Schedule At A Glance
|Tuesday, May 16||Wednesday, May 17||Thursday, May 18|
|10:30 AM||Orbis Biosciences||Sun Pharma|
|11:30 AM||GE Life Science||Dibeta|
|12:30 PM||Shenyang Gold Jyouki Technology Co., Ltd||Pirmal|
|2:30 PM||Unither||Pharmaceutical Technology and BioPharm International|
|3:30 PM||Avista Pharma Solutions, Inc.||DPS Consulting|
Leveraging Controlled Release Powders to Create Patient-Friendly Products.
The rising cost of healthcare and the resultant shift of policies focused on lowering costs and incentivizing better outcomes are driving increased demand for drug delivery solutions that can improve patient compliance and provide economical solutions for special patient populations such as pediatrics and geriatrics. Controlled release solutions play a critical role in patient-centric design, offering the ability to reduce the number of administrations required by the patient. In this session we will explore fabrication techniques for controlled release powders and the role they can play in creating patient-friendly products.
Faster to market—case study on successful process development, and technical transfer
GE Life Sciences
Whether you’re looking to launch a new molecule, enhance existing capacity or bring biosimilars to emerging markets, developing process development skills in key enabling technologies are critical to the long term success of your product. This presentation will focus on a key case study focusing on development and optimization of a biopharmaceutical product, while at the same time ensuring it is of the same quality and is manufactured in a reproducible manner. We will demonstrate how ensuring you identify critical process parameters early on and maintaining those parameters through scale up can ensure you avoid needless process steps later on and increase the overall efficiencies for manufacturing.
CO2-Mediated Formation of Chiral Fine Chemicals
Shenyang Gold Jyouki Technology Co., Ltd
The utilization of carbon dioxide as a feedstock for the synthesis of organic chemicals can contribute to a more sustainable chemical industry, since CO2 is an abundant, inexpensive and non-toxic renewable C1 resource. Nevertheless, far less attention was paid to the stereochemically controlled catalytic CO2 fixation/conversion processes. The presentation therefore aims to principally showcase of the recent progress regarding CO2 mediated formation of chiral fine chemicals, including enantioselective synthesis of cyclic carbonates by asymmetric ring-opening of epoxides with CO2, enantioselective synthesis of oxazolidinones by the coupling reaction of aziridines with CO2 and enantioselective synthesis of CO2-based polycarbonates from epoxides, as well as chiral diols and carbamates via polycarbonate intermediates.
Digital Transformation in the Chemical and Life Sciences Industries
Technology is playing an increasing role in everything we do. In the chemical and allied industries, digital technologies provide actionable solutions to business challenges, and groundbreaking opportunities for innovation. Come and hear Debbie Altham, Industry Director from professional services and technology firm SIKICH, explore overall business trends in the industry and how digital transformation presents new opportunities for business leaders to harness the disruptive force of technology to be more agile, drive efficiency, and ultimately help shape their destiny.
Unit Dose solving an unmet need in the Pharma Industry via Liquid Stick packs and Blow-fill-seal – the wings of a CDMO
Dr. Tatapudy is the Executive Director of Research and Development at Unither Pharmaceuticals in Rochester, NY. He is a member of the Rochester Leadership Team and Global R&D. He is responsible for managing the Activities and Budget of R&D, working on Corporate Strategy reporting to the Site GM who reports to the CEO.
Dr. Tatapudy has been engaged in the US Pharmaceutical Industry in various Leadership Roles for 30 plus years covering OTC, Brand, Generic, Lifecycle management and CMO/ CDMO/ Drug Delivery resulting in successfully developing, filing and commercializing OTC’s, ANDA’s, NDA’s in transdermal, ointment, cream, deep lung delivery, parenteral, oral liquid, oral solid, resin-complexation, extended-release, Blow-fill-seal and Liquid Stick-pack dosage forms as needed to solve an unmet need (unit dose) as well as significantly contributing to Innovation & Growth.
Dr. Tatapudy is Head of all R&D activities at Unither Pharmaceuticals in Rochester, NY including Technical Services and Product Development, Project Management, Analytical Services, Validation and Stability. R&D is responsible for supporting current products and new business opportunities related to Oral Liquids and Solids, Resin-complexation, Extended-release, Blow-fill-seal and Liquid Stick packs for OTC, Generics and Brand Products.
Unither Pharmaceuticals is a CDMO providing end-to-end service by working closely across various groups including Commercial, Business Development, Quality and Compliance at the Rochester site and all other sites in France, and interacting with Customers. The main focus of Unither Pharmaceuticals is Unit Dose in the form of Liquid Stick packs and Blow-fill-seal.
Best Practices in In Vitro Release (IVRT) and In Vitro Permeation Testing (IVPT) for Semisolid Drugs
Theo is the co-founder of Diteba, with more than 30 years of analytical R&D Chemist and pharmaceutical industry experience.
Sean P. Lapekas, Senior Process Safety Engineer, Ash Stevens, LLC
Effective Process Safety Evaluations for CDMO API Operations
Besides addressing the technical challenges associated with executing synthetic organic chemistry on progressively larger scales, the process safety risks must also be fully assessed and understood. API manufacturing processes often utilize exothermic reactions in flammable solvents. In addition, the API and/or intermediate structures may contain functional groups associated with high energy decomposition. Failure to adequately address these hazards can have a devastating impact on a CDMO, their employees, their clients, and the surrounding community. This presentation will review the work-flow and test instruments available for performing thorough process safety assessments.
Laboratory and production Environments in Life Science
The life science industry faces the toughest challenges from a quality and regulatory perspective. In typical laboratory environments the researcher faces chemical, biological and mechanical hazards. The suitable selection of a barrier that provides appropriate hazard protection is crucial. In a production environment this barrier performs a dual function of protecting the researcher as well as protecting the product. In this presentation we will discuss Ansell’s innovative offering designed to meet your stringent requirements across all environments. Ansell’s proprietary solutions tool “Chemical Guardian” is a great asset which recommends optimal glove selection.
Rita Peters & Agnes Shanley
Pharmaceutical Technology and BioPharm International
The editors of Pharmaceutical Technology and BioPharm International share the results of industry-wide survey of the state of quality practices at companies manufacturing drugs for the US market.
Ahmed Elsawah, President, DPS Consulting
Pharma Opportunities and Innovative Business Models in MENA Region
Middle East North Africa region has never been the same for all countries in the region.Business potential of pharma industry and regulations are very much varying.As a result,only four countries are representing 80% of business potential and double digit growth rates. The objective of that briefing is to shed enough light on that lucrative growing market and pinpoint target therapy areas and best successful precedented business models.