Q1 2018 VOLUME 4 NUMBER 1 THE EXECUTIVE EDITION M&A STRATEGY: STRUCTURING AND ALLIANCE WUXI APPTEC AVARA PHARMACEUTICAL FEDERAL EQUIPMENT SAMSUNG BIOLOGICS Creating Comprehensive SERVICES COMPANY Fully Supporting Customer Needs Solutions through Laboratory Uniting the Industry for the Microbial and Biological for Biologics Development and Testing p10 Prevention of Pharmageddon p48 Decontamination of Equipment Manufacturing p64 Bring Peace of Mind p52 > TABLE OF CONTENTS Pharma’s Almanac With over 1,000 pages Refreshingly Adaptable CDMO published in just one year, Pharma’s Almanac is now online. www.PharmasAlmanac.com THE EXECUTIVE EDITION M&A STRATEGY: STRUCTURING AND ALLIANCE A Note from the Editor 04 Cynthia A. Challener, Ph.D., Nice Insight Pharma’s Almanac Publisher’s Page M&A Feature 05 The Pharma’s Almanac Team Nice Insight Overview: An Industry Stacked 06 Enhancing Competitiveness Nigel Walker, That’s Nice LLC/Nice Insight Mergers & Acquisitions in Creating Comprehensive Solutions 10 Through Laboratory Testing Discovery, Manufacturing BioVectra Inc. is a CDMO that serves global A rare provider who is an expert in both Xin Zhang, Ph.D. , WuXi AppTec and Fill/Finish Page 40 Artificial Intelligence in pharmaceutical and biotech companies with and , we offer Cynthia Challener, Ph.D.,Guy Tiene, chemistry biologics 15 Biopharmaceutical Manufacturing Emilie Branch, Nice Insight full-service, cGMP outsourcing. fast-moving development companies Constantin Loghinov, MILS Group LLC significant opportunity to streamline their Ensuring Confidence in 16 Viral Vector Manufacturing With over 45 years of experience, we offer: supply! Christopher Murphy and Michael Wourms, Brammer Bio To learn more about our capabilities, send us Expanding US Supply Options for Scaled, distinct facilities for Biologics 20 Large-Volume Parenterals and Small Molecules a message at [email protected] or meet Marga Viñes, Grifols Partnership with us at an upcoming tradeshow! 24 Overcoming Challenges in the 52 Microbial and Biological 66 Meeting the Need for Small-Volume Large scale, cGMP Microbial Fermentation Complex Market for Clinical Trials Decontamination of Equipment API Manufacturing and Clinical Logistics Brings Peace of Mind Jim Scandura, Avara Pharmaceutical & Purification Wes Wheeler, Marken Matt Hicks, Federal Equipment Company Services 28 Facilitating Implementation 56 Investing in New Technologies for 68 Focused on Fermentation Complex Chemistry and Customer Service with Innovative Pharma Solutions Elise Mous and Thomas De Maria, Offline Serialization Sarath Chandar, SPI Pharma Capua BioServices DCAT Week BPI West Tyler Ewald and Joseph Quales, UPM Process & Analytical Development March19-22nd 2018 March 19-22nd 2018 59 Supporting Parenteral 70 Leveraging Lyophilization New York City San Francisco 32 Driving Change in the Pharma Industry Development and Manufacturing Development Expertise for and Biotech One Relationship at a Time with End-to-End Services Clinical Manufacturing Syed T. Husain and Catherine Hanley, Oskar Gold, Vetter Pharma Jeff Schwegman, Ph.D., Alcami Corporation International GmbH AB Biotechnologies, Inc. Why Business Continuity Death to Cleanrooms in Connecting Buyers & Suppliers 36 Management is Important for CDMOs 60 Biopharmaceutical Manufacturing 71 Bridging Capacity & Demand Mayeul Cauvin, Servier Marc Pelletier, CRB Nice Match InformEx Proteins & Antibodies Congress April 24-26th 2018 April 16-17th 2018 Overcoming Formulation Challenges Meet Chemo CMO: Preferred Partner Company Profiles, Nice Insight 39 with Liquid-fill Capsules 63 for Injectables Manufacturing 72 Philadelphia London Eli Elias, CapsCanada Masha Kononov, Chemo Trending Live: Real-Time Data with 75 Full Transparency 48 Uniting the Industry for the Prevention 64 Fully Supporting Customer Needs Nice Insight BioVectra Inc. of “Pharmageddon” for Biologics Development and Timothy C. Tyson, Avara Pharmaceutical Manufacturing 76 Roundtable: M&A, Operational Services James Park, Samsung BioLogics Excellence, Nice Insight 11 Aviation Avenue 866-883-2872 Charlottetown, PE 902-566-9116 www.biovectra.com C1E 0A1 902-628-2045 PHARMASALMANAC.COM 3 > A NOTE FROM THE EDITOR MARKET IN MOTION: LARGE TRENDS CONTINUE TOWARD Q1 2018 VOLUME 4 NUMBER 1 NICE INSIGHT LLC/THAT’S NICE Pharma’s Almanac 89 Fifth Avenue – 5th Floor – NY 10003 – USA Telephone: + 1 212 366 4455 CREATING OUR NEW INDUSTRY Publisher’s Page New York – Philadelphia – Raleigh San Diego – San Francisco – Dallas > BY CYNTHIA A. CHALLENER, Ph.D., NICE INSIGHT Frankfurt – Shanghai – Shenzhen WWW.NICEINSIGHT.COM Outsourcing solution providers PUBLISHING MANAGING DIRECTOR Nigel Walker | [email protected] contributing to the global supply STRATEGIC CONTENT DIRECTOR chain dialogue with