2022 Drug Development Boot Camp
Nov 16, 2022—Nov 17, 2022
Categories Biopharma & Therapeutics, Industry Partner Event, Industry Partner Events
An Intensive Two Day Course for Biotech and Pharma Company Executives. Georgia Bio members will receive a $50 USD discount off the advertised price, in addition to the discount of the scholarship if ten participants are registered.
The next Drug Development Boot Camp® will take place 16-17 November 2022. We had a wonderful Drug Development Boot Camp® VIRTUAL in 2021. Please scroll down to see the testimonials. Participants also appreciated the Pre-Boot Camp preparation process that helped them in their day-to-day drug development work, even before they took the two-day intensive VIRTUALLY. Would you like to personally benefit, or for your organization to receive the results shown in the testimonials below? For 2022 we are making contingency plans to conduct the Drug Development Boot Camp® in person and virtually in real time, or completely virtually in real time. Please register in the normal way as instructed below.
Many Boot Camp participants have registered because a colleague passed this or another email to them. Please forward to a friend or colleague that would appreciate learning about this training program.
Register Now at www.drugstomarket.com/drugbootcamp/
Drug Development Boot Camp® 2022
www.drugstomarket.com/drugbootcamp/
Early registration is encouraged because there are reading assignments that should be completed prior to Boot Camp participation. These assignments help participants gain a greater understanding of their day-to-day R&D tasks. For this reason, early registration works to their benefit.
The process of pre-Boot Camp preparation and on-boarding consists of the following:
- Register and Pay
- Personal interview with Dr. Speid to determine goals, aspirations and needs. This may be a group discussion with other participants.
- Review a detailed Summary and complete the Questionnaire about past experience and aspirations
- Mandatory – Read the Book on Clinical Trials [Clinical Trials: What Patients and Healthy Volunteers Need to Know] available from OUP website with a discount code]
- Read the relevant sections in the Text Book on Pharmaceutical Medicine – discount code available
- Read the materials provided via a special server (these materials will be provided in September / October 2022)
- Read the final set of materials provided in November – available on the above special server
- Take part in a Webinar for all participants early in November. This is an opportunity to hear a presentation on project management techniques to be used during the Boot Camp. Participants will be able to ask last minute questions and ensure they are clear on logistics, etc.
Register Now at www.drugstomarket.com/drugbootcamp/
Why Drug Development Boot Camp®?
Why is there a need for training in drug development? Drug development is a complex process. Each compound or molecule that enters drug development requires that a unique drug development program is devised by the Project Team. Even after many years of working in drug development, many drug developers with decision-making-authority lack in-depth understanding of the drug development process.
It becomes harder and harder to gain this knowledge the longer one is in the drug development arena. Who wants to admit in front of colleagues that they don’t understand everything discussed in project team meetings? Additionally, in large and mid-sized pharmaceutical companies, many drug developers have tended to become overly specialized. They know the jargon, but do not really know what is behind terminology and commonly used phrases. Many know that they are at a disadvantage when detailed discussions take place. They know that they need to fix this shortcoming, but have few options to get the training that is able to meet their needs.
For biotech a common scenario is this one – many lab researchers started a company on the basis of exciting technology. Unfortunately, too many lacked the in-depth knowledge of the drug development process. They are at a disadvantage and will most likely fail unless this deficiency is addressed. For those biotech companies, conducting drug development on a shoe-string budget, lack of money only compounds this problem.
The Drug Development Boot Camp® was founded by Dr. Lorna Speid, regulatory affairs and drug development professional. After watching many of her clients make avoidable and expensive mistakes, she decided to help as many as she could avoid those mistakes. We wish to stress here that the Drug Development Boot Camp® is not designed and run by meeting organizers. It is run by expert regulatory affairs and drug development experts. The Boot Camp uses accelerated learning techniques to train executives / researchers / drug developers, and others working at the cutting edge of new drug R&D, and drug development. The thirteenth Drug Development Boot Camp® will be held at the Harvard Club at 374 Commonwealth Avenue, Boston MA, on November 16 -17, 2022.
Register Now at www.drugstomarket.com/drugbootcamp/
Many Boot Camp participants have registered because a colleague passed this or another email to them. Please forward to a friend or colleague that would appreciate learning about this training program.
What is Drug Development Boot Camp®?
