The pharmaceutical industry continues to move ahead with its trajectory being tweaked by various outside forces. The highly
regulated nature of our industry is a major contributor, while the need to do more with less continues to vex our everyday
efforts. These factors are acutely realized when we congregate with fellow industry professionals at society and professional
meetings. I use these interactions to explore the next big need for my clients as well as to craft a strategy that will help
address these needs. INTERPHEX 2013, while being a continuation of the journey described by Bob Stewart last year, is also
a realization of this “group thinking” fueled by current needs and pressures of our industry. It takes only a quick glance
at the conference agenda and list of exhibitors to fully appreciate this synergy.
The customized conference content of INTERPHEX 2013 is the product of group thinking carried out in a structured environment,
which we refer to glibly as the advisory board. When you ask 15 industry professionals (the board) from across all sectors
of our industry, you are guaranteed of getting valued input as well as things that are current and need to be addressed. The
five conference tracks—regulatory quality assurance/quality control, product development, facility and process design, manufacturing
and packaging, and supply chain—were pressure tested at INTERPHEX 2012 and have been leveraged effectively here for INTERPHEX
Current Development Best Practices for IR and MR Dosage Forms will be discussed by Glenn Van Buskirk and will touch upon aspects
of the current effort to address the needed updates for FDA guidance in the area of post-approval changes. The industry has
regularly used the Scale-Up and Post-Approval Change (SUPAC) guidances that were issued more than a decade ago. The widespread
use of these guidances along with current industry need has brought about a rethinking in this area and will produce a work
product that will be a reliable and time-proven asset.
A keynote address, Reorganizing for the Future: Succeeding in the New Pharmaceutical Industry, will be given by Rajesh Nair
from his perspective as president of Indegene. With a track record of having worked and consulted for many firms, Indegene
has assisted various companies as they navigate through strategies to become more agile as they bring products to market and
leverage existing product lines through a successful lifecycle.
A team from Duquesne University lead by Jim Drennen and Benoit Inge has assembled a must-see session that will take the attendee
through a practical utilization of aspects of quality by design as well as the application of key process control tools such
as PAT. This will be followed by a panel discussion lead by Carl Anderson, also from Duquesne University. The panel will be
case study-driven with experts from regulatory, development, quality, and the consulting sectors. The panelists will share
their views as well as address must-have answers from attendees.
Combination products along with information-rich case studies will be presented from leading medical device manufacturers.
David Armbruster from DePuy Synthes and Roy Fennimore from Johnson & Johnson will walk the attendees through each of their
sessions. David will discuss the aspects of product realization from concept through manufacture while Roy will detail technology
transfer for design control of convergent products.
A high priority has been placed on the “meeting place” that allows professionals to gather and exchange ideas. As highlighted
by Bob Stewart, “there is a need to connect, face-to-face, in order to teach, to learn, to do business and to know each other
better. Personal collaboration is critical to the industry INTERPHEX serves, and collaboration can begin with a conversation,
with a meeting.” INTERPHEX has established just such a meeting place and forum.
The INTERPHEX team looks forward to meeting you at the Javits Center in New York City on April 23–25, 2103. Let us know your
thoughts, at any time. We intend to serve the industry and continue our mission to make INTERPHEX the venue to learn it, hear
it, see it, touch it, and procure it.