Dr Nonye Onyewuenyi, a pharmaceutical chemist, with over 15 years’ experience within the pharmaceutical and radiopharmaceutical industries, is an associate director and global programme technical project leader at Sandoz-Novartis (New Jersey, US), with expertise in drug product development. In this e-mail interview with TEMITOPE OBAYENDO, she discusses solutions to the perennial problem of substandard and counterfeit drugs in Nigeria, saying there are more than 40 technologies worldwide that can aid in the detection of falsified drugs. She also dissects other key issues in the pharmaceutical industry that require attention, such as high rates of employees turnover and capacity building. Excerpts:
Please, tell us a little about yourself.
My career and life experiences span across what I call the global north and global south, which include the United States, Australia and Nigeria, among others. I have over 15 years of experience within the pharmaceutical and radiopharmaceutical industries, including Australian Nuclear Science & Technology Organisation (ANSTO), Johnson & Johnson, Mallinckrodt Pharmaceuticals, and for the last four-and-a- half years, Sandoz-Novartis.
I have worked with brand and generic organisations for the development of new drugs, both small drug-like molecules and larger protein biologics. Pre-formulation activities, including method development and validation and design of enabled controlled-/ modified release formulations for complex drug products with enhanced bioavailability, were critical for successful submissions with the US FDA of both New Drug Applications (NDA) and Abbreviated NDAs (ANDA) drug products.
I obtained my BSc, MSc and PhD in Chemistry from the University of New South Wales, Sydney, Australia. I also obtained B.Sc. Ed (Chemistry) from Ahmadu Bello University (ABU) Zaria and Masters in Personnel Management from the University of Lagos. I was granted adjunct professorship (on hold) at the New Jersey Institute of Technology, Newark, USA, and University of Missouri, School of Pharmacy (UMKC), USA, for graduate students.
I was the director, Women in Science (WIS), Healthcare Businesswomen Association (HBA), St Louis Chapter, Missouri, USA (2008-2010); board member for the Women Chemists Committee (WCC) of the American Chemical Society (2013 – 2015), and the Nigerian Association of Pharmacists & Pharmaceutical Scientists in the Americas (NAPPSA) (2011- present)
In addition, I was the general secretary for NAPPSA from 2013 to 2019. I also served as the Chair of the Women in Science in Mallinckrodt (WISIM), and have been a member of the American Association of Pharmaceutical Scientists (AAPS) since 2002.
I have over 40 publications, with patents/applications; as well as over 25 invited presentations and meeting presentations. I also co-edited a book, titled “Methodologies for Complex Modified-Release Pharmaceutical Dosage Forms”.
One of the major issues rocking the Nigerian pharmaceutical industry is circulation of fake and substandard medicines. As a quality control expert, which technologies would you recommend to curb this?
In my first experience in the pharmaceutical industry as a quality control chemist for a French-American pharmaceutical company in Sydney, Australia, I was not only charged with developing and validating robust and effective analytical methods, and training new chemists, I was responsible for ensuring that the diverse raw materials and pharmaceutical finished products (tablets, capsules, suspensions, etc.) met the specification and guidelines as provided by Australian regulatory authorities. With this background, I built and developed the skill and skill sets of applying acceptable and best-in-class techniques and technologies for analysing drug products.
According to WHO’s evaluation of six African countries in 2011, they confirmed that Nigeria came last by a long shot. As a result, Nigeria launched an impressive search and methodology for counter-offensive against fake drugs. Patrick Egwu (in “This is Africa, Politics & Society” 2017), noted that Nigeria, “…by utilising a range of technologies…” sought innovation and became one – an innovator.
However, more than 40 technologies worldwide have been identified that can aid in the detection of sub-standard and falsified drugs. These technologies range from simple checklists for evaluating packaging, to complex analytical chemistry for fingerprinting the source of a falsified drug. There are critical factors such as cost, size of organisation that must be considered before choosing appropriate technology for detecting these counterfeit and sub-standard drugs.
