Safis-Solutions

Newsletter

Issue 1 Vol. 2 January 2009
Overcoming Product Development Challenges Through Innovation and Regulation 

Authored by:

Gretchen Parker, PhD, RAC; Gretchen Bowker, MS, RAC; and Usha Srinivasan, MS, RAC
 
The cost of bringing a new drug to market has surpassed
$1 billion (US).  Simultaneously, pharmaceutical companies
are facing budget constraints, empowered patients are demanding high-quality drugs, legislators are demanding increasing oversight to ensure patient safety, and pioneering scientific discoveries are evolving at a rapid pace.  Faced with increasing regulatory requirements regarding patient safety
and the challenges of managing global clinical trials, what can the pharmaceutical industry do to improve the efficiency and cost-effectiveness of drug discovery and development?  Click here to read this article.
Safis to be Recognized for Entrepreneural Success
Safis Solutions is pleased to announce that we will be recognized as an Indiana Small Business Development Center (ISBDC) Economic Growth and Development through Entrepreneurship (EDGE) Award winner, in the established business category, for the Central Region ISBDC.  The ceremony, recognizing all of the statewide winners, will be held at the Indiana Statehouse on February 3rd, between 1 and 3 pm.
 
To learn more about ISBDC, visit www.isbdc.org.
Safis Shares Their Expertise With IU School of Business
Life Sciences is a growing industry in the state of Indiana.  Recognizing this, Indiana University's Kelley School of Business has created the course entilted "The Business of Life Sciences: Life Science Global Events and Trends".  The focus of this course is to overview the key trends shaping the future of life sciences companies - demographics, globalization, regulation, cost controls, mergers and acquisitions, scientific discovery, and technological innovation.
 
As a part of the impressive lineup of industry speakers that will present throughout the semester, Gretchen Bowker, Director of Regulatory Affairs and Compliance Services for Safis Solutions, spoke on January 27, 2009.  Utilizing her extensive industry experience, she presented on the topic of "Government Regulation at Home and Its Use as a Trade Barrier".  During this session, she discussed the implications of regulatory approval, inspection, compliance, and quality standards on the product development life cycle.  
 
To read the full press release, click here.
Safis Welcomes Emily Dukeman and Dawn Schofield
As a consulting company, we know the importance of hiring the best talent. Therefore, we are pleased to announce that we have recently hired Emily Dukeman as a Compliance Analyst, and Dawn Schofield, CQA, as a Compliance Advisor. 
 
Dukeman has brought seven years of professional work experience in the health care industry to Safis.  Previously, she worked at two pharmaceutical companies, Johnson & Johnson/Ortho-McNeil and Novartis Pharmaceutical Corporation, in the neurology and cardiology specialty account management roles.  She also has hospital laboratory, catheter lab, and hospital setting experience.
                                                                                      
Dukeman holds a Bachelor in Political Science from Indiana University, and will complete her Master's Degree (MPA) from IUPUI SPEA in 2009 in which her concentration has been FDA Regulatory Policy Analysis.  
 
Schofield has brought over 12 years of Quality Assurance experience within the pharmaceutical & diagnostic industries.  She is a product development and quality specialist, having spent several years directly supporting drug product development and all phases of clinical trial materials manufacturing.   She has particular expertise in qualification, assessment, and oversight of contract operations for analytical development/testing, manufacturing, label generation, and packaging. Schofield spent her years in the diagnostics industry developing quality systems from the ground up, and led a CLIA compliant laboratory within an ISO certified facility. Schofield has extensive experience in the development and implementation of quality systems, CAPA, deviation, and change control processes.  She is a seasoned auditor with experience auditing hundreds of contract manufacturers, CROs, laboratories, analytical testing facilities, and label and packaging suppliers to GXP and ISO compliance standards.  She has built supplier qualification processes, and managed suppliers at both small and large companies. 
 
Schofield holds a Bachelor's degree in Chemistry from Purdue University, and a Bachelor's degree in Merchandising from Indiana University.
2009 First Quarter Events
 
January
 
January 13; The Indiana Biomedical Entrepreneur Network held a monthly meeting at the Riley Learning Center in Indianapolis, IN, on the topic of "Redirecting Your Development to Fit the Market."  See Website   
 
January 27;
The Indiana Chapter of the Life Science Project Management Group held a monthly meeting at the IUETC in Indianapolis, IN, on the topic of "Project Management in the Life Science Startup."  See Website 
 
February
 
  
 
February 10; The Indiana Biomedical Entrepreneur Network will hold a monthly meeting at the Riley Learning Center in Indianapolis, IN, on the topic of "Intellectual Property and the Start-Up Company."  See Website  
 
February 13;
The Center for the Business of Life Sciences at Indiana University's Kelley School of Business,  will hold a conference entitled "Business Partnerships" at the Eli Lilly and Company's Corporate Headquarters in Indianapolis, IN. See Website 
 
February 26; The Parenteral Drug Association's Midwest Chapter will hold a dinner event entitled "Risk Assessment Of Aseptic Processing ISO 5 Areas" at the Radisson Hotel Northbrook in Northbrook, IL. See Website  
 
March 
 
March 1-3; The University of Notre Dame, in conjunction with the Indiana University School of Medicine and Loyola Medical School, will present a "Workshop on Interdisciplinary Biomedical Research."  The goal of this workshop is to bring together researchers in biomedical, biochemistry, bioengineering, computational & mathematical biology, and biophysics to discuss recent developments in biomedical and experimental modeling, as well as current and possible future collaborations. See Website

March 17-19; Interphex will hold its annual conference and exhibition in New York, NY. See Website 
 
Other Upcoming Events
 
April 1-3; The Regulatory Affairs Professional Society (RAPS) will hold the RAPS Horizons Conference and Exhibition in San Fransisco, CA. See Website
 
April 19-24; The Society of Quality Assurance (SQA) Annual Meeting will be held in San Diego, CA. See Website
 
April 20-24; The Parenteral Drug Association (PDA) Annual Meeting will be held in Las Vegas, NV. See Website 
Safis Solutions, LLC is a regulatory compliance consulting company serving pharmaceutical, medical device, and biotech companies worldwide, to ensure health authority requirements are met.  Areas of expertise include: regulatory approval, clinical strategies, quality systems, validation, IT services, auditing, and post-market surveillance programs.  Let Safis Solutions help you excel in today's complex regulatory compliance environment.
 
In This Issue
Overcoming Product Development Challenges
Safis to be recognized for entrepreneural success
Safis consultant shares her extensive expertise in regulatory affairs
Safis Welcomes Emily Dukeman and Dawn Schofield
2009 First Quarter Events
Bio Corner
 
Brandi Guillemette joined Safis Solutions, LLC, as a Senior Compliance Analyst in 2007, bringing with her almost a decade of IT, manufacturing process validation, analysis, and documentation experience.  Guillemette's experiences include validation and testing of computer systems for manufacturing facilities, process control software, and development of enterprise wide IT systems & custom software applications.  Guillemette is a graduate of Indiana University.

Case Study

A medical device company engaged Safis to validate an IVD (in-vitro diagnostic) assay.
 

 

Did You Know? 

One of Safis Solutions' team members makes his own diesel fuel out of fryer grease from local chinese restaurants. 
 
Rumor has it that when you ride it the car, you swear you can smell french fries.
 
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