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Newsletter Spring 2019 - Jennifer Zhao - Perspectives as a Kinexum Associate

Perspectives as a Kinexum Associate 

Jennifer Zhao

Associate 

I joined Kinexum in July 2018, shortly after I graduated from Dartmouth College a month before. I first learned about Kinexumfrom Zan, who reached out to meearlier that year. Drawn to the unique learning opportunities and projects I could take on using the research, writing, and communicational skills I had acquired and developed in college, I eagerly joined Kinexum as the company’s first associate.   

After nine months at Kinexum(and being in the “real world”), I’ve had the opportunity to reflect on my experiences. Here are my thoughts.   

1. Kinexum provides tremendous opportunity to learn about drug and device development from a regulatory standpoint. 

When I was in college, I studied chemistry and was involved in small molecule synthesis. I had plans to get a PharmD in the future. I had a general idea ofhow drug discovery worked from the labbench side, but I had no ideamuch less heard ofwhat an IND, NDA, or 510(k) meant. 

On my first day at Kinexum, I read the meeting information package of a client working on a pre-IND meeting submission, which felt like learning a new foreign language. I paused every few secondsto look upthe definitionsof FIH (first in human), DP (drug product), DS (drug substance), and several more, along with what the purpose of a pre-IND meeting was. I am sure the people who are reading this article will chuckle at my naivety but can relate to their first experience of plunging into the regulatory world. 

I became more familiar with work at Kinexum through rotations of different projects and observations of Kinexum’s highly seasoned professional consultants. One of my projects from a few months ago was quality control on the clinical modules of an NDA. Reviewing the data and text of hundreds of pages inevitably led me to appreciate the complexity of convincing FDA that a drug candidate was safe and effective. Another project I worked on was writing about the digital health technology landscape, specifically for diabetes. Hours of researching gave me in-depth knowledge of this burgeoning field and how regulatory agencies are approaching mobile health apps in the land of insulin pumps, artificial cardiac pacemakers, and tongue depressors. 

These examples are just a few from my time at Kinexum so far. I started with zero clinical and regulatory knowledge of drug and device development, and now I know more thanks to the unique opportunities that Kinexum has provided me. 

2. The executives at Kinexum are mentors who inspire fellow consultants to achieve professional satisfaction and growth.  

My friends are surprised to hear that I work closely with the President and CEO, as well as the Founder and Executive Chairman, of my company. My status as a college graduate working my first full-time job indeed puts myself in an unusual situation. However, I have had the special opportunity to immerse myself in the fundamentals of how Kinexum functions.   

Zan and Thomas embody the goals of Kinexum, which are to advance translational science and help clients achieve their corporate development objectives. Zan is one of the most impressive people anyone will meet, given his history as a former reviewer at FDA who approved (i.e., led the reviews that resulted in the approvals of) metformin, the first statin, insulin analogs, and more. Thomas is a highly accomplished, forward-thinking entrepreneur who has held senior leadership positions in pharmaceutical, biotech, and medical device companies for the past three decades. AlthoughZan and Thomas’s impressive histories certainly qualify them to lead a company as eminent as Kinexum, that is not the only reason. Additionally, their patience, kindness, and belief in Kinexum members to perform their best work are equally, if not more important, reasons.   

I am grateful to be constantly learning from Zan and Thomas as my mentors and have no doubt they will continue to make their marks in history and on others.   

3. Kinexum members comprise a rich and vibrant community dedicated to advancing global health. 

One of the most interesting aspects of working at Kinexum is participating in pro bono work and discovering what other consultants do outside of client work. For example, former Director of FDA's GI Division and NASH expertBrian Harvey, MD, PhD, volunteers as a veterinary husband and assistant and has cared for over 400 horses with his team in Nicaragua. Former Eli Lilly Senior Medical Fellow Michael Trautmann, MD, practiced general medicine in a health center in Nairobi, Kenya, for six weeks at the end of 2018. 

One of the largest pro bono efforts of Kinexum is the Metabesity movement. Metabesity” refers to the constellation of chronic, non-communicable diseases of aging, including diabetes, obesity, cardiovascular disease, neurodegenerative disease, cancer, and the aging process itself, that have common metabolic roots and thus may be susceptible to common solutions. Emerging science has already indicated that extending healthy lifespan can delay multiple diseases, especially when the rates of these diseases, such as cancer and Alzheimer’s disease, exponentially increase as age increases. In order to successfully target Metabesity and translate emerging science into material gains in global health, the traditional notion of diseases occurring in isolated silos must be discontinued. Additionally, multi-modal approaches, ranging from pharmacology and devices to general well-being, must be developed.   

Kinexum is spearheading efforts to start conversations on Metabesitywith leaders from a wide range of industries, including scientists, regulators, funders, and legislators. Following the inaugural MetabesityCongress that took place in London in October 2017, the next one will take place in Washington, DC, on October 15-16, 2019.   

At Kinexum, there is always something new to learn. I cannot imagine another environment where I get to participate in such interesting work as the youngest member of the company.   

Final Thoughts 

I consider myself lucky to be working at Kinexum, which has undoubtedly fostered my professional and personal growth. Working as a young associate among consultants with decades of experience at FDA, industry, and academia has been a rewarding experience.   

As I am the first associate hired at Kinexum, there will certainly be more generations of associates to follow. I highly recommend soon-to-be college graduates to contact me and learn more.