Galien Golden Jubilee Forum – USA2021

Oct. 28th, 2021
12PM – 1:15PM

In-person registrationLive broadcast registration

Sue Desmond-Hellmann,
Former Chief Executive Officer, Bill & Melinda Gates Foundation, and chair, Prix Galien USA Awards Committee.
Petra Jantzer, Senior Managing Director – Life Sciences, Europe, Accenture

Stephane Bancel,
Chief Executive Officer, Moderna Inc.
Albert Bourla, Chairman and Chief Executive Officer, Pfizer Inc.
Pam Cheng, Executive Vice-President, Operations and Information Technology, AstraZeneca
Alex Gorsky
, Chairman, Board of Directors & CEO, Johnson & Johnson
Leonard Schleifer, Founder, President & CEO, Regeneron
Daniel M. Skovronsky, President Lilly Research Laboratories, Chief Scientific & Medical Officer, Eli Lilly and Company


Vaccines, drugs & the future of pandemics — Lessons from COVID-19

Eighteen months into the COVID-19 pandemic, awareness is building of significant gaps in the capacity of governments and the private-sector to manage emerging threats to health worldwide. Statistics reveal the breadth of the current challenge, with 182m cases of COVID-19 officially recorded to date resulting in over 4m deaths; the real numbers are undoubtedly much higher.  At the same time, some 3.2bn doses of highly efficacious vaccine have been administered worldwide, which is a great success in terms of timing but falls far short of what is needed – immunization rates in low-and middle-income countries most vulnerable to the virus amount to a little more than one per cent of the adult population.

The pandemic has put a harsh spotlight on virtually every aspect of health care financing and delivery. These include inequities in access to basic services, especially preventive vaccines and prophylactic drugs; limited, shareable data on disease states and effective treatment interventions; public trust issues that slow compliance with public health mandates; and a pervasive disconnect between health research priorities and the actual burden of disease.

Perhaps the most glaring deficit relates to institutional preparedness – specifically, the slowness of a coordinated multilateral response to a deadly respiratory virus known for its easy transmissibility across borders. COVID-19 has exposed a piecemeal infrastructure for detecting, assessing and responding to health emergencies where and as they occur.   It’s a stance at odds with the fact that the relevance of national borders to health is dwindling as big existential threats like climate change and loss of biodiversity from habitat destruction increase the likelihood of zoonotic transmission and other viral vectors with the potential to unleash new strains of infections in humans.

The failure to prioritize communicable disease control and prevention around the social determinants of health is another gap in the armamentarium.   Experience in low and middle-income countries shows that health security depends on fostering engagement and awareness among key influencers like women at the grassroots, community level; infectious disease surveillance is not an ad hoc exercise, nor can it be conducted remotely.

With effective vaccines still offering the best chance of defeating COVID-19, the effort to raise immunizations among the world’s most vulnerable population is slowly gathering speed.  Governments and industry suppliers of vaccines are extending offers to donate excess doses to countries in need. More important, the industrialized G-7 countries agreed at its annual summit hosted by the UK in June to impose a comprehensive timetable for ending the global pandemic in late 2022, based on an ambitious target to immunize by then at least 60% of the world’s population – the threshold for “herd immunity.”

To accomplish this, the G-7 affirmed that governments would work out the necessary manufacturing, IP/licensing, regulatory and logistics measures to accelerate rollout of new vaccines in 100 days, up from the year it took to introduce the four vaccines presently in use against COVID-19.   This commitment is particularly important in solving the supply disruptions earlier this spring caused by the diversion of vaccines supplies manufactured in India originally intended for other countries.  Such disruptions have limited COVAX distribution to a mere 91m doses in the first six months of 2021, a tiny fraction of the 11bn doses experts contend is critical to controlling the transmissibility of the virus, including the suppression of powerful new variants that are proving more deadly than the initial Wuhan strain.

