Thursday September 2, 2010 Thursday September 2, 2010
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Ms. Sue Harris
Unit Manager, Licensing Division
MHRA
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Sue is registered as a Pharmacist with the Royal Pharmaceutical Society of Great Britain and is a Fellow of The Organisation for Professionals in Regulatory Affairs
She graduated Bachelor of Pharmacy from the London School of Pharmacy and gained an MSc. in Biopharmacy at Kings College University of London.
She worked in community pharmacy for about 10 years before joining the Medicines Division of the Department of Health and Social Security as a Pharmaceutical Officer in November 1986. Having spent several years as a Senior Pharmaceutical Assessor in the Licensing Division of the Medicines Control Agency (now the MHRA), responsible for assessing new chemical entities’s and all types of abridged applications, Sue is now Unit Manager of PLAT 5, the Product Lifecycle Assessment Team dealing with anti-infectives and antibiotics, genito-unrinary products, obstetric and gynaecological products, herbals and homeopathics.
In 2005, Sue presented on the quality and safety of traditional Chinese herbal medicines (TCMs) at the WHO inter-regional workshop on GACP and GMP for herbal medicines, held in Shanghai. She also attended the Second International Conference on the Modernization of Traditional Chinese Medicine in Chengdu, Sichaun Province and was a member of the British delegation at China-UK Traditional Chinese Medicine Seminar organised by the British Consulate. In 2009, she was invited by the Chinese Government to the Symposium on Legislations and Regulatory Practice of Phytomedicine in the the EU, held in Beijing, to present on the European Regulations for Herbal Medicines: the UK experience of problems with quality and safety.
Sue is one of the UK Experts for the CHMP (Committee on Human Medicinal Products) and is the UK’s alternate delegate to the HMPC (Herbal Medicinal Products Committee) at the EMA (European Medicines Agency) in London.
Mr. Timothy Schofield, M.A.
Director, North American, Regulatory Affairs
GlaxoSmithKline
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Timothy Schofield is a Director in the U.S. Regulatory Affairs department of GlaxoSmithKline, where he provides regulatory support to vaccines. Prior to joining GSK Tim worked at the Merck Research Laboratories heading the Nonclinical Statistics unit, supporting development and manufacture of Merck pharmaceuticals, biologics, and vaccines. In addition to his service to GSK and Merck, Tim has held several positions on industry and regulatory committees. He was elected to the PhRMA Biostatistics and Data Management Technical Group in 2002 where he represented nonclinical statistics for 3-years, and is an active member of the PhRMA CMC Statistics Expert Team since 2004. Tim also served as liaison to the PhRMA Biologicals and Biotechnology Subcommittee, where he was co-chair of the Specifications and Formulation Working Group. In that role he led efforts to publish a PhRMA white paper on A Rational Approach for Setting and Maintaining Specifications for Biological and Biotechnology–Derived Products. He is also a coauthor on a white paper on Quality by Design for Biotech Products. Tim is a member of the USP Bioassay Validation ad hoc Panel, and lead author of Chapter <1033> Bioassay Validation. He received a Bachelor of Science degree in mathematics in 1973 from Lafayette College, Easton, PA, and a Master of Arts degree in statistics in 1976 from the University of Pennsylvania in Philadelphia
Dr. Duu-Gong Wu
Executive Director, Consulting Division
PharmaNet Inc.
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Dr. Wu is currently Executive Director of Consulting Division within PharmaNet Development Group International,a global drug development company located at Princeton New Jersey . Prior to joining PharmaNet, Dr. Wu was with US Food and Drug Administration for more than 12 years, worked as a reviewer, Chemistry Team Leader, and Deputy Division Director of Division of New Drug Chemistry II, Office of New Drug Chemistry (ONDC), which supports CMC review for six clinical divisions in Center for Drug. At FDA, he has participated in drafting ICH and FDA domestic stability guidances including ICH Q1A and Q5C and development of many stability protocols. Dr. Wu’s regulatory experience in dealing with stability issues covered drugs of small molecules and complex drug substance including proteins, peptides, and botanical products. He was a member of ICH Expert Working Group in many CMC related topics. His current position in PharmaNet has expanded his experience further into the areas of combination products including device-drug and device- biologics combinations
Dr. Wu received his Ph.D. degree in Biochemistry and Molecular Biology from University of Maryland Medical School and did his postdoctoral study in Johns Hopkins University Medical School.
