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. SEE AND Read More »
Vitafoods Europe is the leading ingredients andraw materialsevent for the nutraceutical, dietary supplements and functionalfood and drinks industries.
FCE Pharma focuses on the production chain in the pharmaceutical sector, especially the phases of manufacture, supply and distribution of products and services.
FCE Pharma attracts a qualified public of professionals associated with the pharmaceutical industry, suppliers, distributors and dealers of the counrty. The ideal spot for business in the pharmaceutical industry offering a vision of the future, product innovations, equipment and services, all in one place.
BioTrinity is the premier European Biopartnering and Investment Conference, partnering R&D companies with big pharma and more biomedical investors than any other key European partnering conference.
Gathering 603 exhibitors and 10,362 visitors in 2013, BIOtech Japan is Asia's LARGEST industry gathering. 650 exhibitors and 15,000 visitors are expected in 2014!
• Biomarker and PK/PD
• Research and Discovery
• Immunogenicity and Administration Routes
The scientific programming at the 2014 National Biotechnology Conference will feature symposia, roundtables, sunrise sessions, short courses, and workshops.
The conference aims to bring together senior-level professionals on the West Coast, providing a fantastic platform to share ideas with your industry peers and take part in in-depth discussions. The program contains some key presentations from top industry specialists along with the opportunity to network and take part in round table discussions focused on present challenges faced by the industry. The event is tailored specifically to the West Coast and is a fantastic opportunity to meet your industry peers.
IATI is Israels umbrella organisation representing the various constituents of the nations advanced technologies, be it high-tech, biomed, multi-national corporations, start-ups, incubators, accelerators, service providers and more.
AESGP is celebrating its 50th anniversary.
Self care has evolved exponentially in the past 50 years with new ingredients, products and practices, and is now well recognised as a fundamental building block for the delivery of care in advanced health care systems.
Reminding the milestones along the way, the 50th AESGP Annual Meeting, organised in conjunction with the 18th WSMI General Assembly, gathers together the consumer healthcare sector and provides a forum for discussion on the exciting developments expected in the future for self care in Europe and the world.
The Pharma Outsourcing & ProcurementSummit addresses the urgent need for the pharmaceutical industry to identifyand locate the best pharmaceutical outsourcing partnerships and solutions tostay competitive in an uncertain climate whilst addressing heightenedregulatory pressures and need to maintain high quality standards.
Welcome to Biotech Outsourcing Strategies cmc 2014 the CMC focused event for outsourcing professionals in the pharma, biotech and contract services community.
Now in our 7th consecutive year BOS cmc is a popular forum for R&D CMC professionals to meet, network and discuss best practice in CMC outsourcing! With a programme including small molecule and biologics tracks and a strong enthuses on virtual drug development, BOS cmc has been created withthe specific needs of the virtual biotech/pharma in mind. For our CMO sponsors BOS cmc provides a unique partnering event exclusively focused on CMC outsourcing. Join us in Copenhagen to brush up on skills, meet new business partners and network all in a friendly, welcoming environment.
The BIO International Convention is the largest global event for the biotechnology industry and attracts the biggest names in biotech, offers key networking and partnering opportunities, and provides insights and inspiration on the major trends affecting the industry.
Covering the whole process of Pharmaceutical R&D and Manufacturing (from all kinds of equipment, lab devices, contract services, packaging to other total solutions), INTERPHEX JAPAN is firmly established as the one and only business platform where the whole Japanese pharmaceutical industry gets together.
There is no better meeting for reaching the influential and international drug delivery and delivery science audience.
CPhI South America is a pharmaceutical business platform where pharma industry professionals gather to establish business relationships, network and find new business opportunities in the fast growing South American market.
CHPA offers annual meetings and conferences, as well as periodic seminars, workshops, and webinars on topics of importance to the consumer healthcare products industry.
ChemOutsourcing is the largest USA-based API show attracting annually 700-800 chemists from the pharmaceutical, biotech, and chemical industries. The show focuses on API development spanning early drug discovery through chemical development and commercial supply.
