06Jun

The shortage of masks, respirators and other medical supplies that accompanied the rise of COVID-19 cases has added momentum to government efforts to encourage the onshoring of medical manufacturing.

Since the beginning of the year, the US government through the Biomedical Advanced Research and Development Authority (BARDA) has awarded at least billion dollars to bioscience and contract development and manufacturing organizations to create or expand production capability in the US.

In May, four-month old drug manufacturer Phlow got a $354 million award from the federal government to manufacture generic medicines and pharmaceutical ingredients that are needed to treat Covid-19.

In June, Emergent BioSolutions announced a $628 million deal with the government to commit its Baltimore facility manufacturing capacity for production of COVID-19 vaccine candidates through 2021.

Last week, Grand River Aseptic Manufacturing, announced it had completed work on a $60 million privately financed expansion of its Michigan fill/finish facility. GRAM is a contract development and manufacturing firm that completes the final, sterile packaging of injectable drugs for companies that developed or market them.

These are just the latest examples of what FiercePharma describes as a “growing wave of manufacturers and drugmakers pitching their domestic footprint.”

While political interest in bringing drug manufacturing back to the US isn’t new, the current pandemic has given the effort greater momentum. A raft of legislation has been introduced in Congress from both sides of the aisle. FiercePharma says a bill by Arkansas Republican Sen. Tom Cotton “would require government payers to phase out reimbursement for drugs made or sourced in China by 2022. Other bills have also directly targeted China’s role in the supply chain as a possible national security issue.”

The White House said it is working on an executive order to require federal agencies to purchase only US made medical products and drugs.

Though the pharmaceutical industry is opposed to compelling all manufacturing to move to the US, the political winds, not to mention the incentives the government is dangling, is beginning to interest investors.

The real estate equities firm Lincoln Equities Group and H.I.G. Realty Partners, the real estate arm of private equity firm H.I.G. Capital, LLC, which owns the 422 acre former Bristol Myers Squibb lifesciences campus in New Jersey, is making a direct pitch to pharmaceutical manufacturing firms to locate there.

“Given the current public health crisis, we anticipate pharmaceutical and life sciences manufacturers to consider ‘reshoring’ and expanding operations in the U.S.,” said Joel Bergstein, president of Lincoln Equities. “This spacious, modern BMS campus – located in the center of ‘Einstein’s Alley’ in Central New Jersey – is a prime location for continued innovation and expansion.”

Image courtesy Grand River Aseptic Manufacturing

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Green Key
Jun 6, 2023

Here’s How to Land That First Clinical Research Job

Starting a career in clinical research is challenging. Armed with a relevant college degree, an internship or two and even with a certificate in clinical management, landing an entry-level job isn’t easy.

Says Kunal Sampat, MNA, ACRP-CP and host of the Clinical Trial Podcast, “Employers want applicants to have relevant CRA experience.”

That’s the old chicken and egg dilemma: How do you get the experience without having a job and how do you get a job without the experience? Fortunately, it’s not as impossible as it seems.

In an article for the Association of Clinical Research Professionals, Sampat outlines 7 strategies for landing that first job, beginning with knowing what your career goals are.

Figure out, he says, what job or role in clinical research you want. Don’t limit yourself to clinical research associate or coordinator. Consider other areas such as patient recruiter, safety monitor or data manager. Decide what kind of employer you want to work for: pharmaceutical company, contract research organization, research vendor or regulatory agency.

After deciding on an entry-level role, invest in becoming educated about the specific skills for the job. “Look up webinars, YouTube videos, and literature to develop those specific skills,” Sampat writes. You won’t become an expert, “but you will have built confidence in yourself and your ability to speak to these topics during interviews.”

Improve your resume by showing what you did and what you achieved – learned – in the jobs, internships or volunteer work you’ve done. “If you feel like your clinical or medical-oriented experiences are limited, focus on transferable skills for the research position you seek,” he says.

Now, apply to no more than 10 jobs at any one time. That way you have time to personalize the resume and cover letter to focus on what the employer wants. It’s also important to follow up. “By following up with the hiring manager, you’re demonstrating your continued interest in working for the company.”

By doing this and doing it well you demonstrate the communication skills most employers want. “I recommend applicants write a cover letter with three to five bulleted points that outline the benefits of hiring him or her for the job,” Sampat says. “The more personalized your cover letter is to a given employer and role, the greater chance you have for being invited for an interview.”

If you do land an interview, prepare for it as thoroughly as possible. This is advice for every job interview in every industry. Sampat suggests preparing “five to eight examples from your education or professional experiences that you’re proud of or that taught you something valuable.” Create “stories” around these describing the situation, the task, the action you took and the result.

Finally, he says, be prepared for rejection. You’ll get more of those, but eventually you will get a yes.

“You don’t need to sign up for an expensive and time-intensive clinical research certificate program to secure an entry-level job in clinical research,” he says. Instead, follow the strategies and you’ll “increase the odds of your success tremendously.”

Photo by Tima Miroshnichenko

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