During my post-FDA career at Amgen, I worked with 3D Communications
and leveraged the preparation process outlined in this book. I experienced
firsthand why extensive and rigorous preparation is necessary when
sponsor companies develop materials and presentations for advisory
committee meetings. It’s challenging for company teams, which often have
other responsibilities and areas of expertise, to meet strict FDA deadlines
and execute a time-consuming and disciplined preparation process on
their own.
While companies have invested decades of work, hundreds of millions of
dollars, countless resources, and know more about their program than
anyone else, it is sometimes difficult for them to critically evaluate their
data. They often lack a larger-lens perspective on their positions and data
going into advisory committee meetings.
A proven external process, like the one in The FDA Advisory Committee
Survival Manual, and the outside experience of advisory committee
preparation experts, can help sponsors address that gap. A company like
3D brings experience, focus, technology platforms, and an efficient process
to help companies successfully prepare. This includes: providing sponsor
teams with a front-line perspective on how the FDA and advisory committee
members will see the data and the sponsor’s presentation ensuring the
presentations and the written materials are clear and streamlined and
coaching those delivering the data so that even seasoned presenters
are ready to stand up to scrutiny at this unique, and often contentious,
public meeting.
A strong presentation, along with skilled moderating and confident Q&A,
may tip the scales toward approval of product, communicating supportive
information that may not be apparent in the written documentation
available to a committee. In contrast, a poorly executed presentation may
adversely influence an advisory committee and increase the chances that
FDA will not approve the submission.
Over the last two decades, 3D has worked with hundreds of pharmaceutical,
biotech, and medical device companies preparing them to be successful
at FDA advisory committee meetings. This book, and the process detailed
in it, are the result of that experience.
– Steven Galson, MD, MPH
Former Director, FDA CDER
and leveraged the preparation process outlined in this book. I experienced
firsthand why extensive and rigorous preparation is necessary when
sponsor companies develop materials and presentations for advisory
committee meetings. It’s challenging for company teams, which often have
other responsibilities and areas of expertise, to meet strict FDA deadlines
and execute a time-consuming and disciplined preparation process on
their own.
While companies have invested decades of work, hundreds of millions of
dollars, countless resources, and know more about their program than
anyone else, it is sometimes difficult for them to critically evaluate their
data. They often lack a larger-lens perspective on their positions and data
going into advisory committee meetings.
A proven external process, like the one in The FDA Advisory Committee
Survival Manual, and the outside experience of advisory committee
preparation experts, can help sponsors address that gap. A company like
3D brings experience, focus, technology platforms, and an efficient process
to help companies successfully prepare. This includes: providing sponsor
teams with a front-line perspective on how the FDA and advisory committee
members will see the data and the sponsor’s presentation ensuring the
presentations and the written materials are clear and streamlined and
coaching those delivering the data so that even seasoned presenters
are ready to stand up to scrutiny at this unique, and often contentious,
public meeting.
A strong presentation, along with skilled moderating and confident Q&A,
may tip the scales toward approval of product, communicating supportive
information that may not be apparent in the written documentation
available to a committee. In contrast, a poorly executed presentation may
adversely influence an advisory committee and increase the chances that
FDA will not approve the submission.
Over the last two decades, 3D has worked with hundreds of pharmaceutical,
biotech, and medical device companies preparing them to be successful
at FDA advisory committee meetings. This book, and the process detailed
in it, are the result of that experience.
– Steven Galson, MD, MPH
Former Director, FDA CDER