Insight Briefings are in-depth seminars on technical and business topics right on the InformEx exhibition floor, accessible to all exhibition visitors. Topics include accelerated drug approval programs, the digital transformation of the pharmaceutical industry, supply chain security advancements and much more!
Cory Berkland, PhD, Chief Scientific Officer, Orbis Biosciences
Leveraging Controlled Release Powders to Create Patient-Friendly Products.
Tuesday, 10:30 AM - 11:15 PM
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. Download presentation slides.
Andrea Hamilton, Senior Scientist, GE Life Sciences
Faster to market—case study on successful process development, and technical transfer
Tuesday, 11:30 AM - 12:15 PM
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. Download presentation slides.
Xiao-Bing Lu, Shenyang Gold Jyouki Technology Co., Ltd
CO2-Mediated Formation of Chiral Fine Chemicals
Tuesday, 12:30 - 1:15 PM
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.
Debbie Altham, Industry Director, SIKICH
Digital Transformation in the Chemical and Life Sciences Industries
Tuesday, 1:30 - 2:15 PM
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. Download presentation slides.
Dr. Hanumantharao Tatapudy, Executive Director of Research and Development, Unither Pharmaceuticals
Unit Dose solving an unmet need in the Pharma Industry via Liquid Stick packs and Blow-fill-seal – the wings of a CDMO
Tuesday, 2:30 - 3:15 PM
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. Download presentation slides.
Michael J. Hageman, Ph.D., Former Exec. Dir. of Discovery Pharmaceutics, Bristol-Myers Squibb
Facilitated Progression of New Molecular Entities Through the Discovery to Development Interface and Beyond
Tuesday, 3:30 - 4:15 PM
Avista Pharma Solutions, Inc.
A smooth transition of molecules from Discovery into Development should not be a game of chance. Instead, an integrated process from molecular design through synthesis to analytical characterization and on to a developable drug product is critical. In order to effectively reduce downstream attrition and understand risks of progression, the developability of the molecule has to become an integral part of the drug substance to drug product transition. The development of analytical methods and physicochemical property characterization, including preformulation and design of enabled formulations for enhanced bioavailability, is often critical for the successful progression of today's drug candidates. Download presentation slides.
Jim Miller, President, PharmSource Information Services
The Contract Services Market: Status and Strategies
Wednesday 8:30 AM, Room 116
Jim Miller, President, PharmSource Information Services
After several years of aggressive consolidation, the contract services market now features bigger players that offer more diverse services. At the same time, smaller contract service manufacturers are filling the need for smaller run and specialty services. As the bio/pharma market diversifies, will it have the capabilities and capacities that drug owners demand? How will shifts in the political environment in the United States trigger changes to the bio/pharma sector and the supporting contract services market? Industry expert Jim Miller, president of PharmSource Information Services, will share his perspective on the contract services landscape and suggest strategies for outsourcing companies looking to grow in this sector.
Dr. Theo Kapanadze, Ph.D. Chief Scientific Officer, Diteba
In Vitro Approach To Qualify Acyclovir Cream Products For Biowaiver Status
Wednesday 11:30 - 12:15 PM
In accordance with the recently released FDA draft guidance on acyclovir, Diteba presents on a fully compliant approach that combines the extensive acyclovir in vitro release testing (IVRT) and in vitro skin permeation testing (IVPT). This approach provides drug companies with the optimal chance of biowaiver success in lieu of the high cost and long delivery times associated with human clinical trials.
Sean P. Lapekas, Senior Process Safety Engineer, Ash Stevens, LLC
Effective Process Safety Evaluations for CDMO API Operations
Wednesday, 12:30 - 1:15 PM
Piramal (Ash Stevens)
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. Download presentation slides.
George Turner, Senior National Accounts Manager, Ansell
Laboratory and production Environments in Life Science
Wednesday, 1:30 - 2:15 PM
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. Download presentation slides.
Rita Peters & Agnes Shanley, Editorial Director & Senior Editor
Quality Practices: Meeting and Exceeding Regulatory Expectation
Wednesday, 2:30 - 3:15 PM
Pharmaceutical Technology and BioPharm International
Aging equipment, supplier errors, inadequate QA/QC practices, and other factors can contribute to quality problems and regulatory action for drug companies and contract service providers. The editors of Pharmaceutical Technology and BioPharm International, in conjunction with CPhI North America, conducted an industry-wide survey of the state of quality practices at companies manufacturing drugs for the US market. The survey results, which will be released during this session, reveal current quality-related practices in bio/pharma organizations and contract manufacturers producing drug products for patients in the US. Respondents share insight on interactions with regulatory authorities, quality challenges, and supplier oversight. The responses identify areas of best practices and areas needing improvement for bio/pharma companies, contract service providers, and regulatory authorities. Download presentation slides.
Ahmed Elsawah, President, DPS Consulting
Pharma Opportunities and Innovative Business Models in MENA Region
Wednesday, 3:30 - 4:15 PM
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. Download presentation slides.
Wednesday, 4:30 - 5:15 PM
Charlyn Reihman, Allan Ader, Principal Occupational Health Consultant, Managing Director
What does it take to manufacture potent compounds?
Thursday, 10:30 - 11:15 PM
As more highly potent active pharmaceuticals make the way to the research laboratories and eventually the marketplace, a multi-faceted approach is necessary to reduce occupational risk around handling these active pharmaceutical ingredients (API). As patients benefit from the reduced risk of adverse effects and target specific drugs, employees in all phases of manufacturing are at increased risk. SafeBridge will present a comprehensive approach for hazard identification and risk reduction during various phases of API and pharmaceutical manufacturing. Included will be a discussion of the “alphabet soup” of risk assessment terminology needed to successfully work with these compounds including OEB, OHC, OEL, ADE, PDE, and ASL, and the importance of quantitative data in assessing occupational exposure risk. Download presentation slides.
Haig Armaghanian, Founder, CEO and Chief Visionary Officer
Hitchhikers Guide to leveraging M&A in the Pharma Galaxy
Thursday, 12:30 PM
Over the past few years, M&A has fueled hyper-accelerated growth within the Global Pharma industry, here at CPhI North America, Haig and his insightful team will share their experience and collective wisdom about the current climate. In addition to helping you identify ways to navigate through the major challenges of the post-merger integration terrain, you will also get a peak at the future state of the industry with the balance of influence ever-shifting between Big Pharma, CMO/CDMO/CRO and the growing cadre of small innovators. Download presentation slides.
Daniel Reasoner and Jane Arrington, Product Manager, CAS, a division of American Chemical Society
Best Practices for Reducing Regulatory Risk
Thursday 1:30 PM
American Chemical Society
Researching regulatory status can be difficult and time-consuming, and the safety and financial risks of missing key information can be critical to the success of your business. Searches must be accurate and thorough to include all the ways substances are identified scientifically and commercially around the world. From a unique CAS Registry Number to a trade name, your business depends on the ability to navigate the regulatory environment for the chemicals you produce, use, transport or sell.
Join us as we describe and demonstrate search techniques that help ensure regulatory searches are both precise and comprehensive. We’ll also cover how CAS Registry Numbers and substance names are assigned, why some registrations may not include CAS RNs, and resources you can tap to quickly get the information you need when registering substances with regulatory authorities.