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The 2013 AAPS National Biotechnology Conference (NBC) will gather scientists from industry, government, and academia for three days of educational offerings specifically geared toward the biotechnology sector of the pharmaceutical sciences.
Visit our Table #112 and get a coupon for a lunch discount!
CALBIO2013 pursues a goal of bringing together major players in the life sciences sector to foster collaborations in research, development and product commercialization with the goal of curing diseases and improving patient care. This statewide industry event brings together and creates a synergy between San Diego and the San Francisco Bay Area life sciences clusters. CALBIO2013 promotes California as a global innovation engine. It helps to foster connections between California companies, their national and their international counterparts. It helps companies to connect with investors, medical research foundations, thought leaders and innovators.
INTERPHEX JAPAN is the world's leading pharmaceutical event, covering the whole process of Pharmaceutical R&D and Manufacturing, from all kinds of equipment to lab devices, contract services, packaging, total solutions and so on. Firmly established as an annual event for industry professionals to gather at one place for business, the show has been expanding its scale every year.
Exhibit here and grab your chance in one of the largest and most promising markets, Japan & Asia.
The 40th Annual Meeting & Exposition of the Controlled Release Society theme will be Emerging Challenges for Global Delivery
Visit our booth # 207
The CPhI Worldwide 2013 is the world’s leading pharmaceutical networking event with over 29,500 attendees from over 130 countries and 2,200 exhibitors. The event offers the opportunity to meet face-to-face with international pharmaceutical companies, stay informed about the latest industry trends and remain one step ahead of a constantly changing pharmaceutical market.
Visit our booth # 42G03
Biotechnology partnering conference. BIO-Europe features the industry’s most advanced Web-based partnering system, enabling delegates from all parts of the biotechnology value-chain to quickly identify, engage and enter into strategic relationships that drive their business successfully forward.
The Universe of Pre-filled Syringes &Injection Devices brings together industry and regulatory experts to share their experiences, new developments, regulatory considerations, challenges and industry trends in this exciting area. The topics will benefit those looking for a basic understanding of pre-filled syringes and injection devices as well as those looking for a more in depth presentation of current challenges and developments. This is a must attend event for all industry professionals involved in the development, manufacturing, Marketing or use of pre-filled syringes and injection devices.
Scientists from around the world will gather to share the latest scientific discoveries and industry insights at the 2013 AAPS Annual Meeting and Exposition.
Complex Dosage Forms provide novel business opportunities for companies to leverage their existing products and intellectual property. The seminar topics will cover several Life Cycle Management strategies to enhance the product life cycle and extend the patent life of a drug.
Anil Kane: Business Opportunities in Life Cycle Management & Challenges in Multi-Layer Tabletting as an LCM Option
Don Barbieri: Complex Dosage Forms: Considerations in the Development and Utilization of Multi-particulates and Osmotic Delivery Dosage Forms
Doug Stockdale: Complex Dosage Forms: Considerations in the Development of Sterile Solutions for Lyophilized Dosage Forms
John McCarty: Regulatory Opportunities and Challenges in Life Cycle Management
Breakfast and morning refreshments will be served. You are also invited to a networking luncheon after the event. Seating is limited. Please RSVP as soon as possible.
Reaching First-in-Man studies is a critical milestone in the drug development process. However, navigating the road to a successful IND submission while simultaneously maximizing the value of your product is challenging and complex, with many important decisions points along the way. Whether you are faced with bioavailability issues, financial constraints, or pressure to meet accelerated deadlines, having a well-designed development plan for your molecule can make the difference between success and failure.
Massimo Bresciani: Simplification in Formulation Design and Personalised Medicine
Jon Sutch: Formulation Strategies to Quickly and Effectively Advance Oral Drug Products to First-in-Man
Roman Hlodan: Strategies for Early Phase Development of Sterile and Biopharmaceutical Products
Fintan Walton: How to Maximize the Value of your Assets
There will be a networking lunch during the registration and also a drinks reception at the end of the seminar.
Seating is limited so please register as soon as possible.
Patheon's team of expert pharmaceutical scientists provided a complimentary seminar where three scientific leaders shared their experiences and strategies for effectively progressing small molecules through early drug development. Please click on the links below to watch each presentation and also the roundtable session.
