Precision Antibody is a leading biotechnology company specializing in rapid, high-affinity custom antibody development for pharmaceutical, biotech, academic, and government research institutions. With over 25 years of experience, the company offers a comprehensive suite of services, including monoclonal and polyclonal antibody development, antibody production and purification, antibody characterization, humanization, and fully human antibody generation using transgenic mice.
Regulatory and Compliance
Cleracs Consulting has established itself as a trusted partner for global health innovators striving to transform promising discoveries into approved therapies and devices. Headquartered in Boston with a presence in London, the firm works across therapeutic areas and product types, with a distinctive strength in orphan drug development. More than a regulatory adviser, Cleracs serves as a partner that helps clients advance from early research to market approval with clarity and confidence. What distinguishes Cleracs is its 360-degree model, which integrates regulatory expertise with clinical and scientific insight and funding guidance, reinforced by strong industry connections. Rather than applying rigid frameworks, the firm adapts to each client’s style, culture and resources. Clients value how seamlessly this expertise fits into their organizations, expanding regulatory and scientific depth without disrupting internal culture. “Our mission is to move assets forward efficiently, either toward market approval or to the point where the right partner can continue development,” says Dr. Nana Mainoo, regulatory consultant and CEO. This focus on moving programs with speed and precision is supported by practical guidance at every stage. Cleracs works with clients from preclinical planning onward and advises on early regulatory interactions, including pre-investigational new drug (pre-IND) meetings and trial designs. It then manages the major submissions that follow—investigational new drug (IND) applications, new drug applications (NDA) and biologics license applications (BLA). For medical device innovators, Cleracs has guided regulatory planning through U.S. food and drug administration (FDA) pathways and achieved conformité européenne (CE) marking under europe’s medical device regulation (MDR). By embedding study endpoints and risk-mitigation measures early, the firm helps reduce rework, maintain timelines and improve the likelihood of a first-cycle approval..
Cell and Gene Therapy
The clinical research landscape is continuously evolving, prompting an important question—what if the next breakthrough therapy could be delivered with unprecedented speed and precision? Advarra is turning this vision into reality, pushing the boundaries of possibilities in medical innovation. Creating a seamless ecosystem that connects patients, research sites, and sponsors accelerates the clinical trial process, ensuring faster and more efficient delivery of life-saving therapies. “Our unique portfolio of technology and services reduces friction by decreasing technology burden, improving study visibility, and enabling smarter decisions that advance clinical research,” says Gadi Saarony, CEO. This comprehensive portfolio includes trusted independent review bodies, cutting-edge technology platforms, and experienced consultancy offerings. Independent review bodies, such as Institutional Review Boards (IRBs), ensure that trials meet regulatory standards and that participant risks are minimized. Federal regulations require that IRBs consist of scientific and non-scientific members tasked with reviewing study materials, including protocols, informed consent forms, investigator credentials, and safety events. In addition to the IRB, other specialized committees, such as Institutional Biosafety Committees (IBCs) and Data Safety Monitoring Boards (DSMBs), contribute to maintaining the safety of clinical research. IBCs ensure the safety of research participants, study staff, and the community by reviewing and assessing biosafety risks associated with cell and gene therapy techniques, particularly those involving genetic modifications. Independent DSMBs are also responsible for monitoring accumulated data to identify potential risks or benefits, offering recommendations to modify or halt the trial when necessary. .
Antibodies
Why It's Challenging to attract and Retain Employees?
Mike Cleary, VP of Finance and Administration, JRS PHARMA
Biomanufacturing
Facilitating a Lessons Learned Session with your CMO
Yvonne Ware, Director, CMC, BioNTech SE
Antibodies
The Impact of AI on FP&A in the Life Sciences Sector
Lina Parra Cartagena, Associate Director of Finance - Operations, Vertex Pharmaceuticals
Antibodies
Children Are Not Just Small Adults: The Challenges Of Developing New Medicines For Children Living With HIV
Sherene Min, VP, Head of Clinical Development, ViiV Healthcare
Antibodies
Embracing Innovation and Patient-Centered Care
Lori East, ARRT, RT R, CT, Manager of Radiology, Novant Health
Life Science Testing And Compliance
Driving Innovations in Healthcare Compliance with Technology
Melissa Lore, Chief Compliance Officer, FFF Enterprises, Inc
Clinical Laboratory
Technological Evolution in Clinical Data Management
Armand Matejunas, Sr. Director of Clinical Data Operations, Pacira BioSciences Inc
IN MY OPINION
Antibodies
Beyond the Counter: Elevating Pharmacy Technicians Through Education and Leadership
Elone Winston, Program Director, Mount Sinai Health System
LAST WORD
Antibodies
It's all About You- The Key Message We Must Communicate to our Clients for Digital Events
Susan Desmond, Director; Corporate Events, Charles River Laboratories
IN FOCUS
Leveraging Accelerated Pathways for Monoclonal Antibody Therapies
Monoclonal antibodies are revolutionizing biopharmaceuticals, with accelerated pathways such as Breakthrough Therapy Designation and Orphan Drug status accelerating development for critical treatments and rare diseases.
The Strategic Rise of Regulatory Consulting in Life Sciences
Regulatory functions in life sciences have transformed from gatekeepers to strategic partners, actively driving innovation and market access through integrated, proactive approaches in response to evolving therapeutic landscapes.
EDITORIAL
Shaping Antibody Future through Early Regulation
In this environment, advantage is shaped not only by biology but by the timing and quality of regulatory thinking. Developers who internalize this treat regulatory strategy as a design input, on par with epitope choice or manufacturability, rather than as an expensive cleanup job at the end. The payoff shows up as faster iteration, fewer dead ends, cleaner comparability packages, and fundraising narratives that read as de-risked.
Regulatory consulting is shifting with it. The best firms engage upstream, shaping target product profiles, mapping evidence to the questions regulators will actually ask, and surfacing assumptions early enough to change course. Their output is not forms; it is probability shifted toward approval, global reach, and reimbursement.
For antibody developers running against the clock and capital constraints, the edge will come from strong biology guided by clear regulatory foresight. With agencies tightening signals and investors rationing patience, that pairing is no longer optional. It is the gap between a drug that launches and one that stays on the slide.
This edition spotlights Precision Antibody, a specialist in fast, custom development of monoclonal and polyclonal antibodies designed for targeted research, diagnostics, and therapy. The issue also features expert perspectives from Melissa Lore, Chief Compliance Officer at FFF Enterprises, and Sherene Min, VP and Head of Clinical Development at ViiV Healthcare, who unpack current pressures in the field and the practical paths forward.
We hope the valuable insights from industry leaders featured in this edition will help you make informed decisions for your businesses.
