Best Practices for Complying with EMA Policy 70

Lora Killian

EMA Policy 70 requires sponsors to publish anonymized versions of clinical study reports (CSRs) and submission documents submitted in support of a marketing authorization application (MAA) after January 1, 2015. Sponsors must prevent re-identification of people named or referred to in those documents. In March 2016, the detailed guidance document was published. This blog post […]

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Topics: Regulatory Writing

Meet Pharma Transparency Mandates & Engage Study Participants

Behtash Bahador

Most clinical study participants want to know the results of trials they participated in. However, few are actually informed. Lack of communication and transparency jeopardizes the success of the clinical research enterprise. In this blog post, I’ll discuss a new model for communicating trial results in lay language with minimum added burden on sponsors and […]

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Topics: Clinical Trial Design, Regulatory Writing

Diving into Best Practices for Pooling Clinical Trial Data

Steve Sibley

If you’ve worked with a client drug development team approaching submission for approval, it’s likely you’ve heard discussions like this: Team member 1: “But, you can’t integrate the data from those studies because the treatment durations are different.” Team member 2: “That doesn’t matter, we still have to pool the results into a single integrated […]

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Topics: PK/PD Modeling and Simulation, Regulatory Writing

How to Navigate “EMA Policy 70: Publication of Clinical Data” and Ensure Compliance

Nirpal Virdee

The issue of transparency and disclosure of clinical trial data has been growing over the past few years. Clinical trials are essential in offering new therapies to patients. However, individuals participating in these trials put themselves at risk, and therefore, the medical community is obligated to derive as much benefit from that risk as possible. […]

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Topics: Regulatory Writing

Regulatory Writing Experts: Superman or Clark Kent?

Tatyana Wanderer

The day starts out slowly. The clinical lead settles into her comfy chair, pushes up her glasses just a bit and gazes at the shimmering computer screen, as the spring breeze sways the branches on the other side of the window. Then, one email (bing)…two emails (bing, bing)… ten, twenty! The beeps roar like a […]

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Topics: Regulatory Writing

7 Horrible Mistakes You’re Making with Your Drug Development Strategy

Mark Hovde

In thinking about the complex nature of drug development, I’m often reminded of a Dwight Eisenhower quote:

“In preparing for battle, I’ve always found that plans are useless, but planning is essential,”

Drug development is a risky business. According to a 2014 study from the Tufts Center for the Study of Drug Development, “the estimated average pre-tax industry cost per new prescription drug approval (inclusive of failures and capital costs) is $2.5 billion. When so much is at stake—time, money, and the needs of our patients — having a solid drug development strategy is critical. Yet, I frequently see sponsors make the same mistakes over and over again. In this blog post, I’ll discuss these common strategic blunders and provide suggestions of how to address them.

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Topics: Model-based Drug Development, PBPK Modeling and Simulation, PK/PD Modeling and Simulation, Regulatory Writing

The Year in Review for Biosimulation and Regulatory Writing

Suzanne Minton

Happy New Year! 2015 was a year of huge growth— both personally and professionally— for our Certara® family. We’re so grateful for our clients who give us the privilege of supporting them in their work to bring safer and more effective treatments to patients. In this blog post, I’ll be looking back at the top 10 […]

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Topics: Model-based Drug Development, PBPK Modeling and Simulation, Regulatory Writing

Is Your Approach to Regulatory Writing the Elephant in the Room?

Steve Sibley

I’ve helped many clients navigate the world of regulatory writing to gain drug approvals. Our clients’ challenges remind me of the parable of the elephant and the blind men. If you’re not familiar with the story, it goes like this:

A group of blind men hear that an elephant has arrived in their village. Being blind, they have no idea what an elephant is. So, they decide to go and touch it. The blind men describe what they feel as the following:

Hey, the elephant is a pillar,” said the first man who touched his leg.

“Oh, no! It is like a rope,” said the second man who touched the tail.

“Oh, no! It is like a thick branch of a tree,” said the third man who touched the trunk of the elephant.

“It is like a big hand fan” said the fourth man who touched the ear of the elephant.

