Intellectual property protection has improved but remains a key western concern, requiring strong contractual and legal safeguards.
• Communication style: Indirect communication and hierarchical decision-making can slow issue resolution if expectations are not clearly aligned upfront.
India
• Quality consistency across sites: While many companies meet global standards, variability between manufacturing sites can require increased oversight and audits. Progress on improvements can take time.
• Regulatory scrutiny from global authorities: Indian manufacturers are frequently inspected by agencies, with increasing pressure on compliance, data integrity, and current GMP.
• Infrastructure and supply risks: Power stability, logistics delays, and dependence on imported APIs can affect timelines and supply reliability.
• Cost-driven negotiations: Strong focus on price competitiveness may conflict with higher-cost compliance or quality investments.
Japan
• Highly stringent regulatory requirements: Japan’s regulator enforces rigorous standards, often exceeding those of other regions.
• Agreements: the necessity to have clear and detailed agreements on every aspect of the specification requirements, such as test methods and (product inspection) equipment / methods in particular the defects and how to categorize them.
• Language barriers: Technical documentation, quality agreements, and regulatory correspondence are commonly required in Japanese.
• Decision-making speed: Consensus-based decision processes can extend timelines, particularly for changes, deviations, or corrective actions.
• Expectation of long-term commitment: Japanese partners prioritize stability, trust, and long-term relationships over short-term commercial gains
Successful international collaboration is built on trust, transparency, and consistently high product quality - achieved despite differences in culture, regulations & business practices. Plenty of early due diligence will pay rewards.
Richard van Duyse
PHARMA FASHION
“But darling you should take my new weight loss drug - you don't lose as much muscle mass”.
The Editor
Nowadays when tuning in to Bloomberg during the market opening show, you will normally see the current share price of Eli Lilly and Novo Nordisk highlighted, such is the large market capitalisation of the two multinational companies whose weight loss injections have propelled their share price to dizzy heights in the last two years.
Novo Nordisk was first into this market - which is now the world's 3rd largest pharmaceutical market sector** by value - with Wegovy, whereas in 2025 Eli Lilly's similar GLP 1 product Zepbound has taken the lead.
Novo specialised on metabolic diseases, & focused on developing products for diabetes over decades, (eg Insulin manufacture) which led to discovery of its API semaglutide.
One reason Novo Nordisk lost its top the top spot (and its CEO) was that it failed to notice that demand for these products was consumer driven, with many patients paying directly for them. It also underestimated the huge demand. There is a sobering forecast that “by 2030 more people in the world will be overweight or obese than those who are not.”
Amongst the plethora of companies now hoping to get a slice of the action are those with development products aimed at improving the quality of treatment not just the quantity of weight lost. It’s said there are over 160 obesity drugs in development worldwide & there are many obese folk in India China & Brazil.
Pills rather than injections is one obvious goal. Novo already markets a semaglutide pill for diabetes. Both Novo and Eli Lilly are developing oral versions for weight loss, and analysts fuss about whether warnings about when to take these pills will favour one or the other.
Distribution channels are being reinvented too, and for example Novo now has deals with Costco & Walmart to sell its products. Other development products will likely claim fewer side effects, less weight gain after ending treatment, or greater reduction in fat rather than muscle. In short expect there will be a plethora of consumer sales pitches.
In a future consumer driven market, my own nightmare, after a career trying to drive costs down, is the introduction of bespoke packaging:
“Yes, madam the pink carton will match your handbag”
“These grey pills will be unremarkable at the Board Room lunch, Sir”
The Editor
** Antidiabetics & obesity sales $100 billion
THE FAMILY ENVIRONMENT
Christmas in the WFI system
Fellow of Royal Society of Biology. Board level pharma experience. QSM and Aseptic Manufacturing & Control Expertise. Galenisys Managing Director.
Christmas is a great time for the family to get together in a homely environment; and I'm lucky enough to have done the same last week. And it's just the same for fellow species on this planet of ours.
Bacteria are family loving organisms too and they are always on the lookout for a suitable environment in which they can set up home. This is all very well if you're running a mushroom farm or cultivating a vaccine in a bioreactor however it should be strictly taboo in our factories.
Us humans are, or should be, aware, that bacterial populations grow logarithmically. In our industry we (should) try very, very, hard to prevent and control microbial contamination in our utilities and manufacturing processes.
Unfortunately, even today, some pharma plants insist on providing a “Family Friendly” environment in which bacteria can proliferate. There is nowhere more suited for gram negative bacilli to grow than in water systems.
After 50+ years in the life science industries, I find it beyond belief that water systems are still being designed that ensure that bacterial populations will find that “Family Friendly” crevice or media.
Water systems with bacterial retaining filters can still be found today as can systems with plastic pipework, non-heated vent filters, dead-legs of stagnant water and depth filters, water softener resins, carbon filters and other elements that are infrequently disinfected/sanitised by ineffective methods.
Do water system suppliers not realise how to design water systems that prevent and minimise bacterial contamination?
If you are experiencing issues with your water systems or wish to install a water system, then contact Galenisys to ensure that your problems can be effectively treated.
Get a check from us that your new system will not be designed to provide a family friendly environment!
Steve Biddulph
