NDA Partners
The Democratization of Medical Product Development

Traditionally, drug development was limited to a few big pharma companies with substantial infrastructure and access to large supplies of capital needed to bring new products to the market. They discovered, developed, manufactured, marketed, and distributed drugs, focusing on blockbusters that provided steady growth and profitability. However, in the past 20 years, the discovery of new blockbuster drugs has ebbed, and the pace of innovation outside of big pharma has accelerated. Innovative biopharma and medical device companies have established a strong market presence and now lead the way in the development of new medical products. Today, most new drugs brought to market by big pharma companies are licensed or purchased assets of small biopharma or device entities.

This dramatic shift has been disruptive, but the results have been positive. Big pharma now can quickly access new products to leverage an extensive global infrastructure with reduced development costs and risk. The shift has also resulted in the development of new drugs that address small market requirements that big pharma had ignored.

In smaller companies, R&D has become more virtualized. While big pharma has numerous experts available in-house in all functional areas, smaller biopharma and device companies must seek out strategic partners to provide the expertise unavailable to them in-house. Serving as a reliable companion to such businesses is Virginia-based NDA Partners. “We specialize in expanding the capabilities of small medical product developers through strategic partnerships,” says Earle Martin, CEO of NDA Partners. The company provides advisory services and virtual staff, either supplementing the clients’ in-house staff with needed expertise or deploying full product development teams. It also has expertise in providing strategic regulatory guidance, addressing pre-clinical toxicology or CMC issues, and informing clinical development programs by using advanced modeling and simulation approaches. In a nutshell, NDA Partners enhances the value of its clients’ products, finds the shortest pathway to bring new therapies to market, and reduces risk to investors.

"We are democratizing medical product development."

“We call this the democratization of medical product development,” states Martin. NDA Partners supports innovator companies with top-tier expert consultants and provides the full range of strategic and operational support they need through its contract development organization (CDO) business model. The company’s services include strategic product development and regulatory consulting, program management, virtual product development teams, and access to top-tier experts covering the full range of regulatory, technical, and scientific support for their product development life cycle. To facilitate the ongoing development and optimal value for its services, NDA Partners has established six specialty practice areas. Four of these are focused on the type of product under development: drugs, biologics, medical devices, and generic drugs. The remaining two—Product Quality & CMC and Quantitative Drug Development Strategies—are cross-functional and provide specialized support in all product areas.



Expert consultants in each practice area assist clients with critical decision-making to identify and develop product attributes and clinical indications appropriate for their products by incorporating the principles outlined in NDA Partners’ “Five Principles for Optimal Medical Product Development.” They help clients formulate questions and prepare relevant briefing materials for FDA meetings and other interactions that will result in advancing product development, shortening development times, and identifying the key issues needed to ensure the acceptability of regulatory submissions. They also provide strategies to utilize FDA incentives and expedited programs that provide efficient and effective development programs.

A Partner in ‘Drug Development’

NDA Partners’ drug development practice provides expertise for the development of new chemical entities (NCEs) and drugs utilizing the 505(b)(2) regulatory pathway.

We specialize in expanding the capabilities of small medical product developers through strategic partnerships.

In one instance, the company facilitated the design of animal studies, providing pharmacological information early in a development program that reduced the need, time, and expense for prospective clinical studies. In collaboration with another client, the company designed an intensive Phase 2a PK sampling program versus a marketed drug using the same active component, which enabled the client to use the 505(b)(2) pathway by relying on FDA findings for the listed drug’s safety.

In another instance, as an expert witness for the successful defense in a legal case, NDA Partners’ expert consultant pointed to no plausible scientific or pharmacological rationale for a drug associated with the plaintiff’s alleged adverse effect. Indeed, the pharmacological rationale provided by NDA Partners suggested that the alleged drug would have an effect that was opposite to what occurred with the patient. The case was settled within a week of this testimony.

Facilitating the ‘Biologics Development’

NDA Partners’ biologics practice provides expert guidance and support for product development from initial concept through BLA, biosimilar, or other marketing authorization applications. Its areas of expertise include assessment of regulatory requirements, biologics manufacturing, nonclinical studies, and clinical trials. The firm assists clients with early development strategies, recommendations for later-stage clinical development, and preparation of regulatory submissions. Given the company’s experience and numerous interactions with the FDA, NDA Partners helps its clients successfully navigate uncharted waters and escalate challenging issues to the appropriate individuals in the FDA when needed for more timely and decisive resolution.

NDA Partners’ biologics expert consultants focus on problem-solving, whether around biosimilar or 505(b) regulatory issues, companion and other diagnostics, immunogenicity assessments, formulation challenges, or regulatory product classification. For example, the company helped a client focus on choosing a broad vs. narrow indication and a ‘personalized’ vs. off-the-shelf product, leading to a successful Regenerative Medicine Advanced Therapy (RMAT) designation and positive FDA review of preliminary results.

