Success Factors in Your Investigational New Drug (IND) Filing

The successful filing of an Investigational New Drug application (IND) is a pivotal milestone for an emerging pharma company. This webinar is designed to address this crucial topic for the key industry segment.

Citing the FDA website for an Investigational New Drug Application, “Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA.” This webinar is geared towards smaller pharma companies filing an IND for the first time but even experienced drug developers could benefit from an overview of the requirements and considerations. The goal of the webinar is to educate and enable our listeners in pursuit of this key objective. While this particular talk is geared towards small molecule active pharmaceutical ingredients (API) and drug products, much of it applies to biologic products as well.

The Webinar features three prominent experts in the pharmaceutical development arena and each will highlight a different facet of the IND process.

Jennifer Stanek has over 20 years of experience with key roles in CMC regulatory affairs, formulation development and analytical development. She has expertise in the coordination, preparation and management of global clinical trial applications, new marketing registrations, drug master file applications and their life-cycle management. Ms. Stanek began her career at G.D. Searle, moved into CMC consulting and is currently with Takeda where she serves as Director in Global Regulatory Affairs CMC.

Jennifer will be providing an overview of the US IND format including an explanation of Modules 1-5, CMC (Chemistry, Manufacturing & Controls) submission timings, FDA meetings (timing, preparation, etc), and other CMC considerations.

Dan Weissmueller is the Director of Quality at Regis Technologies. Dan’s experience and expertise include analytical development, process and analytical validation, IND support to Regis’ custom API customers, Drug Master File (DMF) regulatory approvals worldwide and FDA inspections. Dan has been with Regis for about 15 years where he has worked with numerous early phase API developments candidates and been the responsible person for the fillings of 3 approved drugs in over 20 countries. Dan is in the process of completing his Masters’ in Quality and Regulatory Sciences from Northwestern University.

Working from the perspective of a custom manufacturing organization (CMO) quality assurance director, Dan has seen both the good and bad in terms of a customer’s preparation for an IND filing. Dan will be highlighting aspects of drug substance development and cGMP scale up as it applies to the IND requirements for small molecule API’s. Topics include the development lifecycle, validation considerations, equipment qualification and risk management.

Steve Pondell brings over 30 years of experience in manufacturing and serves as Vice President of CMC at ESSA Pharmaceuticals and previously as a Principal at Integrated Biotech Solutions in Houston, Texas. Steve is a CMC expert in the manufacturing, compliance and regulatory aspects of product development from clinical manufacturing, through global regulatory approvals and into commercial production. Steve has served a variety of small to medium sized pharma and biotech companies with projects that include GMP Gap Analysis, Phase 1 product development programs, and cGMP compliance.

Steve will focus his talk on the IND requirements for Drug Product along with the corresponding analytical considerations. Topics include container/closure, dosage form (e.g. oral, injectable, etc), analytical method requirements, specifications, validation requirements and product stability.

Speakers

Steve Pondell, Vice President of CMC, ESSA Pharmaceuticals

Steve Pondell is the Vice President of CMC at ESSA Pharmaceuticals. With over 30 years in the industry, he is a CMC expert in the manufacturing, compliance, and regulatory aspects of product development from clinical manufacturing through global regulatory approvals and into commercial production.

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Jennifer Stanek, Director in Global Regulatory Affairs CMC, Takeda

Jennifer Stanek is the Director in Global Regulatory Affairs CMC at Takeda. She has over 20 years experience in key roles within CMC regulatory affairs, formulation development, and analytical develop­ment. Stanek began her career at G.D. Searle and has also done CMC consulting.

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Dan Weissmueller, Director of Quality, Regis Technologies

Dan Weissmueller is the Director of Quality at Regis Technologies. Over the past 15 years, Weissmueller has developed experience and expertise in analytical development, process and analytical validation, IND support to Regis’ custom API customers, Drug Master File (DMF) regulatory approvals worldwide, and FDA inspections. Dan is in the process of completing his Masters in Quality and Regulatory Sciences from Northwestern University.

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