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Past Events

Past Event Information

Details on our past programs, including date/venue, sponsoring organizations, speakers, and agendas.

 

#9 | San Francisco 2017
#8 | San Diego 2017
#7 | Boston 2017
#6 | San Francisco 2016
#5 | San Diego 2016
#4 | Boston 2016
#3 | San Francisco 2015
#2 | San Diego 2015
#1 | San Francisco 2014

 

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  • Past Speaker Interviews

     

    Bob Sheroff, SVP, Technical Operations | Agios Pharmaceuticals
    Is Your Outsourcing Reliable, Responsive, And Continuously Compliant?

    Frank Sorgi, President & CEO | FLAG Therapeutics
    FLAG These Biopharma Outsourcing Beliefs

    Piet Houwen, Head of External Manufacturing | Genzyme
    Sanofi-Genzyme Together On CMO Reputation Management
    In Outsourcing, Genzyme Sees An Advantage

    Todd Mabe, Head of External Quality, Biologics Drug Substance | Genentech
    Genentech Speaks The Language Of CMOs

    Thomas Holmes, Sr. Director, Global External Manufacturing | Biogen Idec
    At Biogen, Three Keys To Outsourcing

    Denise McDade, VP Quality | Capricor Therapeutics
    The Paradox In Measuring Your CMO

    Sylvie Sakata, Sr. Director, External Research Solutions | Pfizer
    Pfizer Says Science First In Alliance Management

    Nils Olsson, VP CMC | Retrophin
    An All-Outsourcing Model For Orphan Drugs
    Timothy Scott, President | Pharmatek Laboratories
    A Global Forum For Outsourcing (With Simple Objectives)

    Kevin Judice | Entrepreneur
    Serial Entrepreneur Points To Initial Funding Sources For Biotechs

    John McKay, SVP Global Quality and Corporate Compliance Officer | CTI BioPharma
    A Trait For Quailty In John McKay's DNA

    Bikash Chatterjee, President and CSO | Pharmatech Associates
    Lean Six Sigma From An Outsourcing Industry Raconteur

    Joe Guiles, Director of Process Chemistry | Medivation
    A Witness To The History of Outsourcing

    Peter Bigelow, President | xCell Strategic Consulting
    Big Pharma Veteran, Peter Bigelow, Will Help "Tell It Like It Is" At Outsourced Pharma

    Firelli Alonso-Caplen, Sr. Director Biotherapeutics & Vaccines Outsourcing | Pfizer
    Learn Pfizer's Guiding Principles For Externalization At Outsourced Pharma

     

  • Past Session Highlights

     

    The Three Pillars Of Industry Conferences

    Boston 2017
    Working at a contract drug development and manufacturing organization years ago, I had direct reports stationed around the globe. Among the lessons learned: There’s an industry-related conference somewhere on practically every day of the year. Read more...

     

    What Are New Board Members Saying About Outsourcing?

    2017
    There are new leaders on the Outsourced Pharma Editorial Advisory Board. They’re not hesitant to provide bold analysis on outsourcing drug development and manufacturing. Read more...

     

    Pharma's Potemkin Village On The River Of Outsourcing

    San Francisco 2016
    Outsourced Pharma brings drug owners together with their contract development and manufacturing organizations (CMOs), and other external partners. We discuss the disciplines and challenges of tech transfer and project management; processes, platforms and scale ups (and downs); reliability, quality and regulatory compliance; partner selection and measurement; costs and models for outsourcing; risk assessment and mitigation; customers and patients. Read more...

     

    Pfizer's Key Questions For CMO Innovation

    Technology in the supply chain | San Diego 2016
    Among the edifying panels at this summer’s Outsourced Pharma San Diego, the one featuring Pfizer’s Bernie Huyghe – Technology in the supply chain – might have gained a conference apogee. The objective was to gain insight into an overriding question: How do we inject more innovation and technology into Pharma’s external drug development and manufacturing supply chain? Read more...

     

    Pharma's Super Heroes Of Innovation

    Conference Preview | San Francisco 2016
    It is an era of innovation in an age of outsourcing. We are fortunate to reside in this flourishing industry now riding the tide of the times. And the supply chain, to add even more adventure, is becoming Pharma’s super hero of innovation. But like any super hero, the drug development and manufacturing supply chain struggles with a dual identity. Read more...