Anatomy of a Typical API Project, Dr. Paul Madeley, Synth-Isis Ltd. – here
Formulation Strategies or Early Development, Dr. John Sutch, Patheon – here
Solubility and Bioavailability Enhancement for Poorly Soluble Drugs, Rick Bastin, M.Sc.,MBA, Patheon – here
Roundtable Session - here
All pharmaceutical manufacturers are required to comply with regulations for cleaning validation. Many companies have incorporated their historical practices with limited scientific underpinning and little evaluation of risk. Some companies have chosen to avoid the debate entirely by using expensive disposable systems exclusively. Using the latitude available in cGMPs for 21st century, scientific data evaluation, and risk-based approaches can streamline the process. By developing sound and defensible programs with rapid and specific testing, cleaning validation can be efficiently and effectively implemented. This webcast will:
• introduce the science-driven risk-based guide for cleaning validation being developed by ISPE;
• discuss practical considerations for implementing cleaning validation programs; and
• highlight the speed and efficiency benefits of LC/MS for development and execution of cleaning test methods.
Industry Professor at Stevens Institute of Technology
Title: “Cleaning Validation for the 21st Century: Overview of New ISPE Cleaning Guide”
Geoff Carr, Ph.D.
Director, Analytical Development, Patheon Inc.
Title: “Use of LC/MS for Testing Cleaning Validation Samples”
Move your product development rapidly, achieving agreed timelines at fixed budgets and with minimal API.
This webinar offers a roadmap to understanding and overcoming solubility issues in Phase I clinical trials. We will discuss how companies can drastically improve solubility to optimize drug development timelines and get regulatory approval faster.
Attend this webinar and learn about:
Robin Platt - Operations Director at Patheon, Milton Park, UK
Jason Vaughn - Director of Formulation and Product Development at Patheon, Cincinnati, US
The tablet is the most common drug formulation on the market, but is it always the best choice to improve bioavailability? In many cases, current drugs would have performed better as softgels. Understanding when to leverage the advantages of softgel technology could save crucial time and resources in development and manufacturing in addition to offering the benefits of finally obtaining a better absorption and formulating a better product than the same tablet. During this 60 minute webcast, learn how softgel technology can be used to solve poor bioavailability challenges. Through case studies and analysis, two leading industry experts will provide an introduction to softgel technology and case studies where softgels have proven to be better.
What is Different about Soft Gelatin Capsules?
Diego Monterroza, Director of Research and Development at PROCAPS S.A., one of the world’s largest softgel manufacturers. In his presentation, Diego will provide an introduction to softgels including gelatin properties,advantages of softgel capsules, the manufacturing process, formulation, and quality controls.
Softgel Delivery Can Improve Drug Bioavailability
Edgar Jaynes, Associate Director, Liquid Fill Softgel, Pharmaceutical Development Services at Patheon, a leading global provider of contract development and manufacturing services. In his presentation, Edgar will review current Rx sofgels on the market, discuss bioavailability concerns, and provide case study examples of bioavailability enhancement using softgel formulations, including Cyclosporin, Digoxin, Dutasteride, Isotretinoin, Progesterone, and Saquinavir.
Historically, tablets have been the go-to formulation for products with multiple active ingredients. However, new softgel technology is emerging and challenges traditional formulation paradigms with innovative solutions to multiple API products and unique dosing regimens.
In this 60 minute webcast, two scientific experts in tablet and softgel formulation development, will examine the traditional approaches to multiple API product formulations and will introduce unique softgel technologies that overcome challenges faced with difficult-to-develop, multiple API products. These unique softgel technologies can be used for life cycle management, create lower-cost products, and enable combinations of multiple delivery systems in a single, patient centric dose, including:
• Multiple active ingredients
• Incompatible materials with different release profiles
• Liquids, granules, solids and hard capsules
• Fast and sustained release
• Gastric and intestinal release
Several formulation design options are available to control or modulate the drug release from a dosage form. The majority of oral dosage forms fall in the category of matrix, reservoir, or osmotic systems. In a hydrophilic matrix system, the drug is embedded in a polymer matrix and the release takes place by diffusion of the drug into the hydrated polymer gel layer and erosion of the gel layer into the release medium. In contrast, reservoir systems have a drug core surrounded or coated by a water-insoluble, but permeable rate-controlling membrane. However, factors such as pH, the presence of food, and other physiological factors may affect drug release from conventional, matrix and reservoir controlled-release systems. Osmotic systems utilize the principle of osmotic pressure for the delivery of drugs. Drug release from these systems is independent of pH and other physiological parameters to a large extent, making it possible to modulate the release characteristic by optimizing the properties of drug and the coating system. In this 60 minute webcast, two scientific experts in formulation development of oral osmotic release dosage forms, will speak on
Basic Formulation/Scale-up Considerations and the Theory behind Oral Osmotic Systems – Don Barbieri, Patheon, Inc
Recent Advances in Osmotic Delivery – Elizabeth Tocce, Dow Chemical Co.
