Life Science Leader Magazine Supplements

CMO 2016

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GLOBAL BUSINESS UPDATE insights Snapshot analyses of selected companies developing new life sciences products and... LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2016 28 PROJECT MANAGEMENT MANUFACTURING By L. Garguilo AH, TO BE A PROJECT MANAGER IN 2016! as a Master of Project Management from Penn State or other universities, is needed. This opinion is bolstered by vari- ous conversations over the last two years with representatives from Big Pharma, biotechs, CMOs, and consultants. No one denies that a well-defined or pronounced subset of "professional PMs" exists in our industry. When asked how companies recruit or acquire project managers, the most often reply is the roles are filled internally with scientists (or engineers) who get "promoted." These people climb the corporate ladder by succes- sively managing a small team, an internal project, projects relying to a high degree on external partners, and culminating in alliance or relationship management positions. A PM in our industry is a scien- tist or engineer who's the product of an incremental increase in responsibilities and on-the-job (OTJ) training. There's certainly nothing wrong with OTJ. But it serves us well to note care- fully this means the project managers at sponsors today are experiential products of the way projects have been managed in the past. On the service provider's side as well, it's common to find PMs who are former pharma project managers. Can these individu- als on either side evolve their roles to meet the trends in the industry? Or, if we understand Hoffmann and many others, is there actually less need of an evolution in the PM role than we might have anticipated? (Count me as an early member of this anticipatory group.) Instead, we see the industry further embracing the traditional role and their service provider — varies with project and organization size." Hoffmann comes at this discussion with over 20 years of experience, includ- ing working on vaccines for influenza (FluMist) and plasmid DNA for gene therapy. She was also part of the team involved in the transfer of Bristol-Meyer Squibb's Orencia (abatacept) produc- tion to a CMO facility in South Korea. Perhaps somewhat surprisingly at first, she suggests that in today's fast-paced drug-development environment, small sponsors, and at times Big Pharma, may not actually need what might be consid- ered "professional" project managers to succeed. The real requirement, she says, is simply ensuring you have someone authorized to make day-to-day decisions who can communicate effectively and directly with the CMO and is capable of weighing overall risks and tradeoffs as projects progress. Sounds simple enough. No specific project management background, such dd the fact of more but smaller projects at a quickened pace of delivery and turnover, and it all leads to, among other things, a weight and force landing on the backs of a particular set of individuals: Ah, to be a project manager in the biopharma industry in 2016! Are "PMs," as they practice their trade today, up to the new challenges and intensifying outsourcing landscape? WHO'S A PROJECT MANAGER ANYWAY? "When we talk about managing projects in our industry," says Heidi Hoffmann, senior director for manufacturing at Sutro BioPharma, "we're often talking about it generically, in terms of how do we ensure both customer and supplier get what they need for a specific project, considering the time and money available and the activities that have to be done? But who is tasked with doing this on each side — sponsor This is the reality that 2016 has wrought: Big Pharma is continuing to organize for enhanced utilization of external partners and supply chains. More business models — biotechs, startups, virtuals – rely on outsourcing. CROs/CMOs are reacting to these client changes with their new service models, technologies and facilities, and M&As. A Ah, To Be A Project Manager In 2016! L O U I S G A R G U I L O Executive Editor, Outsourced Pharma @Louis_Garguilo

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