     

    Top (Secret) Quality Concerns For Selecting CMOs: How Important Are Records?

    Top 10 quality/regulatory topics for your outsourcing | San Diego 2016
    Five experts go undercover to prioritize a secret top-ten list of quality topics for Pharma and Bio sponsors selecting contract development and manufacturing organizations (CMOs). After weeks of discussion, they select a conference venue with a room chockfull of drug industry sponsors and service providers to unveil their work. Read more...

     

    The Price At My CMO Isn't Right … But How Do I Know?

    Real pricing and value in outsourcing | San Diego 2016
    “What we’re doing up here is never done – focusing on that one input in public.” So says the serious moderator of the opening panel at Outsourced Pharma San Diego. “Instead of focusing on money, you talk openly about ‘value,’” he continues. “Well, what is that? Or it’s all about ‘relationships.’ The industry talks partnership in public, but behind closed doors, aren’t prices and costs closing or breaking outsourcing business deals?” Read more...

     

    Emerging Biopharma – And Their CMOs – Crazy Like A Fox

    Boston 2016
    “Most of the CMOs we spoke to, frankly, just thought we were crazy.” -- comment from a biopharma executive at Outsourced Pharma Boston 2016. Crazy, that is, like a fox. And this sponsor found an equally crafty contract development and manufacturing organization willing to join its pursuit in developing a new class of medicines. Today, that sponsor-provider relationship exemplifies a new model of alliance between emerging biopharma and CMOs. Read more...

     

    Value Creation Redefines BioPharma Outsourcing

    Boston To Bangalore: Where in the world do I find my outsourcing partner? | Boston 2016
    Am I starting an article on biopharma outsourcing by noting Frederick Engels, co-author (with Karl Marx) of The Communist Manifesto (1848)? Only to point this out: from collectivism to capitalism and its resultant open markets (Adam Smith wrote The Wealth of Nations in 1776), much thought has been devoted to the concept of product “value.” Like with Engels, the notion has mostly been boiled down to a fundamental equation: value = cost/price plus profit. Read more...

     

    For M&A, Shire Stays Three Dimensional With CMOs

    Shire's Approach: The "golden rule" in outsourcing partnerships | Boston 2016
    How do biopharmaceutical companies handle CMO and supplier relationships that stem from M&A activity? In reply, one might recall the old refrain, “Very carefully.” Actually, with a healthy dose of nuance, that’s not far from accurate. Who better to provide that nuance than Shire? The folks there know M&A and outsourcing as well as anyone in the global biopharma industry today. For them, CMO integration, management and assessment traverses three dimensions: quality, process and supply performance. Read more...

     

    The Creation Of Shire's Outsourcing Model

    Shire's Approach: The "golden rule" in outsourcing partnerships | Boston 2016
    When Mani Sundararajan displayed a world map pinpointing the locations of his company’s outsourcing partners, some gathered in attendance gasped. Portrayed was a global web of locations for API, finished dosage, packaging, testing, distribution, and combinations of those and other services. Sensing the wonderment of the attendees, Sundararajan commented, “Yes, we have a complex network of CMOs, and it’s growing.” Then, as if visualizing further proliferation as he spoke: “We’re probably over sixty by now.” Read more...

     

    Black Swans In Pharmaceutical Outsourcing

    Exploring the Future of Outsourcing | San Francisco 2015
    Reading the newest edition of “The Black Swan – The Impact of the Highly Improbable,” while writing a future-looking article, feels, in a word, risky. Author Nassim Nicholas Taleb has some choice words for those who try to write such articles. Taleb, however, might be somewhat understanding in that here we draw attention to the potential for those rare but highly impactful events – Black Swans – in what currently seems an unstoppable march to more pharmaceutical and biotechnology outsourcing.Read more...

     

    The Global CMO Wars: No More Us Vs. Them (Part 2)

    Getting real: how much is outsourcing my project going to cost? | San Francisco 2015
    The opening of Rudyard Kipling’s “The Ballad of East and West” – a “border ballad” that seemingly remains ever in vogue and relevant – is often quoted: “OH, East is East, and West is West, and never the twain shall meet.” Of course this single line leads most to misinterpret the meaning of the early-1900s poem, but we’ll get to that later. Relevant to all of us now: How long will we carry on our border wars between outsourcing service providers in the East and West? Read more...

