Patheon® is a leading provider of drug substance and drug product services for the global biopharmaceutical industry. SEE AND Read More »
AusBiotech conference is held annually to inform and update the biotechnology sector with current industry facts and knowledge. It provides key presentations and forums to help bring together representatives and professionals from across the biotechnology industry and the globe to experience a comprehensive conference program, extensive bio-industry exhibition, business matching program and associated events such as the AusFoodtech Symposium.
Plan now for the meeting that extends your boundaries.
Schedule a Meeting with Patheon!
BIO-Europe® is Europe's largest partnering conference serving the global biotechnology industry. The conference annually attracts leading dealmakers from biotech, pharma and finance along with the most exciting emerging companies. Produced with the support of BIO, it is regarded as a “must attend” event for the biotech industry.
Featuring EBD Group's sophisticated, web-based partnering system, partneringONE®, the event enables delegates to efficiently identify, meet and get partnerships started with companies across the life science value chain, from large biotech and pharma companies to financiers and innovative start-ups.
Outsourced Pharma West Conference & Exhibition will engage pharmaceutical and biopharmaceutical executives who form and manage partnerships for development and manufacturing. The program includes interactive panels on drug development and partnering led by done-it-before executives, informal networking receptions, and an exhibition showcase of services providers. Presented in its inaugural year by Life Science Leader magazine, BayBio, and OutsourcedPharma.com.
In the last two decades, an enormous global research effort has been directed at the development of novel biopharmaceutical products. However, translation of this new knowledge from basic science into novel therapeutics has proven challenging with small biotech companies struggling to achieve successful early stage clinical trials in a timely manner, resulting in product failures and placing the industry under considerable financial strain. Besides achieving timely proof-of-concept, the right financial structure to progress such products through the clinical development pathway is also critical to success. Although many drug candidates in development may be backed by excellent science, these products are only as strong as the regulatory, technical and commercial strategy the developer has established to see them through to the next value inflection point. Adoption of a more sophisticated and global approach to progressing biopharmaceutical programs to proof-of-concept clinical trials is needed to reduce the failure rate of these important products.
Register Here or https://biocom.org/event/index/Nov_2014_CRO_Bfast
In this event you will hear from financial, manufacturing, bioanalytical, clinical & regulatory experts on how Australian initiatives are enabling U.S. based companies to progress their biopharmaceutical programs to Phase II faster and cheaper than anywhere else in the world, whilst maintaining the high quality standards required by global regulatory authorities. Our special guest, Tunitas Therapeutics, will speak about their experience with these initiatives and the significant value they have brought to their San-Francisco based biotech company.
• Non-dilutive financing for biopharmaceutical programs part run in Australia – up to 45% cash refund provided by the Australian Tax Office through the R&D Tax Incentive.
• Clinical trial start in as little as 4 weeks using the Australian Clinical Trial Notification scheme allowing fast track progression to global Phase II trials.
Register Here or https://baybio.org/lunch-and-learn-faster-phase-ii-11-20-2014
Bringing a molecule to the market reliably and cost-effectively.
Recorded Webcast: Robustness, Reproducibility and Risk Management
For many CDMOs late stage development for solid and sterile pharmaceutical products is a critical phase and a huge challenge; manufacturing a product with reliable high quality requires a significant increase in financial commitment.
Robust, reliable and repeatable processes can pay dividends on the route to successful commercialisation and applying a Quality by Design (QbD) program can guarantee this success. Our webinar leaders will share insights into a proven path through scale up and technology transfer to commercialisation.
Romano Rivolta, Senior Director Business Management and Technology Transfer, Patheon
Mike Dey, Managing Director, Claidmhor Pharma
Active drug layering provides tremendous opportunities in the development of immediate-release dosage forms of a single drug entity or fixed-dose combination drugs. The technique also has been widely used to develop modified-release dosage forms as a monolithic system or as multiparticulates with a possibility of targeting the release to a specific region of the gastrointestinal tract. The development of an active drug-layered formulation can pose challenges based on properties of the API, dose, processing parameters, target release profiles required, and other factors. The webcast discusses applications of this technique, development considerations, manufacturing and analytical challenges, and case studies.
