Q&A
January 27, 2025

Developing a Pre-IND Packing Strategy to Expedite Clinical Trials

A key milestone in new drug development is the submission of an Investigational New Drug (IND) application, which signifies the progression from laboratory research to clinical trials involving human participants. 

To accelerate timelines and prepare for clinical studies, during the wait for the FDA’s Safe to Proceed letter for an IND, companies can leverage a Pre-IND labeling and packaging strategy. Sharlett Burgess, Senior Director of Quality Operations and Global Strategy, offers valuable insights into this approach of efficient clinical trial management.

What is a Pre-IND strategy, and why is it essential for biopharma companies?
A Pre-IND strategy allows companies to prepare and manage clinical trial materials efficiently while awaiting FDA authorization to proceed with human clinical studies. This strategy, when executed in collaboration with a Canadian-based Contract Development and Manufacturing Organization (CDMO), helps reduce First Patient-In (FPI) timelines by up to 6-8 weeks.

Do you have any guidance for companies who are new to the IND process?

For companies entering the Pre-IND phase for the first time, seeking expert third party regulatory support can prove to be beneficial. Not only can the partnering company represent the sponsor company at FDA meetings, but they can also provide valuable insight and assist in preparing the meeting package to ensure it contains appropriate information, such as clear focused questions for the review panel to answer, product overview information, design of preclinical and/or initial IND studies, and appropriate clinical/manufacturing and quality control data.

Tell us more about the IND application process?

Successful IND submissions require careful planning and compliance with FDA regulatory requirements and although not required, a Pre-IND meeting with the FDA is valuable. It is the company’s first opportunity to ask specific questions of an FDA review panel pertaining

to their specific product, reducing the risk of a clinical hold and delaying time of product delivery to clinic. 

Pre-IND meetings provide early FDA feedback on regulatory and scientific issues relating to clinical trial design, non-clinical research, and product related CMC questions. The specific feedback will assist in future drug development plans and preparation for submitting

a complete IND application.

What is the FDA’s review process for an IND application?

After an IND application is submitted, the FDA reviews it within 30 days to evaluate the safety and risks for human subjects. At the end of this review period, the agency will either issue a Safe to Proceed letter or place the study on clinical hold. If a clinical hold is issued, the FDA will provide an explanation within 30 days, and the sponsor must address the identified deficiencies.

The sponsor’s responses will then undergo FDA review, after which the agency will decide whether to lift the hold. If the sponsor does not receive communication from the FDA within 30 calendar days of the initial submission, the IND automatically goes into effect on day 31. Once active, the study can proceed as planned, provided it has also received approval from an Institutional Review Board (IRB), which ensures the rights and welfare of clinical trial participants are protected.

Having filed an IND and received an IND number, can clinical trial material be packed in the US?

Unfortunately not. During the 30 day review period, the FDA does not allow packaging or labeling of clinical trial material at any US facility. Even if a sponsor has filed an IND and received an IND number, they still must wait until day 31, when the IND application is in effect before they can package their clinical material within the US.

How can biopharma companies leverage the benefits of a Canadian Pre-IND strategy?

Many companies are unaware that a strategy exists allowing upstream labeling and packaging of clinical material prior to obtaining their IND Safe to Proceed notification from the FDA. The 30 day review period does not necessarily have to be a period of waiting.

While sponsors are awaiting authorization from the FDA to conduct a human clinical trial in the US, Pre-IND labeling and packaging is possible in a GMP facility operating in Canada. The Canadian site can label and package the Investigational Medicinal Product (IMP) and have finished goods ready to ship to US investigator sites immediately upon receiving the Safe to Proceed notification. This strategy expedites upstream processing and can accelerate

timelines for companies with critical FPI milestones.

What is the import/export process for clinical trial material into Canada?

The process for importing, labeling, and packaging is relatively straightforward. Once the drug product is manufactured, an Annex A document is filed with Health Canada to notify of the drug product import. According to the Conditions for Provision of Packaging/Labeling Services for Drugs under Foreign Ownership (GUIDE-0067), Part 1 of Annex A must be filed with Health Canada 10 days prior to the arrival of the drug product and accompanying shipment into Canada.

The sponsor then arranges for the physical transportation of the clinical material from the manufacturer to CDMO facility in Canada for labeling and packaging under GMP conditions. The Canadian-based CDMO will then hold the finished goods until exportation into the US can occur.

On day 31 following the submission of the IND application, the sponsor can consider the IND approval granted by the FDA. The Canadian CDMO will complete Part 2 of the Annex A document and file with Health Canada 10 days prior to exportation of the clinical finished goods into the US.

What are the requirements for importing material into Canada?

Requirements vary depending on IND status and whether clinical trial material (CTM) will be exported or remain in Canada.

Scenario 1: Importing CTM with an approved IND

You will need:

  1. Bill of Lading / Packing Slip
  2. Canada Customs Invoice
  3. IND #
  4. End Use Letter
  5. No Objection Letter from Health Canada (NOL) – if any CTM is remaining in Canada for distribution.

Scenario 2: Import of CTM with Pre-IND status (awaiting approval)

You will need:

  1. Bill of Lading / Packing Slip
  2. Canada Customs Invoice
  3. End Use Letter (not required but can be helpful)
  4. No Objection Letter from Health Canada (NOL) – if any CTM is remaining in Canada for distribution.
  5. Guide 0067 Annex A* – must be filed with Health Canada 10 days prior to arrival of IMP & accompany shipment into Canada

*Note:  Annex A must be updated with export dates/quantities and sent to Health Canada 10 days before CTM leaves Canada.  CTM cannot be shipped to the US until the IND # is available.

Scenario 3: All CTM Remains in Canada

You will need:

  1. Bill of Lading / Packaging Slip
  2. Canada Customs Invoice
  3. No Objection Letter from Health Canada (NOL)

Are there any risks involved with packaging and labeling CTM before receiving an IND approval? What happens if the FDA doesn’t approve the IND?

If the FDA does not approve the IND, the product cannot enter the U.S. market. However, the risks associated with labeling and packaging before receiving the Safe to Proceed notification are minimal, as sponsors are primarily reporting data already gathered on the molecule. With strong safety data and favorable test results, sponsors are generally well-informed about the likelihood of their IND being approved to proceed.

Sharlett Burgess is the Senior Director of Quality Operations and Global Strategy for the PCI Pharma Services sites in Canada. She has responsibility for the clinical site in Burlington, Ontario as well as the Commercial site in Mississauga, Ontario.

After completing her studies in chemistry and microbiology she began her career as an analytical chemist working with Eli Lilly for 5 years. She went on to work with AstraZeneca for 15 years in various quality roles in their commercial and clinical business.

Sharlett has over 25 years of pharmaceutical experience and has successfully led the Clinical

and Commercial sites for more than 10 years at PCI (formerly Bellwyck Pharma Services). She strives for excellence in Quality and Compliance, ensuring that the sites have robust quality management systems that meet client and regulatory requirements.


We are committed to supporting clients at every stage of the manufacturing cycle, delivering best-in-class services efficiently and effectively.

Find out more about our Speed Solutions.


Our dedicated team of specialists will be happy to discuss any of your Clinical Trials Expediting needs. Contact us on +1 215-613-3600 (US) or +44 1495 711 222 (UK/EU) or email talkfuture@pci.com

Awards

We take pride in celebrating the accomplishments and accolades that distinguish PCI Pharma Services, our employees, and our services. These achievements are a testament to our commitment to excellence, innovation, and the unwavering dedication of our teams