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What is the training program called the Drug Development Boot Camp®?

Someone from the SAS said, "They train you to do certain things, and then you have to do them tired." The Drug Development Boot Camp is a little like that. Come prepared to work very hard.  If you want to sit back, fall asleep, and drop in and out of lectures for two days, Drug Development Boot CampTM is not for you." - Dr. Lorna Speid, Founder and Co-chair.

 

The dates for the 2018 Drug Development Boot Camp(R) are 14 to 15 November.

 

Drug Development Skills are Difficult to Acquire

The pharmaceutical industry has its fair share of Ph.D.s, and MDs, and yet qualifications do not translate into understanding of the drug development process. In fact, even Nobel Laureate scientists can find the drug development process bewildering.

As drug development costs increase, the process of drug development is becoming more and more complex. Those involved with the process of developing new therapeutics (drugs, devices, combination products and diagnostics) must understand the process and be able to navigate it with great skill. These skills are difficult to acquire. At the same time that the process is becoming more complex, researchers and developers are becoming more specialized. The challenge is there is a need to gain a thorough understanding of other areas of research and development in order to be effective in their own areas.

The Drug Development Boot Camp® was founded by Dr. Lorna Speid. The 2018 Boot Camp will be the ninth Drug Development Boot Camp®. The Boot Camp is a very intensive training program designed for those that have relevant experience in the research and development of New Chemical and New Biological Entities. This is a very challenging program not only because of the content, but also because of the amount that must be accomplished in two full days. Participants that complete the Boot Camp can be proud of their accomplishment and the Certificate of Completion that they have earned. 

Prospective participants are interviewed in order to find out their aspirations and goals in taking the Boot Camp. They are also given reading materials so that they can prepare for the Boot Camp. They will take a survey so that the Faculty can gain an understanding of the audience before they attend.

Some Participant Feedback from the Eighth Drug Development Boot Camp®held in 2017

Participants for the 2017 Drug Development Boot Camp® came from Switzerland, Canada, Sweden, Germany, Australia and the USA.

Overall Boot Camp Experience

“It takes a Team to create value. Well you have a great Team and this course definitely added a lot of value to me. Thank you.”

 

“The Boot Camp provides a great opportunity to see drug development end-2-end, understand how different components play together, and define better ways to achieve the challenging mission to bring a new medicine to patients.”

 

“Thorough and digestible approach to learning the key aspects of drug development.”

 

“An excellent overview of drug development.”

 

“The best overview of a complex industry I've ever been exposed to. Helps to streamline the Thinking process and defines the frame for overall development strategy.

Thank you,  Lorna and the Faculty!”

 

“The case studies are very interesting and informative.” 

 

“Worth every minute. By far the best overview of Drug Development I've seen.”

 

“Great course for people new to pharma, biotech. Good refresher for others.

Workshops are most valuable.”

 

“Wonderful materials. Will keep for constant reference.”

 

“Well hosted, well run, and lots of enjoyable work. Amazing facility. Thank you.”

 

“Definitely recommend to others. Very educational for commercial, CMC and clinical design.”

 

“Thank you for including adaptive design. It was important to me, and will be done.”

 

“Very informative Tufts data presentation about industry snapshot. “

 

“Cost driver specifics were eye-opening and helpful.”

 

“Consider building in the role of Quality in the various puzzle pieces. They touch on all processes and it was disappointing to be excluded.”

 

“I enjoyed the Workshop groups and workshop sessions and think it may be worth decreasing the formal presentations and increasing the Workshops further.”

 

“I registered for the Boot Camp with quite some doubts about how much we could learn from a short two day period. It turned out the camp was very well organized; with pre-reading, lectures by industry experts, and hands-on practice for each of the major aspects of drug development. “

 

“I had a great experience from learning from the panel members and the attendees through plenty of discussions.”

 

“A thorough overview of  the drug development process. Great opportunities to share experiences with peers in the workshops.”

 

“A great way to see a lot in a very condensed format.”

 

“Loved the venue!”

 

“I would definitely recommend this program to my colleagues who are passionate about drug development.”

