NEW LANDSCAPE FOR DRUGS STANDARDS

Ian Smith, Vice President of Commercial Operations for Chromatography and Mass Spectrometry Asia Pacific Thermo Fisher Scientific

Todays pharmaceutical industry continues to be highly complex with significant developments or trends worldwide that impact Asias pharmaceutical industry One of these includes drug recalls in developed countries Moving forward how can Asias pharmaceutical industry and its stakeholders collaborate to make the world healthier cleaner and safer for everyone

Over the last decade, governments have been focusing on making healthcare accessible, leading to a decrease in the prices of drugs. This “race to the bottom” has put the spotlight and pressure on the costs of drug production. Pharmaceutical companies are relooking at their processes and supply chains to find ways to be cheap and still keep up to speed with the regulations and competition in the market.

We speak with Mr. Ian Smith, Vice President of Commercial Operations for Chromatography and Mass Spectrometry for Thermo Fisher Scientific in Asia Pacific on the evolution of changes in the pharma landscape over the last 30 years. He talks about the significant trends worldwide that impact Asia’s pharmaceutical industry, with the latest focus being drug recalls in developed countries and discusses how Asia’s pharmaceutical industry and its stakeholders can collaborate to make the world healthier, cleaner and safer for everyone.

What is the landscape for today’s pharmaceutical industry?

Today’s pharma industry landscape is changing rapidly. Pharma makers need to look at increasing productivity while still delivering drugs that are effective, affordable and compliant with strict regulatory requirements.

The major pharma makers have been focusing on research and development (R&D) to deliver new drugs to the market that could be patented and bring in the revenue needed for growth. For instance, in 2018, the United States Food and Drug Administration (FDA) approved an all-time high of 59 new drug therapies. From 2011 to 2018, the FDA approved 309 drugs (an average of more than 38 per year) in the highest sustained productivity. So, we are looking at an industry that is growing and innovating.

However, the idea of innovation in the pharma landscape should not only be about breakthroughs or being ground-breaking. Innovation can be better focused on making things or processes easier, simpler, better and safer.

This type of innovation for simplicity, quality and safety involves a vital concept – the concept of connectivity, in particular, the connectivity between pharma manufacturers and their supply chains in today’s highly complex pharma industry.

This is an interesting concept. Can you share an example so as to give our readers a better idea of what this means?

An example of such connectivity is software integration in the form of Thermo Scientific™ Chromeleon™ Chromatography Data System (CDS). What we typically see is each laboratory using various brands of analytical instruments (be it for routine testing or for R&D). Imagine having a system like Chromeleon CDS where, regardless of the instrument you use, be it Thermo Fisher Scientific’s or any other brand of analytical instrument, all the information can still be integrated and accessed in one place. With its multi-vendor instrument control, Chromeleon CDS offers choice for pharma makers and stakeholders in their supply chain. Plus the ability to integrate to Laboratory Information Management Systems (LIMS) ensures a compliant, seamless flow of knowledge from the instrument to the business. This should be the type of innovation that the pharma industry strives towards as ultimately, connectivity and integration will enable innovation of better quality, safer and more effective drugs for patients.

Great example on innovation from a different perspective. Let’s go back to talking about the landscape for today’s pharma industry. Anything else you’d like to add?

Yes, let’s think about pharma growth on a worldwide scale. According to Statista, the forecast of pharma sector growth between 2017 and 2030 by country shows Asian nations such as India (growth at 232%), China (230%) and Indonesia (196%) in the top three markets of growth. In comparison, the pharma sector worldwide is expected to grow at just 160% during that period. So, we can see that Asia is a very fertile region in terms of growth.

Yes, let’s think about pharma growth on a worldwide scale. According to Statista, the forecast of pharma sector growth between 2017 and 2030 by country shows Asian nations such as India (growth at 232%), China (230%) and Indonesia (196%) in the top three markets of growth. In comparison, the pharma sector worldwide is expected to grow at just 160% during that period. So, we can see that Asia is a very fertile region in terms of growth.

If we narrow the focus to Asia’s pharmaceutical industry, what would you say are the significant developments or trends that are impacting this industry today?

The aging population across the globe is a major concern. It has been estimated that there will be 2 billion people who are 60 years or older around the world by 2050. Such an increase in the elderly means that governments must find ways to meet the increase in medical needs. As such, the world will need large quantities of drug treatments and the industry is expected to be US$1.2 trillion in size by 2024.

With the looming problem of an aging population, medicine prices need to decrease for health care to be affordable for the citizens. So the effect of low prices will impact drug makers and their investments into R&D – for instance, should they focus on breakthroughs to develop drugs that they can patent for higher profits or focus on achieving innovations within their operations to deliver high-quality yet safe and effective drugs for the mass market? These are serious considerations for the pharma makers large and small.

Any other significant trends impacting Asia’s pharmaceutical industry today?

Governmental policies and regulations are another strong industry influence. One example is China’s 4x7 project where major cities band together to purchase certain drugs. This forced drug prices to drop dramatically, impacting pharma supply chain from manufacturers to distributors, but the country will continue this policy and is working on extending this program to include more cities and drugs.

