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Pharma industry leaders gathered virtually to discuss the state of play in the world of pharmaceutical drug development and the lasting effects of COVID-19, in a two-day series of webinars and panel events.

Day 1 | On Demand


Panel Discussion

Opening Remarks | Supply Chain Immunity -
Looking Westwards?

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Lockdowns, remote working and reduced workforces have challenged pharma supply chains like never before. How have pharma companies and their partners adapted quickly to ensure they can meet demand shifts in volatile periods and ensure supply continuity for patients. Discussion points include China Plus One supply chain strategies and drug nationalism trends.


Speakers

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Moderated By:

Anju Ghangurde

Executive Editor, Informa Pharma Intelligence


Anju Ghangurde is Executive Editor (APAC) for Scrip and the Pink Sheet and has about two decades of experience in journalism including stints at India's mainstream financial dailies -The Economic Times, The Hindu Business Line and The Financial Express. She covers a broad range of issues including competition and collaboration between generics and innovator firms, drug pricing and the evolving regulatory and legal framework in the region. She is also a recipient of the British Chevening Scholarship for Young Indian Journalists (2000-01) awarded by the Foreign & Commonwealth Office.

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Jonathan Knight

Director, Market Intelligence and New Technologies, Cambrex


Since joining Cambrex in 1996, Jonathan has had a number of commercial roles, including VP, Sales & Marketing for the Cambrex Innovative Pharmaceutical Business Unit. In 2012, Jonathan established the Innovative Product Group within Cambrex, which comprises a dedicated team responsible for developing new innovative proprietary products. Most recently, Jonathan was made Director of Commercial Insights and New Technologies.

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Jeff Fischer, MBA

President at Longhorn Vaccines and Diagnostics


Jeff Fischer, MBA is responsible for oversight of all non-scientific aspects of the organization, including regulatory affairs. Mr. Fischer co-founded the company and has served as its Chief Financial Officer from 2007-2017. From 1998-2005, Mr. Fischer served as an executive vice president and CFO in the biotechnology industry. He is a former infantry officer in the United States Marine Corps and holds an MBA from the University of Texas at Austin.

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Jim McPherson

Chief Quality and Technical Operations Officer, Centrient Pharmaceuticals


Jim is an alumnus of Edinburgh Napier University, from which he holds a Bachelor of Science, and an MBA graduate from the University of Glasgow. Joining Centrient in early 2019, he brings extensive international exposure and quality experience to our business, gained working in highly regulated environments within the pharmaceutical industry.

Prior to his current role, Jim worked with GSK and Xellia, as well as Sandoz. Most recently, he was the Senior Vice President for Global Product Supply and Global Quality at LEO Pharma in Denmark.

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Anshul Agarwal

Partner, Global Supply Chain & Manufacturing Practice, ZS Associates


Anshul leads ZS’s global supply chain and manufacturing practice. For the past 11 years, he has advised senior leadership teams at both Fortune 500 and emerging life sciences companies on business capability building, transformation and enabling analytics to drive commercial success. Anshul has a unique blend of supply chain & manufacturing domain knowledge and transformative solution building expertise. He helps organizations drive customer satisfaction and revenue, optimize supply chain resource allocation, streamline processes and drive innovation to maximize business value. Anshul’s expertise includes supply chain digitization, predictive and self-learning supply chain solutions, integrated business planning, and re-imagining and defining supply chains for complex therapies such as cell and gene.

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Hosted By:

Maire Gerrard

Custom Content Writer, Informa Pharma Intelligence


Presentation & Panel Discussion

Building A Sustainable Future for Pharma

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As Pharma executes its strategies which include commitments to sustainable solutions, so must the extension of their capabilities through CMOs work to align the supply chain in those same principles. Alignment is challenging as CMOs are structurally different working with numerous different customer supply chains at the same time using multipurpose manufacturing and operations.