Different conditions and availability of funds determine technology selection criteria, e.g.
Purpose of the test: They include testing site and the purpose for testing. Factors related to the testing site include whether there is a consistent electrical supply, what level of training the staff have, and if the purpose of the testing is either screening or confirmation. There are many other handheld technologies, such as the Radio Frequency Identification (RFID) system, Black Eye, and TruScan, etc.
Regulatory authorities: For importers of drugs, regulatory bodies (e.g. NAFDAC) and others involved in pharmaceutical supply chains that would like to ensure that large batches of medicine are genuine, devices such as the CD3, Raman and NIR can be used.
For Patients and healthcare workers: To ensure that the drugs given to patients are genuine, they use technologies for visual inspection approaches such as the WHO checklist as a useful first step. However, this is not sufficient to identify falsified and substandard products.
Other technologies which include paper chromatography, PharmaCheck, and GPHF-MiniLab may be required. These technologies allow clinicians to distinguish between drug resistance and treatment failure due to the organism or treatment failure due to a falsified or substandard drug.
For these settings, cheap, highly feasible tests that require little training and supplies are essential.
National reference laboratories: Highly sensitive technologies such as DART or DESI, HPLC-MS and GC-MS, nanotechnology, gas chromatography, flame ionisation detector (FID) Anion-exchange chromatography, NMR Spectroscopy, etc. are best suited for national reference laboratories for confirmation testing of field-identified falsified and substandard drugs.
These highly sensitive technologies such as HPLC-MS, NMR Spectroscopy, Capillary Electrophoresis, CE-MS, etc. can be a major initiative for the federal government of Nigeria.
It has been observed that scientists in developed climes obtain their drug development ideas from research, which is usually built upon until the manufacturing of the product. This seems not to be so in Nigeria, as there exists a wide gap between research and drug development. What is your opinion on this?
Generally, a pharmaceutical company’s vision is dependent on the area of unmet medical needs they would want to focus on, as well as if they want to play in the generic market or innovator (brand). As I stated earlier, success in initiating pharmaceutical development has to be encouraged from three main initiatives – academic, government and the private sectors.
In my personal experience, and from my perspective, collaboration between the universities and the industry helps in initiating reasonable and profitable research. This was exemplified during my undergraduate studies at the University of New South Wales, Sydney, Australia, where one of my early student projects was to develop a methodology and project plan entailing how to determine oxalates in urine. This analysis of oxalates in urine not only spiked my heightened interest in the medical area/medicine, it launched me into being recruited to work in the pharmaceutical industry.
Another collaboration with a major instrumentation organisation, Agilent Technologies, created a research opportunity for the industry in collaboration with the university. In this research, I undertook a lot of synthesis of sensitive polymers, and ultimately developed optical sensors for the determination of heavy metals, both in environmental and biological samples. The instrumentation was used for preliminary screening of the interactions between the chelating agents and the heavy metals of interest.
Furthermore, this created a Nuclear Magnetic Resonance (NMR) research opportunity in my doctoral work. The NMR was used in the characterisation of the different polymers, sensitive polymers (chelated), including biological members, such as mutton membranes. These works (in different chapters of my doctoral thesis) created opportunities for both the university and the industry.
As a designer of different drug designs and formulations, which designs would you advocate for drug manufacturers in Nigeria?
From my perspective, it would be highly desirable for the pharmaceutical companies to engage in the development of drugs that address diseases that mainly affect developing countries (Nigeria inclusive); infectious and parasitic diseases. These diseases continue to threaten the health of millions of people throughout the world, with the major burden being in developing countries.
These include drugs for neglected diseases, such as kinetoplastid infections of human African trypanosomiasis (HAT), also called, African sleeping sickness, etc.
As a good team player, who has successfully worked with various teams, what are your advice on stemming the gross turnover rates of staff in pharmaceutical industry in Nigeria?
