Chart Your Path: Insight from an Accomplished Drug Development Expert

Gil Price – a physician who has worked with some of the largest pharmaceutical companies and has built two companies himself – has critical guidance for individuals charting their career path:

"The best advice I can give to anyone starting out in the life sciences industry, or any industry, is that you must be able to communicate effectively across multiple lines of management. You have to be able to speak to the CEO as well as the janitor. You need to be able to motivate individuals who have zero stake in your success, and get them to perform on your behalf. If you can’t do that, you will not be successful in any line of work."

While education, technical expertise and work style are all vital in a career path, the lack of ability to communicate with co-workers, management, patients, personnel, and/or the public, can leave your career growth unexpectedly stunted.

When involved in clinical trials, a number of critical people are involved on the path to drug development. Not only might there be communication issues, but another major challenge is drug supply, specifically if the drug is hard to manufacture. This means you will need the manufacturing group to collaborate with you on the way to getting the drug produced.

Background and Training Shapes Your Career’s Success

Communication is key, and so is training. Price received training in Big Pharma early in his career. When he was starting out, GlaxoSmithKline (GSK) presented him with an enticing offer to come on board. At GSK, the executive who hired Gil was also a magnificent mentor. Price was placed into a variety of positions that covered all aspects of drug development, manufacturing, basic sciences and regulatory, a type of training that may be difficult to find in a smaller biotech company, often only existing in large pharmaceutical companies. He calls this time of his career "an 11-½ year internship."

After leaving GSK, Price went to work at Quintiles as executive vice president, with an assurance from the CEO to work more with public markets. He worked with clinical trials for four years and, during this time, Quintiles expanded and acquired several companies in Europe. A former colleague from GSK then called him about an opportunity at MedImmune.

Due to his experience at GSK, Price was given the tremendous opportunity to work on multiple product launches and new invitations for old products. He worked on medical affairs in an umbrella department that was largely responsible for all post-marketing activities involved in commercial drug development, post-marketing pharmacovigilance, post-marketing clinical studies, drug information and publication responsibilities.

After MedImmune is when Price carved out his entrepreneurial career. First, he started his own biotechnology company. He pulled a team together and raised money, then 26 months later, sold the company to a private group on the west coast. Next, he started Drug Safety Solutions, for which he is currently owner, providing services to biotechnology and pharmaceutical companies for all aspects of pharmacovigilance.

Insight and Advice to Further Your Career Path

Price has advice for future entrepreneurs: "If you ever want to be entrepreneurial, being part of a small biotechnology company is an important experience to have."

Although barriers are in every career, they are expected, and will vary with each position. A major barrier in this industry, says Price, may be that the world can throw you a curveball: "All of a sudden, you are basing decisions on the idea that a drug is going to work. Sometimes a drug just doesn't work, even if you perform everything appropriately. Of course you try to discover this as early as possible so you can 'kill' a failing drug quickly. By that time, however, you’ve spent millions of dollars, only to see it go up in flames."

What does Price recommend to someone trying to figure out what next steps to take to chart his/her path?

"It is important to reach out to colleagues who have been successful. Communicate with others who fall under your umbrella of interest so that you can understand what a proper path looks like."

There are many individuals, he says, who have limited interaction with the broader community in conferences, such as Association of Clinical Research Professionals (ACRP) meetings. Many focus on meetings in their particular therapeutic area, such as a cardiology conference. However, staying so narrowly focused eliminates the individual from networking with other drug development physicians and professionals.

While you can never over-expand your network, working in the life sciences industry has significant benefits over many other career paths:

"What this path allows you to do is to potentially impact the health of millions. Your career path has the aspect of being intellectually stimulating and cutting edge where you can affect the lives and well being of thousands of patients."

Let Advanced Clinical keep you on track: advance your path to a rewarding career.

See www.advancedclinical.com

Design Your Dream Job Contest: What Should You Expect to Get from your Dream Job?

Common complaints of clinical job positions from GlassDoor.com are: “Lack of personal development opportunities," "lack of career progression within the company," "a lot of talk and no action," "under pay from market rate," and "no incentive to do better.” In addition, several former clinical employees working with CROs and clinical contract staffing companies have stated on Jobvent.com that they are "fed up with back-stabbing and incompetence,” an “unhealthy environment,” and high turnover.

“What Should You Expect?”

The best companies will provide the opportunity to grow your career, challenge yourself and allow you to provide insight and a point of view. The company as well as the job itself should offer a positive and challenging environment to help cultivate your skill set. Here is the top list of things that you should expect when you get a job.

