To lead a fulfilling life, we need to stay healthy. Only then can we enjoy the rains and the sunshine that life has to offer. To stay healthy, apart from a healthy lifestyle, we do need an occasional administration of medicines or drugs that help us ward off or recuperate from sickness. Developing these drugs to effectively help us stay fit is an ardent and very critical task. A medicine, to be effective, needs to have a precise composition of its elements so that it produces the desired effect and causes no harm or side effects. To ensure the same several branches of science, bioanalysis or bioanalytics being one of them, come together to help develop the perfect drug.
Bioanalysis and Analytical testing has emerged as a critical tool for drug discovery and development. Pharmaceutical Companies have to perform a battery of tests to ensure product quality, safety, efficacy, purity and stability through qualitative and quantitative characterization of their compounds. With the rising emphasis on the use of pharmacokinetic(PK)/toxicokinetics(TK) and the greater potencies of newer drugs, a sensitive and specific bioanalytical technique is essential. Fasced with these challenges, drug developers are turning to expert service providers like CMIC, Inc. (formerly JCL Bioassay USA), which has the capability, capacity and flexibility to handle bioanalytical testing in a new era of drug development.
Located in Hoffman Estates, IL CMIC is a leading Contract Research Organization(CRO) that provides cutting-edge capabilities and sophisticated expertise in bioanalytical method development, method validation/qualification and study sample analysis for small and large molecules. As a strategic drug development partner, CMIC helps sponsors to overcome challenges in bioanalysis with expertise, rapid turn-around-time, and high-quality services. CMIC Group started as a company assisting in the development of pharmaceuticals, and it now offers greatly expanded services that encompass an entire value-chain of pharmaceutical companies, including manufacturing, sales, and marketing, based on its unique “Pharmaceutical Value Creator” (PVC) business model. It now has over 30 years of experience and a reputation for excellence and a strong commitment to helping improve lives around the world. It also offers services to medical device manufacturers, academia, bio-ventures, and medical institutions. It provides prophylaxis and health-enhancing services to the public.
An Accountable Leader
The criticality of CMIC’s work needs someone at the helm who understands the complete process like the back of their hand. Someone who is experienced, has extensive knowledge about the field, knows inside out on how to build a quality system and chain and is a responsible person. Jenny Lin, COO and Board Member is an amalgamation of all these factors and more. Jenny joined CMIC in 2009 and since then has been a voice to reckon with. She has more than 25 years of experience in executive/lab management, bioanalytical and analytical laboratory operations in support of drug research and discovery, and pre-clinical and clinical drug development. She also oversees general operations of Business Development, IT, QA, Safety and financial operations of the company.
Tracing Jenny’s Growth
Jenny began her career in a contract research laboratory at MediChem Research, Inc where she worked in various managerial positions in Chromatography groups and analytical chemistry teams. Moving on she found herself spending 11 years at deCODE Chemistry as Director and then, Vice President of Analytical Chemistry. Jenny directly participated in analytical and bioanalytical development for numerous pre-clinical and clinical trials in support of IND/NDA filings.
Apart from her corporate responsibilities, Jenny has authored and co-authored more than 30 publications, white papers, and presentations for international conferences. She is also the inventor of 7 issued US patents. Jenny earned her BS in Analytical Chemistry at Peking University and her MS in Medicinal Chemistry at the University of Connecticut. She continues to grow her knowledge and is working toward a Master of Business Administration. Jenny is a member of the American Society of Mass Spectrometry (ASMS), American Association of Pharmaceutical Scientists (AAPS), American Chemical Society (ACS), National Association of Professional Woman (NAPW) and Global CRO Council (GCC).
Catching up with the Trend
With each progressive year, there has been a marked shift in research and development(R&D) pipelines, from traditional small-molecule drug candidates towards biologics, oglio-nucleotide-based therapies, PD biomarkers, and other novel compounds that typically combine increased structural complexity with greater susceptibility to disruption and contamination during the developmental process. “It’s a significant trend,” says Jenny.“We have been working with many pharmaceutical and biotech companies and have experienced this shift in development needs first-hand.”
