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The FDA’s Shift from Gate Keeper to Enabler
Soon after Scott Gottlieb announced he was stepping down, he released a statement (Scott Gottlieb’s March 14th, 2019 Statement) that talked about the clinical research landscape and we, at Kineticos, were quite shocked by some of the things that he said. Specifically, former FDA Commissioner Gottlieb stated, “Efforts to streamline medical product development based on … Continue reading The FDA’s Shift from Gate Keeper to Enabler
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Building a Biotech Board
On our 12+ year journey here at Kineticos, we have come to recognize that one reason great science is often kept at bay is poor management. With that in mind, one of the first things a new CEO needs to do when building a biotech company is to put together a board of directors that can … Continue reading Building a Biotech Board
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Bridges and Barriers to Advancing CAR T Therapy
Kineticos’ Operating Executive, Steve Buckanavage, recently caught up with Dr. Jeffrey Skolnik, VP of Clinical Development at Inovio Pharmaceuticals to discuss topics regarding CAR T therapy. Dr. Skolnik is currently responsible for overseeing global clinical development of assets for DNA immunotherapies for oncology at Inovio. Dr. Skolnik has over 10 years of experience leading early … Continue reading Bridges and Barriers to Advancing CAR T Therapy
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Are we Manufacturing the right T-Cells And a Look at the Future of Oncology Precision Medicine
The final part of the discussion between Kineticos’ Operating Executive, Steve Buckanavage and Precision Biosciences’ CMO, Christopher Heery M.D., covers the advancement of T-cell generation and what the future holds for Oncology research. Click the link below to view the whole article. Moderator: Steve Buckanavage, Operating Executive, Kineticos Panelist: Christopher Heery, CMO, Precision Biosciences Kineticos: … Continue reading Are we Manufacturing the right T-Cells And a Look at the Future of Oncology Precision Medicine
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Is Precision Medicine in Oncology Narrowing Patient Population Too Much?
Kineticos’ Operating Executive Steve Buckanavage, continues his discussion with Christopher Heery, M.D., CMO at Precision Biosciences as they tackle the difficulties that Precision Medicine can bring to Oncology studies. To read the whole article, click the link below. Moderator: Steve Buckanavage, Operating Executive, Kineticos Panelist: Christopher Heery, M.D., CMO, Precision Biosciences Kineticos: Our understanding of … Continue reading Is Precision Medicine in Oncology Narrowing Patient Population Too Much?
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Can We Create Companion Diagnostics In Oncology With What We Know About Biomarkers?
As we continue our discussion between Steve Buckanavage, Kineticos’ Operating Executive and Christopher Heery, M.D., CMO at Precision Biosciences, we discuss Biomarkers and their impact in diagnosing individual patients versus segmenting patient populations. To read the whole article, click the link below. Moderator: Steve Buckanavage, Operating Executive, Kineticos Panelist: Christopher Heery, M.D., CMO, Precision Biosciences … Continue reading Can We Create Companion Diagnostics In Oncology With What We Know About Biomarkers?
The Biopharmaceutical practice at Kineticos assists growth-oriented pharmaceutical and biotech companies realize their commercial potential at the corporate, portfolio and product levels. Our consulting team has a depth of expertise across functional areas and therapeutic areas, established through decades of work in consulting or in industry. Overall the practice has a strong commitment to client satisfaction and a proven ability to deliver results through practical solutions.