Another major trend is the drive towards traceability and authentication. On February 9, 2019, the (FDA) imposed a requirement in the Drug Supply Chain Security Act (DSCSA) to include a product identifier on prescription drug packaging for drugs coming from the European Union. This is an important step to reduce drug counterfeiting. According to reports, as much as 40% of the drugs in developing markets are counterfeit.

Yes, counterfeit drugs pose a serious health risk for patients. What can Asia’s pharma industry do about it?

For Asia’s pharma makers who are already facing price pressures on their products, the fight against fakes just add to the many challenges that they face. The pharma supply chain is so complex that it will involve cooperation of every stakeholder in the industry to work together in an interoperable and integrated framework to ensure a high level of integrity in the supply chain for the safety of patients.

Apart from counterfeits, Asia has also been impacted by recalls of drugs by the FDA. What are your comments about that?

Drug recalls have a negative impact on Asia’s drug manufacturers who will have to deal with audits, more tests as well as production downtime. Recently, on September 13, 2019, the FDA issued a statement - “some ranitidine medicines contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA).”

The European Commission (EC) issued its final legally binding decision on medicines containing valsartan, candesartan, irbesartan, losartan and olmesartan on 2 April 2019. It stated “As N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) are classified as probable human carcinogens, manufacturers must ensure that their manufacturing process does not generate such impurities and develop appropriate control strategies. To allow manufacturers to make the necessary changes to their process, a transition period has been agreed by Competent Authorities and strict temporary limits on levels of these impurities introduced in the Test section.” The EC revised the Test section with this requirement: “Nitrosamines. Carry out the test by a suitable method.” This means that manufacturers will have to test every production batch for those nitrosamine impurities.

How is Thermo Fisher Scientific helping your customers in Asia’s pharma industry deal with recalls and more stringent regulations?

At Thermo Fisher Scientific, we are constantly looking ahead and anticipating possible scenarios and situations, which allow us to develop instruments that help pharma makers get off on a clean start with their testing.

For instance, the FDA recently published its method validated to ICH Q2(R1) for detection and quantitation of NDMA in Ranitidine. This high-resolution accurate mass (HRAM) liquid chromatography mass spectrometry (LC-MS) method developed by the FDA uses our Thermo Scientific™ Q Exactive™ LC-MS/MS system. For instrument control and data processing, the Thermo Scientific™ Chromeleon™ Chromatography Data System (CDS) may be used to address the regulatory and GMP requirements asked to be fulfilled by pharma industries. Editor’s note to readers: Please download the method here - https://www.fda.gov/media/130801/download

The FDA also shared a method validated following ICH Q2(R1) for the determination of six nitrosamine impurities (NDMA, NDEA, NEIPA, NDIPA, NDBA, & NMBA) in Angiotensin Receptor Blockers (ARB) drug products including Valsartan. Thus, a single HRAM LC-MS method developed by the FDA can quantify all six nitrosamine impurities simultaneously. This method utilizes the exceptional acquisition speed, sensitivity, and resolving power of our Thermo Scientific™ Q Exactive™ HF-X LC-MS/MS system for the determination of these trace level genotoxic impurities. Editor’s note to readers: Please download the method here - https://www.fda.gov/media/125478/download

We’ve come to the close of our interview. What would you like to say to our readers in Asia’s pharma industry?

In closing, I want to reiterate that rather than risking drug recalls in the future, Asia’s pharma makers can take the bold step to collaborate with stakeholders in the supply chain in order to make the world healthier, cleaner and safer.

Coming back full circle to what I mentioned at the start, connectivity is the key to avoid costly downtime. Pharma makers should consider connectivity using solutions for instrument control and data processing. An example is Chromeleon CDS. With an integrated system, it empowers drug makers with choice and can help make the flow of information from research to routine seamless and effective. What we want to aim for is a seamless, robust flow from the Discovery stage to the Quality Control stage. If done well, we can avoid future problems of drug recalls and economic setbacks. A comprehensive and integrated solution can also help manufacturers address all the regulatory and GMP requirements asked by pharma industries.

I also want to stress the importance of collaborations involving knowledge sharing. Thermo Fisher Scientific has always been proactive in our outreach and education in Asia. We have industry forums or workshops for stakeholders to gain a better understanding of the causes of contamination, how to improve early detection and ultimately achieve better control of impurities within acceptable limits.

One example of such outreach activities is the third Annual Elemental and Genotoxic Impurities Workshop which took place in Hyderabad, India where leading global experts are gathered to focus on updates and developments in impurity-related challenges and breakthroughs, aiming to address what went wrong and how to avoid it in the future.

Ultimately, Asia’s pharma industry needs to have the framework of collaboration and information sharing to better respond to their changing landscape impacting the industry today and tomorrow.

--PFA Issue37--

Author Bio

Ian Smith

Ian Smith is Vice President of Commercial Operations for Chromatography and Mass Spectrometry for Thermo Fisher Scientific in Asia Pacific. For 30 years, Ian has held various commercial and management roles for the company. He has a Fellowship of the Institute of Biomedical Sciences.

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