Financing is also falling into place. Government, philanthropic and private-sector contributions to COVAC, the joint funding instrument established in 2020 under the leadership of the Coalition for Epidemic Preparedness Innovation (CEPI), the Global Alliance for Vaccines (GAVI) and the WHO, have risen to nearly $18bn.  That’s about halfway to the goal of $38bn set last year to deliver vaccines, tests and treatments to patients in more than 180 low- and middle-income countries.

COVAX estimates that advance purchase agreements now in place will result in 1.9bn doses being ready for use by the end of this year, with additional supply options pushing the total to 2.8bn doses by mid-2022; a further 1.3bn doses have been secured as a contingency against further disruptions in the global vaccine market caused by spot outbreaks in nations with high exposure rates to COVID-19 variants.   And in June, the World Bank announced it was increasing financing assistance for vaccine procurement to $20bn over the next 18 months. An example is the joint venture underway between the Bank and South Africa’s Aspen Pharmacare to build a regional manufacturing hub to meet demand for COVID-19 vaccines on the African continent.

All this means that “absorptive capacity” – the ability of health systems to accommodate a surge in available supply – will become a key issue in managing the next phase of the pandemic.   The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), which represents the R&D industry, has proposed a series of actions to cope with a breach between what it says is an “astounding” forecast for incoming supplies of vaccine intended for low- and middle-income countries and the current reality of failing to reach all these priority populations equally. The list includes assistance to countries with fragile health infrastructure to prepare for vaccine deployment; more dose-sharing; eliminating unnecessary trade barriers; and prioritizing development of additional COVID-19 vaccines, by allowing the open sharing of samples and DNA sequences of COVID-19 variants.

Finally, the most important lesson from the current pandemic is sustaining the momentum of new science and innovation against rapidly growing threats to public health.  The task cannot be done alone: public/private partnerships are required to end this pandemic and prevent future ones. COVID-19 is but the third in a family of coronaviruses that have wreaked havoc on the human immune system, all in just the past 20 years.

Thus, a key R&D priority is development of a “polyvalent” vaccine:  one that is broadly protective against future – and possibly far more deadly — coronavirus variants.  Incentives need to be in place to pursue solutions to endemic threats from related viral infections like Chikungunya, Nipah and Lassa fever. Better therapeutic drugs are also necessary, not only for the cost-effective management of COVID-19 symptoms among non-vaccinated patients but also as an added protection against coronavirus variants that render existing vaccines less effective. Research on both tracks offer fresh insights on immune dysregulation and response that can be applied to other conditions like cancer, where the mRNA pathway used for vaccines is getting renewed attention.   The lesson here is it takes a pandemic to prove that innovation, like disease, knows no boundaries.

Core Questions for Discussion

  • Success factors that produced COVID-19 therapies in record time, including identification of the asset opportunity; building partnerships with government, other companies and NGOs; addressing regulatory hurdles and securing EUA; and managing the pricing, manufacturing, distribution, supply chain complexities relating to rollout. What were the most important barriers to success that had to be overcome — and how did you do it?
  • Has the commercial landscape in drugs and vaccines changed in the course of the pandemic? Post=COVID, are realignments necessary in the priorities and organizational structure of company R&D operations? Any plans to adjust the therapeutic pipeline in tandem with the resurgent communicable disease challenge exposed by the pandemic?
  • What is the road map that will define future success for global integrated organizations like your own?  Specifically, given the new global profile of disease, is it now time for new approaches to the perennial issue of medicines pricing and access?  What’s the best way for industry to secure the goal of health equity, in a global context?
  • Industry/company reputation in a post-COVID world. Is leadership in life-saving vaccine and therapeutics innovation a “game-changer” in public and stakeholder perceptions of the big pharma business model – or can we expect a return to a world of short-term, transactional “tough love?” Has COVID-19 introduced any new actors/influencers to the mix of external interests that impact business results?
  • The single most important lesson you’ve derived from serving as CEO during the worst public health crisis of the past 100 years – for your own business and for society overall.