     

    The Global CMO Wars: No More Us Vs. Them (Part 1)

    Getting real: how much is outsourcing my project going to cost? | San Francisco 2015
    During the electric Outsourced Pharma conference, among other topics, the audience and panelists wrestled with the prevailing attitude of us vs. them in the global outsourcing service industry. Us vs. them not as in sponsors (virtual companies and start-ups, biotechs, pharma) versus service providers (contract research, development and manufacturing organizations). Rather, as factions within the service sector, where dividing lines are drawn between the domestics (U.S.- or more broadly Western-based) and the internationals (Asia-based, including India). Read more...

     

    FDA Should Make "Quality Metrics" Public

    Impacts of FDA quality initiatives on your relationship with your CROs/CMOs | San Diego 2015
    Whether or not you agree with the FDA in its determination to collect “quality data” directly from all drug manufacturers – including contract manufacturing organizations (CMOs) – if the agency moves forward, then the real question is this: Should that data, and any rating the agency might assign to individual manufacturing plants for quality standards or “quality culture,” be kept internal at the FDA or made public? Read more...

     

    Don't Sing The BioPharma Supply-Chain Blues

    Don't let an outsourced supply chain put your business at risk | San Diego 2015
    Six biotechnology and pharmaceutical veterans with experiences in one of the most difficult challenges in the drug industry – preventing or correcting supply-chain disruptions – took the stage at Outsourced Pharma to provide insights and best practices. These professionals are responsible for global supply chains in complicated RNAi therapeutics that utilize nanoparticles, anti-obesity drugs, orphan drugs, vaccines, non-opioid analgesics, and providing the industry with global supply-chain logistics. Read more...

     

    Should You Search Globally For A CMO?

    It's a global search to find the right CRO/CMO | San Diego 2015
    In 1983 I found myself buying leather jackets in bulk in what was then a much smaller Seoul. I shipped the jackets to my home in Osaka, where I took to the streets to sell them one at a time. An American start-up (sort of!), utilizing low-cost production in South Korea, selling in what was becoming a hyper-affluent consumer market in Japan. The jackets went at a nice profit, and I’ve never looked back: Going global rocks. Some 32 years later I’m in San Diego at an Outsourced Pharma. Read more...

     

    BioPharma Striving For LifeCycle Outsourcing

    San Diego 2015 Program Review
    I’m usually pretty good at plucking overall themes from the various topics that swirl around international conferences. That’s why initially failing to do so for the recent Outsourced Pharma San Diego conference was bothering me. But having read the headline to this article, you can see I eventually managed my way through. All the discussion and debate, scientific fields and technological edges, and trends and strategies related to biotechnology and pharmaceutical (BioPharma) outsourcing opportunities and challenges, eventually bled together. Read more...

     

    Is China Casting Shadows On Other Opportunities In Asia Pacific?

    Asia Pacific Market Update & Choosing International Partners | San Francisco 2014
    It’s the final session of the two-day, inaugural Outsourced Pharma conference and it’s packed. The aim is an elucidation of the Asia Pacific region for biopharma companies of all kinds. We may have missed the mark. That is, unless all along, the mark really was China. Two experienced China veterans sit on the four-member panel: one an entrepreneur/ consultant, the other an entrepreneur/ executive currently at a biotech. The other panelists are from a global analytical services company headquartered in Europe and an India-based outsourcing service provider.Read more...

     

    Finding Investors And Capital To Match Your Goals

    Finding Capital That Matches Your Goals | San Francisco 2014
    It’s a nagging uneasy feeling that consumes anyone who’s ever developed a new pharmaceutical or launched a new pharma or biopharma company. You need to raise money.Otherwise, your company may never get off the ground, or that scientific breakthrough you’ve been dreaming of will remain just that — a dream. And by the time a molecule is discovered that may hold some potential, putting more money into the company to optimize manufacturing capabilities is not always the first thing on the mind of investors. Read more...

     

    Supply Chain And Contingency Planning Best Practices

    Supply Chain Planning/Contingency Planning Best Practices | San Francisco 2014
    How do you ensure you have selected the right partners and are doing what is necessary to minimize your supply chain risk? Having a good match between sponsor and vendor is critical to this relationship, so finding partners who are a cultural fit is important. Do the two companies manage communications in a similar way? Does your supplier have the same thoughts on managing risk? Do the two companies share similar views on quality and regulatory issues? These are topics that can make or break a relationship from the outset. Read more...

