From The Editor | September 3, 2015

WIB Profile: CROs Must Have The Ability To Deliver

Source: Clinical Leader
Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

WIB Profile: CROs Must Have The Ability To Deliver

Zhaoqing (Ching) Ding has been involved with the sciences for more than 15 years. She earned a B.S. in Microbiology and a M.S. in Immunology, both from the University of California, San Diego. She then earned a Ph.D. in Immunology from the Stanford University School of Medicine before rounding out her education by attending the program in Innovation and Entrepreneurship from the Stanford University Graduate School of Business.

She began her professional career as a research intern at the La Jolla Institute for Allergy and Immunology before becoming research assistant at the Scripps Research Institute. She worked as a research associate for the University of California, San Diego and Stanford University before becoming a postdoctoral fellow at the California Institute for Biomedical Research.

In January 2013 she joined The Janssen Pharmaceutical Companies of Johnson & Johnson as a scientist and is also serving as membership chair of the Southern California chapter of Women in Bio (WIB). In this WIB profile article she shares her experience in working in academia versus pharma, the challenges of working with CROs, and the future potential of biotherapeutics.

Ed Miseta: Tell us about your position at Janssen.

Zhaoqing Ding: My education has provided me with extensive experience in assay development, molecular biology, protein expression, library construction, high throughput screening, flow cytometry, FACS, immuno histochemistry and in vivo animal disease models. I am able to put all of this to use in my position with Janssen. I am also a subject specialist in adaptive (T and B cell) and innate (myeloid) immunological responses during infectious, autoimmune, oncology, and neurological-related diseases. Additionally, I am an experienced immunologist in early discovery and development of biotherapeutics and vaccines.

I am passionate about science and the work that I do. It is a great feeling to be able to work on finding cures for diseases that affect people and I hope to make a positive impact on society with the scientific research I do.

Miseta: You are now working in pharma after spending most of your career in academia. Do you see a difference in how innovation occurs in pharma versus academia?

Ding: In my experience the innovation in pharma is a bit more "de-risked" than academia. I believe this is because the timelines in pharma are shorter and more defined. In pharma the research is much more fast-paced. We don't have the luxury of spending an infinite amount of time trouble-shooting issues that arise. Therefore, many innovations we work on involve using or building upon innovations that may have already been made by academic institutions or smaller biotech firms.

Miseta: I’m guessing that some of the work you need performed must be outsourced to CROs. What can you tell us about your CRO selection process and what you look for in a CRO?

Ding: I think the biggest mistake a CRO can make is to over-promise and under-deliver. With that in mind, the first criteria I look for in a CRO is its ability to deliver. If a CRO can demonstrate to me that they are able to do what they say they can, then I will continue to evaluate them in terms of their experience and expertise in the work we need performed. I will tell CROs that the best way for them to demonstrate their abilities to me is to show me actual data they have acquired on their platform.  

Miseta: Are there areas where the best fit tends to be a large CRO versus a small or mid-sized one?

Ding: That’s a great question. The larger CRO companies tend to provide services that are more established, such as DNA services, in vivo efficacy studies, PK/PD, MS, biochemical analysis, etc. On the other hand, the smaller CRO companies have the ability to offer me services that are more cutting edge, that might happen to be less proven, or that can be better customized to meet our needs.

Miseta: Does Janssen have a preferred provider list that you use?

Ding: Yes, but I do have the ability to go outside that list.

Miseta: When you do have to go outside that preferred provider list, are there additional challenges associated with doing that?

Ding: I have found that there can be additional challenges associated with working with non-preferred CRO's. I won’t get into any of them, but I can say that I have never found any of those challenges to be limiting. 

Miseta: There will likely be CROs reading this who would like to work with J&J. Do you have any advice for them? Is there an approach you recommend that might help them to do business with the company? 

Ding: Most of the CROs I have learned about or become aware of were through word of mouth, published journals, or an industry contact. A good recommendation from someone I trust goes a long way in helping me select a vendor. I have also met many of them through industry-related shows and conferences.

Here is one piece of advice I would give to any CRO looking to work with a company as large as J&J: Do not take one group’s or one person’s disinterest as an endpoint to the conversation. J&J is a huge company with many departments and sub-groups that all have independent projects going on at any point in time. Just because one department or sub-group can’t use your skills doesn’t mean that another won’t welcome them. Don’t ever stop trying.   

Miseta: Biotherapeutics seems to be a hot area in pharma right now. Why do you think that is?

Ding: This is only my opinion, but biotherapeutics such as monoclonal antibodies naturally have a low toxicity profile and high specificity compared to small molecule therapeutics. This makes them ideal for use as a therapeutic agent. I think we are just beginning to fully push the limits of leveraging antibodies as a therapeutic. This is made evident by the sheer number of monoclonal antibodies, antibody drug conjugates (ADCs), and scFv (single-chain fragment variable) currently in various stages of Phase 1 to Phase 3 clinical trials.

A sub-category of biotherapeutics that I'm particularly interested in is utilizing next generation sequencing (NGS) to interrogate the adaptive immune response in various diseases. I see that having a lot of promise in the future.

Miseta: Is there an opportunity for CROs to assist pharma companies in this area?

Ding: Absolutely! To complete the projects I'm currently interested in I will be using multiple CRO's and external collaborations for sample preparations, NGS, and analysis.