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Drug Development Workshop
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Half-day workshop for Drug Discovery researchers, students, and professionals seeking knowledge about clinical, regulatory, and commercialization issues related to drug discovery.

11/11/2019
When: Monday, November 11, 2019
1:00 - 5:00 pm
Where: Kensington Court Hotel
3500 S. State St
Ann Arbor, Michigan  48108
United States
Contact: Alisha Brown
734-527-9147


Online registration is closed.
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ONLINE REGISTRATION FOR THIS EVENT IS CLOSED. YOU MAY STILL REGISTER ON-SITE.

PLEASE CONTACT ALISHA@MICHBIO.ORG WITH QUESTIONS.

 

Drug Development is a complicated process - from initial conception to clinical trials, regulatory compliance, and acquisition or commercialization, the journey from the lab desk to the patient is long and difficult to navigate.

 

The Drug Development Workshop is a half-day event designed to give academic investigators, biopharma professionals, students and other interested individuals working in the field with an overview of therapeutic design, development and commercialization. Lectures will be given by experts with backgrounds in industry-based drug discovery and development. Attendees will find the Workshop to be an excellent lead-in to the Drug Discovery & Development in Michigan Symposium.

 

This workshop is presented by MichBio, the biosciences trade association for the state of Michigan, and the University Research Corridor, an academic research cluster leading innovation in Michigan and the Great Lakes region (an alliance of Michigan State University, the University of Michigan, and Wayne State University). 

 

Students: $30

Non-Students: $75

 

1:00 - 1:20 PM

Welcome and Overview

 

Stephen Rapundalo, PhD, President and CEO, MichBio

1:20 - 1:50 PM

Drug Discovery

Jump right in and explore the Drug Discovery process with the topics of ideation, exploratory discovery, target identification, screening, lead identification and optimization, and in vitro and cell-based validation.

 

Vince Groppi, PhD, Director, Michigan Drug Discovery, University of Michigan

1:50 - 2:20 PM

Pre-Clinical Pharmacology

Move to the pre-clinical pharmacology process with a session covering animal models, safety and toxicology, pharmaco-kinetics, dynamics and metabolism, and predictive pharmacology.

 

Marc Bailie, DVM, PhD, DSP, Partner and Chief Development Officer, INDS

2:20 - 2:50 PM

Investigational New Drug Process

This session will cover the topics of directed safety studies, formulation, and chemistry manufacturing control (CMC)

 

David Barnes, PhD, CEO and CSO, Velesco Pharmaceutical Services

2:50 - 3:10 PM Break
3:10 - 3:40 PM

Clinical Development and Strategy

Move into the clinical phase of drug development with a session focused on clinical trial design and operations, biomarkers, and NDA submissions.

 

Amanda Beaster, PhD, Senior Technical Manager, MMS Holdings

3:40 - 4:10 PM

Product Development and Planning

Learn about the critical pre-commercialization step pr product development and planning in a session focused on regulatory strategy, reimbursement and pricing, and commercial opportunity assessment and markets.

 

Jessica Reed, PhD, Senior Director of Portfolio Management and Development Operations, Millendo Therapeutics

4:10 - 4:50 PM

Commercialization 1

Focus on the first phase of commercialization in this session focused on company formation, governance, capitalization, and business operations.

 

Lindsey Klee, MHSA, Founder and Managing Partner, Intent Capital and Intent Venture Management, LLC; Technology Consultant, Michigan Small Business Development Center

4:50 - 5:20 PM

Commercialization 2

The final phase of the commercialization process if reviewed in this session focused on intellectual property protection, and licensing.

 

DeAnn Smith, JD, Partner, Foley Hoag

5:20 - 5:30 PM

Final Discussion

 

This Drug Development Workshop is Presented in Conjunction with the Cutting Edge Drug Discovery Symposium on November 12th.

 

 

Creating Value
by delivering business-critical resources & bottom line savings
Building Networks
by connecting Michigan's bio-industry one member at a time
Growing Talent
by creating opportunities that develop people & build organizations
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