State of the Business

By BRIAN Sulpizio


Even with all the challenges that last year brought to all of us professionally and personally, I am the most optimistic I’ve been since we began this adventure 8 years ago. Resiliency is the word that comes to mind when I think of our collective efforts and what we have been through together. There’s no question that resiliency is a defining characteristic of this organization and the people that make it up. Our challenges have spanned beyond our drug development work, and into the homes and families of all our amazing employees. I don’t have to point out that navigating through the COVID-19 pandemic, the turbulence of our political issues, and various personal obstacles, made 2020 one of the most difficult years in many, many ways. But I do want to share that I believe it’s going to make us more grateful for 2021.

From a business perspective, in just these first 3 months, we have been approached by more new clients with requests for proposals, leading to more new relationships, and developing more new successful outcomes. From expanding our gene therapy initiatives, to supporting smaller IND start-up companies, to quadrupling our clinical operations revenue stream, and carving out entire medical writing departments, we really are off to a great start. Let’s just say it simply: We rock. And that includes absolutely everyone: from those of you on the front lines, working with our clients and building relationships, to those behind the scenes working tirelessly, day in and day out, to keep the business on track. I know I say it repeatedly, but I’ll never stop saying it: our success literally comes down to you.
You have created opportunities that in turn create new customers. You have shown incredible resiliency through such a challenging year. You are the reason for ISG’s success.

Here’s to becoming something more than what we were before, and to continued success in 2021.

“Resilience is not about overcoming, but becoming.”

— Sherri Mandell

Calendar Contest

Don’t forget to submit your best landscape photos for our 2022 company calendar contest! Joe and Brian have really enjoyed reviewing the submissions from this past quarter and will continue to pick winners every month for the next year. We’re giving out prizes for all the best entries, not just the monthly winner!

Send us your most artistic landscape photos: snowscapes, sunsets/sunrises, mountains, trees, or any other natural beauty. The photographs must be taken by you, with your own camera. No selfies or portraits will be accepted. Photo image specifications are as follows (but we might allow some wiggle room): 1600 x 1200 pixels, > 300 dpi (or ppi) resolution, JPEG images, and landscape format. Please note that all 12 winning images will become the property of inSeption, so please don’t send anything that you would like to use for professional purposes.

We’re excited to see your best photos…feel free to submit as many as you’d like!

Where’s inSeption?

inSeption continues to actively engage in remote conferences to connect with other industry experts. Take a look at a few of the conferences we’ve recently attended! If you happen to know of any future conferences that our clients will be attending and would be of interest to inSeption, please reach out to Adam McKinlay (amckinlay@inseptiongroup.com).

 

Where We’ve Been

  • Clinical Document World: February 24th to 26th
  • Gene Therapy Patient Engagement: March 23rd to 25th
  • Linking Leaders Roundtables
    • Clinical Quality for Small BioPharma
      • Thursday, January 14th
      • Thursday, February 25th
    • Clinical Operations for Small BioPharma
      • Wednesday, February 3rd
      • Wednesday, March 24th

Where We’re Going – Future conferences we plan to attend in 2021

  • Trial Impact Summit: September (date TBD)
  • Patients as Partners 2021: April 7th to 9th
  • Linking Leaders Roundtables
    • Clinical Quality for Small BioPharma
      • Thursday, April 8th
      • Thursday, May 20th
      • Thursday, July 1st
      • Thursday, August 12th
      • Thursday, September 23rd
      • Thursday, November 4th
    • Clinical Operations for Small BioPharma
      • Wednesday, May 5th
      • Wednesday, June 16th
      • Wednesday, July 18th
      • Wednesday, September 15th
      • Wednesday, October 27th
      • Wednesday, December 8th

 

 

 

inSeption Initiatives

Volunteering at COVID-19 Vaccination Sites

We would like acknowledge the inSeption employees who have taken time to volunteer at COVID-19 vaccination sites or participated in one of the many vaccine clinical trials.