This presentation and panel highlights the challenges of integrating different sustainability initiatives driven both by customers and outside influences. The process to identify common interests and strategies is discussed along with the complex road on how to develop a unique sustainability approach and identity for the CMO. This needs to be able to address the unique composition of facilities and types of operations. Each individual facility may have very specific pieces of the solution built on continuous EHS improvement through the years. The challenge is how to leverage the strengths and differences into an effective overall sustainability strategy moving forward. A strategy that is both aligned with customers and drives improvement through the rest of the supply chain.


Speakers

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Moderated By:

Ben Comer

Executive Editor, In Vivo


Ben brings both biopharma expertise and diverse experience. For the past five and a half years, he was a senior manager in PwC’s Health Research Institute. He developed reports on various policy issues and business trends, particularly in the pharma and medtech sectors, provided research for clients and spoke at industry events. Previously, he was a journalist with Pharmaceutical Executive; Medical Marketing & Media, PRWeek and Direct Marketing News; and Ad-Fax Media.

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Seth Levine, P.E.

Senior Director, Regulatory Affairs, Cambrex


Seth has 44 years' experience in environmental engineering with 30 years at Cambrex in operations and corporate EHSS. In previous roles, Seth has worked in waste water and waste recovery systems as a process engineer, air pollution control systems in R&D, waste water treatment and water recovery systems in sales and marketing, and environmental and process safety consulting. Seth is a licensed professional engineer, EHSS due diligence auditor trained under the ASTM standard and a certified EHS management system auditor – Exemplar Global. Seth earned his Master of Environmental and Chemical Engineering and Bachelor of Science in Civil Structural Engineering at Rensselaer Polytechnic Institute.

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Matt Shaughnessy

Head of Operations Sustainability, AstraZeneca


With over the 30 years' experience in Product Development, Clinical Supplies, Manufacturing and Supply Chain, Matt is now accountable for the development and execution of the Sustainability Strategy within AstraZeneca’s Operations function. Matt has worked extensively with external partners in contract manufacturing and logistics and has a deep interest in bringing additional value through partnering in sustainability.

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Hosted By:

William Masters

Writer, Informa Pharma Intelligence


Panel Discussion

How Digitalization In Drug Development Is Optimizing Operations

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This session explores the current uses of technologies such as AI, Machine Learning, IOT in drug development, and how digital will continue to advance the processes required to get critical medicines to market. Discussion will consider the myriad of uses including clinical, regulatory, manufacturing and supply chain.


Speakers

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Moderated By:

Duncan Emerton

Executive Director, Custom Intelligence & Analytics – Informa Pharma Intelligence


Duncan has over 20 years of pharmaceutical industry experience and is currently Director of Informa Pharma’s Custom Intelligence & Analytics team which focuses on supporting pharma, biotech, and life science clients to make informed decisions across the clinical-regulatory-commercial continuum.

Previously worked for a global market research firm where he was responsible for all syndicated disease analysis. Prior to that spent nearly a decade at Datamonitor Healthcare where he worked in company analysis, disease analysis, and the healthcare consulting team. Duncan has also held various roles at several pharma companies focused on non-clinical and clinical R&D, medical affairs, and sales/marketing.

A published authority on biosimilars, COVID-19 and lifecycle management, having authored whitepapers, articles and book chapters on these areas, including two chapters in Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand (Wiley, 2012).

Duncan holds a BSc(Hons) in Biochemistry from the University of Surrey and a PhD in Microbiology from the University of Kent.

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John Piccone

Principal, ZS Associates


John Piccone currently leads the Patient Centricity and Analytics Advisory services at ZS Associates. John is focusing on real world evidence, commercial predictive analytics, applications of patient similarity analytics for precision medicine, population and outcomes studies and predictive analytics in molecular biology and genomics. John’s expertise includes analytics strategy, developing advanced analytics, optimization and enterprise information management solutions for clients in the life sciences industry and developing transformative solutions using cognitive computing and machine learning. He has developed strategies that align predictive analytics capabilities with corporate business objectives and supervised large enterprise information management programs for clients in the life sciences industry.

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Hosted By:

Maire Gerrard

Custom Content Writer, Informa Pharma Intelligence


Day 2 | On Demand


Panel Discussion

The Future Of Drug Development: Key Trends

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Despite the challenges of the last year, the needs of patients across the globe suffering from diseases unrelated to COVID-19 have not diminished. How can the industry come together to ensure patients can access critical medicines for better health outcomes.