Dr. William M. Egan
Vice President
PharmaNet Consulting
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Dr. Egan has more than 30 years experience in the development and regulation of biologics. In his current capacity as Vice President in the Consulting Division at PharmaNet, Dr. Egan advises clients on strategic planning and development of biologics, primarily vaccines and therapeutic proteins; he has consulted on regulatory submissions from pre-IND meetings through to BLA license applications and post-marketing changes. Dr. Egan joined PharmaNet in 2005, after spending 28 years at the FDA’s Center for Biologics Evaluation and Review and its precursor agencies. Dr. Egan was the Office of Vaccines Research and Review’s Acting Director for one and a half years prior to his retirement from FDA in 2005. During his career at FDA, Dr. Egan also held positions as Deputy Director of OVRR (1995 – 2005), OVRR Associate Director for Research (1993 – 2005), and Chief of the Biophysics Laboratory (1983 – 1995). During his tenure at OVRR, Dr. Egan represented the Agency to various National and International organizations and to the US Congress.
Dr. Egan received his Ph.D. in Chemistry from Princeton University and prior to joining CBER was a Post-doctoral fellow at the Division of Physical Chemistry at the Lund Institute of Technology (Sweden) and a Senior Staff Fellow at the National Institutes of Health (Bethesda, MD). Dr. Egan is the author or co-author of over 100 scientific publications, primarily in the area of structural characterization of bio-macromolecules.
Dr. Egan is a member of a number of profession societies, including the International Association for Biologicals, for which he is co-chair for the Human Vaccines Scientific Committee.
Dr. Paula Shadle
Principal Consultant
Shadle Consulting
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Dr. Shadle has over 20 years of hands-on and executive experience in biopharmaceutical and pharmaceutical process development and quality, 35 publications and 4 process patents. Dr. Shadle has written over 35 technical publications and was co-inventor on four process patents, and teaches adult education for the University of Wisconsin, the Parenteral Drug Association, PQRI and the Institute for International Research. In 2000, Dr. Shadle received the Judith Pool Award for excellence in teaching and mentoring from AWIS. She was on the planning committee for the 2001-2003 PDA-FDA Meetings, and is Member-At-Large in the West Coast Chapter of PDA. She has spoken at several EBC briefings, and is a member of the Parenteral Drug Association, the American Society for Quality, the Association for Women in Science, and the California Separations Society (CaSSS). Dr. Shadle is on the editorial board of the journal BioPharm International, and often writes about quality and science. She is currently Member-At-Large in the West Coast Chapter of PDA, Treasurer of the East Bay Chapter of AWIS (Associate for Women in Science), an organization that mentors and supports women in the sciences.
Dr. Shadle received her B.S. and Ph.D. in biochemistry at the University of California and postdoctoral training at the Max-Planck Institute in Germany. She worked in technical and quality control/assurance positions of increasing responsibility at Chiron Corporation, Scios Inc., GlaxoSmithKline plc, and Bayer Corporation before founding Shadle Consulting. At GSK she was director of downstream process development, then of biopharmaceutical quality operations, overseeing QA, QC, analytical methods and validation. At Bayer Corporation, Dr. Shadle was director of quality control of marketed products.
Dr Shadle founded Shadle Consulting in 2001, which offers consulting services for biotechnology and biopharmaceutical firms in quality, process development, and strategic planning of quality systems. Services provided include internal and external audits, GMP training, QC laboratories, and QA systems. Experienced with clinical trials materials, process validation, and more.
Dr. Lina Patel
Associate Director, Analytical Group
Diosynth
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Dr. Patel is currently an QC Analytical Manager in the Analytical Group at Diosynth Biotechnology, Research Triangle Park, NC. She has been with Diosynth Biotechnology since 1998 and has been a manager for several groups – analytical testing, raw materials, clinical release and stability, stability, and quality assurance for clinical phases. Dr. Patel has more than 15 years of experience in the pharmaceutical/biotechnology industry, including experience at Bayer Corporation and AndCare, Inc. She received her PhD in Biochemistry from North Carolina State University in 1989 and her post-doctoral training at the National Institute of Environmental and Health Sciences.
Dr. Mark Alassandro
Pharmaceutical Professional
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Dr. Mark Alasandro earned his Ph.D. in Analytical Chemistry from Indiana University. He chaired the PhRMA Stability Working Group from 2003 to 2009 supporting several industry advocacies. Their most recent advocacy was ensuring issuances of the WHO Stability Guidance. Mark and his group championed science-based stability designs and QbD approaches, while applying these principles in developing a Quality Overall Summary Stability model that he presented at the 2007 AAPS Stability Workshop. The group's QbD approaches were presented at the 2009 AAPS Annual Meeting. For the past eight years, he was the Director of Merck’s Stability Group having responsibility for their registration stability studies. Prior to Merck, he spent 17 years at DuPont Pharmaceuticals where he was responsible for pre-clinical GLP, first-in-man trials, Phase I-III clinical, registration stability studies, and launch. Mark has over 60 combined publications and presentations. Most recently, he was on the planning committee for the 2009 AAPS Stability Workshop. He is a highly sought after speaker on current and future trends in stability.