The Drug Development Boot Camp® is a unique, intensive, integrated drug development training which immerses the participants in the drug development process using a unique approach pioneered by Dr. Lorna Speid. A world quality expert Faculty that has worked together for eleven years to develop the Boot Camp materials will teach the Drug Development Boot Camp®. Not only will you have fun at the Boot Camp, but you will be totally immersed in the principles of drug development for two days, allowing you to take your drug development skills to another level.
Prior to participation at the Drug Development Boot Camp®, each registered participant is offered the opportunity to be interviewed by Dr. Speid to determine their goals in taking the Boot Camp. They will also be requested to complete a Questionnaire, the anonymized results of which, will be provided to the Faculty. This information will allow the Faculty to understand the audience that will take the Boot Camp. Finally, participants are required to complete reading assignments before they take the Boot Camp. This all ensures that the Boot Camp experience commences long before participants arrive for Day 1 of the Boot Camp. Participants should expect to be challenged by the intensity of the program and the pace at which it is run. Participants report benefits long after Boot Camp.
Why Should I attend the Drug Development Boot Camp®?
You are probably thinking “Why should I take the trouble of attending the Drug Development Boot Camp® in Boston when there are many similar courses that I can attend?” We believe that there is nothing like the Drug Development Boot Camp®. From experience, we all know that far too often, speakers at conferences are ill-prepared for the task. Most of the time it is evident that the presenters have not even spoken to each other before meeting at the course, much less worked together on their content. The redundancies and overlaps soon put most people to sleep. The few that remain awake are more intent on asking questions to show how much they know, than with learning anything new. The other challenge with many courses and conferences is that too often they are aimed at those who are new to the industry.
At the Drug Development Boot Camp®, you will be trained using materials that have been carefully thought through, to provide an intensive drug development training, and learning experience.
You are probably wondering what your peers who took the Drug Development Boot Camp® in previous years had to say. Here is some of the feedback.
Participant Feedback from the Drug Development Boot Camp® VIRTUAL 2020 and 2021
The feedback from the very first Drug Development Boot Camp® VIRTUAL held on 18-19 November is included below. The experience was truly remarkable for the commitment shown by all Participants to complete the training VIRTUALLY.
“Dear Lorna
Here is my participant survey. This Workshop was super informative. Thank you!”
“Good morning Lorna –
Please see attached feedback and reporting back forms. Thank you again for a fantastic boot camp.”
“The thorough and robust content makes this course. I am excited to apply the learning to my day-to-day activity. Excellent job overcoming the virtual challenge.”
“An excellent, comprehensive program diving deep into the drug development process with engaging discussion leaders and real-world application workshops. I highly recommend this training for the pharmaceutical professional looking to develop a holistic understanding of drug development.”
“Dr. Speid and Lorraine and Team thank you so much for the intense training – wealth of information.
I really appreciated all of your hard work to put this event on in a virtual manner! Have a great holiday season!”
“Comments/ Feedback: be prepared for a lot of reading and watching videos as this is indeed intense. I think your team did a great job with preparations and it’s astounding the amount of work your team accomplished to make this training so great. I learned so so much! I have a great appreciation for all the work our company does to get more medicines to patients!!!!!!!!!!!!!!”
“The faculty you have involved in the training are unbelievably smart and great teachers. Such patient people as well. They really are experts in drug development. They make this training well worthwhile.”
“Dear Dr. Speid:
Thank you so much for conducting such an informative training program. Though it was very intensive program, I am really glad that I have undertaken the Drug Development Boot Camp as it helped me learn a lot about the complex drug development processes and understand the intricacies of decision making processes. It was really very interesting working with individuals of diverse background and the faculty was simply amazing. You really have done a good job in bringing in the diverse team together and creating an environment that promoted supportive learning. I would also like to extend my sincere thanks to Lorraine, Anna and all faculty members. I have attached the PDF file containing, the participant survey, reporting back form and comments form.”
“Dear Lorna,
Thank you kindly for the update. I have attached my Reporting Back, Survey, and Quote Me forms to this email. A huge thanks to you and the faculty for such a successful and educational virtual boot camp!”
“I believe the Drug Development faculty handled the virtual format with great skill! The zoom breakout rooms were very successful, and I enjoyed the various faculty who popped in from time to time to give advice. For a virtual environment, the whole event felt very connected. This has been a demanding and highly rewarding course. I would highly recommend the Drug Development Boot Camp to anyone who is up to the challenge and interested in expanding their knowledge in everything drug development.”
