From The Editor | October 24, 2013

Best And Worst Outsourcing Experiences: WIB Profile With Pfizer Executive Director of Clinical Development

Source: Clinical Leader

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

Ed Miseta
Pam Garzone, executive director, biotechnology, clinical development, Pfizer WRD

In this Women In Bio (WIB) profile, Pam Garzone, executive director, biotechnology, clinical development at Pfizer WRD (worldwide research & development), discusses her job, lessons learned from her years in clinical outsourcing, and her thoughts on being involved with WIB.

1. Tell us about what you do at Pfizer.

As the clinical team lead, I am accountable for the clinical development strategy for the programs that originate at Rinat. In this role, I work with all of the different functional expert groups within a pharmaceutical company such as biologists, clinicians, both MDs and non-MDs, toxicologists, clinical pharmacologists, statisticians etc. I try to make sure that everyone on the asset team is in the same boat and rowing in the same direction.

2. That sounds like it can be a challenge.

It is a challenge because it is a matrix organization – the functional group representatives are not direct reports. It can be a challenge to set priorities for people who are reporting into another manager. Another challenge is decision-making – who, what, how and when as well as when does the decision need to be consensus driven versus when an ‘expert’ decides exclusively. In these highly functional teams, it is very critical that the lead functional group representative has decision making authority at the meetings.

3. What is the best experience you have had working with a CRO?

The best experiences are the ones where a relationship is established with key personnel and as a team, there is collaboration on all aspects of the project from subject recruitment and selection, study initiation and execution and incorporating quality into all aspects of the project. The best experiences are also ones where I trust the judgment of the principal investigator explicitly, i.e., that s/he will do the right thing for the subject in the event of a safety issue and that there is appropriate follow-up.

4. What is the worst experience you have had in working with a CRO? And is there anything you might have done differently?

When the CRO does not live up to the team’s expectations, for example, when they do not meet enrollment projections, or when an assigned project manager is not doing the best job are types of scenarios that can result in bad experiences. I have found that experience is the best predictor of performance. I do not want to have individuals with minimal to no experience working on a complicated study. If the experience of the CRO team is light, then the oversight is much higher and the trust factor is reduced. These outcomes are not satisfactory or satisfying.

5. When a company needs to part ways with a clinical partner, do you have any advice on what is the best way to handle that?

I think the best approach is always to be honest and straightforward. If the reason for parting is based on performance, I think it would be a good thing to share this with the CRO and also to provide potential solutions so that the CRO can improve upon their rendered service.

6. How has Women In Bio assisted you in your career, and how does it help women involved in life sciences? 

I am fairly new to Women in Bio but I have met some truly amazing, successful women doing very cool things. I am looking forward to growing my professional network in this organization and to also give back to the community of women who are just starting out in their careers as well as reach out to young women in high school about the rewards of a career in biosciences. This organization is committed to the development of women of all ages in biosciences and offers a number of programs and seminars to do this. In addition, WIB provides educational scholarships to women to support their development.