Trinity Partners Announces Findings from FDA-Approved Drug Performance Index

Therapies for breast cancer, multiple myeloma, and HIV ranked the highest across audit of commercial performance, therapeutic value, and R&D complexity.

WALTHAM, Mass. – December 17, 2018 — Trinity Partners, a leading global life science consulting firm, today announced the findings of its third annual Trinity Drug Index which assessed 57 novel drugs approved by the FDA in 2015. The index ranks drug performance against three categories: commercial performance, therapeutic value and R&D complexity, assigning each drug a score in those three areas as well as an overall composite score.

Top findings of this year’s Trinity Drug Index include:

  • Pfizer’s Ibrance, a kinase indicator indicated for breast cancer, was the best performing drug approved in 2015.
    • Ibrance was granted accelerated approval based on strong efficacy reported in Phase II and has demonstrated strong commercial performance given its first mover advantage.
  • Janssen’s Darzalex and Gilead’s Genvoya ranked second and third.
    • Darzalex was the first antibody to be approved in multiple myeloma and has maximized its commercial potential by moving up the treatment paradigm through combination use.
    • Genvoya, an anti-retroviral combination therapy, lowered treatment burden for HIV patients with its once-daily dosing, thus filling unmet need.
  • In 2015, there were 57 unique drug and biologic approvals, a record high in the past ~20 years, with many of these receiving expedited review designations.
  • Oncology dominated FDA approvals with 15 unique products.
  • Many first-in-class products were approved, spanning multiple indications in several less-prominent spaces with varying degrees of commercial success (Bridion, Strensiq, Orkambi, Kanuma, Addyi).
  • Ultra-orphan drugs tended to continue to display lower commercial performance given their therapeutic value; exceptions include Orkambi and Strensiq.

“Based on this third annual index, we found commercial success to be dependent on a drug’s true clinical differentiation relative to the standard of care, or alternatively, indication expansions to widen the patient base,” said Leslie Sandberg Orne, Senior Partner at Trinity Partners. “This is the case even when introducing new products into already crowded markets: being able to adapt to the growing complications of the drug market proves greater success.”

The index includes three case studies that provide additional context for why some products over- or under-performed commercially relative to their perceived therapeutic value. These include more information about Darzalex and Ninlaro (overperformers), Emplicity and Farydak (underperformers), Addyi (underperformer), and Praduent and Repatha (underperformers).

“Providing this evaluation of FDA-approved drugs, this report also dives into some of the intricacies of success and, perhaps more interestingly, failures in the drug market,” said Dave Fitzhenry, Managing Partner at Trinity Partners. “This insight is especially relevant given the rise in competition, pressure around pricing, and the biosimilars market as we move forward into an era of increased innovation in science.”

To view the full index, click here.

Contacts

For Trinity Partners

Danielle Kirsch, 617-502-4372

dkirsch@pancomm.com

Trinity Partners Named a Consulting Magazine “Fastest Growing Firm” for Third Year in a Row and “Best Small Firm to Work For”

Leading global life sciences consulting firm Trinity Partners has been named to Consulting Magazine’s 2018 lists of “Best Small Firms to Work For” as well as the magazine’s list of “Fastest Growing Firms” for the third consecutive year.

Consulting Magazine’s annual ranking of the industry’s “Best Firms to Work For” is based on employee survey responses regarding six areas of employee satisfaction including culture, career development, work/life balance, client engagement, compensation and benefits, and firm leadership. Consulting Magazine’s list of “Fastest Growing Firms” recognizes firms with the highest rates of revenue growth from 2014 to 2017.

“We are thrilled to have received accolades from Consulting Magazine for both our continued growth as well as our dynamic culture,” says Dave Fitzhenry, CEO, Trinity Partners. “This concurrent recognition is a reflection of our firm’s commitment to excellence in client service as well as our belief in the importance of investment in training and development to support the continued growth of our most important asset, our employees.”

Trinity works with more than 100 clients annually, including 18 of the top 25 global biopharmaceutical companies and dozens of leading medical device and diagnostic companies. Trinity has over 150 professionals on staff that focus solely on the life sciences industry.

To learn more about Trinity Partners, click here.

