One-Way Ticket to Commercial Launch

Date
10:00am - 1:00pm
Location
San Francisco Biocom 1 Tower Place #150 South San Francisco, CA 94080
Speakers:
Marisa Reinoso , Marketing Manager, PCI Pharma Services , , Todd Phillips, PharmD , RAC, Director, Executive Consultant, Cardinal , , Ravi Rai, Ph.D. , Senior Research Scientist III, AMRI Albany , , Greig Ross , Director of Business Development, PCI Pharma Services , ,

One-Way Ticket to Commercial Launch: What to consider for drug synthesis, clinical trials, and regulatory filing

Preparing for a successful commercial launch starts long before FDA approval. This seminar will outline what drug synthesis, clinical logistics, packaging design, and regulatory considerations should be considered for commercial launch. This includes:
• The importance of route scouting and development while getting the drug registered and validated
• Avoiding the edge of failure in the drug synthesis process
• Transitioning from clinical to commercial: safety & efficacy data, packaging design,
• A review of the Investigational New Drug (IND) application and the FDA’s marketing authorization process, including common areas that are underestimated
• The packaging design, logistical and regulatory steps needed to flourish under expedited FDA programs (i.e. Fast Track, Breakthrough, Accelerated Review, etc).
Afterwards, join the speakers for lunch and networking.

One-Way Ticket to Commercial Launch

Date
8:00am - 10:00am
Location
San Diego Biocom 10996 Torreyana Rd #200 San Diego, CA 92121
Speakers:
Marisa Reinoso , Marketing Manager, PCI Pharma Services , , Todd Phillips, PharmD , RAC, Director, Executive Consultant, Cardinal Health , , Ravi Rai, Ph.D , Senior Research Scientist III, AMRI Albany , , Greig Ross , Director of Business Development, PCI Pharma Services , ,

One-Way Ticket to Commercial Launch: What to consider for drug synthesis, clinical trials, and regulatory filing

Preparing for a successful commercial launch starts long before FDA approval. This seminar will outline what drug synthesis, clinical logistics, packaging design, and regulatory considerations should be considered for commercial launch. This includes:
• The importance of route scouting and development while getting the drug registered and validated
• Avoiding the edge of failure in the drug synthesis process
• Transitioning from clinical to commercial: safety & efficacy data, packaging design,
• A review of the Investigational New Drug (IND) application and the FDA’s marketing authorization process, including common areas that are underestimated
• The packaging design, logistical and regulatory steps needed to flourish under expedited FDA programs (i.e. Fast Track, Breakthrough, Accelerated Review, etc).

How to accelerate drug development and reduce costs with in-human data before phase I

Date
8:00am - 10:00am
Location
San Diego Biocom 10996 Torreyana Rd #200 San Diego, CA 92121
Speakers:
Go van Dam , CEO and Co-Founder at TRACER , ,

Today, developing a new drug can cost an average of $1.4billion and take 10+ years to reach the market. With lower R&D productivity and higher R&D costs the pressure to achieve return on investment for new innovative drugs is higher than ever before.

The FDA approved microdosing technique offers a solution that provides up to 50% faster time-to-market and up to 50% less development costs. In short, microdosing shows whether the tested compound reaches the target tissue in humans before Phase I.

Why attend? In this in-human microdosing workshop you will learn how to employ a microdosing strategy to accelerate your drug development and enjoy benefits, such as:
• Generate in-human data before Phase I
• Make early go/no-go decision making on MNEs
• Skip costly large animal toxicity studies by having in-human data
• Monitor progression of diseases or results of treatment over time
• Boost company valuations with positive in-human data even before phase 1

Who should attend? In-human microdosing can be applied in small to large organizations that are developing new drugs for the market. Therefore, TRACER and BIOCOM invite:
• All organizations that are actively developing a new drug to the market
• R&D scientist that would like to broaden their horizon
• Business Development Managers that look to optimize their business
• Biotech start-ups wanting to increase company valuation from an early stage
• Life Sciences investors that want to learn how to increase asset value and decrease investment risk through microdosing

Speakers
Prof. Go van Dam, CEO and Co-Founder at TRACER, will host the interactive workshop in both San Diego and San Francisco. He published the 1st in-human application of targeted fluorescence imaging in 2011 (Nature Medicine) and published more than 140 papers predominantly on the subject of clinical translation of innovative-targeted optical molecular imaging. He is considered an expert in his field and strives to make in-human microdosing and molecular imaging a standard in drug development.

How to accelerate drug development and reduce costs with in-human data before phase I

Date
11:00am - 1:00pm
Location
San Francisco Biocom 1 Tower Place #150 South San Francisco, CA 94080
Speakers:
Go van Dam , CEO and Co-Founder at TRACER , ,

Today, developing a new drug can cost an average of $1.4billion and take 10+ years to reach the market. With lower R&D productivity and higher R&D costs the pressure to achieve return on investment for new innovative drugs is higher than ever before.

The FDA approved microdosing technique offers a solution that provides up to 50% faster time-to-market and up to 50% less development costs. In short, microdosing shows whether the tested compound reaches the target tissue in humans before Phase I.

Why attend? In this in-human microdosing workshop you will learn how to employ a microdosing strategy to accelerate your drug development and enjoy benefits, such as:
• Generate in-human data before Phase I
• Make early go/no-go decision making on MNEs
• Skip costly large animal toxicity studies by having in-human data
• Monitor progression of diseases or results of treatment over time
• Boost company valuations with positive in-human data even before phase 1

Who should attend? In-human microdosing can be applied in small to large organizations that are developing new drugs for the market. Therefore, TRACER and BIOCOM invite:
• All organizations that are actively developing a new drug to the market
• R&D scientist that would like to broaden their horizon
• Business Development Managers that look to optimize their business
• Biotech start-ups wanting to increase company valuation from an early stage
• Life Sciences investors that want to learn how to increase asset value and decrease investment risk through microdosing

Speakers
Prof. Go van Dam, CEO and Co-Founder at TRACER, will host the interactive workshop in both San Diego and San Francisco. He published the 1st in-human application of targeted fluorescence imaging in 2011 (Nature Medicine) and published more than 140 papers predominantly on the subject of clinical translation of innovative-targeted optical molecular imaging. He is considered an expert in his field and strives to make in-human microdosing and molecular imaging a standard in drug development.