pharmaceutical and medical device industry has the most complex regulations of
any industry. So how do disruptors and SMEs get new medicines approved? We look
at the unique consultancy services provided by NDA Partners.
Pharmaceutical and medical regulation are
vital in ensuring the safety and efficacy of drugs, biotechnology and medical
devices. Yet, as Jeffry Braithwaite, Professor of Health Systems Research and
president-elect of the International Society for Quality in Health Care,
remarked in the British Medical Journal in 2018:
“No other system is more complex: not banking, education, manufacturing,
or the military. No other industry or sector has the equivalent range and
breadth—such intricate funding models, the multiple moving parts, the complicated
clients with diverse needs, and so many options and interventions for any one
Despite its complexity, pharmaceuticals are providing a fertile field
for SMEs. The European Medicines Agency reported in 2016 that 10 to 15% of
applications to authorise new medicines come from SMEs and that their success
rate for authorisations had increased from 68% in 2010-12 to 75% in 2015. Over
half of all medicines that SMEs recommended for market authorisation in the
past decade contained a new active substance, showing the critical role they
are playing in meeting medical needs.
The CDO Model
It matters to get it right. NDA Partners LLC, which provides
product development and regulatory services to the pharmaceutical,
biotechnology, and medical device industries worldwide, has developed a new
model of consultancy – the CDO or consulting and contract development organisation.
And it’s a model that is entirely suited to small innovators and SMEs.
NDA Partners introduced its innovative new CDO services
to the industry in 2018. The CDO model provides a turn-key service to biopharma
and medical device companies where NDA Partners plans, manages and executes
their product development program on a contract basis. The model can be an
ideal solution for early-stage companies that lack the experience and internal
expertise needed to conduct programs most efficiently and effectively in-house
and for investors and IP holders who do not want to hire full-time staff.
“The emergence of a CDO industry sector is analogous
to the emergence of the CRO sector 30 years ago,” says Earle Martin, CEO
of NDA Partners. “As big pharma changes its focus and adjusts its business
model for sourcing new products, service providers like NDA Partners will
introduce new capabilities that fill the gaps”.
As the founder and former CEO of PRA International,
Martin has seen this type of change take place before, and is excited about taking
an industry leadership role in this next-generation opportunity.
Medical Product Development
NDA Partners distinguishes itself from other
consultancies through its ability to assign top-tier expert consultants on all
engagements. It provides the full spectrum of functional expertise needed to
conduct complete product development programs from bench to marketing authorisation.
The company is highly regarded throughout the
biopharma industry due to the high quality of its services and its operational
approach. Consultants deliver its services with unsurpassed industry experience
and credentials, including:
- Three former US Food and Drug Administration (FDA)
- Fourteen former FDA Director or Deputy Director
- The former Head of the UK Medicines and Healthcare
Products Regulatory Agency (MHRA)
- Three former EU regulatory agency senior staff
- The former Chief Executive Officer and Chief Science
Officer at the United States Pharmacopeial Convention (USP)
- Dozens of highly experienced former biopharma and medical
device industry executives
Through this approach, says Martin, NDA Partners “utilise
the very best talent available anywhere in the world, delivering extraordinary
value to its clients.”
The company helps early-stage biopharma and device
companies identify the most appropriate regulatory pathways, prepare effective
pre-clinical and clinical development plans, design efficient and informative
study protocols, assess data, evaluate readiness for regulatory submissions,
prepare for meetings with regulatory agencies and submit regulatory
It helps Asian and European pharmaceutical companies
navigate US regulatory requirements and assists US companies entering global
markets. The company assists investment funds with due diligence and in
addressing difficult development, regulatory, and scientific issues faced by
portfolio companies. It is a significant provider of litigation support and
expert testimony services for law firms dealing with the complex issues of
patent infringement, product liability and supply chain failures.
Disruptors and SMEs changing the
Most of NDA Partners’ clients are
early-stage innovator companies and small-to-medium size biopharma companies
with a limited portfolio of new products in development. These companies are usually
investor-funded and face the constant challenge of meeting milestones attached
to the last round of funding and closing the next round.
Over the past decade, a major shift has occurred in the
way big pharma sources new products. In the past, new products were developed
almost exclusively in-house by major pharmaceutical companies, who then navigated
the regulatory approval process and provided manufacturing and distribution.
The emergence of a rapidly-growing number of start-up
and early-stage innovator biopharma companies supported by venture capital and
other investor funding sources has changed the industry dynamics. Most of the new
products being released by big pharma companies today were either acquired or
in-licensed from these small biopharma and device companies.
This remarkable industry change has created a
significant market opportunity for NDA Partners.
While early-stage biopharma companies can be incredible
innovators, they often lack the experience and comprehensive functional skills
needed to efficiently and effectively conduct product development programs
The NDA Partners CDO model addresses this need by bringing
in their expert consultants and partnering with clients to plan and manage the
development of their products, either by assuming full responsibility or
working as an integrated team with their current staff.
CDO services fill a considerable gap in the market for
supporting the rapidly-growing biopharma industry.
“We believe that outsourcing of product development
program management and execution to credible contractors will be embraced not
only by biopharma and device companies but also by the investment community and
prospective big pharma purchasers who will benefit from greater certainty in
the effective management and success of these development programs,” says
NDA Partners is experiencing significant growth in all
its primary target markets. It has partnered with nearly a dozen clients to
plan and manage their development programs and has a substantial pipeline of
prospective new clients ready to begin shortly.
Martin is optimistic that NDA Partners will play an
important role in the future of the industry: “We believe that the company is
positioned to establish itself as a global leader in medical product
development on par with the elite global strategy consultancies in other