Make a difference.
You should have the chance to make a difference in clinical research, helping bring drugs to market.

Have your ideas heard.
The company should allow you to showcase your expertise to further the Life Sciences field, creating new efficiencies and effectiveness in companies based on experience.

Become a Star.
While working at a company, they should have resources to get your name out there. You should have plenty of opportunities to effectively market yourself and your abilities to the Life Sciences industry

Be CHALLENGED.
Learn new skills and encounter new opportunities with their breadth and depth of available work experiences.

Be Part of a Community.
Beyond just exchanging information with each other, the company should have an elite team and consultant community that collaborates. Look for an extensive alumni program, superior benefits and a comprehensive loyalty program.

Pursue your Dreams.
Make sure you are truly happy at your workplace and can maintain an optimal work and life balance. Accommodating your personal preferences and career goals goes hand in hand.

Grow!
Understand your desired career path and ensure that you have job opportunities that help you build your skills in your desired direction. There should be sufficient intellectual capital that will help you get best practices experience every day.

These seven points were developed and are currently utilized by Advanced Clinical’s “AC Experience” framework for its consultants. We expect our consultants to work at the highest level possible, and we provide them with the opportunity and environment to do so.

So… “What's Your Dream Job?"

World-class Clinical Strategic Sourcing Organization (hybrid CRO and Clinical Contracting solutions), Advanced Clinical, wants you to “design your dream job,” and give us suggestions on how to provide the perfect work environment for clinical consultants. We will not only take requests to heart, but match you with a job as best as we can.

The best entry will win a $200 gift card to any store of his or her choosing, and two runners-up will each win an iPod shuffle.

You can enter by submitting a description of your dream job, a video, or any other creative form.

Design your dream job here.

Enter to win …August 17th is the new date we will choose a winner!

See www.advancedclinical.com

Advancing Discoveries: Regulatory and Risk Decisions in Adaptive Designs

Although adaptive designs produce numerous benefits for clinical trials, there are also a number of risks associated with it. Below, Advanced Clinical outlines some of the key risks when conducting adaptive designs as well as ways people mitigate them. Also are some FDA-accepted designs, including the more well known Bayesian approach.

What are the big, key risks?

One major concern is the effect of adaptive designs on statistical measures. Though addressed broadly, the issue of preservation of type I error rate remains a key issue in adaptive design. Also, changes in sample size, hypotheses, and other statistical measures affect the validity of the outcome data in clinical trials. Logistic concerns include methods on how to collect data. With interim decision making, data must be collected rapidly, and with short follow-up times in order for that data to remain relevant to the current state of the study. The main procedural issue to be followed closely relates to data review, careful decision making, and implementation of decisions during adaptive trials while maintaining trial integrity.

click picture for full view!

How do you mitigate those risks?

To mitigate risks that come with adaptive design, careful planning pre-clinical trial must take place. The right statistical measures must be in place and through simulation, the right statistical changes must be determined in case interim data suggests changes on statistical procedures. During clinical trials, it is recommended to have a Data Monitoring Committee (DMC) to review interim results and determine whether relative changes can be made. Also during trials, the use of clinical technologies such as EDC, IVRS and IWRS as well as light EDC are highly recommended in order to deal with the logistic concern of quick, responsive data analysis.

Some commonly accepted designs approved by the FDA (click picture for full view!)

Bayesian Adaptive Dose Allocation Approach (click picture for full view!)

See www.advancedclinical.com

Advancing Discoveries: Adaptive Designs in Clinical Trials

What is Adaptive?

In the past several decades there has been a recognized trend of increased spending within pharmaceutical, biopharmaceutical, medical device as well as biotechnology research without a proportional increase in success rate of clinical trials - there used to be 8 IDAs for 1 commercial success; now 16 INDs for 1 commercial success. Some of these could be due to diminishing improvement margins for new drugs, unchanging failure rates, escalating costs, and other clinical limitations. By advancing discoveries, Advanced Clinical seeks to determine the most efficient and effective way to conduct clinical trials without decreasing the safety or efficacy of the trial. Adaptive designs have recently become the frontrunner in advancing clinical trials. Adaptive designs are clinical study designs that utilize accumulating clinical data to modify the study as it progresses, without undermining the validity and integrity of the trial. Not all clinical trials are suited for adaptive design. Stay tuned for our next blog post on Adaptive Risk Management, and FDA accepted adaptive designs/regulatory perspectives!

Why do it?

