State of the Business

For this inaugural edition of the inSeption newsletter, I hope you will allow me the opportunity to share a few of my thoughts. It has been an amazing honor to witness your tireless efforts. I am so proud to call myself your colleague. I know it’s been a challenging time recently. But through the uncertainty and change, because of your dedication to excellence, inSeption continues to build its presence and capture mindshare within the pharmaceutical industry. We’re whispered about in networking circles, talked about in the halls of pharma, and praised by many with the highest regard for our quality deliverables and outstanding people. There’s nothing more fulfilling than that. It never, ever gets old. We have accomplished so much already, and we have so much more in front of us to achieve. This first newsletter is just the beginning of our efforts to increase overall communication within inSeption so that we all know what is happening in different areas of our company. Thank you for your enthusiasm and interest, and for all that you do.

— Brian Sulpizio, Managing Partner

2019 Recap

Awards

For the first time in its history, ISG was ranked among the Inc. 5000 Most Successful Companies in America for 2019. This award is granted to the top fastest-growing privately held companies in the U.S. We are proud to have been recognized for our sustained annual growth, and it’s thanks to the hard work of all of you—our inSeption colleagues—that this prestigious award was possible.

In addition, on October 24, inSeption attended the Philadelphia 100 awards dinner, celebrating the top 100 small businesses in the Philadelphia region. Brian Sulpizio and Joe Arcangelo accepted the award on behalf of the entire team. From Joe: “We owe gratitude to all of our colleagues who have worked tirelessly to make this (accolade) a reality.”

 

Awards

A Few of inSeption’s Recent Success Stories

  • Orchard Therapeutics received validation of their EMA submission for metachromatic leukodystrophy; all documents for Orchard’s OTL-101 (ADA-SCID) submission have been routed for approval.
  • AstraZeneca confirmed that the FDA granted approval of Acalabrutinib for CLL and SLL. To quote Anne Marie McCormack, Head of Medical Writing: “Participation in the FDA’s Real-Time Oncology Review and in Project Orbis (concurrent FDA, Health Canada, and Australia’s Therapeutic Goods Administration submission and review) meant approvals from these three countries after submission earlier this autumn.”
  • Esperion’s Chief Development Officer shared the news of their successful marketing approval: “I wanted to extend my ultimate gratitude to the inSeption team. Approval of Nexletol could not have happened without InSeption. You were and are amazing.”
  • Esperion submissions to Australia and Canada will be completed this year.
  • Myovant submissions for Relugolix in uterine fibroids and prostate carcinoma were also submitted earlier this year.
  • Mallinckrodt’s rolling submission for the use of Terlipressin in hepatorenal syndrome was finalized in April of this year.

inSeption’s Staircase to Success

Staircase to Success

Corporate News

 

inSeption’s future is secure, as we garner new business from existing clients, while continuing to attract new clients. In addition, we are busy expanding our service offerings to include new areas of expertise.

Expanding Our Capabilities

The scope of our Regulatory Operations Team has broadened recently to provide submission-level publishing to a growing number of clients, in a growing number of formats. Using FDA’s Electronic Submissions Gateway (ESG), we have successfully transmitted 50+ submissions since the beginning of this service in March 2020. Most recently, we submitted an Electronic Common Technical Document (eCTD) Clinical Trial Application (CTA) to Health Canada as well as an Orphan Drug Designation Request (ODDR) to FDA. This experience has opened the door to ISG providing continued support to our clients for their upcoming applications.

One of the key services our Regulatory Operations team offers to inSeption’s clients is guidance to help them avoid health authority refusals and/or delays in drug approval. We provide source document formatting, study report compilation, PDF publishing, and submission preparation services in accordance with stringent FDA, ICH, Health Canada, and other applicable regional publishing and submissions requirements.

ORIGINAL SUBMISSION

  • IND
  • NDA
  • sNDA
  • BLA
  • ANDA
  • DMF
  • ORPHANDRUG APPLICATIONS

MAINTENANCE

  • AMENDMENTS
  • SUPPLEMENTS
  • ANNUAL REPORTS
  • SAFETY REPORTS
  • LABELING
  • CMC
  • PROMOTIONAL MATERIALS

INTERNATIONAL

  • CTA
  • CTA-A
  • CTA-N
  • NDS
  • sNDS
  • MAA
  • OTHER

Expanding Our Technology

To support the growth of the Regulatory Operations Team’s services, we plan to expand our technology capabilities by implementing a new Submissions Publishing system. The team has selected a system and the implementation is planned for next quarter. This system will be used to prepare submission structure, to compile and validate submissions, and to allow clients the opportunity to review submissions before they are finalized. The system will support publishing in electronic formats accepted by the agencies around the world, including the United States, Canada, and Europe.

OpenAir was rolled-out about a month ago for timesheet entry, and we wanted to relay our appreciation to all users who are now up-to-speed and entering time successfully each week. Additional thanks to those of you who have provided us with insightful questions and feedback, which helped us revise the User Guide with several key updates. If you have not yet received a copy, please email a request to Openair_Requests@inseptiongroup.com. If you have any questions about the system or time entry, please don’t hesitate to email us at the same address.