Corporate News

New Clients

inSeption is proud to announce our new clients (and new business with current clients). We work hard to partner our clients with the right inSeption team members for each project, as well as provide them with quality deliverables—every time.

Clients Websites Therapeutic Areas Projects
Arcus Biosciences arcusbio.com Oncology Medical Writing, QC
Cellectis cellectis.com Immuno-Oncology, Gene Editing Project Management, Clinical Operations, Medical Writing, QC
Disc Medicine discmedicine.com Hematology QC Services for an IND
Immune Regulation immuneregulation.com Immunology Regulatory Affairs, Medical Writing, QC
Gilead Sciences gilead.com Virology, Oncology, Inflammatory Disease Physicians, Clinical Scientists, Medical Writing, QC
Latigo Biotherapeutics Oncology Regulatory Operations, Medical Writing, QC
Nabriva Therapeutics nabriva.com Bacterial Infection Medical Writing, QC
Neuron23 neuron23.com Genetic Disorder Medical Writing, QC, Regulatory Operations
Neurona Therapeutics neuronatherapeutics.com Genetic Disorder Regulatory Operations
Nuvation Bio nuvationbio.com Oncology Regulatory Operations, Technical Editing, Medical Writing, QC
Passage Bio passagebio.com CNS Disorders (Gene Therapy) Medical Writing, QC, Regulatory Operations
Retrotope retrotope.com Mitochondrial Myopathies, Neurodegenerative Diseases Clinical Research
Vincerx vincerx.com Oncology Medical Writing, QC and Regulatory Operations

Technology Improvements

Resourcing Team Technology Update

In January, the inSeption resourcing team transitioned from their long standing Customer Relationship Management (CRM) database to a new system. Act! CRM was used for resourcing employees since inSeption’s start in 2011. The new system, SharpSpring, has improved functionality and user friendliness. It provides for field customization, so that key information on potential new employees (“contacts”) are grouped and identified individually, rather than buried in a comment field. This eases the recruiters’ efforts for sorting and filtering information on prospects.

In order to complete the transition, nearly 60,000 contacts needed to be reviewed, cleaned up, or deleted. Data fields were mapped between the 2 systems, and all remaining data was migrated from the old system to the new. This effort was no small feat. The burden of the planning and data cleanup fell to Brian and Joe, who spent evenings and weekends ensuring that the new system was most representative of inSeption’s current and future staffing efforts. The final dataset included less than 38,000 contacts.

The recruiters were trained on this new system on January 18th and began tracking contacts the same week.


Phish Alert Button Report

Although inSeption as implemented many safeguards to protect against data breaches and/or loss due to phishing/scam emails (e.g., firewall, antivirus, quarantine for suspicious emails), it is important for everyone to be aware that scammers are very creative and continuously find new ways to infiltrate emails/systems. Accordingly, ISG has implemented additional measures to upgrade our email security platform. One such measure is the Phish Alert Button (PAB), which has been added to Outlook so that ISG users no longer need to determine on their own if an email is malicious. In addition, to further reduce the risk of opening a compromised email, users no longer need to directly forward suspicious emails to GO2 for evaluation. Users simply push the PAB in their Outlook toolbar, and GO2 will receive notice, address the suspicious email, and provide guidance accordingly. Another level of security recently added to our platform is the ability to send and receive outside of the ISG organization secure/encrypted emails which requires the recipient to ensure a password prior to accessing secure emails.

Please do not hesitate to reach out to (sdejewski@inseptiongroup.com) and/or (priggs@inseptiongroup.com) regarding any questions related to the PAB and/or secure emails.

Marketing

As inSeption begins to grow, one thing we need to ensure is that our brand stays consistent with our messaging. Here is where you can see the latest on inSeption’s Full Page Advertisements, brochures, social media posts, and more! Check them out by hitting the button below, hope you enjoy!