The Biopharmaceutical Practice at Kineticos supports clients across six service areas including:
Corporate Strategy
- R&D Strategy
- Commercial Assessment
- Primary Market Research
Corporate Development
- In-licensing
- Out-licensing
- Transaction Support
Commercial Strategy
- Business Model Design
- Market Access
- Forecasting
Commercial Performance
- Planning and Execution
- Commercial Operations
- Omni-channel Strategies
HCP and Patient Engagement
- Customer Experience
- Advocacy Relations
- Congress Planning
Medical Affairs Effectiveness
- MSL Strategies and Solutions
- Organization Models
- Business Requirements
Click the Tabs Below for Biopharmaceutical Practice Case Studies, White Papers and Articles, and Blog
Corporate Strategy
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Business Model Design
Situation: A specialty pharmacy company focused in rare hematological disorders needed support and guidance establishing their ex-US commercialization strategy. The sponsor had recently experienced a successful US launch but required support evaluating commercialization models for Canada. The sponsor established some foundational assumptions regarding the market opportunity but needed specific expertise to tease out the unique … Continue reading Business Model Design
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Indication Prioritization and Forecasting
Situation: A publicly traded Oncology company with 3 technology platforms and limited resources was in need of narrowing their indication focus. Their next generation cancer vaccine technology demonstrated early proof of principle in 14 unique tumor types and retained Kineticos to conduct an indication prioritization exercise. The primary objective of the engagement was to objectively … Continue reading Indication Prioritization and Forecasting
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Portfolio Optimization
Situation: A fully integrated pharmaceutical company developing a class of immuno-oncology therapies was in need of a deeper understanding of one of their program’s differentiating attributes. Several indications were under consideration and before further investing in clinical and commercial activities, the sponsor needed to gain insights into available therapies, what drives prescriber decisions, and how … Continue reading Portfolio Optimization
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Portfolio Prioritization – Oncology
Situation: A publicly traded Oncology company with 3 technology platforms and limited resources was in need of narrowing their focus. Their next generation cancer vaccine technology had applicability to 14 unique cancer tumor types but given the need to narrow their focus, the sponsor retained Kineticos to conduct a portfolio prioritization exercise. The primary objective … Continue reading Portfolio Prioritization – Oncology
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Oncology Commercial Assessment – Melanoma
Situation: A clinical-stage oncology company with a potentially ground-breaking technology requested Kineticos to help determine which tumor type(s) had the greatest potential to demonstrate patient benefit. The sponsor was considering 2 tumor types internally and requested that Kineticos conduct a Commercial Assessment to help understand the patient journey, unmet need, and commercial potential of Melanoma … Continue reading Oncology Commercial Assessment – Melanoma
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Product Search
Situation: A drug delivery technology company identified an opportunity to generate additional revenue by acquiring products to further develop and enhance their innovative technology. Thus, the executive management team hired Kineticos to conduct a scan of the market with a goal of identifying attractive investment opportunities. Process: Kineticos initially focused on becoming very familiar … Continue reading Product Search
Corporate Development
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Portfolio Optimization
Situation: A fully integrated pharmaceutical company developing a class of immuno-oncology therapies was in need of a deeper understanding of one of their program’s differentiating attributes. Several indications were under consideration and before further investing in clinical and commercial activities, the sponsor needed to gain insights into available therapies, what drives prescriber decisions, and how … Continue reading Portfolio Optimization
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Portfolio Prioritization – Oncology
Situation: A publicly traded Oncology company with 3 technology platforms and limited resources was in need of narrowing their focus. Their next generation cancer vaccine technology had applicability to 14 unique cancer tumor types but given the need to narrow their focus, the sponsor retained Kineticos to conduct a portfolio prioritization exercise. The primary objective … Continue reading Portfolio Prioritization – Oncology
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Oncology Commercial Assessment – Melanoma
Situation: A clinical-stage oncology company with a potentially ground-breaking technology requested Kineticos to help determine which tumor type(s) had the greatest potential to demonstrate patient benefit. The sponsor was considering 2 tumor types internally and requested that Kineticos conduct a Commercial Assessment to help understand the patient journey, unmet need, and commercial potential of Melanoma … Continue reading Oncology Commercial Assessment – Melanoma
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Product Search
Situation: A drug delivery technology company identified an opportunity to generate additional revenue by acquiring products to further develop and enhance their innovative technology. Thus, the executive management team hired Kineticos to conduct a scan of the market with a goal of identifying attractive investment opportunities. Process: Kineticos initially focused on becoming very familiar … Continue reading Product Search
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Commercial Assessment
Situation: A clinical-stage oncology company with a potentially ground-breaking technology requested Kineticos to help determine which tumor type(s) had the greatest potential to demonstrate patient benefit. The sponsor was considering 2 tumor types internally and requested that Kineticos conduct a Commercial Assessment to help understand the patient journey, unmet need, and commercial potential of Melanoma … Continue reading Commercial Assessment
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Business Development and Licensing
