SELECTBIO’s Academic Drug Discovery 2015, Cambridge, UK, will be a progression from our successful academic discovery events in the USA. Creating a European platform to bridge the gap between basic research and commercial application for innovative technologies. With talks from global experts on partnering models between both industrial and academic organizations that have successfully contributed to modern medical interventions.

Keynote Speakers:
– Stephen Frye
Director of The Center for Integrative Chemical Biology and Drug Discovery, University of North Carolina
– Marcie Glicksman
Co-Director, Harvard NeuroDiscovery Center and Brigham and Women’s Hospital

Agenda Topics:

•    Drug discovery technology transfer
•    European lead generation and enabling open innovation
•    Novel approaches across different therapeutic areas
•    Partnering models for academia and industry
•    Professional translational research

The agenda is available to view online.

http://selectbiosciences.com/conferences/index.aspx?conf=ADD2015

Featuring an array of leading international speakers, the 11^th annual meeting aims to provide an insight into the latest developments in Discovery Chemistry.

Hot topics to be covered include Fragment Based Lead Discovery, DOS & Other Chemistries and Protein-protein Interactions. Attending this event will provide excellent opportunities for networking with like-minded peers, helping you to find solutions and build collaborations. The agenda is available to view online.

A co-loated exhibition will cover the latest technological advances and associated services from leading solution providers within this field.

http://selectbiosciences.com/conferences/index.aspx?conf=DCC2015

8th Annual Pharmacovigilance 2015 will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry.  The entire program will cover the detection, analysis and prevention of adverse drug reactions.  It will be studied with the help of case studies and industry experiences. This conference will help the drug safety representatives from the pharmaceutical industry and academic and quality research organisations who wish to understand how to avoid common deficiencies in inspections by learning from the experiences of others; to gain a greater understanding of new and existing pharmacovigilance requirements, and to improve their organisations’ compliance with pharmacovigilance requirements. Also it can help you control your product’s lifecycle, your patient’s trust, and your revenue. Hence, this conference will provide an important platform for pharmacovigilance stakeholders to discuss and share best practices in expediting pharmacovigilance development.

KEY THEMES

• Update yourself with respect to terms of legislation, policies, systems, technology, communication strategies and best practice in PV
• Developing Pharmacovigilance into high quality management system and its components
• Audit and Inspection: Realistic steps for a fruitful consequence
• EMA PSMF – Assuring compliance and provide standardization
• Discover approaches for collecting, integrating and analyzing all of the safety data generated from preclinical models
• Exploiting the pharmacy automations and technologies for enhancement of medication safety
• Developments in Pharmacovigilance, drug safety & risk management to ensure safer drugs to market
• Improving patient care and safety in relation to use of medicines and all medical and paramedical interventions
• Determining the steps and strategies for enhancing quality in healthcare
• Emerging signal detection data gathering successful tools to highlight emerging risks
• IT solutions for Pharmacovigilance – Learn & Explore
• Maintaining proper balance in relationships: Sponsor – Site – CRO & Patients
• GVP Module V and XVI – explaining authority expectations and avoid speculation and differing interpretation of the current guidelines
• Review the use of (PSURs) post-authorisation for safety signals
• ICH-R3 standards – Determining where future challenges could arise
• The developing regulatory framework in advanced and developing markets
• Accelerating new medicine introduction in developing world & overcoming challenges
• Explaining how to use the data sources and observational research for effective safety analysis
• Be part of a major networking opportunity

WHO SHOULD ATTEND

• Pharmacovigilance
• Pharmacoepidemiology
• Pharmacogenomics
• Drug/Product Safety
• Drug Development
• Information and Clinical Data Management
• Clinical Pharmacology
• Clinical Safety
• Periodical safety update Reports
• Risk Management
• Research & Development
• Quality Assurance
• Patient Safety
• Signal Detection
• Safety Surveillance
• Outcomes Research
• Data Analysis
• Epidemiology
• Medical Affairs
• Regulatory Affairs and Compliance
• Information technology
• Sales and Marketing

http://www.virtueinsight.com/pharma/8th-Pharmacovigilance-2015/

The Stem Cell Summit 2015 taking place on April 27 – 29, 2015 in Boston, MA at the Hyatt Regency Boston Hotel. This summit includes two parallel conferences which include joint sessions. GTCbio’s Stem Cell Summit 2015 provides cutting-edge information on developments in all areas of stem cell research including the biology, medicine, applications, regulations, product development and business of stem cells.