‘Medical Device Development’ with a Hand-in-Hand Effort

The ever-increasing need for delivering industry-best services for patients drives the design and development of several medical devices, including orthopedic implants, surgical tools, diagnostic devices, pacemakers, neurostimulators, and even more. NDA Partners’ medical device practice works with many small companies that are at the prototype stage, often academic spinouts. The company’s expert consultants often start with an analysis of regulatory pathway options, including preparation of a request for designation to determine the FDA lead reviewing center. This is followed by early meetings (“PreSub”) with the FDA to discuss classifications, approval requirements, engineering and clinical testing plans, and to take advantage of FDA programs, including breakthrough devices, humanitarian device exemptions, and other incentive programs.

The ability of NDA Partners to provide a customized team with the necessary background and experience enables it to fill the gaps in the expertise of clients’ in-house teams. The expert consultants provide regulatory readiness reviews, product development plans, scientific and operational support, and assistance in communicating with investors and other funding sources such as NIH, SBIR, or defense department grants.

Guiding to Successful ‘Generic Drug’ Tests

The primary focus of the generic industry today is complex generics that include transdermal patches (TDS), auto-injectors, and orally inhaled and nasal delivery products (OINDP).

Pursuing a complex generic requires an investment in equipment and expertise but pays dividends as companies who have not made a similar investment are automatically excluded from the market. Specialization is providing exclusivity in modern generics markets, but despite this, more than 40 percent of off-patent complex generics are still not on the market.

NDA Partners’ expert consultants advise on regulatory requirements and strategy, prepare clients for FDA meetings, attend the meetings, and assist them with follow-up activities. The company deploys excellent biostatisticians to advise on bioequivalence criteria and in the CMC area. Whether testing a spray pattern for an inhaler, invitro release methodology for a topical product, or human factor requirements for a device, NDA Partners can solve these issues quickly. In answering client questions, its expert consultants explain how things work and the significance of the data by not just airdropping checklists of requirements.

Ensuring ‘Product Quality & CMC’

NDA Partners’ product quality & CMC practice works with clients developing both small molecules and biologics from the early preclinical stage through to drug approval and commercialization. “Our team is comprised of both former industry and FDA chemists and biologists including former FDA reviewers,” says David Savello, PhD, who leads the Product Quality and CMC Practice Area. The company provides CMC strategy and development plans, regulatory readiness reviews, CMC procedures and methods development, regulatory agency meetings and submissions, identification of well-qualified CMOs, and preparation for audits.

Dr. Savello recalls the engagement with a client developing a unique drug substance that fell between a small molecule and a biologic. Although it was a small molecule, it contained peptide linkages that made it look like a therapeutic protein. NDA Partners’ highly experienced team worked with the client to request a pre-IND meeting with the FDA to discuss CMC issues and address the regulatory pathway issue. The team developed specific questions for FDA response, prepared the meeting briefing book, and led the meeting with the FDA. The meeting was highly successful, all potential issues were addressed with helpful responses from the FDA staff, and the IND was successfully filed several months later.

Quantitative Drug Development Strategies (QDDS)

NDA Partners’ QDDS practice provides advanced pharmacometric, computational, and biostatistical skills needed to support regulatory submissions including INDs, NDAs, MAAs, BLAs, and ANDAs. The expert consultants bring state-of-the-art quantitative methodologies and data-analytic approaches for systems and quantitative clinical pharmacology, population PKPD and PBPK modeling, clinical simulation, and FDA-encouraged Model-Informed-Drug Development (MIDD) and Complex Innovative Trial Designs (CID) procedures for dosage optimization to client programs. These approaches help clients predict optimal dose and clinical outcomes more accurately, optimize information value and efficiency of clinical trial designs, identify patients who would benefit most from therapy, and produce compelling evidence of effectiveness.

According to Roger Williams, MD, the Practice Manager, the firm’s QDDS practice adds value for clients by focusing on the most clinically relevant development questions. NDA Partners supports the design and execution of clinical trials that can accelerate development programs and produce high-quality regulatory packages containing the data needed to secure regulatory approvals without delays.

Assisting Future Medical Advancements

With such an outstanding base of top-tier expert consultants, a comprehensive range of functional skills that support all aspects of medical product development, and the introduction of robust and dynamic new services such as its CDO model, NDA Partners has established itself as the premier product development partner in the industry. By helping its clients that span several early-stage innovator companies to small-to-medium size biopharma and device companies, NDA Partners plans to continue its winning streak for the years to come.