Plan to have the website up and running by April 2021 – Stayed tuned…

inSeption Brochures

Overview Brochure VIEW
MW/QC Brochure VIEW
TMF Brochure VIEW
RegOps Brochure VIEW

Life Science Full Page Ads

December Ad VIEW
April Ad VIEW

Clinical Research as a Care Option (CRAACO) and Chief Medical Officer (CMO) Newsletter full page ads

CRAACO Ad VIEW
CMO Ad VIEW

Social Media Posts

Sandra – Employee Recognition VIEW
“Stay Connected” Dawn’s Article VIEW
Rare Disease Day VIEW
“Straight Outta Chemo” Repost VIEW

Life Science Connect Agreement

inSeption is pleased to announce our partnership with Life Science Connect, a niche life-sciences focused marketing company based in Pittsburgh, PA. Our partnership with Life Science Connect will help ensure that inSeption’s unique approach to outsourcing solutions reaches our target audience within the industry. These services include full page advertisements, ghost written articles, research analytics, newsletter sponsorships, and others to ensure our marketing penetration. We are excited to be working alongside Life Science Connect as we continue to provide sorely needed innovation, expertise, responsiveness, and accountability to the clinical development process.

 

 

 

Family News

Congrats, Grad!

inSeption would like to wish Adam McKinlay, Marketing Manager, congratulations on recently completing his bachelor’s degree in advertising.

A little background from Adam on how he reached his personal milestone: “Growing up, school wasn’t my biggest strength, which made me very hesitant to pursue a college education. However, I was offered the chance to play baseball at the collegiate level. This opportunity, combined with the fact that I never wanted to work another day of construction in my life, helped encourage my decision. My first steps into higher education were more challenging than I anticipated, and my baseball career ended. After a (very!) long year of personal struggle, I ended up at a crossroads. I thought a lot about giving up, but instead I began a new journey in South Jersey, at Rowan University. Looking back from where I am now, I realize that I made one of the best decisions in my life. After a 4-and-a-half-year journey that sometimes felt like 10, it all felt worth it. I wrapped up my final class in December 2020 and became a full-time employee at inSeption just a few weeks later. I’m on cloud nine and couldn’t be more excited to be walking across the stage this May in a cap and gown!”

Employee Anniversaries

We would like to take the time to recognize our employees’ milestones. We asked individuals whose work anniversaries occurred from January through March of this year to provide a short blurb about their time at inSeption Group.

Thank you to those who work hard every day to make inSeption’s vision a reality.

 

Jerri Rosini – March 16th, 2015

“I’ve been with inSeption Group since March 2015. Having been here during the early days, and being a part of the incredible journey, has been a great experience with lots of hard work by everyone. I greatly admire Joe’s passion for success, Brian’s tenacity to never give up, and my inSeption colleagues for their belief in building ISG. Working through the challenges and accomplishments is very rewarding. The experience of meeting new people and learning great things has been awesome. Not to mention more than a few good laughs, mostly at Joe or Brian! In good nature of course! 😊”

 

Katherine Polich – January 9th, 2017

“I’m thankful for being a part of the inSeption Group for the past 4 years. I’m grateful for the opportunity to work with a very supportive group of people, which helps to make my job fulfilling.”

 

Lori Buckenmyer – March 4th, 2019

“After deciding to leave a 30+ year career with a large CRO in the fall of 2018, I had no way of knowing how much a phone call from Joe in January 2019 would change my life for the positive. Not only was I welcomed into the ISG family with lots of love, respect, and support, I have been given the opportunity and autonomy to grow the Clinical Operations and Project Management team and pursue any opportunity that would be beneficial to the company. Nothing is “off the table” with Joe and Brian. After years of navigating all the corporate politics, I view joining the ISG family 2 years ago as one of the biggest blessings of my life.”