Among other defined and well documented tips to stem gross turnover rates, including hiring the right employees, pharmaceutical industries in Nigeria can utilise and implement the following:
Cultivate and demonstrate a respectful work environment. This is even more prominent or evident in our culture back home where respect is engrained in each tribal culture. Lack of respect is one of the key factors in employee turnover. Endeavour not to discount respect when it comes to creating a magnetic and inclusive culture. Always look for ways to cultivate and nurture respect in the pharma industry.
An inclusive environment/vision is one of the key factors in employee engagement and happiness. Offer employees in their work environment a strong sense of belonging and loyalty to your organisation. This increases employees’ sense of purpose and meaning in whatever they do at work
Clean up performance reviews, as this offers a prime opportunity for a big win to increase trust and fortify the company relationship with employees.
Keep compensation and benefits current, paying employees the fair going wage for their work (or better still), offer them competitive benefits.
Offer flexibility because today’s employees crave a flexible life/work balance. If all resources and necessary technologies are available, e.g. constant power supply, etc. every necessary tool and technique can become a constant to support the paradigm shift needed to create flexible work-life balance. Aligning the Nigerian petrochemical industry to all aspects of development in Nigeria will make a huge difference.
Recognise and reward employees. Show employees that they are valued and appreciated by offering them real-time recognition that celebrates their successes and their efforts.
Pay attention to, and build a culture of engagement in your company all year long.
Encourage pro-social behaviour in your employees. In other words, encourage a sense of generosity and gratitude in the employees. This gives the employees opportunity to connect with one another through acts of generosity and the expression of gratitude, thereby creating employees that will be healthier and happier, with a sense of ownership of the company
The global pandemic has introduced new normal operations in different fields. How has it affected you as a pharmaceutical scientist?
To me, as a pharmaceutical scientist and a programme/project manager in a major pharmaceutical company, the pandemic affected me personally and professionally enabling me to learn more about my resilience, motivation, attitude, creative thinking and innovation to ensure the project activities and deliverables are executed and goals met.
With the potential impact on application submission delay, I had to optimise how to manage the short term (e.g. transportation of clinical study materials, etc.) and long term impacts (e.g. response from the FDA, etc.).
As the PM leading key subject matter experts (SMEs) (of different backgrounds and high academic achievements) to achieve an actionable outcome, I learnt to create comprehensive contingency plans that can help manage new and evolving risks. In addition, I honed in on my disciplined agility and upskilling to learn new collaborative approaches to lead a virtual meeting setting (using MS Team, Webex, Zoom, Skype, Retro Tool) and other collaboration tools. The agile practices have become increasingly commonplace for me and in the industry.
Drug development and manufacturing is your core area of practice, could you share with us crucial factors that enhance a successful process of drug development?
As a project leader, I know that driving a drug product to the market safely, quickly, and cheaply is the best way for a pharmaceutical company to be successful. Drug development and manufacturing process is very complex, and faces enormous challenges, including risk management during the long product-development process. And with today’s fast-paced competition, drug development requires efficiency in all aspects of business.
The identification of risks at the right stage and an effective mitigation plan are key factors for success, both financially and technically. The complex drug-development process from lab to launch includes management of several business processes, such as technical development, using Quality by Design (QbD) regulatory strategy, clinical studies, and supply chain, as well as managing people (internal project team members and external partners).
These processes are affected not only by many circumstantial factors but also by each other. Managing these processes / factors and the interaction between them is effectively driven by project management (PjM) of these strategies and/or factors.
Simply put, PjM is the management of people, activities, time, and money toward the successful completion of a stated goal. And it is highly imperative in the complex world of pharmaceutical development {with all the circumstantial factors and its needed subject matter experts (SMEs) to have a single point person responsible for ensuring that all the pieces of a project come together efficiently, effectively, and on schedule.
A single point of project contact, an experienced pharmaceutical scientist as a project manager, must be focused on making the project successful, with the awareness of the organisation’s strategic goals, ensuring the role of the following is implemented in the project, viz. role of the project manager (PM), stakeholders, team communication, and business processes.