Trinity Shares Forecast Modeling Expertise in New Article for In Vivo

Experts from Trinity Partners have published a bylined article in In Vivo. The article, titled, “You May Be Making These Drug Forecasting Mistakes,” breaks down the most common missteps in forecasting and highlights how to design and use the best models for the most accurate outcomes. In the article, Alex Chiang, Principal, and Adrian Watson, Senior Manager, Modeling and Analytics, discuss the top 10 most common drug forecasting errors, which fall into three broad categories: model design issues, model maintenance issues, and model abuse issues.  The authors also provide strategies to avoid these errors and achieve a successful forecasting process.

To view the full text of Alex and Adrian’s In Vivo article, please visit: http://bit.ly/2PSbNmd

Trinity Partners and Pfizer Present Panel Discussion on Tissue-Agnostic Cancer Drug Development

Waltham, MA—Global life sciences consulting firm Trinity Partners today announced it will present the panel discussion, “Tissue-Agnostic Cancer Drug Development: An Emerging Paradigm Shift?” along with Pfizer and the Healthcare Businesswomen’s Association (HBA). The event, featuring perspectives from clinical, commercial, regulatory and market access experts, will take place at Pfizer’s headquarters in New York City on October 23, 2018 from 5:30-8 pm.

Cancer treatment has made significant strides toward the promise of personalized medicine in recent years. With Keytruda’s tissue-agnostic MSI-H/dMMR approval last year, basket trials are now a viable registrational strategy to pursue such tissue-agnostic, biomarker-based indications. The panel will focus on what this means for oncology treatment and for industry, including whether it will lead to a shift in the oncology treatment paradigm.

The discussion will be moderated by Geeta Devgan, PhD, Medical Director of US Medical Affairs, Pfizer Oncology. Panelists include:

  • David Hyman, MD, Chief, Early Drug Development, Memorial Sloan Kettering Cancer Center
  • Chris Boshoff, MD, PhD, Head & SVP of Immuno-Oncology, Early Development & Translational Oncology, Pfizer
  • Jillian Scaife, MPH, MBA, Principal, Trinity Partners
  • Leigh Marcus, MD, Medical Officer, Office of Hematology & Oncology Products, CDER, FDA
  • Nitin Patel, Sr. Principal, Market Access, IQVIA

“While the emergence of truly registrational basket trials have been limited to-date, the growing pool of mid-phase and/or exploratory tissue-agnostic trials suggests that, in the near term, interest in tissue-agnostic basket trial development is likely to grow,” said Jillian Scaife. “It is critical to consider the potential impact multiple oncology products approved with tissue-agnostic indications could have for oncology treatment and for industry.”

Register to attend the tissue-agnostic cancer drug-development panel. For more information on this emerging paradigm shift, read Trinity Partners’ whitepaper on oncology basket trials.

About Trinity Partners

Trinity Partners is a trusted life sciences strategy consulting firm that takes a personalized approach to working with pharmaceutical, biotech, medical device, and diagnostic clients worldwide to create tailored, evidence-based solutions that drive business strategy and impact bottom lines. Trinity works with more than 100 clients annually, including 18 of the top 25 global biopharmaceutical companies and dozens of leading medical device and diagnostic companies. Trinity has over 150 professionals on staff that focus solely on the life sciences industry. Trinity is partnered with Parthenon Capital Partners, a leading, growth-oriented private equity firm. To learn more about Trinity Partners, click here.

Trinity Partners to Acquire TGaS® Advisors

Click here to visit TGaS.com

Next milestone in Trinity’s build, buy and partner growth strategy further accelerates the firm’s mission and vision to lead transformation in the life sciences industry

Waltham, MA—Global life sciences consulting firm Trinity Partners today announced it has acquired TGaS® Advisors, the leading benchmarking and advisory services firm for commercial organizations in the life sciences industry. The acquisition marks another proof point in Trinity Partners’ overarching growth strategy and builds upon previous successes and momentum including a strengthened leadership team, U.S. and global expansion, and enhanced product offerings.

TGaS Advisors will operate as a wholly-owned division of Trinity Partners and brings to bear more than 15 years of industry experience including work with a majority of the top 50 pharmaceutical companies and a growing number of biotech companies. Under terms of the agreement, Trinity will add TGaS’s unique benchmarking products to its real-world evidence and primary market research capabilities to power its strategic advisory offerings in corporate and product strategy, launch readiness, pricing and market access, and health economics. The joint go-to-market offerings will enhance clients’ ability to deliver life changing innovations to patients around the globe.