 

Domenic DePascale – March 12th, 2019

“I’ve strictly worked for small businesses since entering the workforce full time. inSeption is unique in that it does not pretend to be something it is not as a company. I love that inSeption trusts it’s employees to be the driving force behind the company’s growth and acknowledges us as the integral part we are. I couldn’t be happier to be on the inSeption team.”

 

Kara Storti – January 2nd, 2020

“I had been a QC reviewer at a biotech company for many years when the opportunity at inSeption came along. It sounded too good to be true: I’d have a chance to work with talented people who would feel like a family, learn, and be challenged by different disease areas, improve my skills in a nurturing work environment, all while having good work/life balance. Now I know that the perks were true—inSeption is as special as advertised. I have never felt so fulfilled, happily challenged, and satisfied with my career.”

 

Anna Fogoros – January 13th, 2020

“After working with the QC team here at inSeption as a contractor for just under a year, I joined full time in January of 2020; I couldn’t be happier with my decision! In the fall of 2020 I stepped into a new role as QC Lead for 3 of our clients, and this new role has been a great opportunity for professional growth and achievement. Cheers to many more years with inSeption!”

 

Patricia Scolis – February 4th, 2019

“I’ve worked in the pharmaceutical industry for approximately 27 years. I love that inSeption hires experienced people who bring so much dedication and knowledge to the table. It’s a place where my skills are valued, respected, and appreciated. I have definitely found my home here. A rare gem.”

 

Kimberly Marlin – February 17th, 2020

“I enjoy working alongside my colleagues at inSeption. Everyone is dedicated, hardworking, and friendly.”

Introducing inSeption’s Functional Areas

Quality Assurance

Did you know?

Our QA group is doing much more than writing SOPs and chasing compliance issues for our internal group, we also have been busy with several client projects:

  • Helping a group focused on cystic fibrosis research select, validate, and implement a new eTMF and Document Management System
  • Conducting a gap analysis and developing a Quality System plan for an emerging oncology company
  • Supporting the eTMF for a Gene Therapy company focusing on breakthrough therapies in hemophilia and Huntington’s disease
  • Developing SOPs and Quality System documents for companies with limited or no internal QA resource
  • Performing a Mock Inspection for a company currently preparing an NDA

Quality Assurance

Quality Management System Assessment, Development, Implementation

  • Quality System Documentation including SOP, Policy, and Associated Document Development
  • Gap analysis – Quality System, eTMF, Training, etc.
  • Vendor Qualification, Audits, Oversight
  • Training Development and Delivery (for the QMS<GCP, and Study Level)
  • Site Audits
  • Computer System Implementation support
  • Mock Inspections
  • eTMF implementation and oversight (Sponsor/Client system)
  • Change Management

Corporate Philanthropy

inSeption has started a campaign with NORD (National Organization of Rare Disorders) to raise awareness of rare disorders. NORD is a patient advocacy organization dedicated to individuals with rare diseases and the organizations that serve them. NORD, along with its more than 300 patient organization members, are committed to the identification, treatment, and cure of rare disorders through programs on education, advocacy, research, and patient services.

inSeption will be 100% matching all donations from employees in this effort! The “inSeption Group Fights Against Rare Diseases” campaign link is below if you would like to participate.

Thank you to everyone who participates in the campaign! All donations are greatly appreciated! 😊

Donate Now

HR News

Building a Nest Egg of Wealth

You will want to be sure you’ve saved enough to reach your retirement goals. Planning today for what you want tomorrow will help you reach those goals. You can start by taking advantage of our 401K retirement plan.

 

Planning Ahead

By investing early, you can make a large difference in the amount you have saved by retirement age. The sooner you begin saving or contributing to a retirement savings plan, the better your chance of growing your investment over time.

 

Tax Advantages

The contributions you make to our company’s traditional 401K plan are deducted from your pay before taxes are withheld. As a result, your taxable income is reduced and you pay less in taxes.

See (priggs@inseptiongroup.com) for more information on the 401K Plan.

Call for Content / Q&A

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