Expert's Opinion
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APIs
Biocatalysis for APIs
Engineered enzymes pave easier, faster road to scalable API manufacturingMichael Aldridge, SVP of Corporate and Strategic Development, Codexis 09.12.17
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Evolution of the CRO Project Manager
As clinical project managers become more strategic, more advanced technology must support their evolving rolesAndy Mehrotra, CEO, EightSpokes 08.31.17
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CRO Competition Heats Up: Differentiate Offerings to Retain Site Loyalty
Site centricity becomes even more critical with increased CRO competition and M&ADave Espenshade, Vice President of CRO Partnerships, Greenphire 07.25.17
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The Analytical Challenges of the Biosimilar Boom
The growing biosimilar industry and its implications on the current drug marketMario DiPaola, Senior Scientific Director, Charles River Laboratories 07.03.17
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Differentiating in the Biosimilar Market: Surviving the Cost of Entry
Companies need to improve customer experience, produce additional evidence, and create valuable engagement with stakeholdersMichael Turner and Magnus Franzen, Life Sciences Experts, PA Consulting Group 06.19.17
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When Big Data is Not Enough
Leveraging real-world data and advanced analytics to develop more targeted recruiting strategies for rare diseasesAdina Knight , Medical Director and Medical Strategy Lead at QuintilesIMS 06.16.17
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Bio News
Know the Challenges of Biosimilar Manufacturing
Best Practices for a Competitive MarketJerry Martin, Pharmaceutical and Life Sciences Consultant to PMMI, and, Dr. Michiel Ultee, Principal, Ulteemit BioConsulting, LLC 06.12.17
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Opportunity Knocks for Inhalers in Emerging Markets
As key drugs and delivery devices come off-patent emerging markets offer potential for inhaled genericsDr. Anselm Ebert, Global Business Development Manager, H&T Presspart 06.05.17
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Solving the Pharma Talent Crunch
Addressing talent shortages in today's pharmaceutical sectorJim Sykes, Managing Director, Pharmaceutical & Life Sciences, Alexander Mann Solutions 05.30.17
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Regulatory Affairs
Using Pragmatic Randomization in Real-World Studies
How PCTs increase the robustness of real world studies at a fraction of the cost of classic randomized trialsNancy Dreyer, MPH, Ph.D. , Global Chief of Scientific Affairs and Senior Vice President, Real-World & Late Phase Research, QuintilesIMS 05.22.17
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Breaking New Ground: How Industry Collaboration is Transforming Clinical Research
An increasingly complex clinical trial landscape drives the life sciences industry to support broad collaborationsJill Johnston, Vice President, Veeva Vault, Veeva Systems 05.15.17
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Can In Vitro Testing Replace Human Clinical Trials for Topical Drugs?
The future of topical bioequivalence studiesTheo Kapanadze, Chief Scientific Officer, Diteba 05.08.17
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Aseptic Processing | cGMP Manufacture | Facilities | Fill/Finish
Innovative Manufacturing Technology for Aseptic Filling
V-CRT: Combining quality and OEE advantagesGerald Buerkle, Vice President Production, Vetter Pharma-Fertigung GmbH & Co. KG 04.20.17
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Regulatory Affairs
How to Maximize Potential and Sidestep Pitfalls of MAPs
MAPs offers an ethical, compliant way to distribute investigational products to patients in need, but doing so is complicatedPhilippe Devos, World Wide Head, Managed Access Programs, Peggy Schrammel, Vice President, Scientific Affairs, and Kaushik Patel, Vice President, Market Access, PAREXEL International 04.01.17
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Protecting Pharma Intellectual Property
SmartFile CEO offers ways to protect against theftJohn Hurley, chief executive officer, SmartFile 01.09.17
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Qualification of an Assay
With applications for investigating functional comparability of an originator and biosimilarNicolas Fourrier, Director Biomarker and Biopharmaceutical Testing, SGS; Abhishek Saharia, Director of Cell-Based Assays & Biologics, DiscoverX; Fiona Greer, Global Director, Biopharma Services Development, Life Sciences, SGS 11.30.16
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The Rise of Virtual Models to Speed Development
How leveraging the cloud can help maximize relationships with partnersMike Jovanis, VP of Vault Quality, Veeva Systems 11.10.16
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Rethinking Immunotherapy Clinical Endpoints in Oncology Studies
Chris Smyth and Joy Yucaitis of Novella Clinical evaluate criteria, regulations, and limitationsChris Smyth, Ph.D. and Joy Yucaitis, Novella Clinical 10.28.16
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Manufacturing Processes Require Financial Justification
Improvements are necessary to meet regulations and stay competitiveGirish Malhotra, President, EPCOT International 09.27.16
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An Adoption Divide: CDISC Standards
Survey addresses challenges, advantages, and costs associated with implementing clinical data standardsDavid A. Evans, managing director quality governance and regulatory compliance, Accenture Life Sciences 07.20.16