Situation: A publicly traded pharmaceutical company seeking a strategic partner for their IND-ready asset was in need of support with executing on their partnering strategy. Thus, Kineticos was retained to lead and manage the business development and licensing process. Process: Kineticos was first charged with developing a clear and concise pitch deck to be leveraged … Continue reading Business Development and Licensing
Commercial Strategy
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Commercial Strategy
Situation: A mid-size pharmaceutical company unexpectedly obtained a marketed CNS drug and needed to understand the financial impact of various commercialization strategies. Due to the newly acquired drug being in an adjacent market to the sponsor’s flagship product, there was uncertainty regarding investing in commercialization or eliminating from their product mix. Given the volatility of … Continue reading Commercial Strategy
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Portfolio Optimization
Situation: A fully integrated pharmaceutical company developing a class of immuno-oncology therapies was in need of a deeper understanding of one of their program’s differentiating attributes. Several indications were under consideration and before further investing in clinical and commercial activities, the sponsor needed to gain insights into available therapies, what drives prescriber decisions, and how … Continue reading Portfolio Optimization
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Portfolio Prioritization – Oncology
Situation: A publicly traded Oncology company with 3 technology platforms and limited resources was in need of narrowing their focus. Their next generation cancer vaccine technology had applicability to 14 unique cancer tumor types but given the need to narrow their focus, the sponsor retained Kineticos to conduct a portfolio prioritization exercise. The primary objective … Continue reading Portfolio Prioritization – Oncology
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Oncology Commercial Assessment – Melanoma
Situation: A clinical-stage oncology company with a potentially ground-breaking technology requested Kineticos to help determine which tumor type(s) had the greatest potential to demonstrate patient benefit. The sponsor was considering 2 tumor types internally and requested that Kineticos conduct a Commercial Assessment to help understand the patient journey, unmet need, and commercial potential of Melanoma … Continue reading Oncology Commercial Assessment – Melanoma
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Business Development & Licensing
Situation: An innovative oncology diagnostics company retained Kineticos to assist in developing their pitch deck, as well as developing and executing an outreach strategy designed to secure partnering meetings with key decision makers at biopharmaceutical companies and ultimately, boost revenue for the organization. The sponsor’s technology was validated through existing partnerships and there were internal … Continue reading Business Development & Licensing
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Product Search
Situation: A drug delivery technology company identified an opportunity to generate additional revenue by acquiring products to further develop and enhance their innovative technology. Thus, the executive management team hired Kineticos to conduct a scan of the market with a goal of identifying attractive investment opportunities. Process: Kineticos initially focused on becoming very familiar … Continue reading Product Search
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Growth by Acquisition in Life Sciences: Do You Have a Plan?
As the life sciences landscape continually changes, growth by acquisition has become increasingly common. Recent deals, such as Roche’s acquisition of Ariosa Diagnostics and LabCorp’s acquisition of Covance, bring to light an important question for decision makers in the life sciences industry: When it comes to growth by acquisition, what is your plan? … Continue reading Growth by Acquisition in Life Sciences: Do You Have a Plan?
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R&D Revolutionaries: Why the Actavis/Allergan Deal Takes a Stand for Biopharma’s True Roots in Innovation
James Forte of Kineticos takes an in-depth look at the recent Actavis/Allergan deal including the role R&D innovation played in shaping the deal’s outcome. Let’s be candid. It’s been awhile since any biopharma company was able to claim R&D as a core competency with a straight face. Biopharma’s R&D efforts have long been challenged, and rightly so given its output, but the Actavis/Allergan deal shows that the right investment in R&D can revolutionize a business. Could efficient R&D be the new definition of innovation?
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Merck KGaA and Bayer Choose Opposite Strategies
Europe’s two largest chemical and drug conglomerates are changing course in starkly opposite ways. As reported in recent blogs, Merck KGaA and Bayer are both responding to the basic core of their original strategies—Merck KGaA is acquiring Sigma-Aldrich to diversify their materials and services and Bayer is “spinning-off” (and eventually selling, over the … Continue reading Merck KGaA and Bayer Choose Opposite Strategies
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Foundation Medicine and Clovis Expand Partnership
In April 2014, Foundation Medicine and Clovis Oncology announced the expansion of their partnership by developing a companion diagnostic for a Clovis drug currently in clinical trials.1 Specifically, the test is being developed in conjunction with the FDA new drug application submission for Rucaparib, a polymerase inhibitor for the treatment of…
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Role of Companion Diagnostics in Immuno-oncology Race Unfolding
Important oncology events, including ASCO and ESMO, have recently displayed the fruits of the huge investment drug companies have put into oncology, especially the immuno-oncology therapies centered on PD-1. In previous blogs, I noted that BMS appeared to be leaning toward not incorporating a companion diagnostic for nivolumab (another anti-PD-1 therapy) in melanoma … Continue reading Role of Companion Diagnostics in Immuno-oncology Race Unfolding
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Bayer to Divest Plastics Unit to Improve R&D, Acquisition Capacity
As reported by Bloomberg and the Wall Street Journal, Bayer is expected to announce plans to sell its plastics unit, creating a key shift from chemicals to the life science industry. Along with Merck KGaA, Bayer is one of Europe’s last foremost drug and chemical multinationals, making the shift unprecedented, if not unexpected. … Continue reading Bayer to Divest Plastics Unit to Improve R&D, Acquisition Capacity