17Jan

Todd Gabianelli, Partner at Green Key leading the Pharma team, was recently selected as an Old Master at Purdue University. Established in 1950, the Purdue Old Masters Program is an annual event that invites accomplished individuals to share their insights and experiences with students. Over 600 distinguished figures have contributed to this tradition over the years, representing diverse fields. 

According to Purdue Old Masters, “To Purdue students and faculty, an Old Master is an exceptional person who has made significant contributions to his or her own field. There is no typical Old Master, all walks of life are represented. It is not necessary for an Old Master to be a graduate of Purdue. Each person, however, possesses the same desire to share philosophies and experiences with Purdue students.” 

Todd was invited back to Purdue’s campus, where he had the opportunity to speak with several classes on how the decisions he made during his college experience set him up for a career in sales and recruiting.     

To be chosen as an Old Master, alumni first need to be nominated, and then selected by the Central Committee, comprising of student leaders and advisors who organize the program every year. The program offers Purdue students the opportunity to interact with the Old Masters in various classroom settings, round-table discussions, and topic driven panels throughout the multi-day program. 

We had the opportunity to chat with Todd about his experience as an Old Master and how his time at Purdue set him up for a successful career in recruiting!

What does this honor mean to you? 

“It was an incredible honor to be selected as a Purdue Old Master, a top 5 life moment!  The students that planned, hosted, and executed the Old Masters program laid it out in such a way that gave us the opportunity to have meaningful interactions with the students, student leaders, faculty, and former mentors. The Old Masters experience is a 73-year-old annual event designed to give Purdue students the opportunity to learn from alumni and various others that have built successful careers and/or business and have made an impact on others along the way.  It was fun to be back on campus and tell the story about how I ended up at Purdue sight unseen from a small town in Connecticut and to share the many obstacles I had to overcome, mostly academic, while at school that helped prepare me for my career.” 

Can you share some of the experiences or lessons from your career that you imparted to Purdue students as an old master? 

“One of the lessons I shared was to always be looking a few years ahead of where you want to be in your career, find people doing what you want to be doing at a high level and get around them.  The old saying that ‘success leaves clues’ is true and those that have found success are often the ones willing to share the most to help others be successful.” 

In your journey, what aspects of your Purdue education have played a significant role in shaping your success? 

“Although my professors were great, I attribute a lot of my growth and success at Purdue to the experiences I had outside of the classroom in various student organizations.  I was on an Education/Guidance counseling track so not exactly a direct path to a career in sales, but the skills that I learned and developed studying this curriculum ultimately gave me a competitive advantage that helped propel the growth of my career.” 

What advice do you have for current students who aspire to follow in your footsteps? 

“One of my favorite quotes is simple and straightforward; ‘Successful people are those willing to do the things that others aren’t.’ I’ve used this as a guide for the decisions I’ve made along the way in my career and my advice would be the same to the students regardless of which major they are in, or career path they are pursuing.  Create good daily habits, get out of your comfort zone each day, and find ways to help other people get what they want.” 

Jun 6, 2023

Virtual Clinical Trials Could Become the New Normal

Since Pfizer launched the first randomized clinical trial to be conducted entirely remotely in 2011, virtual clinical trials have been a trend waiting to happen. Now, prompted by the COVID-19 pandemic, and given the blessing of the FDA, broad acceptance of decentralized trials is becoming a reality.

Writing in the May DIA Global Forum, Dr. Jonathan Cotliar, says that with the impact COVID-19 is having on traditional, face-to-face trials, “Those who were once skeptical of the virtual model are now compelled to embrace it out of necessity.”

As chief medical officer of the virtual clinical trial management company Science 37, Cotliar would be expected to say that. But he’s not alone. Since the beginning of the year, interest in virtual clinical trials has grown; dozens of articles extolling their benefits and predicting their broader adoption have been published.

After the Food and Drug Administration released its “Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” in March, interest in decentralized trials has soared.

The Guidance says that for trials already underway, “Sponsors should determine if in-person visits are necessary to fully assure the safety of trial participants.” The FDA says “sponsors should evaluate whether alternative methods” – among them, virtual visits and phone contact – would be adequate substitutes for in-person contact.

