Ask The Board December 2012

Q: What is the best way to match mentors and pupils for leadership development?
There are many factors to successful mentoring, three of which I will spotlight with regard to matching up mentors and pupils:
1.       clear objective for what the pupil wants to accomplish
2.       mentor with expertise on the target objective
3.       chemistry of the relationship.
Mentoring varies from a brief interaction to a lifelong relationship. Mentors can be found within your company, your association, your community, or your family. They can be either senior or junior to you and be in person or on the other side of the world. The consistent thread in all of these scenarios is the foundation of a successful pairing. Building a personal board of mentors is a critical tool in supporting your leadership advancement, so don’t shy away from adding mentors with subject matter expertise nor discontinuing a relationship if the chemistry is not right.

Laurie P. Cooke, B.S., RPh, PGDip, CAE is the CEO of the Healthcare Businesswomen’s Association (HBA), the leading nonprofit professional association in the women’s leadership space in healthcare globally.

Q: What is your opinion on the CMS/FDA proposed parallel review process?
CMS (Centers for Medicare and Medicaid Services) and the FDA have proposed creating a parallel review process in which CMS would begin its national coverage determination review process while the FDA completes its premarket review and play a role in discussions regarding investigational products under development. BIO does not believe that the existence of separate FDA and CMS review processes has resulted in significant problems in the review and coverage of drugs and biologics and questions whether there is any need for a new parallel process. Sponsors who wish to involve both the FDA and CMS in clinical development and premarket review discussions may do so voluntarily under current practice, and we encourage both agencies to continue to provide opportunities for early consultation. BIO understands and fully supports the need to minimize the length of time between marketing approval and commercial availability of new drugs and biologics.

Alan Eisenberg serves as executive VP for emerging companies and business development at the Biotechnology Industry Organization (BIO). In this role, he manages and directs BIO’s services and advocacy efforts for BIO’s emerging companies.

Q: What advice would you have on creating single-use industry standards?
The first step is to define what is meant as a “standard.” Is it a consensus practice, a formulation or design specification enabling interchangeability of components, or a fixed single-use system (SUS) dimension and design?  For practices, users have called for standard extractables data packages from suppliers.  While reasonable for new products, suppliers do not want to see the value of costly prior studies invalidated due to minor changes in methodologies.  Standardization of components and systems is more challenging, as many components are either proprietary formulations (films) or are covered by IP (sterile connectors). For these to become true standards, sterile connector patents need to expire and users must come to agreement on what formulations and designs to standardize. Those interested in developing standards should develop consensus within their own company first, then work with trade groups, professional societies, and standards organizations to reach a consensus across the industry.

Jerold Martin is senior VP, global scientific affairs for Pall Life Sciences, and chairman of the Bio-Process Systems Alliance (BPSA) single-use biomanufacturing trade association. He has over 32 years of experience in the biotech and pharmaceutical industries.

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