KCAS Q&A with John Pirro (Senior Director of LBA Services)

HOW WILL YOUR BACKGROUND IN SCIENCE AND OPERATIONAL MANAGEMENT PLAY A ROLE IN YOUR NEW SENIOR DIRECTOR OF REGULATED LBA POSITION?

 

The cornerstone of my background is in the Science. Early on in my career, I questioned the dogma of protein/therapeutic assays, and looked to see if we could make them more reliable and adhere to the requirements of GLP. Using this background and applying these techniques to therapeutics drugs helped me understand the issues of bringing a drug through discovery and into the clinic. My greater than 15 years in the CRO field allowed me to hone my skills understanding the business aspects of the CRO industry and helped me develop an understanding of the client perspective – making sure that timelines and quality of the data meets the government agency standards as well as the clients. My skill set has evolved consistently in my CRO management roles, where I’ve learned different and complimentary lessons about customer partnering, optimizing operational processes, aliening the requirements of the FDA and EMEA to help deliver quality data to our clients.

 

Using these skills will help not only the client with timely and quality data, but will help the business grow in an orderly manner.

 

TELL US A LITTLE ABOUT YOUR BACKGROUND AND HOW YOU CAME TO JOIN KCAS?

 

I have 12 years of large Pharmaceutical experience where my cell biology background permitted me to be co-inventor of 8 patents using my blood brain barrier model for BMS and drug by design at Bayer, which allowed me to follow a drug for osteoarthritis from early discovery to the clinic. This background and knowledge helped me make the decision to move into the CRO industry to help and guide the drugs, specifically large molecule therapeutics, to the clinic.

 

As I moved into the CRO industry, I recognized that large molecule therapeutics would become a major part of the future drug industry. As such, the assays and meeting the regulations of GLP were an integral part of moving these types of drugs through the development process and into the clinic. This process started at CRL in the proteomic group, which we green-fielded while I was General Manager. It was at CRL that we developed the Microwave technology for protein analysis with the use of the Advion Nano-spray system and the use of chicken immunoglobulin’s (IgY) for difficult depletions and use for LBA assays.

 

From there, I was asked by MDS in Montreal Canada to help solve issues they had with bioanalysis and the FDA. I moved to Montreal and the day I joined, my manager quit. Then MDS received the 3 year review request from the FDA, for all bioanalysis work done at the two labs in Canada. I was asked to help them to get a plan in front of the FDA and quickly evaluate the studies if scientifically sound. This process took about a year and there are over 250 reports with my name on them registered at the FDA. One of them was for the popular blood thinner Clopidogrel, which would have been pulled off the shelf if the data did not pass the review. This painful experience enlightened me for the need to establish a foundation incorporating the 3 CRO functions of; operations, business needs and Regulatory guidance. This would require a change in how regulated work is performed in the lab and institute change in the Bioanalytical culture that existed at that time.

 

As my career moved into management, and changing the way biotherapeutics were analyzed in the lab, my military training helped this area. I spent 8 years in the Naval Reserve as a Seabee (CBMU 202) out of Groton CT. I was honored to be part of the “4 Square” leadership training the Navy provides and it has helped me in leading my teams to change the way we do things in operations, and reduce the “dogma” of practices that are not quality related. I was responsible for the performance of the operational biotherapeutics teams in many other CROs like Synomics, SGS, AIT, and WuXi AppTec, where I had oversight of running departments but also dealing directly with customers. In running these groups, I would make priority calls when there were clashes for internal resources. I would also be integral to discussions when assays showed issues and we needed to talk them through with customers. I also went on the road to visit customers (domestic and international) and talk about their projects directly and establish the voice of the customer. Combining my leadership skills, operational knowledge and keeping abreast of new technologies and science, helped me grow and maintain quality at the CROs I worked for.

 

As I have been exposed to more than a few CROs, I was looking for a company who understood the complexities of growing a best in practice CRO and was focused on the client with a high expectation of regulatory excellence. I also did my undergraduate degree at the University of Iowa in Iowa City. I love the Midwest so my evaluation brought me to KCAS. The management team at KCAS has a solid foundation of operational excellence and I intend to help grow the company to serve our clients.

 

HOW WILL COMMUNICATION AND COLLABORATION PLAY A PART IN THE GROWTH OF THE REGULATED LBA SERVICE?

 

Communication has always been a priority in ensuring projects run smoothly. The customer wants to be aware of what’s happening particularly when an assay hits a problem. Biotherapeutics are evolving faster than the government agencies can deal with the unique biotherapeutics. As such, communication with the client and setting up a true collaboration with the client scientists is a necessity. By implementing open communication and establishing a relationship with the client, we can guide them to the proper assays and more importantly, reagents for PK, Immunogenicity assays and neutralizing cell based assays as well.

 

These are true collaborations, because helping the client to choose the right positive control or antibody pair could help them get through the clinic without any issues.  The relationship built during this time helps establish trust and clients will seek you and your company to help them with other therapeutics in the future.

 

WHAT ARE YOU MOST EXCITED ABOUT FOR YOUR NEW ROLE AS SENIOR DIRECTOR OF REGULATED LBA  AT KCAS?

 

I’m excited to be a part of a team with a strong vision of where they want to take the business with a plan on how to get there.

 

I’ve already observed the willingness of the team here to adopt the changes to the operations to meet client’s timelines and continuous efforts to improve quality are very exciting. We are adopting new operational software for our reports and data, which will provide an added level of quality to reports and data to our clients.

 

If you have any thoughts or questions, please use the form below. Additionally, you can reach out to John Pirro directly, or any other member of KCAS’ leadership team. Thank you.