In the last few years, Lin continues, “we have noticed a lot more clients wanting, for example, antisense oligonucleotide drug-development work done, rather than classic small-molecule therapeutic development. And particularly in most recent years, the significant role that biomarkers play in drug safety and efficacy evaluation is becoming more and more apparent.” The fast-growing influence of biomarkers in steering drug development has evolved in parallel to increasing molecular complexity. With margins under pressure, companies are looking to instill more precision and efficiency into their target-identification and translational-medicine activities.
“Most of the pharmaceutical companies are looking at exploratory biomarkers that could direct and correlate drug research and development programs,” Lin elaborates.
The current focus on more productive, better differentiated drug-development programs, and the need for cutting-edge analytical/bioanalytical testing that informs and supports those programs, also reflects the commercial realities of a marketplace in which many conventional large-volume blockbusters are genericized or marginalized, and demand for value extends far beyond innovation for its own sake.
As drug-development pipelines have adapted to these changing circumstances, they have created new challenges and expectations for bioanalytical testing of experimental medicines.Product complexity has also spawned new instrument platforms and assays that demand advanced technical know-how. “Even from the regulatory point of view, there are many unknown factors and requirements that come as a big challenge to the industry,” Lin comments. One way in which CMIC stays abreast of these developments is by participating in leading CRO consortia such as the Global CRO Council (GCC), where “we closely interface with our peers in the industry and closely monitor regulatory changes”, she says.
The company is also an early adopter of new technologies, working hand in hand with its sponsors to develop in-house expertise that addresses emerging needs at different stages of drug research and development. “For example, we are established leaders at providing bioanalytical testing for oligonucleotides,” Jenny explains. “We have supported numerous development programs, including the top oligonucleotide developers in the US. Seeing all the different phases of oligonucleotide development, experiencing different oligonucletide strategies, tackling different issues in the lab, we have built a very strong technology platform and know-how.” This breadth of experience has enabled a specialist provider such as CMIC to move beyond traditional CRO services and into more of a consultancy role in bioanalytical testing, Jenny adds. “We can help them look into certain issues propose some solutions and provide some resolution to drug-development programs relating to bioanalytical challenges.”
Looking Forward to Growth
CMIC has responded to the growing demand for analytical/bioanalytical-testing partners capable of handling complex new drug candidates by investing significantly to expand, deepen and diversify its capabilities, technologies, infrastructure and human resources in the field.
It now offers a comprehensive suite of safety evaluation, bioanalysis, chemistry, manufacturing and control, and biomarker testing services from facilities in Japan, the US and China, with particular expertise in fast-emerging areas such as oligonucleotide analysis and exploratory biomarkers.
As of 30 January 2018, CMIC had either completed or was actively handling 77 oligonucleotide-analysis projects. Its biomarker-analysis capabilities run all the way from identifying and optimizing drug targets to PK/PD studies, proof-of-concept testing, patient stratification, target validation and post-approval safety testing.
With many diseases still sorely lacking optimal therapeutic options, if indeed any therapeutic options, the shift towards more complex drug candidates is likely to continue unabated. That will put even more pressure on analytical-services providers to keep pace with innovation. With its mixture of innovation and experience, breadth of services and highly specialized capabilities, flexibility and stability, CMIC is determined to stay ahead of the curve.
As a prominent woman leader, Jenny shares that the most prominent challenge for women in the business world is balancing business and family life. She believes that the dual responsibly towards business and family, and finding ways to devote time to both can be challenging at times. However, she does think that the culture of work is shifting to allow women more flexibility, which is a welcoming change.
As a leader, Jenny encourages women to take up more of leadership positions. She emphasizes the importance of continuous learning; continual development of necessary knowledge and skills; maintaining positive attitudes and focus; valuing team success and preparing self (never a believer of glass ceiling); not being afraid to take on additional responsibilities; and conscientiousness.
To know more, please visit www.cmic-inc.com