Speakers

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Moderated By:

Bowman Cox

Executive Editor, Manufacturing, Informa Pharma Intelligence


Bowman Cox leads the Pink Sheet's coverage of pharmaceutical manufacturing quality issues. He writes and edits articles on the challenges and opportunities that developments in science, technology and regulatory policy pose to drug manufacturers and their quality organizations.

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Shirish Belapure

Senior Technical Advisor, Indian Pharmaceutical Alliance


Shirish G Belapure has a total experience of 42 years in managing pharmaceutical manufacturing. Currently he is supporting the activities of Quality Forum of Indian Pharmaceutical Alliance as Senior Technical Advisor. Earlier he was Managing Director of Zydus Hospira Oncology P.Ltd., (ZHOPL), a joint venture company of Zydus & Pfizer for manufacturing and distributing sterile oncological injectables. This company exports Oncology injectables to 61 countries including USA, Japan & Europe with highest regulatory compliance and quality standards. His previous experience includes working in reputed companies FDC, Cipla, Cynamid and Sun Pharma in various capacities and departments . He is currently on the governing board of Parenteral Drug Association (PDA-India) and an active member of other professional bodies like ISPE, IPA (Quality forum) as well as the Indian Pharmaceutical Association.

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Brian Wong

CEO, RAPT Therapeutics


Dr. Wong is a physician/scientist with 20 plus years of experience leading organizations at the forefront of innovative drug development. Prior to RAPT, he served as Senior Vice President, Research, and Head of Immuno-Oncology at Five Prime Therapeutics. Prior to FivePrime, Dr. Wong served as Director in the Inflammation Disease Biology Area at Roche. There, he led the discovery and supported the development of Roche’s autoimmune disease portfolio, consisting of more than 20 biologics and small-molecule programs from discovery to late-stage clinical development and through approval. Prior to Roche, he held various leadership roles at Rigel Pharmaceuticals, where he identified and developed clinical candidates for allergic, autoimmune and respiratory disorders, including Tavalisse™.

Dr. Wong received his M.D. from the Weill Cornell Medical College and his Ph.D. in Immunology from Rockefeller University.

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Matthew R. Price

Co-founder, EVP & COO, Phosplatin Therapeutics


Mr. Price is Executive Vice President, Chief Operating Officer and co-founder of Phosplatin Therapeutics, and is responsible for strategy, finance and operations across the company's activities, which have expanded to fifteen countries since inception. He helped negotiate the original license for the company's PT-112 development program, and currently oversees the clinical and translational research and development involving phase I / II studies in solid tumors and hematological malignancies. He is also responsible for the company's sub-license collaboration with SciClone Pharmaceuticals for greater China. In addition, he led the design and launch of the clinical trials collaboration jointly with Pfizer and Merck KGaA, Darmstadt, Germany.

He holds an AB from Princeton University, graduating summa cum laude and Phi Beta Kappa. He previously held research and managerial roles in the NGO and non-profit sectors working in the US and Germany. He earned an MBA from Columbia Business School, where he was a Chazen Society Fellow in International Business.

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Stephan Haitz

President CDMO Sales & Marketing, Cambrex


Since joining Cambrex in 2014, Stephan has been responsible for the sales and business development activities at Cambrex. Most recently as President, Business Unit CDMO Marketing and Sales, Stephan has global responsibility for all sales and business development activities in the field of custom development and custom manufacturing for drug substance, drug product and early phase development and analytical testing. Prior to joining Cambrex, Stephan worked at Lonza and was the Head of Business Development for Africa and India.

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Hosted By:

Maire Gerrard

Custom Content Writer, Informa Pharma Intelligence


Presentation & Panel Discussion

Ensuring Manufacturing Efficiencies With Continuous Flow Technology

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Continuous flow chemistry offers significant advantages over traditional batch manufacturing for a wide array of operational and technical reasons. It is well known that chemistries involving high energy, highly hazardous reagents, and inherently unstable intermediates are prime candidates for flow technologies. Additionally, continuous flow also has the potential to enable reductions in cost, manpower and even development time.