Adaptive clinical designs save resources and increases efficiency of the clinical trial. Greater flexibility within the adaptive design framework can translate into better treatment of patients within trials (stopping ineffective/dangerous doses early), more efficient drug development, and better use of available resources (need for less patients). Adaptive designs are not only advantageous to drug development, but they are ethically beneficial to the patients. Trials can be cut earlier if they are ineffective, thus efficiently and effectively ensuring patients are well served with the appropriate dosages. This is most important not only because the clinical trial can save resources by cutting off ineffective arms, but the trial can also stop harmful treatments early on in order to prevent patient harm and preserve the overall safety of the clinical trial. Adaptive designs for clinical trials provide efficient tools to demonstrate the safety and effectiveness of new medical products in faster timeframes with more certainty, at lower costs, and with better information.

Types of Adaptive Design Options (click picture to view!)

With adaptive study design, there are many design options that affect different aspects of a trial. above are some of the more widely known adaptive options.

What are the Pros and Cons of Adaptive Design? (click picture to view!)

Adaptive designs, though having a lot of advantages, can have some disadvantages as well. Stay tuned for our next blog posting about the risks and regulatory perspectives surrounding adaptive designs.

Also, don't forget to add our facebook page! www.facebook.com/advclinical

See www.advancedclinical.com

DIA Conference Recap: Come join our discussion!

Advanced Clinical attended the DIA conference June 13-17^th, 2010 in downtown DC at the Washington Convention Center. It was an awesome week. We were able to meet so many people, while networking, brainstorming, and discussing numerous topics surrounding the clinical and pharmaceutical industry.

Our team was able to sit in on and discuss many interesting presentations. The one presentation that really hit it for us was the session “Fiscally Responsible Protocol Development: Minimizing Potholes and Avoiding Sinkholes” hosted by Anna Hindle, Anne Cropp and Ken Getz. The session outlined:

a) The financial impact of protocol amendments including the hidden costs

b) Protocol amendments correlation with therapeutic areas and functional areas, e.g., data management, clinical operations, etc.

c) Triggers/causes of protocol amendments

d) Characteristics of protocols that generate lots of amendments, e.g., the more Investigator sites, the more amendments

e) Amendments that are avoidable and amendments that are not avoidable

f) Lessons learned and tips / techniques for circumventing / preventing the avoidable amendments

Some interesting facts about amendments we learned: 40% of amendments occur before the first patient is in, 631 hours/amendment approval, 484 hours/amendment to implement, and a minimum of $60K per amendment - $400K per amendment. We also learned that the key triggers of amendments were due to: standard of care changes, safety issues, and the need to deal with sub-populations.

Advanced Clinical had some additional thoughts on the amendment front upon reflecting on this presentation:

a) Would be good to determine the characteristics of a good amendment and a “bad amendment”

b) It’s important to perform the analysis of doing the amendment vs. not doing the amendment

c) Perhaps consider the following items to deal with amendments more efficiently:

• Think about doing amendments in “release” schedules like people do in software development
• Use tools that allow standard language document components – there are some good document management tools that have this functionality
• Create guidelines for the organization to evaluate whether or not an amendment should be performed
• Understand the causes of amendments in your organization. Gather data around amendments for therapeutic area; cause; sub-population; hours to design/gain approval for amendment; hours to implement amendment
• Create an ecosystem of experts to review the protocol before finalizing it to avoid amendments. Put more time into the protocol up front to ensure completeness and consideration of key areas where changes could occur
• Make the language more flexible in the protocol to avoid the amendment, e.g., put in “5-9 sites” instead of “7 sites”

On top of the presentations, the exhibitions were excellent. Our favorite was Oracle’s demonstration of their new Oracle Clinical product. We were able to talk with Oracle and their product roadmap as it relates to their EDC product, “RDC”. Also we were able to discuss Oracle Clinical’s “big picture architecture including IVRS, IWRS, EDC, Business intelligence as well as the anchor Oracle Clinical Product.

Were there any presentations or exhibitions you particularly enjoyed or thought was informational? What are some of your thoughts on the presentations given? Hanging questions? Comments? Please let us know! Come join our discussion and comment or write on our wall in our Blog or on our Facebook page. We’d love to hear your ideas and takeaways from the DIA Conference.

AC also had the opportunity to host OYA for a networking happy hour. It was a huge success! We were able to gather so many great people from the DIA Conference. There was a lot of relaxing, socializing and brainstorming for advancing discoveries. If you weren’t able to make it, please join our discussion for Advancing Discoveries on our Facebook page at www.facebook.com/AdvClinical

See www.advancedclinical.com

Men’s Health and Cancer Awareness Week

With Father's Day coming up this Sunday, June 20, it also marks the week for men's health and cancer awareness. See our blog post on women's cancer awareness week.

