Archive for the “Industry” Category

The LIFE (Learn about Industry From Experts) seminar series presents:

‘Biogenerics:   The Next Big Money Battleground between Pharmaceutical Companies and the Generics Industry’ by

Paul Salo, Ph.D.
Technical Advisor, Merchant & Gould, LLC

When: Tuesday, April 21st, 4pm-5pm
Where: IBB Seminar Room (#1128 IBB)

Food and drink will be provided!!

Paul is a Technical Advisor in the Atlanta office of Merchant & Gould, and assists in the preparation and prosecution of patent applications and provides technical expertise in support of freedom to operate and invalidity opinions.  He graduated from Georgia Tech in 2007 with a Ph.D. in Biochemistry and was in the TI:GER (Technological Innovation: Generating Economic Results) Program. In 2003, Paul earned a M.S. in Paper Science and Engineering from the Institute of Paper Science and Technology at Georgia Tech.

During the past several years, there has been increasing interest in the development of follow-on biologic products in light of advances in manufacturing technology, process control, and protein characterization.  The term biogenerics, or follow-on biologic products, generally refers to proteins and peptides that are intended to be sufficiently similar to a product already approved under the Federal Food, Drug, and Cosmetic Act, or licensed under the Public Health Service Act, to permit the applicant to rely on certain existing scientific knowledge about the safety and effectiveness of the approved biologic product.  Biogeneric products may be produced through biotechnology or derived from natural sources.  The FDA has been considering the circumstances in which review and approval of biogeneric products may be appropriate.  In addition, biogenerics legislation is currently pending in Congress and will likely pass this year.  This presentation will examine the legal, regulatory, and scientific issues surrounding biogenerics.

Thanks!

BBUGS Industry Committee

2009 BIO Career Fair

Considering a new career?  Have an opening at your company?  Consider participating at the 2009 BIO Career Fair, Monday, May 18 at the Georgia World Congress Center.  BIO Career Fair is FREE to all job seekers. You don’t need to attend the event to upload your resume.  Employers can exhibit, post a job, sponsor, or advertise in the onsite program.  Posting jobs on the BIO Career Fair website will market your jobs to thousands of job seekers PLUS it will be automatically cross-posted to BioSpace.com! Your jobs will be viewable to the largest bioscience audience in the industry.  Learn more at www.biocareerfair.org.

The LIFE (Learn about Industry From Experts) seminar series presents:

‘Development of New Technology: Concept Evaluation‘ by

Steven Shaya, Ph.D.
Transform Consulting, LLC

When: Wednesday, January 14th, 9:30am-10:30am
Where: IBB Seminar Room (#1128 IBB)

Food and drink will be provided!!

Dr. Shaya retired as a Vice President in Johnson & Johnson’s Corporate Office of Science & Technology in 2007.  His role was to identify emerging technologies with the potential to disrupt health care categories, build connections to key research in these areas, and support adoption into J&J’s product development structure. His scope of interests is as broad as that of J&J’s 200 subsidiary health care companies.  In retirement, he started a consultant firm and consults on assessment and development of emerging science.

Dr. Shaya’s areas of focus have been tissue engineering, novel drug delivery platforms, patient monitoring and diagnostic business models.  He has patents for informatic services and monitors to impact medical outcomes. Steve has experience building and managing alliances across firms and created a novel infrastructure to enable collaboration across J&J’s decentralized R&D community.

This talk will provide an overview of the decision process of beginning or continuing an R&D project in industry. The decision is based on evaluation of costs, time, and risks of the entire development path as well as the potential for market profits.  An example project will be evaluated for scientific, technological, patent, clinical, manufacturing, and marketing risks and potential.  The net present value of the entire development and marketing phases of the product will be calculated in order to decide on project initiation or survival.

Thanks!

BBUGS Industry Committee