“It is like a huge wall,” said the fifth man who touched the belly of the elephant.

“It is like a solid pipe,” Said the sixth man who touched the tusk of the elephant.

They began to argue about the elephant, and every one of them insisted that he was right. A wise man was passing by and he saw this. He stopped and asked them, “What is the matter?” They said, “We cannot agree to what the elephant is like.” Each one of them told what he thought the elephant was like. The wise man explained to them, “You are all correct. Every one of you is telling it differently because you each touched a different part of the elephant. So, actually, the elephant has all those features that you all said.”

My clients are bright, talented individuals. They are committed to bringing innovative new therapies to patients. But, working in silos means that they do not have perspective on the entire process. A full service regulatory writing team can help them increase their efficiency and profitability.

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Topics: Regulatory Writing

Regulatory Writing Experts Can Make You a Lean, Mean Pharma Machine

Kelley Hill

Getting your body into shape has a lot in common with helping implement regulatory medical writing best practices at a biopharmaceutical organization. Specifically, there are a number of similarities between engaging a regulatory writing consultancy and hiring a physical trainer. Unlike “Hans and Franz” of Saturday Night Live fame, who just want to “Pump YOU up!”, a good physical trainer listens to your goals and then develops a plan to help you achieve them. Likewise, experienced regulatory and medical writers possess the unique blend of talent— scientific acumen, oral and writing communication skills, project management expertise, and deep knowledge of the regulatory landscape— that can help you develop a strategic roadmap for your drug.

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Topics: Regulatory Writing

Improve Your Approach to Sharing Clinical Trial Data

Kim Green

Transparency and disclosure of clinical trial data has been a hot topic, growing in prominence and strategic discussions over the past few years. Disclosing clinical trial information and creating transparency around clinical trial results are key steps toward increasing trust between the public and the industry. Increased transparency regarding data about ongoing research could spur new products or therapeutic approaches and potentially avoid unnecessary trials.

From ClinicalTrials.gov to EudraCT, and from redacted clinical trial reports to lay summaries, there are a number of platforms and opportunities from which to share data with the public. Pharmaceutical, biotech, and academic researchers need to be conscious of the regulations, stay ahead of the game, and put the most efficient practices in place to keep up with the evolving disclosure landscape. In this blog post, I’ll discuss why the best practices for meeting these regulations involves leveraging the unique skill set and knowledge of regulatory writing groups.

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Topics: Regulatory Writing

What NASA’s New Horizons has in Common with Regulatory Writing

Michael Blaze

Today, NASA’s New Horizons spacecraft will pass by Pluto in the outer solar system after a journey of more than 7.8 million miles (12.5 million kilometers). That is, if everything goes well. After a 6-year journey and a cost of $728 million dollars, mission managers are hoping to avoid a mission ending error caused by a lack of quality control. Surely the engineers and scientists at NASA have checked and double-checked every line of code in order to preserve this costly, historic mission?

Not so fast. Consider the September 1999 loss of the NASA Mars Climate Orbiter, launched in 1998. The orbiter missed its target altitude insertion by 80 to 90 km and burned up in the Martian atmosphere. Findings of the failure review board indicated that the navigation error leading to the loss of the spacecraft resulted from some commands being sent in English units instead of being converted to metric. After a journey of 10 months and a cost of $193.1 million, a simple English to metric units conversion ended up being this program’s downfall. With a $728 million dollar, 6-year mission on the line, one would hope that NASA has invested significantly more funding in dedicated quality control this time around. We won’t have to wait long to find out.

While a lack of dedicated quality control in regulatory documentation preparation may not result in such costly failures, they may still cause significant problems with government regulatory bodies. Consider the time and cost investment into your product. How much is that worth to you? To your shareholders? To the patient population you are hoping to serve?

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Topics: Regulatory Writing

Pediatric Clinical Trials and Tribulations

Ellen Leinfuss

Last month, Certara sponsored the 11th Pediatric Clinical Trials conference in Philadelphia. First, I have to say that the content of this conference was among the best I have ever heard. Each speaker added to the dialogue, and the group was able to share and collaborate on how to make meaningful improvements to the field of pediatric drug approvals.