 

“I found the workshops to be very useful and will be recommending it to my colleagues.”

 

 

“I wish I had taken this course 10 years ago. It filled in a lot of gaps in my understanding of drug development.” 

 

Commercial Session

“Case study was very good exercise.”

 

“This was an excellent session.”

 

“Very balanced overview to connect the end to end overview of drug development.””

 

“Excellent session.”

 

“Great session. Importance of considerating all the different stakeholders and criteria for making a commercial decision to move forward.”

 

“Tony Sarraino is a great presenter”

 

“Enjoyed case.”

 

“Understanding payers influence my customers' decisions and the EEF concept for prioritization - my partners are performing that now to justify next year's budget.”

 

“Greater understanding of the complexity associates with drug discovery activity.”

 

“Liked Workshops very much.”

 

“I have many questions to take home to my company.”

 

“Enjoyed the case study - vaccine market is not one I'm familiar with so good learnings.”

 

“Great session.”

 

“Good engaging speakers  - the difficulty of reimbursement was well covered.”

 

“Considerations regarding market access and commercial value should be considered from the beginning of the development program, and not just during clinical development. It's not just about regulatory approval.”

 

“Great session.”

 

“Interesting new insights into business strategies.”

 

“Increasing benefit of molecular biomarker to predict perspective.”

 

“Good insight on how to select leads, and importance of studying metabolites.”

 

“Now I understand the marketing and reimbursement perspective of drug development. Very useful.”

 

“The need to understand target product profile and the druggability and consideration and not just efficacy and toxicity.”

 

“Well laid out.”

 

“Commercial decisions are based on very detailed financial calculations (ROI). This seems like it should be obvious, but on the discovery we don't often get to see the math behind the decisions reflected in our companies' press releases.”

 

Global and Strategic Regulatory Affairs Session

“Interesting insights into Priority Review Voucher.”

 

“Very informative to delineate the differences between the IND/CTA.”

 

Very important to understand the 7 Mistakes. Helpful to be told this.”

 

“I will Keep the 7 most common mistakes listed on my mind throughout the programme development.”

 

“Carlos was great.”

 

“Keep the 7 most common mistakes listed on my mind throughout the programme development.”

 

“I liked the idea of a strong plot for development of CTD/regulatory strategy.”

 

“Be the expert on your drug.”

 

“I learned about the difference between plan and strategy.”

 

“Importance of creating a regulatory strategy early with review often.”

 

“7 Mistakes to avoid for IND/.CTA - failure to develop a TPP etc.”

 

“As this impacts many other development disciplines as well, one could put more emphasis on this topic.”

 

“7 Mistakes in Regulatory Affairs.”

 

“Things I haven't even considered before - good perspectives.”

 

“Learnt how important it is to have a comprehensive regulatory strategy.”

 

“Plan your TPP so you can determine key Go/No Go details early. Don't rush talk with FDA. Open a dialogue.”

 

“7 Mistakes was a nice reminder. Don't let questions become justifications.”

 

“The 7 Mistakes. Will print this out and keep on my desk.”

 

“Importance of the Target Product Profile.”

 

“Importance of TPP.”

 

“Very informative session.”

 

“To design proper studies that will define the TPP.”

 

“This session gave a thorough understanding on the IND/CTA application and about registration of drugs.”

 

“Terminology relevant for various regulatory requirements (CTA, etc.).”

 

“Developing relationships with FDA.”

 

 

Preclinical Efficacy Session

“Good oveview of PK/PD essentials.”

 

“Very interesting discussion on delayed effects.”

 

“Information and content was clear even though the topic is foreign and distant for me.”

 

“The mathematical modeling to determine dosing was very relevant. The exercise we were given was extremely useful.”

 

“This was an excellent session. How PK relates to PD using the applied math software.”

 

“The Workshop questions were great and really reinforced the learnings.”

 

“Mathematical modeling is fun.”

 

“I now understand PK/PD data and how to interpret the data.”

 

“The bath tub model is a great way to conceptualize PK model.”