Speakers: Don Barbieri, Terri Williamson, Robert Diehl
Drug delivery technology based on the softgels is widely accepted as preferred dosage form in the consumer healthcare, and is recognized as an interesting life cycle opportunity for pharmaceutical products. One such opportunity is the development of dosage forms for specific populations, like pediatrics, although this area of formulation development is relatively uncovered and novel. The European Medicines Agency has stated: “The joint goal for industry, regulators, practitioners and patients is to encourage pediatric drug development in order to create a situation where substantially more children have access to safe and effective medication…”.
The webinar will present the benefits and limitations offered by Chewels™ as a pediatric dosage form through an actual case study of an approved generic application of a chewable softgel. Formulation options, manufacturing, and regulatory aspects will be discussed, with relevant subjects like pediatric guidelines, cross linking of gelatin and regulatory perception, bioequivalence approach, and general feedback on the dosage form by health authorities during the registration process.
Kaspar van den Dries - Senior Director Formulation Sciences Solid Dose and Softgels, Patheon
Katja van Eijndhoven - Regulatory Affairs Manager, Banner Life Sciences
Recorded Webcast: Lyophilization Cycle Design and Scale Up – Practical Methodologies for Developing Cycles
Lyophilization or freeze drying is a well established process in manufacturing of sterile injectable products. The Lyocycle involves freezing, primary drying and secondary drying. Development of a lyo cycle and understanding of heat and mass transfer under different load conditions is critical in development of a robust lyophilization process.
The webinar will focus on establishing a lyophilization scale- up model that is aimed to demonstrate the full scalability between lab and production lyo in order to allow to perform the development or optimisation of a freeze-drying cycle in the pilot freeze dryer with significant cost savings.
Enrico Corona, Formulation and Production Manager, Patheon
Ronald Pate, Lyophilization Scientist, Customer Project Support, Patheon
Recorded Webcast: QbD Strategies for Successful Drug Product Formulation
Quality-by-Design (QbD) is a strategic approach that helps companies achieve higher process understanding, enhanced control, better product quality, increased data for continuous improvement and potential for reduced FDA approval times. Implementing a robust QbD strategy allows Pharma, Biotech and contract service providers to build leaner processes and achieve the ultimate goal for successful product development and manufacturing.
This live webinar examines the opportunities in QbD projects, including the hurdles in implementing QbD from a contractors’ perspective. Join us to discover how to define a successful strategy and execute a systematic scientific plan to overcome challenges and meet regulatory requirements.
Anil Kane Ph.D. MBA, Global Head of Formulations, Patheon
Steve Closs, Director, Global Technical Affairs, Patheon
Recorded Webcast: Analytical Challenges and Case Studies in Method Development for Fixed-Dose Combinations
Combining two or more active pharmaceutical ingredients in a single-dosage form can increase a drug’s efficacy and improve patient compliance. Pharmaceutical companies are turning to these fixed-dose combinations to maximize product value and expand a product’s lifecycle.
In this webcast, experts will discuss challenges and solutions for the development of analytical methods associated with fixed-dose combinations. Case studies will demonstrate the complexities involved with analyzing these dosage forms.
Gordon Marr, PDS Analytical Development
Maureen McLaughlin, Analytical Chemist
Yue Chen, PDS Analytical Development
Recorded Webcast: API Characterization for a Speedy and Successful Formulation Strategy
The physicochemical properties of the API in a solid state are extremely important as they affect the choice and design of formulation as well as the performance of the dosage form. A robust solid-state characterization of the API at an early stage helps drug developers better understand the properties of the API and the effect these characteristics have on the drug behavior, especially on uniform distribution, solubility, stability, and its in-vitro dissolution and bioavailability. This information impacts formulation and development decisions. In this webinar, experts examine key API properties and their impact on formulation design and development decisions.
In this webinar, experts examine key API properties and their impact on formulation design and development decisions.
Anil Kane Ph.D. MBA, Executive Director, Global Formulation Sciences, PDS
Friedrich Brandl, Quality Manager, DSM Pharma Chemicals, Regensburg (ResCom®)
4721 Emperor Blvd
Durham, NC 27703-8580
+1 919 226 3200
[Location,jobs] - [Region,jobs]