In June I will be traveling to La Havana, Cuba, to teach a course in General Toxicology and Food Safety with Dr. A. Wallace Hayes PhD, and Dr. Azita Cuevas PhD, MPH.  The Toxicology group of the Cuban Society of Laboratory Animal Science (SCCAL) is hosting the course.  The SCCAL's core objective is to disseminate in Cuba the current trends in toxicological hazard and risk evaluation within the context of animal protection and 3Rs philosophy.  We are looking to forward to meeting scientists from the region and visiting Cuba! 

Looking forward to moderating the "Regulatory Perspectives on Innovative Healthcare Technologies" panel discussion on Monday, November 21st at 10:15 am.  Panel participants include Dr. Damien Bates, Chief Medical Officer & Head of Research, SanBio, Inc.; Ms. Mya Thomae, Vice President, Regulatory, Clinical and Medical Affairs, Illumina, Inc.; Mr. Yoshiaki Tojo, Chief Executive Director, The Japan External Trade Organization, A Ministry of Economy, Trade and Industry; Mr. Michael Werner, Executive  Director, Alliance for Regenerative Medicine; Partner, Holland & Knight LLP.  

Attending this event in the role as Past-President and had a great time teaching a CE course titled "The Role of Toxicologist Post IND:  What Comes Next."  

I will be presenting with Urte Gayko, SVP Global RA at Pharmacyclics, at a free live training on March 1st at 1:00 pm PT, 4:00 PM ET. 

We will be presenting on the following:

• Definitions of each expedited approval pathway
• Benefits and risks to each expedited pathway
• How to determine which expedited pathway is right for your molecule
• How to ensure alignment of expedited approval strategy across multi-disciplinary teams

Click here to register. 

Greetings Friends,

Looking forward to catching up with friends and colleagues at the upcoming SOT Annual Meeting.  I'll be hosting the ACT Exhibit Booth on the following days and times so please stop by if you have the time!

Monday, March 14th, 11:00 AM - 12:00 PM CST
Tuesday, March 15th, 11:30 AM - 12:30 PM CST
Wednesday, March 16th, 3:30 PM - 5:00 PM CST









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I am grateful to have had the opportunity to serve as ACT president this year, and am appreciative to all those who contributed to making the 2015 Annual ACT Meeting a very successful event.  It was an honor to have Dr. Frank Young of Braeburn Pharmaceuticals present the keynote address at this year's conference in addition to presenting him with the 2015 ACT Distinguished Scientist Award.  

In a press release announcing the award, Dr. Young stated "I am deeply honored to receive this year's ACT Distinguished Scientist Award. I have been afforded many extraordinary opportunities to serve in academia, government and the private sector, all of which built on my original training and research as a pathologist.  Toxicology is fundamental to modern society because it is the framework for ensuring human safety amidst scientific and technological advances.  Through my role at Braeburn, I am thankful to apply my toxicology expertise in an effort to bring innovative and safe treatments to patient populations in dire need of new options."

Thanks again to all of those who attended and contributed to the success of this year's event!

Click here to see additional photos from the 2015 Annual ACT Meeting. 

Attending the 2015 RAPS Annual Conference?  I will be a panelist at the New Pathways to Support Drug Development session on Monday at 11:00 am.  Other expert panelists include:  Elizabeth Ford, associate director of regulatory affairs, Office of Clinical Pharmacology, CDER, FDA; Xavier Luria, MD, senior consultant, drug development and regulation; and Sabine Haubenreisser, MSc, PhD, EMA liaison official at FDA.   For more information on the session click here. Hope to see you there! 

Charles River is holding their 21st Annual Biotech Symposium September 28th - 30th.  On Monday the 28th, I will be presenting at the session titled BiTE Blincyto:  Regulatory and Nonclinical Challenges of a Breakthrough Therapy.  

Looking forward to the conference and seeing many of you there!

Huntingdon Life Sciences recently held their 5th Annual Biologics Symposium in New Jersey where I presented on the "Regulatory history, challenges, and progress in developing biologics."   The slides from the presentation are available here for those of you unable to attend the event but interested in the talk. Feel free to let me know if you have any questions. 

Special thanks to the Biotechnology Specialty Section of SOT for selecting me as the recipient of the 2015 Career Achievement Award.  The awards ceremony was held at the SOT annual meeting in San Diego and was a wonderful event.  It was an honor to be selected as the recipient of this award!