     

    CMO Best Practices For Establishing And Maintaining A Balanced Quality Agreement

    Establishing And Managing A Balanced Quality Agreement | San Francisco 2014
    With the FDA cracking down on the responsibilities of both parties in the relationship, it is more important than ever for both sides to be in agreement on the actions that need to be taken when a quality issue comes to light. A panel discussion at the Outsourced Pharma West Conference & Exhibition focused on these agreements, with representatives of both large- and small-sponsor companies sharing insights on the topic. Read more...

     

    "Phase-Appropriate" Drug Development The New "Time And Place"

    Phase To Phase Scale-Up Strategies | San Francisco 2014
    Parents today still caution children with the phrase, “Everything in its time and place.” For me, it just took “the look” for my parents to convey: This wasn’t the right time or place. In our biopharma industry that axiom gets replaced with, “Everything in its time and phase.” And “the look” might come from veteran project managers, outsourcing providers, or consultants regarding scale-up strategies. Read more...

     

    Effective Scaling Strategies In Pharma

    Phase To Phase Scale-Up Strategies | San Francisco 2014
    You have a molecule that appears to hold potential for a disease state. You also have some funding in place. But several challenges still lie ahead. You need to hire the right people to help you move forward. You need to learn how to get along with your investors. And you need to locate new partners and investors to help you develop the product and take it to market. Nothing at this stage in your company’s growth is easy or inexpensive, and unfortunately, this stage often determines the success or failure of your business. Read more...

     

    Maximizing Pharma Partnerships: Dos And Don'ts From Industry Experts

    Maximizing Pharma Partnerships | San Francisco 2014
    In today’s life sciences industry, the most common type of partnership seems to be pharma partnering with pharma. But how do you determine if this model is right for you? If it is, how should you then identify partners, come to an acceptable agreement, and execute the partnerships? Read more...

     

    How To Match A CMO To Your Stage Of Development

    Matching A Vendor To Your Stage Of Development | San Francisco 2014
    One of the most informative sessions from last fall’s Outsourced Pharma West Conference & Exhibition in San Francisco discussed matching a vendor to your stage of development. With a lineup of panelists that included Firelli Alonso-Caplen of Pfizer, Joe Guiles of Medivation, Bob Munday of CMC Biologics, Patrick Murphy of Versartis, David Enloe of Althea, and Jon Crate of FAI Testing Services, attendees were sure to hear from executives with first-hand knowledge of the topic. The speakers did not disappoint. Read more...

     

    How To Qualify A CMO's Capabilities And Benchmark Its Performance

    Qualifying CDMO Capabilities & Benchmarking Your CDMOs Performance | San Francisco 2014
    Choose the wrong CMO and your project could easily be derailed, costing your company billions. But how do you avoid making such a mistake? To help answer that question, Life Science Leader brought together a panel of outsourcing experts at the inaugural Outsourced Pharma West conference and exhibition in San Francisco last November. Our panelists share some personal experiences and lessons learned on the topic. Read more...

     

    Why Outsourced Pharma 2014 Proved Pivotal In Connecting Collaborators

    San Francisco 2014 Program Review
    At this year’s Outsourced Pharma West (OPW) conference and exhibition, I began my opening remarks with a story, which actually involves a person named Story Musgrave. A former NASA astronaut with 30 years experience, Dr. Musgrave had recently asked me to connect on LinkedIn. I shared with OPW 2014 attendees some of Dr. Musgrave’s impressive credentials and asked, “So, do you think I accepted his LinkedIn request?” I was met with a chorus of “Yes.” But while I indeed did accept his request, I didn’t do so right away. Read more...

     

    Outsourced Pharma Participants Question One-Stop-Shop Model

    Building An Internal Outsourcing Infrastructure | San Francisco 2014
    The industry trend—and concept—of the “One-Stop-Shop” biopharmaceutical service provider took a rhetorical hit at the inaugural Outsourced Pharma West conference in San Francisco (November 10-11). Outsourced Pharma West, presented by the Life Science Leader magazine and BayBio (Outsourced Pharma was a supporting organization), offered a unique opportunity for leaders from pharma and bio to gather with those from service providers and industry consultants to openly discuss topics and perspectives in our growing and global industry. Read more...