Basics of Biotech and Clinical Trials Summit are now available on demand! View the courses until Monday, November 30.
Basics of Biotech is a comprehensive virtual course providing you with an overview of the development of biopharmaceuticals. The course will start with foundational basics and give a detailed overview of the entire process from discovery to commercialization. As an attendee, you will learn a bit of the science behind biotech products, the clinical research process, regulatory filings, and scale-up for manufacturing. Different types of products such as biologic drugs, biosimilars, personalized medicine, stem cell, and regenerative medicine will be outlined.
Recieve up to 6 CLE credits upon the completion of the on demand course!
This training will progress under the umbrella of the development timeline, from start to finish.
Learning Objectives:
This virtual course will…
- Explain the biotech processes, what they are and how they work
- Explain the biotech lab, what it looks like and how it operates
- Explain the biotech product development process
- Examine how manufacturing facilities are built and operate
- Examine the evolution of biotech manufacturing
- Relate each step to the previous steps, and provide you with a seamless, consistent overview
- Provide an overview of basic science, terminology and common areas of failure in product development
- Prepare you to improve in your current role, or be ready to enter the biotech field with foundational knowledge
- Provide an overview of the cell therapy manufacturing process and RMAT product types
Who Should Attend?
This course will benefit anyone who is new to the biotech/biopharma industries, needs to know the process at a high-level, or those who need a refresher. There is no level of prerequisite knowledge or understanding necessary to attend. Additionally, this course will be of value to those who support any step within the development process, including outside vendors.
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The Clinical Trials Summit (formerly called the CRO/CMO Summit) hosted biotechnology, pharmaceutical, medical device and diagnostic companies from the Mid-Atlantic region and included a Keynote Opening Speaker, and two panels to discuss topics of importance to individuals planning or managing clinical trials.
Who Should Attend:
· Individuals interested in becoming involved in a strategic partnership with a CRO or CMO in the next 12 to 18 months
· Biotech, pharma, medical device or diagnostic companies planning a clinical trial
· Individuals who have secured a CRO and CMO and the relationship has not been successful
AGENDA:
Welcome: Chris Molineaux, LSPA welcomes Executive Champion from West Pharmaceutical Services, Cindy Reiss-Clark, SVP Market Units and Commercial Solutions
Opening Keynote: Understanding Vaccines and the landscape of COVID-19 Clinical Trials
*Keynote Speaker, Paul Duprex, PhD, Director, Center for Vaccine Research, Professor of Microbiology and Molecular Genetics, University of Pittsburgh
Panel Discussion: Hot Legal Topics for Clinical Trials Today
Clinical Trial-Related Injuries
Updates to common rule/informed consent
Broad consent for future research using blood and other biospecimens obtained in clinical trials: Don’t miss out on this opportunity
Subject injury language in clinical trial agreements: How to avoid violating the Medicare Secondary Payer Act
Section 111 reporting obligations in clinical trials: Civil money penalties are coming
Clinical Trial Support and the Anti-kickback Statute
How to get comparator drug for clinical trials when competitors won’t cooperate
Implications of upcoming changes to the Sunshine Act reporting requirements
Speakers: Judy O'Grady, Partner and Ronni Fuchs, Partner, Troutman Pepper
Panel Discussion: Strategy for Planning and Executing Clinical Trials – Looking Forward and Ensuring Business Continuity
Managing disruption – shifting the size, duration and number of endpoints
Protocol considerations: design and implementation for smaller and niche populations
COVID-19 influence on patients, on-going studies, sites, visits.
Data collection considerations for decentralized or partially-decentralized studies.
Panelists: Takashi Asahi, Corporate Officer, Division Head of Project Management at CMIC Group; Fran DeGrazio, Chief Scientific Officer, West Pharmaceutical Services; JeanMarie Markham, CEO, Clinlogix and Earl Sands, MD, SVP and Senior Medical Officer, Parexel; Kristine Koontz, Head US Clinical Operations, GSK