Mr. Ronald Turton
Chief Scientific Officer
QCL- Quality Compliance Laboratories
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Mr. Turton has been involved within the Health Canada and FDA regulated pharmaceutical industries continuously since 1971. His experience covers the areas of Research and Development, Quality Assurance, Quality Control, Compliance, Technical Services and all aspects of Validation from a senior Management perspective. Currently, Mr. Turton is the Chief Scientific Officer at Quality Compliance Laboratories (QCL) providing a wide range of analytical testing services to the pharmaceutical, bio-pharmaceutical, nutraceutical and related industries. Mr. Turton was instrumental in implementing most of QCL's quality systems including the stability storage and testing program.
Prior to QCL, Mr. Turton was associated with Patheon for five years overseeing a team of people responsible for Stability, LIMS, Instrument Validation and Calibration, Technical Writing, Sampling and Packaging Material Control and Annual Product Review (APR). This team was critical to the attainment of committed goals as their internal and external customers included personel and functions extending beyond the laboratory.
Mr. Turton began his career as a bench analyst with Adam's Brands in Toronto. Within a year, he'd transferred to their pharmaceutical division (Warner Lambert) where he worked in various laboratory departments before leaving to join Sandoz Pharmaceuticals where he progressed through laboratory Supervisor to various Management roles with ever increasing responsibilities. When Sandoz merged with CIBA to become Novartis Pharmaceuticals, one of Mr. Turton's duties was to facilitate the transfer of more than 50 product lines into the Whitby manufacturing site from the Dorval manufacturing site while maintaining product Compliance with no major disruptions in product supply.
Mr. Turton is a member of the editorial board of "Pharmaceutical Canada", the only Canadian magazine devoted to providing information specifically targeting the pharmaceutical industry. As well, he is the current chairman of the Research Ethics Board (REB) of Lakeridge Health Corporation overseeing ethical approval of clinical trials conducted at several sites affiliated with Lakeridge Health.
Mr. Turton is also affiliated with a number of pharmaceutical organizations such as: the International Pharmaceutical Academy, the American Chemical Society, the Chemical Institute of Canada and the Association of the Chemical Profession of Ontario. He obtained his Master of Science degree in Chemistry from York University, Toronto and his Bachelor of Technology in Chemical Technology from Ryerson University, Toronto, Ontario.
Dr. Nicholas Cappuccino
Chief Executive Officer
Pharmaceutical Intellectual Resource Services LLC
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Dr. Cappuccino is the Chief Executive Officer of Pharmaceutical Intellectual Resource Services LLC, in Lambertville, NJ USA. His specialty is Pharmaceutical Development with an emphasis in Generic Drugs. Prior to that, Dr. Cappuccino was the Chief Scientific Officer of Eagle Pharmaceuticals Inc. in Woodcliff Lake, New Jersey, USA. Dr. Cappuccino was formerly the Executive Vice-President, Chief Scientific and Technical Officer of Andrx Pharmaceuticals and Watson Laboratories in Weston, Florida. Prior to Andrx, Dr. Cappuccino was the Vice-President of Research and Development and a member of the Executive Management Committee for Sandoz Inc. in Princeton, NJ. Prior to joining Sandoz he was Vice-President of R&D for Apotex, Inc., Toronto, Canada, responsible for world-wide generic drug development at Apotex.
Dr. Cappuccino currently serves as the Chair of the Science Committee for the International Generic Pharmaceutical Alliance (IGPA) and represents the generic industry as an Observer on the ICH Steering Committee and as an Industry Observer on the WHO Expert Committee for Specifications for Pharmaceutical Preparations. Dr. Cappuccino is currently a member of the ICH Quality Implementation Working Group (QIWG) and the Q4B (Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions) Expert Working Group. Nick has been a member of the ICH Expert Working Groups for Stability (Q1A-F), Impurities (Q3A/3B), and Pharmaceutical Development (Q8). He is a member of the American Association of Pharmaceutical Scientists, the Drug Information Association, and the American Chemical Society. Dr. Cappuccino is a member of the Editorial Board of the Journal of Generic Medicines.
