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Past Event Information

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


Past Speaker Interviews

Ravi Kiron, Head of BioPharma External Innovation | EMD Serono

Innovation Envy: Surfing California For Next Biopharma Wave

Stephen Harrison, CSO & SVP | Engine Biosciences

Not Enough Data To Utilize AI And Machine Learning In Drug Development

Susanne Somerville, Founder & Leader | The MediLedger Project

Big Pharma Moving The Blockchain Needle

Hugh Wight, VP of Technical Operations | Allena Pharmaceuticals

From CMO To CMO: A Biopharma With All The Right Moves

Vadim Klyushnichenko, VP Pharmaceutical Development & Quality | Calibr

10 CDMOs, 2 Cancer Therapies, And An Eye On Analytical Services

John McKay, SVP Global Quality and Corporate Compliance Officer | CTI BioPharma

A Trait For Quailty In John McKay's DNA

Todd Mabe, Head of External Quality, Biologics Drug Substance | Genentech

Genentech Speaks The Language Of CMOs

Bob Sheroff, SVP, Technical Operations | Agios Pharmaceuticals

Is Your Outsourcing Reliable, Responsive, And Continuously Compliant?

Thomas Holmes, Sr. Director, Global External Manufacturing | Biogen

At Biogen, Three Keys To Outsourcing

Bikash Chatterjee, President & CSO | Pharmatech Associates

Considerations For Biologic Drug Substance And Drug Product Testing

Denise McDade, VP Quality | Capricor Therapeutics

The Paradox In Measuring Your CMO

Marilyn Bruno, President | Aequor

You Can Do Everything Right, But Still Get Burned By Outsourcing

Sylvie Sakata, Sr. Director, External Research Solutions | Pfizer

Pfizer Says Science First In Alliance Management

Firelli Alonso-Caplen, Sr. Director Biotherapeutics & Vaccines Outsourcing | Pfizer

Learn Pfizer's Guiding Principles For Externalization At Outsourced Pharma

Steve Cook, Head, Global Biologic Supply Chain Operations | MedImmune

What Is Supply Chain Capacity In 2017?

Lee Spach, Director, Global Product & Supply Chain Security | Biogen

Biogen Leads Fight Against Supply-Chain Criminals

2 Reasons Your CDMOs Are Consolidating: Money & Muscle

San Diego 2018

Private equity is providing the M&A fuel for contract development and manufacturing organizations (CDMOs), fill-and-finish specialists, and clinical and commercial packaging partners

External web link - https://www.outsourcedpharma.com/doc/reasons-your-cdmos-are-consolidating-money-muscle-0001

Levels Of Risk Severity In Biopharma's Global Outsourcing

Regulation 'Round The World: How To Navigate International Outsourcing | Philadelphia 2018

It’s unanimous across this panel of international biopharma outsourcing experts: global playing fields are uneven, the players unequal, and supply-chain risks imbalanced.

External web link - https://www.outsourcedpharma.com/doc/levels-of-risk-severity-in-biopharma-s-global-outsourcing-0001

Biopharma And CDMOs: No Strategic Relationships In The Long Run?

New Business Models With CDMOs Include Better Pricing | Boston 2018

Edwin Beale has provided drug development and manufacturing services to biopharma companies for over 20 years. He’s heard it all when it comes to negotiating contracts between biopharma and CDMOs.

External web link - https://www.outsourcedpharma.com/doc/biopharma-and-cdmos-no-strategic-relationships-in-the-long-run-0001

Your Supply Chain At Risk: How To Stay Ahead Of The Villains

Lowering Risk To Your Physical Supply Chain | Boston 2018

Your supply chain – raw materials and intermediates, APIs and particularly commercial products – is at serious risk from bad actors. We are talking about falsified or stolen materials, counterfeiting, gray-market diversion, and other nefarious behaviors.  

External web link - https://www.outsourcedpharma.com/doc/your-supply-chain-at-risk-how-to-stay-ahead-of-the-villains-0001

3 Questions To Guide You At Biopharma Conferences

2018

Outsourced Pharma conference season: Boston, Philadelphia, San Diego, San Francisco … here we come. Time for you to lead and learn among others in the industry, with the goal of making outsourcing more productive for your organization.

