The 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 person’s needs.”

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.

Leadership in 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) Centre Directors
  • Fourteen former FDA Director or Deputy Director Division heads
  • 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 applications.

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 game

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 in-house.

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 Martin.

Growth dynamics

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 industry sectors”.