StartingPoint Template information sharing sessions were provided to the Medical Writing team on 2 dates (June 23 and 24), conducted by our Regular Operations and Quality Control teams. These sessions provided an overview of the StartingPoint template technology, specifics about inSeption’s template, and review of the application’s functionality. If you are not familiar with the StartingPoint template, it is an electronic Microsoft Word template that provides a macro-enabled toolbar. It creates a formatting ‘backbone,’ for documents, to ensure that pre-determined heading and body styles, content formatting, and one-click error checking are easily accessible for any document to which it is applied.

For inSeption’s employees, our IT team, GO2, provides a full range of technology expertise and solutions on behalf of inSeption. As such, in the event of an IT-related issue or concern, please contact GO2 directly.

Support requests may be submitted using either of the following contact methods:

Email: support@inseptiongroup.com or support@go2tech.com
Phone: 610-567-3462

Please be prepared to provide the following information within your message: full contact information (name, email address, and the best number at which the tech can reach you), as well as a detailed description of your issue or request. Once the request is received, a ticket will be generated for you by GO2’s Operations Coordinator and a copy of the request emailed to you.

(For contract employees, all tech support issues should be approved prior to reaching out to GO2.)

Expanding Our Profile

Rebranding initiatives are ongoing, in an effort to weave inSeption’s corporate identity throughout our communications. You may have noticed recent updates to our web site as well as our email signatures. In addition, ISG headquarters has received a make-over. Below is an interview with Patty Riggs, inSeption’s Office Manager, who shared her thoughts on this effort as well some background on how ISG is helping to keep its office-based employees healthy during the COVID-19 pandemic:

What is your favorite part about the rebranding around the office?

Patty: “What a wonderful surprise to come back to, the office now shouts inSeption Group and unifies the message. My favorite part is the glass on the conference room windows. It looks spectacular.”

 

Why do you think it was important to rebrand the office?

Patty: “I think that it is important for our clients to come in and see our branding and message, and the professional presentation this projects. I also feel it gives the employees great pride in their workspace and reminds us that we represent inSeption Group in everything we do here.”

 

It has been a long time since anyone has been able to work in the office. What was the process like of gathering materials and making sure everyone feels that same comfort when they get back to the office?

Patty: “I started working on that process back in April as I researched where I could get the masks, sanitizer, wipes etc. and took on the challenge of digging deep to find good pricing and delivery dates that worked. Of course, there were cancelled orders along the way and many times it was back to the drawing board, however, in the end we acquired everything that was needed.

The important thing was to make our employees feel safe as they returned.”

Corporate Philanthropy

Planting Seeds of Support in Guatemala

In January, Brian traveled with a team of volunteers, including two optometrists, to rural Guatemala. While there, they organized mobile eye clinics and delivered used prescription eyeglasses donated by inSeption Group friends, family, and colleagues.

As Brian noted, “In a world that can feel isolated at times, we are more driven now than ever by a duty to help others… I hope that it gives some sort of silent permission for others to do the same. Whether it’s helping a friend, lending an ear, or spearheading a charity effort, we can all be responsible for the betterment of the world we live in.”

Corporate Philanthropy

Supporting Those in Need Nearby

ISG is honored to have the opportunity to make a difference in our local community, especially during this exceptional time of need and uncertainty. We have made a corporate donation to Manna on Main Street, an organization located just down the road from our headquarters in Lansdale, PA.

 

 

Manna on Main Street has had an enduring and deep-rooted commitment to ending hunger in the North Penn community. Since they first opened their doors as a soup kitchen nearly 40 years ago, they have grown to provide food, social services, education, and community outreach so that those in need might have access to warm meals as well as sustained opportunities for financial independence. In the near future, inSeption hopes to build on this commitment by providing in-person giving, such as volunteering time at the soup kitchen or packing to-go lunches for Manna’s clients. If you live near the inSeption office and would like to volunteer your time to help Manna, please email Alison Meehan.

Company Growth

inSeption has grown considerably over the past few years! This map represents locations where our team members live and work.

Company Growth

Welcome New Employees

As of June 2020, a total of 125 incredible people (including you!) are supporting inSeption’s mission to provide authentic and innovative service to our clients, and we continue to grow each year. During 2019, more than 50 full-time employees and contractors joined the team.

In addition, Adam McKinlay joined us in May as our Marketing Intern. Welcome Adam!

HR News

Benefits Open Enrollment

The Open Enrollment window for benefits election changes (Independence Blue Cross and Delta Dental) has just ended. As of August 1st, any changes made and all price increases will be reflected. All participating employees have been contacted with their individual information. Of course, you may revise your benefits elections at any time as a result of a qualifying life event (resulting in a change in status, such as getting married, having a baby, or losing health coverage). If you have any questions, Patty Riggs is happy to assist.

Call for Content / Q&A

If you have ideas for future newsletter stories (including helpful Q&A), please reach out to Alison Meehan. We would love for this newsletter to represent the people who make inSeption so special and look forward to sharing your ideas and stories!