The path to First in Man studies is a long road with many choices to make based on little to no information. In many cases, knowing the right path to take is dependent upon the signs read along the way and understanding which signs contain relevant information. Whether you are faced with bioavailability issues, financial constraints, or pressure to meet accelerated deadlines, having a well-designed development plan for your molecule can make the difference between success and failure. This webcast will provide you with insight into how to find the right signs and understand them to help you speed along the path to achieve the best outcomes. You will hear a detailed case study about the development of an insoluble compound that otherwise never would have made it to First in Man and lessons learned from that experience. These presentations and interactive Q&A sessions will provide you with insight into how to speed your molecule to First in Man studies with an optimal formulation strategy.
“Successful Dosage Form Development for First in Man”
JasonVaughn, Ph.D., Director of Scientific Affairs, Patheon, Inc
“A Case Study on Getting an Insoluble Compound into Man”
JimWright, Ph.D., Chief Scientific Officer at BIND Biosciences
A well-designed Quality by Design (QbD) approach to drug development and manufacturing can substantially minimize development and scale-up challenges and increase the reliability of the manufacturing process. While a wealth of information exists on the theory behind QbD, there is no “one size fits all” application of it. For a project to reap the added benefits of quality and robustness resulting from QbD, it is critical to understand how to use some of the QbD tools to identify and control the factors contributing to product variability. For example, reduced product variability from QbD can lead to cost savings as a result of decreased batch failure during routine manufacture.
During this 60-minute webcast, two industry experts will share case studies and their experience with QbD and offer insight into how the practical application of QbD contributed to the success of their projects — steps that can be universally applied to your projects.
Don Barbieri, associate director of formulation and process development, Patheon, will present case studies demonstrating different aspects of the QbD approach, including identifying CQAs (critical quality attributes) and CPPs (critical processing parameters) as well as risk assessment determination, risk mitigation, DoE, and more.
David Smith, pharmaceutical specialist, formulation and process development, Patheon, will present a case study where the pragmatic application of QbD enabled a successful tech transfer of a film-coated tablet from Phase III to commercial scale.
Trends in Safe Handling of Potent Compounds in Pharmaceutical Manufacturing Processes
In the pharmaceutical industry, an increasing number of new drug candidates are considered “highly potent”, which can have significant impact on how they can be safely handled in drug product development and manufacturing.This webcast explores what the term “highly potent” means and discusses what is required to manufacture these drugs from an equipment containment perspective.The main focus will be on the safe handling of these drugs (e.g. safety of equipment operators). However, these principles also apply to meeting Good Manufacturing Practices (GMP) requirements for minimizing cross-contaminationto other drugs manufactured in the same facility. The use of control banding, a procedure for assigning an active pharmaceutical ingredient to a potent or non-potenthazard category corresponding to an airborne concentration range, will also be discussed. Two case studies that are designed to highlight the key take home messages of this session will be presented.
Marvin Faber, PhD, DOHS, CRSP - Sr. Director, Global Head EH&S at Patheon: “Overview of Safe Potent Compound Handling”
Giuseppe Galati, PhD - Manager, Toxicology Services Corporate Environmental, Health & Safety at Patheon: “Toxicological Principles of Banding”
Jeff Dinyer – Director, Environment, Health and Safety, North America and Global High Potency at Patheon: “Containment Trends and Practices
4721 Emperor Blvd
Durham, NC 27703-8580
+1 919 226 3200
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