This presentation and panel will focus on providing specific and general examples that illustrate the development and process intensification of continuous flow processes to enable gains in quality, throughput, development time and costs. Inherently, the design and construction of fit-for-purpose continuous reactors from the development to actualization stages of a project lifecycle can improve safety, cost, and process mass intensity while enabling use of preferred reagents and unlocking otherwise unattainable operating conditions.


Speakers

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Moderated By:

Jane Denny

Editor, Custom Content, Informa Pharma Intelligence


Jane has been a storyteller and creator of content for print, broadcast and digital platforms since 1999. Before joining Informa Pharma Intelligence, Jane was the branded content editor at Chemistry World – the Royal Society of Chemistry’s flagship title. Content marketing campaigns and communications strategies devised by Jane have been used by companies including AstraZeneca, contract research organization RSSL, engineering and design consultancy Atkins and Rolls-Royce.

Shawn Conway

Director Of Engineering Research & Development, Cambrex


Since joining Cambrex in 2017, Shawn has been involved in a number of initiatives with the main focus being the formation and launch of the Cambrex Center of Excellence for Continuous Flow Process Development. The Cambrex continuous flow team has successfully developed numerous flow processes for API production and has demonstrated these processes in GMP clinical and commercial batches. Prior to joining Cambrex, Shawn earned his PhD in Chemical Engineering and subsequently worked for over 15 years in a variety of technical and operations roles, all focused on the development of new technologies and products.

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Moiz Diwan

Director, Head of Enabling Technology Group, AbbVie


Moiz Diwan is a director within the Process Research and Development organization at AbbVie. Moiz has led early to late-stage pharmaceutical development teams involving drug substance control strategy development, establishing global supply chain, process tech-transfer and scale-up, and authored global regulatory filings for 1st Gen. HCV Viekira and HCV Next Gen. Mavyret drugs. Presently, Moiz is leading Center of Excellence, a cross functional team of chemists, engineers and PAT scientists focusing on fundamentals‐driven process development through application of enabling technologies, data rich experimentation, and predictive modeling. This center has supported commercial process development and regulatory submissions for 5 commercial drugs and >50 clinical assets in the last 4 years. Moiz also built from ground-up FAST – Flow and Automation Strategy Team at AbbVie. FAST is a multi-disciplinary team of scientists and engineers from 6+ AbbVie sites across Discovery, Development, and Operations Manufacturing organization to efficiently share capabilities and resources, facilitate collaboration and provide strategic advancement on lab automation, plant automation, information management and continuous manufacturing technologies to maximize the impact. Moiz is passionate about people, building and sustaining high performance organizations, continuous learning, and translating science and innovation into products that make a difference to human health.

Dr. Fernando J. Muzzio

Distinguished Professor, Chemical and Biochemical Engineering, Rutgers University


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Hosted By:

William Masters

Writer, Informa Pharma Intelligence


Presentation

Virtual Quality Audits: Technologies & Trends | Closing Remarks

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The COVID pandemic has enhanced the importance of effective virtual quality audits. This session provides a perspective on related technologies, best practices and current trends.


Speakers

Bruce Johnson

Vice President - Site Director, Cambrex


Bruce is an accomplished pharmaceutical R&D executive with more than 27 years of experience in both innovative and generic product development. Bruce has built and led global R&D results-driven organizations of scientific professionals across sites in India, United Kingdom, Mexico, Australia and the United States.

Prior to joining Cambrex in January 2020, Bruce held leadership roles as Vice President R&D at Perrigo Company plc; Director at Pfizer, Inc; and Research Fellow at Merck & Co., Inc.

Bruce earned a Ph.D. in analytical chemistry from the University of Minnesota, and a bachelor’s degree in chemistry from Concordia College in Moorhead, Minnesota. He has authored 18 scientific manuscripts and holds three patent applications.

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Hosted By:

Maire Gerrard

Custom Content Writer, Informa Pharma Intelligence


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