We advise drug and biologic sponsors, including sponsors of advanced therapies, across the development lifecycle, from preclinical and IND planning through NDA/BLA approval and post-approval. Our work focuses on high-value matters where regulatory strategy, FDA requirements, patient need, and business objectives converge.

Drawing on experience across drug development, patient advocacy, FDA policy and disputes, private equity and capital markets, licensing, and litigation, we help sponsors develop regulatory strategies grounded in FDA precedent, agency policy, and available regulatory flexibility, while keeping broader business strategy in view. Our goal is to anticipate and address issues as early as possible, and to push back on FDA when appropriate.

We work closely with scientific and medical experts, in-house teams, and consultants, taking the lead where appropriate and often serving as senior FDA regulatory counsel and strategic advisor on highly technical matters.

When Clients Bring Us In

Varond Law & FDA Strategy is brought in at critical development and review inflection points, where FDA strategy can affect approval, labeling, exclusivity, and product value.

We are often asked to help with:

Development and approval strategy, including indication selection, endpoint strategy, comparator selection, trial design, and FDA evidentiary expectations
Key FDA interactions and formal FDA Type A/B/C/D meetings
Clinical holds, complete response letters, refusal-to-file issues, formal disputes, and other significant FDA concerns
Rare disease, accelerated approval, expedited-program, and patient-focused strategies
Clinical trial conduct, safety, inspectional, and post-approval issues that may affect development or continued marketing
Label scope, regulatory exclusivity, lifecycle opportunities, and follow-on competition

The core areas of this practice are summarized below.

Clinical Development & Trial Design

Indication, endpoints, comparators, and trial design determine how FDA evaluates the program, how meetings unfold, and what the label can support. We counsel sponsors on these decisions from preclinical planning through approval.

Orphan Drugs, Expedited Programs & Regulatory Flexibility

Rare disease and serious-condition programs require deliberate planning around regulatory flexibility, expedited programs, and evidentiary strategy, often well before the first IND. We counsel sponsors on building the program, engaging with FDA over time, and knowing when and how to ask the agency to apply the flexibility available under its authorities.

Patient Advocacy & Patient Experience Data

Patient experience can be decisive in FDA's assessment of unmet need, acceptable uncertainty, and benefit-risk. We counsel sponsors and patient organizations on integrating that perspective into development strategy, FDA meetings, advisory committee preparation, and review strategy.

Clinical Trial Conduct, Safety & Compliance

Protocol deviations, emerging safety signals, sponsor oversight issues, and inspectional findings can stall a development program or shape what FDA expects at the next decision point. We advise sponsors on FDA regulatory issues during clinical trials and on FDA-relevant provisions in clinical trial, CRO, and research-collaboration agreements.

FDA Meetings, Review Issues & Dispute Strategy

How and when sponsors engage with FDA review divisions, and what they put in writing, define what FDA expects from the program at every subsequent decision point. We counsel sponsors on FDA meeting strategy, review-cycle communications, and informal and formal dispute resolution.

Approval, Labeling & Post-Approval Strategy

Supplemental approvals, labeling negotiations, REMS modifications, and postmarketing requirements continue to shape what a product can claim, who can prescribe it, and how it competes long after approval. We counsel sponsors on FDA strategy throughout the post-approval lifecycle.

Lifecycle & Exclusivity Strategy

Regulatory exclusivities, label scope, and follow-on competition shape product value across the lifecycle, and most of these questions are FDA regulatory strategy questions before they become disputes. We counsel sponsors and investors on identifying and securing exclusivities, preserving lifecycle opportunities, and assessing follow-on competition.

Drug & Biologic Development Expertise

Alexander Varond has focused on drug and biologic development for nearly 15 years. In 2023, LMG Life Sciences recognized Alex as one of the top five pharmaceutical regulatory attorneys in the country. With Frank Sasinowski, he co-authored a widely cited Food and Drug Law Journal article on FDA's flexibility in Subpart H accelerated approvals. Trained as a biomedical engineer, Alex brings technical depth to programs involving novel modalities and complex scientific and regulatory questions. He spent six months seconded to a leading antisense oligonucleotide sponsor, working on FDA marketing approval and commercialization.

Alex has led briefing book strategy and review team engagement for sponsors at end-of-Phase 2, pre-NDA/BLA, Type A dispute resolution meetings, and other formal FDA interactions. He has counseled sponsors through clinical holds, refusal-to-file letters, complete response letters, and formal dispute resolution, including programs that received multiple CRLs before approval. His work spans a wide range of therapeutic areas, including neurology, cardiorenal, inborn errors of metabolism, ophthalmology, dermatology, infectious disease, oncology, and numerous rare diseases. He has led successful orphan drug, breakthrough therapy, fast track, RMAT, and QIDP designations, and helped secure priority review vouchers. He has also handled high-stakes clinical and development-related compliance matters, including GCP, GLP, GMP-related issues, and responses to Form FDA 483 observations.

Alex has worked closely with patient advocates and patient organizations, helping them integrate patient experience and unmet need into development strategy, FDA meetings, advisory committee preparation, and benefit-risk framing. He served on the board of an ultrarare disease patient advocacy organization, supporting its institutional development and securing grants from the Chan Zuckerberg Initiative.

Alex's practice extends beyond client matters into FDA policy, scholarship, and academic regulatory work. He has counseled trade groups including PhRMA and AAM on FDA policy related to drug and biologic development, prepared congressional testimony, and written extensively on drug development and FDA flexibility. He has served on the Food and Drug Law Institute's Drug and Biologics Committee and other industry committees and has provided regulatory guidance to incubators and academic teams, including Stanford's Center for Definitive and Curative Medicine on cell, gene, and curative therapy development.

As former co-chair of Goodwin's FDA Litigation practice, Alex has counseled numerous sponsors and investors on regulatory exclusivities, label expansions and supplemental applications, competitive-entry risks under the 505(b)(2) and biosimilar pathways, and lifecycle planning, including in M&A and licensing diligence and capital markets work.