compelling Guy Tiene | [email protected] elcome to the first Phar- potent APIs (HPAPIs), as well as cell and SCIENTIFIC CONTENT DIRECTOR ma’s Almanac edition of gene therapies, specialty knowledge and and insightful content. Cynthia Challener, Ph.D. | [email protected] 2018, in which we take a capabilities are critical. STRATEGIC CONTENT MANAGER Emilie Branch | [email protected] look at the mergers and When it comes to contract research SCIENTIFIC CONTRIBUTORS acquisitions, consolidation and special- organizations (CROs), the top ten handle Carrie Cao, Ph.D. | [email protected] ization taking place in contract services, much of the market — and much of the David Torrone | [email protected] and the entire pharma-biotech industry. North American market. Specialization Dear Pharma’s Almanac Reader: CONTENT EDITORS This is in the face of a surge in demand in this sector is occurring around early- Mark Allen | [email protected] Maria Gordon | [email protected] and mandated improvements in process- stage development services, late-phase MARKET RESEARCH DIRECTOR es, efficiency and security of supply — clinical trials and central laboratory You are receiving this print edition of Pharma’s Almanac at the Govindra Singh | [email protected] we’re talking “Pharmageddon.” services. request of one of our contributors, based on your organization, SCIENTIFIC RESEARCH MANAGER We are excited to deliver this first edi- We invite you to enjoy this, our “Execu- Kshitij Ladage | [email protected] or your active role in the industry. tion of the year to you, our print read- tive Edition,” with a feature article cov- SCIENTIFIC RESEARCH ASSOCIATES ership comprising a select group of ering M&A activity at the research and Saakshi Gupta | [email protected] Maurice Spicer | [email protected] pharma-biotech professionals. Our new discovery, contract manufacturing and BY THE NUMBERS 2017 Nice Insight’s Pharma’s Almanac has grown into a premier PUBLISHING ACCOUNT DIRECTOR content marketing approach brings you finished drug-product levels. This topic content universe, recognized for offering in-depth analysis of Wei Gao | [email protected] valuable and insightful commentary is also addressed in our Roundtable, with pharma-biotech research and discovery, manufacturing, supply PUBLISHING DESIGN DIRECTOR from a variety of contributors. both CDMO and CRO perspectives. 83,708 Young Tae | [email protected] chain, regulatory and future technologies. This content universe This edition includes fantastic con- Welcome to the issue! P # of returning visitors tributions from a great group of thought includes a robust and highly active web portal that delivers leaders at some of the best solution pro- content and data, as well as archives of all past issues. viders around the world, covering top- ics from viral vector manufacturing and 1,192+ Nice Insight is the market research division of In 2017, PharmasAlmanac.com had over 80,000 visits, with That’s Nice LLC, A Science Agency, leading marketing parenterals to customer partnerships # of articles, blogs, videos & news in the life sciences. thousands of views of more than 1000 articles, blogs, videos and clinical trial logistics, with more on The print version of Pharma’s Almanac is delivered to and news pieces posted. To reach our audience, we send out a targeted group of 20,000 leaders from all sectors of serialization. the industry who are implementing new strategies and The pharma-biotechs are simplify- “Trending Now,” a tri-weekly e-mail newsletter that extends the technologies creating collaboration models with drug 68,299 developers to deliver on the global mission to provide ing their supply chains, attempting to reach and consumption of Pharma’s Almanac content, which the reliable supply of safe effective pharmaceuticals work with fewer contract service provid- # of e-newsletter readers and therapeutic agents worldwide. The custom print is sent to over 62,000 readers. distribution includes individuals across big pharma, the ers, such as contract development and biotechs, mid-sized and specialty pharma, virtual pharma- manufacturing organizations (CDMOs), biotechs as well as regulatory, governmental agencies, We invite you to visit www.pharmasalmanac.com to read academia, and consumer patient touch points. and doing so in more strategic and cost- 938+ effective ways. # of supplier company profiles more, examine our research section, review over 900 supplier The utilization of pathways for accel- company profiles, and sign up for Trending Now. erated drug approvals requires agility Pharma’s Almanac Online and scalability from outsource partners. Nice Insight’s Content Community With the continued growth of antibody- 112,800 Sincerely, www.PharmasAlmanac.com drug conjugates (ADC)