Discussing the FDA guidance, Clinical Leader chief editor Ed Miseta, wrote, “With patients concerned for their health and hesitant about leaving their homes or visiting clinics or hospitals, incorporating virtual aspects into trials may be the only way to ensure their continued participation.”

The clinical news and information portal HCPLive, published a perspective in April pointing out, “The ongoing advancements in cloud, mobile, and IoT, combined with video conferencing and wearables, are opening up unprecedented opportunities for pharma and healthcare, bringing about the evolution of clinical trial management.”

Those technologies writes Daniel Piekarz SVP of Life Sciences & Healthcare at the software development firm, DataArt, will make virtual clinical trials and digital healthcare the “new normal post-COVID-19.”

There are significant benefits to both patients and trial sponsors and managers of virtual trials versus conventional, centralized trials. As Piekarz explains, “Virtual visits and remote patient monitoring in place of mandated in-person site visits gives trial participants a choice as well as the added peace of mind that they won’t be exposed to unnecessary risks. Virtual visits allow sponsors to reach a larger population of participants improving subject recruitment, engagement, and retention.”

Indeed, last month, the managed care company UnitedHealth Group and Yale School of Medicine said they would be launching a virtual study examining the potential role of ACE inhibitors in preventing the severe consequences of COVID-19. The study “Will adopt an innovative, modern approach as one of the first virtual COVID-19 clinical trials to be launched at scale with a suite of digital tools.”

And just last week Reuters reported that LabCorp and software provider Medable will work together “to speed up the adoption of virtual clinical trials, as many participants are dropping out of ongoing studies due to the COVID-19 pandemic.”

Photo by Chris Montgomery on Unsplash

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Jun 6, 2023

Most New Drugs Never Make it to Market

The amazing speed with which the pharmaceutical industry developed, tested and won emergency approval for the COVID-19 vaccine was not just surprising, but in at least one way, misleading.

As the new report, Clinical Development Success Rates and Contributing Factors 2011 – 2020 from Bio.org makes clear, the COVID vaccines and therapeutics that became available mere months into the pandemic were a dramatic and rare exception.

On average, the report tells us it takes almost 11 years to go from a Phase I program to regulatory approval. And that’s only for those drugs and therapies that make it through. Over the 10 years from 2011, the likelihood that a drug in a Phase I trial would ultimately win approval was 7.9%.

That may be better odds than winning the Powerball lottery, however, the investment in a drug’s development can dwarf all but the largest jackpots. Making it even more of a gamble for a pharmaceutical firm is that the average success rate has declined since Bio’s 2016 report. Then the average for the previous 10 years was 9.6%.

Heavy with tables, charts and graphs, the Bio.org report (in conjunction with Informa Pharma Intelligence and QLS Advisors) reviews success rates across 21 major diseases. It reports specifics on 14 of them, combining the balance into an “Other” category. The detailed diseases are: Allergy, Autoimmune, Cardiovascular, Endocrine, Gastroenterology (non-IBD), Hematology, Infectious disease, Metabolic, Neurology, Oncology, Ophthalmology, Psychiatry, Respiratory, and Urology.

Comparing the success rates in the current report to the previous one, Bio found 12 categories had a lower likelihood of progressing from Phase 1 to approval. The largest decline was in urology. In the 2016 report, therapeutics in this category averaged 11.4% success. In the recent report, the average fell to 3.6%.

Hematology has the highest likelihood of approval at 23.9%, though it too saw a decline from 26.1%.

Drugs to treat rare diseases fared better than other therapies. The report said these drugs had a 17% likelihood of success.

The decrease, explains a Bio.org discussion of the report, “Can be attributed to two main factors: A greater participation from smaller firms participating in drug candidate development and their willingness to disclose early failures.”

Said David Thomas, BIO VP, industry research, “That all ties into what we see, which is a lower success rate overall from our last paper in 2016.”

Drug development remains difficult with far less than 1 in 10 clinical drug programs ever reaching patients,” says the Bio.org account. “It usually takes 10 to 10.5 years to develop a vaccine, which makes the existing COVID-19 vaccines on the market all the more incredible.”

Success, adds Thomas, takes “many shots on goal.”

Photo by ThisisEngineering RAEng on Unsplash

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