Thanks to tremendous support from the Indiana life sciences community, the Kelley School of Business’ Center for the Business of Life Sciences is  proud to announce the fifth year of the Indiana Life Sciences Collaboration Conference Series. Assisting as series sponsors are Biocrossroads and Duke Energy.

Our kickoff conference for the year, Healthcare Reform: The Road Ahead, will be held on Friday, September 17^th, in Indianapolis This first conference will be of interest  to anyone connected to the life sciences industry, personally and/or professionally.  The three panels and our keynote speaker, Nick Littlefield, former Chief of Staff for Senator Ted Kennedy, will provide details and perspective on the past, present and future of healthcare reform.  The agenda for the day is available on the CBLS website at http://www.kelley.iu.edu/CBLS/conferences/page19188.html.

George Telthorst would like to extend a special “Thank You” to this conference’s  primary sponsors, Baker & Daniels LLP, Clarian Health, and Eli Lilly and Company, and supporting sponsors, Aledo Consulting, BSA LifeStructures and Meyer Najem Corporation.

Should you be?

Many companies fear FDA. Some probably should because business practices, documentation and records, and compliance are not up to snuff.

Many years ago, the company where I worked was preparing for ISO auditors (not really like FDA inspectors but kind of) to come in for recertification. I speculated that the office chatter was probably similar to Paul Revere’s midnight ride: “The auditors are coming. The auditors are coming!” Several of my colleagues would remind me of this several days ahead of time. This was puzzling to me. I responded by asking why wouldn’t we act / do the same things whether auditors were present or not.

And it’s true. If you are afraid of the FDA (or ISO), you probably have one of two reasons for this fear:

1. You know your company is out of compliance.
2. You don’t know what you don’t know.

In either case, I would encourage you to seek help to remove your fears. Find a company, consultant, or resource to come in to help (hint).

Or you can roll the dice and wait for a FDA inspection and take your chances.

Medical Design & Manufacturing Trade Shows 2010

September 28-30, 2010
Rosemont (Chicago), IL
Donald E. Stephens Convention Center
MDMMidwest.com

Co-located with Design & Manufacturing Midwest, Assembly & Automation Technology Expo (AATExpo), Electronics Midwest, PLASTEC Midwest, and Green Manufacturing Expo East.

INpact is in the IBJ again…

As they continue to help Indiana medical device companies get their products to market, more and more people are taking notice. They have grown to 30 members from when they started in 2008 and roughly 50 people in attendance at their monthly meetings. If you’d like more information on the INpact meetings, contact Jon Speer.

Probably their best example of how they help local medical device companies is with Daraza, the subsidiary of Therametric Technologies. Daraza developed a devide called FluoreCam with the assistance of the INpact members that will help with early detection of cavities.

For more information on the process that INpact members took Daraza through, click here.

BioPharm America 2010 from the EBD Group

09/15/2010 at the Marriott Boston Copley Place, Boston, MA

BioPharm America is where biotech industry partnerships get started. Meet face-to-face with biotech and pharma executives from around the world to identify and enter strategic relationships. Equipped with partneringONE®, the world’s leading web-based partnering system for the life science industry, BioPharm America is the only event in North America based on the same reputable formula as EBD Group’s acclaimed European events BIO-Europe and BIO-Europe Spring.

Contact:
Holly Mersy
tvoigt@ebdgroup.com
760-930-0500

FDA Boot Camp

Sponsor: ACI
Web Site: http://www.americanconference.com

August 25, 2010 - Sheraton Fisherman’s Wharf, San Francisco, CA

ACI’s FDA Boot Camp - the industry standard in providing non-regulatory professionals with a regulatory background - has been designed to give products or patent litigators, a strong working knowledge of core FDA regulatory competencies.

Contact:
customercare@americanconference.com
212-352-3220

Global Pharmaceutical & Biotechnology R&D - Challenges, Opportunities & Pathways

Sponsor: BioPharmaPM
Web Site: http://www.mscholar.com/xgpo
Date:08/24/2010
Time: 1:00:00 PM
Location:Online EST
Details:
The pharmaceutical and biotech industries have entered an era of unprecedented change and Action for Results, Inc. (AfR) consultant Thomas J. Schulze, PhD, PMP, plans to guide industry professionals through it in a complimentary webinar. Schulze will address the issues that arise from threats to the industry’s current business model including profitability challenges, patent expirations, cost constrained healthcare systems and demanding regulatory requirements. Additionally, he will help attendees understand the objectives and outcomes necessary for successful drug discovery research, development and commercialization.

Contact:
Patrick J. Riley
pjriley@icmarcom.com
603-893-6510