“The Virtual Drug Development Boot Camp® was an intensive training that I have undergone in a virtual platform. The Workshop sessions were beneficial and Faculty members joining to give context to the assignments was helpful. I learned a lot about the drug development process in the context of the life threatening and non-life-threatening drug development. The acceleration presentations by the faculty members before each session was informative in concisely outlining each session. Really appreciate the time and efforts that each Faculty member and staff took in formulating such as concise, well rounded intensive boot camp in the virtual platform. It was fascinating to see the thought processes of my classmates (in the assigned company and group) during the workshop sessions. Throughout the camp. The
environment was very supportive and promoted learning. I will surely. Recommend this boot camp training program to my colleagues and peers. It was unfortunate that each of us was not able to have a networking opportunity with broader team members who attended the virtual boot camp. Thank you again for allowing me to attend the course. It was tremendously helpful. Please see attached survey. I would highly recommend this course to anyone planning to move into management level and higher in the pharmaceutical industry. This is very helpful in ways to understand how all the different functions impact each other, and how to better strategize. I think this training should be a requirement for anyone going into CMC.”
Participant Feedback from the Previous Drug Development Boot Camp®s
Over the years, participants have come from many countries to take the Drug Development Boot Camp® , including Australia, the UK, Canada, Germany, Belgium, Israel, The Netherlands, Singapore, Switzerland, Japan, Spain, and, of course, many parts of the United States.
The percentage of participants that would recommend the Drug Development Boot Camp® to friends and colleagues was 100%
Please Quote Me!
“A very good overview of drug development A to Z.”
“A comprehensive learning experience in drug development. Terrific experience!”
“I think this intensive course should be taken by any academic considering a drug development start-up. There is much to think about and properly plan ahead for drug development to approval.”
“Intensive Drug Development Boot Camp that everyone who is interested in building a career in drug development should take. Complete life cycle management from Discovery to Commercialization.”
“The mock projects are extremely helpful, and help with Teamwork.”
“This was a very helpful overview of the drug development process.”
“Great immersive learning experience.”
“Well organized materials and sessions. The Boot Camp has equipped me with new knowledge. I’ll never approach / see drug development the same again!”
“Excellent overview of later stages of drug development. Great workshops, informative and thought provoking.”
“Overall excellent course.”
“This Boot Camp enhanced my knowledge in the drug development aspects and will help me to better function as a program officer for translational sciences portfolio at NIH.”
“Comprehensive training towards a drug development Blackbelt!”
“DDBC is built for a diverse audience. I found tremendous value in the camp, even a member of the animal health pharmaceutical industry.”
“Congratulations on completing 10 years of Drug Development Boot Camp®! Great sessions!”
“Very enjoyable few days with valuable workshop break-out sessions and very experienced speakers …. Maybe Day 1 was too much and would love more time on PKPD and toxicology and trial design.”
“It is a well organized course, which provides a lot of useful information for drug development.”
“Fantastic overview of the interconnected pieces of drug development. Would certainly recommend to my colleagues and anyone involved in advancing novel therapeutics into patient.”
“Great all-around intro to overall drug development. Good for anyone in the industry.”
“Very comprehensive overview of different aspects of drug development.”
“The most comprehensive Drug Development course! Two days of great learning, collaborating to solve problems, and getting the Big Picture of Drug Development! I would do it again!”
“I wish I had taken this class on Day 1 in pharma.”
“Very well-organized learning experience.”
“Speakers fantastic, even on somewhat dry subjects.”
“Diverse and very nice attendees.”
“Excellent coverage of the many areas relevant to drug development.”
“I work in R&D (disease modeling, phenotype discovery and early drug discovery) and this Boot Camp was a great and productive way to learn about all the downstream processes and challenges in drug development pipeline.”
“I wish I had this training years ago – it was very insightful into all drug development areas, including preclinical and CMC.”
“Case studies were really useful.”
“Food and location were great.”
“This gave me a very comprehensive understanding of drug development process with all elements from GLP tox to clinical trials to commercialization.”
“Loved the setup. Lectures and network opportunities. Thank you.”
“Content was great, presenters were WONDERFUL, cases were very engaging.”
“An intense but informative 2-day session. Engaging speakers and team activities made for a great learning experience.”
“Speakers/presenters were fantastic!”