Jointly organized in its 6th edition by the Spanish Bioindustry Association (ASEBIO), SPRI (Government of the Basque Country) and the BioBasque agency, Biospain 2012 has become one of the leading biotech events in Europe, being the perfect setting for forging new partnerships and strengthening existing business relationships in the biotechnological market.
The world's leading pharmaceutical networkingevent, co-located with ICSE, P-MEC and InnoPack and hosting over 34,000attendees from 140 countries and 2,200 exhibitors.
Meet face-to-face with international pharmaceutical companies, stay informedabout the latest industry trends and remain one step ahead of a constantlychanging pharmaceutical market.
The Conference Forum is delighted to present the 4th Annual PODD, Partnership Opportunities in Drug Delivery event. This annual Boston based conference is designed with three purposes:
The focus for BOS 2014 is discovery/early development outsourcing and clinical operations outsourcing. Our programme will include speakers from Pharma, Biotech and the CRO & CMO community. Attendee's at BOS 2014 will be able to access all parallel tracks. BOS has a broad outsourcing reach covering discovery right through to phase III clinical development including chemistry, biology, non clinical, CMC and clinical operations.
Plan now for the meeting that extends your boundaries.
Meet with Patheon!
The goal of early development is to develop a simple but stable and effective formulation and analytical methodology to take the drug candidate to a speedy “proof of concept” first in man studies. After a successful proof of efficacy, safety and exposure data generated from the pharmacokinetic study in humans, the next critical milestone is to confirm the safety and efficacy in larger patient population with a better dose definition. In many development programs the dosage form and the formulation needs to be changed to a more scalable and stable drug product that can met the scientific and regulatory requirements for a larger clinical study. For example a transition between a simple drug in a capsule to a tablet formulation is very common. Considerations of scalability and working towards a final market image are critical to save time and investment in the development program.
The seminar will address challenges in development from preclinical stage to proof of concept and formulation strategies employed in bringing speed to “first in man” clinical trials.. The event will also cover challenges of transitioning dosage forms, formulations and analytical methods used in Phase I clinical studies to a better dose defined scalable drug product suitable for larger scale manufacture to support Phase III clinical programs and meeting regulatory requirements with a goal for filing an NDA. The speakers will cover case studies and examples to demonstrate challenges and discuss solutions used to overcome the challenges.
· Anil Kane, Ph.D., MBA, ExecutiveDirector, PDS Formulation Sciences, Patheon
· WilliamWeiser, Ph.D., Executive Driector,PDS Analytical Sciences, Patheon
· Jason Vaughn,Ph.D., Director, Formulation andProduct Development, Patheon
· BradleyMorgan, Ph.D., Vice President, DrugDiscovery&Early Development, Cytokinetics
· Paul Scholes,Ph.D., Chief Scientific Officer, Quotient Clinical
The challenges posed in manufacturing drug product batches for early stage clinical trials include obtaining material of the right quality against tight timeline constraints, ensuring correct scale-up for GMP manufacture, as well as the viable production of batches at an appropriate scale for phase of clinical development. The mitigation of these challenges will be discussed, such as the use of disposable manufacturing systems in fill/finish operations. Following the progression of a biopharmaceutical product through clinical trials, product development and registration requirements will be discussed. The requirements for testing of extractables and leachables in late stage development will form part of the event.
Tony Pidgeon, Senior Manager, Global Science and Technology at Patheon
Dr. Sharon Real, Vice President of Product Development at TRACON Pharmaceuticals
Dr. Roman Hlodan, expert in biopharmaceuticals development at Patheon
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, MTOPRA, Regulatory Affairs Manager, Banner Life Sciences
As the healthcare industry moves away from clinical visits, notably those for injected therapies, pharmaceutical companies need to find new ways to capitalize on the opportunities in the evolving marketplace. Whether you are developing a new drug or exploring lifecycle management opportunities, formulation expertise and latest technologies will enable you to launch a high-quality sterile product into the market place.
Presenter: Tony Pidgeon, Senior Manager, Global Science and Technology, Patheon
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
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”
Recorded Webcast: Overcoming Challenges in Developmentof Oral Enteric and Controlled-Release Dosage Forms
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 discuss challenges and case studies in the development of enteric and controlled-release properties in a variety of solid dosage forms such 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
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