Info from IRISYS

We’re proud to share the wisdom of Dr. Jerry Yakatan, Chairman, CEO and founder of IRISYS, who has decades of experience with pharmaceutical development, clinical trial strategy and design, and regulatory affairs. Info from IRISYS includes the Yakatan Rules for Pharma R&D Efficiency, which are extracted from his popular seminar, “Where Have All the New Drugs Gone:  A Model for Improving the Efficiency and Costs of Pharmaceutical R&D.”

Info from IRISYS also presents insights from other members of our Leadership group, whose expertise spans all aspects of pharma discovery and development.

IRISYS receives Exceptional rating as contractor from NCI

August 13th, 2018
We are happy to receive our new Contractor Performance Assessment Report (CPAR) from the National Cancer Institute (NCI) a part of the National Institute of Health (NIH) for the period of June 2017 to June 2018. It is now the second year in a row that we have received a rating of “Exceptional”. We have …

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The Future Of Drug Development in China

July 19th, 2018
IRISYS Chairman, CEO & Founder Dr. Gerald Yakatan has written a guest blog titled “The Future Of Drug Development in China” giving insight on the emerging drug market in China, you can find the article online here: https://www.biopharmatrend.com/post/68-the-future-of-drug-development-in-china/ Here’s a small snippet of the article: In China, when the government makes a decision about what should …

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Meeting: Dispelling the Mystique of Pre-IND Meetings

July 9th, 2018
Biocom Regulatory Affairs Committee (RAC) IN-PERSON MEETING Thursday, July 12, 2018 12:00pm PST McGraw Conference Room, Biocom Office 10996 Torreyana Rd, Ste 200, San Diego RAC Credits Available Conference Call/Webinar Details: Number: 917-408-6563 Participant Code: 1007369663 Link: https://join.shoretel.com/conference/1007369663  “Dispelling the Mystique of Pre-IND Meetings” Learn how to conduct a pre-IND meeting with Dr. Gerald Yakatan, …

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China’s CROs Make Connection in S.D.

June 11th, 2018
We had the honor to be featured on this week’s issue of the San Diego Business Journal, you can find the article online here: https://www.sdbj.com/news/2018/jun/10/chinas-cros-make-connection-sd/ Here’s a small snippet of the article: Meanwhile, San Diego CROs Irisys, MicroConstants, Anticancer and Alan Lab opened satellite offices in China. Irisys, specializing in product development and manufacturing, saw a …

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Proprietary Liposomal Formulation Platform Technology Partnership Opportunity

June 6th, 2018
To meet the demand for developing chemotherapies with decreased toxicity and higher safety margins, IRISYS LLC, leveraging its formulation development expertise and extensive experience in the pharmaceutical sciences, has developed a proprietary liposomal formulation technology platform. The release characteristics of these liposomal formulations provide for release of higher concentrations of antitumor agents at the tumor …

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How New Drugs Are Made

May 2nd, 2018
General Information This infographic describes the drug development process leading up to phase 1 clinical trials. These are steps that companies must perform for each drug they are trying to get into the clinic. While many recognize how difficult it is to discover a drug, a significant portion of the costs and challenges of getting …

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Event: FDA Regulatory Strategies and CMC Considerations

March 13th, 2018
March 21st, 2018 5:00 pm to 7:00 pm 6828 Nancy Ridge Drive, Suite 100, San Diego, CA 92121 Are you interested in resurrecting shelved projects from big pharma R&D pipelines? Are you working on drug re-purposing and would like to know how to obtain market exclusivity or extend patent lives? Have you anticipated the impact …

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The Yakatan Rules for Pharma R&D Efficiency #2

November 2nd, 2017
Welcome to The Yakatan Rules blog, which shares the opinions of Dr. Jerry Yakatan, Chairman, CEO and founder of IRISYS. Please see Rule #1 – Establish small discovery teams led by “Drug Finders” Rule #2 – Assign responsibility & authority to teams Program identification Budget Hiring Funding “Feed & clothe” Program identification is the first – …

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Z-Endoxifen manufactured for the National Cancer Institute

September 11th, 2017
IRISYS is privileged to have manufactured capsules of Z-Endoxifen for the National Cancer Institute that made a major difference in the life of a cancer patient in a Mayo Clinic trial.  We invite you to watch the following brief video, which shows why researchers are encouraged by the early results for patients using Z-Endoxifen: Further …

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The Yakatan Rules for Pharma R&D Efficiency #1

September 4th, 2017
“…a man should share the passion and action of his time, at peril of being judged not to have lived”. – Oliver Wendell Holmes, Jr., 1884 (1841-1935). Welcome to The Yakatan Rules blog, which shares the opinions of Dr. Jerry Yakatan, Chairman, CEO and founder of IRISYS. To set the stage, over the last decade… …

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