 

“Stronger appreciation for the importance of PK/PD relationship for clinical trial progression.”

 

“Information and content was clear even though the topic is foreign and distant for me.”

 

“The mathematical modeling to determine dosing was very relevant. The exercise we were given was extremely useful.”

 

“This was an excellent session. How PK relates to PD using the applied math software.”

 

“The Workshop questions were great and really reinforced the learnings.”

 

“Mathematical modeling is fun.”

 

“The bath tub model is a great way to conceptualize PK model.”

 

“PK/PD models can help us make predictions about as yet unstudied scenarios.”

 

“Much better understanding of PK/PD”

 

“Great introduction to PK/PD. Modeling helps.”

 

“Modeling - is this something I can discuss with my sponsors?  Yes!  This will help me understand the evaluation they have gone through.  Great presentation!  Learnt a lot.”

 

“Ability to understand the importance and utility of PK/PD data.”

 

“The bathtub analogy for PK/PD is fantastic.”

 

“Very interested in computerized model for planning.

 

Ability to model different dosage levels/schedules.”

 

“Super helpful for me. Good charts for cross species.”

 

“Interesting to see how physiology affects PK/PD.”

 

Fast! But good overview of preclinical. Would like to hear more about preclinical R&D and tox and MABEL approach to FIH biologics.”

 

“PK/PD modeling and the Workshop were very helpful and I really learned a lot.”


“Really interesting modeling workshop. Good speakers.”

 

“Very good”

 

“Use of the pharmacology software was a great way to apply the information offered during the lecture part.”

 

“PK/PD software is great.”

 

“PK/PD modeling is very very useful.”

 

“Enjoyed the session.”

 

“So far I have only been thinking about primary PD. This session gave me thoughts on secondary PD.

using the software to model PK/PD was eye opening. I had seen similar graphs before but really felt like I grasped the concepts better after the simulation.”

 

“Simple definition of PK.”

 

Toxicology Session

“Very good overview of what is needed to start the different clinical development stages.”

 

“Very good Workshop feedback on how to carefully interpret toxicology findings.”

 

“I found this well structured and very informative. Scott Boley did a fantastic job on toxicology.”

 

“Great material. Well presented. The Workshop exemplified how to determine dosage. Too tired to get the most out of this session.”

 

“Another excellent session and Workshop exercise.”

 

“This will definitely change the way I look at risk mitigation strategy prior to the FIH studies.”

 

Case studies very helpful to understand principles.”

 

“I found this well structured and very informative. Scott Boley did a fantastic job on toxicology.”

 

“Great material. Well presented. The Workshop exemplified how to determine dosage. Too tired to get the most out of this session.”

 

“Another excellent session and Workshop exercise.”

 

“This will definitely change the way I look at risk mitigation strategy prior to the FIH studies.”

 

 “How to calculate the starting dose in Phase 1.”

 

“Scott was great.”

 

“Greater understanding of how doses are determined for early phase trials.”

 

“It was helpful to learn how type of compound affects tox development path.”

 

“Would like to hear more about toxicology of bio layer molecules.”

 

“Best lecture of the first day. Liked simple rules for FIH dose. Complex issues made simple so those outside expertise have some framework.”

 

“Enjoyed the review of how to develop development plan.”

 

“Very good overview of small molecule vs biologic - learned a lot about small molecule development. Also good overview of differences for "chronic non life threatening" vs acute life threatening approaches.”

 

“Interesting review of tox for biopharmaceuticals.”

 

“The human equivalence dose calculation table with be a tool I can refer back to again and again.”

 

“The key differences between small molecules, biologics, and life threatening  vs non life threatening diseases.”

 

“Good session”

 

“Great session! Really enjoyed the toxicology workshop.”

 

“The conversion formulas for animals to human.”

“How to design toxicology studies from previous data.”

 

“Very interesting session!”

 

“Toxicology session and workshop - thoroughly enjoyed.”

 

“Very interesting session.”

 

“How to design toxicology studies relevant to or leading to IND/CTA Phase 1/2.”

