ARCHIVED NEWS AND EVENTS

Intrinsik Presents at upcoming BioContact Meeting in Québec

Dr. Jon Daniels and Mr. Mike Luksic will be attending and presenting at the BioContact Québec partnership symposium taking place on October 7-8, 2009 at the Château Frontenac, Québec. Intrinsik's presentation will take place on Wednesday October 7 at 10:30am in Salle Place d'Armes and will focus on the challenges faced by small and emerging life sciences companies during development and points to consider in de-risking these activities.

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Intrinsik attends BioPartnering Europe and China events next week

Mike Luksic, Associate Director, will be attending the 17th Annual BioPartnering Europe conference, October 11-13, 2009, along with BioPartnering China event on October 14th, both events will be taking place in London, England at the Queen Elizabeth II Conference Center. If you would like to meet Mike at either event, please contact us at info@intrinsik.com.

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Join us at the Annual Meeting of the American College of Toxicology in Palm Springs

Intrinsik is pleased to announce that Dr. Jon Daniels, Vice President and Senior Toxicologist, and Dr. Geoff Goodfellow, Senior Scientist will be attending and speaking at the Annual Meeting of the American College of Toxicology (ACT) which will take place November 1-4, 2009 in Palm Springs, California. The title of Dr. Daniels’ presentation is Outsourcing Nonclinical Safety Studies: Best Practices for Selecting a CRO and will be part of the continuing education course on study placement and monitoring.

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Annual Safety Pharmacology Society Meeting in Strasburg, France

Kathryn Bibeau, Senior Scientist recently attended the 9th Annual Safety Pharmacology Society Meeting in Strasburg, France from September 15-19, 2009. This conference targets the role of safety pharmacology in drug development, highlighting new areas in which safety pharmacology is thought to have an impact in the future to improve drug safety and market success.

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Effective Due Diligence Assessments - September 9, 2009

Toronto, ON and Chicago, IL (September 8, 2009) – Intrinsik Health Sciences Inc. (Intrinsik), a leading provider of toxicology, product development and regulatory affairs consulting services, announced today that Dr. Jon Daniels, Vice President and Senior Toxicologist, will be speaking on preclinical drug development and the role of the toxicologist in due diligence evaluations at a workshop entitled Issues and Opportunities in Due Diligence Reviews. The course, accredited by the Canadian Healthcare Licensing Association (CHLA), will take place September 29 & 30, 2009 in Montreal, Canada.

Click Here to download PDF.

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Nonclinical Development of Anticancer Drugs and Biologics

Drs. Jon Daniels and Geoff Goodfellow recently published an invited article in Biotechnology Focus (Volume 11, August 2008) entitled Regulatory Harmonization of the Nonclinical Development of Anticancer Drugs and Biologics. To view the full article published in the Bioscienceworld Journal, please visit: http://www.bioscienceworld.ca.

For additional information or to request a reprint or the article, please contact info@intrinsik.com.

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American College of Toxicology

Intrinsik’s Dr. Geoff Goodfellow and Dr. Jon Daniels attended the 2008 American College of Toxicology conference in Tucson, AZ. For more information on the symposia or topics discussed please contact info@intrinsik.com.

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Intrinsik Leading Session in Boston on the Preclinical Development of Anticancer Drugs
June 2008

Dr. Jon Daniels, Vice President and Senior Toxicologist, is chairing a session at the Annual Meeting of the Drug Information Association on June 26, 2008 in Boston, MA entitled "Harmonization of Requirements for the Preclinical Development of Anticancer Drugs".

For more information about the session, visit http://www.diahome.org/DIAHOME/FlagshipMeetings/SearchSesTut.aspx?meetingid=14235&productID=15903

Approaches to the preclinical development of oncology drug products are not harmonised and continue to be independently discussed and developed in the United States, Europe and Japan. The European Medicines Evaluation Agency (EMEA) has official preclinical guidance for the development of cytotoxic cancer treatments and the U.S. Food and Drug Administration (FDA) has been developing an official guidance that has yet to be released outside the Agency for comment, although sponsors have for many years received unofficial guidance from a publication authored by senior FDA staff. Adding to the lack of harmonised guidance in this area, most current ICH safety guidances and the ICH M3 guidance either explicitly or implicitly exclude cancer therapies from their recommendations, yet there is no alternative offered for a harmonized product development strategy leaving sponsors to inappropriately rely upon ICH M3 or ICH S6 guidances for non-cytotoxic and biologic agents in development of cancer therapeutics. Recently, the ICH Steering Committee adopted a new work item to develop a nonclinical safety guideline, “Preclinical Guideline on Oncology Therapeutic Development” (ICH S9) which will cover both small molecules and products of biotechnology (but will exclude therapeutic vaccines, cell and gene therapy products.

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Intrinsik will Speak at the Architects of Alliances Course On Due Diligence Reviews

Dr. Jon Daniels, Vice President and Senior Toxicologist, will be speaking on preclinical drug development and the role of the toxicologist in due diligence evaluations at a workshop entitled Issues and Opportunities in Due Diligence Reviews: A Business Development Course. The course content was developed in conjunction with the Education Subcomittee of the Canadian Healthcare Licensing Association (CHLA) and will take place September 10th & 11th, 2008 in Toronto, Ontario, Canada.

This course will appeal to those who are involved in deal-making, either with technologies to license or looking for products to be acquired, and specifically will help with the multidisciplinary approach common to today’s due diligence environment, including the need to bring together financial, development, regulatory and other disciplines in order to successfully manage the due diligence process and complete deals.

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Assessment of Genotoxic Impurities in Human Pharmaceuticals

Intrinsik’s Kathryn Bibeau and Jon Daniels recently gave an invited presentation entitled Assessment of (Genotoxic) Impurities: Regulatory and Toxicological Perspectives (October 22, 2008). For more information on this presentation please contact info@intrinsikscience.com.

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