Advance
of an important cell therapy is in your court.
What
will it take to succeed?
After taking
this course you will:
- Appreciate the common mistakes that slow
or prevent the advance of a cell therapy
- Be able to conquer requirements and
guidelines with precision
- Know what you'll need to educate, inform
and assure regulators
- Use innovative testing to define a cellular
product/intermediate and support safety
- Know how to easily pinpoint key safety
issues for your product
- Be more confident that your submissions
will be free of avoidable regulatory
delays.
- Know how to make every clinical test well
worth the time and expense
- Have the right information to
support the approval of your novel therapy
- Better appreciate the businessimpact of
your process.
 Training you won't get
from other courses...
As successful biotech pioneers in the space and
acknowledged scientific and industry experts, our course instructors
will
share their insights on real-world strategies that work, issues that
everyone should be
aware of, and lessons learned. This course is not a list of guidleines,
procedures and tests! Rather, it delves into their purpose and how to
fullfil that purpose to produce a medically and commercially sound
therapy.
Who
should
enroll:
Entrepreneurs, contract research and manufacturing organizations,
testing providers, regulatory staff, translational biologists and
clinicians
involved in cell-based regenerative medicine, stem cell therapy or
tissue engineering
Enrollment is
per location
Take the course
to advance your own professional expertise
Use the course
to educate and inform an entire team
Level:
Intermediate to advanced (the course covers scientific, strategic and
managment issues)
Flexible,
accessible course format
- On
demand
Training that
fits with your schedule
Listen as often
as you like
Anywhere,
anytime until the close of the course
- Total
lecture time: 3.5 hours.
The content is divided into lectures by topic for easy listening and
course navigation.
- The added option of a private tutorial by teleconference gives
participants the opportunity to get specific advice on issues most
relevant to their process and business.
Practical
content from a uniquely valuable perspective 
Part 1. Cell Bank Development and Use
- Cell Banking Principles and Strategy for
Cell-Based Therapies
- What the Regulators (and You) Really Want
to Know and Why
- Handling Different Types of Heterogeneity
- Defining Your Banks and Intermediates in
a Way that Meets the Needs of Regulators, Your Process, and Your
Company's Bottom Line
Part 2.
Science-Based Testing
- Assuring Safety, Purity and Potency
- Using In Vitro Testing to Maximum
Financial and Regulatory Advantage
- Beyond CMC: The Business Benefits of
Bioequivalence
- Quality Assurance, Quality Control and
Cost of Goods
Part .3 The
Make or Break Decisions
- Handling the Hurdles: Determining When to
Accept the Status Quo, Work Around or Conquer
- Establishing Effective Connectivity
Between Process, Product and Commercial Potential
- Determining When Your Process is Ready
for Clinical Trials
Optional
Private
Tutorial
A one hour high-value Q&A session with course instructors that
gives participants the opportunity to discuss, and get answers to,
specific
issues related to their process, product and business -- privately.
Available
on demand through November 30, 2010
Private tutorials are scheduled with course instructors on a first
come, first served basis.
Rolling enrollment closes
November 15, 2010
Click here to
enroll today
About
the instructors
Forget the old saying "Those who can, do, those who can't teach."
A few do both. Drs. Parenteau and Hardin Young have already been
where you are today. They will bring their pioneering experience to
bear for your goals and product.; teaching you what they have learned,
concept to completion, science to business, in successfully
bringing living cell therapy and tissue engineered products to
market..
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