Regulatory Strategies To Employ When Your Study Doesn’t Qualify For Breakthrough/Prime

Thu, Sep 12th 2019
MassBio Offices, Cambridge

Content from

It is well understood that achieving Breakthrough or Prime Designation status provides sponsors with significant advantages in the regulatory process to achieve approval. However – not every drug candidate will qualify. This Forum will showcase best practice and real world examples of regulatory success, even without achieving coveted breakthrough status. Register here.

  • Overview of Breakthrough vs Fast Track vs Accelerated Approval, etc.
  • FDA and EMA engagement techniques to keep momentum and enthusiasm even without Breakthrough
  • Panel will share success stories and real-world examples of their strategies and FDA / EMA interactions that allowed for regulatory success
  • Equally important – what NOT TO DO examples will be shared


Niki Gallo, RAC Associate Principal Consultant, Regulatory Affairs, Halloran Consulting

Niki has over 12 years of experience in regulatory affairs and drug development. Her drug development experience covers cell and gene therapies, small molecules, and therapeutic biologics with an emphasis on the disease areas of CNS, immuno-oncology and oncology. Her experience spans multiple stages of drug development from executing early development strategies to supporting and executing marketing applications. Through partnering with clients, Niki leads early key milestone development activities such as, generating the overall program development strategy, initial interactions with the U.S FDA (INTERACT and Pre-IND Meetings), original IND applications and subsequent FDA milestone meetings and expedited pathways discussions following the generation of clinical data. Before joining Halloran, Niki was the regulatory lead for a global Phase 3 program focused on cognitive impairment in Schizophrenia for FORUM Pharmaceuticals. Prior to FORUM, Niki worked at Dana Farber Cancer Institute where she provided clinical and regulatory support for industry and investigator sponsored clinical studies in hematology oncology. Niki has a Regulatory Affairs Certification (RAC), with a U.S.-focus and a Bachelor’s of Science (BS) specializing in molecular, cellular, and developmental biology from the University of New Hampshire.


Amy Jennings, Ph.D. Senior Vice President, Head of Regulatory

Dr. Jennings regulatory experience encompasses drug development across multiple therapeutic realms, including diabetes, cardiovascular disease, obesity, viral infections and hematology. Amy is currently SVP, Head of Regulatory Affairs at Casebia Therapeutics, a company looking to harness the power of gene editing to transform the lives of patients and families affected by a wide array of genetic diseases. Prior to Casebia, Amy was the SVP, Head of Regulatory at Achillion Pharmaceuticals, where she was responsible for global regulatory strategy, regulatory operations, quality assurance and medical writing. During her time at Achillion, Dr. Jennings led successful IND submissions for two rare disease indications for which phase 2 patient trials are ongoing. Earlier, Dr. Jennings served as Sanofi’s associate vice president for global regulatory affairs in the company’s North American diabetes program. At Sanofi she led a US and global regulatory affairs team and was also responsible for labeling and advertising/promotions. Before Sanofi, Dr. Jennings held positions of increasing responsibility at Bristol-Myers Squibb, including leadership of US regulatory affairs for its cardiovascular/metabolic programs. She was ultimately group director in global regulatory affairs for special products. During her tenure at BMS, Dr. Jennings headed regulatory efforts that led to the approval of two new diabetes drugs. Amy was a post-doctoral fellow at the Harvard-affiliated Joslin Diabetes Center. She received her Ph.D. in Biochemistry from The Ohio State University and her Bachelor of Science in Chemistry from the University of Wisconsin-Madison.


Alexander Varond Associate, Technology & Life Sciences group, Goodwin Law

Alexander Varond is an associate in Goodwin’s Technology & Life Sciences group. Mr. Varond advises drug, biotech, and device clients on a wide range of FDA regulatory matters. He has extensive experience in medical device and drug development, Hatch-Waxman patent and exclusivity issues, and regulatory strategy. Mr. Varond also counsels on advertising and promotional issues, defends companies during civil and criminal investigations on a variety of issues, including off-label promotion and GMPs, and regularly advises on corporate transactions. Prior to joining Goodwin in 2017, Mr. Varond was a senior associate at Hyman, Phelps & McNamara, PC. His perspective is bolstered by having worked closely alongside numerous in-house regulatory and legal teams through various critical projects, including NDA preparation, formal dispute resolutions, FDA and regulatory strategy advisory meetings, and product launches. In 2018, LMG Life Sciences awarded Mr. Varond its U.S. Regulatory Rising Star Award in recognition of his experience in FDA regulatory law.

Andrew Verderame, RAC, MBA Partner, PharmaLex US Corporation

Andrew has over 30 years experience in pharma. He has led over two hundred meetings with FDA, managed multi-site regulatory teams, and has presented to FDA Advisory Committees with successful outcomes.