External web link - https://www.outsourcedpharma.com/doc/questions-to-guide-you-at-biopharma-conferences-0001

Pastries And Process: A Recipe for Innovation At CDMOs

Aligning Motivations For Sponsor And Supplier Innovations | San Francisco 2017

Hard truths offset by soft skills make up the outsourced drug development and manufacturing industry.

External web link - https://www.outsourcedpharma.com/doc/pastries-and-process-a-recipe-for-innovation-at-cdmos-0001

Two Strategies For Getting Your CMO To Really Listen

San Diego 2017

CMOs were listening to biotech and pharma executives at Outsourced Pharma San Diego 2017. Those executives, in turn, were hearing out their service providers. From the many best practices and insights both sides offered, I’ve picked two to bring to you today. Let’s title them, “In The Line Of Sight,” and “Do Incentives Talk?”

External web link - https://www.outsourcedpharma.com/doc/two-strategies-for-getting-your-cmo-to-really-listen-0001

Risk And Small "i" Innovation In Pharma Outsourcing

Learning to fly: How to support incremental innovative solutions | Boston 2017

The Summit on Modern Day Drug Development and Manufacturing Outsourcing (Outsourced Pharma Boston, April 26-27) purposely led off with a session on incremental – or small “i” – innovation. That’s not because we were looking for “baby steps” to ease into tougher discussions. In fact, the mission was to kick-start us into advanced contemplations between drug sponsors and service providers.

External web link - https://www.outsourcedpharma.com/doc/risk-and-small-i-innovation-in-pharma-outsourcing-0001

Channeling Socrates With The FDA On Innovative Technologies

Boston 2017

Paraphrasing Henry Hoppe, a long-time veteran of Sanofi Genzyme, and currently Vice President, Drug Development, Xenetic Bioscience: Companies on the bleeding edge of innovative technology in drug development and manufacturing should treat visits to the FDA more like Socratic dialogues than stressful duels.

External web link - https://www.outsourcedpharma.com/doc/class-in-session-interacting-with-the-fda-on-innovative-technologies-0001

Instant Innovation In The Supply Chain

Learning to Fly: How to Support Incremental Innovative Solutions | Boston 2017

We’re told that in the ranks of drug companies, more often than not, individuals wait for the “culture” to descend from the highest levels of the organization to miraculously instill the mindset that they can be innovative, and won’t be faulted if at times they come up short.

External web link - https://www.outsourcedpharma.com/doc/instant-innovation-in-the-supply-chain-0001

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.

External web link - https://www.outsourcedpharma.com/doc/the-three-pillars-of-industry-conferences-0001

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.

External web link - https://www.outsourcedpharma.com/doc/what-are-new-board-members-saying-about-outsourcing-0001

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.

External web link - https://www.outsourcedpharma.com/doc/pharma-s-potemkin-village-on-the-river-of-outsourcing-0001

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?

External web link - https://www.outsourcedpharma.com/doc/pfizer-s-key-questions-for-cmo-innovation-0001

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.

External web link - https://www.outsourcedpharma.com/doc/pharma-s-super-heroes-of-innovation-0001

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.

External web link - https://www.outsourcedpharma.com/doc/top-secret-quality-concerns-for-selecting-cmos-how-important-are-records-0001

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?”

External web link - https://www.outsourcedpharma.com/doc/the-price-at-my-cmo-isn-t-right-but-how-do-i-know-0001

Some Biopharma Haven't Caught Outsourcing Enthusiasm

Boston 2016

I often write – and you read – about those individuals at biopharma companies openly enthusiastic about outsourcing. In common is a partiality to sharing strategies and best practices with anybody who’ll listen. These people have come to believe in a camaraderie of industry; a rising tide lifts all boats.

External web link - https://www.outsourcedpharma.com/doc/some-biopharma-haven-t-caught-outsourcing-enthusiasm-0001

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.

External web link - https://www.outsourcedpharma.com/doc/emerging-biopharma-and-their-cmos-crazy-like-a-fox-0001

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.

External web link - http://www.outsourcedpharma.com/doc/value-creation-redefines-biopharma-outsourcing-0001

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.

External web link - https://www.outsourcedpharma.com/doc/for-m-a-shire-stays-three-dimensional-with-cmos-0001