“Our clients operate in a highly competitive marketplace. Their success hinges on ensuring they have the best strategic partner with industry expertise, insights, and analytics on their side,” said David Fitzhenry, CEO & Managing Partner, Trinity Partners.  “There is immediate benefit to our clients as we bring TGaS Advisors into the Trinity family and realize our combined potential. We look forward to expanding on their proven track record, built-in network and benchmarking capabilities and including them into our commercialization offerings.”

“Joining forces with Trinity Partners will undeniably make us a better and stronger collective entity not only for our clients and prospects, but also for our employees,” said Gary McWalters, President, TGaS Advisors. “I look forward to this next chapter as it is the perfect long-term scenario to accelerate investment in building our additional benchmarking offerings, delivering our vendor insights to the market and combining those core competencies with a strong Trinity portfolio that will improve the value proposition for our clients.”

“Moving forward, we will continue to target companies across new geographies to expand our influence, accelerate expansion, identify strategic adjacencies that expand collective influence and acquire outside talent and technology to offer new services to clients,” added Fitzhenry.

About TGaS Advisors

TGaS Advisors is the leading benchmarking and advisory services firm for commercial organizations in the life sciences industry. With a roster of more than 100 companies, including large, mid-tier, emerging and precommercial life sciences companies, TGaS provides robust comparative intelligence and collaborative network membership services. The team includes more than 50 experienced professionals, most with senior-level experience in the life sciences and related industries.

About Trinity Partners

Trinity Partners is a trusted life sciences strategy consulting firm that takes a personalized approach to working with pharmaceutical, biotech, medical device, and diagnostic clients worldwide to create tailored, evidence-based solutions that drive business strategy and impact bottom lines. Trinity is partnered with Parthenon Capital Partners, a leading, growth-oriented private equity firm. To learn more about Trinity Partners, click here.

Contacts

For Trinity Partners

Danielle Kirsch, 617-502-4372

dkirsch@pancomm.com

Trinity Partners Welcomes Christian Frois, PhD to Leadership Team, Among 7 Leadership Team Promotions

Boston, August 20, 2018 – Leading global life sciences consulting firm Trinity Partners today announced that it has welcomed new Principal, Christian Frois, PhD, to the firm as well as seven other individuals to its leadership team. Trinity also welcomes new full-time hires, totaling 40 new employees company-wide this year to date.

Frois specializes in the development and evaluation of innovative commercial and evidence strategies for biopharmaceutical and medical device companies, and is a recognized expert on pricing, contracting and market access strategy. Prior to his appointment to principal at Trinity Partners, Frois was an assistant principal in the pharmaceuticals practice of CRA International. Over the course of his career, Frois has led numerous consulting engagements, developing U.S. and global launch, marketing, pricing, market access, and evidence generation strategies for medications across therapeutic areas, in both retail and institutional settings. Previously, Frois served as an assistant director at Ernst & Young in London, and a senior consultant with Mars & Co.  Frois has a Ph.D. in economics from Massachusetts Institute of Technology and an Ingénieur degree from Ecole Polytechnique, France.

Trinity also expanded its leadership team with the promotions of:

  • Eric Sholk from principal to partner. Sholk’s expertise ranges across areas that are critical to bringing products to market, as well as those that create additional value for clients through LCM and L&A opportunities.
  • Nandini Hadker from principal to partner. Hadker’s specializes in HEOR, RWE, primary and secondary research, and scientific publications.
  • Chad Faulkner from engagement manager to principal. Faulkner is an expert in licensing & acquisition, corporate strategy, pipeline and portfolio optimization, launch planning, market analytics, forecasting, and primary market research.
  • Kevin Chithran from engagement manager to principal. Chithran’s areas of specialization include market analytics, forecasting, new product planning, pipeline & portfolio optimization, and licensing & acquisition assessments.
  • Michelle Adams from director to senior director. Adams specializes in corporate communications, organizational planning, facilitated training, public speaking, instructional design, and performance management.

These 2018 additions to the leadership team follow the December 2017 promotions of Susheel Sukhtankar from engagement manager to principal, and John Gillis from associate director to principal. In addition to these promotions, Trinity Partners also welcomed 40 new full-time hires to the firm in 2018 thus far.

Based just outside of Boston, Trinity has more than 100 employees with offices in San Francisco and New York City, and has been named to Consulting Magazine’s list of ‘Fastest Growing Firms’ as well as a Boston Business Journal ‘Best Places to Work.’

