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 topics in organic and process chemistry. Our short intensive training courses enable scientists to learn about highly relevant topics, to broaden their knowledge and to keep abreast of new science, new technology and new techniques. www.scientificupdate.co.uk | [email protected] 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 [email protected] 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 [email protected] 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 attendee(s) @ $950.00 First Attendee Name Purchase Order No. Payment Method Company Title I would like to charge the fee(s) to my credit card. 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