Discussions on recent developments in pre-clinical and clinical trials of stem cell therapy, regenerative medicine and tissue engineering, cancer stem cells, immunotherapy, stem cell reprogramming, regulatory policies regarding stem cell research, manufacturing and product development will be addressed. Challenges and potential strategies for overcoming these challenges will also be addressed. What categories of companies are currently commercially viable? How are they being funded? What kind of strategic relationships are available within the industry? How do you create sustainable business models?

Stem Cell Summit 2015 includes two parallel conferences including joint sessions:

Conference A: Stem Cell Research & Regenerative Medicine
I. Joint Session: Stem Cell Research in the Diabetes Space
II. Joint Session: Stem Cell Therapies from Bench to Bedside
III. Joint Session: Regulatory Guidance
IV. Cells for Therapeutic Development & Drug Discovery
IV. Advances in Adult & Pluripotent Stem Cells
V. Tissue Engineering
VI. Immunotherapy: Revolution in Cancer Treatments

Conference B: Stem Cell Product Development & Commercialization
I. Joint Session: Stem Cell Research in the Diabetes Space
II. Joint Session: Stem Cell Therapies from Bench to Bedside
III. Joint Session: Regulatory Guidance
IV. Manufacturing & Product Development
V. Challenges in Developing Clinical Efficacy
VI. Funding Opportunities
VI. Commercialization: Creating Sustainable Business Models

https://www.gtcbio.com/conferences/stem-cell-summit-overview

Improved Designs and Enhanced Ease-of-Use Features Key Factors in Patient Acceptance according to Greystone Research Associates

(Amherst, NH) – The aging global population is having a major impact on the growing emphasis on drug self-administration. This trend is creating an increased demand for medical devices that are patient-friendly and cost-effective. Autoinjectors, a relatively new class of injection devices, have been a major benefactor of this trend, and have grown rapidly to overtake pen injectors as the third largest injection device segment.

Autoinjectors owe their existence to the emergence of the prefilled syringe as a major drug delivery platform. The number of drugs available in prefilled syringes as a percentage of all injectable drugs continues to grow. So too does the number of injectable drugs indicated for chronic conditions and self-administration. These market factors foretell positive market dynamics for autoinjectors for the remainder of the decade.

Until a few years ago autoinjectors were designed to be reused. The reason was that the injectors were too expensive to be successfully marketed as a throw-away device. Recent improvements in materials technology and device design are enabling the creation of autoinjectors that can be made economically in high production quantities, opening the door for the disposable autoinjector. Since autoinjectors have about a dozen parts and a cost substantially more than a disposable syringe, this is a critical factor.

Suppliers of autoinjectors face several challenges as the market evolves and matures. Continued interest in plastic prefilled syringes will require non-brand specific injector manufacturers to validate that their devices function consistently and safely over the range of these emerging PFS devices – devices with rigidity, barrel lubricity and flexural properties that differ not insignificantly from type 1 glass. They will have to compete – in some cases head-on – with prefilled syringe suppliers, who are increasingly incorporating autoinjector-like ease-of-use features into their PFS designs to differentiate their product lines and in some cases to meet their pharma customer requirements for product-specific syringe designs.

In the past 24 months, the competitive picture for autoinjectors has evolved considerably as companies modify and refine their product strategies to reflect changing market conditions. SHL Medical continues to be aggressive in terms of facilities and infrastructure investment at its manufacturing hub (Taiwan), and remains the autoinjectors segment leader in terms of the number of branded autoinjector products. Ypsomed has adjusted its autoinjector offerings as the company consolidates its injection device business to reflect the loss of Sanofi as a major OEM customer and as it continues to build its diabetes franchise which is being driven in large part by its distribution agreement with Insulet (USA) for the OmniPod wearable insulin pump.

One long-time autoinjector supplier has retired several of its autoinjector products from the market, while a newer market entrant has announced a new platform of power assisted injectors. A European supplier has exited the autoinjector market entirely. Becton Dickinson continues to be deliberate in its approach to this segment. The company introduced a new prefillable syringe designed to be paired with its Physioject autoinjector for the delivery of biological drugs.

The evolving autoinjector market is detailed in a new and comprehensive report researched and written by Greystone Research Associates.  Autoinjectors to 2022 analyzes the global market for autoinjectors by therapeutic market, device class and competitor. The report analyzes demand drivers, development factors, market considerations, and strategic and economic factors, and provides profiles of market sector participants.

More information is available at http://www.greystoneassociates.org