How to Identify, Characterize, Select, and Isolate the Optimal Solid State

How to Identify, Characterize, Select,
and Isolate the Optimal Solid State
Form for Pharmaceutical Development
A New Two Day Course
15 - 16 May 2014
Rutgers University Inn & Conference Center
New Brunswick, NJ, USA
Held in conjunction with
“Scientific Update Courses are always very
informative – with a lot of interesting &
useful data. Good helpful case studies,
and excellent reference material.”
Previous Course Attendee
PROFESSIONAL DEVELOPMENT TRAINING
Scientific Update provides training courses for industrial chemists and chemical
engineers in chemical development and scale-up and many other specialist
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We’ve Got Chemistry
How to Identify, Characterize, Select, and
Isolate the Optimal Solid State Form for
Pharmaceutical Development
15 - 16 May 2014 Rutgers University Inn & Conference Ctr., New Brunswick, NJ, USA
Introduction
Course Outline
Day One
Day 2
API or drug product is critical to
any pharmaceutical development
project.
0830Registration
0830
0845
Introduction To Solid Forms
This type of information is crucial from
a scientific, regulatory, and intellectual
property standpoint.
0945
What Is Polymorphism?
As the scientific complexity of drug
development increases, finding the
optimal development path for both
drug substance (API) and drug
product (formulation) is of utmost
importance.
1100
1145
Solid-state characterization of an
This demands a fundamental
understanding of the materials
science surrounding the API and
formulations.
This course will provide bench level
scientists, engineers, and lawyers an
in-depth understanding of the solidstate as it applies to all aspects of
pharmaceuticals.
1030Coffee
Amorphous Solid Dispersions.
Characterisation Of Solid Forms
1130
Thermodynamic Stability And
Principles Of Crystallisation.
Amorphous Dispersion Screening,
Characterization, And Selection
1230Lunch
Workshop Session
1500Tea
1530
1000Coffee
1030
1230Lunch
1400
Case Studies In Polymorph
Crystallisation And Form Control
On Scale Up.
Polymorph Screening And
Selection
1615
Solvates And Hydrates
1700
Polymorphs And Patents
1745
End of day 1
1830
Course Dinner
Who Should Attend?
• Organic/Medicinal Chemists –
anyone where solid state impacts
material quality and performance
• Pre-formulation Scientists
• Chemical Engineers
• Formulators
• Intellectual property lawyers and
legal team
• Pharmaceutical Scientists
• Analytical Chemists
• Solid State/Material Scientists
• Regulatory Personnel
Register for this course by using the form overleaf or call:
1400
Workshop Session
1500Tea
1530
Co-Crystal Screening And
Characterisation
1615
Regulatory Guidance On
Co-Crystals
1715
Round Table Discussion Around
Scaling Up Co-Crystals
1745
End of course
“Scientific Update Courses are always
very well organised and presented in an
understandable way.”
Previous Course Attendee
We’ve Got Chemistry
Course Tutors
John Knight gained a first
class honours degree in
chemistry at the University of
Southampton, UK. At
Southampton he studied for his
PhD in synthetic methodology after which,
John moved to Columbia University, NY, USA
where he worked as a NATO Postdoctoral
Fellow with Professor Gilbert Stork. John joined
Glaxo Group Research (now GSK) in 1987 as a
medicinal chemist before moving to the process
research and development department within
Glaxo. During his time at Glaxo, John worked on
a number of projects and gained considerable
plant experience (pilot and manufacturing). in
1994 whilst working at Oxford Asymmetry he
worked with a consultant project manager to
design, build and commission a small pilot plant,
whilst in parallel developing the chemistry PRD
effort at Oxford Asymmetry. The plant was fully
operational within 18 months. He had
considerable input into the design of a second
plant, which was completed and commissioned
in 2000.
During his time at Evotec he established a
team to perform polymorph and salt screening
studies and established and maintained high
standards of development expertise across the
department. John has managed the chemical
development and transfer of numerous NCE’s
into the plant for clients and been involved in
process validations. He joined Scientific Update
in January 2008 as Scientific Director.
Ann Newman is currently a
pharmaceutical consultant at
Seventh Street Development
Group with over 20 years of
large pharma and contract
research experience. She is also VP of Scientific
Development and Head of the Scientific
Advisory Board at Crystal Pharmatech. Ann
received her PhD in Chemistry from the
University of Connecticut. For ten years, Dr.
Newman performed characterization studies on
a wide range of pharmaceutical systems at
Bristol-Myers Squibb, covering drug substance
and product scale-up from late drug discovery
to launch and manufacturing.
After that she was Vice President of Materials
Science at SSCI, Inc. overseeing characterization
of API and drug product samples, crystallization
and polymorph screens, salt and cocrystal
selections, quantitative assays, amorphous
projects, and problem solving for the
pharmaceutical industry. As Vice President
of Research and Development at Aptuit, she
instituted a companywide R&D initiative over
six global sites and covering areas such as API,
preclinical (toxicology, safety, pharmacokinetics),
formulation, solids, analytical, clinical packaging,
and regulatory. She holds an adjunct faculty
in Industrial and Physical Pharmacy at Purdue
University and is author/collaborator on over 45
publications, 90 technical presentations, and 55
webinars.
Robert Wenslow is a seasoned
drug development scientist
with a strong background in
pharmaceutical characterization.
He has extensive experience in
all solid-state research issues relating to the
pharmaceutical industry. In his new role as Vice
President of Business Development at Crystal
Pharmatech, he and his team will work with
you to speed up your drug discovery, research
and development needs at a containable cost.
Before joining Crystal Pharmatech, Robert spent
14 years at Merck & Co. His group supported,
on average, 30 drug development projects per
year. They contributed to salt and polymorph
selection, crystallization development and
optimization, preparation of registration
documents, and specification setting in the area
of solid-state support for both bulk drug
substance and drug product. Robert received
his Ph.D. in Analytical Chemistry from The
Pennsylvania State University; has presented as
invited lecturer at over 10 conferences; has
published over 25 peer reviewed journal
articles, and is co-author on over 10 patents.
Robert also spent two years at Merck’s
Manufacturing site in Ballydine, Ireland where
he was responsible for creating and leading the
first research based Analytical Science Group in
the Merck Manufacturing Network. The group
provides drug substance and drug product
analytical development and testing for late
stage drug candidates. crystalpharmatech.com
twitter.com/crystalpharma
john.knight@scientificupdate.co.uk
Venue
Rutgers University Inn & Conference Center
178 Ryders Lane, New Brunswick, NJ 08901-8556, USA
www.meeteatsleep.rutgers.edu
A limited number of rooms have been reserved at the special rate of $68 plus tax
per room per night. Please use the hotel booking form, which will be sent when you
register.
Travel: Newark International Airport is approximately 25 miles away.
Fee & General
Information
$950.00
Includes lunch & refreshments, course
dinner and comprehensive course manual.
The course begins with registration from
8.30am on Thursday 15 May and finishes
at approximately 5.45pm on Friday
16 May.
tel +44 (0)1435 873062 info@scientificupdate.co.uk fax +44 (0)1435 872734
The organisers reserve the right to change the published programme of events and course content as circumstances dictate.
Identify, Characterize, Select, and Isolate the Optimal
Solid State Form for Pharmaceutical Development
15 - 16 May 2014 Rutgers University Inn & Conference Ctr., New Brunswick, NJ, USA
We’ve Got Chemistry
Please register
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