About Trinity Partners

Trinity Partners is a trusted life sciences strategy consulting firm that takes a personalized approach to working with pharmaceutical, biotech, medical device, and diagnostic clients worldwide to create tailored, evidence-based solutions that drive business strategy and impact bottom lines. To learn more about Trinity Partners, click here.

Trinity team attends Battle Summit to hear how Cycle for Survival funding is helping rare cancer patients

Trinity’s Breanna Liponis and Alyssa Blaize recently attended Battle Summit to hear firsthand from Memorial Sloan Kettering doctors and researchers how Cycle for Survival funding is helping rare cancer patients everywhere. The team heard about important studies, initiatives and clinical trials funded through Cycle for Survival donors and participants for salivary gland cancer, pancreatic neuroendocrine tumors and advanced melanoma, among other areas. In addition, the team heard the latest updates on Loxo Oncology’s TRK fusion inhibitor, larotrectinib, developed with Cycle for Survival funding, and its path to FDA approval. At Trinity Partners, we are proud to support Cycle for Survival to help advance rare cancer research. Learn more about Cycle for Survival: https://bit.ly/2KqaFmI and read more about larotrectinib in our latest whitepaper: https://bit.ly/2lCatD5

Trinity Partners Named a Forbes Best Management Consulting Firm for Third Consecutive Year

Leading global life sciences consulting firm Trinity Partners today announced that it has been named to the Forbes America’s Best Management Consulting Firms 2018 list. Trinity Partners has been named among the best management consulting firms every year since the inaugural ranking in 2016.

The list, developed by Forbes in partnership with Statista, considers more than 1,300 consulting firms and surveys more than 1,000 senior executives to determine the best management consulting firms  based on recent performance and first-hand experience. The list represents 16 different industries including healthcare and life sciences.

“In today’s competitive environment, we’re proud to be recognized for the service we provide to our clients year after year,” said Dave Fitzhenry, CEO at Trinity Partners. “It’s a great reflection of our focus on customer satisfaction and strategic partnership, and we commend Forbes for putting the resources into this comprehensive list each year.”

Trinity works with more than 100 clients annually, including 18 of the top 25 global biopharmaceutical companies and dozens of leading medical device and diagnostic companies. Trinity has over 150 professionals on staff that focus solely on the life sciences industry.

To learn more about Trinity Partners, click here.

Trinity Partners Releases New Report on Oncology Basket Trials

Leading global life sciences consulting firm Trinity Partners today released a new whitepaper analyzing the oncology clinical trial pipeline to determine the extent to which basket trials are being utilized and, in particular, how many are likely to be registrational studies resulting in tissue-agnostic indications.

Historically, basket trials have been used to explore multiple tumor types in one trial in order to prioritize the ones with the greatest response for further research. However, with Keytruda’s MSI-H and dMMR approval, basket trials have now become a viable registrational strategy to pursue a tissue-agnostic indication. Key findings from the whitepaper include:

  • Only 2 trials appear to clearly be pursuing a tissue-agnostic regulatory filing; there are no basket trials currently in Phase III.
  • Although many of the trials identified are not clearly linked to a planned regulatory filing for a tissue-agnostic indication, the authors expect that the results of these trials, if positive in the broad indication, could lead to future registrational trials in the next 1-3 years.
  • Across the 37 basket trials identified for analysis, 16+ types of biomarkers or genetic mutations are currently being studied. This broad scope verifies the growing trend of tumor-agnostic research across oncologic agents, regardless of biomarker studied.

“In the near term, pending the results of these trials, interest in tissue-agnostic basket trial development is likely to grow, especially as next-generation genomic sequencing continues to become more widespread in oncology,” said Jillian Godfrey Scaife, principal at Trinity Partners. “Whether the number of tissue-agnostic indication approvals will ever be substantial enough to drive a significant shift in treatment approaches remains an open question.”

“With this research, we sought to better understand whether and when there will be a tipping point in the oncology treatment paradigm,” added Vivian DeWoskin, engagement manager. “The growing pool of mid-phase/exploratory tissue-agnostic trials suggests we could be headed in that direction, leading to many long-term implications on the clinical application, commercialization and development of targeted oncolytics in the next several years.”

Trinity works with more than 100 clients annually, including 18 of the top 25 global biopharmaceutical companies and dozens of leading medical device and diagnostic companies. Trinity has over 150 professionals on staff that focus solely on the life sciences industry.

To view the full whitepaper, click here.