 

“Very well laid out. Can use this as a checklist for myself.”

 

“I really appreciated hearing about which tox studies are required in which situations. I feel like I can understand my tox colleagues efforts much better.”

 

“Dose selection strategies and conversion tables.”

 

Chemistry Manufacturing Controls Session

“Good overview and introduction of quality by design (QbD) -- also the importance of QTPP.”

 

“It was great to hear mistakes not to make.”

 

“Understood the increased amount of variability for biologics. Relly liked the "scaling up" challenges description by Seshu: Building/Country/Org.”

 

“Great session, positioned importance clearly and in a digestible manner.”

 

“Key points and how to avoid mistakes.”

 

“Good session.”

 

“Fabulous! Brought great key messages for me to use.”

 

“That CMC can be quite fun. Excellent Faculty.”

 

“I have a better appreciation for the variety of challenges respect to manufacturing - particularly the academia - industry transition.”

 

“Good session.”

 

“An excellent, engaging session.”

 

“Liked very much Biologics section.”

 

“Very informative.”

 

“Education of CMC tasks, challenges, time needed, and complexity is very much needed by all the personnel involved in drug development.”

 

“Very good coverage of a complex topic.”

 

“Could be a bit less detailed to allow other sessions to have more time. This was excellent though!”

 

“Very nice presentations!”

 

“Increased appreciation for this function.”

 

“Very informative session.”

 

“Both CMC sessions were great.”

 

“Now I know why my Chemistry colleagues get so excited about process improvements!”

 

Clinical Session

“Workshop with statistical modeling was good.”

 

“I learnt about the use of appropriate designs!”

 

I'll consider adaptive design for upcoming Phase 2 study.”

 

“I liked the format.”

 

“Think, rethink and challenge myself / others to design "smart clinical trials."

 

“Use of the stats software was great. Should have spent more time on it.”

 

“Dr. Chang's statistic program for Adaptive design was exceptionally useful for clinical designs.”

 

“I have developed a much more comprehensive understanding of clinical trial design in conjunction with process development. All of this will enable me to make better decisions and ask the right questions.”

 

“Very good explanation / examples of Trial Designs (Adaptive).”

 

“Interesting to learn how clinical trials are designed.”

 

“Use of adaptive design.  Better understanding of how to better design clinical trials.”

 

Day 2 Afternoon Workshop Session

“This was so helpful in bringing all of our learnings together - great session!”

 

“A strategic perspective of how to incorporate all aspects in a full program.”

 

“Very interesting case.”

 

“This activity was excellent.”

 

“The real-world development story is stirring. I am so impressed!”

 

“Even with limited CMC CMC expertise we could make useful comments.”

 

“Good collaborative team work.”

 

“An understanding of the challenges in the preclinical lead optimization phase.”

 

“During the final reporting back was great to see the actual development unfold. Very well structured.”

 

“Very good case! Very interesting to see the real-life story.”

 

“A little bit of a struggle, but very productive.”

 

Final Session: Sending Out the Special Forces!

“The economic framework and holistic picture on the industry are crical for participants to understand drivers behind drug development trends.”

 

“Understanding the major cost driver is clinical trial cost (Tuft's analysis).” 

 

“The economic framework and holistic picture on the industry are critical for participants to understand drivers behind drug development trends.”

 

Need for efficiency in our industry due to the cost of bringing a drug to market.

 

The key major take home message is "Think out of the box."

 

The figures were revealing about the trends - certainly delivering programs is getting tougher, competition for patients is driving up costs and timelines.

 

Great insight into the driving forces around the future directions of the industry.

“Interesting look at costs and collaborative opportunities. Adequate scope of due diligence and consequences of decisions.”

 

“Tufts data provides nice call to action to plan to increase productivity.”

 

“Great presenters”

 

“Very interesting. Right tempo.”

 

“Interesting to have broad view of the industry.”

 

“This session really completes our learning on drug development.”

 

“Very informative session.”

___________________________________________________

Why Drug Development Boot Camp®?