“Breakout workshops were the most valuable aspects of the Boot Camp.”
“Meticulously planned and executed.”
“High quality speakers. Very well laid out learning materials.”
“The workshops are excellent in getting to know other attendees, their expertise, and different ways of looking at our industry, and how to do things better.”
“A very informative course that provides all elements of drug development with good tools for future reference during the day to day activities.”
“Excellent program. Highly recommended.”
“Excellent program. Highly recommended.”
“Overall excellent course.”
“Thank you!”
Overall Boot Camp Experience
“It was a great overview of the different disciplines and the right amount of time was spent on each piece.”
“Very well organized Workshop; learned a lot in short time. Very good quality of participants.”
“Good overview of entire drug development processes with the latest technologies. Case study and group workshop are efficient format.”
“Great program with broad topic coverage. Case studies and workshops were very useful.”
“Excellent Faculty, superbly organized. Subject lectures followed by workshops drove home concepts.”
“Overall, great presentation.”
“Very good design and well managed! Speakers were wonderful.”
“Developing preclinical and CMC strategy was very informative. Workshops are the key element of going over what was learnt in each session.”
“Great sessions and reading materials. Schedule is intense but results are apparent.”
“It was a decent overview of the material.”
“Overall great overview and gives a better understanding of the other aspects of drug development that are related to my day to day work.”
“I really enjoyed learning about the whole pharmaceutical process from start to end. As I am embedded in early discovery in my day to day job, this was a good way to understand the later stages.
The Workshops were fantastic for applying what we were learning and to even learn from others in our Workshop groups who may have been in that area.“
“I greatly appreciate the time and expertise shared by the speakers. Really enjoyed the breakout session with the various groups on different scenarios. It is invaluable to directly interact with peers for
problem solving.“
“I like that participants were each required to report back.”.
“Workshops were *FANTASTIC*”
“Engaging speakers. Thank you!”
“Very informative training!”
“Intense — in the best way possible. All subjects were covered thoroughly at a level that could be understood. Thank you for the background reading!”
“I was quite worried that I might not have enough background knowledge to get much out of the course. However, the pre-readings helped boost my knowledge in areas I was familiar with, while introducing the basics for those I was not well-versed in. The spirit of learning together that the other participant brought was also helpful in forming a collaborative environment, especially for the Workshops.”
“Comprehensive review of all functions and integration required for development.”
“Comprehensive modules covering key aspects of drug development. I found it very useful to study these topics and get new insight; Also met new colleagues from various organizations.”
“Tremendous! I love the case study methodology.”
“In depth coverage of multiple areas.”
“Workshops”
“Faculty/support excellent!”
“Very efficient crash course to cover an enormous knowledge space. This will change how I think about my research program.”
“Great people here of very diverse expertise backgrounds, and this was great to experience.”
“Workshop 2 was very good.”
“People (including me) really enjoyed Dr. Chang’s talk and thought that getting feedback on the examples beneficial. Very few speakers gave direct feedback.”
“Brilliant organization and highly professional set-up.”
“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.”
“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
“It was very helpful to learn about medicinal chemistry and target optimization considerations. I usually come into the process later and need an understanding of this work.”
“I liked the comparison / contrast between chronic and life threatening disorders. It also made me think of marketing early something I generally don’t think about.”
“Starting to think about what package / argument/ data to provide to payers, and how it’s not going to be the same as the FDA approval.”
“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
“A wonderful overview! Essential! It’s all laid out.”
“I found “7 Mistakes” presentation to be very helpful.”
“Seven Mistakes – #6 CMC. Very relevant to me with gene therapy space. Plasmid vector more complicated than small molecules.”
“The 7 Mistakes. We think we are doing these things but may only be doing them in part or not following through with our own initial targets or safety.”
“Very much appreciated “7 Mistakes ” to avoid.”
“7 Mistakes to avoid.”
“We are working on a TPP at my company right now. I like the idea of defining go/no-go product criteria.”
“The different requirements for approval in the EU and Japan. It was good to delve into the best ways to approach those regulatory authorities.”
“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.”
“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.”
Register Now at www.drugstomarket.com/drugbootcamp/
Preclinical Efficacy Session
“Amount of guidelines available is astounding! ICH S9 for rare / ICH M3 for non life threatening.”
“Safety, Safety, Safety! Modeling can help predict safe and efficacious dose. Early simulation could help me with prioritizing on my team.”
