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The Business Development Issue Rethinking the Ethical Corporate Vision Q1 2019 VOLUME 5 NUMBER 1 THE BUSINESS DEVELOPMENT ISSUE RETHINKING THE ETHICAL CORPORATE VISION YOURWAY BRAMMER BIO UPM PHARMACEUTICALS CRB USA Integrated Clinical Packaging, Digital Droplet PCR Adjusting Internal Structure to Leveraging Operational Warehousing and Transport for Viral Vector Analysis p18 Better Meet Demands of Unmet Simulations to Design Cell Therapy Services Supporting Pharma Business p28 Facilities p32 and Biopharma p10 WUXI ADVANCED THERAPIES SPI PHARMA BIOVECTRA ALBEMARLE FCS Driving Growth of the Cell and Reprioritizing to Bring FY2020 Supporting Client Projects for Process Understanding Central to Gene Therapy Sector p38 Into Focus p46 CDMO Success p100 Successful Drug Synthesis p104 NICEINSIGHT.COM 1 > TABLE OF CONTENTS Pharma’s Almanac BD 72 A World-Class Partner for 96 Generics Manufacturing and BUSINESS DEVELOPMENT Today’s Market Changing Equipment Needs Oliver Ju, Porton Pharma Solutions Justin Kadis, Federal Equipment Company 74 Speed and Customized Support THE BUSINESS DEVELOPMENT ISSUE from Gene to GMP Manufacturing Supporting Client Projects for Giedrius Žunda, Biotechpharma 100 CDMO Success Marc Sauer, Ph.D., and Mark Wellman, RETHINKING THE ETHICAL CORPORATE VISION Pharma Makes Moves to BioVectra 76 Leverage Artificial Intelligence Cynthia Challener, Ph.D., Nice Insight Process Understanding Central to 104 Successful Drug Synthesis Overcoming Challenges in James J. Springer and Robert Hughes, 81 Microbial Process Development Albemarle Fine Chemistry Services Elise Mous, Capua BioServices S.p.A. 04 A Note from the Editor THE BUSINESS DEVELOPMENT ISSUE FEATURE 107 Design Logic: Formulated Solutions David Alvaro, Ph.D., Nice Insight Twin-Screw Melt Granulation Nice Insight 82 as a Platform Technology for 05 Nice Passion: Continuous Manufacturing 110 Pharma’s Almanac Inspired. Personal. Passion. Evolving Business Tony Listro, Foster Delivery Science Most Impactful Thought Nice Insight Leadership of 2018 62 HIGHLIGHTING LEADERSHIP 83 Accelerating Biosimilar Nice Insight 06 Nice Insight Overview: IN BUSINESS DEVELOPMENT Development Pharma Tackles the Big Issues Models and an Ethical John Gabrielson, Elion Labs, Collaborating for Immunotherapy Nigel Walker, Nice Insight Guy Tiene, Nice Insight a division of KBI Biopharma 112 Development Kshitij (TJ) Ladage, Nice Insight 10 Integrated Clinical Packaging, Paradigm Shift p. 54 63 Preparing Middle-Market Firms to 84 Facilitating Complex Clinical Warehousing and Transport Services Attract Investment Trials for Rare Diseases 116 Award-Winning Performance Supporting Pharma and Biopharma By David Alvaro, Ph.D., Emilie Branch and Cynthia Challener, Ph.D., Nice Insight Jeffrey Marlough, Castleford Capital Ariette van Strien, Marken Driven by an Award-Winning Gulam Jaffer, Yourway Workplace Culture 64 Setting Expectations for Facility and 88 Fill/Finish: Increasing Investment Peter Pekos, Dalton Pharma Services 16 How Agile Investment Business Sales in the CDMO Sector and Flexibility for Effective Drives Innovation Balancing Ethical William B. Wiederseim, Manufacturing Rapid Growth in the ADC Thibaut Fraisse, Fareva PharmaBioSource, Inc. B.J. Hull, Emergent BioSolutions 117 Market Drives Strategic and Fiduciary Partnership Interest 18 Digital Droplet PCR for 65 Selecting the Right Private 92 The Ideal Capsule Supplier: Allan Davidson, Piramal Pharma Viral Vector Analysis Responsibilities Equity Partner to Build a Leading Using A Holistic Approach to Solutions Diego Matayoshi, Sushma Ogram, Ph.D., Outsourcing Provider Facilitate Customer Success Susan D’Costa, Ph.D., and in Drug Pricing David Q. Anderson, Ampersand Capital Jonathan Gilinski, CapsCanada Understanding the FDA’s Approach Richard O. Snyder, Ph.D., Brammer Bio Partners 118 to Real-World Evidence p. 55 94 A Research Partner with David Alvaro, Ph.D., Nice Insight 22 Investing in Form-Fill-Seal Technology 66 Quality of Earnings: The Most Proven Results Lluc Mercadé, Grifols Important Term You Probably Daniel Conlon, IRBM S.p.A. 120 Roundtable: Ethical Practice & Evolving Ethical Don’t Know Artificial Intelligence 24 Aligning the Outsourcing Relationship Eric Mattson and Michael Geldart, 95 Addressing the Challenges of Nice Insight Gwenaël Servant, Ph.D., Servier Conduct Concerns Excellere Partners Comparator Drug Sourcing for Clinical Trials 124 Company Profiles Preclinical to Nearly Commercial Virus in Clinical Trials 67 Factors Driving Consolidation in the Salman Pathan, Globyz Pharma Nice Insight 27 and Viral Vector Manufacturing CDMO Space Jean Bléhaut, Novasep p. 58 Jason Foss, Results Healthcare Adjusting Internal Structure 68 Similar, Different and Constantly 28 to Better Meet Demands of Varied Unmet Business Steve King, 21159Pharma We