Dr. Speid is a global regulatory affairs and drug development expert. After watching many of her client companies make expensive and avoidable mistakes, she decided to help as many as possible avoid making the same mistakes over and over again.

Who Should Attend?

  • Large Pharma / Large Biotech - whole project teams can, and have been trained
  • Small Medium and Virtual Biotech companies - CEOs, CFOs, COOs, officers, executives
  • Executives involved with the drug development process
  • Small and virtual company executives
  • Drug researchers and laboratory-based scientists and senior scientists
  • Large pharma professionals involved in silos of drug development, but who want to understand the whole process.
  • NIH/NCI, FDA, BPharm, MHRA, and professionals from major regulatory authorities
  • Regulatory affairs professionals, clinical research professionals, senior research scientists, toxicologists
  • Clinical investigators who would like to gain an understanding of drug development, or improve their understanding of the drug development process
  • Harvard University Investigators - contact Office of Technology Development for information on how to register for the Drug Development Boot Camp

What Will You Learn?

This is not an entry level program. It is an extremely intensive training program. It is intended for those involved with R&D of new drugs. If you make drug development decisions on a daily basis, the Boot Camp is for you. A minimum of 5 years of relevant drug research or drug development experience is required in order to be accepted onto the Drug Development Boot Camp® because of the depth and intensity of the program.

This is a unique opportunity to be totally immersed in drug development for two days and to mix with a Faculty that has proven themselves by bringing drugs to market, or that has contributed to this success.  For this reason, the number of spaces is limited.

Those who do not attend the Drug Development Boot Camp® or a similar program are at risk of the following:

  • Wasting huge sums of investors' money on patent prosecution which will ultimately be useless, lead to costly litigation and prevent the asset from finding an appropriate exit.
  • Spend many years and huge sums of money developing a drug or drugs that the market does not want, and will not pay for.
  • Make costly mistakes throughout the development process, which will ultimately cost the company, one's reputation and may even lead to safety problems in those administered the company's products.
  • Experience a lack of direction from the top management team because of a failure to take the time to receive real training in drug development.
  • Clinical hold situations which are extremely costly.
  • Failure to design a clinical program/clinical programs which could lead to registration of the drug.
  • A US-centric approach, rather than a global approach to drug development.  This will lead to many problems later in development.
  • End up with a "good drug bad development syndrome".
  • Face expensive CRO and consulting bills, with no additional assurance of success.
  • Be forced to rely on the input from CROs.   There is a likelihood that you will be assigned the E Team by the CRO because of inability to tell the difference between an A Team and an E Team.
  • Inability to take the drug to the market in the timeframe promised to investors, analysts, the Board of Directors and patient groups.
  • Inability to manage the expectations of the Board of Directors.
  • Ineffective decision making mechanisms.
  • Inability to raise funds or to find an appropriate exit.
  • Inability to work effectively wtih major health authorities.
  • Loss of company, job and reputation.

I have been in the pharmaceutical industry for many years and have a lot of experience. I don't need to attend the Boot Camp!

If only the many years that people have been in the industry would translate into experience, we would not have the current attrition rate in the pharmaceutical industry. Sadly many years in the industry do not denote experience or expertise. Likewise, attendance at many conferences and even courses, will not necessarily improve one's drug development experience level. You need the Drug Development Boot Camp®. The unique total immersion, open and interactive atmosphere, promotes hands-on learning, and is quite unique.

Start pre-Boot Camp course work today! Register now.

As with any intensive training process, participants should prepare in advance. All participants are given reading assignments that are relevant for their day to day work. All participants are encouraged to avail themselves of the opportunity to discuss their drug development needs with Dr. Speid.  All participants will be asked to complete a detailed questionnaire about their research and/or development experience after registration. 

 

   
Harvard University Office of Technology Development and Speid and Associates
Additional Informationsee flyerProgram BrochureRegister & PayHotelsSponsors

Drug Development
Boot Camp®
November 14-15, 2018
The Harvard Club • Boston, MA

Cost
$ 3,600.00  USD per participant if paid before 07/15/2018 
Register