Dear Members and Friends,

After a spate of unusually overcast and rainy days, I’m really not sure if I should make any more weather-based predictions. Nevertheless, I’m going to look forward to our fall programs as we return from our summer break. We’ll be kicking things off in late September with Dr. Geoff Carr, the Director of Analytical Development of Patheon Pharmaceuticals, who will be talking about profiling impurities in drug formulations.

 From there, we’ll be looking forward to our upcoming Awards Banquet in October, to be held at the UCSD Faculty Club. As an ACS Section, we’ve always had great success in our chemistry award, often awarding upcoming local chemists who later gain significant national and international recognition. In addition to the Awards Banquet, we’re looking forward to our annual ChemExpo to be held on October 31^st at Balboa Park.

 As always, we’d love to see you come out and volunteer for this and other activities. To this end, we invite you to attend our monthly board meetings at Pharmatek, and to think about how you can contribute to the section to make 2011 as successful as 2010. With elections coming soon in November, we’re taking nominations and we welcome your nominations. If you are interested in running for a position on the San Diego board, please contact myself at rsmith1@illumina.com, or our secretary, Bill Tolley, at b_tolley@juno.com.

Randy Smith, PhD

Chair 2010

“Dealing with Potential Genotoxic Impurities

in Drug Substances and Pharmaceutical Products“

 Dr. Geoff Carr

Director Analytical Development, Patheon Inc., Canada

  DATE:                    Wednesday, September 29, 2010

 TIME:                    6:00 PM    Light dinner

                                7:00 PM    Lecture          

 PLACE:                Johnson & Johnson PRD

                              3210 Merryfield Row
                              San Diego, CA 92121

DIRECTION:  http://www.jnjpharmarnd.com/jnjpharmarnd/lajolla/lajolla_main.html

RESERVATION:    By Friday, September 24, 2010

  About the Speaker:

Geoff Carr was appointed as  Manager, Analytical Development, at Patheon Inc., Ontario, Canada in 2000 and is now Director, Analytical Development, Canada. Prior to that, he held positions of Manager, Analytical Sciences at Celltech-Chiroscience, UK, Head of Analytical Development at Medgenix, Belgium and before that at Wyeth Research, UK. He originally started his career in pharmaceutical analysis at The British Pharmacopoeia Laboratory where he held several posts and was finally appointed Head of the Laboratory. He has been a member of various British Pharmacopoeia Committees, a UK representative to Committees of the European Pharmacopoeia, and member of USP Committees and is currently a member of the 2010-2015 Cycle USP General Chapters - Chemical Methods Expert Committee. He is the author of numerous papers and presentations at international conferences on various topics related to pharmaceutical analysis.

 About the Lecture:  

ICH Guidelines Q3A(R2) and Q3B(R2) provide detailed information on how to report impurities in pharmaceutical drug substances and drug products and how to decide on suitable acceptable limits. Over the last four years new guidelines have been issued initially by European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) that require considerably stricter controls over impurities that are considered to be potentially genotoxic. The introduction of these guidelines is leading to completely new ways for designing analytical studies on impurities. This presentation will discuss:

•  The genotoxic impurities and how is it decided whether a new impurity should be considered to be a potential genotoxin.
• A review of the requirements of EMA and FDA guidelines.
• Specification limits that are required to control these impurities.
• Analytical methods that are available that are capable of providing the required controls.
• The implications to a pharmaceutical development program.

CATE Lecture Series

Come and hear Chemists’ Approaches To Entrepreneurship (CATE) from real chemist entrepreneurs!   This lecture series is sponsored by an Innovative Project Grant (IPG) awarded to the San Diego Section by National ACS in the spring of 2010. 

Title:                Is Being an Entrepreneur Your Cup of Tea?

Organizer:       American Chemical Society, San Diego Section

Date:               Saturday, September 11, 2010

Time:                Registration: 8:30- 9:00AM

                        Program:      9:00-11:00AM

Venue:          Ardea Biosciences Inc

                        4939 Directors Place

                        San Diego, CA 92121-3829

RSVP:               By Thursday, September 9, 2010 to http://sandiegoacscatelecture.eventbrite.com/

 For further information, please contact Ruo Steensma at ruo.steensma@steensmaconsulting.com. 

ChemExpo 2010

It’s fun! It’s educational! It’s free!

Sunday, October 17^th

11 AM - 3 PM

CHEM EXPO, part of National Chemistry Week celebrations, is a great opportunity to instill greater public awareness in the importance of chemistry in our everyday lives and the roles that chemists play in our community.

We need Exhibits by Local Companies & Organization

• • Chemistry Demonstrations Hands-On Activities
  • Free Raffles Middle & High School Extra Credit

and Much More! Celebrating its 23rd year!

To volunteer contact the San Diego ACS

For free space for educational exhibits contact

Tony Bottone at   (858)484-6839 

Sponsored by the San Diego Section of the American Chemical Society

IMPORTANT NOTICE

The San Diego Chemist is now available to you as an electronic version ONLY as of the June 2009 issue. To ensure proper delivery to your mailbox, please update your personal data in the ACS National roster either by accessing your account using your password, or simply e-mailing a request to update the information to service@acs.org. In your e-mail, be sure to include your Member ID. Alternatively, you can input you email into our signup box on the right, or you can sign up for the listserver following the instructions HERE. The San Diego Chemist is available by the 16th of each month HERE.