Due to a lack of awareness, poor health education and culturally induced behavioral patterns in their work and personal lives, men’s health and well being are deteriorating rapidly. Statistics show that men live sicker and die younger than American women. Men’s Health Week is to bring awareness to the fact that men can do things to prevent suffering and even dying from many avoidable and treatable diseases. It is important for men to pay attention to their bodies and visit a doctor whenever suspicious symptoms arise. Annual physicals are recommended to ensure proper screenings are done. Early detection and treatment of disease is extremely important to maximize your health. To download a Blueprint For Men’s Heath – a publication that discusses the main health issues that men face today – click on this link here.

Best wishes to all Fathers this coming Sunday. To quote Congressman Bill Richardson (Congressional Record, H3905-H39906, May 24, 1994):

“Recognizing and preventing men’s health problems is not just a man’s issue. Because of its impact on wives, mothers, daughters, and sisters, men’s health is truly a family issue.”

Medicine is making new strides everyday to advance discoveries to ease symptoms, cure disease, and better the human situation. Clinicians are a part of this discovery process, so it's important that your needs as an employee are met, too. Enter our “Design Your Dream Job” contest and you could win a $200 gift card to the store of your choice, an iPod shuffle, and even your dream job!

See www.advancedclinical.com

Advanced Clinical: The CRO with Experienced Employees

Advanced Clinical has advanced many discoveries and has experience in over 192 trials in many therapeutic areas across Phases 1 though 4. Over the years, we've worked together with pharmaceutical companies to enhance medicine in disciplines which include but are not limited to:

1. Analgesia
2. Anti-Infective
3. Antiviral
4. Cardiology
5. Endocrinology
6. Gastrointestinal*
7. Geriatrics
8. Gynecology*
9. Hematology
10. Infectious Disease
11. Infertility
12. Musculoskeletal
13. Neurology
14. Oncology
15. Urology
16. Ophthalmology
17. Renal
18. Respiratory
19. Rheumatology*
20. Women's Health

*Advanced Clinical has over 25 trials' experience in these indicated disciplines.

Of our 192 trials, a whopping 191 of them used Advanced Clinical's Data Management service. Our Data Management service is reliable, resilient, and depended on by the best pharmaceutical, biotech and medical device companies in the industry. Our technology platform utilizes state-of-the-art tools: Oracle Clinical, Electronic Data Capture (EDC), and IVRS and IWRS (Interactive Voice or Web Response Systems).

Advanced Clinical also adheres to CDISC and SDTM standards with integrity checks and trial monitoring reports. Advanced Clinical is compliant with ICH, the FDA (21 CFR part 11) and GCP.

Our Biostatistics team is among the best in the nation and we continue to add strength and capabilities to the team in strategic therapeutic areas.

Advanced Clinical is prepared to handle any size trial. Within our body of work, 15 percent had over 500 subjects; one of those trials had over 5,000. We've done trials within the US at one site, and globally over hundreds of sites. Whatever your trial needs are, we will develop a plan and do our part to partner in your development.

Advanced Clinical's leading practices help drive the speed, improve the quality, and ensure the highest probability of success at the lowest total cost of ownership. Some of the delivery assets we use are:

• Our approach to collaborate, innovate, and optimize. Advanced Clinical believes in working together in collaboration, innovation through the Industry Leading R&D Process, and maintaining a continuous learning approach to optimize trials.

• Resource Management Model. Advanced Clinical not only retains, but nurtures our consultants to keep the best ones loyal and available for our exciting projects.

• Team Integration. Advanced Clinical wants to make the client team and the Advanced Clinical team integrated into one.

• Risk Management. Advanced Clinical identifies, assesses, prioritizes, mitigates, and tracks risks to proactively avoid issues that might arise

• Continuous Learning. Continually improving the trial as it goes on will optimize its overall success.

• Ramping. Advanced Clinical onboards, trains, and adapts the team to the client's environment, culture, project and needs.

• Project Management with Supply / Demand Management. Advanced Clinical will ensure clients get the right team, at the right time, and with optimal productivity with collaborative project management.

Use a clinical research organization with experience and an approach to support your growth: Advanced Clinical.

Our employees are well-versed in all of the above areas, and we take great care of them. If you want to have a more fulfilling job, check out our design your dream job contest: you may win a $200 gift certificate and also get your dream job!

See www.advancedclinical.com