are extremely excited to invite our James E. Gregory, UPM Pharmaceuticals 69 U.K. Healthcare Firms Creating readers to visit our newly relaunched online Investing in the Future of Potent 38 Driving Growth of the Cell and Gene 46 Virtual Panel: Reprioritizing to Bring Value Worldwide content portal at PharmasAlmanac.com. 31 Compounds Therapy Sector FY2020 Into Focus Hemavli Bali, Clearwater International Frederic Desdouits, Seqens Felix Hsu, WuXi Advanced Therapies Jeanne Thoma, Sarath Chandar, Graeme Corporate Finance Macleod, Jon Struthers, Joe Rogus, Following an updated web design, we are now able to provide a more Leveraging Operational Simulations 44 Developing and Characterizing DPI Coralyn Gonzalez, and John Creighton, 70 The Value Triangle: Risk Management 32 to Design Cell Therapy Facilities Formulations for Biologics SPI Pharma for RMATs streamlined and engaging experience for our wide online readership, Niranjan Kulkarni, CRB USA Constança Cacela, Ph.D., and John D. Wass, CAI giving us new opportunities to match insightful thought leadership Eunice Costa, Ph.D., Hovione 50 Rentschler BioPharma SE Sets Foot in content with our audience. A World of Opportunity: What to the U.S. to Strengthen Its World-Class 71 Finding the Right Product Platform: 37 Expect from CPhI & P-MEC China CDMO Position A Personal Perspective We hope you enjoy our fresh approach to past and current Pharma’s Almanac CPhl Federico Pollano, Rentschler Biopharma SE Ori Gutwerg, MBA content on our revamped platform! 2 PHARMA’S ALMANAC GLOBAL PHARMACEUTICAL SUPPLY CHAIN TRENDS Q1 2019 PHARMASALMANAC.COM 3 COME VISIT > A NOTE FROM THE EDITOR Nice Passion NICEPASSION.COM BUSINESS DEVELOPMENT Inspired. Personal. Passion. LAUNCHING APRIL 2, 2019 — AND CHECK AND INNOVATION OUT OUR FIRST PASSION PROJECT! Q1 2019 VOLUME 5 NUMBER 1 > THAT’S NICE LLC/NICE INSIGHT BY DAVID ALVARO, Ph .D., NICE INSIGHT And stay tuned for 89 Fifth Avenue – 5th Floor – NY 10003 – USA more original Nice Telephone: + 1 212 366 4455 Passion content. New York – Raleigh – San Diego – San Francisco e are excited to kick 2019 ties. As such, we also present a number Dallas – Frankfurt – Shanghai – Shenzhen off with this oversized is- of articles focused on cutting-edge tech- WWW.PHARMASALMANAC.COM sue, which features an nology and big data initiatives, including unprecedented number leveraging artificial intelligence for drug PUBLISHING MANAGING DIRECTOR Wof contributors, many of whom are making development, operational design simu- Nigel Walker | [email protected] their first appearance in our pages. We are lations, cell and gene therapy, next-gen- BUSINESS DIRECTOR Guy Tiene | [email protected] thrilled to expand our thought leadership eration PCR technology and continuous SCIENTIFIC EDITORIAL DIRECTOR community and to provide a forum for the manufacturing. David Alvaro, Ph.D. | [email protected] promotion of new ideas and evolving busi- Additionally, we pause to look back at SCIENTIFIC CONTENT DIRECTOR ness models. last year’s most exciting Pharma’s Alma- Cynthia A. Challener, Ph.D. | [email protected] As this is our “Business” issue, one of our nac content with our “Most Impactful STRATEGIC CONTENT MANAGER primary areas of focus is business develop- Thought Leadership of 2018” article, a Emilie Branch | [email protected] ment — most notably in a dedicated Busi- kind of informal awards show recognizing CONTENT EDITORS Mark Allen | [email protected] ness Development section, which features some of the most influential articles, com- Maria Gordon | [email protected] insight from a number of thought leaders panies and contributors of 2018. MARKET RESEARCH ANALYSIS DIRECTOR with backgrounds in private equity, adviso- In concert with the publication of our Kshitij Ladage | [email protected] ry and consulting, as well as commission- Q1 2019 issue of Pharma’s Almanac, we SCIENTIFIC RESEARCH ASSOCIATES ing, discussing issues related to invest- are also relaunching our online content Cesar Benjumea | [email protected] ment, M&A, and best business practices. portal PharmasAlmanac.com. The new PUBLISHING ACCOUNT DIRECTOR Wei Gao | [email protected] This issue additionally includes a number design of the website will provide a more PUBLISHING DESIGN DIRECTOR of contributions from top executives at streamlined and engaging experience for Young Tae | [email protected] outsourcing services companies sharing our wide online readership, giving us new their strategies for growth and expansion. opportunities to match insightful thought In industries like pharma, biopharma leadership content with the most relevant and their supporting service sectors, it and engaged audience. And with that, is essential to strive to balance fiduciary we urge you to enjoy the issue and, if you Our First Nice Passion Project: concerns
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