It is time for In Vivo's 11th annual Deals of the Year contest. We've selected 18 nominees in three categories – Top Alliance, Top Financing and Top M&A – and you get to pick the winners. (It's free.)

It is time for In Vivo's 11th annual Deals of the Year contest. We've selected 18 nominees in three categories – Top Alliance, Top Financing and Top M&A – and you get to pick the winners. (It's free.)

It is time for In Vivo's 11th annual Deals of the Year contest. We've selected 18 nominees in three categories – Top Alliance, Top Financing and Top M&A – and you get to pick the winners. (It's free.)

The clinical trial embodies the hope and the hassle of biopharma’s mission to develop new drugs for patients. It is an endlessly imperfect process: C-suite calls for more efficiency and speed at lower cost has been the story for decades. But an In Vivo conversation with a leading expert on trial management pinpoints three key trends that suggest better days are ahead for this central pillar of the innovation imperative.

Lift the burden of paper on drug quality reviews and the pace of innovation is no longer a problem for structural engineers or couriers – or even print or electronic document rooms. The focus at the US FDA is now on enabling direct transmission and analysis of critical quality data.

Consolidation of hospital networks and professionalization of purchasing teams are putting pressure on medtech prices, and they are just two of the factors that are encouraging medtech leaders to renew their focus on spending visibility and accountability. Zero-based budgeting is a tool that could help them deliver a triple win, Patrick O’Hagan and Jason Evers of Bain & Company suggest.

Patient access, regenerative medicine and immuno-oncology feature heavily in a list of the Top 10 most read In Vivo features from 2018, highlighting the issues and disease areas that are top of mind for biopharma and medtech leaders.

"All-hands-on-deck" has been the policy pursued by the US industry association AdvaMed in recent times, as it has sought to play its part in promoting user-friendly, responsive and transparent regulation and market access for medical and digital health care technology. AdvaMed chair Nadim Yared believes that, with one or two noteworthy exceptions, there is more to come in 2019 from a largely improving medtech ecosystem globally.

In view of the political and regulatory threats and opportunities likely to emerge in 2019, for those in the medtech industry, it pays to be vigilant, advises ZS' Brian Chapman. And while some new tech entrants appear to represent a threat to established medtech players, their emergence in general promises significant opportunities for savings and innovation in health care. At the same time, there will likely be a short-term return to both old medtech industry values, and to major M&A.  

Scott Gottlieb's FDA continues to push out policy reforms and experiments at a rapid pace, with special focus on digital and AI technologies. In parallel, US Medicare officials are more publicly signaling plans to roll out policies for a quicker path to reimbursement for new devices. However, public scrutiny of whether device regulations properly protect patient safety is growing, and it could have an impact. 

The health care world once viewed barriers to access in terms of reimbursement and legislation. While these are still prevalent in the conversation, there is a greater focus on nuanced barriers – such as how treatments impact quality of life, convenience for patients, route of administration and side effects.

Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, the Dealmaking column is a survey of recent health care transactions listed by relevant industry segment – In Vitro Diagnostics, Medical Devices, and Pharmaceuticals – and then categorized by type – Acquisition, Alliance, or Financing. This month’s column covers deals announced in December 2018.

Even though 2018 did not feature the big influx of biopharma M&A that was expected, there were still encouraging signs that major advancements and breakthroughs in the biotech industry attract buy-outs. Cancer-focused companies and oncology assets again drove volume in alliances and financing transactions.

A company’s contracts of today drive its income of tomorrow – but also its disputes. Dorothee Schramm, a partner at Sidley Austin who specializes in international commercial disputes, provides tips on how to avoid partnership conflicts.