Dr. Cappuccino holds a Ph.D. in Organic Chemistry from Stevens Institute of Technology, Hoboken, NJ, USA and an MBA from Fairleigh Dickinson University, Madison, NJ, USA.
Mr. Steven Walfish, MS, MBA
President
Statistical Outsourcing Services
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Mr. Steven Walfish is the President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to variety of industries. Prior to starting Statistical Outsourcing Services, Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD. Prior to joining HGS, Mr. Walfish was a Senior Associate at PricewaterhouseCoopers specializing in the pharmaceutical industry.
Mr. Walfish brings over 20 years of industrial expertise in the development and application of statistical methods for solving complex business issues including data collection, analysis and reporting. Mr. Walfish concentrates his efforts on the medical device, pharmaceutical and biotechnology industries.
Mr. Walfish holds a Bachelors of Arts in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers University and an Executive MBA from Boston University.
Dr. Charlie Sodano
President
eOrganizedWorld
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Dr. Sodano is an experienced information management professional within the research and development field. He began his career as a Research Chemist at Pfizer and served as Information Services Manager at Nabisco, Inc. He is currently at Berlex Biosciences in Richmond California where he has responsibility for electronic and paper records management, the technical library and administration of global research electronic information systems. Dr. Sodano holds B.Sc. and M.Sc. degrees in Chemistry from Seton Hall University and a Ph.D. in organic chemistry from Arizona State University.
Dr. Sodano has made numerous presentations at local and national American Chemical Society, ARMA meetings and other national symposiums and workshops. He has participated in Information committees in the Institute of Food Technologists, the American Chemical Society, American Association of Cereal Chemists. and CENSA. Dr. Sodano currently is vice president and webmaster (arma-sfbay.org) of the Mt. Diablo Chapter of ARMA.
| Day 1 Tuesday March 23, 2010 | |
| 08:00 AM - 08:30 AM | Registration and Continental Breakfast |
| 08:30 AM - 09:15 AM | How the ICH guidelines have influenced Stability guidelines around the world. |
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| 09:15 AM - 10:15 AM | Stability -An Overview of European Regulatory Requirements |
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| 10:15 AM - 10:30 AM | Mid-Morning Refreshment Break |
| 10:30 AM - 11:15 AM | US Regulatory Perspective on Stability Testing of Drug Products |
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| 11:15 AM - 12:00 PM | Stability Studies and the Product Life Cycle |
| 12:00 PM - 01:15 PM | Luncheon |
| 01:15 PM - 02:15 PM | Q1E - ICH Harmonised Tripartite Guideline - Evaluation for Stability Data |
| Using Practical Statistics to Interpret Stability Results | |
| 02:15 PM - 04:00 PM | Stability Challenges of Biologics Stability Indicating Profile for Biotechnology Products: Considerations for Development of Stability Testing Program for Biopharmaceuticals |
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| 04:00 PM - 04:15 PM | Mid-Afternoon Refreshment |
| 04:15 PM - 05:00 PM | Effective Records and SOP management to Assure Data and Record Integrity in Stability Programs |
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Record keeping is often neglected or has a low priority in many organizations. A properly designed records program does not consume scarce resources. It assures regulatory compliance and the preservation and retrieval of essential information . Record life cycle management is the key to controlling maintenance costs and assuring that records will be available when needed.
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| 05:00 PM - 05:15 PM | Questions & Answers |
| 05:15 PM | Conclusion of Day One |
| 05:30 PM - 07:00 PM | Networking, Wine & Cheese Reception |
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Take your discussions further and build new relationships in a relaxed and informal setting |
| Day 1- Parallel Workshop Sessions | |
| 10:30 AM - 12:00 PM | Use of Statistics to Establish a Stability Trend - Matrixing |
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| 01:30 PM - 04:00 PM | Effective OOS and Failure Investigations: |
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When an OOS observation is made, a firm is required to perform a complete and thorough failure investigation. Beside the goal of determining whether the stability study has had a true failure, a firm is attempting to identify the root causes of the failure and take action to make it less likely to recur. Despite considerable attention by firms, this area remains the most-cited for deficiencies by regulatory authorities. In this session, we will discuss the following:
Best practices in OOS investigations and reports |
| Day 2 Wednesday March 24, 2010 | |
| 08:00 AM - 08:30 AM | Continental Breakfast |
| 08:30 AM - 09:15 AM | Key Challenges in Stability Testing for Generics |
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| 09:15 AM - 10:15 AM | Outsourced Stability Studies: Challenges and Best Practices |
Many firms have outsourced both manufacturing and stability testing to an external CMO. Regulations and good business practices require that the sponsor exercise due oversight, and regulators hold the sponsor ultimately responsible for any deficiencies. With sponsor and CMO sometimes far apart geographically, different in size and experience, and in an environment of cost containment, the CMC team has several obstacles to navigate. In this session, we will consider the stability study and outsourcing, discuss common challenges and best practices to address them.