“Modeling workshop was very insightful.”
“I enjoyed playing around with PK/PD simulations.”
“I liked the tool presented.”
“I thought the preclinical modeling is a great tool to use when approaching the FDA and to inform clinical trial design. It wlil be something I aim to implement.”
“Good overview of PK/PD essentials.”
“Very interesting discussion on delayed effects.”
“Information and content were 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
“Toxicology work is comprehensive. I need to review those as a Medical Monitor.”
“I have now done a toxicology dose calculation – not part of my everyday work, but all knowledge is good.”
“Better understanding of PK variables and what they mean.”
“What you need to know to start Phase 1. Life threatening vs non life threatening. Relevant species. Justify your starting dose. I can use this to better assess tox studies I am reviewing.”
“An excellent presentation followed by the workshop.”
“Very useful workshop exercise. I liked the practical data based approach.”
“I learned how to calculate human equivalent dose.”
“The computational model – compute animal to human was quite useful.”
“It was valuable to see that you do not need to do as many Phase 1 and 2 tox studies to enable the clinical program.”
“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
“Better understanding of CMC.”
“I have much more experience with CMC and preclinical areas of drug development.”
“Great session!”
“Very useful to have insight into manufacturing – usually takes place somewhere distant from rest of process.”
“I will definitely use the impurity decision tree.”
“I have a lot to learn!”
“The different requirements needed for CMC between Phase 1 and 2 trials,a s well as comparability requirements when scaling up.
“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
“Adaptive designs!!”
“Better understanding of dosing regimens.”
“I will consider incorporating adaptive designs, whenever possible.”
“Considerations for type of study design.”
“Giving actual examples of drugs that used adaptive designs would be extremely useful.”
“Resources for planning clinical trials and the variety of approaches.”
“I haven’t worked on adaptive designs before and can bring some ideas back to the team.”
“It was great working as a team!”
“It was great to work with a cross functional team to approach a problem no one of us could accomplish alone.”
“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
“Enjoyed it very much!”
“Loved this. Really liked working through the case study.”
“Learnt a lot about toxicology (was in the toxicology break out group)”
“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!
“Informative presentation.”
“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.”
“The follow-on timings for “me-toos” was a new datapoint for me. Will use in financial modeling.”
Register Now at www.drugstomarket.com/drugbootcamp/
Perhaps you still have doubts. You may be thinking “I can’t afford the cost of the tuition to attend the Boot Camp.”
The mistakes that are made by companies are incredibly expensive. The price of the Boot Camp is set deliberately low to encourage participation by those that need to attend. The cost of not taking this course will far outweigh the cost of this very reasonably priced Boot Camp.
Register Now at www.drugstomarket.com/drugbootcamp/
Why should I attend the Drug Development Boot Camp® since my company will hire consultants and contract research organizations?
Without a thorough understanding of drug development you will be at the mercy of those that have more understanding than you have. You will be unable to understand when consultants and contract research organizations are giving you the best advice, versus giving you the advice that serves their interests best.
Who will attend the Drug Development Boot Camp®?
Participants come from large pharma, mid-sized pharma, biotechnology companies, academia, government organizations. Venture Capitalists have been in attendance from major venture firms. You will be taught by Faculty from large pharma who understand classical drug development, and who have contributed to the science and practice of drug development at leading pharmaceutical companies. You can see the currently confirmed Faculty at the Boot Camp website at www.drugstomarket.com/drugbootcamp under Program Brochure.
Training of Teams
We will train whole Project Teams or individuals from Teams. These may be Core Project Teams, executives from the senior management team, or Board Members. We have trained many such teams. From time to time the leader of the Team has come to the training as well.
Costs
Early Bird discounts apply up to 18 October 2021. Pharma and biotech companies that register ten participants will be given a scholarship for two additional participants to take the Boot Camp, free of charge. Participants could come from any part of the organization geographically, but must be working in research or development, not an administrative function of the firm (such as accounting or HR).
Members of BIO organizations that sponsor the Boot Camp will receive a 50 USD discount off the advertised price, in addition to the discount of the scholarship if ten participants are registered.
Pharma and large biotech companies that are engaged in partnerships with small companies or academia that would benefit from the training can pay the registration fee for the participants that they would like to take the Boot Camp.
Payments
We will accept payments using credit card over the telephone, via wire transfer, overnight check. PO payments are not permitted.