Patheon is a global provider of development and commercial manufacturing services for solid and sterile prescription drugs, offering a wide variety of services and products. Read More »
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
Join us in Brazil for CPhI South America 2013, the pharmaceutical and food ingredients networking event.
Visit us at booth # K50
Focused exclusively around opportunities, connections, and face time with consumer healthcare executives.
Touted as the most comprehensive, face-to-face business meeting of the year, Market Exchange features a convenient and time-efficient networking forum, featuring up to 24 pre-scheduled appointments with existing and prospective customers.
With high-powered presentations and a tabletop exhibition featuring 160 contract service providers and vendors, Contracting & Outsourcing 2013 is the premier event for Pharma & Biopharma decision-makers!
This meeting focuses on delivering in a commercial environment. You will receive a lot of firsthand industry and regulatory knowledge from experts across multiple facets of pre-filled syringe development.
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.
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.
Given the increasing R&D investment and regulatory hurdles that must be navigated precisely in order to get new drugs to global markets, setting the right course early in clinical development is critical. The framework for deciding to progress to first-in-man studies, and the goals and expectations of early clinical development requires critical appraisal. This seminar provides insight into some of the current issues in getting a molecule from the preclinical through to early clinical development in humans with the aim in providing better decision making.
Most virtual to mid-size biotech and pharmaceutical specialty companies plan to select a partner to progress their molecule. Readiness for due diligence and partnering discussions are key to progressing the molecule faster to the next stage of development.
During this seminar, hosted by Patheon and Qb3, you will hear case studies and analysis from industry leading experts on preformulation and formulation development for IND enablement and regulatory strategies for IND Submission. You will also hear a venture capitalist experience on business models of in-licensing /out-licensing and readiness for partnering along with case studies.
Anil Kane, Ph.D., Executive Director, Global Formulation Sciences, PDS at Patheon
Jason M. Vaughn, Ph.D., Director of Formulation and Product Development at Patheon
Khalid Shah, Ph.D., Senior Director of Formulations Development, Manufacturing and Clinical Supplies at Exelixis
Jamie Topper, M.D., Ph.D., General Partner, Menlo Park, Frazier Healthcare
Reaching First-in-Man studies is a critical milestone in the drug development
process. However, the road to a successful IND submission is long and complex,
with many important decision points along the way that can have long-term
effects on the development of the molecule. Whether you are faced with API
development challenges, bioavailability issues, financial constraints or pressure
to meet accelerated deadlines, having a well-designed development plan for your
molecule can mean the difference between success & failure.
During this seminar, you will hear case studies and analysis from industry
leading experts on API Process Development, Preformulation and Formulation
Development for IND enablement for both sterile and non-sterile products and
Regulatory Strategies for IND Submission.
Bill Heggie, Ph.D., Chief Scientific Officer, Hovione: Past the Discovery Phase in the Development of NCEs
Anil Kane, Ph.D., MBA, Executive Director, PDS Formulation Sciences at Patheon: Strategies for Efficient & Effective Formulation to Advance Oral Drug Products to First in Man
Tony Pidgeon, Senior Manager, Global Science and Technology at Patheon: Strategies to Progress Sterile Drug Products to First in Man
John McCarty, President, McCarty Pharma Consultants Inc.: Filing an IND for Early Clinical Studies: What You Need to Have for First in Man Studies
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
Overcoming Challenges in Technology/Knowledge Transferfrom Early Development Stage to Commercial
How to Quickly Guide Clinical Trial and Market-ReadyProducts through Technology Transfer
Regardless of the phase or type of molecule, technologytransfers can be described with three Cs: challenging, complex, andcritical. Whether you are faced with knowledge transfer for apreclinical product to proof of concept or a site transfer for adevelopment-phase product to commercial supply, understanding how to manage thetransfer of knowledge and technology can make the difference between successand failure.
During this seminar, you will hear case studies and analysisfrom industry leading experts that will provide you with an overview of thechallenges that must be overcome in knowledge transfer for products in allphases of development (from Phase I to market).
Presentations will focus on:
· Navigating timelines, regulations and trends
· Strategies to quickly transfer Preclinical andPreformulation projects to Proof of Concept and Phase I/IIa clinical studies
· Considerations in analytical method developmentfor various phases of clinical development and transfer to quality control
· Case studies on site transfers for solid doseand sterile dose products for registration
· Regulatory considerations in site transfers
· Anil Kane, Ph.D., MBA, Executive Director, PDSFormulation Sciences, Patheon
· William Weiser, Ph.D., Executive Director, PDSAnalytical Sciences , Patheon
· Stephen Closs, Director, Global TechnicalAffairs, Patheon
· John McCarty, President, McCarty PharmaConsultants Inc.
For more information, visit http://www.patheon.com/marketing/nj_web_1/index_website.html
Enteric-coated dosage forms are designed to resist the destructive action of gastric fluid and to disintegrate in the higher pH environment of the intestinal fluid. This need may arise if the API degrades upon exposure to an acidic environment or causes irritation of the gastric mucosa. The complexity of developing a controlled-release dosage form increases for drug molecules that possess narrow therapeutic windows, and where absorption site is in the upper or lower part of the small intestine and/or colon. Some small and large molecules further need solubility/permeability enhancement at the intestinal pH range while others need to be protected from moisture in solid dosage form, thus requiring multiple layers of coating – enteric, moisture barrier, controlled-release, etc.
During this 60-minute interactive webcast, three industry experts will discusses challenges and case studies in the development of enteric and controlled-release properties in a variety of solid dosage form ssuch as multi-particulate, tablets, capsules, and softgels.
Anil Kane, Ph.D., Executive Director, Global Formulation Sciences, PDS, Patheon
Nazaneen Pourkavoos, Ph.D. , Director, Formulation Development, Patheon, High Point
Jason M. Vaughn, Ph.D., Director, Formulation and Product Development, Patheon, Cincinnati
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
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