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| 10:15 AM - 10:30 AM | Mid-Morning Refreshment Break |
| 10:30 AM - 11:15 AM | Update on the WHO Stability Guideline |
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| 11:15 AM - 12:15 PM | Quality by Design (QbD) and Stability Testing |
Since the role out of FDA’s 21st Century GMP Initiative on August 21, 2002, there have been many guidances on pharmaceutical Quality by Design (QbD). These guidances provide us with a common terminology as well as a set of tools to assess process risks. These coupled with the well established guidances, such as the SUPAC, Stability Guidances (ICH Q1A through Q1E), provide some unique opportunities to conduct science-based stability approaches. Such approaches have been well presented by the former Pharmaceutical Research and Manufacturers of America (PhRMA) Stability Working Group. The application of such approaches does not always require more work, and can provide a more focused and integrated approach. This talk will review some of the key principles and tools to build a process that will improve on while quickly understanding the critical stability factors.
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| 12:15 PM - 01:30 PM | Luncheon |
| 01:30 PM - 02:30 PM | Establishing and maintaining a digital records archive |
The replacement of traditional paper records archives with computer files has been accelerating for the past few years. This is primarily due to the fact that most records are currently authored electronically. There is some resistance to this movement, particularly in areas that are government regulated. Digital archives have distinct advantages and challenges. There are numerous global and international guidelines and an explosion of commercial software products available to aid the digital records archivist. How to begin to organize a digital archive Strategies to maintain an archive with minimal resources and user training Long term e-record preservation planning |
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| 02:30 PM - 03:30 PM | Developing Stability SOPs and Study Protocols |
| 03:30 PM - 04:15 PM | Stability and Analytical Global Regulatory Considerations and Challenges for Biologics Especially Vaccines and Biosimilars: Vaccine Shelf Life and Post-licensure Stability Studies |
Biologics are continuing to find increasing importance in the treatment and prevention of disease. It has been predicted that by 2014, seven out of the ten top selling drugs will be biologics. There are many challenges in bringing a new biologic to the market. Among these are the analytical challenges to understand and control product stability. To meet these challenges, we must apply a well executed strategy so we can deliver high quality products with maximum product shelf life. To achieve this, we also need to understand the global regulations. Understanding and integrating both will enable us to build a concerted process across development designing in quality, accelerated development and enabling continuous improvement. This talk discusses some of the analytical and regulatory challenges in designing a quality product, allowing maximization of shelf-life and minimization of post-licensure stability studies.
Shelf-life and post-licensure stability studies |
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| 04:15 PM - 04:30 PM | Question & Answer |
| 04:30 PM | Conclusion of the course |
| Day 2- Parallel Workshop Sessions | |
| 09:00 AM - 12:00 PM | WORKSHOP: |
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Designing and Implementing an Effective Commercial (Marketed products) Stability Program
Stability Challenges of OTCs, Nutraceuticals and Combination Products |
| 01:15 PM - 04:45 PM | WORKSHOP: |
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This two day program is directed toward Directors, Managers, Supervisors, Analysts, and Associates in the Pharmaceutical, Biopharmaceutical, Biotech, and allied industries with daily responsibilities in the following areas:
Registration Fee Includes: Presentation Materials, Luncheon, and Refreshments
Cancellation/Substitutions Policy:
All cancellations are subject to a USD $150.00/person processing fee. To receive cancellation credits for attendance at an upcoming course, IPA must be notified of the cancellation in writing (by email, mail or fax) up to 3 weeks prior to the program start date. Cancellations submitted less than 3 weeks prior to the event will not be qualified for refund or credit. Substitution of delegate/s with the member/s of the same organization is permitted at any time with no penalty.
IPA reserves the right to postpone an event, prior to which time all the registered attendees will be notified a minimum of 2 weeks in advance. IPA shall not be responsible for any air fare, hotel or transportation costs incurred by registrant/s.
Holiday Inn Somerset 195 Davidson Avenue |
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A special room rate has been prearranged for conference participants. Call the hotel directly at the above number and mention IPA to receive the reduced room rate. For more information, please call us at 416-410-7402 or enquiry@ipacanada.com |
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