The subject is complex, often heartbreaking, and in many ways can be defined as a “Catch 22.” It is extremely challenging (both logistically and ethically) to enroll children in clinical trials, yet without a proper and approved clinical process, physicians are left with inaccurate dosing and therapeutic approaches for children. The result is a continuation of the off-label, experiential ‘wild wild west’ of prescribing. Here’s some interesting factoids that were revealed at the conference:

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Topics: Clinical Trial Design, Regulatory Writing

How to Explain the Value of Biosimulation to Your Grandma

Suzanne Minton

As most scientists can attest, it’s not always easy to communicate the importance of your work to non-scientists. I personally experienced this when my fiercely intelligent grandmother, a former elementary school teacher, asked to read a copy of my dissertation. When I asked her what she thought of it, I realized that her understanding of the concepts I was trying to convey was much like that of a kid in a Charlie Brown cartoon listening to a teacher talk. She perceived my dissertation as though it was written in a foreign language and got little out of it.

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Topics: Model-based Drug Development, Regulatory Writing

Do the Right Thing: Ethical Mandates for Clinical Trial Transparency

Kelley Kendle

The history of biomedical research in the United States has long been plagued with ethical problems. Writer Rebecca Skloot details a famous example of this history in her book, “The Immortal Life of Henrietta Lacks.” The non-fiction work recounts the origin of the HeLa cells— derived from the tumor of a Baltimore woman named Henrietta Lacks. A poor, African American woman, Lacks was suffering from cervical cancer when she received treatment, including a tissue biopsy, at Johns Hopkins University. Violating the principle of informed consent, university researchers cultured the cells from Lacks’ tissue without her knowledge or permission. She succumbed to her disease in 1951, at the age of 30.

The breach of trust in creating the eponymous HeLa cell line caused lasting trauma to the Lacks family. Part of their distress may have also been rooted in the failure of the research community to share with them the incredible positive impact that their mother’s cells had on biomedical research and health outcomes. One of the things that may have brought them a sense of closure was visiting the lab of a Johns Hopkins University researcher to learn about his use of HeLa cells. Skloot described the scene wherein Henrietta’s daughter, Deborah, first saw a cryovial of HeLa cells:

“…she raised the vial and touched it to her lips. “You’re famous,” she whispered. “Just nobody knows it.”

While ethical conduct of clinical research has improved tremendously over the past sixty years, we can still do better. When volunteers participate in clinical trials, they entrust pharmaceutical researchers with their bodies. In return, we have an ethical obligation to share with them the results of clinical trials.

Studies consistently show that 90% of clinical trial volunteers expect to be told the overall results of their trial. Unfortunately, most never hear anything back from the sponsor or research center after the last study visit, leaving many volunteers wondering if their participation mattered or was appreciated. In this blog post, I’ll discuss our recent partnership with the nonprofit Center for Information and Study of Clinical Research Participation (CISCRP) to help pharmaceutical companies “Do the Right Thing” by developing lay summaries of clinical trial results to inform the general public.

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Topics: Regulatory Writing

Clinical Data Transparency Mandates Are Reshaping Regulatory Writing

Keith Kleeman

New European and U.S. clinical trial data transparency initiatives — such as EMA Policy 70, which goes into effect this month — are creating additional disclosure compliance requirements for pharma and biotech companies. In this blog post, I’ll discuss the implications of these data transparency initiatives and present how Synchrogenix,powered by ClinGenuity and a Certara company, is addressing […]

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Topics: Regulatory Writing

Strategic Regulatory Writing for Drug Development Success

Kelley Kendle

Happy New Year! The start of a new year brings the promise of new opportunities for growth— both personally and professionally. As the CEO for Synchrogenix, Certara’s regulatory writing consultancy, I’ve been thinking a lot lately about how changes in the regulatory writing landscape will shape the drug development process in 2015. It’s becoming more and […]

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Topics: Regulatory Writing
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